[USC02] 42 USC CHAPTER 6A, SUBCHAPTER II, Part B: Federal-State Cooperation
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42 USC CHAPTER 6A, SUBCHAPTER II, Part B: Federal-State Cooperation
From Title 42—THE PUBLIC HEALTH AND WELFARECHAPTER 6A—PUBLIC HEALTH SERVICESUBCHAPTER II—GENERAL POWERS AND DUTIES

Part B—Federal-State Cooperation

§243. General grant of authority for cooperation

(a) Enforcement of quarantine regulations; prevention of communicable diseases

The Secretary is authorized to accept from State and local authorities any assistance in the enforcement of quarantine regulations made pursuant to this chapter which such authorities may be able and willing to provide. The Secretary shall also assist States and their political subdivisions in the prevention and suppression of communicable diseases and with respect to other public health matters, shall cooperate with and aid State and local authorities in the enforcement of their quarantine and other health regulations, and shall advise the several States on matters relating to the preservation and improvement of the public health.

(b) Comprehensive and continuing planning; training of personnel for State and local health work; fees

The Secretary shall encourage cooperative activities between the States with respect to comprehensive and continuing planning as to their current and future health needs, the establishment and maintenance of adequate public health services, and otherwise carrying out public health activities. The Secretary is also authorized to train personnel for State and local health work. The Secretary may charge only private entities reasonable fees for the training of their personnel under the preceding sentence.

(c) Development of plan to control epidemics and meet emergencies or problems resulting from disasters; cooperative planning; temporary assistance; reimbursement of United States

(1) The Secretary is authorized to develop (and may take such action as may be necessary to implement) a plan under which personnel, equipment, medical supplies, and other resources of the Service and other agencies under the jurisdiction of the Secretary may be effectively used to control epidemics of any disease or condition and to meet other health emergencies or problems. The Secretary may enter into agreements providing for the cooperative planning between the Service and public and private community health programs and agencies to cope with health problems (including epidemics and health emergencies).

(2) The Secretary may, at the request of the appropriate State or local authority, extend temporary (not in excess of six months) assistance to States or localities in meeting health emergencies of such a nature as to warrant Federal assistance. The Secretary may require such reimbursement of the United States for assistance provided under this paragraph as he may determine to be reasonable under the circumstances. Any reimbursement so paid shall be credited to the applicable appropriation for the Service for the year in which such reimbursement is received.

(July 1, 1944, ch. 373, title III, §311, 58 Stat. 693; Pub. L. 89–749, §5, Nov. 3, 1966, 80 Stat. 1190; Pub. L. 90–174, §4, Dec. 5, 1967, 81 Stat. 536; Pub. L. 91–515, title II, §282, Oct. 30, 1970, 84 Stat. 1308; Pub. L. 94–317, title II, §202(b), (c), June 23, 1976, 90 Stat. 703; Pub. L. 97–35, title IX, §902(c), Aug. 13, 1981, 95 Stat. 559; Pub. L. 97–414, §8(d), Jan. 4, 1983, 96 Stat. 2060; Pub. L. 99–117, §11(a), Oct. 7, 1985, 99 Stat. 494.)

Amendments

1985—Subsec. (c)(1). Pub. L. 99–117 struck out "referred to in section 247b(f) of this title" after "epidemics of any disease or condition", "involving or resulting from disasters or any such disease" after "health emergencies or problems" in first sentence, and struck out "resulting from disasters or any disease or condition referred to in section 247b(f) of this title" after "(including epidemics and health emergencies)" in second sentence.

1983—Subsec. (c)(2). Pub. L. 97–414 substituted "six months" for "forty-five days" after "not in excess of".

1981—Subsec. (a). Pub. L. 97–35, §902(c)(1), inserted applicability to other public health matters, and struck out reference to section 246 of this title.

Subsec. (b). Pub. L. 97–35, §902(c)(2), substituted "public health activities" for "the purposes of section 246 of this title".

1976—Subsec. (b). Pub. L. 94–317, §202(c), inserted provision authorizing Secretary to charge only private entities reasonable fees for training of their personnel.

Subsec. (c). Pub. L. 94–317, §202(b), made changes in phraseology and restructured provisions into pars. (1) and (2) and, in par. (1), as so restructured, inserted provisions authorizing Secretary to develop a plan utilizing Public Health Service personnel, equipment, medical supplies and other resources to control epidemics of any disease referred to in section 247b of this title.

1970—Subsecs. (a), (b). Pub. L. 91–515 substituted "Secretary" for "Surgeon General" wherever appearing.

1967—Subsec. (c). Pub. L. 90–174 added subsec. (c).

1966Pub. L. 89–749 designated existing provisions as subsec. (a), added subsec. (b), and amended subsec. (b) to permit Surgeon General to train personnel for State and local health work.

Effective Date of 1981 Amendment

Amendment by Pub. L. 97–35 effective Oct. 1, 1981, see section 902(h) of Pub. L. 97–35, set out as a note under section 238l of this title.

Effective Date of 1966 Amendment

Pub. L. 89–749, §5(a), Nov. 3, 1966, 80 Stat. 1190, provided that subsec. (b) of this section is effective July 1, 1966.

Pub. L. 89–749, §5(b), Nov. 3, 1966, 80 Stat. 1190, provided that the amendment of subsec. (b) of this section, permitting the Surgeon General to train personnel for State and local health work, is effective July 1, 1967.

Food Allergens in the Food Code

Pub. L. 108–282, title II, §209, Aug. 2, 2004, 118 Stat. 910, provided that: "The Secretary of Health and Human Services shall, in the Conference for Food Protection, as part of its efforts to encourage cooperative activities between the States under section 311 of the Public Health Service Act (42 U.S.C. 243), pursue revision of the Food Code to provide guidelines for preparing allergen-free foods in food establishments, including in restaurants, grocery store delicatessens and bakeries, and elementary and secondary school cafeterias. The Secretary shall consider guidelines and recommendations developed by public and private entities for public and private food establishments for preparing allergen-free foods in pursuing this revision."

Training of Private Persons Subject to Reimbursement or Advances to Appropriations

Pub. L. 103–333, title II, Sept. 30, 1994, 108 Stat. 2550, provided in part: "That for fiscal year 1995 and subsequent fiscal years training of private persons shall be made subject to reimbursement or advances to this appropriation for not in excess of the full cost of such training".

§244. Public access defibrillation programs

(a) In general

The Secretary shall award grants to States, political subdivisions of States, Indian tribes, and tribal organizations to develop and implement public access defibrillation programs—

(1) by training and equipping local emergency medical services personnel, including firefighters, police officers, paramedics, emergency medical technicians, and other first responders, to administer immediate care, including cardiopulmonary resuscitation and automated external defibrillation, to cardiac arrest victims;

(2) by purchasing automated external defibrillators, placing the defibrillators in public places where cardiac arrests are likely to occur, and training personnel in such places to administer cardiopulmonary resuscitation and automated external defibrillation to cardiac arrest victims;

(3) by setting procedures for proper maintenance and testing of such devices, according to the guidelines of the manufacturers of the devices;

(4) by providing training to members of the public in cardiopulmonary resuscitation and automated external defibrillation;

(5) by integrating the emergency medical services system with the public access defibrillation programs so that emergency medical services personnel, including dispatchers, are informed about the location of automated external defibrillators in their community; and

(6) by encouraging private companies, including small businesses, to purchase automated external defibrillators and provide training for their employees to administer cardiopulmonary resuscitation and external automated defibrillation to cardiac arrest victims in their community.

(b) Preference

In awarding grants under subsection (a), the Secretary shall give a preference to a State, political subdivision of a State, Indian tribe, or tribal organization that—

(1) has a particularly low local survival rate for cardiac arrests, or a particularly low local response rate for cardiac arrest victims; or

(2) demonstrates in its application the greatest commitment to establishing and maintaining a public access defibrillation program.

(c) Use of funds

A State, political subdivision of a State, Indian tribe, or tribal organization that receives a grant under subsection (a) may use funds received through such grant to—

(1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and Drug Administration;

(2) provide automated external defibrillation and basic life support training in automated external defibrillator usage through nationally recognized courses;

(3) provide information to community members about the public access defibrillation program to be funded with the grant;

(4) provide information to the local emergency medical services system regarding the placement of automated external defibrillators in public places;

(5) produce materials to encourage private companies, including small businesses, to purchase automated external defibrillators;

(6) establish an information clearinghouse, that shall be administered by an organization that has substantial expertise in pediatric education, pediatric medicine, and electrophysiology and sudden death, that provides information to increase public access to defibrillation in schools; and

(7) further develop strategies to improve access to automated external defibrillators in public places.

(d) Application

(1) In general

To be eligible to receive a grant under subsection (a), a State, political subdivision of a State, Indian tribe, or tribal organization shall prepare and submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require.

(2) Contents

An application submitted under paragraph (1) shall—

(A) describe the comprehensive public access defibrillation program to be funded with the grant and demonstrate how such program would make automated external defibrillation accessible and available to cardiac arrest victims in the community;

(B) contain procedures for implementing appropriate nationally recognized training courses in performing cardiopulmonary resuscitation and the use of automated external defibrillators;

(C) contain procedures for ensuring direct involvement of a licensed medical professional and coordination with the local emergency medical services system in the oversight of training and notification of incidents of the use of the automated external defibrillators;

(D) contain procedures for proper maintenance and testing of the automated external defibrillators, according to the labeling of the manufacturer;

(E) contain procedures for ensuring notification of local emergency medical services system personnel, including dispatchers, of the location and type of devices used in the public access defibrillation program; and

(F) provide for the collection of data regarding the effectiveness of the public access defibrillation program to be funded with the grant in affecting the out-of-hospital cardiac arrest survival rate.

(e) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated $25,000,000 for for 1 each of fiscal years 2003 through 2014. Not more than 10 percent of amounts received under a grant awarded under this section may be used for administrative expenses.

(July 1, 1944, ch. 373, title III, §312, as added Pub. L. 107–188, title I, §159(c), June 12, 2002, 116 Stat. 634; amended Pub. L. 108–41, §2, July 1, 2003, 117 Stat. 839; Pub. L. 111–148, title X, §10412, Mar. 23, 2010, 124 Stat. 990.)

Prior Provisions

A prior section 244, acts July 1, 1944, ch. 373, title III, §312, 58 Stat. 693; July 3, 1946, ch. 538, §8, 60 Stat. 424; Dec. 5, 1967, Pub. L. 90–174, §12(b), 81 Stat. 541; Oct. 30, 1970, Pub. L. 91–515, title II, §282, 84 Stat. 1308, provided for health conferences, prior to repeal by Pub. L. 93–353, title I, §102(a), July 23, 1974, 88 Stat. 362. See section 242o(a) of this title.

A prior section 312 of act July 1, 1944, was classified to section 244–1 of this title prior to repeal by Pub. L. 94–484.

Amendments

2010—Subsec. (c)(6). Pub. L. 111–148, §10412(1), inserted ", that shall be administered by an organization that has substantial expertise in pediatric education, pediatric medicine, and electrophysiology and sudden death," after "clearinghouse".

Subsec. (e). Pub. L. 111–148, §10412(2), substituted "for each of fiscal years 2003 through 2014" for "fiscal year 2003, and such sums as may be necessary for each of the fiscal years 2004 through 2006".

2003—Subsec. (c)(6), (7). Pub. L. 108–41 added par. (6) and redesignated former par. (6) as (7).

Findings

Pub. L. 107–188, title I, §159(b), June 12, 2002, 116 Stat. 634, provided that: "Congress makes the following findings:

"(1) Over 220,000 Americans die each year from cardiac arrest. Every 2 minutes, an individual goes into cardiac arrest in the United States.

"(2) The chance of successfully returning to a normal heart rhythm diminishes by 10 percent each minute following sudden cardiac arrest.

"(3) Eighty percent of cardiac arrests are caused by ventricular fibrillation, for which defibrillation is the only effective treatment.

"(4) Sixty percent of all cardiac arrests occur outside the hospital. The average national survival rate for out-of-hospital cardiac arrest is only 5 percent.

"(5) Communities that have established and implemented public access defibrillation programs have achieved average survival rates for out-of-hospital cardiac arrest as high as 50 percent.

"(6) According to the American Heart Association, wide use of defibrillators could save as many as 50,000 lives nationally each year.

"(7) Successful public access defibrillation programs ensure that cardiac arrest victims have access to early 911 notification, early cardiopulmonary resuscitation, early defibrillation, and early advanced care."

1 So in original.

§244–1. Repealed. Pub. L. 94–484, title V, §503(b), Oct. 12, 1976, 90 Stat. 2300

Section, act July 1, 1944, ch. 373, title III, §312, formerly §306, as added Aug. 2, 1956, ch. 871, title I, §101, 70 Stat. 923; amended July 23, 1959, Pub. L. 86–105, §1, 73 Stat. 239; Sept 8, 1960, Pub. L. 86–720, §1(b), 74 Stat. 820; Aug. 27, 1964, Pub. L. 88–497, §2, 78 Stat. 613; Aug. 16, 1968, Pub. L. 90–490, title III, §302(b), 82 Stat. 789; Mar. 12, 1970, Pub. L. 91–208, §3, 84 Stat. 52; Oct. 30, 1970, Pub. L. 91–515, title VI, §601(b)(2), 84 Stat. 1311; June 18, 1973, Pub. L. 93–45, title I, §104(a), 87 Stat. 91; renumbered §312 and amended July 23, 1974, Pub. L. 93–353, title I, §102(b), 88 Stat. 362; Oct. 12, 1976, Pub. L. 94–484, title I, §101(a)(1), 90 Stat. 2244, related to graduate or specialized training for physicians, engineers, nurses, and other professional personnel.

Effective Date of Repeal

Pub. L. 94–484, title V, §503(c), Oct. 12, 1976, 90 Stat. 2300, provided that: "The amendments made by this section [amending former section 295f–2 of this title and repealing this section and section 245a of this title] shall take effect October 1, 1977."

§244a. Repealed. Pub. L. 93–353, title I, §102(a), July 23, 1974, 88 Stat. 362

Section, act July 1, 1944, ch. 373, title III, §312a, as added Aug. 31, 1954, ch. 1158, §2, 68 Stat. 1025, related to birth and death statistics, annual collection, and compensation for transcription. See section 242k(h) of this title.

§245. Public access defibrillation demonstration projects

(a) In general

The Secretary shall award grants to political subdivisions of States, Indian tribes, and tribal organizations to develop and implement innovative, comprehensive, community-based public access defibrillation demonstration projects that—

(1) provide cardiopulmonary resuscitation and automated external defibrillation to cardiac arrest victims in unique settings;

(2) provide training to community members in cardiopulmonary resuscitation and automated external defibrillation; and

(3) maximize community access to automated external defibrillators.

(b) Use of funds

A recipient of a grant under subsection (a) shall use the funds provided through the grant to—

(1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and Drug Administration;

(2) provide basic life training in automated external defibrillator usage through nationally recognized courses;

(3) provide information to community members about the public access defibrillation demonstration project to be funded with the grant;

(4) provide information to the local emergency medical services system regarding the placement of automated external defibrillators in the unique settings; and

(5) further develop strategies to improve access to automated external defibrillators in public places.

(c) Application

(1) In general

To be eligible to receive a grant under subsection (a), a political subdivision of a State, Indian tribe, or tribal organization shall prepare and submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require.

(2) Contents

An application submitted under paragraph (1) may—

(A) describe the innovative, comprehensive, community-based public access defibrillation demonstration project to be funded with the grant;

(B) explain how such public access defibrillation demonstration project represents innovation in providing public access to automated external defibrillation; and

(C) provide for the collection of data regarding the effectiveness of the demonstration project to be funded with the grant in—

(i) providing emergency cardiopulmonary resuscitation and automated external defibrillation to cardiac arrest victims in the setting served by the demonstration project; and

(ii) affecting the cardiac arrest survival rate in the setting served by the demonstration project.

(d) Authorization of appropriations

There is authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2002 through 2006. Not more than 10 percent of amounts received under a grant awarded under this section may be used for administrative expenses.

(July 1, 1944, ch. 373, title III, §313, as added Pub. L. 107–188, title I, §159(c), June 12, 2002, 116 Stat. 636.)

Prior Provisions

A prior section 245, acts July 1, 1944, ch. 373, title III, §313, 58 Stat. 693; Oct. 30, 1970, Pub. L. 91–515, title II, §282, 84 Stat. 1308, provided for collection of vital statistics, prior to repeal by Pub. L. 93–353, title I, §102(a), July 23, 1974, 88 Stat. 362. See section 242k(g) of this title.

A prior section 313 of act July 1, 1944, was classified to section 245a of this title prior to repeal by Pub. L. 94–484.

§245a. Repealed. Pub. L. 94–484, title V, §503(b), Oct. 12, 1976, 90 Stat. 2300

Section, act July 1, 1944, ch. 373, title III, §313, formerly §309, as added Sept. 8, 1960, Pub. L. 86–720, §1(a), 74 Stat. 819; amended Aug. 27, 1964, Pub. L. 88–497, §3, 78 Stat. 613; Nov. 3, 1966, Pub. L. 89–749, §4, 80 Stat. 1190; Dec. 5, 1967, Pub. L. 90–174, §§2(g), 8(c), 81 Stat. 534, 540; Aug. 16, 1968, Pub. L. 90–490, title III, §302(a), 82 Stat. 788; Mar. 12, 1970, Pub. L. 91–208, §§1, 2, 84 Stat. 52; June 30, 1970, Pub. L. 91–296, title IV, §401(b)(1)(B), 84 Stat. 352; June 18, 1973, Pub. L. 93–45, title I, §104(b), (c), 87 Stat. 91; renumbered §313 and amended July 23, 1974, Pub. L. 93–353, title I, §102(c), 88 Stat. 362; Oct. 12, 1976, Pub. L. 94–484, title I, §101(a)(2), (3), 90 Stat. 2244, related to graduate public health training grants.

Effective Date of Repeal

Repeal effective Oct. 1, 1977, see section 503(c) of Pub. L. 94–484, set out as a note under section 244–1 of this title.

§246. Grants and services to States

(a) Comprehensive health planning and services

(1) In order to assist the States in comprehensive and continuing planning for their current and future health needs, the Secretary is authorized during the period beginning July 1, 1966, and ending June 30, 1973, to make grants to States which have submitted, and had approved by the Secretary, State plans for comprehensive State health planning. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $2,500,000 for the fiscal year ending June 30, 1967, $7,000,000 for the fiscal year ending June 30, 1968, $10,000,000 for the fiscal year ending June 30, 1969, $15,000,000 for the fiscal year ending June 30, 1970, $15,000,000 for the fiscal year ending June 30, 1971, $17,000,000 for the fiscal year ending June 30, 1972, $20,000,000 for the fiscal year ending June 30, 1973, and $10,000,000 for the fiscal year ending June 30, 1974.

(2) In order to be approved for purposes of this subsection, a State plan for comprehensive State health planning must—

(A) designate, or provide for the establishment of, a single State agency, which may be an interdepartmental agency, as the sole agency for administering or supervising the administration of the State's health planning functions under the plan;

(B) provide for the establishment of a State health planning council, which shall include representatives of Federal, State, and local agencies (including as an ex officio member, if there is located in such State one or more hospitals or other health care facilities of the Department of Veterans Affairs, the individual whom the Secretary of Veterans Affairs shall have designated to serve on such council as the representative of the hospitals or other health care facilities of such Department which are located in such State) and nongovernmental organizations and groups concerned with health (including representation of the regional medical program or programs included in whole or in part within the State), and of consumers of health services, to advise such State agency in carrying out its functions under the plan, and a majority of the membership of such council shall consist of representatives of consumers of health services;

(C) set forth policies and procedures for the expenditure of funds under the plan, which, in the judgment of the Secretary, are designed to provide for comprehensive State planning for health services (both public and private and including home health care), including the facilities and persons required for the provision of such services, to meet the health needs of the people of the State and including environmental considerations as they relate to public health;

(D) provide for encouraging cooperative efforts among governmental or nongovernmental agencies, organizations and groups concerned with health services, facilities, or manpower, and for cooperative efforts between such agencies, organizations, and groups and similar agencies, organizations, and groups in the fields of education, welfare, and rehabilitation;

(E) contain or be supported by assurances satisfactory to the Secretary that the funds paid under this subsection will be used to supplement and, to the extent practicable, to increase the level of funds that would otherwise be made available by the State for the purpose of comprehensive health planning and not to supplant such non-Federal funds;

(F) provide such methods of administration (including methods relating to the establishment and maintenance of personnel standards on a merit basis, except that the Secretary shall exercise no authority with respect to the selection, tenure of office, and compensation of any individual employed in accordance with such methods) as are found by the Secretary to be necessary for the proper and efficient operation of the plan;

(G) provide that the State agency will make such reports, in such form and containing such information, as the Secretary may from time to time reasonably require, and will keep such records and afford such access thereto as the Secretary finds necessary to assure the correctness and verification of such reports;

(H) provide that the State agency will from time to time, but not less often than annually, review its State plan approved under this subsection and submit to the Secretary appropriate modifications thereof;

(I) effective July 1, 1968, (i) provide for assisting each health care facility in the State to develop a program for capital expenditures for replacement, modernization, and expansion which is consistent with an overall State plan developed in accordance with criteria established by the Secretary after consultation with the State which will meet the needs of the State for health care facilities, equipment, and services without duplication and otherwise in the most efficient and economical manner, and (ii) provide that the State agency furnishing such assistance will periodically review the program (developed pursuant to clause (i)) of each health care facility in the State and recommend appropriate modification thereof;

(J) provide for such fiscal control and fund accounting procedures as may be necessary to assure proper disbursement of and accounting for funds paid to the State under this subsection; and

(K) contain such additional information and assurances as the Secretary may find necessary to carry out the purposes of this subsection.


(3)(A) From the sums appropriated for such purpose for each fiscal year, the several States shall be entitled to allotments determined, in accordance with regulations, on the basis of the population and the per capita income of the respective States; except that no such allotment to any State for any fiscal year shall be less than 1 per centum of the sum appropriated for such fiscal year pursuant to paragraph (1). Any such allotment to a State for a fiscal year shall remain available for obligation by the State, in accordance with the provisions of this subsection and the State's plan approved thereunder, until the close of the succeeding fiscal year.

(B) The amount of any allotment to a State under subparagraph (A) for any fiscal year which the Secretary determines will not be required by the State, during the period for which it is available, for the purposes for which allotted shall be available for reallotment by the Secretary from time to time, on such date or dates as he may fix, to other States with respect to which such a determination has not been made, in proportion to the original allotments to such States under subparagraph (A) for such fiscal year, but with such proportionate amount for any of such other States being reduced to the extent it exceeds the sum the Secretary estimates such State needs and will be able to use during such period; and the total of such reductions shall be similarly reallotted among the States whose proportionate amounts were not so reduced. Any amount so reallotted to a State from funds appropriated pursuant to this subsection for a fiscal year shall be deemed part of its allotment under subparagraph (A) for such fiscal year.

(4) From each State's allotment for a fiscal year under this subsection, the State shall from time to time be paid the Federal share of the expenditures incurred during that year or the succeeding year pursuant to its State plan approved under this subsection. Such payments shall be made on the basis of estimates by the Secretary of the sums the State will need in order to perform the planning under its approved State plan under this subsection, but with such adjustments as may be necessary to take account of previously made underpayments or overpayments. The "Federal share" for any State for purposes of this subsection shall be all, or such part as the Secretary may determine, of the cost of such planning, except that in the case of the allotments for the fiscal year ending June 30, 1970, it shall not exceed 75 per centum of such cost.

(b) Project grants for areawide health planning; authorization of appropriations; prerequisites for grants; application; contents

(1)(A) The Secretary is authorized, during the period beginning July 1, 1966, and ending June 30, 1974, to make, with the approval of the State agency administering or supervising the administration of the State plan approved under subsection (a), project grants to any other public or nonprofit private agency or organization (but with appropriate representation of the interests of local government where the recipient of the grant is not a local government or combination thereof or an agency of such government or combination) to cover not to exceed 75 per centum of the costs of projects for developing (and from time to time revising) comprehensive regional, metropolitan area, or other local area plans for coordination of existing and planned health services, including the facilities and persons required for provision of such services; and including the provision of such services through home health care; except that in the case of project grants made in any State prior to July 1, 1968, approval of such State agency shall be required only if such State has such a State plan in effect at the time of such grants. No grant may be made under this subsection after June 30, 1970, to any agency or organization to develop or revise health plans for an area unless the Secretary determines that such agency or organization provides means for appropriate representation of the interests of the hospitals, other health care facilities, and practicing physicians serving such area, and the general public. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $5,000,000 for the fiscal year ending June 30, 1967, $7,500,000 for the fiscal year ending June 30, 1968, $10,000,000 for the fiscal year ending June 30, 1969, $15,000,000 for the fiscal year ending June 30, 1970, $20,000,000 for the fiscal year ending June 30, 1971, $30,000,000 for the fiscal year ending June 30, 1972, $40,000,000 for the fiscal year ending June 30, 1973, and $25,100,000 for the fiscal year ending June 30, 1974.

(B) Project grants may be made by the Secretary under subparagraph (A) to the State agency administering or supervising the administration of the State plan approved under subsection (a) with respect to a particular region or area, but only if (i) no application for such a grant with respect to such region or area has been filed by any other agency or organization qualified to receive such a grant, and (ii) such State agency certifies, and the Secretary finds, that ample opportunity has been afforded to qualified agencies and organizations to file application for such a grant with respect to such region or area and that it is improbable that, in the foreseeable future, any agency or organization which is qualified for such a grant will file application therefor.

(2)(A) In order to be approved under this subsection, an application for a grant under this subsection must contain or be supported by reasonable assurances that there has been or will be established, in or for the area with respect to which such grant is sought, an areawide health planning council. The membership of such council shall include representatives of public, voluntary, and nonprofit private agencies, institutions, and organizations concerned with health (including representatives of the interests of local government of the regional medical program for such area, and of consumers of health services). A majority of the members of such council shall consist of representatives of consumers of health services.

(B) In addition, an application for a grant under this subsection must contain or be supported by reasonable assurances that the areawide health planning agency has made provision for assisting health care facilities in its area to develop a program for capital expenditures for replacement, modernization, and expansion which is consistent with an overall State plan which will meet the needs of the State and the area for health care facilities, equipment, and services without duplication and otherwise in the most efficient and economical manner.

(c) Project grants for training, studies, and demonstrations; authorization of appropriations

The Secretary is also authorized, during the period beginning July 1, 1966, and ending June 30, 1974, to make grants to any public or nonprofit private agency, institution, or other organization to cover all or any part of the cost of projects for training, studies, or demonstrations looking toward the development of improved or more effective comprehensive health planning throughout the Nation. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $1,500,000 for the fiscal year ending June 30, 1967, $2,500,000 for the fiscal year ending June 30, 1968, $5,000,000 for the fiscal year ending June 30, 1969, $7,500,000 for the fiscal year ending June 30, 1970, $8,000,000 for the fiscal year ending June 30, 1971, $10,000,000 for the fiscal year ending June 30, 1972, $12,000,000 for the fiscal year ending June 30, 1973, and $4,700,000 for the fiscal year ending June 30, 1974.

(July 1, 1944, ch. 373, title III, §314, 58 Stat. 693; July 3, 1946, ch. 538, §9, 60 Stat. 424; June 16, 1948, ch. 481, §5, 62 Stat. 468; 1953 Reorg. Plan No. 1, §§5, 8, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Aug. 1, 1956, ch. 852, §18, 70 Stat. 910; Pub. L. 85–544, §1, July 22, 1958, 72 Stat. 400; Pub. L. 87–395, §2(a)–(d), Oct. 5, 1961, 75 Stat. 824; Pub. L. 87–688, §4(a)(1), Sept. 25, 1962, 76 Stat. 587; Pub. L. 89–109, §4, Aug. 5, 1965, 79 Stat. 436; Pub. L. 89–749, §3, Nov. 3, 1966, 80 Stat. 1181; Pub. L. 90–174, §§2(a)–(f), 3(b)(2), 8(a), (b), 12(d), Dec. 5, 1967, 81 Stat. 533–535, 540, 541; Pub. L. 91–296, title I, §111(b), title IV, §401(b)(1)(C), (D), June 30, 1970, 84 Stat. 340, 352; Pub. L. 91–513, title I, §3(b), Oct. 27, 1970, 84 Stat. 1241; Pub. L. 91–515, title II, §§220, 230, 240, 250, 260(a)–(c)(1), 282, Oct. 30, 1970, 84 Stat. 1304–1306, 1308; Pub. L. 91–616, title III, §331, Dec. 31, 1970, 84 Stat. 1853; Pub. L. 91–648, title IV, §403, Jan. 5, 1971, 84 Stat. 1925, as amended Pub. L. 95–454, title VI, §602(c), Oct. 13, 1978, 92 Stat. 1189; Pub. L. 92–255, title IV, §403(a), Mar. 21, 1972, 86 Stat. 77; Pub. L. 93–45, title I, §106, June 18, 1973, 87 Stat. 92; Pub. L. 93–151, §8, Nov. 9, 1973, 87 Stat. 568; Pub. L. 94–63, title I, §102, title V, §501(b), title VII, §701(a), (b), July 29, 1975, 89 Stat. 304, 346, 352; Pub. L. 94–484, title IX, §905(b)(1), Oct. 12, 1976, 90 Stat. 2325; Pub. L. 95–83, title III, §302, Aug. 1, 1977, 91 Stat. 387; Pub. L. 95–454, title VI, §602(c), Oct. 13, 1978, 92 Stat. 1189; Pub. L. 95–622, title I, §109, Nov. 9, 1978, 92 Stat. 3417; Pub. L. 95–626, title II, §201(a), (b)(2), Nov. 10, 1978, 92 Stat. 3570; Pub. L. 96–32, §6(e), (f), July 10, 1979, 93 Stat. 83; Pub. L. 96–79, title I, §115(k)(2), Oct. 4, 1979, 93 Stat. 610; Pub. L. 96–398, title I, §107(d), Oct. 7, 1980, 94 Stat. 1571; Pub. L. 97–35, title IX, §902(b), Aug. 13, 1981, 95 Stat. 559; Pub. L. 99–117, §12(a), Oct. 7, 1985, 99 Stat. 495; Pub. L. 102–54, §13(q)(1)(D), June 13, 1991, 105 Stat. 279.)

Amendments

1991—Subsec. (a)(2)(B). Pub. L. 102–54 substituted "Department of Veterans Affairs" for "Veterans' Administration", "Secretary of Veterans Affairs" for "Administrator of Veterans' Affairs" and "such Department" for "such Administration".

1985—Subsec. (g). Pub. L. 99–117 directed that subsec. (g) be repealed. Previously, subsec. (g) was repealed by Pub. L. 96–398. See 1980 Amendment note below.

1981—Subsec. (d). Pub. L. 97–35 struck out subsec. (d) which related to grants for services, form, manner, etc., of application, review of activities undertaken, allotments, and authorization of appropriations.

1980—Subsec. (g). Pub. L. 96–398 struck out subsec. (g) which related to application, procedures applicable, amount, etc., for State mental health program grants.

1979—Subsec. (d)(2)(C)(ii). Pub. L. 96–32, §6(e), substituted "uniform national health program reporting system" for "uniform national reporting system".

Subsec. (d)(4)(A). Pub. L. 96–32, §6(f), in provision following subd. (II) of cl. (ii), substituted "the preceding provisions of this subparagraph" for "clauses (i) and (ii)" and "amount" for "amounts" and inserted provision that if the amount appropriated for a fiscal year is equal to or less than the amount appropriated for fiscal year ending Sept. 30, 1979, the total amount of grants for a State health authority shall be an amount which bears the same ratio to the amount appropriated as the total amount of grants received by such authority from appropriations for fiscal year ending Sept. 30, 1979, bears to the amount appropriated for that fiscal year.

Subsec. (g)(2)(D)(iv). Pub. L. 96–79 substituted "a plan which is consistent with the State health plan in effect for the State under section 300m–3(c) of this title and" for "a plan".

1978—Subsec. (d). Pub. L. 95–626, §201(b)(2), completely revised subsec. (d) under which the Secretary is authorized to make grants to State health authorities to assist in meeting the costs of providing comprehensive public health services by including requirements that the States submit an application outlining how funds will be used to supplement non-Federal support for the provision of public health services in the State, by setting out formulae under which funds will be made available to States including definitions of "applicable grant computation percentage" and "State and local expenditures for comprehensive public health services", by requiring implementation of a national health program reporting system to assure accountability for expenditure of funds, and by authorizing appropriations of $150,000,000 for fiscal year ending Sept. 30, 1980, and $170,000,000 for fiscal year ending Sept. 30, 1981.

Subsec. (d)(7)(A). Pub. L. 95–626, §201(a)(1), inserted provision authorizing an appropriation of $103,000,000 for fiscal year ending Sept. 30, 1979.

Subsec. (d)(7)(B). Pub. L. 95–626, §201(a)(2), inserted provision authorizing an appropriation of $20,000,000 for fiscal year ending Sept. 30, 1979.

Subsec. (f). Pub. L. 95–454 designated existing provisions of section 403 of Pub. L. 91–648 (see 1971 Amendment note below) as subsec. (a) thereof and added subsec. (b) thereto repealing subsec. (f) of this section as subsec. (f) of this section had applied to commissioned officers of the Public Health Service.

Subsec. (g). Pub. L. 95–622 substituted provisions relating to grants for State mental health programs for provisions relating to regulations and amendments with respect to grants to States under subsecs. (a) and (d) and reduction and suspension of subsec. (a) and (d) grant payments.

1977—Subsec. (d)(7)(A). Pub. L. 95–83, §302(a), substituted provision for an appropriation authorization for fiscal year ending Sept. 30, 1977, for prior such authorization for fiscal year 1977, and authorized appropriation of $106,750,000 for fiscal year ending Sept. 30, 1978.

Subsec. (d)(7)(B). Pub. L. 95–83, §302(b), substituted provision for an appropriation authorization for fiscal year ending Sept. 30, 1977, for prior such authorization for fiscal year 1977, and authorized appropriation of $12,680,000 for fiscal year ending Sept. 30, 1978.

1976—Subsec. (g)(4)(B). Pub. L. 94–484 defined "State" to include the Northern Mariana Islands.

1975—Subsec. (d). Pub. L. 94–63, §§102, 701(a), substituted provisions relating to grants made pursuant to allotments to State health and mental health authorities for meeting the costs of providing comprehensive public health services, for provisions relating to grants made pursuant to appropriations for fiscal year ending June 30, 1968 to fiscal year ending June 30, 1975, to State health or mental health authorities to aid in the establishment and maintenance of adequate public health services, including the training of personnel for State and local health work.

Subsec. (e). Pub. L. 94–63, §§501(b), 701(b), struck out subsec. (e) which authorized appropriations from fiscal year ending June 30, 1968 through fiscal year ending June 30, 1975 for project grants for health services and related training, set forth procedures for making such grants, and prohibited grants after the fiscal year ending June 30, 1975, for provisions of this chapter amended by title VII of the Health Revenue Sharing and Health Services Act of 1975.

1973—Subsec. (a)(1). Pub. L. 93–45, §106(a)(1), authorized appropriations of $10,000,000 for fiscal year ending June 30, 1974.

Subsec. (b)(1)(A). Pub. L. 93–45, §106(a)(2), (b), authorized appropriations of $25,100,000 for fiscal year ending June 30, 1974, and extended period for making project grants from June 30, 1973, to June 30, 1974.

Subsec. (c). Pub. L. 93–45, §106(a)(3), (b), authorized appropriations of $4,700,000 for fiscal year ending June 30, 1974, and extended period for grants from June 30, 1973, to June 30, 1974.

Subsec. (d)(1). Pub. L. 93–45, §106(a)(4), authorized appropriations of $90,000,000 for fiscal year ending June 30, 1974.

Subsec. (e). Pub. L. 93–151 prohibited use of appropriated funds for lead based paint poisoning control.

Pub. L. 93–45, §106(a)(5), authorized appropriations of $230,700,000 for fiscal year ending June 30, 1974, and prohibited any grant for such fiscal year to cover cost of services described in cl. (1) or (2) of the first sentence if a grant or contract to cover cost of such services may be made or entered into from funds authorized to be appropriated for such fiscal year under an appropriations authorization in any provision of this chapter (other than this subsection) amended by title I of the Health Programs Extension Act of 1973.

1972—Subsec. (d)(2)(K). Pub. L. 92–255 required State plans to provide for licensing of facilities for treatment and rehabilitation of persons with drug abuse and other drug dependence problems and for expansion of State mental health programs and other prevention and treatment programs in the field of drug abuse and drug dependence.

1971—Subsec. (f). Pub. L. 91–648, §403(a), as amended by Pub. L. 94–454, §602(c), repealed subsec. (f) which authorized the Secretary to arrange the interchange of personnel with States to aid in discharge of responsibilities in field of health care, except as subsec. (b) applied to commissioned officers of the Public Health Service. See 1978 Amendment note above.

1970Pub. L. 91–515, §282, substituted "Secretary" for "Surgeon General" in subsecs. (a)(1), (a)(2)(C), (E) to (H), (K), (a)(3)(B), (a)(4), (b)(1)(A), (c), (d)(1), (d)(2)(C), (F) to (H), (J), (d)(4)(A), (d)(6), and (g)(1) to (3).

Subsec. (a)(1). Pub. L. 91–515, §220(a), extended period for making grants to States from June 30, 1970 to June 30, 1973, and authorized appropriations for the fiscal years ending June 30, 1971, June 30, 1972, and June 30, 1973.

Subsec. (a)(2)(B). Pub. L. 91–515, §220(b), (c), inserted provisions authorizing appointment of an exofficio member from representatives of Federal, State, and local agencies involved, and requiring representation of the regional medical program or programs included in whole or in part within the State.

Subsec. (a)(2)(C). Pub. L. 91–515, §220(d), inserted "and including home health care" after "private" and "and including environmental considerations as they relate to public health" after "people of the State".

Subsec. (b). Pub. L. 91–515, §230, redesignated existing provisions as subsec. (b)(1)(A), and, as so redesignated, extended period for making project grants from June 30, 1970 to June 30, 1973, inserted "and including the provision of such services through home health care" after "such services", and authorized appropriations for the fiscal years ending June 30, 1971, June 30, 1972, and June 30, 1973, and added subsec. (b)(1)(B) and (b)(2).

Pub. L. 91–296, §111(b), inserted provisions requiring that before grants be made to agencies or organizations to develop or revise health plans for an area the Secretary determine that the agency or organization provides means for appropriate representation of the interests of the hospitals, practicing physicians, and the general public.

Subsec. (c). Pub. L. 91–515, §240, extended period for making grants from June 30, 1970, to June 30, 1973, and authorized appropriations for the fiscal years ending June 30, 1971, June 30, 1972, and June 30, 1973.

Subsec. (d)(1). Pub. L. 91–515, §250(a), authorized appropriations for fiscal years ending June 30, 1971, June 30, 1972, and June 30, 1973.

Pub. L. 91–296, §401(b)(1)(C), struck out except which provided for use of up to 1 per centum by Secretary for evaluation.

Subsec. (d)(2)(C). Pub. L. 91–515, §250(b), inserted provisions requiring State plan to contain assurances that the plan is compatible with total health program of the State.

Subsec. (d)(2)(K). Pub. L. 91–513 added subpar. (K).

Subsec. (d)(2)(L). Pub. L. 91–616 added subpar. (L).

Subsec. (e). Pub. L. 91–515, §260(a), (b), (c)(1), inserted provisions authorizing appropriations for fiscal years ending June 30, 1971, June 30, 1972, and June 30, 1973, provisions authorizing grants to cover part of cost of equity requirements and amortization of loans on facilities acquired from the Office of Economic Opportunity or construction in connection with any program or project transferred from the Office of Economic Opportunity, and provisions requiring the application for any grant made under this subsection to be referred for review and comment to the appropriate areawide health planning agency, or, if no such agency is in the area, then to such other public or nonprofit private agency or organization (if any) which performs similar functions.

Pub. L. 91–296, §401(b)(1)(D), struck out provision for use of up to 1 per centum of appropriation for grants under subsec. (e) by the Secretary for evaluation.

1967—Subsec. (a)(1). Pub. L. 90–174, §2(a)(1), extended period for making grants to States from June 30, 1968, to June 30, 1970, increased appropriations authorization for fiscal year ending June 30, 1968, from $5,000,000 to $7,000,000, and authorized appropriations of $10,000,000 and $15,000,000 for fiscal years ending June 30, 1969, and 1970, respectively.

Subsec. (a)(2)(I) to (K). Pub. L. 90–174, §2(a)(2), added subpar. (I) and redesignated former subpars. (I) and (J) as (J) and (K), respectively.

Subsec. (a)(4). Pub. L. 90–174, §2(a)(3), limited Federal share of expenditures, in case of allotments for fiscal year ending June 30, 1968, to 75 per centum of cost of planning.

Subsec. (b). Pub. L. 90–174, §2(b)(1), (2), extended period for making grants to public or nonprofit private organizations from June 30, 1968, to June 30, 1970, and authorized appropriations of $10,000,000 and $15,000,000 for fiscal years ending June 30, 1969, and 1970, respectively, and provided for appropriate representation of interests of local government where recipient of grant is not a local government or combination thereof or an agency of such government or combination, respectively.

Subsec. (c). Pub. L. 90–174, §2(c), extended period for making grants to public or nonprofit private organizations from June 30, 1968, to June 30, 1970, and authorized appropriations of $5,000,000 and $7,500,000 for fiscal years ending June 30, 1969, and 1970, respectively.

Subsec. (d)(1). Pub. L. 90–174, §§2(d)(1), 8(a), increased appropriations authorization for fiscal year ending June 30, 1968, from $62,500,000 to $70,000,000, and authorized appropriations of $90,000,000 and $100,000,000 for fiscal years ending June 30, 1969, and 1970, respectively, and made program evaluation funds available for any fiscal year ending after June 30, 1968, respectively.

Subsec. (d)(5). Pub. L. 90–174, §2(d)(2), made Federal share of 662/3 per centum applicable to the Trust Territory of the Pacific Islands.

Subsec. (d)(7). Pub. L. 90–174, §2(d)(3), provided for an allocation of 70 per centum of funds for provision under the State plan of services in communities of the State.

Subsec. (e). Pub. L. 90–174, §§2(e), 3(b)(2), 8(b), increased appropriations authorization for fiscal year ending June 30, 1968, from $62,500,000 to $90,000,000, authorized appropriations of $95,000,000 and $80,000,000 for fiscal years ending June 30, 1969, and 1970, respectively, inserted "(including related training)" after "providing services" in cl. (1), substituted "developing" for "stimulating" and inserted "(including related training)" after "health services" in cl. (2), struck out cl. (3) which authorized grants to cover part of cost of undertaking studies, demonstrations, or training designed to develop new methods or improve existing methods of providing health services, and made program evaluation funds available for any fiscal year ending after June 30, 1968.

Subsec. (f)(5). Pub. L. 90–174, §12(d)(1), inserted "for" before "the expenses of travel".

Subsec. (f)(6), (8). Pub. L. 90–174, §12(d)(2), substituted "Department" for "Service".

Subsec. (g)(4)(B). Pub. L. 90–174, §2(f), defined "State" to include the Trust Territory of the Pacific Islands.

1966—Subsec. (a). Pub. L. 89–749 substituted provisions authorizing the Surgeon General to make grants to States to assist in comprehensive and continuing planning for their current and future health needs, authorizing appropriations therefor, setting out the requirements for an acceptable State plan for comprehensive State health planning, covering the allotting of the appropriated sums to the States, and the payment of the allotted funds, for provisions authorizing the Surgeon General, through the use of grants and other assistance, to help local programs of prevention, treatment, and control of venereal diseases, covering the payment of the costs of assistance by personnel of the Public Health Service to assist in carrying out the purposes of the section with respect to venereal disease, and authorizing the appropriation of funds.

Subsec. (b). Pub. L. 89–749 substituted provisions for project grants by the Surgeon General covering the development of comprehensive regional, metropolitan, or local coordination of existing and planned health facilities and persons required for providing services and the authorization of appropriations of $5,000,000 for fiscal 1967 and $7,500,000 for fiscal 1968 for provisions authorizing the appropriation of funds to enable the Surgeon General to aid in the development of measures for the local prevention, treatment, and control of tuberculosis.

Subsec. (c). Pub. L. 89–749 substituted provisions for project grants for the development of improved or more effective comprehensive health planning throughout the United States and the authorization of appropriations of $1,500,000 for fiscal 1967 and $2,500,000 for fiscal 1968 for provisions authorizing the Surgeon General to assist, through grants and otherwise, in the establishment and maintenance of adequate public health services by States, counties, health districts, and other political subdivisions, authorizing appropriations therefor, and covering the allotment, payment, and allocation of appropriated funds.

Subsec. (d). Pub. L. 89–749 substituted provisions authorizing grants by the Surgeon General to State health or mental health authorities to assist in establishing and maintaining adequate public health services, setting out the requirements for an acceptable State plan for the supplying of public health services, authorizing an appropriation of $62,500,000 for fiscal 1968, the allotment of appropriated funds, payments to States, and the determination of the Federal share for provisions covering the allotment of appropriated funds among the several States on the basis of population, incidence of venereal disease, tuberculosis, mental health problems, and the financial needs of the various States.

Subsec. (e). Pub. L. 89–749 substituted provisions for project grants for health services development to public or private nonprofit agencies and for the authorization of an appropriation of $62,500,000 for fiscal 1968 for provisions covering the establishment and maintenance of community programs of heart disease control and the allotments and appropriations therefor.

Subsec. (f). Pub. L. 89–749 substituted provisions covering the interchange of personnel with States, the application of statutes covering Federal employees to interchanged personnel, and the coverage of State officers and employees, for provisions for the determination and certification of amounts paid to each State from allotments thereto.

Subsec. (g). Pub. L. 89–749 substituted provisions for consultation with State health planning agencies concerning regulations and amendments with respect to grants to States, the reduction of payments, cessation of payments for non-compliance, and definitions, for provisions limiting the expending of grant funds for purposes specified by statute and by the agency, organization, or institution to which payment was made.

Subsecs. (h) to (m). Pub. L. 89–749 struck out subsecs. (h) to (m) which dealt, respectively, with requirement that State funds be provided for same purpose as that for which allotted funds are spent, cessation of Federal aid and procedures in connection therewith, promulgation of rules and regulations and consultation with State health authorities precedent thereto, availability of appropriated funds for administrative expenses including printing and travel expenses, applicability of section to Guam and Samoa, and reduction of payments commensurate to expense of detailing of Public Health Service personnel to States.

1965—Subsec. (c). Pub. L. 89–109 substituted "first six fiscal years ending after June 30, 1961" for "first five fiscal years ending after June 30, 1961" and "$5,000,000" for "$2,500,000".

1962—Subsec. (l). Pub. L. 87–688 inserted "and American Samoa", "or American Samoa", and "or American Samoa, respectively" after "Guam".

1961—Subsec. (c). Pub. L. 87–395, §2(a)–(c), substituted "of the first five fiscal years ending after June 30, 1961, the sum of $50,000,000" for "fiscal year a sum not to exceed $30,000,000", "such amount as may be necessary" for "an amount, not to exceed $3,000,000", "$2,500,000" for "$1,000,000", and provided that when an appropriating act provides that the amounts it specifies are available only for allotments and payments for such services and activities under this subsection as specified in such act, the requirements of subsec. (h) shall apply to such allotments and payments.

Subsec. (m). Pub. L. 87–395, §2(d), added subsec. (m).

1958—Subsec. (c). Pub. L. 85–544 designated existing provisions of second sentence as cl. (1) and added cl. (2).

1956—Subsec. (l). Act Aug. 1, 1956, added subsec. (l).

1948—Subsec. (e). Act June 16, 1948, §5(a), added subsec. (e) to provide for community programs of heart disease control. Former subsec. (e) redesignated (f).

Subsec. (f). Act June 16, 1948, §5(a), (b), redesignated former subsec. (e) as (f) and inserted proviso relating to determination and certification of amounts to be paid under subsec. (e). Former subsec. (f) redesignated (g).

Subsec. (g). Act June 16, 1948, §5(a), (c), redesignated former subsec. (f) as (g) and brought subsecs. (e) and (f)(1) within the provisions of this subsection. Former subsec. (g) redesignated (h).

Subsec. (h). Act June 16, 1948, §5(a), (d), redesignated former subsec. (g) as (h) and made subsection applicable to agencies, institutions or other organizations specified in subsec. (f)(1). Former subsec. (h) redesignated (i).

Subsec. (i). Act June 16, 1948, §5(a), (e), redesignated former subsec. (h) as (i), made subsection applicable to subsec. (e), and made technical changes as a result of the renumbering of subsections. Former subsec. (i) redesignated (j).

Subsecs. (j), (k). Act June 16, 1948, §5(a), redesignated former subsecs. (i) and (j) as (j) and (k), respectively.

1946—Subsec. (c). Act July 3, 1946, increased annual appropriation from $20,000,000 to $30,000,000, and increased annual amount available to provide demonstrations and to train personnel for State and local health work from $2,000,000 to $3,000,000.

Subsec. (d). Act July 3, 1946, provided that Surgeon General shall give special consideration to the extent of the mental health problem as well as other special problems.

Subsecs. (f), (h), (i). Act July 3, 1946, provided that in matters relating to work in field of mental health Surgeon General shall deal with State mental health authorities where they differ from general health authorities.

Effective Date of 1981 Amendment

Amendment by Pub. L. 97–35 effective Oct. 1, 1981, see section 902(h) of Pub. L. 97–35, set out as a note under section 238l of this title.

Effective Date of 1980 Amendment

Section 107(d) of Pub. L. 96–398 provided that the amendment made by that section is effective Sept. 30, 1981. See Repeals note below.

Effective Date of 1979 Amendment

Amendment by Pub. L. 96–79 effective one year after Oct. 4, 1979, see section 129(a) of Pub. L. 96–79.

Effective Date of 1978 Amendments

Pub. L. 95–626, title II, §201(b)(2), Nov. 10, 1978, 92 Stat. 3570, provided that the amendment made by section is effective Oct. 1, 1979.

Pub. L. 91–648, title IV, §403(b), as added by Pub. L. 95–454, title VI, §602(c), Oct. 13, 1978, 92 Stat. 1189, provided that the repeal of subsec. (f) of this section (as applicable to commissioned officers of the Public Health Service) is effective beginning on the effective date of the Civil Service Reform Act of 1978, i.e., 90 days after Oct. 13, 1978.

Effective Date of 1975 Amendment

Pub. L. 94–63, title I, §102, July 29, 1975, 89 Stat. 304, provided that the amendment made by that section is effective with respect to grants made under subsec. (d) of this section from appropriations under such subsection for fiscal years beginning after June 30, 1975.

Amendment by section 501(b) of Pub. L. 94–63 effective July 1, 1975, see section 608 of Pub. L. 94–63, set out as a note under section 247b of this title.

Effective Date of 1971 Amendment

Repeal of subsec. (f) of this section (less applicability to commissioned officers of the Public Health Service) by section 403(a) of Pub. L. 91–648, as amended by Pub. L. 94–454, §602(c), effective sixty days after Jan. 5, 1971, see section 404 of Pub. L. 91–648, set out as an Effective Date note under section 3371 of Title 5, Government Organization and Employees.

Effective Date of 1970 Amendments

Pub. L. 91–515, title II, §260(c)(2), Oct. 30, 1970, 84 Stat. 1306, provided that: "The amendment made by paragraph (1) [amending this section] shall be effective with respect to grants under section 314(c) of the Public Health Service Act [42 U.S.C. 246(e)] which are made after the date of enactment of this Act [Oct. 30, 1970.]"

Pub. L. 91–296, title IV, §401(b)(1), June 30, 1970, 84 Stat. 352, provided that the amendment made by that section is effective with respect to appropriations for fiscal years beginning after June 30, 1970.

Effective Date of 1967 Amendment

Pub. L. 90–174, §2(d)(2), (f), Dec. 5, 1967, 81 Stat. 534, provided that the amendments made by that section are effective July 1, 1968.

Pub. L. 90–174, §3(b), Dec. 5, 1967, 81 Stat. 535, provided that the amendment of this section, the repeal of section 291n of this title, and the enactment of provisions set out as a note under section 242b of this title by such section 3(b) is effective with respect to appropriations for fiscal years ending after June 30, 1967.

Effective Date of 1966 Amendment

Pub. L. 89–749, §6, Nov. 3, 1966, 80 Stat. 1190, provided in part that: "The amendments made by section 3 [amending this section] shall become effective as of July 1, 1966, except that the provisions of section 314 of the Public Health Service Act [42 U.S.C. 246] as in effect prior to the enactment of this Act shall be effective until July 1, 1967, in lieu of the provisions of subsections (d) and (e), and the provisions of subsections (g) insofar as they relate to such subsections (d) and (e), of section 314 of the Public Health Service Act as amended by this Act."

Effective Date of 1962 Amendment

Pub. L. 87–688, §4(b), Sept. 25, 1962, 76 Stat. 587, provided that: "The amendments made by this section [amending this section and sections 291g, 291i, and 291t of this title] shall become effective July 1, 1962."

Effective and Termination Date of 1958 Amendment

Pub. L. 85–544, §2, July 22, 1958, 72 Stat. 401, provided that: "The amendment made by the first section of this Act [amending this section] shall be applicable only to the fiscal years beginning July 1, 1958, and July 1, 1959."

Effective Date of 1956 Amendment

Act Aug. 1, 1956, ch. 852, §18, 70 Stat. 910, provided that the amendment made by that section is effective July 1, 1956.

Repeals

The directory language of, but not the amendment made by, Pub. L. 96–398, title I, §107(d), cited as a credit to this section and set out as an Effective Date of 1980 Amendment note above, which provided for repeal of subsec. (g) of this section, effective Sept. 30, 1981, was repealed by section 902(e)(1) of Pub. L. 97–35, title IX, Aug. 13, 1981, 95 Stat. 560, effective Oct. 1, 1981.

Transfer of Functions

Functions, powers, and duties of Secretary of Health and Human Services under subsecs. (a)(2)(F) and (d)(2)(F) of this section, insofar as relates to the prescription of personnel standards on a merit basis, transferred to Office of Personnel Management, see section 4728(a)(3)(C) of this title.

Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under section 3501 of this title. Federal Security Agency and office of Administrator abolished by section 8 of Reorg. Plan No. 1 of 1953. Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section 3508(b) of Title 20, Education.

Year 2000 Health Objectives Planning

Pub. L. 101–582, Nov. 15, 1990, 104 Stat. 2867, provided for grants for State plans regarding health objectives for year 2000, prior to repeal by Pub. L. 102–531, title I, §105, Oct. 27, 1992, 106 Stat. 3474.

Congressional Findings and Declaration

Pub. L. 95–626, title II, §201(b)(1), Nov. 10, 1978, 92 Stat. 3570, provided that: "The Congress finds and declares that—

"(A) individual health status can be effectively and economically improved through an adequate investment in community public health programs and services;

"(B) the Federal Government and the States and their communities share in the financial responsibility for funding public health programs;

"(C) the Federal contribution to funds for public health programs should serve as an incentive to an additional investment by State and local governments;

"(D) existing categorical programs of Federal financial assistance to combat specific public health problems should be supplemented by a national program of stable generic support for such public health activities as the prevention and control of environmental health hazards, prevention and control of diseases, prevention and control of health problems of particularly vulnerable population groups, and development and regulation of health care facilities and health services delivery systems; and

"(E) the States and their communities, not the Federal Government, should have primary responsibility for identifying and measuring the impact of public health problems and the allocation of resources for their amelioration."

Pub. L. 89–749, §2, Nov. 3, 1966, 80 Stat. 1180, provided that:

"(a) The Congress declares that fulfillment of our national purpose depends on promoting and assuring the highest level of health attainable for every person, in an environment which contributes positively to healthful individual and family living; that attainment of this goal depends on an effective partnership, involving close intergovernmental collaboration, official and voluntary efforts, and participation of individuals and organizations; that Federal financial assistance must be directed to support the marshaling of all health resources—national, State, and local—to assure comprehensive health services of high quality for every person, but without interference with existing patterns of private professional practice of medicine, dentistry, and related healing arts.

"(b) To carry out such purpose, and recognizing the changing character of health problems, the Congress finds that comprehensive planning for health services, health manpower, and health facilities is essential at every level of government; that desirable administration requires strengthening the leadership and capacities of State health agencies; and that support of health services provided people in their communities should be broadened and made more flexible."

Act July 3, 1956, ch. 852, §2, 70 Stat. 908, provided that:

"(a) The Congress hereby finds and declares—

"(1) that the latest information on the number and relevant characteristics of persons in the country suffering from heart disease, cancer, diabetes, arthritis and rheumatism, and other diseases, injuries, and handicapping conditions is now seriously out of date; and

"(2) that periodic inventories providing reasonably current information on these matters are urgently needed for purposes such as (A) appraisal of the true state of health of our population (including both adults and children), (B) adequate planning of any programs to improve their health, (C) research in the field of chronic diseases, and (D) measurement of the numbers of persons in the working ages so disabled as to be unable to perform gainful work.

"(b) It is, therefore, the purpose of this Act [see Short Title of 1956 Amendment note set out under section 201 of this title] to provide (1) for a continuing survey and special studies to secure on a non-compulsory basis accurate and current statistical information on the amount, distribution, and effects of illness and disability in the United States and the services received for or because of such conditions; and (2) for studying methods and survey techniques for securing such statistical information, with a view toward their continuing improvement."

Limitation on Grants-in-Aid to Schools of Public Health

Pub. L. 85–544, §2, July 22, 1958, 72 Stat. 401, which had limited the authority of the Surgeon General to make grants-in-aid totaling not to exceed $1,000,000 annually to schools of public health for fiscal year beginning July 1, 1958, and July 1, 1959, was repealed by section 2 of Pub. L. 86–720, Sept. 8, 1960, 74 Stat. 820.

Grants to States To Provide for Vaccination Against Poliomyelitis

The Poliomyelitis Vaccination Assistance Act of 1955, act Aug. 12, 1955, ch. 863, 69 Stat. 704, as amended Feb. 15, 1956, ch. 39, 70 Stat. 18, authorized appropriations to remain available until close of June 30, 1957 and provided for allotments to States, State application for funds, payments to States, use of funds paid to States, furnishing of vaccine by Surgeon General, diversion of Federal funds, supervision over exercise of functions, and definitions.

Applicability of Reorganization Plan No. 3 of 1966

Pub. L. 89–749, §7, Nov. 3, 1966, 80 Stat. 1190, provided that: "The provisions enacted by this Act [amending this section and sections 242g and 243 of this title] shall be subject to the provisions of Reorganization Plan No. 3 of 1966 [42 U.S.C. 202 note]."

§246a. Bureau of State Services management fund; establishment; advancements; availability

For the purpose of facilitating the economical and efficient conduct of operations in the Bureau of State Services which are financed by two or more appropriations where the costs of operation are not readily susceptible of distribution as charges to such appropriations, there is established the Bureau of State Services management fund. Such amounts as the Secretary may determine to represent a reasonable distribution of estimated costs among the various appropriations involved may be advanced each year to this fund and shall be available for expenditure for such costs under such regulations as may be prescribed by the Secretary: Provided, That funds advanced to this fund shall be available only in the fiscal year in which they are advanced: Provided further, That final adjustments of advances in accordance with actual costs shall be effected wherever practicable with the appropriations from which such funds are advanced.

(Pub. L. 86–703, title II, §201, Sept. 2, 1960, 74 Stat. 765; Pub. L. 91–515, title II, §282, Oct. 30, 1970, 84 Stat. 1308.)

Codification

Section was not enacted as part of the Public Health Service Act which comprises this chapter.

Amendments

1970Pub. L. 91–515 substituted "Secretary" for "Surgeon General" wherever appearing.

§247. Assisting veterans with military emergency medical training to meet requirements for becoming civilian health care professionals

(a) Program

(1) In general

The Secretary may establish a program, in consultation with the Secretary of Labor, consisting of awarding demonstration grants to States to streamline State requirements and procedures in order to assist veterans who held certain military occupational specialties related to medical care or who have completed certain medical training while serving in the Armed Forces of the United States to meet certification, licensure, and other requirements applicable to civilian health care professions (such as emergency medical technician, paramedic, licensed practical nurse, registered nurse, physical therapy assistant, or physician assistant professions) in the State.

(2) Consultation and collaboration

In determining the eligible military occupational specialties or training courses and the assistance required as described in paragraph (1), the Secretary shall consult with the Secretary of Defense, the Secretary of Veterans Affairs, and the Assistant Secretary of Labor for Veterans' Employment and Training, and shall collaborate with the initiatives carried out under section 4114 of title 38 and sections 1142 through 1144 of title 10.

(b) Use of funds

Amounts received as a demonstration grant under this section shall be used to—

(1) prepare and implement a plan to streamline State requirements and procedures as described in subsection (a), including by—

(A) determining the extent to which the requirements for the education, training, and skill level of civilian health care professions (such as emergency medical technicians, paramedics, licensed practical nurses, registered nurses, physical therapy assistants, or physician assistants) in the State are equivalent to requirements for the education, training, and skill level of veterans who served in medical related fields while a member of the Armed Forces of the United States; and

(B) identifying methods, such as waivers, for veterans who served in medical related fields while a member of the Armed Forces of the United States to forgo or meet any such equivalent State requirements; and


(2) if necessary to meet workforce shortages or address gaps in education, training, or skill level to meet certification, licensure or other requirements applicable to becoming a civilian health care professional (such as an emergency medical technician, paramedic, licensed practical nurse, registered nurse, physical therapy assistant, or physician assistant professions) in the State, develop or expand career pathways at institutions of higher education to support veterans in meeting such requirements.

(c) Report

Upon the completion of the demonstration program under this section, the Secretary shall submit to Congress a report on the program.

(d) Funding

No additional funds are authorized to be appropriated for the purpose of carrying out this section. This section shall be carried out using amounts otherwise available for such purpose.

(e) Sunset

The demonstration program under this section shall not exceed 5 years.

(July 1, 1944, ch. 373, title III, §315, as added Pub. L. 114–198, title I, §105, July 22, 2016, 130 Stat. 701.)

Prior Provisions

A prior section 247, act July 1, 1944, ch. 373, title III, §315, as added Oct. 4, 1988, Pub. L. 100–471, §1, 102 Stat. 2284, which related to grants for treatment drugs for acquired immune deficiency syndrome, ceased to exist Mar. 31, 1989, pursuant to subsec. (d) thereof.

Another prior section 247, act July 1, 1944, ch. 373, title III, §315, as added Nov. 10, 1978, Pub. L. 95–626, title II, §203, 92 Stat. 3578; amended July 10, 1979, Pub. L. 96–32, §6(h), 93 Stat. 83, related to formula grants to States for preventive health service programs, prior to repeal by Pub. L. 99–117, §12(b), Oct. 7, 1985, 99 Stat. 495.

Another prior section 247, acts July 1, 1944, ch. 373, title III, §315, 58 Stat. 695; Oct. 30, 1970, Pub. L. 91–515, title II, §282, 84 Stat. 1308, provided for publication of health educational information, prior to repeal by Pub. L. 93–353, title I, §102(a), July 23, 1974, 88 Stat. 362. See section 242o(b) of this title.

§247a. Family support groups for Alzheimer's disease patients

(a) Establishment; priorities

Subject to available appropriations, the Secretary, acting through the National Institute of Mental Health, the National Institutes of Health, and the Administration on Aging, shall promote the establishment of family support groups to provide, without charge, educational, emotional, and practical support to assist individuals with Alzheimer's disease or a related memory disorder and members of the families of such individuals. In promoting the establishment of such groups, the Secretary shall give priority to—

(1) university medical centers and other appropriate health care facilities which receive Federal funds from the Secretary and which conduct research on Alzheimer's disease or provide services to individuals with such disease; and

(2) community-based programs which receive funds from the Secretary, acting through the Administration on Aging.

(b) National network to coordinate groups

The Secretary shall promote the establishment of a national network to coordinate the family support groups described in subsection (a).

(July 1, 1944, ch. 373, title III, §316, as added Pub. L. 99–319, title IV, §401, May 23, 1986, 100 Stat. 489; amended Pub. L. 103–43, title XX, §2008(a), June 10, 1993, 107 Stat. 210.)

Prior Provisions

A prior section 247a, act July 1, 1944, ch. 373, title III, §316, as added Nov. 10, 1978, Pub. L. 95–626, title II, §208(a), 92 Stat. 3586; amended Aug. 13, 1981, Pub. L. 97–35, title XXI, §2193(a)(1)(A), 95 Stat. 826, related to lead-based paint poisoning prevention programs, prior to repeal by Pub. L. 97–35, title XXI, §2193(b)(1), Aug. 13, 1981, 95 Stat. 827.

Another prior section 247a, act July 1, 1944, ch. 373, title III, §316, as added Oct. 30, 1970, Pub. L. 91–515, title II, §281, 84 Stat. 1307, provided for establishment, composition, qualifications of members, terms of office, vacancies, reappointment, compensation, travel expenses, and functions of National Advisory Council on Comprehensive Health Planning Programs, prior to repeal by Pub. L. 93–641, §5(d), Jan. 4, 1975, 88 Stat. 2275.

Amendments

1993—Subsec. (c). Pub. L. 103–43 struck out subsec. (c) which read as follows: "The Secretary shall report to Congress, not later than one year after May 23, 1986, on family support groups and the network of such groups established pursuant to this section."

§247b. Project grants for preventive health services

(a) Grant authority

The Secretary may make grants to States, and in consultation with State health authorities, to political subdivisions of States and to other public entities to assist them in meeting the costs of establishing and maintaining preventive health service programs.

(b) Application

No grant may be made under section (a) 1 unless an application therefor has been submitted to, and approved by, the Secretary. Such an application shall be in such form and be submitted in such manner as the Secretary shall by regulation prescribe and shall provide—

(1) a complete description of the type and extent of the program for which the applicant is seeking a grant under subsection (a);

(2) with respect to each such program (A) the amount of Federal, State, and other funds obligated by the applicant in its latest annual accounting period for the provision of such program, (B) a description of the services provided by the applicant in such program in such period, (C) the amount of Federal funds needed by the applicant to continue providing such services in such program, and (D) if the applicant proposes changes in the provision of the services in such program, the priorities of such proposed changes, reasons for such changes, and the amount of Federal funds needed by the applicant to make such changes;

(3) assurances satisfactory to the Secretary that the program which will be provided with funds under a grant under subsection (a) will be provided in a manner consistent with the State health plan in effect under section 300m–3(c) 1 of this title and in those cases where the applicant is a State, that such program will be provided, where appropriate, in a manner consistent with any plans in effect under an application approved under section 247 1 of this title;

(4) assurances satisfactory to the Secretary that the applicant will provide for such fiscal control and fund accounting procedures as the Secretary by regulation prescribes to assure the proper disbursement of and accounting for funds received under grants under subsection (a);

(5) assurances satisfactory to the Secretary that the applicant will provide for periodic evaluation of its program or programs;

(6) assurances satisfactory to the Secretary that the applicant will make such reports (in such form and containing such information as the Secretary may by regulation prescribe) as the Secretary may reasonably require and keep such records and afford such access thereto as the Secretary may find necessary to assure the correctness of, and to verify, such reports;

(7) assurances satisfactory to the Secretary that the applicant will comply with any other conditions imposed by this section with respect to grants; and

(8) such other information as the Secretary may by regulation prescribe.

(c) Approval; annual project review

(1) The Secretary shall not approve an application submitted under subsection (b) for a grant for a program for which a grant was previously made under subsection (a) unless the Secretary determines—

(A) the program for which the application was submitted is operating effectively to achieve its stated purpose,

(B) the applicant complied with the assurances provided the Secretary when applying for such previous grant, and

(C) the applicant will comply with the assurances provided with the application.


(2) The Secretary shall review annually the activities undertaken by each recipient of a grant under subsection (a) to determine if the program assisted by such grant is operating effectively to achieve its stated purposes and if the recipient is in compliance with the assurances provided the Secretary when applying for such grant.

(d) Amount of grant; payment

The amount of a grant under subsection (a) shall be determined by the Secretary. Payments under such grants may be made in advance on the basis of estimates or by the way of reimbursement, with necessary adjustments on account of underpayments or overpayments, and in such installments and on such terms and conditions as the Secretary finds necessary to carry out the purposes of such grants.

(e) Reduction

The Secretary, at the request of a recipient of a grant under subsection (a), may reduce the amount of such grant by—

(1) the fair market value of any supplies (including vaccines and other preventive agents) or equipment furnished the grant recipient, and

(2) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or employee,


when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out a program with respect to which the grant under subsection (a) is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant recipient.

(f) Recordkeeping; audit authority

(1) Each recipient of a grant under subsection (a) shall keep such records as the Secretary shall by regulation prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the undertaking in connection with which such grant was made, and the amount of that portion of the cost of the undertaking supplied by other sources, and such other records as will facilitate an effective audit.

(2) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipient of grants under subsection (a) that are pertinent to such grants.

(g) Use of grant funds; mandatory treatment prohibited

(1) Nothing in this section shall limit or otherwise restrict the use of funds which are granted to a State or to an agency or a political subdivision of a State under provisions of Federal law (other than this section) and which are available for the conduct of preventive health service programs from being used in connection with programs assisted through grants under subsection (a).

(2) Nothing in this section shall be construed to require any State or any agency or political subdivision of a State to have a preventive health service program which would require any person, who objects to any treatment provided under such a program, to be treated or to have any child or ward treated under such program.

(h) Reports

The Secretary shall include, as part of the report required by section 300u–4 of this title, a report on the extent of the problems presented by the diseases and conditions referred to in subsection (j); on the amount of funds obligated under grants under subsection (a) in the preceding fiscal year for each of the programs listed in subsection (j); and on the effectiveness of the activities assisted under grants under subsection (a) in controlling such diseases and conditions.

(i) Technical assistance

The Secretary may provide technical assistance to States, State health authorities, and other public entities in connection with the operation of their preventive health service programs.

(j) Authorization of appropriations

(1) Except for grants for immunization programs the authorization of appropriations for which are established in paragraph (2), for grants under subsections (a) and (k)(1) for preventive health service programs to immunize without charge children, adolescents, and adults against vaccine-preventable diseases, there are authorized to be appropriated such sums as may be necessary. Not more than 10 percent of the total amount appropriated under the preceding sentence for any fiscal year shall be available for grants under subsection (k)(1) for such fiscal year.

(2) For grants under subsection (a) for preventive health service programs for the provision without charge of immunizations with vaccines approved for use, and recommended for routine use, there are authorized to be appropriated such sums as may be necessary.

(k) Additional grants to States, political subdivisions, and other public and nonprofit private entities

(1) The Secretary may make grants to States, political subdivisions of States, and other public and nonprofit private entities for—

(A) research into the prevention and control of diseases that may be prevented through vaccination;

(B) demonstration projects for the prevention and control of such diseases;

(C) public information and education programs for the prevention and control of such diseases; and

(D) education, training, and clinical skills improvement activities in the prevention and control of such diseases for health professionals (including allied health personnel).


(2) The Secretary may make grants to States, political subdivisions of States, and other public and nonprofit private entities for—

(A) research into the prevention and control of diseases and conditions;

(B) demonstration projects for the prevention and control of such diseases and conditions;

(C) public information and education programs for the prevention and control of such diseases and conditions; and

(D) education, training, and clinical skills improvement activities in the prevention and control of such diseases and conditions for health professionals (including allied health personnel).


(3) No grant may be made under this subsection unless an application therefor is submitted to the Secretary in such form, at such time, and containing such information as the Secretary may by regulation prescribe.

(4) Subsections (d), (e), and (f) of this section shall apply to grants under this subsection in the same manner as such subsections apply to grants under subsection (a) of this section.

(l) Authority to purchase recommended vaccines for adults

(1) In general

The Secretary may negotiate and enter into contracts with manufacturers of vaccines for the purchase and delivery of vaccines for adults as provided for under subsection (e).

(2) State purchase

A State may obtain additional quantities of such adult vaccines (subject to amounts specified to the Secretary by the State in advance of negotiations) through the purchase of vaccines from manufacturers at the applicable price negotiated by the Secretary under this subsection.

(m) Demonstration program to improve immunization coverage

(1) In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish a demonstration program to award grants to States to improve the provision of recommended immunizations for children, adolescents, and adults through the use of evidence-based, population-based interventions for high-risk populations.

(2) State plan

To be eligible for a grant under paragraph (1), a State shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including a State plan that describes the interventions to be implemented under the grant and how such interventions match with local needs and capabilities, as determined through consultation with local authorities.

(3) Use of funds

Funds received under a grant under this subsection shall be used to implement interventions that are recommended by the Task Force on Community Preventive Services (as established by the Secretary, acting through the Director of the Centers for Disease Control and Prevention) or other evidence-based interventions, including—

(A) providing immunization reminders or recalls for target populations of clients, patients, and consumers;

(B) educating targeted populations and health care providers concerning immunizations in combination with one or more other interventions;

(C) reducing out-of-pocket costs for families for vaccines and their administration;

(D) carrying out immunization-promoting strategies for participants or clients of public programs, including assessments of immunization status, referrals to health care providers, education, provision of on-site immunizations, or incentives for immunization;

(E) providing for home visits that promote immunization through education, assessments of need, referrals, provision of immunizations, or other services;

(F) providing reminders or recalls for immunization providers;

(G) conducting assessments of, and providing feedback to, immunization providers;

(H) any combination of one or more interventions described in this paragraph; or

(I) immunization information systems to allow all States to have electronic databases for immunization records.

(4) Consideration

In awarding grants under this subsection, the Secretary shall consider any reviews or recommendations of the Task Force on Community Preventive Services.

(5) Evaluation

Not later than 3 years after the date on which a State receives a grant under this subsection, the State shall submit to the Secretary an evaluation of progress made toward improving immunization coverage rates among high-risk populations within the State.

(6) Report to Congress

Not later than 4 years after March 23, 2010,1 the Secretary shall submit to Congress a report concerning the effectiveness of the demonstration program established under this subsection together with recommendations on whether to continue and expand such program.

(7) Authorization of appropriations

There is authorized to be appropriated to carry out this subsection, such sums as may be necessary for each of fiscal years 2010 through 2014.

(July 1, 1944, ch. 373, title III, §317, as added Pub. L. 87–868, §2, Oct. 23, 1962, 76 Stat. 1155; amended Pub. L. 89–109, §2, Aug. 5, 1965, 79 Stat. 435; Pub. L. 91–464, §2, Oct. 16, 1970, 84 Stat. 988; Pub. L. 92–449, title I, §101, Sept. 30, 1972, 86 Stat. 748; Pub. L. 93–354, §4, July 23, 1974, 88 Stat. 376; Pub. L. 94–63, title VI, §601, July 29, 1975, 89 Stat. 346; Pub. L. 94–317, title II, §202(a), June 23, 1976, 90 Stat. 700; Pub. L. 94–380, §2, Aug. 12, 1976, 90 Stat. 1113; Pub. L. 95–626, title II, §§202, 204(b)(2), Nov. 10, 1978, 92 Stat. 3574, 3583; Pub. L. 96–32, §6(i), July 10, 1979, 93 Stat. 83; Pub. L. 97–35, title IX, §928, Aug. 13, 1981, 95 Stat. 569; Pub. L. 98–555, §2, Oct. 30, 1984, 98 Stat. 2854; Pub. L. 99–117, §11(c), Oct. 7, 1985, 99 Stat. 495; Pub. L. 100–177, title I, §§110(a), 111, Dec. 1, 1987, 101 Stat. 990, 991; Pub. L. 101–368, §2, Aug. 15, 1990, 104 Stat. 446; Pub. L. 101–502, §2(a), Nov. 3, 1990, 104 Stat. 1285; Pub. L. 103–183, title III, §301(b), Dec. 14, 1993, 107 Stat. 2235; Pub. L. 105–392, title III, §303, Nov. 13, 1998, 112 Stat. 3586; Pub. L. 106–310, div. A, title XVII, §1711, Oct. 17, 2000, 114 Stat. 1152; Pub. L. 111–148, title IV, §4204(a)–(c), Mar. 23, 2010, 124 Stat. 571, 572.)

References in Text

Section 300m–3 of this title, referred to in subsec. (b)(3), was repealed by Pub. L. 99–660, title VII, §701(a), Nov. 14, 1986, 100 Stat. 3799.

Section 247 of this title, referred to in subsec. (b)(3), was repealed by Pub. L. 99–117, §12(b), Oct. 7, 1985, 99 Stat. 495.

March 23, 2010, referred to in subsec. (m)(6), was in the original "the date of enactment of the Affordable Health Choices Act", and was translated as meaning the date of enactment of the Patient Protection and Affordable Care Act, Pub. L. 111–148, to reflect the probable intent of Congress. No act named the "Affordable Health Choices Act" has been enacted.

Amendments

2010—Subsec. (j)(1). Pub. L. 111–148, §4204(c)(1), struck out "for each of the fiscal years 1998 through 2005" after "necessary".

Subsec. (j)(2). Pub. L. 111–148, §4204(c)(2), struck out "after October 1, 1997," after "routine use,".

Subsecs. (l), (m). Pub. L. 111–148, §4204(a), (b), added subsecs. (l) and (m).

2000—Subsec. (j)(1). Pub. L. 106–310 substituted "1998 through 2005" for "1998 through 2002" in first sentence.

1998—Subsec. (j)(1). Pub. L. 105–392, §303(1), substituted "children, adolescents, and adults against vaccine-preventable diseases, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1998 through 2002." for "individuals against vaccine-preventable diseases, there are authorized to be appropriated $205,000,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 through 1995."

Subsec. (j)(2). Pub. L. 105–392, §303(2), substituted "1997" for "1990".

1993—Subsec. (j). Pub. L. 103–183, §301(b)(1), redesignated subpars. (A) and (B) of par. (1) as pars. (1) and (2), respectively, substituted "established in paragraph (2)" for "established in subparagraph (B)" in par. (1), and struck out former par. (2), which read as follows: "For grants under subsection (a) of this section for preventive health service programs for the prevention, control, and elimination of tuberculosis, and for grants under subsection (k)(2) of this section, there are authorized to be appropriated $24,000,000 for fiscal year 1988, $31,000,000 for fiscal year 1989, $36,000,000 for fiscal year 1990, $36,000,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 through 1995. Not more than 10 percent of the total amount appropriated under the preceding sentence for any fiscal year shall be available for grants under subsection (k)(2) of this section for such fiscal year."

Subsec. (k)(2). Pub. L. 103–183, §301(b)(2)(A), (B), redesignated par. (3) as (2) and struck out former par. (2) which read as follows: "The Secretary may make grants to States, political subdivisions of States, and other public and nonprofit private entities for—

"(A) research into the prevention, control, and elimination of tuberculosis, especially research concerning strains of tuberculosis resistant to drugs and research concerning cases of tuberculosis that affect certain populations;

"(B) demonstration projects for the prevention, control, and elimination of tuberculosis;

"(C) public information and education programs for prevention, control, and elimination of tuberculosis; and

"(D) education, training, and clinical skills improvement activities in the prevention, control, and elimination of tuberculosis for health professionals, including allied health personnel."

Subsec. (k)(3). Pub. L. 103–183, §301(b)(2)(B), redesignated par. (4) as (3). Former par. (3) redesignated (2).

Subsec. (k)(4), (5). Pub. L. 103–183, §301(b)(2)(B), (C), redesignated par. (5) as (4) and made technical amendments to references to subsections (d), (e), and (f) of this section and subsection (a) of this section, to reflect change in references to corresponding provisions of original act. Former par. (4) redesignated (3).

Subsec. (l). Pub. L. 103–183, §301(b)(3), struck out subsec. (l) which related to establishment and function of Advisory Council for the Elimination of Tuberculosis.

1990—Subsec. (j)(1)(A). Pub. L. 101–502, §2(a)(1), substituted provisions authorizing appropriations for fiscal years 1991 through 1995 for provisions authorizing appropriations for fiscal years 1988 through 1990.

Subsec. (j)(1)(B). Pub. L. 101–502, §2(a)(2), substituted Oct. 1, 1990, for Dec. 1, 1987, and provisions authorizing appropriations as may be necessary for provisions authorizing appropriations for fiscal years 1988 to 1990.

Subsec. (j)(1)(C). Pub. L. 101–502, §2(a)(3), struck out subpar. (C) which, on the implementation of part 2 of subchapter XIX of this chapter, authorized appropriations for grants under subsec. (a) of this section for fiscal years 1988 to 1990.

Subsec. (j)(2). Pub. L. 101–368, §2(c), inserted provisions authorizing appropriations of $36,000,000 for fiscal year 1991, and such sums as may be necessary for fiscal years 1992 through 1995.

Pub. L. 101–368, §2(a)(1), substituted "preventive health service programs for the prevention, control, and elimination of tuberculosis" for "preventive health service programs for tuberculosis".

Subsec. (k)(2)(A) to (D). Pub. L. 101–368, §2(a)(2), substituted "prevention, control, and elimination" for "prevention and control".

Subsec. (l). Pub. L. 101–368, §2(b), added subsec. (l).

1987—Subsec. (j). Pub. L. 100–177, §§110(a), 111(a), amended subsec. (j) generally, substituting provisions authorizing appropriations for fiscal years 1988 to 1990 for grants under subsecs. (a) and (k) of this section for former provisions authorizing appropriations for fiscal years 1982 to 1987 for grants under subsec. (a) of this section.

Subsec. (k). Pub. L. 100–177, §111(b), added subsec. (k).

1985—Subsec. (j). Pub. L. 99–117 amended directory language of Pub. L. 97–35, §928(b), to correct a technical error. See 1981 Amendment note below.

1984—Subsec. (j)(1). Pub. L. 98–555, §2(a), substituted "immunize individuals against vaccine-preventable diseases" for "immunize children against immunizable diseases" and inserted provisions authorizing appropriations for fiscal years ending Sept. 30, 1985, 1986, and 1987.

Subsec. (j)(2). Pub. L. 98–555, §2(b), inserted provisions authorizing appropriations for fiscal years ending Sept. 30, 1985, 1986, and 1987.

1981—Subsec. (a). Pub. L. 97–35, §928(a), struck out par. (1) which related to grants to State health authorities, and redesignated par. (2) as entire section and, as so redesignated, struck out reference to former par. (1).

Subsec. (j). Pub. L. 97–35, §928(b), as amended by Pub. L. 99–117, substituted provisions authorizing appropriations for fiscal years ending Sept. 30, 1982, 1983, and 1984, for provisions setting forth appropriations through fiscal year ending Sept. 30, 1981, and provisions setting forth limitations, conditions, etc., for appropriations.

1979—Subsec. (j)(4), (5). Pub. L. 96–32 added par. (4), redesignated former par. (4) as (5) and, in par. (5) as so redesignated, substituted "paragraph (1), (2), (3), or (4)" for "paragraph (1), (2), or (3)".

1978Pub. L. 95–626, §202, amended section generally, substituting provisions relating to project grants for preventive health services for provisions relating to grants for disease control programs.

Subsec. (g)(2). Pub. L. 95–626, §204(b)(2), struck out "Except as provided in section 247c of this title," before "No funds appropriated under any provision of this chapter".

1976Pub. L. 94–317 amended section generally to include many non-communicable diseases as well as expanding coverage of communicable diseases, increased appropriations for grants, widened scope of Secretary's authority to make grants and enter into contracts to include nonprofit private entities, and required a report from the Secretary on the effectiveness of all Federal and other public and private activities in controlling the diseases covered under this section.

Subsecs. (j) to (l). Pub. L. 94–380 added subsecs. (j) to (l).

1975—Subsec. (d)(3). Pub. L. 94–63, §601(b), inserted authorization of appropriation for fiscal year 1976.

Subsec. (h)(1). Pub. L. 94–63, §601(a), inserted reference to diseases borne by rodents.

1974—Subsec. (a). Pub. L. 93–354, §4(1)–(3), substituted "communicable and other disease control" for "communicable disease control", "communicable and other diseases" for "communicable diseases", and "communicable and other disease control program" for "communicable disease program".

Subsec. (b)(2)(C). Pub. L. 93–354, §4(1), (4), substituted "communicable or other disease" for "communicable disease" in cl. (i) and "communicable and other disease control" for "communicable disease control" in cl. (ii).

Subsecs. (b)(3), (d)(1), (2), (3), (f)(1). Pub. L. 93–354, §4(1), substituted "communicable and other disease control" for "communicable disease control".

Subsec. (h)(1). Pub. L. 93–354, §4(1), (5), substituted "communicable and other disease control" for "communicable disease control" in two places and inserted reference to diabetes mellitus.

Subsec. (i). Pub. L. 93–354, §4(1), substituted "communicable and other disease control" for "communicable disease control".

1972—Subsec. (a). Pub. L. 92–449 substituted provision for grants by the Secretary in consultation with the State health authority to agencies and political subdivisions of States, for former provision for grants by the Secretary with the approval of the State health authority to political subdivisions or instrumentalities of States, incorporated existing provisions in provision designated as cl. (1), inserting ", in the area served by the applicant for the grant,", substituted a cl. (2) reading "design of the applicant's communicable disease program to determine its effectiveness", for former provision reading "levels of performance in preventing and controlling such diseases", struck out appropriations authorization of $75,000,000 and $90,000,000 for fiscal years ending June 30, 1971, and 1972, now covered for subsequent years in subsec. (d), and struck out provision for use of grants to meet cost of studies to determine the control needs of communities and the means of best meeting such needs, now covered in subsec. (h)(1) of this section.

Subsec. (b). Pub. L. 92–449 substituted provisions of par. (1) respecting applications for grants, submission, approval, form, and content of applications; par. (2) respecting application requirements; and par. (3) incorporating former subsec. (g) provisions respecting consent of individuals for former definitions provision now incorporated in subsec. (h) of this section.

Subsec. (c). Pub. L. 92–449 designated existing provisions as par. (1) and among minor punctuation changes inserted "under grants" after "Payments"; and redesignated former subsec. (d) as par. (2), inserted "of the Government" after "officer or employee", substituted "in detailing the personnel" for "personal services", and struck out provision that reduced amount shall, for purposes of subsec. (c), be deemed to have been paid to the agency.

Subsec. (d). Pub. L. 92–449 substituted provisions respecting authorization of appropriations and limitation on use of funds for provisions respecting grant reduction.

Subsec. (e). Pub. L. 92–449 substituted provisions for emergency plan development and authorization of appropriations for provisions relating to use of funds.

Subsec. (f). Pub. L. 92–449 substituted provisions respecting conditional limitation on use of funds for provisions for an annual report.

Subsec. (g). Pub. L. 92–449 incorporated former subsec. (f) provisions in introductory text and cl. (3), prescribed a January 1 submission date, and inserted provisions of cls. (1), (2), and (4). Former subsec. (g) consent of individuals provision respecting communicable disease control and vaccination assistance were covered in subsec. (b)(3) of this section and section 247c(h) of this title.

Subsec. (h). Pub. L. 92–449 redesignated former subsec. (b) as (h), substituted in introductory text "this section" for "this subsection", and in par. (1) struck out "venereal disease" after "tuberculosis,", inserted "(other than venereal disease)" after "other communicable diseases", and included in definition of "communicable disease control program" vaccination programs, laboratory services, and control studies.

Subsec. (i). Pub. L. 92–449 redesignated former subsec. (e) as (i), inserted reference to agency of a State, and substituted "under provisions of Federal law (other than this chapter)" for "under other provisions of this chapter or other Federal law".

1970—Subsec. (a). Pub. L. 91–464 authorized appropriation of $75,000,000 for fiscal year ending June 30, 1971, and $90,000,000 for fiscal year ending June 30, 1972, and made award of grants dependent upon extent of communicable disease and success of programs and permitted use of grants for meeting cost of programs and studies to control communicable diseases and struck out reference to purchase of vaccines and use of grants for salaries and expenses of personnel and to authority of the Surgeon General.

Subsec. (b). Pub. L. 91–464 substituted definitions of "communicable disease control program" and "State" for definition of "immunization program".

Subsec. (c). Pub. L. 91–464 substituted reference to Secretary for reference to Surgeon General and struck out provisions relating to purchasing and furnishing of vaccines and requirement of obtaining assurances from recipients of grants.

Subsec. (d). Pub. L. 91–464 substituted reference to Secretary for reference to Surgeon General and struck out reference to Public Health Service.

Subsec. (e). Pub. L. 91–464 struck out reference to title V of the Social Security Act and substituted provisions for the use of funds for the conduct of communicable disease control programs for provisions for the purchase of vaccine or for organizing, promoting, conducting, or participating in immunization programs.

Subsecs. (f), (g). Pub. L. 91–464 added subsecs. (f) and (g).

1965—Subsec. (a). Pub. L. 89–109, §2(a), (b), (d)(1), inserted "and each of the next three fiscal years", substituted "any fiscal year ending prior to July 1, 1968" for "the fiscal years ending June 30, 1963, and June 30, 1964", "tetanus, and measles" for "and tetanus", "of preschool age" for "under the age of five years", and "immunization" for "intensive community vaccination", and permitted grants to be used to pay costs in connection with immunization of other infectious diseases.

Subsec. (b). Pub. L. 89–109, §2(c), (d)(1), substituted "against the diseases referred to in subsection (a) of this section" for "against poliomyelitis, diphtheria, whooping cough, and tetanus", "of preschool age" for "who are under the age of five years" and "immunization" for "intensive community vaccination" in two places.

Subsec. (c). Pub. L. 89–109, §2(d)(1), (e), inserted "on the basis of estimates" and "(with necessary adjustments on account of underpayments or overpayments)" in par. (1), and substituted "immunization" for "intensive community vaccination" in pars. (2) and (3).

Effective Date of 1978 Amendment

Pub. L. 95–626, title II, §202, Nov. 10, 1978, 92 Stat. 3574, as amended by Pub. L. 96–32, §6(g), July 10, 1979, 93 Stat. 83, provided that the amendment made by that section is effective Oct. 1, 1978.

Effective Date of 1976 Amendment

Pub. L. 94–317, title II, §202(a), Nov. 10, 1978, 92 Stat. 3574, provided that the amendment made by that section is effective with respect to grants under this section for fiscal years beginning after June 30, 1975.

Effective Date of 1975 Amendment

Pub. L. 94–63, title VI, §608, July 29, 1975, 89 Stat. 352, provided that: "Except as may otherwise be specifically provided, the amendments made by this title [enacting sections 300c–21 and 300c–22 of this title, amending this section, and enacting provisions set out as notes under sections 289, 289k–2, and 1395x of this title] and by titles I [amending section 246 of this title and enacting provisions set out as notes under section 246 of this title], II [enacting sections 300a–6a and 300a–8 of this title, amending sections 300 and 300a–1 to 300a–4 of this title, repealing section 3505c of this title, and enacting provision set out as a note under section 300 of this title], III [enacting sections 2689 to 2689aa of this title, amending sections 2691 and 2693 to 2696 of this title, and enacting provisions set out as notes under section 2689 of this title], IV [amending sections 218 and 254b of this title and enacting provision set out as a note under section 254b of this title], and V [enacting section 254c of this title and amending section 246 of this title] of this Act shall take effect July 1, 1975. The amendments made by this title and by such titles to the provisions of law amended by this title and by such titles are made to such provisions as amended by title VII of this Act [amending sections 246, 254b, 300, 300a–1 to 300a–3 of this title and sections 2681, 2687, 2688a, 2688d, 2688j–1, 2688j–2, 2688l, 2688l–1, 2688n–1, 2688o, and 2688u of this title]."

Effective Date of 1972 Amendment

Pub. L. 92–449, title I, §102, Sept. 30, 1972, 86 Stat. 750, provided that: "The amendment made by section 101 of this title [amending this section] shall apply to grants made under section 317 of the Public Health Service Act [42 U.S.C. 247b] after June 30, 1972, except that subsection (d) of such section as amended by section 101 shall take effect on the date of enactment of this Act [Sept. 30, 1972]."

Rule of Construction Regarding Access to Immunizations

Pub. L. 111–148, title IV, §4204(d), Mar. 23, 2010, 124 Stat. 572, provided that: "Nothing in this section [amending this section] (including the amendments made by this section), or any other provision of this Act [see Tables for classification] (including any amendments made by this Act) shall be construed to decrease children's access to immunizations."

Assistance of Administrator of Veterans' Affairs in Administration of National Swine Flu Immunization Program of 1976; Claims for Damages

Pub. L. 94–420, §3, Sept. 23, 1976, 90 Stat. 1301, provided that, in order to assist Secretary of Health, Education, and Welfare in carrying out National Swine Flu Immunization Program of 1976 pursuant to 42 U.S.C. 247b(j), as added by Pub. L. 94–380, Administrator of Veterans' Affairs, in accordance with 42 U.S.C. 247b(j), could authorize administration of vaccine, procured under such program and provided by Secretary at no cost to Veterans' Administration, to eligible veterans (voluntarily requesting such vaccine) in connection with provision of care for a disability under chapter 17 of title 38, in any health care facility under jurisdiction of Administrator, and provided for consideration and processing of claims and suits for damages for personal injury or death, in connection with administration of vaccine.

Study by Secretary of Scope and Extent of Liability Arising Out of Immunization Program; Alternative Protective Approaches; Report to Congress

Pub. L. 94–380, §3, Aug. 12, 1976, 90 Stat. 1118, directed Secretary to conduct a study of liability for personal injuries or death arising out of immunization programs and of alternative approaches to provide protection against such liability and report to Congress on findings of such study by Aug. 12, 1977.

1 So in original. Probably should be "subsection (a)".

1 See References in Text note below.

§247b–1. Screenings, referrals, and education regarding lead poisoning

(a) Authority for grants

(1) In general

Subject to paragraph (2), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States and political subdivisions of States for the initiation and expansion of community programs designed—

(A) to provide, for infants and children—

(i) screening for elevated blood lead levels;

(ii) referral for treatment of such levels; and

(iii) referral for environmental intervention associated with such levels; and


(B) to provide education about childhood lead poisoning.

(2) Authority regarding certain entities

With respect to a geographic area with a need for activities authorized in paragraph (1), in any case in which neither the State nor the political subdivision in which such area is located has applied for a grant under paragraph (1), the Secretary may make a grant under such paragraph to any grantee under section 254b, 254b, or 256a of this title 1 for carrying out such activities in the area.

(3) Provision of all services and activities through each grantee

In making grants under paragraph (1), the Secretary shall ensure that each of the activities described in such paragraph is provided through each grantee under such paragraph. The Secretary may authorize such a grantee to provide the services and activities directly, or through arrangements with other providers.

(b) Status as medicaid provider

(1) In general

Subject to paragraph (2), the Secretary may not make a grant under subsection (a) unless, in the case of any service described in such subsection that is made available pursuant to the State plan approved under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] for the State involved—

(A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation agreement under the State plan and is qualified to receive payments under such plan; or

(B) the applicant will enter into an agreement with a provider under which the provider will provide the service, and the provider has entered into such a participation agreement and is qualified to receive such payments.

(2) Waiver regarding certain secondary agreements

(A) In the case of a provider making an agreement pursuant to paragraph (1)(B) regarding the provision of services, the requirement established in such paragraph regarding a participation agreement shall be waived by the Secretary if the provider does not, in providing health care services, impose a charge or accept reimbursement available from any third-party payor, including reimbursement under any insurance policy or under any Federal or State health benefits plan.

(B) A determination by the Secretary of whether a provider referred to in subparagraph (A) meets the criteria for a waiver under such subparagraph shall be made without regard to whether the provider accepts voluntary donations regarding the provision of services to the public.

(c) Priority in making grants

In making grants under subsection (a), the Secretary shall give priority to applications for programs that will serve areas with a high incidence of elevated blood lead levels in infants and children.

(d) Grant application

No grant may be made under subsection (a), unless an application therefor has been submitted to, and approved by, the Secretary. Such an application shall be in such form and shall be submitted in such manner as the Secretary shall prescribe and shall include each of the following:

(1) A complete description of the program which is to be provided by or through the applicant.

(2) Assurances satisfactory to the Secretary that the program to be provided under the grant applied for will include educational programs designed to—

(A) communicate to parents, educators, and local health officials the significance and prevalence of lead poisoning in infants and children (including the sources of lead exposure, the importance of screening young children for lead, and the preventive steps that parents can take in reducing the risk of lead poisoning) which the program is designed to detect and prevent; and

(B) communicate to health professionals and paraprofessionals updated knowledge concerning lead poisoning and research (including the health consequences, if any, of low-level lead burden; the prevalence of lead poisoning among all socioeconomic groupings; the benefits of expanded lead screening; and the therapeutic and other interventions available to prevent and combat lead poisoning in affected children and families).


(3) Assurances satisfactory to the Secretary that the applicant will report on a quarterly basis the number of infants and children screened for elevated blood lead levels, the number of infants and children who were found to have elevated blood lead levels, the number and type of medical referrals made for such infants and children, the outcome of such referrals, and other information to measure program effectiveness.

(4) Assurances satisfactory to the Secretary that the applicant will make such reports respecting the program involved as the Secretary may require.

(5) Assurances satisfactory to the Secretary that the applicant will coordinate the activities carried out pursuant to subsection (a) with related activities and services carried out in the State by grantees under title V or XIX of the Social Security Act [42 U.S.C. 701 et seq., 1396 et seq.].

(6) Assurances satisfactory to the Secretary that Federal funds made available under such a grant for any period will be so used as to supplement and, to the extent practical, increase the level of State, local, and other non-Federal funds that would, in the absence of such Federal funds, be made available for the program for which the grant is to be made and will in no event supplant such State, local, and other non-Federal funds.

(7) Assurances satisfactory to the Secretary that the applicant will ensure complete and consistent reporting of all blood lead test results from laboratories and health care providers to State and local health departments in accordance with guidelines of the Centers for Disease Control and Prevention for standardized reporting as described in subsection (m).

(8) Such other information as the Secretary may prescribe.

(e) Relationship to services and activities under other programs

(1) In general

A recipient of a grant under subsection (a) may not make payments from the grant for any service or activity to the extent that payment has been made, or can reasonably be expected to be made, with respect to such service or activity—

(A) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or

(B) by an entity that provides health services on a prepaid basis.

(2) Applicability to certain secondary agreements for provision of services

Paragraph (1) shall not apply in the case of a provider through which a grantee under subsection (a) provides services under such subsection if the Secretary has provided a waiver under subsection (b)(2) regarding the provider.

(f) Method and amount of payment

The Secretary shall determine the amount of a grant made under subsection (a). Payments under such grants may be made in advance on the basis of estimates or by way of reimbursement, with necessary adjustments on account of underpayments or overpayments, and in such installments and on such terms and conditions as the Secretary finds necessary to carry out the purposes of such grants. Not more than 10 percent of any grant may be obligated for administrative costs.

(g) Supplies, equipment, and employee detail

The Secretary, at the request of a recipient of a grant under subsection (a), may reduce the amount of such grant by—

(1) the fair market value of any supplies or equipment furnished the grant recipient; and

(2) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or employee;


when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out a program with respect to which the grant under subsection (a) is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant recipient.

(h) Records

Each recipient of a grant under subsection (a) shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the undertaking in connection with which such grant was made, and the amount of that portion of the cost of the undertaking supplied by other sources, and such other records as will facilitate an effective audit.

(i) Audit and examination of records

The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipient of a grant under subsection (a), that are pertinent to such grant.

(j) Annual report

(1) In general

Not later than May 1 of each year, the Secretary shall submit to the Congress a report on the effectiveness during the preceding fiscal year of programs carried out with grants under subsection (a) and of any programs that are carried out by the Secretary pursuant to subsection (l)(2).

(2) Certain requirements

Each report under paragraph (1) shall include, in addition to any other information that the Secretary may require, the following information:

(A) The number of infants and children screened.

(B) Demographic information on the population of infants and children screened, including the age and racial or ethnic status of such population.

(C) The number of screening sites.

(D) A description of the severity of the extent of the blood lead levels of the infants and children screened, expressed in categories of severity.

(E) The sources of payment for the screenings.

(F) The number of grantees that have established systems to ensure mandatory reporting of all blood lead tests from laboratories and health care providers to State and local health departments.

(G) A comparison of the data provided pursuant to subparagraphs (A) through (F) with the equivalent data, if any, provided in the report under paragraph (1) preceding the report involved.

(k) Indian tribes

For purposes of this section, the term "political subdivision" includes Indian tribes.

(l) Funding

(1) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated $40,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 2005.

(2) Allocation for other programs

Of the amounts appropriated under paragraph (1) for any fiscal year, the Secretary may reserve not more than 20 percent for carrying out programs regarding the activities described in subsection (a) in addition to the program of grants established in such subsection.

(m) Guidelines for standardized reporting

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall develop national guidelines for the uniform reporting of all blood lead test results to State and local health departments.

(July 1, 1944, ch. 373, title III, §317A, as added Pub. L. 100–572, §3, Oct. 31, 1988, 102 Stat. 2887; amended Pub. L. 102–531, title III, §303(a), Oct. 27, 1992, 106 Stat. 3484; Pub. L. 103–183, title VII, §705(a), Dec. 14, 1993, 107 Stat. 2241; Pub. L. 105–392, title IV, §404, Nov. 13, 1998, 112 Stat. 3588; Pub. L. 106–310, div. A, title XXV, §§2501(a), (b), 2504, Oct. 17, 2000, 114 Stat. 1161, 1164; Pub. L. 107–251, title VI, §601(a), Oct. 26, 2002, 116 Stat. 1664; Pub. L. 108–163, §2(m)(1), Dec. 6, 2003, 117 Stat. 2023.)

References in Text

The reference to section 254b of this title the first place appearing, referred to in subsec. (a)(2), was in the original a reference to section 329, meaning section 329 of act July 1, 1944, which was omitted in the general amendment of subpart I (§254b et seq.) of part D of this subchapter by Pub. L. 104–299, §2, Oct. 11, 1996, 110 Stat. 3626.

Section 256a of this title, referred to in subsec. (a)(2), was repealed by Pub. L. 104–299, §4(a)(3), Oct. 11, 1996, 110 Stat. 3645.

The Social Security Act, referred to in subsecs. (b)(1) and (d)(5), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Titles V and XIX of the Act are classified generally to subchapters V (§701 et seq.) and XIX (§1396 et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables.

Prior Provisions

A prior section 247b–1, Pub. L. 95–626, title IV, §401, Nov. 10, 1978, 92 Stat. 3590; S. Res. 30, Mar. 7, 1979; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; H. Res. 549, Mar. 25, 1980, related to demonstration and evaluation of optimal methods for organizing and delivering comprehensive preventive health services to defined populations, prior to repeal by Pub. L. 97–35, title IX, §902(a), (h), Aug. 13, 1981, 95 Stat. 559, 561, eff. Oct. 1, 1981.

Amendments

2003—Subsec. (a)(2). Pub. L. 108–163 substituted "254b" for "254c, 254b(h)" before ", or".

2002—Subsec. (a)(2). Pub. L. 107–251 substituted "254b(h)" for "256".

2000—Subsec. (d)(7), (8). Pub. L. 106–310, §2501(a)(1), added par. (7) and redesignated former par. (7) as (8).

Subsec. (j)(2)(F), (G). Pub. L. 106–310, §2501(a)(2), added subpar. (F), redesignated former subpar. (F) as (G), and substituted "(F)" for "(E)".

Subsec. (l)(1). Pub. L. 106–310, §2504, substituted "1994 through 2005" for "1994 through 2002".

Subsec. (m). Pub. L. 106–310, §2501(b), added subsec. (m).

1998—Subsec. (l)(1). Pub. L. 105–392 substituted "2002" for "1998".

1993—Subsec. (l)(1). Pub. L. 103–183 substituted "through 1998" for "through 1997".

1992Pub. L. 102–531 amended section generally, substituting present provisions for provisions relating to grants to States for lead poisoning prevention, grant applications, conditions for approval, method and amount of payment, reduction of amount, recordkeeping and audits, inclusion of Indian tribes as grant recipients, and authorization of appropriations.

Effective Date of 2003 Amendment

Amendment by Pub. L. 108–163 deemed to have taken effect immediately after the enactment of Pub. L. 107–251, see section 3 of Pub. L. 108–163, set out as a note under section 233 of this title.

Development and Implementation of Effective Data Management by the Centers for Disease Control and Prevention

Pub. L. 106–310, div. A, title XXV, §2501(c), Oct. 17, 2000, 114 Stat. 1161, provided that:

"(1) In general.—The Director of the Centers for Disease Control and Prevention shall—

"(A) assist with the improvement of data linkages between State and local health departments and between State health departments and the Centers for Disease Control and Prevention;

"(B) assist States with the development of flexible, comprehensive State-based data management systems for the surveillance of children with lead poisoning that have the capacity to contribute to a national data set;

"(C) assist with the improvement of the ability of State-based data management systems and federally-funded means-tested public benefit programs (including the special supplemental food program for women, infants and children (WIC) under section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786) and the early head start program under section 645A of the Head Start Act (42 U.S.C. 9840a(h)) to respond to ad hoc inquiries and generate progress reports regarding the lead blood level screening of children enrolled in those programs;

"(D) assist States with the establishment of a capacity for assessing how many children enrolled in the Medicaid, WIC, early head start, and other federally-funded means-tested public benefit programs are being screened for lead poisoning at age-appropriate intervals;

"(E) use data obtained as result of activities under this section to formulate or revise existing lead blood screening and case management policies; and

"(F) establish performance measures for evaluating State and local implementation of the requirements and improvements described in subparagraphs (A) through (E).

"(2) Authorization of appropriations.—There are authorized to be appropriated to carry out this subsection such sums as may be necessary for each [sic] the fiscal years 2001 through 2005.

"(3) Effective date.—This subsection takes effect on the date of the enactment of this Act [Oct. 17, 2000]."

1 See References in Text notes below.

§247b–2. Repealed. Pub. L. 97–35, title IX, §902(a), Aug. 13, 1981, 95 Stat. 559

Section, Pub. L. 95–626, title IV, §402, Nov. 10, 1978, 92 Stat. 3591; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695, related to deterrence of smoking and alcoholic beverage use among children and adolescents.

Effective Date of Repeal

Repeal effective Oct. 1, 1981, see section 902(h) of Pub. L. 97–35, set out as an Effective Date of 1981 Amendment note under section 300aaa–12 of this title.

§247b–3. Education, technology assessment, and epidemiology regarding lead poisoning

(a) Prevention

(1) Public education

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall carry out a program to educate health professionals and paraprofessionals and the general public on the prevention of lead poisoning in infants and children. In carrying out the program, the Secretary shall make available information concerning the health effects of low-level lead toxicity, the causes of lead poisoning, and the primary and secondary preventive measures that may be taken to prevent such poisoning.

(2) Interagency Task Force

(A) Not later than 6 months after October 27, 1992, the Secretary shall establish a council to be known as the Interagency Task Force on the Prevention of Lead Poisoning (in this paragraph referred to as the "Task Force"). The Task Force shall coordinate the efforts of Federal agencies to prevent lead poisoning.

(B) The Task Force shall be composed of—

(i) the Secretary, who shall serve as the chair of the Task Force;

(ii) the Secretary of Housing and Urban Development;

(iii) the Administrator of the Environmental Protection Agency; and

(iv) senior staff of each of the officials specified in clauses (i) through (iii), as selected by the officials respectively.


(C) The Task Force shall—

(i) review, evaluate, and coordinate current strategies and plans formulated by the officials serving as members of the Task Force, including—

(I) the plan of the Secretary of Health and Human Services entitled "Strategic Plan for the Elimination of Lead Poisoning", dated February 21, 1991;

(II) the plan of the Secretary of Housing and Urban Development entitled "Comprehensive and Workable Plan for the Abatement of Lead-Based Paint in Privately Owned Housing", dated December 7, 1990; and

(III) the strategy of the Administrator of the Environmental Protection Agency entitled "Strategy for Reducing Lead Exposures", dated February 21, 1991;


(ii) develop a unified implementation plan for programs that receive Federal financial assistance for activities related to the prevention of lead poisoning;

(iii) establish a mechanism for sharing and disseminating information among the agencies represented on the Task Force;

(iv) identify the most promising areas of research and education concerning lead poisoning;

(v) identify the practical and technological constraints to expanding lead poisoning prevention;

(vi) annually carry out a comprehensive review of Federal programs providing assistance to prevent lead poisoning, and not later than May 1 of each year, submit to the Committee on Labor and Human Resources of the Senate and the Committee on the Environment and Public Works of the Senate, and to the Committee on Energy and Commerce of the House of Representatives, a report that summarizes the findings made as a result of such review and that contains the recommendations of the Task Force on the programs and policies with respect to which the Task Force is established, including related budgetary recommendations; and

(vii) annually review and coordinate departmental and agency budgetary requests with respect to all lead poisoning prevention activities of the Federal Government.

(b) Technology assessment and epidemiology

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, directly or through grants or contracts—

(1) provide for the development of improved, more cost-effective testing measures for detecting lead toxicity in children;

(2) provide for the development of improved methods of assessing the prevalence of lead poisoning, including such methods as may be necessary to conduct individual assessments for each State;

(3) provide for the collection of data on the incidence and prevalence of lead poisoning of infants and children, on the demographic characteristics of infants and children with such poisoning (including racial and ethnic status), and on the source of payment for treatment for such poisoning (including the extent to which insurance has paid for such treatment); and

(4) provide for any applied research necessary to improve the effectiveness of programs for the prevention of lead poisoning in infants and children.

(July 1, 1944, ch. 373, title III, §317B, as added Pub. L. 102–531, title III, §303(b), Oct. 27, 1992, 106 Stat. 3488; amended Pub. L. 103–43, title XX, §2008(i)(1)(B)(i), June 10, 1993, 107 Stat. 212.)

Amendments

1993Pub. L. 103–43 made technical amendment to directory language of Pub. L. 102–531, §303(b), which enacted this section.

Change of Name

Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.

Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104–14, set out as a note preceding section 21 of Title 2, The Congress. Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.

§247b–3a. Training and reports by the Health Resources and Services Administration

(a) Training

The Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration and in collaboration with the Administrator of the Centers for Medicare & Medicaid Services and the Director of the Centers for Disease Control and Prevention, shall conduct education and training programs for physicians and other health care providers regarding childhood lead poisoning, current screening and treatment recommendations and requirements, and the scientific, medical, and public health basis for those policies.

(b) Report

The Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, annually shall report to Congress on the number of children who received services through health centers established under section 254b of this title and received a blood lead screening test during the prior fiscal year, noting the percentage that such children represent as compared to all children who received services through such health centers.

(c) Authorization of appropriations

There are authorized to be appropriated to carry out this section such sums as may be necessary for each 1 the fiscal years 2001 through 2005.

(Pub. L. 106–310, div. A, title XXV, §2503, Oct. 17, 2000, 114 Stat. 1163; Pub. L. 108–173, title IX, §900(e)(6)(E), Dec. 8, 2003, 117 Stat. 2374.)

Codification

Section was enacted as part of the Children's Health Act of 2000, and not as part of the Public Health Service Act which comprises this chapter.

Amendments

2003—Subsec. (a). Pub. L. 108–173 substituted "Centers for Medicare & Medicaid Services" for "Health Care Financing Administration".

1 So in original. Probably should be followed by "of".

§247b–4. National Center on Birth Defects and Developmental Disabilities

(a) In general

(1) National Center

There is established within the Centers for Disease Control and Prevention a center to be known as the National Center on Birth Defects and Developmental Disabilities (referred to in this section as the "Center"), which shall be headed by a director appointed by the Director of the Centers for Disease Control and Prevention.

(2) General duties

The Secretary shall carry out programs—

(A) to collect, analyze, and make available data on birth defects, developmental disabilities, and disabilities and health (in a manner that facilitates compliance with subsection (c)(2)), including data on the causes of such defects and disabilities and on the incidence and prevalence of such defects and disabilities;

(B) to operate regional centers for the conduct of applied epidemiological research on the prevention of such defects and disabilities;

(C) to provide information and education to the public on the prevention of such defects and disabilities;

(D) to conduct research on and to promote the prevention of such defects and disabilities, and secondary health conditions among individuals with disabilities; and

(E) to support a National Spina Bifida Program to prevent and reduce suffering from the Nation's most common permanently disabling birth defect.

(3) Folic acid

The Secretary shall carry out section 247b–11 of this title through the Center.

(4) Certain programs

(A) Transfers

All programs and functions described in subparagraph (B) are transferred to the Center, effective upon the expiration of the 180-day period beginning on October 17, 2000.

(B) Relevant programs

The programs and functions described in this subparagraph are all programs and functions that—

(i) relate to birth defects; folic acid; cerebral palsy; intellectual disabilities; child development; newborn screening; autism; fragile X syndrome; fetal alcohol syndrome; pediatric genetic disorders; disability prevention; or other relevant diseases, disorders, or conditions as determined 1 the Secretary; and

(ii) were carried out through the National Center for Environmental Health as of the day before October 17, 2000.

(C) Related transfers

Personnel employed in connection with the programs and functions specified in subparagraph (B), and amounts available for carrying out the programs and functions, are transferred to the Center, effective upon the expiration of the 180-day period beginning on October 17, 2000. Such transfer of amounts does not affect the period of availability of the amounts, or the availability of the amounts with respect to the purposes for which the amounts may be expended.

(b) Grants and contracts

(1) In general

In carrying out subsection (a), the Secretary may make grants to and enter into contracts with public and nonprofit private entities.

(2) Supplies and services in lieu of award funds

(A) Upon the request of a recipient of an award of a grant or contract under paragraph (1), the Secretary may, subject to subparagraph (B), provide supplies, equipment, and services for the purpose of aiding the recipient in carrying out the purposes for which the award is made and, for such purposes, may detail to the recipient any officer or employee of the Department of Health and Human Services.

(B) With respect to a request described in subparagraph (A), the Secretary shall reduce the amount of payments under the award involved by an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.

(3) Application for award

The Secretary may make an award of a grant or contract under paragraph (1) only if an application for the award is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out the purposes for which the award is to be made.

(c) Biennial report

Not later than February 1 of fiscal year 1999 and of every second such year thereafter, the Secretary shall submit to the Committee on Commerce of the House of Representatives, and the Committee on Labor and Human Resources of the Senate, a report that, with respect to the preceding 2 fiscal years—

(1) contains information regarding the incidence and prevalence of birth defects, developmental disabilities, and the health status of individuals with disabilities and the extent to which these conditions have contributed to the incidence and prevalence of infant mortality and affected quality of life;

(2) contains information under paragraph (1) that is specific to various racial and ethnic groups (including Hispanics, non-Hispanic whites, Blacks, Native Americans, and Asian Americans);

(3) contains an assessment of the extent to which various approaches of preventing birth defects, developmental disabilities, and secondary health conditions among individuals with disabilities have been effective;

(4) describes the activities carried out under this section;

(5) contains information on the incidence and prevalence of individuals living with birth defects and disabilities or developmental disabilities, information on the health status of individuals with disabilities, information on any health disparities experienced by such individuals, and recommendations for improving the health and wellness and quality of life of such individuals;

(6) contains a summary of recommendations from all birth defects research conferences sponsored by the Centers for Disease Control and Prevention, including conferences related to spina bifida; and

(7) contains any recommendations of the Secretary regarding this section.

(d) Applicability of privacy laws

The provisions of this section shall be subject to the requirements of section 552a of title 5. All Federal laws relating to the privacy of information shall apply to the data and information that is collected under this section.

(e) Advisory committee

Notwithstanding any other provision of law, the members of the advisory committee appointed by the Director of the National Center for Environmental Health that have expertise in birth defects, developmental disabilities, and disabilities and health shall be transferred to and shall advise the National Center on Birth Defects and Developmental Disabilities effective on December 3, 2003.

(f) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2003 through 2007.

(July 1, 1944, ch. 373, title III, §317C, as added Pub. L. 102–531, title III, §306(a), Oct. 27, 1992, 106 Stat. 3494; amended Pub. L. 103–43, title XX, §2008(i)(1)(B)(iii), June 10, 1993, 107 Stat. 213; Pub. L. 105–168, §2, Apr. 21, 1998, 112 Stat. 43; Pub. L. 106–310, div. A, title VI, §611, Oct. 17, 2000, 114 Stat. 1119; Pub. L. 108–154, §2, Dec. 3, 2003, 117 Stat. 1933; Pub. L. 111–256, §2(f)(1), Oct. 5, 2010, 124 Stat. 2644.)

Amendments

2010—Subsec. (a)(4)(B)(i). Pub. L. 111–256 substituted "intellectual disabilities;" for "mental retardation;".

2003—Subsec. (a)(2)(A). Pub. L. 108–154, §2(1)(A), substituted ", developmental disabilities, and disabilities and health" for "and developmental disabilities" and "subsection (c)(2)" for "subsection (d)(2)".

Subsec. (a)(2)(D), (E). Pub. L. 108–154, §2(1)(B)–(D), added subpars. (D) and (E).

Subsecs. (b), (c). Pub. L. 108–154, §2(2),(4), redesignated subsecs. (c) and (d) as (b) and (c), respectively, and struck out former subsec. (b) which related to additional provisions regarding collection of data.

Subsec. (d). Pub. L. 108–154, §2(4), redesignated subsec. (e) as (d). Former subsec. (d) redesignated (c).

Subsec. (d)(1). Pub. L. 108–154, §2(3)(A), added par. (1) and struck out former par. (1) which read as follows: "contains information regarding the incidence and prevalence of birth defects and the extent to which birth defects have contributed to the incidence and prevalence of infant mortality;".

Subsec. (d)(3). Pub. L. 108–154, §2(3)(B), inserted ", developmental disabilities, and secondary health conditions among individuals with disabilities" after "defects".

Subsec. (d)(5) to (7). Pub. L. 108–154, §2(3)(C)–(E), added pars. (5) and (6) and redesignated former par. (5) as (7).

Subsec. (e). Pub. L. 108–154, §2(5), added subsec. (e). Former subsec. (e) redesignated (d).

Subsec. (f). Pub. L. 108–154, §2(6) substituted "such sums as may be necessary for each of fiscal years 2003 through 2007." for "$30,000,000 for fiscal year 1999, $40,000,000 for fiscal year 2000, and such sums as may be necessary for each of the fiscal years 2001 and 2002."

2000Pub. L. 106–310, §611(1), substituted "National Center on Birth Defects and Developmental Disabilities" for "Programs regarding birth defects" in section catchline.

Subsec. (a). Pub. L. 106–310, §611(2), added subsec. (a) and struck out heading and text of former subsec. (a) relating to Secretary's responsibility, acting through the Centers for Disease Control and Prevention, to carry out programs regarding birth defects.

Subsec. (b)(1). Pub. L. 106–310, §611(3), substituted "subsection (a)(2)(A) of this section" for "subsection (a)(1) of this section" in introductory provisions.

1998Pub. L. 105–168 amended section generally, substituting present provisions for provisions which directed Secretary to encourage and assist States in collection and analysis of epidemiological data on birth defects and to establish and maintain National Information Clearinghouse on Birth Defects, required report not later than July 1, 1993, and biennially thereafter, and authorized appropriations for fiscal years 1993, 1994, and 1995.

1993Pub. L. 103–43 made technical amendment to directory language of Pub. L. 102–531, §306(a), which enacted this section.

Change of Name

Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.

Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.

Congressional Findings

Pub. L. 105–168, §1(b), Apr. 21, 1998, 112 Stat. 43, provided that: "Congress makes the following findings:

"(1) Birth defects are the leading cause of infant mortality, directly responsible for one out of every five infant deaths.

"(2) Thousands of the 150,000 infants born with a serious birth defect annually face a lifetime of chronic disability and illness.

"(3) Birth defects threaten the lives of infants of all racial and ethnic backgrounds. However, some conditions pose excess risks for certain populations. For example, compared to all infants born in the United States, Hispanic-American infants are more likely to be born with anencephaly spina bifida and other neural tube defects and African-American infants are more likely to be born with sickle-cell anemia.

"(4) Birth defects can be caused by exposure to environmental hazards, adverse health conditions during pregnancy, or genetic mutations. Prevention efforts are slowed by lack of information about the number and causes of birth defects. Outbreaks of birth defects may go undetected because surveillance and research efforts are underdeveloped and poorly coordinated.

"(5) Public awareness strategies, such as programs using folic acid vitamin supplements to prevent spina bifida and alcohol avoidance programs to prevent Fetal Alcohol Syndrome, are essential to prevent the heartache and costs associated with birth defects."

Definitions

For meaning of references to an intellectual disability and to individuals with intellectual disabilities in provisions amended by section 2 of Pub. L. 111–256, see section 2(k) of Pub. L. 111–256, set out as a note under section 1400 of Title 20, Education.

1 So in original. Probably should be followed by the word "by".

§247b–4a. Early detection, diagnosis, and interventions for newborns and infants with hearing loss

(a) Definitions

For the purposes of this section only, the following terms in this section are defined as follows:

(1) Hearing screening

Newborn and infant hearing screening consists of objective physiologic procedures to detect possible hearing loss and to identify newborns and infants who, after rescreening, require further audiologic and medical evaluations.

(2) Audiologic evaluation

Audiologic evaluation consists of procedures to assess the status of the auditory system; to establish the site of the auditory disorder; the type and degree of hearing loss, and the potential effects of hearing loss on communication; and to identify appropriate treatment and referral options. Referral options should include linkage to State IDEA part C coordinating agencies or other appropriate agencies, medical evaluation, hearing aid/sensory aid assessment, audiologic rehabilitation treatment, national and local consumer, self-help, parent, and education organizations, and other family-centered services.

(3) Medical evaluation

Medical evaluation by a physician consists of key components including history, examination, and medical decision making focused on symptomatic and related body systems for the purpose of diagnosing the etiology of hearing loss and related physical conditions, and for identifying appropriate treatment and referral options.

(4) Medical intervention

Medical intervention is the process by which a physician provides medical diagnosis and direction for medical and/or surgical treatment options of hearing loss and/or related medical disorder associated with hearing loss.

(5) Audiologic rehabilitation

Audiologic rehabilitation (intervention) consists of procedures, techniques, and technologies to facilitate the receptive and expressive communication abilities of a child with hearing loss.

(6) Early intervention

Early intervention (e.g., nonmedical) means providing appropriate services for the child with hearing loss and ensuring that families of the child are provided comprehensive, consumer-oriented information about the full range of family support, training, information services, communication options and are given the opportunity to consider the full range of educational and program placements and options for their child.

(b) Purposes

The purposes of this section are to clarify the authority within the Public Health Service Act [42 U.S.C. 201 et seq.] to authorize statewide newborn and infant hearing screening, evaluation and intervention programs and systems, technical assistance, a national applied research program, and interagency and private sector collaboration for policy development, in order to assist the States in making progress toward the following goals:

(1) All babies born in hospitals in the United States and its territories should have a hearing screening before leaving the birthing facility. Babies born in other countries and residing in the United States via immigration or adoption should have a hearing screening as early as possible.

(2) All babies who are not born in hospitals in the United States and its territories should have a hearing screening within the first 3 months of life.

(3) Appropriate audiologic and medical evaluations should be conducted by 3 months for all newborns and infants suspected of having hearing loss to allow appropriate referral and provisions for audiologic rehabilitation, medical and early intervention before the age of 6 months.

(4) All newborn and infant hearing screening programs and systems should include a component for audiologic rehabilitation, medical and early intervention options that ensures linkage to any new and existing statewide systems of intervention and rehabilitative services for newborns and infants with hearing loss.

(5) Public policy in regard to newborn and infant hearing screening and intervention should be based on applied research and the recognition that newborns, infants, toddlers, and children who are deaf or hard-of-hearing have unique language, learning, and communication needs, and should be the result of consultation with pertinent public and private sectors.

(c) Statewide newborn and infant hearing screening, evaluation and intervention programs and systems

Under the existing authority of the Public Health Service Act [42 U.S.C. 201 et seq.], the Secretary of Health and Human Services (in this section referred to as the "Secretary"), acting through the Administrator of the Health Resources and Services Administration, shall make awards of grants or cooperative agreements to develop statewide newborn and infant hearing screening, evaluation and intervention programs and systems for the following purposes:

(1) To develop and monitor the efficacy of statewide newborn and infant hearing screening, evaluation and intervention programs and systems. Early intervention includes referral to schools and agencies, including community, consumer, and parent-based agencies and organizations and other programs mandated by part C of the Individuals with Disabilities Education Act [20 U.S.C. 1431 et seq.], which offer programs specifically designed to meet the unique language and communication needs of deaf and hard-of-hearing newborns, infants, toddlers, and children.

(2) To collect data on statewide newborn and infant hearing screening, evaluation and intervention programs and systems that can be used for applied research, program evaluation and policy development.

(d) Technical assistance, data management, and applied research

(1) Centers for Disease Control and Prevention

Under the existing authority of the Public Health Service Act [42 U.S.C. 201 et seq.], the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall make awards of grants or cooperative agreements to provide technical assistance to State agencies to complement an intramural program and to conduct applied research related to newborn and infant hearing screening, evaluation and intervention programs and systems. The program shall develop standardized procedures for data management and program effectiveness and costs, such as—

(A) to ensure quality monitoring of newborn and infant hearing loss screening, evaluation, and intervention programs and systems;

(B) to provide technical assistance on data collection and management;

(C) to study the costs and effectiveness of newborn and infant hearing screening, evaluation and intervention programs and systems conducted by State-based programs in order to answer issues of importance to State and national policymakers;

(D) to identify the causes and risk factors for congenital hearing loss;

(E) to study the effectiveness of newborn and infant hearing screening, audiologic and medical evaluations and intervention programs and systems by assessing the health, intellectual and social developmental, cognitive, and language status of these children at school age; and

(F) to promote the sharing of data regarding early hearing loss with State-based birth defects and developmental disabilities monitoring programs for the purpose of identifying previously unknown causes of hearing loss.

(2) National Institutes of Health

Under the existing authority of the Public Health Service Act, the Director of the National Institutes of Health, acting through the Director of the National Institute on Deafness and Other Communication Disorders, shall for purposes of this section, continue a program of research and development on the efficacy of new screening techniques and technology, including clinical studies of screening methods, studies on efficacy of intervention, and related research.

(e) Coordination and collaboration

(1) In general

Under the existing authority of the Public Health Service Act [42 U.S.C. 201 et seq.], in carrying out programs under this section, the Administrator of the Health Resources and Services Administration, the Director of the Centers for Disease Control and Prevention, and the Director of the National Institutes of Health shall collaborate and consult with other Federal agencies; State and local agencies, including those responsible for early intervention services pursuant to title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] (Medicaid Early and Periodic Screening, Diagnosis and Treatment Program); title XXI of the Social Security Act [42 U.S.C. 1397aa et seq.], (State Children's Health Insurance Program); title V of the Social Security Act [42 U.S.C. 701 et seq.] (Maternal and Child Health Block Grant Program); and part C of the Individuals with Disabilities Education Act [20 U.S.C. 1431 et seq.]; consumer groups of and that serve individuals who are deaf and hard-of-hearing and their families; appropriate national medical and other health and education specialty organizations; persons who are deaf and hard-of-hearing and their families; other qualified professional personnel who are proficient in deaf or hard-of-hearing children's language and who possess the specialized knowledge, skills, and attributes needed to serve deaf and hard-of-hearing newborns, infants, toddlers, children, and their families; third-party payers and managed care organizations; and related commercial industries.

(2) Policy development

Under the existing authority of the Public Health Service Act, the Administrator of the Health Resources and Services Administration, the Director of the Centers for Disease Control and Prevention, and the Director of the National Institutes of Health shall coordinate and collaborate on recommendations for policy development at the Federal and State levels and with the private sector, including consumer, medical and other health and education professional-based organizations, with respect to newborn and infant hearing screening, evaluation and intervention programs and systems.

(3) State early detection, diagnosis, and intervention programs and systems; data collection

Under the existing authority of the Public Health Service Act, the Administrator of the Health Resources and Services Administration and the Director of the Centers for Disease Control and Prevention shall coordinate and collaborate in assisting States to establish newborn and infant hearing screening, evaluation and intervention programs and systems under subsection (c) and to develop a data collection system under subsection (d).

(f) Rule of construction

Nothing in this section shall be construed to preempt any State law.

(g) Authorization of appropriations

(1) Statewide newborn and infant hearing screening, evaluation and intervention programs and systems

For the purpose of carrying out subsection (c) under the existing authority of the Public Health Service Act [42 U.S.C. 201 et seq.], there are authorized to the Health Resources and Services Administration appropriations in the amount of $5,000,000 for fiscal year 2000, $8,000,000 for fiscal year 2001, and such sums as may be necessary for fiscal year 2002.

(2) Technical assistance, data management, and applied research; Centers for Disease Control and Prevention

For the purpose of carrying out subsection (d)(1) under the existing authority of the Public Health Service Act, there are authorized to the Centers for Disease Control and Prevention, appropriations in the amount of $5,000,000 for fiscal year 2000, $7,000,000 for fiscal year 2001, and such sums as may be necessary for fiscal year 2002.

(3) Technical assistance, data management, and applied research; National Institute on Deafness and Other Communication Disorders

For the purpose of carrying out subsection (d)(2) under the existing authority of the Public Health Service Act, there are authorized to the National Institute on Deafness and Other Communication Disorders appropriations for such sums as may be necessary for each of the fiscal years 2000 through 2002.

(Pub. L. 106–113, div. B, §1000(a)(4) [title VI, §601], Nov. 29, 1999, 113 Stat. 1535, 1501A-276.)

References in Text

The Public Health Service Act, referred to in subsecs. (b) to (e) and (g), is act July 1, 1944, ch. 373, 58 Stat. 682, as amended, which is classified generally to this chapter (§201 et seq.). For complete classification of this Act to the Code, see Short Title note set out under section 201 of this title and Tables.

The Individuals with Disabilities Education Act, referred to in subsecs. (c)(1) and (e)(1), is title VI of Pub. L. 91–230, Apr. 13, 1970, 84 Stat. 175, as amended. Part C of the Act is classified generally to subchapter III (§1431 et seq.) of chapter 33 of Title 20, Education. For complete classification of this Act to the Code, see section 1400 of Title 20 and Tables.

The Social Security Act, referred to in subsec. (e)(1), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Titles V, XIX, and XXI of the Act are classified generally to subchapters V (§701 et seq.), XIX (§1396 et seq.), and XXI (§1397aa et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables.

Codification

Section was enacted as part of the Departments of Labor, Health, and Human Services, and Education, and Related Agencies Appropriations Act, 2000, and not as part of the Public Health Service Act which comprises this chapter.

§§247b–4b to 247b–4d. Repealed. Pub. L. 109–416, §3(b)(1)–(3), Dec. 19, 2006, 120 Stat. 2829

Section 247b–4b, Pub. L. 106–310, div. A, title I, §102, Oct. 17, 2000, 114 Stat. 1107, related to developmental disabilities surveillance and research programs.

Section 247b–4c, Pub. L. 106–310, div. A, title I, §103, Oct. 17, 2000, 114 Stat. 1108, related to information and education.

Section 247b–4d, Pub. L. 106–310, div. A, title I, §104, Oct. 17, 2000, 114 Stat. 1109, related to Inter-agency Autism Coordinating Committee.

§247b–4e. Repealed. Pub. L. 109–416, §3(b)(4), Dec. 19, 2006, 120 Stat. 2829; Pub. L. 109–482, title I, §104(b)(3)(D), Jan. 15, 2007, 120 Stat. 3694

Section, Pub. L. 106–310, div. A, title I, §105, Oct. 17, 2000, 114 Stat. 1109, related to annual report to Congress concerning the implementation of this section and sections 247b–4b to 247b–4d and 284g of this title.

Effective Date of Repeal

Repeal by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as an Effective Date of 2007 Amendment note under section 281 of this title.

§247b–4f. Research relating to preterm labor and delivery and the care, treatment, and outcomes of preterm and low birthweight infants

(a) Omitted

(b) Studies and activities on preterm birth

(1) In general

The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, may, subject to the availability of appropriations—

(A) conduct epidemiological studies on the factors relating to prematurity, such as clinical, biological, social, environmental, genetic, and behavioral factors, and other determinants that contribute to health disparities and are related to prematurity, as appropriate;

(B) conduct activities to improve national data to facilitate tracking the burden of preterm birth; and

(C) continue efforts to prevent preterm birth, including late preterm birth, through the identification of opportunities for prevention and the assessment of the impact of such efforts.

(2) Report

Not later than 2 years after November 27, 2013, and every 2 years thereafter, the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall submit to the appropriate committees of Congress reports regarding activities and studies conducted under paragraph (1), including any applicable analyses of preterm birth. Such report shall be posted on the Internet website of the Department of Health and Human Services..1

(c) Pregnancy risk assessment monitoring survey

The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall—

(1) continue systems for the collection of maternal-infant clinical and biomedical information, including electronic health records, electronic databases, and biobanks, to link with the Pregnancy Risk Assessment Monitoring System (PRAMS) and other epidemiological studies of prematurity in order to track, to the extent practicable, all pregnancy outcomes and prevent preterm birth; and

(2) provide technical assistance, as appropriate, to support States in improving the collection of information pursuant to this subsection.

(d) Evaluation of existing tools and measures

The Secretary of Health and Human Services shall review existing tools and measures to ensure that such tools and measures include information related to the known risk factors of low birth weight and preterm birth.

(e) Authorization of appropriations

There is authorized to be appropriated to carry out this section, $2,000,000 for each of fiscal years 2019 through 2023.

(Pub. L. 109–450, §3, Dec. 22, 2006, 120 Stat. 3341; Pub. L. 113–55, title I, §102, Nov. 27, 2013, 127 Stat. 641; Pub. L. 115–328, §2, Dec. 18, 2018, 132 Stat. 4471.)

Codification

Section 2 of Pub. L. 115–328, which directed the amendment of section 2 of the Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act (Pub. L. 109–450), was executed to this section, which is section 3 of Pub. L. 109–450, to reflect the probable intent of Congress. See 2018 Amendment notes below.

Section is comprised of section 3 of Pub. L. 109–450. Subsec. (a) of section 3 of Pub. L. 109–450 amended section 241 of this title.

Section was enacted as part of the Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act or the PREEMIE Act, and not as part of the Public Health Service Act which comprises this chapter.

Amendments

2018—Subsec. (b)(1)(A). Pub. L. 115–328, §2(1)(A), substituted "factors relating to prematurity, such as clinical, biological, social, environmental, genetic, and behavioral factors, and other determinants that contribute to health disparities and are related" for "clinical, biological, social, environmental, genetic, and behavioral factors relating". See Codification note above.

Subsec. (b)(2). Pub. L. 115–328, §2(1)(B), substituted "regarding activities and studies conducted under paragraph (1), including any applicable analyses of preterm birth. Such report shall be posted on the Internet website of the Department of Health and Human Services." for "concerning the progress and any results of studies conducted under paragraph (1)". See Codification note above.

Subsec. (c). Pub. L. 115–328, §2(2), added subsec. (c) and struck out former subsec. (c) which established a pregnancy risk assessment monitoring survey and authorized appropriations. See Codification note above.

Subsec. (e). Pub. L. 115–328, §2(3), substituted "$2,000,000 for each of fiscal years 2019 through 2023" for "except for subsection (c), $1,880,000 for each of fiscal years 2014 through 2018". See Codification note above.

2013—Subsec. (b). Pub. L. 113–55, §102(a), added subsec. (b) and struck out former subsec. (b) which related to studies and reports on the relationship between prematurity and birth defects.

Subsec. (e). Pub. L. 113–55, §102(b), substituted "$1,880,000 for each of fiscal years 2014 through 2018." for "$5,000,000 for each of fiscal years 2007 through 2011."

Advisory Committee on Infant Mortality

Pub. L. 113–55, title I, §104(b), Nov. 27, 2013, 127 Stat. 643, as amended by Pub. L. 115–328, §4, Dec. 18, 2018, 132 Stat. 4473, provided that:

"(1) Establishment.—The Secretary of Health and Human Services (referred to in this section [enacting this note and repealing section 247b–4g of this title] as the 'Secretary') may establish an advisory committee known as the 'Advisory Committee on Infant Mortality' (referred to in this section as the 'Advisory Committee').

"(2) Duties.—The Advisory Committee shall provide advice, recommendations, or information to the Secretary as may be necessary to improve activities and programs to reduce severe maternal morbidity, maternal mortality, infant mortality, and preterm birth, which may include recommendations, advice, or information related to the following:

"(A) Programs of the Department of Health and Human Services that are directed at reducing infant mortality, preterm birth, and improving the health status of pregnant women and infants, and information on cost-effectiveness and outcomes of such programs.

"(B) Strategies to coordinate the various Federal programs and activities with State, local, and private programs and efforts that address factors that affect infant mortality.

"(C) The Healthy Start program under section 330H of the Public Health Service Act (42 U.S.C. 254c–8) and Healthy People 2020 infant mortality objectives.

"(D) Implementation of Healthy People objectives related to maternal and infant health.

"(E) Strategies to reduce racial, ethnic, geographic, and other health disparities in birth outcomes, including by increasing awareness of Federal programs related to appropriate access to, or information regarding, prenatal care to address risk factors for preterm labor and delivery.

"(F) Strategies, including the implementation of such strategies, to address gaps in Federal research, programs, and education efforts related to the prevention of severe maternal morbidity, maternal mortality, infant mortality, and other adverse birth outcomes.

"(3) Membership.—The Secretary shall ensure that the membership of the Advisory Committee includes the following:

"(A) Representatives provided for in the original charter of the Advisory Committee.

"(B) A representative of the National Center for Health Statistics.

"(4) Biennial report.—Not later than 1 year after the date of enactment of the PREEMIE Reauthorization Act of 2018 [Dec. 18, 2018], and every 2 years thereafter, the Advisory Committee shall—

"(A) publish a report summarizing activities and recommendations of the Advisory Committee since the publication of the previous report;

"(B) submit such report to the Secretary and the appropriate Committees of Congress; and

"(C) post such report on the Internet website of the Department of Health and Human Services."

Purpose

Pub. L. 109–450, §2, Dec. 22, 2006, 120 Stat. 3341, provided that: "It is the purpose of this Act [enacting this section and sections 247b–4g and 280g–5 of this title and amending sections 241 and 280g–4 of this title] to—

"(1) reduce rates of preterm labor and delivery;

"(2) work toward an evidence-based standard of care for pregnant women at risk of preterm labor or other serious complications, and for infants born preterm and at a low birthweight; and

"(3) reduce infant mortality and disabilities caused by prematurity."

1 So in original.

§247b–4g. Repealed. Pub. L. 113–55, title I, §104(a), Nov. 27, 2013, 127 Stat. 643

Section, Pub. L. 109–450, §5, Dec. 22, 2006, 120 Stat. 3343, related to establishment and activities of the Interagency Coordinating Council on Prematurity and Low Birthweight.

§247b–5. Preventive health measures with respect to prostate cancer

(a) In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States and local health departments for the purpose of enabling such States and departments to carry out programs that may include the following:

(1) To identify factors that influence the attitudes or levels of awareness of men and health care practitioners regarding screening for prostate cancer.

(2) To evaluate, in consultation with the Agency for Health Care Policy and Research and the National Institutes of Health, the effectiveness of screening strategies for prostate cancer.

(3) To identify, in consultation with the Agency for Health Care Policy and Research, issues related to the quality of life for men after prostrate 1 cancer screening and followup.

(4) To develop and disseminate public information and education programs for prostate cancer, including appropriate messages about the risks and benefits of prostate cancer screening for the general public, health care providers, policy makers and other appropriate individuals.

(5) To improve surveillance for prostate cancer.

(6) To address the needs of underserved and minority populations regarding prostate cancer.

(7) Upon a determination by the Secretary, who shall take into consideration recommendations by the United States Preventive Services Task Force and shall seek input, where appropriate, from professional societies and other private and public entities, that there is sufficient consensus on the effectiveness of prostate cancer screening—

(A) to screen men for prostate cancer as a preventive health measure;

(B) to provide appropriate referrals for the medical treatment of men who have been screened under subparagraph (A) and to ensure, to the extent practicable, the provision of appropriate followup services and support services such as case management;

(C) to establish mechanisms through which State and local health departments can monitor the quality of screening procedures for prostate cancer, including the interpretation of such procedures; and

(D) to improve, in consultation with the Health Resources and Services Administration, the education, training, and skills of health practitioners (including appropriate allied health professionals) in the detection and control of prostate cancer.


(8) To evaluate activities conducted under paragraphs (1) through (7) through appropriate surveillance or program monitoring activities.

(b) Requirement of matching funds

(1) In general

The Secretary may not make a grant under subsection (a) unless the applicant involved agrees, with respect to the costs to be incurred by the applicant in carrying out the purpose described in such section, to make available non-Federal contributions (in cash or in kind under paragraph (2)) toward such costs in an amount equal to not less than $1 for each $3 of Federal funds provided in the grant. Such contributions may be made directly or through donations from public or private entities.

(2) Determination of amount of non-Federal contribution

(A) Non-Federal contributions required in paragraph (1) may be in cash or in kind, fairly evaluated, including equipment or services (and excluding indirect or overhead costs). Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.

(B) In making a determination of the amount of non-Federal contributions for purposes of paragraph (1), the Secretary may include only non-Federal contributions in excess of the average amount of non-Federal contributions made by the applicant involved toward the purpose described in subsection (a) for the 2-year period preceding the fiscal year for which the applicant involved is applying to receive a grant under such subsection.

(C) In making a determination of the amount of non-Federal contributions for purposes of paragraph (1), the Secretary shall, subject to subparagraphs (A) and (B) of this paragraph, include any non-Federal amounts expended pursuant to title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] by the applicant involved toward the purpose described in paragraphs (1) and (2) of subsection (a).

(c) Education on significance of early detection

The Secretary may not make a grant under subsection (a) unless the applicant involved agrees that, in carrying out subsection (a)(3), the applicant will carry out education programs to communicate to men, and to local health officials, the significance of the early detection of prostate cancer.

(d) Requirement of provision of all services by date certain

The Secretary may not make a grant under subsection (a) unless the applicant involved agrees—

(1) to ensure that, initially and throughout the period during which amounts are received pursuant to the grant, not less than 60 percent of the grant is expended to provide each of the services or activities described in paragraphs (1) and (2) of such subsection;

(2) to ensure that, by the end of any second fiscal year of payments pursuant to the grant, each of the services or activities described in such subsection is provided; and

(3) to ensure that not more than 40 percent of the grant is expended to provide the services or activities described in paragraphs (3) through (6) of such section.2

(e) Additional required agreements

(1) Priority for low-income men

The Secretary may not make a grant under subsection (a) unless the applicant involved agrees that low-income men, and men at risk of prostate cancer, will be given priority in the provision of services and activities pursuant to paragraphs (1) and (2) of such subsection.

(2) Limitation on imposition of fees for services

The Secretary may not make a grant under subsection (a) unless the applicant involved agrees that, if a charge is imposed for the provision of services or activities under the grant, such charge—

(A) will be made according to a schedule of charges that is made available to the public;

(B) will be adjusted to reflect the income of the man involved; and

(C) will not be imposed on any man with an income of less than 100 percent of the official poverty line, as established by the Director of the Office of Management and Budget and revised by the Secretary in accordance with section 9902(2) of this title.

(3) Relationship to items and services under other programs

The Secretary may not make a grant under subsection (a) unless the applicant involved agrees that the grant will not be expended to make payment for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to such item or service—

(A) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or

(B) by an entity that provides health services on a prepaid basis.

(4) Coordination with other prostate cancer programs

The Secretary may not make a grant under subsection (a) unless the applicant involved agrees that the services and activities funded through the grant will be coordinated with other Federal, State, and local prostate cancer programs.

(5) Limitation on administrative expenses

The Secretary may not make a grant under subsection (a) unless the applicant involved agrees that not more than 10 percent of the grant will be expended for administrative expenses with respect to the grant.

(6) Restrictions on use of grant

The Secretary may not make a grant under subsection (a) unless the applicant involved agrees that the grant will not be expended to provide inpatient hospital services for any individual.

(7) Records and audits

The Secretary may not make a grant under subsection (a) unless the applicant involved agrees that—

(A) the applicant will establish such fiscal control and fund accounting procedures as may be necessary to ensure the proper disbursal of, and accounting for, amounts received by the applicant under such section; 3 and

(B) upon request, the applicant will provide records maintained pursuant to paragraph (1) to the Secretary or the Comptroller of the United States for purposes of auditing the expenditures by the applicant of the grant.

(f) Reports to Secretary

The Secretary may not make a grant under subsection (a) unless the applicant involved agrees to submit to the Secretary such reports as the Secretary may require with respect to the grant.

(g) Description of intended uses of grant

The Secretary may not make a grant under subsection (a) unless—

(1) the applicant involved submits to the Secretary a description of the purposes for which the applicant intends to expend the grant;

(2) the description identifies the populations, areas, and localities in the applicant 4 with a need for the services or activities described in subsection (a);

(3) the description provides information relating to the services and activities to be provided, including a description of the manner in which the services and activities will be coordinated with any similar services or activities of public or nonprivate entities; and

(4) the description provides assurances that the grant funds will be used in the most cost-effective manner.

(h) Requirement of submission of application

The Secretary may not make a grant under subsection (a) unless an application for the grant is submitted to the Secretary, the application contains the description of intended uses required in subsection (g), and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.

(i) Method and amount of payment

The Secretary shall determine the amount of a grant made under subsection (a). Payments under such grants may be made in advance on the basis of estimates or by way of reimbursement, with necessary adjustments on account of the underpayments or overpayments, and in such installments and on such terms and conditions as the Secretary finds necessary to carry out the purposes of such grants.

(j) Technical assistance and provision of supplies and services in lieu of grant funds

(1) Technical assistance

The Secretary may provide training and technical assistance with respect to the planning, development, and operation of any program or service carried out pursuant to subsection (a). The Secretary may provide such technical assistance directly or through grants to, or contracts with, public and private entities.

(2) Provision of supplies and services in lieu of grant funds

(A) Upon the request of an applicant receiving a grant under subsection (a), the Secretary may, subject to subparagraph (B), provide supplies, equipment, and services for the purpose of aiding the applicant in carrying out such section and, for such purpose, may detail to the applicant any officer or employee of the Department of Health and Human Services.

(B) With respect to a request described in subparagraph (A), the Secretary shall reduce the amount of payments under the grant under subsection (a) to the applicant involved by an amount equal to the costs of detailing personnel (including pay, allowances, and travel expenses) and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.

(k) "Units of local government" defined

For purposes of this section, the term "units of local government" includes Indian tribes.

(l) Authorization of appropriations

(1) In general

For the purpose of carrying out this section, there are authorized to be appropriated $20,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 2004.

(2) Allocation for technical assistance

Of the amounts appropriated under paragraph (1) for a fiscal year, the Secretary shall reserve not more than 20 percent for carrying out subsection (j)(1).

(July 1, 1944, ch. 373, title III, §317D, as added Pub. L. 102–531, title III, §308, Oct. 27, 1992, 106 Stat. 3495; amended Pub. L. 103–43, title XX, §2010(i)(1)(B)(iv), June 10, 1993, 107 Stat. 213; Pub. L. 103–183, title VII, §705(b), Dec. 14, 1993, 107 Stat. 2241; Pub. L. 105–392, title IV, §401(a)(3), Nov. 13, 1998, 112 Stat. 3587; Pub. L. 106–505, title VI, §602(a), Nov. 13, 2000, 114 Stat. 2345.)

References in Text

The Social Security Act, referred to in subsec. (b)(2)(C), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Title XIX of the Act is classified generally to subchapter XIX (§1396 et seq.) of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables.

Amendments

2000—Subsec. (a). Pub. L. 106–505, §602(a)(1), added subsec. (a) and struck out heading and text of former subsec. (a). Text read as follows: "The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States and local health departments for the purpose of enabling such States and departments to carry out programs—

"(1) to screen men for prostate cancer as a preventive health measure;

"(2) to provide appropriate referrals for medical treatment of men screened pursuant to paragraph (1) and to ensure, to the extent practicable, the provision of appropriate follow-up services;

"(3) to develop and disseminate public information and education programs for the detection and control of prostate cancer;

"(4) to improve the education, training, and skills of health professionals (including appropriate allied health professionals) in the detection and control of prostate cancer;

"(5) to establish mechanisms through which the States and such departments can monitor the quality of screening procedures for prostate cancer, including the interpretation of such procedures; and

"(6) to evaluate activities conducted under paragraphs (1) through (5) through appropriate surveillance or program monitoring activities."

Subsec. (l)(1). Pub. L. 106–505, §602(a)(2), substituted "2004" for "1998".

1998—Subsec. (l)(1). Pub. L. 105–392 made technical amendment to directory language of Pub. L. 103–183. See 1993 Amendment note below.

1993Pub. L. 103–43 made technical amendment to directory language of Pub. L. 102–531, §308, which enacted this section.

Subsec. (l)(1). Pub. L. 103–183, as amended by Pub. L. 105–392, substituted "through 1998" for "through 1996".

Effective Date of 1998 Amendment

Amendment by Pub. L. 105–392 deemed to have taken effect immediately after enactment of Pub. L. 103–183, see section 401(e) of Pub. L. 105–392, set out as a note under section 242m of this title.

1 So in original. Probably should be "prostate".

2 So in original. Probably should be "subsection."

3 So in original. Probably should be "subsection;".

4 So in original. Probably should be "application".

§247b–6. National strategy for combating and eliminating tuberculosis

(a) In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States, political subdivisions, and other public entities for preventive health service programs for the prevention, control, and elimination of tuberculosis.

(b) Research and development; demonstration projects; education and training

With respect to the prevention, treatment, control, and elimination of tuberculosis, the Secretary may, directly or through grants to public or nonprofit private entities, carry out the following:

(1) Research, with priority given to research and development concerning latent tuberculosis infection, strains of tuberculosis resistant to drugs, and research concerning cases of tuberculosis that affect certain populations at risk for tuberculosis.

(2) Research and development and related activities to develop new tools for the elimination of tuberculosis, including drugs, diagnostics, vaccines, and public health interventions, such as directly observed therapy and non-pharmaceutical intervention, and methods to enhance detection and response to outbreaks of tuberculosis, including multidrug resistant tuberculosis. The Secretary is encouraged to give priority to programmatically relevant research so that new tools can be utilized in public health practice.

(3) Demonstration projects for—

(A) the development of regional capabilities to prevent, control, and eliminate tuberculosis and prevent multidrug resistant and extensively drug resistant strains of tuberculosis;

(B) the intensification of efforts to reduce health disparities in the incidence of tuberculosis;

(C) the intensification of efforts to control tuberculosis along the United States-Mexico border and among United States-Mexico binational populations, including through expansion of the scope and number of programs that—

(i) detect and treat binational cases of tuberculosis; and

(ii) treat high-risk cases of tuberculosis referred from Mexican health departments;


(D) the intensification of efforts to prevent, detect, and treat tuberculosis among foreign-born persons who are in the United States;

(E) the intensification of efforts to prevent, detect, and treat tuberculosis among populations and settings documented as having a high risk for tuberculosis; and

(F) tuberculosis detection, control, and prevention.


(4) Public information and education activities.

(5) Education, training, clinical skills improvement activities, and workplace exposure prevention for health professionals, including allied health personnel and emergency response employees.

(6) Support of Centers to carry out activities under paragraphs (1) through (4).

(7) Collaboration with international organizations and foreign countries in carrying out such activities.

(8) Develop, enhance, and expand information technologies that support tuberculosis control including surveillance and database management systems with cross-jurisdictional capabilities, which shall conform to the standards and implementation specifications for such information technologies as recommended by the Secretary.

(c) Cooperation with providers of primary health services

The Secretary may make a grant under subsection (a) or (b) only if the applicant for the grant agrees that, in carrying out activities under the grant, the applicant will cooperate with public and nonprofit private providers of primary health services or substance abuse services, including entities receiving assistance under section 254b, 254b, or 256a of this title 1 or under subchapter III–A or XVII.

(d) Application for grant

(1) In general

The Secretary may make a grant under subsection (a) or (b) only if an application for the grant is submitted to the Secretary and the application, subject to paragraph (2), is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out the subsection involved.

(2) Plan for prevention, control, and elimination

The Secretary may make a grant under subsection (a) only if the application under paragraph (1) contains a plan regarding the prevention, control, and elimination of tuberculosis in the geographic area with respect to which the grant is sought.

(3) Determination of amount of nonfederal contributions

(A) Priority

In awarding grants under subsection (a) or (b), the Secretary shall give highest priority to an applicant that provides assurances that the applicant will contribute non-Federal funds to carry out activities under this section, which may be provided directly or through donations from public or private entities and may be in cash or in kind, including equipment or services.

(B) Federal amounts not to be included as contributions

Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of non-Federal contributions as described in subparagraph (A).

(e) Supplies and services in lieu of grant funds

(1) In general

Upon the request of a grantee under subsection (a) or (b), the Secretary may, subject to paragraph (2), provide supplies, equipment, and services for the purpose of aiding the grantee in carrying out the subsection involved and, for such purpose, may detail to the State any officer or employee of the Department of Health and Human Services.

(2) Corresponding reduction in payments

With respect to a request described in paragraph (1), the Secretary shall reduce the amount of payments under the grant involved by an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.

(f) Advisory Council

(1) In general

The Secretary shall establish an advisory council to be known as the Advisory Council for the Elimination of Tuberculosis (in this subsection referred to as the "Council").

(2) Duties

The Council shall provide advice and recommendations regarding the elimination of tuberculosis to the Secretary. In addition, the Council shall, with respect to eliminating such disease, provide to the Secretary and other appropriate Federal officials advice on—

(A) coordinating the activities of the Department of Health and Human Services and other Federal agencies that relate to the disease, including activities under subsection (b);

(B) responding rapidly and effectively to emerging issues in tuberculosis; and

(C) efficiently utilizing the Federal resources involved.

(3) Comprehensive plan

(A) In general

In carrying out paragraph (2), the Council shall make or update recommendations on the development, revision, and implementation of a comprehensive plan to eliminate tuberculosis in the United States.

(B) Consultation

In carrying out subparagraph (A), the Council may consult with appropriate public and private entities, which may, subject to the direction or discretion of the Secretary, include—

(i) individuals who are scientists, physicians, laboratorians, and other health professionals, who are not officers or employees of the Federal Government and who represent the disciplines relevant to tuberculosis elimination;

(ii) members of public-private partnerships or private entities established to address the elimination of tuberculosis;

(iii) members of national and international nongovernmental organizations whose purpose is to eliminate tuberculosis;

(iv) members from the general public who are knowledgeable with respect to tuberculosis elimination including individuals who have or have had tuberculosis; and

(v) scientists, physicians, laboratorians, and other health professionals who reside in a foreign country with a substantial incidence or prevalence of tuberculosis, and who represent the specialties and disciplines relevant to the research under consideration.

(C) Certain components of plan

In carrying out subparagraph (A), the Council shall, subject to the direction or discretion of the Secretary—

(i) consider recommendations for the involvement of the United States in continuing global and cross-border tuberculosis control activities in countries where a high incidence of tuberculosis directly affects the United States; and

(ii) review the extent to which progress has been made toward eliminating tuberculosis.

(4) Biennial report

(A) In general

The Council shall submit a biennial report to the Secretary, as determined necessary by the Secretary, on the activities carried under this section. Each such report shall include the opinion of the Council on the extent to which its recommendations regarding the elimination of tuberculosis have been implemented, including with respect to—

(i) activities under subsection (b); and

(ii) the national plan referred to in paragraph (3).

(B) Public

The Secretary shall make a report submitted under subparagraph (A) public.

(5) Composition

The Council shall be composed of—

(A) ex officio representatives from the Centers for Disease Control and Prevention, the National Institutes of Health, the United States Agency for International Development, the Agency for Healthcare Research and Quality, the Health Resources and Services Administration, the United States-Mexico Border Health Commission, and other Federal departments and agencies that carry out significant activities related to tuberculosis;

(B) State and local tuberculosis control and public health officials;

(C) individuals who are scientists, physicians, laboratorians, and other health professionals who represent disciplines relevant to tuberculosis elimination; and

(D) members of national and international nongovernmental organizations established to address the elimination of tuberculosis.

(6) Staff, information, and other assistance

The Secretary shall provide to the Council such staff, information, and other assistance as may be necessary to carry out the duties of the Council.

(g) Federal Tuberculosis Task Force

(1) Duties

The Federal Tuberculosis Task Force (in this subsection referred to as the "Task Force") shall provide to the Secretary and other appropriate Federal officials advice on research into new tools under subsection (b)(2), including advice regarding the efficient utilization of the Federal resources involved.

(2) Comprehensive plan for new tools development

In carrying out paragraph (1), the Task Force shall make recommendations on the development of a comprehensive plan for the creation of new tools for the elimination of tuberculosis, including drugs, diagnostics, and vaccines.

(3) Consultation

In developing the comprehensive plan under paragraph (1),2 the Task Force shall consult with external parties including representatives from groups such as—

(A) scientists, physicians, laboratorians, and other health professionals who represent the specialties and disciplines relevant to the research under consideration;

(B) members from public-private partnerships, private entities, or foundations (or both) engaged in activities relevant to research under consideration;

(C) members of national and international nongovernmental organizations established to address tuberculosis elimination;

(D) members from the general public who are knowledgeable with respect to tuberculosis including individuals who have or have had tuberculosis; and

(E) scientists, physicians, laboratorians, and other health professionals who reside in a foreign country with a substantial incidence or prevalence of tuberculosis, and who represent the specialties and disciplines relevant to the research under consideration.

(h) Authorization of appropriations

(1) General program

(A) In general

For the purpose of carrying out this section, there are authorized to be appropriated $200,000,000 for fiscal year 2009, $210,000,000 for fiscal year 2010, $220,500,000 for fiscal year 2011, $231,525,000 for fiscal year 2012, and $243,101,250 for fiscal year 2013.

(B) Reservation for emergency grants

Of the amounts appropriated under subparagraph (A) for a fiscal year, the Secretary may reserve not more than 25 percent for emergency grants under subsection (a) for any geographic area, State, political subdivision of a State, or other public entity in which there is, relative to other areas, a substantial number of cases of tuberculosis, multidrug resistant tuberculosis, or extensively drug resistant tuberculosis or a substantial rate of increase in such cases.

(C) Priority

In allocating amounts appropriated under subparagraph (A), the Secretary shall give priority to allocating such amounts for grants under subsection (a).

(D) Allocation of funds

(i) Requirement of formula

Of the amounts appropriated under subparagraph (A), not reserved under subparagraph (B), and allocated by the Secretary for grants under subsection (a), the Secretary shall distribute a portion of such amounts to grantees under subsection (a) on the basis of a formula.

(ii) Relevant factors

The formula developed by the Secretary under clause (i) shall take into account the level of tuberculosis morbidity and case complexity in the respective geographic area and may consider other factors relevant to tuberculosis in such area.

(iii) No change to formula required

This subparagraph does not require the Secretary to modify the formula that was used by the Secretary to distribute funds to grantees under subsection (a) for fiscal year 2009.

(2) Limitation

The authorization of appropriations established in paragraph (1) for a fiscal year is effective only if the amount appropriated under such paragraph for such year equals or exceeds the amount appropriated to carry out this section for fiscal year 2009.

(July 1, 1944, ch. 373, title III, §317E, as added Pub. L. 103–183, title III, §301(a), Dec. 14, 1993, 107 Stat. 2233; amended Pub. L. 105–392, title IV, §§401(b)(1), 405, Nov. 13, 1998, 112 Stat. 3587, 3588; Pub. L. 107–251, title VI, §601(a), Oct. 26, 2002, 116 Stat. 1664; Pub. L. 108–163, §2(m)(1), Dec. 6, 2003, 117 Stat. 2023; Pub. L. 110–392, title I, §§101, 111(a), (c), 131, Oct. 13, 2008, 122 Stat. 4196, 4197, 4199, 4200.)

References in Text

The reference to section 254b of this title the first place appearing, referred to in subsec. (c), was in the original a reference to section 329, meaning section 329 of act July 1, 1944, which was omitted in the general amendment of subpart I (§254b et seq.) of part D of this subchapter by Pub. L. 104–299, §2, Oct. 11, 1996, 110 Stat. 3626.

Section 256a of this title, referred to in subsec. (c), was repealed by Pub. L. 104–299, §4(a)(3), Oct. 11, 1996, 110 Stat. 3645.

Amendments

2008Pub. L. 110–392, §101(1), substituted "National strategy for combating and eliminating tuberculosis" for "Preventive health services regarding tuberculosis" in section catchline.

Subsec. (b). Pub. L. 110–392, §101(2), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to research, demonstration projects, education, and training for the purpose of prevention, control, and elimination of tuberculosis.

Subsec. (d)(3). Pub. L. 110–392, §101(3), added par. (3).

Subsec. (f)(2) to (6). Pub. L. 110–392, §111(a), added pars. (2) to (5), redesignated former par. (5) as (6), and struck out former pars. (2) to (4) which related to general duties, certain activities, and composition of the Council, respectively.

Subsec. (g). Pub. L. 110–392, §111(c)(2), added subsec. (g). Former subsec. (g) redesignated (h).

Subsec. (h). Pub. L. 110–392, §131, added subsec. (h) and struck out former subsec. (h) which authorized appropriations for grants, research, demonstration projects, education, and training for fiscal years 1994 to 2002.

Pub. L. 110–392, §111(c)(1), redesignated subsec. (g) as (h).

2003—Subsec. (c). Pub. L. 108–163 substituted "254b" for "254c, 254b(h)" before ", or".

2002—Subsec. (c). Pub. L. 107–251 substituted "254b(h)" for "256".

1998—Subsec. (g)(1)(A). Pub. L. 105–392, §405(1)(A), substituted "2002" for "1998".

Subsec. (g)(1)(B). Pub. L. 105–392, §405(1)(B), substituted "25 percent" for "$50,000,000".

Subsec. (g)(2). Pub. L. 105–392, §405(2), substituted "2002" for "1998".

Pub. L. 105–392, §401(b)(1), substituted "carrying out subsection (b)" for "making grants under subsection (b)".

Effective Date of 2003 Amendment

Amendment by Pub. L. 108–163 deemed to have taken effect immediately after the enactment of Pub. L. 107–251, see section 3 of Pub. L. 108–163, set out as a note under section 233 of this title.

Effective Date of 1998 Amendment

Amendment by section 401(b)(1) of Pub. L. 105–392 deemed to have taken effect immediately after enactment of Pub. L. 103–183, see section 401(e) of Pub. L. 105–392, set out as a note under section 242m of this title.

Construction of 2008 Amendment

Pub. L. 110–392, title I, §111(b), Oct. 13, 2008, 122 Stat. 4199, provided that: "With respect to the advisory council under section 317E(f) of the Public Health Service Act [42 U.S.C. 247b–6(f)], the amendments made by subsection (a) [amending this section] may not be construed as terminating the membership on such council of any individual serving as such a member as of the day before the date of the enactment of this Act [Oct. 13, 2008]."

Termination of Advisory Councils

Advisory councils established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a council established by the President or an officer of the Federal Government, such council is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a council established by Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770, 776, set out in the Appendix to Title 5, Government Organization and Employees.

Pub. L. 93–641, §6, Jan. 4, 1975, 88 Stat. 2275, set out as a note under section 217a of this title, provided that an advisory committee established pursuant to the Public Health Service Act shall terminate at such time as may be specifically prescribed by an Act of Congress enacted after Jan. 4, 1975.

1 See References in Text notes below.

2 So in original. Probably should be "paragraph (2),".

§247b–7. Loan repayment program

(a) In general

(1) Authority

Subject to paragraph (2), the Secretary may carry out a program of entering into contracts with appropriately qualified health professionals under which such health professionals agree to conduct prevention activities or preparedness and response activities, including rapid response to public health emergencies and significant public health threats, as employees of the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry, in consideration of the Federal Government agreeing to repay, for each year of such service, not more than $50,000 of the principal and interest of the educational loans of such health professionals.

(2) Limitation

The Secretary may not enter into an agreement with a health professional pursuant to paragraph (1) unless such professional—

(A) has a substantial amount of educational loans relative to income; and

(B) agrees to serve as an employee of the Centers for Disease Control and Prevention or the Agency for Toxic Substances and Disease Registry for purposes of paragraph (1) for a period of not less than 2 years.

(b) Applicability of certain provisions

With respect to the National Health Service Corps Loan Repayment Program established in subpart III of part D of this subchapter, the provisions of such subpart shall, except as inconsistent with subsection (a), apply to the program established in this section in the same manner and to the same extent as such provisions apply to the National Health Service Corps Loan Repayment Program.

(c) Authorization of appropriations

(1) In general

For the purpose of carrying out this section, except as described in paragraph (2), there are authorized to be appropriated $500,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 2002.

(2) Epidemic Intelligence Service program

For purposes of carrying out this section with respect to qualified health professionals serving in the Epidemic Intelligence Service, as authorized under section 247b–8 of this title, there is authorized to be appropriated $1,000,000 for each of fiscal years 2019 through 2023.

(d) Availability of appropriations

Amounts appropriated for a fiscal year for contracts under subsection (a) shall remain available until the expiration of the second fiscal year beginning after the fiscal year for which the amounts were appropriated.

(July 1, 1944, ch. 373, title III, §317F, as added Pub. L. 103–183, title VII, §703, Dec. 14, 1993, 107 Stat. 2240; amended Pub. L. 105–392, title IV, §406, Nov. 13, 1998, 112 Stat. 3588; Pub. L. 116–22, title III, §301(c), June 24, 2019, 133 Stat. 932.)

Amendments

2019—Subsec. (a)(1). Pub. L. 116–22, §301(c)(1)(A), inserted "or preparedness and response activities, including rapid response to public health emergencies and significant public health threats" after "conduct prevention activities" and substituted "$50,000" for "$35,000".

Subsec. (a)(2)(B). Pub. L. 116–22, §301(c)(1)(B), substituted "2 years" for "3 years".

Subsec. (c). Pub. L. 116–22, §301(c)(2), designated existing provisions as par. (1), inserted heading, substituted "For the purpose of carrying out this section, except as described in paragraph (2)" for " For the purpose of carrying out this section", and added par. (2).

1998—Subsec. (a)(1). Pub. L. 105–392, §406(1), substituted "$35,000" for "$20,000".

Subsec. (c). Pub. L. 105–392, §406(2), substituted "2002" for "1998".

Subsec. (d). Pub. L. 105–392, §406(3), added subsec. (d).

§247b–8. Fellowship and training programs

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish fellowship and training programs to be conducted by such Centers to train individuals to develop skills in epidemiology, surveillance, laboratory analysis, and other disease detection and prevention methods. Such programs shall be designed to enable health professionals and health personnel trained under such programs to work, after receiving such training, in local, State, national, and international efforts toward the prevention and control of diseases, injuries, and disabilities. Such fellowships and training may be administered through the use of either appointment or nonappointment procedures.

(July 1, 1944, ch. 373, title III, §317G, as added Pub. L. 105–115, title IV, §408(b)(1), Nov. 21, 1997, 111 Stat. 2371.)

Effective Date

Pub. L. 105–115, title IV, §408(b)(2), Nov. 21, 1997, 111 Stat. 2371, provided that: "The amendment made by this subsection [enacting this section] is deemed to have taken effect July 1, 1995."

§247b–9. Diabetes in children and youth

(a) Surveillance on juvenile diabetes

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall develop a sentinel system to collect data on juvenile diabetes, including with respect to incidence and prevalence, and shall establish a national database for such data.

(b) Type 2 diabetes in youth

The Secretary shall implement a national public health effort to address type 2 diabetes in youth, including—

(1) enhancing surveillance systems and expanding research to better assess the prevalence and incidence of type 2 diabetes in youth and determine the extent to which type 2 diabetes is incorrectly diagnosed as type 1 diabetes among children; and

(2) developing and improving laboratory methods to assist in diagnosis, treatment, and prevention of diabetes including, but not limited to, developing noninvasive ways to monitor blood glucose to prevent hypoglycemia and improving existing glucometers that measure blood glucose.

(c) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.

(July 1, 1944, ch. 373, title III, §317H, as added Pub. L. 106–310, div. A, title IV, §401, Oct. 17, 2000, 114 Stat. 1112.)

§247b–9a. Better diabetes care

(a) Short title

This section may be cited as the "Catalyst to Better Diabetes Care Act of 2009".

(b) National diabetes report card

(1) In general

The Secretary, in collaboration with the Director of the Centers for Disease Control and Prevention (referred to in this section as the "Director"), shall prepare on a biennial basis a national diabetes report card (referred to in this section as a "Report Card") and, to the extent possible, for each State.1

(2) Contents

(A) In general

Each Report Card shall include aggregate health outcomes related to individuals diagnosed with diabetes and prediabetes including—

(i) preventative care practices and quality of care;

(ii) risk factors; and

(iii) outcomes.

(B) Updated reports

Each Report Card that is prepared after the initial Report Card shall include trend analysis for the Nation and, to the extent possible, for each State, for the purpose of—

(i) tracking progress in meeting established national goals and objectives for improving diabetes care, costs, and prevalence (including Healthy People 2010); and

(ii) informing policy and program development.

(3) Availability

The Secretary, in collaboration with the Director, shall make each Report Card publicly available, including by posting the Report Card on the Internet.

(c) Improvement of vital statistics collection

(1) In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in collaboration with appropriate agencies and States, shall—

(A) promote the education and training of physicians on the importance of birth and death certificate data and how to properly complete these documents, including the collection of such data for diabetes and other chronic diseases;

(B) encourage State adoption of the latest standard revisions of birth and death certificates; and

(C) work with States to re-engineer their vital statistics systems in order to provide cost-effective, timely, and accurate vital systems data.

(2) Death certificate additional language

In carrying out this subsection, the Secretary may promote improvements to the collection of diabetes mortality data, including the addition of a question for the individual certifying the cause of death regarding whether the deceased had diabetes.

(d) Study on appropriate level of diabetes medical education

(1) In general

The Secretary shall, in collaboration with the Institute of Medicine and appropriate associations and councils, conduct a study of the impact of diabetes on the practice of medicine in the United States and the appropriateness of the level of diabetes medical education that should be required prior to licensure, board certification, and board recertification.

(2) Report

Not later than 2 years after March 23, 2010, the Secretary shall submit a report on the study under paragraph (1) to the Committees on Ways and Means and Energy and Commerce of the House of Representatives and the Committees on Finance and Health, Education, Labor, and Pensions of the Senate.

(e) Authorization of appropriations

There are authorized to be appropriated to carry out this section such sums as may be necessary.

(Pub. L. 111–148, title X, §10407, Mar. 23, 2010, 124 Stat. 976.)

Codification

Section was enacted as part of the Patient Protection and Affordable Care Act, and not as part of the Public Health Service Act which comprises this chapter.

1 So in original.

§247b–10. Compilation of data on asthma

(a) In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall—

(1) conduct local asthma surveillance activities to collect data on the prevalence and severity of asthma and the quality of asthma management;

(2) compile and annually publish data on the prevalence of children suffering from asthma in each State; and

(3) to the extent practicable, compile and publish data on the childhood mortality rate associated with asthma nationally.

(b) Surveillance activities

The Director of the Centers for Disease Control and Prevention, acting through the representative of the Director on the National Asthma Education Prevention Program Coordinating Committee, shall, in carrying out subsection (a), provide an update on surveillance activities at each Committee meeting.

(c) Collaborative efforts

The activities described in subsection (a)(1) may be conducted in collaboration with eligible entities awarded a grant under section 280g of this title.

(d) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.

(July 1, 1944, ch. 373, title III, §317I, as added Pub. L. 106–310, div. A, title V, §531, Oct. 17, 2000, 114 Stat. 1117.)

§247b–11. Effects of folic acid in prevention of birth defects

(a) In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall expand and intensify programs (directly or through grants or contracts) for the following purposes:

(1) To provide education and training for health professionals and the general public for purposes of explaining the effects of folic acid in preventing birth defects and for purposes of encouraging each woman of reproductive capacity (whether or not planning a pregnancy) to consume on a daily basis a dietary supplement that provides an appropriate level of folic acid.

(2) To conduct research with respect to such education and training, including identifying effective strategies for increasing the rate of consumption of folic acid by women of reproductive capacity.

(3) To conduct research to increase the understanding of the effects of folic acid in preventing birth defects, including understanding with respect to cleft lip, cleft palate, and heart defects.

(4) To provide for appropriate epidemiological activities regarding folic acid and birth defects, including epidemiological activities regarding neural tube defects.

(b) Consultations with States and private entities

In carrying out subsection (a), the Secretary shall consult with the States and with other appropriate public or private entities, including national nonprofit private organizations, health professionals, and providers of health insurance and health plans.

(c) Technical assistance

The Secretary may (directly or through grants or contracts) provide technical assistance to public and nonprofit private entities in carrying out the activities described in subsection (a).

(d) Evaluations

The Secretary shall (directly or through grants or contracts) provide for the evaluation of activities under subsection (a) in order to determine the extent to which such activities have been effective in carrying out the purposes of the program under such subsection, including the effects on various demographic populations. Methods of evaluation under the preceding sentence may include surveys of knowledge and attitudes on the consumption of folic acid and on blood folate levels. Such methods may include complete and timely monitoring of infants who are born with neural tube defects.

(e) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.

(July 1, 1944, ch. 373, title III, §317J, as added Pub. L. 106–310, div. A, title VI, §601, Oct. 17, 2000, 114 Stat. 1118.)

§247b–12. Safe motherhood

(a) Surveillance

(1) Purpose

The purposes of this subsection are to establish or continue a Federal initiative to support State and tribal maternal mortality review committees, to improve data collection and reporting around maternal mortality, and to develop or support surveillance systems at the local, State, and national level to better understand the burden of maternal complications and mortality and to decrease the disparities among populations at risk of death and severe complications from pregnancy.

(2) Activities

For the purpose described in paragraph (1), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may carry out the following activities:

(A) The Secretary may continue and improve activities related to a national maternal mortality data collection and surveillance program to identify and support the review of pregnancy-associated deaths and pregnancy-related deaths that occur during, or within 1 year following, pregnancy.

(B) The Secretary may expand the Pregnancy Risk Assessment Monitoring System to provide surveillance and collect data in each State.

(C) The Secretary may expand the Maternal and Child Health Epidemiology Program to provide technical support, financial assistance, or the time-limited assignment of senior epidemiologists to maternal and child health programs in each State.

(D) The Secretary may, in cooperation with States, Indian tribes, and tribal organizations, develop a program to support States, Indian tribes, and tribal organizations in establishing or operating maternal mortality review committees, in accordance with subsection (d).

(b) Prevention research

(1) Purpose

The purpose of this subsection is to provide the Secretary with the authority to further expand research concerning risk factors, prevention strategies, and the roles of the family, health care providers and the community in safe motherhood.

(2) Research

The Secretary may carry out activities to expand research relating to—

(A) prepregnancy counseling, especially for at risk populations such as women with diabetes and women with substance use disorder;

(B) the identification of critical components of prenatal delivery and postpartum care;

(C) the identification of outreach and support services, such as folic acid education, that are available for pregnant women;

(D) the identification of women who are at high risk for complications;

(E) preventing preterm delivery;

(F) preventing urinary tract infections;

(G) preventing unnecessary caesarean sections;

(H) the identification of the determinants of disparities in maternal care, health risks, and health outcomes, including an examination of the higher rates of maternal mortality among African American women and other groups of women with disproportionately high rates of maternal mortality;

(I) activities to reduce disparities in maternity services and outcomes;

(J) an examination of the relationship between interpersonal violence and maternal complications and mortality;

(K) preventing and reducing adverse health consequences that may result from smoking and substance abuse and misuse before, during and after pregnancy;

(L) preventing infections that cause maternal and infant complications; and

(M) other areas determined appropriate by the Secretary.

(c) Prevention programs

The Secretary may carry out activities to promote safe motherhood, including—

(1) public education campaigns on healthy pregnancies;

(2) education programs for physicians, nurses and other health care providers;

(3) activities to promote community support services for pregnant women; and

(4) activities to promote physical, mental, and behavioral health during, and up to 1 year following, pregnancy, with an emphasis on prevention of, and treatment for, mental health disorders and substance use disorder.

(d) Maternal mortality review committees

(1) In general

In order to participate in the program under subsection (a)(2)(D), the applicable maternal mortality review committee of the State, Indian tribe, or tribal organization shall—

(A) include multidisciplinary and diverse membership that represents a variety of clinical specialties, State, tribal, or local public health officials, epidemiologists, statisticians, community organizations, geographic regions within the area covered by such committee, and individuals or organizations that represent the populations in the area covered by such committee that are most affected by pregnancy-related deaths or pregnancy-associated deaths and lack of access to maternal health care services; and

(B) demonstrate to the Centers for Disease Control and Prevention that such maternal mortality review committee's methods and processes for data collection and review, as required under paragraph (3), use best practices to reliably determine and include all pregnancy-associated deaths and pregnancy-related deaths, regardless of the outcome of the pregnancy.

(2) Process for confidential reporting

States, Indian tribes, and tribal organizations that participate in the program described in this subsection shall, through the State maternal mortality review committee, develop a process that—

(A) provides for confidential case reporting of pregnancy-associated and pregnancy-related deaths to the appropriate State or tribal health agency, including such reporting by—

(i) health care professionals;

(ii) health care facilities;

(iii) any individual responsible for completing death records, including medical examiners and medical coroners; and

(iv) other appropriate individuals or entities; and


(B) provides for voluntary and confidential case reporting of pregnancy-associated deaths and pregnancy-related deaths to the appropriate State or tribal health agency by family members of the deceased, and other appropriate individuals, for purposes of review by the applicable maternal mortality review committee; and

(C) shall include—

(i) making publicly available contact information of the committee for use in such reporting; and

(ii) conducting outreach to local professional organizations, community organizations, and social services agencies regarding the availability of the review committee.

(3) Data collection and review

States, Indian tribes, and tribal organizations that participate in the program described in this subsection shall—

(A) annually identify pregnancy-associated deaths and pregnancy-related deaths—

(i) through the appropriate vital statistics unit by—

(I) matching each death record related to a pregnancy-associated death or pregnancy-related death in the State or tribal area in the applicable year to a birth certificate of an infant or fetal death record, as applicable;

(II) to the extent practicable, identifying an underlying or contributing cause of each pregnancy-associated death and each pregnancy-related death in the State or tribal area in the applicable year; and

(III) collecting data from medical examiner and coroner reports, as appropriate;


(ii) using other appropriate methods or information to identify pregnancy-associated deaths and pregnancy-related deaths, including deaths from pregnancy outcomes not identified through clause (i)(I);


(B) through the maternal mortality review committee, review data and information to identify adverse outcomes that may contribute to pregnancy-associated death and pregnancy-related death, and to identify trends, patterns, and disparities in such adverse outcomes to allow the State, Indian tribe, or tribal organization to make recommendations to individuals and entities described in paragraph (2)(A), as appropriate, to improve maternal care and reduce pregnancy-associated death and pregnancy-related death;

(C) identify training available to the individuals and entities described in paragraph (2)(A) for accurate identification and reporting of pregnancy-associated and pregnancy-related deaths;

(D) ensure that, to the extent practicable, the data collected and reported under this paragraph is in a format that allows for analysis by the Centers for Disease Control and Prevention; and

(E) publicly identify the methods used to identify pregnancy-associated deaths and pregnancy-related deaths in accordance with this section.

(4) Confidentiality

States, Indian tribes, and tribal organizations participating in the program described in this subsection shall establish confidentiality protections to ensure, at a minimum, that—

(A) there is no disclosure by the maternal mortality review committee, including any individual members of the committee, to any person, including any government official, of any identifying information about any specific maternal mortality case; and

(B) no information from committee proceedings, including deliberation or records, is made public unless specifically authorized under State and Federal law.

(5) Reports to CDC

For fiscal year 2019, and each subsequent fiscal year, each maternal mortality review committee participating in the program described in this subsection shall submit to the Director of the Centers for Disease Control and Prevention a report that includes—

(A) data, findings, and any recommendations of such committee; and

(B) as applicable, information on the implementation during such year of any recommendations submitted by the committee in a previous year.

(6) State partnerships

States may partner with one or more neighboring States to carry out the activities under this subparagraph. With respect to the States in such a partnership, any requirement under this subparagraph relating to the reporting of information related to such activities shall be deemed to be fulfilled by each such State if a single such report is submitted for the partnership.

(7) Appropriate mechanisms for Indian tribes and tribal organizations

The Secretary, in consultation with Indian tribes, shall identify and establish appropriate mechanisms for Indian tribes and tribal organizations to demonstrate, report data, and conduct the activities as required for participation in the program described in this subsection. Such mechanisms may include technical assistance with respect to grant application and submission procedures, and award management activities.

(8) Research availability

The Secretary shall develop a process to ensure that data collected under paragraph (5) is made available, as appropriate and practicable, for research purposes, in a manner that protects individually identifiable or potentially identifiable information and that is consistent with State and Federal privacy law.

(e) Definitions

In this section—

(1) the terms "Indian tribe" and "tribal organization" have the meanings given such terms in section 5304 of title 25;

(2) the term "pregnancy-associated death" means a death of a woman, by any cause, that occurs during, or within 1 year following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy; and

(3) the term "pregnancy-related death" means a death of a woman that occurs during, or within 1 year following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy—

(A) from any cause related to, or aggravated by, the pregnancy or its management; and

(B) not from accidental or incidental causes.

(f) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated $58,000,000 for each of fiscal years 2019 through 2023.

(July 1, 1944, ch. 373, title III, §317K, as added Pub. L. 106–310, div. A, title IX, §901, Oct. 17, 2000, 114 Stat. 1125; amended Pub. L. 115–344, §2, Dec. 21, 2018, 132 Stat. 5047.)

Amendments

2018—Subsec. (a)(1). Pub. L. 115–344, §2(1)(A), substituted "purposes of this subsection are to establish or continue a Federal initiative to support State and tribal maternal mortality review committees, to improve data collection and reporting around maternal mortality, and to develop or support" for "purpose of this subsection is to develop" and "populations at risk of death and severe" for "population at risk of death and".

Subsec. (a)(2)(A). Pub. L. 115–344, §2(1)(B)(i), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: "The Secretary may establish and implement a national surveillance program to identify and promote the investigation of deaths and severe complications that occur during pregnancy."

Subsec. (a)(2)(D). Pub. L. 115–344, §2(1)(B)(ii), added subpar. (D).

Subsec. (b)(2)(A). Pub. L. 115–344, §2(2)(A), substituted "prepregnancy" for "encouraging preconception" and "women with diabetes and women with substance use disorder" for "diabetics".

Subsec. (b)(2)(H). Pub. L. 115–344, §2(2)(B), inserted "the identification of the determinants of disparities in maternal care, health risks, and health outcomes, including" before "an examination" and "and other groups of women with disproportionately high rates of maternal mortality" before semicolon at end.

Subsec. (b)(2)(I). Pub. L. 115–344, §2(2)(E), added subpar. (I). Former subpar. (I) redesignated (J).

Pub. L. 115–344, §2(2)(C), substituted "interpersonal" for "domestic".

Subsec. (b)(2)(J). Pub. L. 115–344, §2(2)(D), redesignated subpar. (I) as (J). Former subpar. (J) redesignated (K).

Subsec. (b)(2)(K). Pub. L. 115–344, §2(2)(D), (F), redesignated subpar. (J) as (K) and substituted "and substance abuse and misuse" for ", alcohol and illegal drug use". Former subpar. (K) redesignated (L).

Subsec. (b)(2)(L), (M). Pub. L. 115–344, §2(2)(D), redesignated subpars. (K) and (L) as (L) and (M), respectively.

Subsec. (c). Pub. L. 115–344, §2(3)(A), (B), struck out par. (1) designation and heading "In general" before "The Secretary" and redesignated subpars. (A) to (C) of former par. (1) as pars. (1) to (3), respectively. Amendment was executed to reflect the probable intent of Congress notwithstanding minor error in quoted par. (1) heading in original text directed to be struck out.

Subsec. (c)(1). Pub. L. 115–344, §2(3)(C), struck out "and the building of partnerships with outside organizations concerned about safe motherhood" after "pregnancies".

Subsec. (c)(4). Pub. L. 115–344, §2(3)(D)–(F), added par. (4).

Subsecs. (d), (e). Pub. L. 115–344, §2(5), added subsecs. (d) and (e). Former subsec. (d) redesignated (f).

Subsec. (f). Pub. L. 115–344, §2(4), (6), redesignated subsec. (d) as (f) and substituted "$58,000,000 for each of fiscal years 2019 through 2023" for "such sums as may be necessary for each of the fiscal years 2001 through 2005".

§247b–13. Prenatal and postnatal health

(a) In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall carry out programs—

(1) to collect, analyze, and make available data on prenatal smoking and alcohol and other substance abuse and misuse, including—

(A) data on—

(i) the incidence, prevalence, and implications of such activities; and

(ii) the incidence and prevalence of implications and outcomes, including neonatal abstinence syndrome and other maternal and child health outcomes associated with such activities; and


(B) additional information or data, as appropriate, on family health history, medication exposures during pregnancy, demographic information, such as race, ethnicity, geographic location, and family history, and other relevant information, to inform such analysis;


(2) to conduct applied epidemiological research on the prevention and long-term outcomes associated with prenatal and postnatal smoking, alcohol and other substance abuse and misuse;

(3) to support, conduct, and evaluate the effectiveness of educational, treatment, and cessation programs;

(4) to provide information and education to the public on the prevention and implications of prenatal and postnatal smoking, alcohol and other substance abuse and misuse; and

(5) to issue public reports on the analysis of data described in paragraph (1), including analysis of—

(A) long-term outcomes of children affected by neonatal abstinence syndrome;

(B) health outcomes associated with prenatal smoking, alcohol, and substance abuse and misuse; and

(C) relevant studies, evaluations, or information the Secretary determines to be appropriate.

(b) Grants

In carrying out subsection (a), the Secretary may award grants to and enter into contracts with States, local governments, tribal entities, scientific and academic institutions, federally qualified health centers, and other public and nonprofit entities, and may provide technical and consultative assistance to such entities.

(c) Coordinating activities

To carry out this section, the Secretary may—

(1) provide technical and consultative assistance to entities receiving grants under subsection (b);

(2) ensure a pathway for data sharing between States, tribal entities, and the Centers for Disease Control and Prevention;

(3) ensure data collection under this section is consistent with applicable State, Federal, and Tribal privacy laws; and

(4) coordinate with the National Coordinator for Health Information Technology, as appropriate, to assist States and Tribes in implementing systems that use standards recognized by such National Coordinator, as such recognized standards are available, in order to facilitate interoperability between such systems and health information technology systems, including certified health information technology.

(d) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2019 through 2023.

(July 1, 1944, ch. 373, title III, §317L, as added Pub. L. 106–310, div. A, title IX, §911, Oct. 17, 2000, 114 Stat. 1127; amended Pub. L. 115–271, title VII, §7064, Oct. 24, 2018, 132 Stat. 4021.)

Amendments

2018—Subsec. (a)(1). Pub. L. 115–271, §7064(1)(A), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "to collect, analyze, and make available data on prenatal smoking, alcohol and illegal drug use, including data on the implications of such activities and on the incidence and prevalence of such activities and their implications;".

Subsec. (a)(2). Pub. L. 115–271, §7064(1)(B), substituted "prevention and long-term outcomes associated with" for "prevention of" and "other substance abuse and misuse" for "illegal drug use".

Subsec. (a)(3). Pub. L. 115–271, §7064(1)(C), substituted ", treatment, and cessation programs;" for "and cessation programs; and".

Subsec. (a)(4). Pub. L. 115–271, §7064(1)(D), substituted "other substance abuse and misuse; and" for "illegal drug use.".

Subsec. (a)(5). Pub. L. 115–271, §7064(1)(E), added par. (5).

Subsec. (b). Pub. L. 115–271, §7064(2), inserted "tribal entities," after "local governments,".

Subsec. (c). Pub. L. 115–271, §7064(4), added subsec. (c). Former subsec. (c) redesignated (d).

Subsec. (d). Pub. L. 115–271, §7064(3), (5), redesignated subsec. (c) as (d) and substituted "2019 through 2023" for "2001 through 2005".

Improving Data and the Public Health Response

Pub. L. 114–91, §4, Nov. 25, 2015, 129 Stat. 725, provided that: "The Secretary [of Health and Human Services] may continue activities, as appropriate, related to—

"(1) providing technical assistance to support States and Federally recognized Indian Tribes in collecting information on neonatal abstinence syndrome through the utilization of existing surveillance systems and collaborating with States and Federally recognized Indian Tribes to improve the quality, consistency, and collection of such data; and

"(2) providing technical assistance to support States in implementing effective public health measures, such as disseminating information to educate the public, health care providers, and other stakeholders on prenatal opioid use and neonatal abstinence syndrome."

§247b–13a. Screening and treatment for maternal depression

(a) Grants

The Secretary shall make grants to States to establish, improve, or maintain programs for screening, assessment, and treatment services, including culturally and linguistically appropriate services, as appropriate, for women who are pregnant, or who have given birth within the preceding 12 months, for maternal depression.

(b) Application

To seek a grant under this section, a State shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require. At a minimum, any such application shall include explanations of—

(1) how a program, or programs, will increase the percentage of women screened and treated, as appropriate, for maternal depression in 1 or more communities; and

(2) how a program, or programs, if expanded, would increase access to screening and treatment services for maternal depression.

(c) Priority

In awarding grants under this section, the Secretary may give priority to States proposing to improve or enhance access to screening services for maternal depression in primary care settings.

(d) Use of funds

The activities eligible for funding through a grant under subsection (a)—

(1) shall include—

(A) providing appropriate training to health care providers; and

(B) providing information to health care providers, including information on maternal depression screening, treatment, and followup support services, and linkages to community-based resources; and


(2) may include—

(A) enabling health care providers (including obstetrician-gynecologists, pediatricians, psychiatrists, mental health care providers, and adult primary care clinicians) to provide or receive real-time psychiatric consultation (in-person or remotely) to aid in the treatment of pregnant and parenting women;

(B) establishing linkages with and among community-based resources, including mental health resources, primary care resources, and support groups; and

(C) utilizing telehealth services for rural areas and medically underserved areas (as defined in section 254c–14(a) of this title).

(e) Authorization of appropriations

To carry out this section, there are authorized to be appropriated $5,000,000 for each of fiscal years 2018 through 2022.

(July 1, 1944, ch. 373, title III, §317L–1, as added Pub. L. 114–255, div. B, title X, §10005, Dec. 13, 2016, 130 Stat. 1266.)

§247b–14. Oral health promotion and disease prevention

(a) Grants to increase resources for community water fluoridation

(1) In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States and Indian tribes for the purpose of increasing the resources available for community water fluoridation.

(2) Use of funds

A State shall use amounts provided under a grant under paragraph (1)—

(A) to purchase fluoridation equipment;

(B) to train fluoridation engineers;

(C) to develop educational materials on the benefits of fluoridation; or

(D) to support the infrastructure necessary to monitor and maintain the quality of water fluoridation.

(b) Community water fluoridation

(1) In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in collaboration with the Director of the Indian Health Service, shall establish a demonstration project that is designed to assist rural water systems in successfully implementing the water fluoridation guidelines of the Centers for Disease Control and Prevention that are entitled "Engineering and Administrative Recommendations for Water Fluoridation, 1995" (referred to in this subsection as the "EARWF").

(2) Requirements

(A) Collaboration

In collaborating under paragraph (1), the Directors referred to in such paragraph shall ensure that technical assistance and training are provided to tribal programs located in each of the 12 areas of the Indian Health Service. The Director of the Indian Health Service shall provide coordination and administrative support to tribes under this section.

(B) General use of funds

Amounts made available under paragraph (1) shall be used to assist small water systems in improving the effectiveness of water fluoridation and to meet the recommendations of the EARWF.

(C) Fluoridation specialists

(i) In general

In carrying out this subsection, the Secretary shall provide for the establishment of fluoridation specialist engineering positions in each of the Dental Clinical and Preventive Support Centers through which technical assistance and training will be provided to tribal water operators, tribal utility operators and other Indian Health Service personnel working directly with fluoridation projects.

(ii) Liaison

A fluoridation specialist shall serve as the principal technical liaison between the Indian Health Service and the Centers for Disease Control and Prevention with respect to engineering and fluoridation issues.

(iii) CDC

The Director of the Centers for Disease Control and Prevention shall appoint individuals to serve as the fluoridation specialists.

(D) Implementation

The project established under this subsection shall be planned, implemented and evaluated over the 5-year period beginning on the date on which funds are appropriated under this section and shall be designed to serve as a model for improving the effectiveness of water fluoridation systems of small rural communities.

(3) Evaluation

In conducting the ongoing evaluation as provided for in paragraph (2)(D), the Secretary shall ensure that such evaluation includes—

(A) the measurement of changes in water fluoridation compliance levels resulting from assistance provided under this section;

(B) the identification of the administrative, technical and operational challenges that are unique to the fluoridation of small water systems;

(C) the development of a practical model that may be easily utilized by other tribal, State, county or local governments in improving the quality of water fluoridation with emphasis on small water systems; and

(D) the measurement of any increased percentage of Native Americans or Alaskan Natives who receive the benefits of optimally fluoridated water.

(c) School-based dental sealant program

(1) In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in collaboration with the Administrator of the Health Resources and Services Administration, shall award a grant to each of the 50 States and territories and to Indians, Indian tribes, tribal organizations and urban Indian organizations (as such terms are defined in section 1603 of title 25) to provide for the development of school-based dental sealant programs to improve the access of children to sealants.

(2) Use of funds

A State shall use amounts received under a grant under paragraph (1) to provide funds to eligible school-based entities or to public elementary or secondary schools to enable such entities or schools to provide children with access to dental care and dental sealant services. Such services shall be provided by licensed dental health professionals in accordance with State practice licensing laws.

(3) Eligibility

To be eligible to receive funds under paragraph (1), an entity shall—

(A) prepare and submit to the State an application at such time, in such manner and containing such information as the State may require; and

(B) be a public elementary or secondary school—

(i) that is located in an urban area in which and 1 more than 50 percent of the student population is participating in Federal or State free or reduced meal programs; or

(ii) that is located in a rural area and, with respect to the school district in which the school is located, the district involved has a median income that is at or below 235 percent of the poverty line, as defined in section 9902(2) of this title.

(d) Oral health infrastructure

(1) Cooperative agreements

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall enter into cooperative agreements with State, territorial, and Indian tribes or tribal organizations (as those terms are defined in section 1603 of title 25) to establish oral health leadership and program guidance, oral health data collection and interpretation,2 (including determinants of poor oral health among vulnerable populations), a multi-dimensional delivery system for oral health, and to implement science-based programs (including dental sealants and community water fluoridation) to improve oral health.

(2) Authorization of appropriations

There is authorized to be appropriated such sums as necessary to carry out this subsection for fiscal years 2010 through 2014.

(e) Definitions

For purposes of this section, the term "Indian tribe" means an Indian tribe or tribal organization as defined in section 5304(b) and section 5304(c) 3 of title 25.

(f) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.

(July 1, 1944, ch. 373, title III, §317M, as added Pub. L. 106–310, div. A, title XVI, §1602, Oct. 17, 2000, 114 Stat. 1148; amended Pub. L. 111–148, title IV, §4102(b), (c), Mar. 23, 2010, 124 Stat. 551, 552.)

References in Text

Section 5304 of title 25, referred to in subsec. (e), has been amended, and subsecs. (b) and (c) of section 5304 no longer define the terms "Indian tribe" and "tribal organization". However, such terms are defined elsewhere in that section.

Amendments

2010—Subsec. (c)(1). Pub. L. 111–148, §4102(b), substituted "shall award a grant to each of the 50 States and territories and to Indians, Indian tribes, tribal organizations and urban Indian organizations (as such terms are defined in section 1603 of title 25)" for "may award grants to States and Indian tribes".

Subsecs. (d) to (f). Pub. L. 111–148, §4102(c), added subsec. (d) and redesignated former subsecs. (d) and (e) as (e) and (f), respectively.

1 So in original. The word "and" probably should not appear.

2 So in original. The comma probably should not appear.

3 See References in Text note below.

§247b–14a. Identification of interventions that reduce the burden and transmission of oral, dental, and craniofacial diseases in high risk populations; development of approaches for pediatric oral and craniofacial assessment

(a) In general

The Secretary of Health and Human Services, through the Maternal and Child Health Bureau, the Indian Health Service, and in consultation with the National Institutes of Health and the Centers for Disease Control and Prevention, shall—

(1) support community-based research that is designed to improve understanding of the etiology, pathogenesis, diagnosis, prevention, and treatment of pediatric oral, dental, craniofacial diseases and conditions and their sequelae in high risk populations;

(2) support demonstrations of preventive interventions in high risk populations including nutrition, parenting, and feeding techniques; and

(3) develop clinical approaches to assess individual patients for the risk of pediatric dental disease.

(b) Compliance with State practice laws

Treatment and other services shall be provided pursuant to this section by licensed dental health professionals in accordance with State practice and licensing laws.

(c) Authorization of appropriations

There are authorized to be appropriated such sums as may be necessary to carry out this section for each 1 the fiscal years 2001 through 2005.

(Pub. L. 106–310, div. A, title XVI, §1601, Oct. 17, 2000, 114 Stat. 1148.)

Codification

Section was enacted as part of the Children's Health Act of 2000, and not as part of the Public Health Service Act which comprises this chapter.

1 So in original. Probably should be followed by "of".

§247b–15. Surveillance and education regarding infections associated with illicit drug use and other risk factors

(a) In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may (directly or through grants to public and nonprofit private entities) provide for programs for the following:

(1) To cooperate with States and Indian tribes in implementing or maintaining a national system to determine the incidence of infections commonly associated with illicit drug use, such as viral hepatitis, human immunodeficiency virus, and infective endocarditis, and to assist the States in determining the prevalence of such infections, which may include the reporting of cases of such infections.

(2) To identify, counsel, and offer testing to individuals who are at risk of infections described in paragraph (1) resulting from illicit drug use, receiving blood transfusions prior to July 1992, or other risk factors.

(3) To provide appropriate referrals for counseling, testing, and medical treatment of individuals identified under paragraph (2) and to ensure, to the extent practicable, the provision of appropriate follow-up services.

(4) To develop and disseminate public information and education programs for the detection and control of infections described in paragraph (1), with priority given to high-risk populations as determined by the Secretary.

(5) To improve the education, training, and skills of health professionals in the detection and control of infections described in paragraph (1), including to improve coordination of treatment of substance use disorders and infectious diseases, with priority given to substance use disorder treatment providers, pediatricians and other primary care providers, obstetrician-gynecologists, and infectious disease clinicians, including HIV clinicians.

(b) Laboratory procedures

The Secretary may (directly or through grants to public and nonprofit private entities) carry out programs to provide for improvements in the quality of clinical-laboratory procedures regarding infections described in subsection (a)(1).

(c) Definition

In this section, the term "Indian tribe" has the meaning given that term in section 5304 of title 25.

(d) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated $40,000,000 for each of the fiscal years 2019 through 2023.

(July 1, 1944, ch. 373, title III, §317N, as added Pub. L. 106–310, div. A, title XVIII, §1801, Oct. 17, 2000, 114 Stat. 1152; amended Pub. L. 115–271, title VII, §7141, Oct. 24, 2018, 132 Stat. 4056.)

Amendments

2018Pub. L. 115–271 amended section generally. Prior to amendment, section related to surveillance and education regarding hepatitis C virus.

Study and Demonstration Projects Regarding Cases of Hepatitis C Among Certain Emergency Response Employees

Pub. L. 106–398, §1 [[div. A], title XVII, §1704], Oct. 30, 2000, 114 Stat. 1654, 1654A-365, provided that:

"(a) Study Regarding Prevalence Among Certain Emergency Response Employees.—

"(1) In general.—The Secretary of Health and Human Services (referred to in this section as the 'Secretary'), in consultation with the Secretary of Labor, shall conduct a study to determine—

"(A) an estimate of the prevalence of hepatitis C among designated emergency response employees in the United States; and

"(B) the likely means through which such employees become infected with such disease in the course of performing their duties as such employees.

"(2) Designated emergency response employees.—For purposes of this section, the term 'designated emergency response employees' means firefighters, paramedics, and emergency medical technicians who are employees or volunteers of units of local government.

"(3) Date certain for completion; report to congress.—The Secretary shall commence the study under paragraph (1) not later than 90 days after the date of the enactment of this Act [Oct. 30, 2000]. Not later than one year after such date, the Secretary shall complete the study and submit to the Congress a report describing the findings of the study.

"(b) Demonstration Projects Regarding Training and Treatment.—

"(1) In general.—The Secretary, in consultation with the Secretary of Labor, shall make grants to qualifying local governments for the purpose of carrying out demonstration projects that (directly or through arrangements with nonprofit private entities) carry out each of the following activities:

"(A) Training designated emergency response employees in minimizing the risk of infection with hepatitis C in performing their duties as such employees.

"(B) Testing such employees for infection with the disease.

"(C) Treating the employees for the disease.

"(2) Qualifying local governments.—For purposes of this section, the term 'qualifying local government' means a unit of local government whose population of designated emergency response employees has a prevalence of hepatitis C that is not less than 200 percent of the national average for the prevalence of such disease in such populations.

"(3) Confidentiality.—A grant may be made under paragraph (1) only if the qualifying local government involved agrees to ensure that information regarding the testing or treatment of designated emergency response employees pursuant to the grant is maintained confidentially in a manner not inconsistent with applicable law.

"(4) Evaluations.—The Secretary shall provide for an evaluation of each demonstration project under paragraph (1) in order to determine the extent to which the project has been effective in carry [sic] out the activities described in such paragraph.

"(5) Report to congress.—Not later than 180 days after the date on which all grants under paragraph (1) have been expended, the Secretary shall submit to Congress a report providing—

"(A) a summary of evaluations under paragraph (4); and

"(B) the recommendations of the Secretary for administrative or legislative initiatives regarding the activities described in paragraph (1).

"(c) Authorization of Appropriations.—For the purpose of carrying out this section, there is authorized to be appropriated to the Department of Health and Human Services and the Department of Labor $10,000,000 for fiscal year 2001."

§247b–16. Grants for lead poisoning related activities

(a) Authority to make grants

(1) In general

The Secretary shall make grants to States to support public health activities in States and localities where data suggests that at least 5 percent of preschool-age children have an elevated blood lead level through—

(A) effective, ongoing outreach and community education targeted to families most likely to be at risk for lead poisoning;

(B) individual family education activities that are designed to reduce ongoing exposures to lead for children with elevated blood lead levels, including through home visits and coordination with other programs designed to identify and treat children at risk for lead poisoning; and

(C) the development, coordination and implementation of community-based approaches for comprehensive lead poisoning prevention from surveillance to lead hazard control.

(2) State match

A State is not eligible for a grant under this section unless the State agrees to expend (through State or local funds) $1 for every $2 provided under the grant to carry out the activities described in paragraph (1).

(3) Application

To be eligible to receive a grant under this section, a State shall submit an application to the Secretary in such form and manner and containing such information as the Secretary may require.

(b) Coordination with other children's programs

A State shall identify in the application for a grant under this section how the State will coordinate operations and activities under the grant with—

(1) other programs operated in the State that serve children with elevated blood lead levels, including any such programs operated under title V, XIX, or XXI of the Social Security Act [42 U.S.C. 701 et seq., 1396 et seq., 1397aa et seq.]; and

(2) one or more of the following—

(A) the child welfare and foster care and adoption assistance programs under parts B and E of title IV of such Act [42 U.S.C. 620 et seq., 670 et seq.];

(B) the head start program established under the Head Start Act (42 U.S.C. 9831 et seq.);

(C) the program of assistance under the special supplemental nutrition program for women, infants and children (WIC) under section 1786 of this title;

(D) local public and private elementary or secondary schools; or

(E) public housing agencies, as defined in section 1437a of this title.

(c) Performance measures

The Secretary shall establish needs indicators and performance measures to evaluate the activities carried out under grants awarded under this section. Such indicators shall be commensurate with national measures of maternal and child health programs and shall be developed in consultation with the Director of the Centers for Disease Control and Prevention.

(d) Authorization of appropriations

There are authorized to be appropriated to carry out this section such sums as may be necessary for each of the fiscal years 2001 through 2005.

(July 1, 1944, ch. 373, title III, §317O, as added Pub. L. 106–310, div. A, title XXV, §2502(a), Oct. 17, 2000, 114 Stat. 1162.)

References in Text

The Social Security Act, referred to in subsec. (b)(1), (2)(A), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Parts B and E of title IV of the Act are classified generally to parts B (§620 et seq.) and E (§670 et seq.), respectively, of subchapter IV of chapter 7 of this title. Titles V, XIX, and XXI of the Act are classified generally to subchapters V (§701 et seq.), XIX (§1396 et seq.), and XXI (§1397aa et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables.

The Head Start Act, referred to in subsec. (b)(2)(B), is subchapter B (§§635–657) of chapter 8 of subtitle A of title VI of Pub. L. 97–35, Aug. 13, 1981, 95 Stat. 499, as amended, which is classified generally to subchapter II (§9831 et seq.) of chapter 105 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 9801 of this title and Tables.

§247b–17. Human papillomavirus (Johanna's Law)

(a) Surveillance

(1) In general

The Secretary, acting through the Centers for Disease Control and Prevention, shall—

(A) enter into cooperative agreements with States and other entities to conduct sentinel surveillance or other special studies that would determine the prevalence in various age groups and populations of specific types of human papillomavirus (referred to in this section as "HPV") in different sites in various regions of the United States, through collection of special specimens for HPV using a variety of laboratory-based testing and diagnostic tools; and

(B) develop and analyze data from the HPV sentinel surveillance system described in subparagraph (A).

(2) Report

The Secretary shall make a progress report to the Congress with respect to paragraph (1) no later than 1 year after the effective date of this section.

(b) Prevention activities; education program

(1) In general

The Secretary, acting through the Centers for Disease Control and Prevention, shall conduct prevention research on HPV, including—

(A) behavioral and other research on the impact of HPV-related diagnosis on individuals;

(B) formative research to assist with the development of educational messages and information for the public, for patients, and for their partners about HPV;

(C) surveys of physician and public knowledge, attitudes, and practices about genital HPV infection; and

(D) upon the completion of and based on the findings under subparagraphs (A) through (C), develop and disseminate educational materials for the public and health care providers regarding HPV and its impact and prevention.

(2) Report; final proposal

The Secretary shall make a progress report to the Congress with respect to paragraph (1) not later than 1 year after the effective date of this section, and shall develop a final report not later than 3 years after such effective date, including a detailed summary of the significant findings and problems and the best strategies to prevent future infections, based on available science.

(c) HPV education and prevention

(1) In general

The Secretary shall prepare and distribute educational materials for health care providers and the public that include information on HPV. Such materials shall address—

(A) modes of transmission;

(B) consequences of infection, including the link between HPV and cervical cancer;

(C) the available scientific evidence on the effectiveness or lack of effectiveness of condoms in preventing infection with HPV; and

(D) the importance of regular Pap smears, and other diagnostics for early intervention and prevention of cervical cancer purposes in preventing cervical cancer.

(2) Medically accurate information

Educational material under paragraph (1), and all other relevant educational and prevention materials prepared and printed from this date forward for the public and health care providers by the Secretary (including materials prepared through the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration), or by contractors, grantees, or subgrantees thereof, that are specifically designed to address STDs including HPV shall contain medically accurate information regarding the effectiveness or lack of effectiveness of condoms in preventing the STD the materials are designed to address. Such requirement only applies to materials mass produced for the public and health care providers, and not to routine communications.

(d) Johanna's Law

(1) National public awareness campaign

(A) In general

The Secretary shall carry out a national campaign to increase the awareness and knowledge of health care providers and women with respect to gynecologic cancers.

(B) Written materials

Activities under the national campaign under subparagraph (A) shall include—

(i) maintaining a supply of written materials that provide information to the public on gynecologic cancers; and

(ii) distributing the materials to members of the public upon request.

(C) Public service announcements

Activities under the national campaign under subparagraph (A) shall, in accordance with applicable law and regulations, include developing and placing, in telecommunications media, public service announcements intended to encourage women to discuss with their physicians their risks of gynecologic cancers. Such announcements shall inform the public on the manner in which the written materials referred to in subparagraph (B) can be obtained upon request, and shall call attention to early warning signs and risk factors based on the best available medical information.

(2) Report and strategy

(A) Report

Not later than 6 months after January 12, 2007, the Secretary shall submit to the Congress a report including the following:

(i) A description of the past and present activities of the Department of Health and Human Services to increase awareness and knowledge of the public with respect to different types of cancer, including gynecologic cancers.

(ii) A description of the past and present activities of the Department of Health and Human Services to increase awareness and knowledge of health care providers with respect to different types of cancer, including gynecologic cancers.

(iii) For each activity described pursuant to clause (i) or (ii), a description of the following:

(I) The funding for such activity for fiscal year 2006 and the cumulative funding for such activity for previous fiscal years.

(II) The background and history of such activity, including—

(aa) the goals of such activity;

(bb) the communications objectives of such activity;

(cc) the identity of each agency within the Department of Health and Human Services responsible for any aspect of the activity; and

(dd) how such activity is or was expected to result in change.


(III) How long the activity lasted or is expected to last.

(IV) The outcomes observed and the evaluation methods, if any, that have been, are being, or will be used with respect to such activity.

(V) For each such outcome or evaluation method, a description of the associated results, analyses, and conclusions.

(B) Strategy

(i) Development; submission to Congress

Not later than 3 months after submitting the report required by subparagraph (A), the Secretary shall develop and submit to the Congress a strategy for improving efforts to increase awareness and knowledge of the public and health care providers with respect to different types of cancer, including gynecological cancers.

(ii) Consultation

In developing the strategy under clause (i), the Secretary should consult with qualified private sector groups, including nonprofit organizations.

(3) Full compliance

(A) In general.—Not later than March 1, 2008, the Secretary shall ensure that all provisions of this section, including activities directed to be carried out by the Centers for Disease Control and Prevention and the Food and Drug Administration, are fully implemented and being complied with. Not later than April 30, 2008, the Secretary shall submit to Congress a report that certifies compliance with the preceding sentence and that contains a description of all activities undertaken to achieve such compliance.

(B) If the Secretary fails to submit the certification as provided for under subparagraph (A), the Secretary shall, not later than 3 months after the date on which the report is to be submitted under subparagraph (A), and every 3 months thereafter, submit to Congress an explanation as to why the Secretary has not yet complied with the first sentence of subparagraph (A), a detailed description of all actions undertaken within the month for which the report is being submitted to bring the Secretary into compliance with such sentence, and the anticipated date the Secretary expects to be in full compliance with such sentence.

(4) Consultation with nonprofit gynecologic cancer organizations

In carrying out the national campaign under this subsection, the Secretary shall consult with nonprofit gynecologic cancer organizations, with a mission both to conquer ovarian or other gynecologic cancer and to provide outreach to State and local governments and communities, for the purpose of determining the best practices for providing gynecologic cancer information and outreach services to varied populations.

(6) 1 Authorization of appropriations

For the purpose of carrying out this subsection, there is authorized to be appropriated $16,500,000 for the period of fiscal years 2007 through 2009 and $18,000,000 for the period of fiscal years 2012 through 2014.

(July 1, 1944, ch. 373, title III, §317P, as added Pub. L. 106–554, §1(a)(1) [title V, §516(a)], Dec. 21, 2000, 114 Stat. 2763, 2763A-72; amended Pub. L. 109–475, §2, Jan. 12, 2007, 120 Stat. 3565; Pub. L. 111–324, §1, Dec. 22, 2010, 124 Stat. 3536.)

References in Text

Johanna's Law, referred to in section catchline and subsec. (d), is Pub. L. 109–475, Jan. 12, 2007, 120 Stat. 3565, also known as the Gynecologic Cancer Education and Awareness Act of 2005, which amended this section. For complete classification of this Act to the Code, see Short Title of 2007 Amendment note set out under section 201 of this title and Tables.

The effective date of this section, referred to in subsecs. (a)(2) and (b)(2), is the date of enactment of Pub. L. 106–554, which was approved Dec. 21, 2000.

Amendments

2010—Subsec. (d)(4). Pub. L. 111–324, §1(b), added par. (4). Former par. (4) redesignated (6).

Pub. L. 111–324, §1(a)(1), inserted "and $18,000,000 for the period of fiscal years 2012 through 2014" after "2009".

Subsec. (d)(6). Pub. L. 111–324, §1(a)(2), redesignated par. (4) as (6).

2007Pub. L. 109–475, §2(1), inserted "(Johanna's Law)" after "papillomavirus" in section catchline.

Subsec. (d). Pub. L. 109–475, §2(2), added subsec. (d).

1 So in original. No par. (5) has been enacted.

§247b–18. Surveillance and research regarding muscular dystrophy

(a) In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants and cooperative agreements to public or nonprofit private entities (including health departments of States and political subdivisions of States, and including universities and other educational entities) for the collection, analysis, and reporting of data on Duchenne and other forms of muscular dystrophy. In making such awards, the Secretary may provide direct technical assistance in lieu of cash.

(b) National muscular dystrophy epidemiology program

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants to public or nonprofit private entities (including health departments of States and political subdivisions of States, and including universities and other educational entities) for the purpose of carrying out epidemiological activities regarding Duchenne and other forms of muscular dystrophies, including collecting and analyzing information on the number, incidence, correlates, and symptoms of cases. In carrying out the preceding sentence, the Secretary shall provide for a national surveillance program and, to the extent possible, ensure that data be representative of all affected populations and shared in a timely manner. In making awards under this subsection, the Secretary may provide direct technical assistance in lieu of cash.

(c) Coordination with centers of excellence

The Secretary shall ensure that epidemiological information under subsections (a) and (b) is made available to centers of excellence supported under section 283g(b) of this title by the Director of the National Institutes of Health.

(d) Data

In carrying out this section, the Secretary may ensure that any data on patients that is collected as part of the Muscular Dystrophy STARnet (under a grant under this section) is regularly updated to reflect changes in patient condition over time.

(e) Reports and study

(1) Annual report

Not later than 18 months after October 8, 2008, and annually thereafter, the Director of the Centers for Disease Control and Prevention shall submit to the appropriate committees of the Congress a report—

(A) concerning the activities carried out by MD STARnet site 1 funded under this section during the year for which the report is prepared;

(B) containing the data collected and findings derived from the MD STARnet sites each fiscal year (as funded under a grant under this section during fiscal years 2008 through 2012); and

(C) that every 2 years outlines prospective data collection objectives and strategies.

(2) Tracking health outcomes

The Secretary may provide health outcome data on the health and survival of people with muscular dystrophy.

(f) Authorization of appropriations

There are authorized to be appropriated such sums as may be necessary to carry out this section.

(July 1, 1944, ch. 373, title III, §317Q, as added Pub. L. 107–84, §4, Dec. 18, 2001, 115 Stat. 828; amended Pub. L. 110–361, §3, Oct. 8, 2008, 122 Stat. 4010; Pub. L. 113–166, §3, Sept. 26, 2014, 128 Stat. 1880.)

Amendments

2014—Subsec. (b). Pub. L. 113–166 inserted "and, to the extent possible, ensure that data be representative of all affected populations and shared in a timely manner" after "surveillance program".

2008—Subsecs. (d) to (f). Pub. L. 110–361 added subsecs. (d) and (e) and redesignated former subsec. (d) as (f).

Findings

Pub. L. 107–84, §2, Dec. 18, 2001, 115 Stat. 823, provided that: "Congress makes the following findings:

"(1) Of the childhood muscular dystrophies, Duchenne Muscular Dystrophy (DMD) is the world's most common and catastrophic form of genetic childhood disease, and is characterized by a rapidly progressive muscle weakness that almost always results in death, usually by 20 years of age.

"(2) Duchenne muscular dystrophy is genetically inherited, and mothers are the carriers in approximately 70 percent of all cases.

"(3) If a female is a carrier of the dystrophin gene, there is a 50 percent chance per birth that her male offspring will have Duchenne muscular dystrophy, and a 50 percent chance per birth that her female offspring will be carriers.

"(4) Duchenne is the most common lethal genetic disorder of childhood worldwide, affecting approximately 1 in every 3,500 boys worldwide.

"(5) Children with muscular dystrophy exhibit extreme symptoms of weakness, delay in walking, waddling gait, difficulty in climbing stairs, and progressive mobility problems often in combination with muscle hypertrophy.

"(6) Other forms of muscular dystrophy affecting children and adults include Becker, limb girdle, congenital, facioscapulohumeral, myotonic, oculopharyngeal, distal, and Emery-Dreifuss muscular dystrophies.

"(7) Myotonic muscular dystrophy (also known as Steinert's disease and dystrophia myotonica) is the second most prominent form of muscular dystrophy and the type most commonly found in adults. Unlike any of the other muscular dystrophies, the muscle weakness is accompanied by myotonia (delayed relaxation of muscles after contraction) and by a variety of abnormalities in addition to those of muscle.

"(8) Facioscapulohumeral muscular dystrophy (referred to in this section as 'FSHD') is a neuromuscular disorder that is inherited genetically and has an estimated frequency of 1 in 20,000. FSHD, affecting between 15,000 to 40,000 persons, causes a progressive and sever [sic] loss of skeletal muscle gradually bringing weakness and reduced mobility. Many persons with FSHD become severely physically disabled and spend many decades in a wheelchair.

"(9) FSHD is regarded as a novel genetic phenomenon resulting from a crossover of subtelomeric DNA and may be the only human disease caused by a deletion-mutation.

"(10) Each of the muscular dystrophies, though distinct in progressivity and severity of symptoms, have a devastating impact on tens of thousands of children and adults throughout the United States and worldwide and impose severe physical and economic burdens on those affected.

"(11) Muscular dystrophies have a significant impact on quality of life—not only for the individual who experiences its painful symptoms and resulting disability, but also for family members and caregivers.

"(12) Development of therapies for these disorders, while realistic with recent advances in research, is likely to require costly investments and infrastructure to support gene and other therapies.

"(13) There is a shortage of qualified researchers in the field of neuromuscular research.

"(14) Many family physicians and health care professionals lack the knowledge and resources to detect and properly diagnose the disease as early as possible, thus exacerbating the progressiveness of symptoms in cases that go undetected or misdiagnosed.

"(15) There is a need for efficient mechanisms to translate clinically relevant findings in muscular dystrophy research from basic science to applied work.

"(16) Educating the public and health care community throughout the country about this devastating disease is of paramount importance and is in every respect in the public interest and to the benefit of all communities."

Report to Congress

Pub. L. 107–84, §6, Dec. 18, 2001, 115 Stat. 829, which directed the Secretary of Health and Human Services to prepare and submit to appropriate committees of Congress a report concerning the implementation of Pub. L. 107–84 not later than Jan. 1, 2003, and each Jan. 1 thereafter, was repealed by Pub. L. 109–482, title I, §104(b)(3)(H), Jan. 15, 2007, 120 Stat. 3694.

1 So in original. Probably should be plural.

§247b–19. Information and education

(a) In general

The Secretary of Health and Human Services (referred to in this Act as the "Secretary") shall establish and implement a program to provide information and education on muscular dystrophy to health professionals and the general public, including information and education on advances in the diagnosis and treatment of muscular dystrophy and training and continuing education through programs for scientists, physicians, medical students, and other health professionals who provide care for patients with muscular dystrophy.

(b) Stipends

The Secretary may use amounts made available under this section provides 1 stipends for health professionals who are enrolled in training programs under this section.

(c) Requirements

In carrying out this section, the Secretary may—

(1) partner with leaders in the muscular dystrophy patient community;

(2) cooperate with professional organizations and the patient community in the development and issuance of care considerations for pediatric and adult patients, including acute care considerations, for Duchenne-Becker muscular dystrophy, and various other forms of muscular dystrophy, and in periodic review and updates, as appropriate;

(3) in developing and updating care considerations under paragraph (2), incorporate strategies specifically responding to the findings of the national transitions survey of minority, young adult, and adult communities of muscular dystrophy patients; and

(4) widely disseminate the Duchenne-Becker muscular dystrophy and various other forms of muscular dystrophy care considerations as broadly as possible, including through partnership opportunities with the muscular dystrophy patient community.

(d) Authorization of appropriations

There are authorized to be appropriated such sums as may be necessary to carry out this section.

(Pub. L. 107–84, §5, Dec. 18, 2001, 115 Stat. 828; Pub. L. 110–361, §4, Oct. 8, 2008, 122 Stat. 4011; Pub. L. 113–166, §4, Sept. 26, 2014, 128 Stat. 1880.)

References in Text

This Act, referred to in subsec. (a), is Pub. L. 107–84, Dec. 18, 2001, 115 Stat. 823, known as the Muscular Dystrophy Community Assistance, Research and Education Amendments of 2001 and also as the MD–CARE Act. For complete classification of this Act to the Code, see Short Title of 2001 Amendment note set out under section 201 of this title and Tables.

Codification

Section was enacted as part of the Muscular Dystrophy Community Assistance, Research and Education Amendments of 2001, also known as the MD–CARE Act, and not as part of the Public Health Service Act which comprises this chapter.

Amendments

2014—Subsec. (c)(2). Pub. L. 113–166, §4(1), inserted "for pediatric and adult patients, including acute care considerations," after "issuance of care considerations" and "various" before "other forms of muscular dystrophy" and struck out "and" at end.

Subsec. (c)(3), (4). Pub. L. 113–166, §4(2)–(4), added par. (3), redesignated former par. (3) as (4), and, in par. (4), inserted "various" before "other forms of muscular dystrophy".

2008—Subsecs. (c), (d). Pub. L. 110–361 added subsec. (c) and redesignated former subsec. (c) as (d).

1 So in original. Probably should be "to provide".

§247b–20. Food safety grants

(a) In general

The Secretary may award grants to States and Indian tribes (as defined in section 5304(e) of title 25) to expand participation in networks to enhance Federal, State, and local food safety efforts, including meeting the costs of establishing and maintaining the food safety surveillance, technical, and laboratory capacity needed for such participation.

(b) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated $19,500,000 for fiscal year 2010, and such sums as may be necessary for each of the fiscal years 2011 through 2015.

(July 1, 1944, ch. 373, title III, §317R, as added Pub. L. 107–188, title III, §312, June 12, 2002, 116 Stat. 674; amended Pub. L. 108–75, §2(1), Aug. 15, 2003, 117 Stat. 898; Pub. L. 111–353, title II, §205(d), Jan. 4, 2011, 124 Stat. 3939.)

Amendments

2011—Subsec. (b). Pub. L. 111–353 substituted "2010" for "2002" and "2011 through 2015" for "2003 through 2006".

2003Pub. L. 108–75 made technical amendment relating to placement of section within original act.

§247b–21. Mosquito-borne diseases; coordination grants to States; assessment and control grants to political subdivisions

(a) Coordination grants to States; assessment grants to political subdivisions

(1) In general

With respect to mosquito control programs to prevent and control mosquito-borne diseases (referred to in this section as "control programs"), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States for the purpose of—

(A) coordinating control programs in the State involved; and

(B) assisting such State in making grants to political subdivisions of the State to conduct assessments to determine the immediate needs in such subdivisions for control programs, including programs to address emerging infectious mosquito-borne diseases, and to develop, on the basis of such assessments, plans for carrying out control programs in the subdivisions or improving existing control programs.

(2) Preference in making grants

In making grants under paragraph (1), the Secretary shall give preference to States that have one or more political subdivisions with an incidence, prevalence, or high risk of mosquito-borne disease, or a population of infected mosquitoes, that is substantial relative to political subdivisions in other States.

(3) Certain requirements

A grant may be made under paragraph (1) only if—

(A) the State involved has developed, or agrees to develop, a plan for coordinating control programs in the State, and the plan takes into account any assessments or plans described in subsection (b)(3) that have been conducted or developed, respectively, by political subdivisions in the State;

(B) in developing such plan, the State consulted or will consult (as the case may be under subparagraph (A)) with political subdivisions in the State that are carrying out or planning to carry out control programs;

(C) the State agrees to monitor control programs in the State in order to ensure that the programs are carried out in accordance with such plan, with priority given to coordination of control programs in political subdivisions described in paragraph (2) that are contiguous;

(D) the State agrees that the State will make grants to political subdivisions as described in paragraph (1)(B), and that such a grant will not exceed $10,000; and

(E) the State agrees that the grant will be used to supplement, and not supplant, State and local funds available for the purpose described in paragraph (1).

(4) Reports to Secretary

A grant may be made under paragraph (1) only if the State involved agrees that, promptly after the end of the fiscal year for which the grant is made, the State will submit to the Secretary a report that—

(A) describes the activities of the State under the grant; and

(B) contains an evaluation of whether the control programs of political subdivisions in the State were effectively coordinated with each other, which evaluation takes into account any reports that the State received under subsection (b)(5) from such subdivisions.

(5) Number of grants

A State may not receive more than one grant under paragraph (1).

(b) Prevention and control grants to political subdivisions

(1) In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to political subdivisions of States or consortia of political subdivisions of States, for the operation, including improvement, of control programs.

(2) Preference in making grants

In making grants under paragraph (1), the Secretary shall give preference to a political subdivision or consortium of political subdivisions that—

(A) has—

(i) a history of elevated incidence or prevalence of mosquito-borne disease;

(ii) a population of infected mosquitoes;

(iii) met criteria determined by the Secretary to suggest an increased risk of elevated incidence or prevalence of mosquito-borne disease in the pending fiscal year, including an emerging infectious mosquito-borne disease that presents a serious public health threat; or

(iv) a public health emergency due to the incidence or prevalence of a mosquito-borne disease that presents a serious public health threat;


(B) demonstrates to the Secretary that such political subdivision or consortium of political subdivisions will, if appropriate to the mosquito circumstances involved, effectively coordinate the activities of the control programs with contiguous political subdivisions;

(C) demonstrates to the Secretary (directly or through State officials) that the State in which such a political subdivision or consortium of political subdivisions is located has identified or will identify geographic areas in such State that have a significant need for control programs and will effectively coordinate such programs in such areas; and

(D)(i) is located in a State that has received a grant under subsection (a); or

(ii) that 1 demonstrates to the Secretary that the control program is consistent with existing State mosquito control plans or policies, or other applicable State preparedness plans.

(3) Requirement of assessment and plan

A grant may be made under paragraph (1) only if the political subdivision or consortium of political subdivisions involved—

(A) has conducted an assessment to determine the immediate needs in such subdivision or consortium for a control program, including an entomological survey of potential mosquito breeding areas; and

(B) has, on the basis of such assessment, developed a plan for carrying out such a program.

(4) Requirement of matching funds

(A) In general

With respect to the costs of a control program to be carried out under paragraph (1) by a political subdivision or consortium of political subdivisions, a grant under such paragraph may be made only if the subdivision or consortium agrees to make available (directly or through donations from public or private entities) non-Federal contributions toward such costs in an amount that is not less than 1/3 of such costs ($1 for each $2 of Federal funds provided in the grant).

(B) Determination of amount contributed

Non-Federal contributions required in subparagraph (A) may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.

(C) Waiver

The Secretary may waive the requirement established in subparagraph (A) if the Secretary determines that—

(i) extraordinary economic conditions in the political subdivision or consortium of political subdivisions involved justify the waiver; or

(ii) the geographical area covered by a political subdivision or consortium for a grant under paragraph (1) has an extreme mosquito control need due to—

(I) the size or density of the potentially impacted human population;

(II) the size or density of a mosquito population that requires heightened control; or

(III) the severity of the mosquito-borne disease, such that expected serious adverse health outcomes for the human population justify the waiver.

(5) Reports to Secretary

A grant may be made under paragraph (1) only if the political subdivision or consortium of political subdivisions involved agrees that, promptly after the end of the fiscal year for which the grant is made, the subdivision or consortium will submit to the Secretary, and to the State within which the subdivision or consortium is located, a report that describes the control program and contains an evaluation of whether the program was effective.

(6) Number of grants

A political subdivision or a consortium of political subdivisions may not receive more than one grant under paragraph (1).

(c) Applications for grants

A grant may be made under subsection (a) or (b) only if an application for the grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.

(d) Technical assistance

Amounts appropriated under subsection (f) may be used by the Secretary to provide training and technical assistance with respect to the planning, development, and operation of assessments and plans under subsection (a) and control programs under subsection (b). The Secretary may provide such technical assistance directly or through awards of grants or contracts to public and private entities.

(e) Definition of political subdivision

In this section, the term "political subdivision" means the local political jurisdiction immediately below the level of State government, including counties, parishes, and boroughs. If State law recognizes an entity of general government that functions in lieu of, and is not within, a county, parish, or borough, the Secretary may recognize an area under the jurisdiction of such other entities of general government as a political subdivision for purposes of this section.

(f) Authorization of appropriations

(1) In general

For the purpose of carrying out this section, there are authorized to be appropriated $100,000,000 for each of fiscal years 2019 through 2023.

(2) Public health emergencies

In the case of control programs carried out in response to a mosquito-borne disease that constitutes a public health emergency, the authorization of appropriations under paragraph (1) is in addition to applicable authorizations of appropriations under this chapter and other medical and public health preparedness and response laws.

(3) Fiscal year 2019 appropriations

For fiscal year 2019, 50 percent or more of the funds appropriated under paragraph (1) shall be used to award grants to political subdivisions or consortia of political subdivisions under subsection (b).

(July 1, 1944, ch. 373, title III, §317S, as added Pub. L. 108–75, §2(2), Aug. 15, 2003, 117 Stat. 898; amended Pub. L. 116–22, title VI, §607(a), June 24, 2019, 133 Stat. 959.)

Amendments

2019—Subsec. (a)(1)(B). Pub. L. 116–22, §607(a)(1), inserted "including programs to address emerging infectious mosquito-borne diseases," after "subdivisions for control programs," and "or improving existing control programs" after "in the subdivisions".

Subsec. (b)(1). Pub. L. 116–22, §607(a)(2)(A), inserted ", including improvement," after "operation".

Subsec. (b)(2)(A)(iii). Pub. L. 116–22, §607(a)(2)(B)(i)(II), substituted ", including an emerging infectious mosquito-borne disease that presents a serious public health threat; or" for semicolon at end.

Subsec. (b)(2)(A)(iv). Pub. L. 116–22, §607(a)(2)(B)(i)(I), (III), added cl. (iv).

Subsec. (b)(2)(D). Pub. L. 116–22, §607(a)(2)(B)(ii), amended subpar. (D) generally. Prior to amendment, subpar. (D) read as follows: "is located in a State that has received a grant under subsection (a)."

Subsec. (b)(4)(C). Pub. L. 116–22, §607(a)(2)(C), substituted "that—" for "that extraordinary economic conditions in the political subdivision or consortium of political subdivisions involved justify the waiver." and added cls. (i) and (ii).

Subsec. (b)(6). Pub. L. 116–22, §607(a)(2)(D), amended par. (6) generally. Prior to amendment, par. (6) related to amount of grant and number of grants.

Subsec. (f)(1). Pub. L. 116–22, §607(a)(3)(A), substituted "for each of fiscal years 2019 through 2023" for "for fiscal year 2003, and such sums as may be necessary for each of fiscal years 2004 through 2007".

Subsec. (f)(2). Pub. L. 116–22, §607(a)(3)(B), substituted "this chapter and other medical and public health preparedness and response laws" for "the Public Health Security and Bioterrorism Preparedness and Response Act of 2002".

Subsec. (f)(3). Pub. L. 116–22, §607(a)(3)(C), substituted "2019" for "2004" in heading and "2019," for "2004," in text.

1 So in original.

§247b–22. Microbicide research

(a) In general

The Director of the Centers for Disease Control and Prevention is strongly encouraged to fully implement the Centers' microbicide agenda to support research and development of microbicides for use to prevent the transmission of the human immunodeficiency virus.

(b) Authorization of appropriations

There are authorized to be appropriated such sums as may be necessary for each of fiscal years 2009 through 2013 to carry out this section.

(July 1, 1944, ch. 373, title III, §317T, as added Pub. L. 110–293, title II, §203(d), July 30, 2008, 122 Stat. 2941.)

§247c. Sexually transmitted diseases; prevention and control projects and programs

(a) Technical assistance to public and nonprofit private entities and scientific institutions

The Secretary may provide technical assistance to appropriate public and nonprofit private entities and to scientific institutions for their research in, and training and public health programs for, the prevention and control of sexually transmitted diseases.

(b) Research, demonstration, and public information and education projects

The Secretary may make grants to States, political subdivisions of States, and any other public and nonprofit private entity for—

(1) research into the prevention and control of sexually transmitted diseases;

(2) demonstration projects for the prevention and control of sexually transmitted diseases;

(3) public information and education programs for the prevention and control of such diseases; and

(4) education, training, and clinical skills improvement activities in the prevention and control of such diseases for health professionals (including allied health personnel).

(c) Project grants to States

The Secretary is also authorized to make project grants to States and, in consultation with the State health authority, to political subdivisions of States, for—

(1) sexually transmitted diseases surveillance activities, including the reporting, screening, and followup of diagnostic tests for, and diagnosed cases of, sexually transmitted diseases;

(2) casefinding and case followup activities respecting sexually transmitted diseases, including contact tracing of infectious cases of sexually transmitted diseases and routine testing, including laboratory tests and followup systems;

(3) interstate epidemiologic referral and followup activities respecting sexually transmitted diseases; and

(4) such special studies or demonstrations to evaluate or test sexually transmitted diseases prevention and control strategies and activities as may be prescribed by the Secretary.

(d) Grants for innovative, interdisciplinary approaches

The Secretary may make grants to States and political subdivisions of States for the development, implementation, and evaluation of innovative, interdisciplinary approaches to the prevention and control of sexually transmitted diseases.

(e) Authorization of appropriations; terms and conditions; payments; recordkeeping; audit; grant reduction; information disclosure

(1) For the purpose of making grants under subsections (b) through (d), there are authorized to be appropriated $85,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 1998.

(2) Each recipient of a grant under this section shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the project or undertaking in connection with which such grant was given or used, and the amount of that portion of the cost of the project or undertaking supplied by other sources, and such other records as will facilitate an effective audit.

(3) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipients of grants under this section that are pertinent to such grants.

(4) The Secretary, at the request of a recipient of a grant under this section, may reduce such grant by the fair market value of any supplies or equipment furnished to such recipient and by the amount of pay, allowances, travel expenses, and any other costs in connection with the detail of an officer or employee of the United States to the recipient when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such recipient and for the purpose of carrying out the program with respect to which the grant under this section is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies, equipment, or personal services on which the reduction of such grant is based.

(5) All information obtained in connection with the examination, care, or treatment of any individual under any program which is being carried out with a grant made under this section shall not, without such individual's consent, be disclosed except as may be necessary to provide service to him or as may be required by a law of a state or political subdivision of a State. Information derived from any such program may be disclosed—

(A) in summary, statistical, or other form; or

(B) for clinical or research purposes;


but only if the identity of the individuals diagnosed or provided care or treatment under such program is not disclosed.

(f) Consent of individuals

Nothing in this section shall be construed to require any State or any political subdivision of a State to have a sexually transmitted diseases program which would require any person, who objects to any treatment provided under such a program, to be treated under such a program.

(July 1, 1944, ch. 373, title III, §318, as added Pub. L. 92–449, title II, §203, Sept. 30, 1972, 86 Stat. 751; amended Pub. L. 94–317, title II, §203(b)–(i), June 23, 1976, 90 Stat. 704, 705; Pub. L. 94–484, title IX, §905(b)(2), Oct. 12, 1976, 90 Stat. 2325; Pub. L. 95–626, title II, §204(b)(1), (c), (d), Nov. 10, 1978, 92 Stat. 3583; Pub. L. 96–32, §6(j), July 10, 1979, 93 Stat. 84; Pub. L. 97–35, title IX, §929, Aug. 13, 1981, 95 Stat. 569; Pub. L. 98–555, §3, Oct. 30, 1984, 98 Stat. 2854; Pub. L. 100–607, title III, §311, Nov. 4, 1988, 102 Stat. 3112; Pub. L. 103–183, title IV, §401, Dec. 14, 1993, 107 Stat. 2236; Pub. L. 105–392, title IV, §401(b)(2), (c), Nov. 13, 1998, 112 Stat. 3587.)

Prior Provisions

A prior section 247c, act July 1, 1944, ch. 373 title III, §318, as added Aug. 18, 1964, Pub. L. 88–443, §2, 78 Stat. 447, related to grants for assisting in the areawide planning of health and related facilities, prior to repeal by Pub. L. 89–749, §6, Nov. 3, 1966, 80 Stat. 1190 eff. July 1, 1967.

Amendments

1998—Subsec. (e). Pub. L. 105–392, §401(b)(2), redesignated subsec. (e), relating to consent of individuals, as (f).

Subsec. (e)(5). Pub. L. 105–392, §401(c), made technical amendment to directory language of Pub. L. 103–183, §401(c)(3). See 1993 Amendment note below.

Subsec. (f). Pub. L. 105–392, §401(b)(2), redesignated subsec. (e), relating to consent of individuals, as (f).

1993—Subsec. (b)(3). Pub. L. 103–183, §401(c)(1), substituted "; and" for ", and".

Subsec. (c)(3). Pub. L. 103–183, §401(c)(2), which directed the substitution of "; and" for ", and", could not be executed because ", and" did not appear.

Subsec. (d). Pub. L. 103–183, §401(a)(2), added subsec. (d). Former subsec. (d) redesignated (e).

Subsec. (e). Pub. L. 103–183, §401(a)(1), redesignated subsec. (d), relating to authorization of appropriations, etc., as (e).

Subsec. (e)(1). Pub. L. 103–183, §401(b), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "For the purpose of making grants under subsections (b) and (c) of this section there are authorized to be appropriated $45,000,000 for the fiscal year ending September 30, 1979, $51,500,000 for the fiscal year ending September 30, 1980, $59,000,000 for the fiscal year ending September 30, 1981, $40,000,000 for the fiscal year ending September 30, 1982, $46,500,000 for the fiscal year ending September 30, 1983, $50,000,000 for the fiscal year ending September 30, 1984, $57,000,000 for the fiscal year ending September 30, 1985, $62,500,000 for the fiscal year ending September 30, 1986, $68,000,000 for the fiscal year ending September 30, 1987, $78,000,000 for fiscal year 1989, and such sums as may be necessary for each of the fiscal years 1990 and 1991. For grants under subsection (b) of this section in any fiscal year, the Secretary shall obligate not less than 10 per centum of the amount appropriated for such fiscal year under the preceding sentence. Grants made under subsection (b) or (c) of this section shall be made on such terms and conditions as the Secretary finds necessary to carry out the purposes of such subsection, and payments under any such grants shall be made in advance or by way of reimbursement and in such installments as the Secretary finds necessary."

Subsec. (e)(5). Pub. L. 103–183, §401(c)(3), as amended by Pub. L. 105–392, §401(c), substituted "form; or" for "form, or" in subpar. (A) and "purposes;" for "purposes," in subpar. (B).

1988Pub. L. 100–607, §311(1), amended section catchline.

Subsec. (d). Pub. L. 100–607, §311(2), (3), redesignated subsec. (e) as (d) and struck out former subsec. (d) which related to acquired immune deficiency syndrome.

Subsec. (d)(1). Pub. L. 100–607, §311(4), substituted "(b) and (c)" for "(b), (c), and (d)", struck out "and" after "1986,", and inserted ", $78,000,000 for fiscal year 1989, and such sums as may be necessary for each of the fiscal years 1990 and 1991" before period at end of first sentence; substituted "(b) or (c)" for "(b), (c), or (d)" in third sentence; and struck out at end "If the appropriations under the first sentence for fiscal year 1985 exceed $50,000,000, one-half of the amount in excess of $50,000,000 shall be made available for grants under subsection (d) of this section; if the appropriations under the first sentence for fiscal year 1986 exceed $52,500,000, one-half of the amount in excess of $52,500,000 shall be made available for such grants; and if the appropriations under the first sentence for fiscal year 1987 exceed $55,000,000, one-half of the amount in excess of $55,000,000 shall be made available for such grants."

Subsecs. (e) to (g). Pub. L. 100–607, §311(2), (3), struck out subsec. (f) which related to conditional limitation on use of funds and redesignated subsecs. (e) and (g) as (d) and (e), respectively.

1984—Subsec. (a). Pub. L. 98–555, §3(b)(1), substituted "research in, and training and public health programs for, the prevention and control of sexually transmitted diseases" for "research, training, and public health programs for the prevention and control of venereal disease".

Subsec. (b). Pub. L. 98–555, §3(b)(2), in amending subsec. (b) generally, designated existing provisions as pars. (1) to (3), added par. (4), and substituted references to sexually transmitted diseases for reference to venereal disease.

Subsec. (c). Pub. L. 98–555, §3(b)(3), (6)(A), substituted "sexually transmitted diseases" for "venereal disease" wherever appearing, struck out par. (4) relating to professional venereal disease education, training and clinical skills improvement activities, and redesignated par. (5) as (4).

Subsec. (d). Pub. L. 98–555, §3(b)(5)(A), added subsec. (d). Former subsec. (d) redesignated (e).

Subsec. (e). Pub. L. 98–555, §3(a), (b)(4), (5), redesignated subsec. (d) as (e), and in par. (1) of subsec. (e) as so redesignated, substituted "(b), (c), and (d)" for "(b) and (c)", inserted provisions authorizing appropriations for fiscal years ending Sept. 30, 1985, 1986, and 1987, substituted "10 per centum" for "5 per centum", and inserted provisions directing that one-half the excess of appropriations in fiscal years 1985, 1986, and 1987 over certain amounts be made available for grants under subsec. (d). Notwithstanding language of section 3(b)(5)(B)(ii) directing the substitution of "(b), (c), or (d)" for "(b) or (c)" in second sentence of subsec. (e)(1), the amendment was executed by making the substitution in third sentence of subsec. (e)(1) to reflect the probable intent of Congress because "(b) or (c)" did not appear in second sentence. Former subsec. (e) redesignated (f).

Subsecs. (f), (g). Pub. L. 98–555, §3(b)(5)(A), (6)(A), (C), redesignated subsecs. (e) and (f) as (f) and (g), respectively, in subsecs. (f) and (g) as so redesignated, substituted "sexually transmitted diseases" for "venereal disease", and struck out former subsec. (g) which defined venereal disease.

1981—Subsec. (d)(1). Pub. L. 97–35 inserted provisions authorizing appropriations for fiscal years ending Sept. 30, 1982, 1983, and 1984.

1979—Subsec. (b). Pub. L. 96–32 amended directory language of Pub. L. 95–626, §204(c)(2), and required no change in text. See 1978 Amendment note below.

1978—Subsec. (b). Pub. L. 95–626, §204(c)(2), as amended by Pub. L. 96–32, substituted "research, demonstrations, and public information and education for the prevention and control of venereal disease" for "research, demonstrations, education, and training for the prevention and control of venereal disease", struck out "(1)" preceding provisions thus amended, and struck out par. (2) which authorized appropriation of $5,000,000 for fiscal year 1976, $6,600,000 for fiscal year 1977, and $7,600,000 for fiscal year 1978 for purpose of carrying out this subsection.

Subsec. (c). Pub. L. 95–626, §204(d), struck out "(1)" after "(c)" at beginning of existing provisions, changed designations at beginning of each of the five clauses from "(A)", "(B)", "(C)", "(D)", and "(E)" to "(1)", "(2)", "(3)", "(4)", and "(5)", respectively, substituted "The Secretary is also authorized" for "The Secretary is authorized" in provisions preceding cl. (1) as redesignated, substituted "professional (including appropriate allied health personnel) venereal disease education, training and clinical skills improvement activities" for "professional and public venereal disease education activities" in cl. (4) as redesignated, and struck out former par. (2) which had authorized appropriations of $32,000,000 for fiscal year 1976, $41,500,000 for fiscal year 1977, and $43,500,000 for fiscal year 1978.

Subsec. (d)(1). Pub. L. 95–626, §204(c)(1), inserted provisions authorizing appropriations of $45,000,000 for fiscal year ending Sept. 30, 1979, $51,500,000 for fiscal year ending Sept. 30, 1980, and $59,000,000 for fiscal year ending Sept. 30, 1981, for purpose of making grants under subsecs. (b) and (c) of this section, and inserted provisions directing Secretary to obligate not less than 5 per centum of amount appropriated for any fiscal year.

Subsec. (f). Pub. L. 95–626, §204(b)(1), redesignated subsec. (g) as (f). Former subsec. (f), requiring that not to exceed 50 per centum of amounts appropriated for any fiscal year under subsecs. (b) and (c) of this section could be used by Secretary for grants for such fiscal year under section 247b of this title, was struck out.

Subsec. (g). Pub. L. 95–626, §204(b)(1), redesignated subsec. (h) as (g). Former subsec. (g) redesignated (f).

1976—Subsec. (a). Pub. L. 94–317, §203(c), substituted "public and nonprofit private entities and to" for "public authorities and".

Subsec. (b)(1). Pub. L. 94–317, §203(i), inserted "education," before "and training".

Subsec. (b)(2). Pub. L. 94–317, §203(b)(1), substituted provisions authorizing appropriations of $5,000,000 for fiscal year 1976, $6,600,000 for fiscal year 1977, and $7,600,000 for fiscal year 1978, for provisions authorizing appropriations of $7,500,000 for fiscal year ending June 30, 1973, and for each of the next two fiscal years.

Subsec. (c). Pub. L. 94–484, purported to amend former subsec. (c)(1) by defining "State" to include the Northern Mariana Islands. Former subsec. (c) of this section had been previously repealed by section 203(f)(1) of Pub. L. 94–317. See par. below.

Pub. L. 94–317, §203(b)(2), (d), (e), (f)(1), (3), (8), redesignated subsec. (d) as (c), inserted, in par. (1)(B), reference to routine testing, including laboratory tests and followup systems and substituted in par. (1)(E). "prevention and control strategies and activities" for "control" and, in par. (2), provisions authorizing appropriations of $32,000,000 for fiscal year 1976, $41,500,000 for fiscal year 1977, and $43,500,000 for fiscal year 1978, for provisions authorizing appropriations of $30,000,000 for the fiscal year ending June 30, 1973, and for each of the next two succeeding fiscal years. Former subsec. (c), which provided for authorization of appropriations to enable the Secretary to make grants to state health authorities to establish and maintain programs for diagnosis and treatment of venereal disease was amended by striking out reference to dark-field microscope techniques for diagnosis of both gonorrhea an syphilis, and as so amended, was repealed.

Subsec. (d). Pub. L. 94–317, §203(f)(2), (4), (5), (8), redesignated subsec. (e) as (d), substituted in par. (1) "or (c)" for "or (d)", struck out in par. (4) provisions relating to the amount of reduction of a grant under former subsec. (c) whereby such amount shall be deemed a part of the grant to the recipient of the grant and shall be deemed to have been paid to such recipient, and inserted in par. (5) reference to requirement by law of a State or political subdivision of a state. Former subsec. (d) redesignated (c).

Subsec. (e). Pub. L. 94–317, §203(f)(8), (g), redesignated subsec. (f) as (e) and substituted "247b(g)(2) of this title" for "247b(d)(4) of this title". Former subsec. (e) redesignated (d).

Subsec. (f). Pub. L. 94–317, §203(f)(6), (8), redesignated subsec. (g) as (f) and substituted "and (c)" for ", (c), and (d)". Former subsec. (f) redesignated (e).

Subsec. (g). Pub. L. 94–317, §203(f)(7), (8), redesignated subsec. (h) as (g) and struck out "treated or to have any child or ward of his" after "a program, to be". Former subsec. (g) redesignated (f).

Subsec. (h). Pub. L. 94–317, §203(h), added subsec. (h). Former subsec. (h) redesignated (g).

Effective Date of 1998 Amendment

Amendment by Pub. L. 105–392 deemed to have taken effect immediately after enactment of Pub. L. 103–183, see section 401(e) of Pub. L. 105–392, set out as a note under section 242m of this title.

Distribution of Information on Acquired Immune Deficiency Syndrome by Director of Centers for Disease Control to Every American Household

Pub. L. 100–202, §101(h) [title II], Dec. 22, 1987, 101 Stat. 1329–256, 1329-365, provided: "That the Director shall cause to be distributed without necessary clearance of the content by any official, organization or office, an AIDS mailer to every American household by June 30, 1988, as approved and funded by the Congress in Public Law 100–71 [July 11, 1987, 101 Stat. 391]."

Congressional Findings and Declarations

Pub. L. 95–626, title II, §204(a), Nov. 10, 1978, 92 Stat. 3582, provided that: "The Congress finds and declares that—

"(1) the number of reported cases of venereal disease persists in epidemic proportions in the United States;

"(2) the number of persons affected by venereal disease and reported to public health authorities is only a fraction of those actually affected;

"(3) the incidence of venereal disease continues to be particularly high among American youth, ages fifteen to twenty-nine, and among populations in metropolitan areas;

"(4) venereal disease accounts for severe permanent disabilities and sometimes death in newborns and causes reproductive dysfunction in women of childbearing age;

"(5) it is conservatively estimated that the public cost of health care for persons suffering from complications of venereal disease exceeds one-half billion dollars annually;

"(6) the number of trained Federal venereal disease prevention and control personnel has fallen to a dangerously inadequate level;

"(7) no vaccine for syphilis, gonorrhea, or any other venereal disease has yet been developed, nor does a blood test for the detection of asymptomatic gonorrhea in women exist, nor are safe and effective therapeutic agents available for some other venereal diseases;

"(8) school health education programs, public information and awareness campaigns, mass diagnostic screening and case followup have all been found to be effective venereal disease prevention and control methodologies;

"(9) skilled and knowledgeable health care providers, informed and concerned individuals and active, well-coordinated voluntary groups are fundamental to venereal disease prevention and control;

"(10) biomedical research toward improved diagnostic and therapeutic tools is of singular importance to the elimination of venereal disease; and

"(11) an increasing number of sexually transmissible diseases besides syphilis and gonorrhea have become a public health hazard."

Pub. L. 94–317, title II, §203(a), June 23, 1976, 90 Stat. 703, provided that: "The Congress finds and declares that—

"(1) the number of reported cases of venereal disease continues in epidemic proportions in the United States;

"(2) the number of patients with venereal disease reported to public health authorities is only a fraction of those actually infected;

"(3) the incidence of venereal disease is particularly high in the 15–29-year age group, and in metropolitan areas;

"(4) venereal disease accounts for needless deaths and leads to such severe disabilities as sterility, insanity, blindness, and crippling conditions;

"(5) the number of cases of congenital syphilis, a preventable disease, tends to parallel the incidence of syphilis in adults;

"(6) it is conservatively estimated that the public cost of care for persons suffering the complications of venereal disease exceed $80,000,000 annually;

"(7) medical researchers have no successful vaccine for syphilis or gonorrhea, and have no blood test for the detection of gonorrhea among the large reservoir of asymptomatic females;

"(8) school health education programs, public information and awareness campaigns, mass diagnostic screening and case followup activities have all been found to be effective disease intervention methodologies;

"(9) knowledgeable health providers and concerned individuals and groups are fundamental to venereal disease prevention and control;

"(10) biomedical research leading to the development of vaccines for syphilis and gonorrhea is of singular importance for the eventual eradication of these dreaded diseases; and

"(11) a variety of other sexually transmitted diseases, in addition to syphilis and gonorrhea, have become of public health significance."

Pub. L. 92–449, title II, §202, Sept. 30, 1972, 86 Stat. 750, provided that:

"(a) The Congress finds and declares that—

"(1) the number or reported cases of venereal disease has reached epidemic proportions in the United States;

"(2) the number of patients with venereal disease reported to public health authorities is only a fraction of those treated by physicians;

"(3) the incidence of venereal disease is particularly high among individuals in the 20–24 age group, and in metropolitan areas;

"(4) venereal disease accounts for needless deaths and leads to such severe disabilities as sterility, insanity, blindness, and crippling conditions;

"(5) the number of cases of congenital syphilis, a preventable disease, in infants under one year of age increased by 331/3 per centum between 1970 and 1971;

"(6) health education programs in schools and through the mass media may prevent a substantial portion of the venereal disease problem; and

"(7) medical authorities have no successful vaccine for syphilis or gonorrhea and no blood test for the detection of gonorrhea among the large reservoir of asymptomatic females.

"(b) In order to preserve and protect the health and welfare of all citizens, it is the purpose of this Act [enacting this section, amending sections 247b and 300 of this title, and enacting provisions set out as notes under sections 201 and 247b of this title] to establish a national program for the prevention and control of venereal disease."

§247c–1. Infertility and sexually transmitted diseases

(a) In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States, political subdivisions of States, and other public or nonprofit private entities for the purpose of carrying out the activities described in subsection (c) regarding any treatable sexually transmitted disease that can cause infertility in women if treatment is not received for the disease.

(b) Authority regarding individual diseases

With respect to diseases described in subsection (a), the Secretary shall, in making a grant under such subsection, specify the particular disease or diseases with respect to which the grant is to be made. The Secretary may not make the grant unless the applicant involved agrees to carry out this section only with respect to the disease or diseases so specified.

(c) Authorized activities

With respect to any sexually transmitted disease described in subsection (a), the activities referred to in such subsection are—

(1) screening women for the disease and for secondary conditions resulting from the disease, subject to compliance with criteria issued under subsection (f);

(2) providing treatment to women for the disease;

(3) providing counseling to women on the prevention and control of the disease (including, in the case of a woman with the disease, counseling on the benefits of locating and providing such counseling to any individual from whom the woman may have contracted the disease and any individual whom the woman may have exposed to the disease);

(4) providing follow-up services;

(5) referrals for necessary medical services for women screened pursuant to paragraph (1), including referrals for evaluation and treatment with respect to acquired immune deficiency syndrome and other sexually transmitted diseases;

(6) in the case of any woman receiving services pursuant to any of paragraphs (1) through (5), providing to the partner of the woman the services described in such paragraphs, as appropriate;

(7) providing outreach services to inform women of the availability of the services described in paragraphs (1) through (6);

(8) providing to the public information and education on the prevention and control of the disease, including disseminating such information; and

(9) providing training to health care providers in carrying out the screenings and counseling described in paragraphs (1) and (3).

(d) Requirement of availability of all services through each grantee

The Secretary may make a grant under subsection (a) only if the applicant involved agrees that each activity authorized in subsection (c) will be available through the applicant. With respect to compliance with such agreement, the applicant may expend the grant to carry out any of the activities directly, and may expend the grant to enter into agreements with other public or nonprofit private entities under which the entities carry out the activities.

(e) Required providers regarding certain services

The Secretary may make a grant under subsection (a) only if the applicant involved agrees that, in expending the grant to carry out activities authorized in subsection (c), the services described in paragraphs (1) through (7) of such subsection will be provided only through entities that are State or local health departments, grantees under section 254b, 254b, 256a, or 300 of this title,1 or are other public or nonprofit private entities that provide health services to a significant number of low-income women.

(f) Quality assurance regarding screening for diseases

For purposes of this section, the Secretary shall establish criteria for ensuring the quality of screening procedures for diseases described in subsection (a).

(g) Confidentiality

The Secretary may make a grant under subsection (a) only if the applicant involved agrees, subject to applicable law, to maintain the confidentiality of information on individuals with respect to activities carried out under subsection (c).

(h) Limitation on imposition of fees for services

The Secretary may make a grant under subsection (a) only if the applicant involved agrees that, if a charge is imposed for the provision of services or activities under the grant, such charge—

(1) will be made according to a schedule of charges that is made available to the public;

(2) will be adjusted to reflect the income of the individual involved; and

(3) will not be imposed on any individual with an income of less than 150 percent of the official poverty line, as established by the Director of the Office of Management and Budget and revised by the Secretary in accordance with section 9902(2) of this title.

(i) Limitations on certain expenditures

The Secretary may make a grant under subsection (a) only if the applicant involved agrees that not less than 80 percent of the grant will be expended for the purpose of carrying out paragraphs (1) through (7) of subsection (c).

(j) Reports to Secretary

(1) Collection of data

The Secretary may make a grant under subsection (a) only if the applicant involved agrees, with respect to any disease selected under subsection (b) for the applicant, to submit to the Secretary, for each fiscal year for which the applicant receives such a grant, a report providing—

(A) the incidence of the disease among the population of individuals served by the applicant;

(B) the number and demographic characteristics of individuals in such population;

(C) the types of interventions and treatments provided by the applicant, and the health conditions with respect to which referrals have been made pursuant to subsection (c)(5);

(D) an assessment of the extent to which the activities carried pursuant to subsection (a) have reduced the incidence of infertility in the geographic area involved; and

(E) such other information as the Secretary may require with respect to the project carried out with the grant.

(2) Utility and comparability of data

The Secretary shall carry out activities for the purpose of ensuring the utility and comparability of data collected pursuant to paragraph (1).

(k) Maintenance of effort

With respect to activities for which a grant under subsection (a) is authorized to be expended, the Secretary may make such a grant only if the applicant involved agrees to maintain expenditures of non-Federal amounts for such activities at a level that is not less than the average level of such expenditures maintained by the applicant for the 2-year period preceding the fiscal year for which the applicant is applying to receive such a grant.

(l) Requirement of application

(1) In general

The Secretary may make a grant under subsection (a) only if an application for the grant is submitted to the Secretary, the application contains the plan required in paragraph (2), and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.

(2) Submission of plan for program of grantee

(A) In general

The Secretary may make a grant under subsection (a) only if the applicant involved submits to the Secretary a plan describing the manner in which the applicant will comply with the agreements required as a condition of receiving such a grant, including a specification of the entities through which activities authorized in subsection (c) will be provided.

(B) Participation of certain entities

The Secretary may make a grant under subsection (a) only if the applicant provides assurances satisfactory to the Secretary that the plan submitted under subparagraph (A) has been prepared in consultation with an appropriate number and variety of—

(i) representatives of entities in the geographic area involved that provide services for the prevention and control of sexually transmitted diseases, including programs to provide to the public information and education regarding such diseases; and

(ii) representatives of entities in such area that provide family planning services.

(m) Duration of grant

The period during which payments are made to an entity from a grant under subsection (a) may not exceed 3 years. The provision of such payments shall be subject to annual approval by the Secretary of the payments and subject to the availability of appropriations for the fiscal year involved to make the payments in such year. The preceding sentence may not be construed to establish a limitation on the number of grants under such subsection that may be made to an entity.

(n) Technical assistance, and supplies and services in lieu of grant funds

(1) Technical assistance

The Secretary may provide training and technical assistance to grantees under subsection (a) with respect to the planning, development, and operation of any program or service carried out under such subsection. The Secretary may provide such technical assistance directly or through grants or contracts.

(2) Supplies, equipment, and employee detail

The Secretary, at the request of a recipient of a grant under subsection (a), may reduce the amount of such grant by—

(A) the fair market value of any supplies or equipment furnished the grant recipient; and

(B) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or employee;


when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out a program with respect to which the grant under subsection (a) is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant recipient.

(o) Evaluations and reports by Secretary

(1) Evaluations

The Secretary shall, directly or through contracts with public or private entities, provide for annual evaluations of programs carried out pursuant to subsection (a) in order to determine the quality and effectiveness of the programs.

(2) Report to Congress

Not later than 1 year after the date on which amounts are first appropriated pursuant to subsection (q), and biennially thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report—

(A) summarizing the information provided to the Secretary in reports made pursuant to subsection (j)(1), including information on the incidence of sexually transmitted diseases described in subsection (a); and

(B) summarizing evaluations carried out pursuant to paragraph (1) during the preceding fiscal year.

(p) Coordination of Federal programs

The Secretary shall coordinate the program carried out under this section with any similar programs administered by the Secretary (including coordination between the Director of the Centers for Disease Control and Prevention and the Director of the National Institutes of Health).

(q) Authorization of appropriations

For the purpose of carrying out this section, other than subsections (o) and (r), there are authorized to be appropriated $25,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 1998.

(r) Separate grants for research on delivery of services

(1) In general

The Secretary may make grants for the purpose of conducting research on the manner in which the delivery of services under subsection (a) may be improved. The Secretary may make such grants only to grantees under such subsection and to public and nonprofit private entities that are carrying out programs substantially similar to programs carried out under such subsection.

(2) Authorization of appropriations

For the purpose of carrying out paragraph (1), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1993 through 1998.

(July 1, 1944, ch. 373, title III, §318A, as added Pub. L. 102–531, title III, §304, Oct. 27, 1992, 106 Stat. 3490; amended Pub. L. 103–43, title XX, §2008(i)(1)(B)(ii), June 10, 1993, 107 Stat. 212; Pub. L. 103–183, title IV, §402, Dec. 14, 1993, 107 Stat. 2236; Pub. L. 107–251, title VI, §601(a), Oct. 26, 2002, 116 Stat. 1664; Pub. L. 108–163, §2(m)(1), Dec. 6, 2003, 117 Stat. 2023.)

References in Text

The reference to section 254b of this title the first place appearing, referred to in subsec. (e), was in the original a reference to section 329, meaning section 329 of act July 1, 1944, which was omitted in the general amendment of subpart I (§254b et seq.) of part D of this subchapter by Pub. L. 104–299, §2, Oct. 11, 1996, 110 Stat. 3626.

Section 256a of this title, referred to in subsec. (e), was repealed by Pub. L. 104–299, §4(a)(3), Oct. 11, 1996, 110 Stat. 3645.

Amendments

2003—Subsec. (e). Pub. L. 108–163 substituted "254b" for "254c, 254b(h)" before ", 256a".

2002—Subsec. (e). Pub. L. 107–251 substituted "254b(h)" for "256".

1993Pub. L. 103–43 made technical amendment to directory language of Pub. L. 102–531, §304, which enacted this section.

Subsec. (o)(2). Pub. L. 103–183, §402(a), substituted "subsection (q)" for "subsection (s)".

Subsec. (q). Pub. L. 103–183, §402(b)(1), substituted "through 1998" for "and 1995".

Subsec. (r)(2). Pub. L. 103–183, §402(b)(2), substituted "1998" for "1995".

Change of Name

Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.

Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104–14, set out as a note preceding section 21 of Title 2, The Congress. Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.

Effective Date of 2003 Amendment

Amendment by Pub. L. 108–163 deemed to have taken effect immediately after the enactment of Pub. L. 107–251, see section 3 of Pub. L. 108–163, set out as a note under section 233 of this title.

1 See References in Text notes below.

§247c–2. Data collection regarding programs under subchapter XXIV

For the purpose of collecting and providing data for program planning and evaluation activities under subchapter XXIV, there are authorized to be appropriated to the Secretary (acting through the Director of the Centers for Disease Control and Prevention) such sums as may be necessary for each of the fiscal years 2001 through 2005. Such authorization of appropriations is in addition to other authorizations of appropriations that are available for such purpose.

(July 1, 1944, ch. 373, title III, §318B, as added Pub. L. 106–345, title IV, §412, Oct. 20, 2000, 114 Stat. 1350.)

§247d. Public health emergencies

(a) Emergencies

If the Secretary determines, after consultation with such public health officials as may be necessary, that—

(1) a disease or disorder presents a public health emergency; or

(2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists,


the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and (2). Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determination.

(b) Public Health Emergency Fund

(1) In general

There is established in the Treasury a fund to be designated as the "Public Health Emergency Fund" to be made available to the Secretary without fiscal year limitation to carry out subsection (a) only if a public health emergency has been declared by the Secretary under such subsection or if the Secretary determines there is the significant potential for a public health emergency, to allow the Secretary to rapidly respond to the immediate needs resulting from such public health emergency or potential public health emergency. The Secretary shall plan for the expedited distribution of funds to appropriate agencies and entities. There is authorized to be appropriated to the Fund such sums as may be necessary.

(2) Uses

The Secretary may use amounts in the Fund established under paragraph (1), to—

(A) facilitate coordination between and among Federal, State, local, Tribal, and territorial entities and public and private health care entities that the Secretary determines may be affected by a public health emergency or potential public health emergency referred to in paragraph (1) (including communication of such entities with relevant international entities, as applicable);

(B) make grants, provide for awards, enter into contracts, and conduct supportive investigations pertaining to a public health emergency or potential public health emergency, including further supporting programs under section 247d–3a, 247d–3b, or 247d–3c of this title;

(C) facilitate and accelerate, as applicable, advanced research and development of security countermeasures (as defined in section 247d–6b of this title), qualified countermeasures (as defined in section 247d–6a of this title), or qualified pandemic or epidemic products (as defined in section 247d–6d of this title), that are applicable to the public health emergency or potential public health emergency under paragraph (1);

(D) strengthen biosurveillance capabilities and laboratory capacity to identify, collect, and analyze information regarding such public health emergency or potential public health emergency, including the systems under section 247d–4 of this title;

(E) support initial emergency operations and assets related to preparation and deployment of intermittent disaster response personnel under section 300hh–11 of this title and the Medical Reserve Corps under section 300hh–15 of this title; and

(F) carry out other activities, as the Secretary determines applicable and appropriate.

(3) Report

Not later than 90 days after the end of each fiscal year, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Commerce and the Committee on Appropriations of the House of Representatives a report describing—

(A) the expenditures made from the Public Health Emergency Fund in such fiscal year; and

(B) each public health emergency for which the expenditures were made and the activities undertaken with respect to each emergency which was conducted or supported by expenditures from the Fund.

(4) Review

Not later than 2 years after June 24, 2019, the Secretary, in coordination with the Assistant Secretary for Preparedness and Response, shall conduct a review of the Fund under this section and provide recommendations to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives on policies to improve such Fund for the uses described in paragraph (2).

(5) GAO report

Not later than 4 years after June 24, 2019, the Comptroller General of the United States shall—

(A) conduct a review of the Fund under this section, including its uses and the resources available in the Fund; and

(B) submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on such review, including recommendations related to such review, as applicable.

(c) Supplement not supplant

Funds appropriated under this section shall be used to rapidly respond to public health emergencies or potential public health emergencies and supplement and not supplant other Federal, State, and local public funds provided for activities under this chapter or funds otherwise provided for emergency response.

(d) Data submittal and reporting deadlines

In any case in which the Secretary determines that, wholly or partially as a result of a public health emergency that has been determined pursuant to subsection (a), individuals or public or private entities are unable to comply with deadlines for the submission to the Secretary of data or reports required under any law administered by the Secretary, the Secretary may, notwithstanding any other provision of law, grant such extensions of such deadlines as the circumstances reasonably require, and may waive, wholly or partially, any sanctions otherwise applicable to such failure to comply. Before or promptly after granting such an extension or waiver, the Secretary shall notify the Congress of such action and publish in the Federal Register a notice of the extension or waiver.

(e) Temporary reassignment of State and local personnel during a public health emergency

(1) Emergency reassignment of federally funded personnel

Notwithstanding any other provision of law, and subject to paragraph (2), upon request by the Governor of a State or a tribal organization or such Governor or tribal organization's designee, the Secretary may authorize the requesting State or Indian tribe to temporarily reassign, for purposes of immediately addressing a public health emergency in the State or Indian tribe, State and local public health department or agency personnel funded in whole or in part through programs authorized under this chapter, as appropriate.

(2) Activation of emergency reassignment

(A) Public health emergency

The Secretary may authorize a temporary reassignment of personnel under paragraph (1) only during the period of a public health emergency determined pursuant to subsection (a).

(B) Contents of request

To seek authority for a temporary reassignment of personnel under paragraph (1), the Governor of a State or a tribal organization shall submit to the Secretary a request for such reassignment flexibility and shall include in the request each of the following:

(i) An assurance that the public health emergency in the geographic area of the requesting State or Indian tribe cannot be adequately and appropriately addressed by the public health workforce otherwise available.

(ii) An assurance that the public health emergency would be addressed more efficiently and effectively through the requested temporary reassignment of State and local personnel described in paragraph (1).

(iii) An assurance that the requested temporary reassignment of personnel is consistent with any applicable All-Hazards Public Health Emergency Preparedness and Response Plan under section 247d–3a of this title.

(iv) An identification of—

(I) each Federal program from which personnel would be temporarily reassigned pursuant to the requested authority; and

(II) the number of personnel who would be so reassigned from each such program.


(v) Such other information and assurances upon which the Secretary and Governor of a State or tribal organization agree.

(C) Consideration

In reviewing a request for temporary reassignment under paragraph (1), the Secretary shall consider the degree to which the program or programs funded in whole or in part by programs authorized under this chapter would be adversely affected by the reassignment.

(D) Termination and extension

(i) Termination

A State or Indian tribe's temporary reassignment of personnel under paragraph (1) shall terminate upon the earlier of the following:

(I) The Secretary's determination that the public health emergency no longer exists.

(II) Subject to clause (ii), the expiration of the 30-day period following the date on which the Secretary approved the State or Indian tribe's request for such reassignment flexibility.

(ii) Extension of reassignment flexibility

The Secretary may extend reassignment flexibility of personnel under paragraph (1) beyond the date otherwise applicable under clause (i)(II) if the public health emergency still exists as of such date, but only if—

(I) the State or Indian tribe that submitted the initial request for a temporary reassignment of personnel submits a request for an extension of such temporary reassignment; and

(II) the request for an extension contains the same information and assurances necessary for the approval of an initial request for such temporary reassignment pursuant to subparagraph (B).

(3) Voluntary nature of temporary reassignment of State and local personnel

(A) In general

Unless otherwise provided under the law or regulation of the State or Indian tribe that receives authorization for temporary reassignment of personnel under paragraph (1), personnel eligible for reassignment pursuant to such authorization—

(i) shall have the opportunity to volunteer for temporary reassignment; and

(ii) shall not be required to agree to a temporary reassignment.

(B) Prohibition on conditioning Federal awards

The Secretary may not condition the award of a grant, contract, or cooperative agreement under this chapter on the requirement that a State or Indian tribe require that personnel eligible for reassignment pursuant to an authorization under paragraph (1) agree to such reassignment.

(4) Notice to Congress

The Secretary shall give notice to the Congress in conjunction with the approval under this subsection of—

(A) any initial request for temporary reassignment of personnel; and

(B) any request for an extension of such temporary reassignment.

(5) Guidance

The Secretary shall—

(A) not later than 6 months after March 13, 2013, issue proposed guidance on the temporary reassignment of personnel under this subsection; and

(B) after providing notice and a 60-day period for public comment, finalize such guidance.

(6) Report to Congress

Not later than 4 years after March 13, 2013, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate committees of the Congress a report, on temporary reassignment under this subsection, including—

(A) a description of how, and under what circumstances, such temporary reassignment has been used by States and Indian tribes;

(B) an analysis of how such temporary reassignment has assisted States and Indian tribes in responding to public health emergencies;

(C) an evaluation of how such temporary reassignment has improved operational efficiencies in responding to public health emergencies;

(D) an analysis of the extent to which, if any, Federal programs from which personnel have been temporarily reassigned have been adversely affected by the reassignment; and

(E) recommendations on how medical surge capacity could be improved in responding to public health emergencies and the impact of the reassignment flexibility under this section on such surge capacity.

(7) Definitions

In this subsection—

(A) the terms "Indian tribe" and "tribal organization" have the meanings given such terms in section 5304 of title 25; and

(B) the term "State" includes, in addition to the entities listed in the definition of such term in section 201 of this title, the Freely Associated States.

(8) Sunset

This subsection shall terminate on September 30, 2023.

(f) Determination with respect to Paperwork Reduction Act waiver during a public health emergency

(1) Determination

If the Secretary determines, after consultation with such public health officials as may be necessary, that—

(A)(i) the criteria set forth for a public health emergency under paragraph (1) or (2) of subsection (a) has been met; or

(ii) a disease or disorder, including a novel and emerging public health threat, is significantly likely to become a public health emergency; and

(B) the circumstances of such public health emergency, or potential for such significantly likely public health emergency, including the specific preparation for and response to such public health emergency or threat, necessitate a waiver from the requirements of subchapter I of chapter 35 of title 44 (commonly referred to as the Paperwork Reduction Act),


then the requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during the immediate investigation of, and response to, such public health emergency during the period of such public health emergency or the period of time necessary to determine if a disease or disorder, including a novel and emerging public health threat, will become a public health emergency as provided for in this paragraph. The requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during the immediate postresponse review regarding such public health emergency if such immediate postresponse review does not exceed a reasonable length of time.

(2) Transparency

If the Secretary determines that a waiver is necessary under paragraph (1), the Secretary shall promptly post on the Internet website of the Department of Health and Human Services a brief justification for such waiver, the anticipated period of time such waiver will be in effect, and the agencies and offices within the Department of Health and Human Services to which such waiver shall apply, and update such information posted on the Internet website of the Department of Health and Human Services, as applicable.

(3) Effectiveness of waiver

Any waiver under this subsection shall take effect on the date on which the Secretary posts information on the Internet website as provided for in this subsection.

(4) Termination of waiver

Upon determining that the circumstances necessitating a waiver under paragraph (1) no longer exist, the Secretary shall promptly update the Internet website of the Department of Health and Human Services to reflect the termination of such waiver.

(5) Limitations

(A) Period of waiver

The period of a waiver under paragraph (1) shall not exceed the period of time for the related public health emergency, including a public health emergency declared pursuant to subsection (a), and any immediate postresponse review regarding the public health emergency consistent with the requirements of this subsection.

(B) Subsequent compliance

An initiative subject to a waiver under paragraph (1) that is ongoing after the date on which the waiver expires, shall be subject to the requirements of subchapter I of chapter 35 of title 44 and the Secretary shall ensure that compliance with such requirements occurs in as timely a manner as possible based on the applicable circumstances, but not to exceed 30 calendar days after the expiration of the applicable waiver.

(July 1, 1944, ch. 373, title III, §319, as added Pub. L. 106–505, title I, §102, Nov. 13, 2000, 114 Stat. 2315; amended Pub. L. 107–188, title I, §§141, 144(a), 158, June 12, 2002, 116 Stat. 626, 630, 633; Pub. L. 113–5, title II, §201, Mar. 13, 2013, 127 Stat. 170; Pub. L. 114–255, div. A, title III, §3087, Dec. 13, 2016, 130 Stat. 1147; Pub. L. 116–22, title II, §206, title VII, §701(c), June 24, 2019, 133 Stat. 925, 961.)

Prior Provisions

A prior section 247d, act July 1, 1944, ch. 373, title III, §319, as added Pub. L. 98–49, July 13, 1983, 97 Stat. 245; amended Pub. L. 100–607, title II, §256(a), Nov. 4, 1988, 102 Stat. 3110; Pub. L. 102–321, title I, §163(b)(2), July 10, 1992, 106 Stat. 376; Pub. L. 102–531, title III, §312(d)(2), Oct. 27, 1992, 106 Stat. 3504, authorized the Secretary to take appropriate action relating to public health emergencies, prior to repeal by Pub. L. 106–505, title I, §102, Nov. 13, 2000, 114 Stat. 2315.

Another prior section 247d, act July 1, 1944, ch. 373, title III, §319, formerly §310, as added Sept. 25, 1962, Pub. L. 87–692, 76 Stat. 592, and amended and renumbered, which related to migrant health centers, was renumbered section 329 of act July 1, 1944, by Pub. L. 95–626, title I, §102(a), Nov. 10, 1978, 92 Stat. 3551, and transferred to section 254b of this title, prior to being omitted in the general amendment of subpart I (§254b et seq.) of part D of this subchapter by Pub. L. 104–299, §2.

Change of Name

Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.

Amendments

2019—Subsec. (b)(1). Pub. L. 116–22, §206(1)(A), substituted "under such subsection or if the Secretary determines there is the significant potential for a public health emergency, to allow the Secretary to rapidly respond to the immediate needs resulting from such public health emergency or potential public health emergency. The Secretary shall plan for the expedited distribution of funds to appropriate agencies and entities." for "under such subsection."

Subsec. (b)(2), (3). Pub. L. 116–22, §206(1)(B), (C), added par. (2) and redesignated former par. (2) as (3).

Subsec. (b)(4), (5). Pub. L. 116–22, §206(1)(D), added pars. (4) and (5).

Subsec. (c). Pub. L. 116–22, §206(2), inserted "rapidly respond to public health emergencies or potential public health emergencies and" after "used to" and substituted "activities under this chapter or funds otherwise provided for emergency response." for "activities under this section."

Subsec. (e)(8). Pub. L. 116–22, §701(c), substituted "2023" for "2018".

2016—Subsec. (f). Pub. L. 114–255 added subsec. (f).

2013—Subsec. (e). Pub. L. 113–5 added subsec. (e).

2002—Subsec. (a). Pub. L. 107–188, §158, substituted "grants, providing awards for expenses, and" for "grants and" in concluding provisions.

Pub. L. 107–188, §144(a), inserted at end of concluding provisions "Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determination."

Subsec. (d). Pub. L. 107–188, §141, added subsec. (d).

Effective Date of 2002 Amendment

Pub. L. 107–188, title I, §144(b), June 12, 2002, 116 Stat. 630, provided that: "The amendment made by subsection (a) [amending this section] applies to any public health emergency under section 319(a) of the Public Health Service Act [42 U.S.C. 247d(a)], including any such emergency that was in effect as of the day before the date of the enactment of this Act [June 12, 2002]. In the case of such an emergency that was in effect as of such day, the 90-day period described in such section with respect to the termination of the emergency is deemed to begin on such date of enactment."

§247d–1. Vaccine tracking and distribution

(a) Tracking

The Secretary, together with relevant manufacturers, wholesalers, and distributors as may agree to cooperate, may track the initial distribution of federally purchased influenza vaccine in an influenza pandemic. Such tracking information shall be used to inform Federal, State, local, and tribal decision makers during an influenza pandemic.

(b) Distribution

The Secretary shall promote communication between State, local, and tribal public health officials and such manufacturers, wholesalers, and distributors as agree to participate, regarding the effective distribution of seasonal influenza vaccine. Such communication shall include estimates of high priority populations, as determined by the Secretary, in State, local, and tribal jurisdictions in order to inform Federal, State, local, and tribal decision makers during vaccine shortages and supply disruptions.

(c) Confidentiality

The information submitted to the Secretary or its contractors, if any, under this section or under any other section of this chapter related to vaccine distribution information shall remain confidential in accordance with the exception from the public disclosure of trade secrets, commercial or financial information, and information obtained from an individual that is privileged and confidential, as provided for in section 552(b)(4) of title 5, and subject to the penalties and exceptions under sections 1832 and 1833 of title 18 relating to the protection and theft of trade secrets, and subject to privacy protections that are consistent with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996. None of such information provided by a manufacturer, wholesaler, or distributor shall be disclosed without its consent to another manufacturer, wholesaler, or distributor, or shall be used in any manner to give a manufacturer, wholesaler, or distributor a proprietary advantage.

(d) Guidelines

The Secretary, in order to maintain the confidentiality of relevant information and ensure that none of the information contained in the systems involved may be used to provide proprietary advantage within the vaccine market, while allowing State, local, and tribal health officials access to such information to maximize the delivery and availability of vaccines to high priority populations, during times of influenza pandemics, vaccine shortages, and supply disruptions, in consultation with manufacturers, distributors, wholesalers and State, local, and tribal health departments, shall develop guidelines for subsections (a) and (b).

(e) Authorization of appropriations

There are authorized to be appropriated to carry out this section, $30,800,000 for each of fiscal years 2019 through 2023.

(f) Report to Congress

As part of the National Health Security Strategy described in section 300hh–1 of this title, the Secretary shall provide an update on the implementation of subsections (a) through (d).

(July 1, 1944, ch. 373, title III, §319A, as added Pub. L. 106–505, title I, §102, Nov. 13, 2000, 114 Stat. 2316; amended Pub. L. 107–188, title I, §111(1), June 12, 2002, 116 Stat. 611; Pub. L. 109–417, title II, §204(a), Dec. 19, 2006, 120 Stat. 2850; Pub. L. 113–5, title II, §202(b), Mar. 13, 2013, 127 Stat. 175; Pub. L. 116–22, title VII, §701(b), June 24, 2019, 133 Stat. 961.)

References in Text

Section 264(c) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (c), is section 264(c) of Pub. L. 104–191, which is set out as a note under section 1320d–2 of this title.

Amendments

2019—Subsec. (e). Pub. L. 116–22 substituted "2019 through 2023" for "2014 through 2018".

2013—Subsec. (e). Pub. L. 113–5 substituted "$30,800,000 for each of fiscal years 2014 through 2018" for "such sums for each of fiscal years 2007 through 2011".

2006Pub. L. 109–417 amended section catchline and text generally, substituting provisions relating to vaccine tracking and distribution for provisions relating to establishment of capacities to combat threats to public health.

2002—Subsec. (a)(1). Pub. L. 107–188 substituted "five years" for "10 years".

§§247d–2, 247d–3. Repealed. Pub. L. 109–417, title II, §204(b)(1), Dec. 19, 2006, 120 Stat. 2851

Section 247d–2, act July 1, 1944, ch. 373, title III, §319B, as added Pub. L. 106–505, title I, §102, Nov. 13, 2000, 114 Stat. 2317; amended Pub. L. 107–188, title I, §111(2), June 12, 2002, 116 Stat. 611, related to grants to States to assess public health needs.

Section 247d–3, act July 1, 1944, ch. 373, title III, §319C, as added Pub. L. 106–505, title I, §102, Nov. 13, 2000, 114 Stat. 2317; amended Pub. L. 107–188, title I, §131(b), June 12, 2002, 116 Stat. 626, related to grants to improve State and local public health agencies.

§247d–3a. Improving State and local public health security

(a) In general

To enhance the security of the United States with respect to public health emergencies, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall award cooperative agreements to eligible entities to enable such entities to conduct the activities described in subsection (d).

(b) Eligible entities

To be eligible to receive an award under subsection (a), an entity shall—

(1)(A) be a State;

(B) be a political subdivision determined by the Secretary to be eligible for an award under this section (based on criteria described in subsection (h)(4)); or

(C) be a consortium of States; and

(2) prepare and submit to the Secretary an application at such time, and in such manner, and containing such information as the Secretary may require, including—

(A) an All-Hazards Public Health Emergency Preparedness and Response Plan which shall include—

(i) a description of the activities such entity will carry out under the agreement to meet the goals identified under section 300hh–1 of this title, including with respect to chemical, biological, radiological, or nuclear threats, whether naturally occurring, unintentional, or deliberate;

(ii) a description of the activities such entity will carry out with respect to pandemic influenza, as a component of the activities carried out under clause (i), and consistent with the requirements of paragraphs (2) and (5) of subsection (g);

(iii) preparedness and response strategies and capabilities that take into account the medical and public health needs of at-risk individuals in the event of a public health emergency;

(iv) a description of the mechanism the entity will implement to utilize the Emergency Management Assistance Compact, or other mutual aid agreement, for medical and public health mutual aid, and, as appropriate, the activities such entity will implement pursuant to section 247d–7b of this title to improve enrollment and coordination of volunteer health care professionals seeking to provide medical services during a public health emergency, which may include—

(I) providing a public method of communication for purposes of volunteer coordination (such as a phone number);

(II) providing for optional registration to participate in volunteer services during processes related to State medical licensing, registration, or certification or renewal of such licensing, registration, or certification; or

(III) other mechanisms as the State determines appropriate;


(v) a description of how the entity will include the State Unit on Aging in public health emergency preparedness;

(vi) a description of how, as appropriate, the entity may partner with relevant public and private stakeholders, including public health agencies with specific expertise that may be relevant to public health security, such as environmental health agencies, in public health emergency preparedness and response;

(vii) a description of how, as applicable, such entity may integrate information to account for individuals with behavioral health needs following a public health emergency;

(viii) a description of how the entity, as applicable and appropriate, will coordinate with State emergency preparedness and response plans in public health emergency preparedness, including State educational agencies (as defined in section 7801 of title 20) and State child care lead agencies (designated under section 9858b of this title);

(ix) in the case of entities that operate on the United States-Mexico border or the United States-Canada border, a description of the activities such entity will carry out under the agreement that are specific to the border area including disease detection, identification, investigation, and preparedness and response activities related to emerging diseases and infectious disease outbreaks whether naturally occurring or due to bioterrorism, consistent with the requirements of this section;

(x) a description of any activities that such entity will use to analyze real-time clinical specimens for pathogens of public health or bioterrorism significance, including any utilization of poison control centers;

(xi) a description of how the entity will partner with health care facilities, including hospitals and nursing homes and other long-term care facilities, to promote and improve public health preparedness and response; and

(xii) a description of how, as appropriate and practicable, the entity will include critical infrastructure partners, such as utility companies within the entity's jurisdiction, in planning pursuant to this subparagraph to help ensure that critical infrastructure will remain functioning during, or return to function as soon as practicable after, a public health emergency;


(B) an assurance that the entity will report to the Secretary on an annual basis (or more frequently as determined by the Secretary) on the evidence-based benchmarks and objective standards established by the Secretary to evaluate the preparedness and response capabilities of such entity under subsection (g);

(C) an assurance that the entity will conduct, on at least an annual basis, an exercise or drill that meets any criteria established by the Secretary to test the preparedness and response capabilities of such entity, including addressing the needs of at-risk individuals, and that the entity will report back to the Secretary within the application of the following year on the strengths and weaknesses identified through such exercise or drill, and corrective actions taken to address material weaknesses;

(D) an assurance that the entity will provide to the Secretary the data described under section 247d–4(c)(3) of this title as determined feasible by the Secretary;

(E) an assurance that the entity will conduct activities to inform and educate the hospitals within the jurisdiction of such entity on the role of such hospitals in the plan required under subparagraph (A);

(F) an assurance that the entity, with respect to the plan described under subparagraph (A), has developed and will implement an accountability system to ensure that such entity makes satisfactory annual improvement and describes such system in the plan under subparagraph (A);

(G) a description of the means by which to obtain public comment and input on the plan described in subparagraph (A) and on the implementation of such plan, that shall include an advisory committee or other similar mechanism for obtaining comment from the public and from other State, local, and tribal stakeholders; and

(H) as relevant, a description of the process used by the entity to consult with local departments of public health to reach consensus, approval, or concurrence on the relative distribution of amounts received under this section.

(c) Limitation

Beginning in fiscal year 2009, the Secretary may not award a cooperative agreement to a State unless such State is a participant in the Emergency System for Advance Registration of Volunteer Health Professionals described in section 247d–7b of this title.

(d) Use of funds

(1) In general

An award under subsection (a) shall be expended for activities to achieve the preparedness goals described under paragraphs (1), (2), (4), (5), and (6) of section 300hh–1(b) of this title.

(2) Effect of section

Nothing in this subsection may be construed as establishing new regulatory authority or as modifying any existing regulatory authority.

(e) Coordination with local response capabilities

An entity shall, to the extent practicable, ensure that activities carried out under an award under subsection (a) are coordinated with activities of relevant Metropolitan Medical Response Systems, local public health departments, the Cities Readiness Initiative, local emergency plans, and any regional health care emergency preparedness and response system established pursuant to the applicable guidelines under section 247d–3c of this title.

(f) Consultation with Homeland Security

In making awards under subsection (a), the Secretary shall consult with the Secretary of Homeland Security to—

(1) ensure maximum coordination of public health and medical preparedness and response activities with the Metropolitan Medical Response System, and other relevant activities;

(2) minimize duplicative funding of programs and activities; and

(3) analyze activities, including exercises and drills, conducted under this section to develop recommendations and guidance on best practices for such activities.

(g) Achievement of measurable evidence-based benchmarks and objective standards

(1) In general

Not later than 180 days after December 19, 2006, the Secretary shall develop or where appropriate adopt, and require the application of, measurable evidence-based benchmarks and objective standards that measure levels of preparedness with respect to the activities described in this section and with respect to activities described in section 247d–3b of this title. In developing such benchmarks and standards, the Secretary shall consult with and seek comments from State, local, and tribal officials and private entities, as appropriate. Where appropriate, the Secretary shall incorporate existing objective standards. Such benchmarks and standards shall—

(A) include outcome goals representing operational achievements of the National Preparedness Goals developed under section 300hh–1(b) of this title with respect to all-hazards, including chemical, biological, radiological, or nuclear threats; and

(B) at a minimum, require entities to—

(i) measure progress toward achieving the outcome goals; and

(ii) at least annually, test, exercise, and rigorously evaluate the public health and medical emergency preparedness and response capabilities of the entity, and report to the Secretary on such measured and tested capabilities and measured and tested progress toward achieving outcome goals, based on criteria established by the Secretary.

(2) Criteria for pandemic influenza plans

(A) In general

Not later than 180 days after December 19, 2006, the Secretary shall develop and disseminate to the chief executive officer of each State criteria for an effective State plan for responding to pandemic influenza. The Secretary shall periodically update, as necessary and appropriate, such pandemic influenza plan criteria and shall require the integration of such criteria into the benchmarks and standards described in paragraph (1).

(B) Rule of construction

Nothing in this section shall be construed to require the duplication of Federal efforts with respect to the development of criteria or standards, without regard to whether such efforts were carried out prior to or after December 19, 2006.1

(3) Technical assistance

The Secretary shall, as determined appropriate by the Secretary, provide to a State, upon request, technical assistance in meeting the requirements of this section, including the provision of advice by experts in the development of high-quality assessments, the setting of State objectives and assessment methods, the development of measures of satisfactory annual improvement that are valid and reliable, and other relevant areas.

(4) Notification of failures

The Secretary shall develop and implement a process to notify entities that are determined by the Secretary to have failed to meet the requirements of paragraph (1) or (2). Such process shall provide such entities with the opportunity to correct such noncompliance. An entity that fails to correct such noncompliance shall be subject to paragraph (5).

(5) Withholding of amounts from entities that fail to achieve benchmarks or submit influenza plan

Beginning with fiscal year 2019, and in each succeeding fiscal year, the Secretary shall—

(A) withhold from each entity that has failed substantially to meet the benchmarks and performance measures described in paragraph (1) for either of the 2 immediately preceding fiscal years (beginning with fiscal year 2018), pursuant to the process developed under paragraph (4), the amount described in paragraph (6); and

(B) withhold from each entity that has failed to submit to the Secretary a plan for responding to pandemic influenza that meets the criteria developed under paragraph (2), the amount described in paragraph (6).

(6) Amounts described

(A) In general

The amounts described in this paragraph are the following amounts that are payable to an entity for activities described in this section or section 247d–3b of this title:

(i) For no more than one of each of the first 2 fiscal years immediately following a fiscal year in which an entity experienced a failure described in subparagraph (A) or (B) of paragraph (5), an amount equal to 10 percent of the amount the entity was eligible to receive for the respective fiscal year.

(ii) For no more than one of the first 2 fiscal years immediately following the third consecutive fiscal year in which an entity experienced such a failure, in lieu of applying clause (i), an amount equal to 15 percent of the amount the entity was eligible to receive for the respective fiscal year.

(B) Separate accounting

Each failure described in subparagraph (A) or (B) of paragraph (5) shall be treated as a separate failure for purposes of calculating amounts withheld under subparagraph (A).

(7) Reallocation of amounts withheld

(A) In general

The Secretary shall make amounts withheld under paragraph (6) available for making awards under section 247d–3b of this title to entities described in subsection (b)(1) of such section.

(B) Preference in reallocation

In making awards under section 247d–3b of this title with amounts described in subparagraph (A), the Secretary shall give preference to eligible entities (as described in section 247d–3b(b)(1) of this title) that are located in whole or in part in States from which amounts have been withheld under paragraph (6).

(8) Waive or reduce withholding

The Secretary may waive or reduce the withholding described in paragraph (6), for a single entity or for all entities in a fiscal year, if the Secretary determines that mitigating conditions exist that justify the waiver or reduction.

(h) Funding

(1) Authorization of appropriations

(A) In general

For the purpose of carrying out this section, there is authorized to be appropriated $685,000,000 for each of fiscal years 2019 through 2023 for awards pursuant to paragraph (3) (subject to the authority of the Secretary to make awards pursuant to paragraphs (4) and (5)).

(B) Requirement for State matching funds

Beginning in fiscal year 2009, in the case of any State or consortium of two or more States, the Secretary may not award a cooperative agreement under this section unless the State or consortium of States agree that, with respect to the amount of the cooperative agreement awarded by the Secretary, the State or consortium of States will make available (directly or through donations from public or private entities) non-Federal contributions in an amount equal to—

(i) for the first fiscal year of the cooperative agreement, not less than 5 percent of such costs ($1 for each $20 of Federal funds provided in the cooperative agreement); and

(ii) for any second fiscal year of the cooperative agreement, and for any subsequent fiscal year of such cooperative agreement, not less than 10 percent of such costs ($1 for each $10 of Federal funds provided in the cooperative agreement).

(C) Determination of amount of non-Federal contributions

As determined by the Secretary, non-Federal contributions required in subparagraph (B) may be provided directly or through donations from public or private entities and may be in cash or in kind, fairly evaluated, including plant, equipment or services. Amounts provided by the Federal government, or services assisted or subsidized to any significant extent by the Federal government, may not be included in determining the amount of such non-Federal contributions.

(2) Maintaining State funding

(A) In general

An entity that receives an award under this section shall maintain expenditures for public health security at a level that is not less than the average level of such expenditures maintained by the entity for the preceding 2 year period.

(B) Rule of construction

Nothing in this section shall be construed to prohibit the use of awards under this section to pay salary and related expenses of public health and other professionals employed by State, local, or tribal public health agencies who are carrying out activities supported by such awards (regardless of whether the primary assignment of such personnel is to carry out such activities).

(3) Determination of amount

(A) In general

The Secretary shall award cooperative agreements under subsection (a) to each State or consortium of 2 or more States that submits to the Secretary an application that meets the criteria of the Secretary for the receipt of such an award and that meets other implementation conditions established by the Secretary for such awards.

(B) Base amount

In determining the amount of an award pursuant to subparagraph (A) for a State, the Secretary shall first determine an amount the Secretary considers appropriate for the State (referred to in this paragraph as the "base amount"), except that such amount may not be greater than the minimum amount determined under subparagraph (D).

(C) Increase on basis of population

After determining the base amount for a State under subparagraph (B), the Secretary shall increase the base amount by an amount equal to the product of—

(i) the amount appropriated under paragraph (1)(A) for the fiscal year, less an amount equal to the sum of all base amounts determined for the States under subparagraph (B), and less the amount, if any, reserved by the Secretary under paragraphs (4) and (5); and

(ii) subject to paragraph (4)(C), the percentage constituted by the ratio of an amount equal to the population of the State over an amount equal to the total population of the States (as indicated by the most recent data collected by the Bureau of the Census).

(D) Minimum amount

Subject to the amount appropriated under paragraph (1)(A), an award pursuant to subparagraph (A) for a State shall be the greater of the base amount as increased under subparagraph (C), or the minimum amount under this subparagraph. The minimum amount under this subparagraph is—

(i) in the case of each of the several States, the District of Columbia, and the Commonwealth of Puerto Rico, an amount equal to the lesser of—

(I) $5,000,000; or

(II) if the amount appropriated under paragraph (1)(A) is less than $667,000,000, an amount equal to 0.75 percent of the amount appropriated under such paragraph, less the amount, if any, reserved by the Secretary under paragraphs (4) and (5); or


(ii) in the case of each of American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, and the Virgin Islands, an amount determined by the Secretary to be appropriate, except that such amount may not exceed the amount determined under clause (i).

(4) Certain political subdivisions

(A) In general

For fiscal year 2007, the Secretary may, before making awards pursuant to paragraph (3) for such year, reserve from the amount appropriated under paragraph (1) for the year an amount determined necessary by the Secretary to make awards under subsection (a) to political subdivisions that have a substantial number of residents, have a substantial local infrastructure for responding to public health emergencies, and face a high degree of risk from bioterrorist attacks or other public health emergencies. Not more than three political subdivisions may receive awards pursuant to this subparagraph.

(B) Coordination with Statewide plans

An award pursuant to subparagraph (A) may not be made unless the application of the political subdivision involved is in coordination with, and consistent with, applicable Statewide plans described in subsection (b).

(C) Relationship to formula grants

In the case of a State that will receive an award pursuant to paragraph (3), and in which there is located a political subdivision that will receive an award pursuant to subparagraph (A), the Secretary shall, in determining the amount under paragraph (3)(C) for the State, subtract from the population of the State an amount equal to the population of such political subdivision.

(D) Continuity of funding

In determining whether to make an award pursuant to subparagraph (A) to a political subdivision, the Secretary may consider, as a factor indicating that the award should be made, that the political subdivision received public health funding from the Secretary for fiscal year 2006.

(5) Significant unmet needs; degree of risk

(A) In general

For fiscal year 2007, the Secretary may, before making awards pursuant to paragraph (3) for such year, reserve from the amount appropriated under paragraph (1) for the year an amount determined necessary by the Secretary to make awards under subsection (a) to eligible entities that—

(i) have a significant need for funds to build capacity to identify, detect, monitor, and respond to a bioterrorist or other threat to the public health, which need will not be met by awards pursuant to paragraph (3); and

(ii) face a particularly high degree of risk of such a threat.

(B) Recipients of grants

Awards pursuant to subparagraph (A) may be supplemental awards to States that receive awards pursuant to paragraph (3), or may be awards to eligible entities described in subsection (b)(1)(B) within such States.

(C) Finding with respect to District of Columbia

The Secretary shall consider the District of Columbia to have a significant unmet need for purposes of subparagraph (A), and to face a particularly high degree of risk for such purposes, on the basis of the concentration of entities of national significance located within the District.

(6) Funding of local entities

The Secretary shall, in making awards under this section, ensure that with respect to the cooperative agreement awarded, the entity make available appropriate portions of such award to political subdivisions and local departments of public health through a process involving the consensus, approval or concurrence with such local entities.

(7) Availability of cooperative agreement funds

(A) In general

Amounts provided to an eligible entity under a cooperative agreement under subsection (a) for a fiscal year and remaining unobligated at the end of such year shall remain available to such entity for the next fiscal year for the purposes for which such funds were provided.

(B) Funds contingent on achieving benchmarks

The continued availability of funds under subparagraph (A) with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the pandemic influenza plan as described in subsection (g).

(i) Administrative and fiscal responsibility

(1) Annual reporting requirements

Each entity shall prepare and submit to the Secretary annual reports on its activities under this section and section 247d–3b of this title. Each such report shall be prepared by, or in consultation with, the health department. In order to properly evaluate and compare the performance of different entities assisted under this section and section 247d–3b of this title and to assure the proper expenditure of funds under this section and section 247d–3b of this title, such reports shall be in such standardized form and contain such information as the Secretary determines and describes within 180 days of December 19, 2006 (after consultation with the States) to be necessary to—

(A) secure an accurate description of those activities;

(B) secure a complete record of the purposes for which funds were spent, and of the recipients of such funds;

(C) describe the extent to which the entity has met the goals and objectives it set forth under this section or section 247d–3b of this title;

(D) determine the extent to which funds were expended consistent with the entity's application transmitted under this section or section 247d–3b of this title; and

(E) publish such information on a Federal Internet website consistent with subsection (j).

(2) Audits; implementation

(A) In general

Each entity receiving funds under this section or section 247d–3b of this title shall, not less often than once every 2 years, audit its expenditures from amounts received under this section or section 247d–3b of this title. Such audits shall be conducted by an entity independent of the agency administering a program funded under this section or section 247d–3b of this title in accordance with the Comptroller General's standards for auditing governmental organizations, programs, activities, and functions and generally accepted auditing standards. Within 30 days following the completion of each audit report, the entity shall submit a copy of that audit report to the Secretary.

(B) Repayment

Each entity shall repay to the United States amounts found by the Secretary, after notice and opportunity for a hearing to the entity, not to have been expended in accordance with this section or section 247d–3b of this title and, if such repayment is not made, the Secretary may offset such amounts against the amount of any allotment to which the entity is or may become entitled under this section or section 247d–3b of this title or may otherwise recover such amounts.

(C) Withholding of payment

The Secretary may, after notice and opportunity for a hearing, withhold payment of funds to any entity which is not using its allotment under this section or section 247d–3b of this title in accordance with such section. The Secretary may withhold such funds until the Secretary finds that the reason for the withholding has been removed and there is reasonable assurance that it will not recur.

(j) Compilation and availability of data

The Secretary shall compile the data submitted under this section and make such data available in a timely manner on an appropriate Internet website in a format that is useful to the public and to other entities and that provides information on what activities are best contributing to the achievement of the outcome goals described in subsection (g).

(k) Evaluation

(1) In general

Not later than 2 years after June 24, 2019, and every 2 years thereafter, the Secretary shall conduct an evaluation of the evidence-based benchmarks and objective standards required under subsection (g). Such evaluation shall be submitted to the congressional committees of jurisdiction together with the National Health Security Strategy under section 300hh–1 of this title, at such time as such strategy is submitted.

(2) Content

The evaluation under this paragraph shall include—

(A) a review of evidence-based benchmarks and objective standards, and associated metrics and targets;

(B) a discussion of changes to any evidence-based benchmarks and objective standards, and the effect of such changes on the ability to track whether entities are meeting or making progress toward the goals under this section and, to the extent practicable, the applicable goals of the National Health Security Strategy under section 300hh–1 of this title;

(C) a description of amounts received by eligible entities described in subsection (b) and section 247d–3b(b) of this title, and amounts received by subrecipients and the effect of such funding on meeting evidence-based benchmarks and objective standards; and

(D) recommendations, as applicable and appropriate, to improve evidence-based benchmarks and objective standards to more accurately assess the ability of entities receiving awards under this section to better achieve the goals under this section and section 300hh–1 of this title.

(July 1, 1944, ch. 373, title III, §319C–1, as added Pub. L. 107–188, title I, §131(a), June 12, 2002, 116 Stat. 617; amended Pub. L. 109–417, title II, §201, Dec. 19, 2006, 120 Stat. 2837; Pub. L. 113–5, title II, §§202(a), (c)(1), 204(b), Mar. 13, 2013, 127 Stat. 173, 175, 179; Pub. L. 114–95, title IX, §9215(kkk)(1), Dec. 10, 2015, 129 Stat. 2187; Pub. L. 116–22, title II, §§201(a), 202(a), (b)(1), (d), 203(e)(1), 207(b), title VII, §705(b), June 24, 2019, 133 Stat. 907–910, 914, 927, 964.)

Codification

December 19, 2006, referred to in subsec. (g)(2)(B), was in the original "the date of enactment of this section", which was translated as meaning the date of enactment of Pub. L. 109–417, which enacted subsec. (g) of this section, to reflect the probable intent of Congress.

Amendments

2019—Subsec. (a). Pub. L. 116–22, §202(a)(1), inserted ", acting through the Director of the Centers for Disease Control and Prevention," after "the Secretary".

Subsec. (b)(2)(A)(iv). Pub. L. 116–22, §207(b), amended cl. (iv) generally. Prior to amendment, cl. (iv) read as follows: "a description of the mechanism the entity will implement to utilize the Emergency Management Assistance Compact or other mutual aid agreements for medical and public health mutual aid;".

Subsec. (b)(2)(A)(vi). Pub. L. 116–22, §202(a)(2)(A), inserted ", including public health agencies with specific expertise that may be relevant to public health security, such as environmental health agencies," after "stakeholders".

Subsec. (b)(2)(A)(vii) to (x). Pub. L. 116–22, §202(a)(2)(B), (C), added cl. (vii) and redesignated former cls. (vii) to (ix) as (viii) to (x), respectively.

Subsec. (b)(2)(A)(xi), (xii). Pub. L. 116–22, §202(a)(2)(D), (E), added cls. (xi) and (xii).

Subsec. (b)(2)(C). Pub. L. 116–22, §705(b)(1), substituted "individuals," for "individuals,,".

Subsec. (b)(2)(F). Pub. L. 116–22, §705(b)(2), substituted "makes satisfactory annual improvement and describes" for "make satisfactory annual improvement and describe".

Subsec. (e). Pub. L. 116–22, §203(e)(1), substituted ", local emergency plans, and any regional health care emergency preparedness and response system established pursuant to the applicable guidelines under section 247d–3c of this title." for ", and local emergency plans."

Subsec. (g)(5). Pub. L. 116–22, §202(b)(1)(A)(i), substituted "Beginning with fiscal year 2019" for "Beginning with fiscal year 2009" in introductory provisions.

Subsec. (g)(5)(A). Pub. L. 116–22, §202(b)(1)(A)(ii), substituted "for either of the 2 immediately preceding fiscal years" for "for the immediately preceding fiscal year" and "2018" for "2008".

Subsec. (g)(6)(A). Pub. L. 116–22, §202(b)(1)(B), amended subpar. (A) generally. Prior to amendment, subpar. (A) consisted of cls. (i) to (iv) describing amounts payable to an entity for the fiscal year immediately following one to four fiscal years in which the entity experienced a failure described in subsec. (g)(5)(A) or (B).

Subsec. (h)(1)(A). Pub. L. 116–22, §202(d), substituted "$685,000,000 for each of fiscal years 2019 through 2023 for awards pursuant to paragraph (3) (subject to the authority of the Secretary to make awards pursuant to paragraphs (4) and (5))." for "$641,900,000 for fiscal year 2014 for awards pursuant to paragraph (3) (subject to the authority of the Secretary to make awards pursuant to paragraphs (4) and (5)), and $641,900,000 for each of fiscal years 2015 through 2018."

Subsec. (k). Pub. L. 116–22, §201(a), added subsec. (k).

2015—Subsec. (b)(2)(A)(vii). Pub. L. 114–95 substituted "including State educational agencies (as defined in section 7801 of title 20)" for "including State educational agencies (as defined in section 7801(41) of title 20)".

2013—Subsec. (b)(1)(B). Pub. L. 113–5, §202(c)(1), substituted "subsection (h)(4)" for "subsection (i)(4)".

Subsec. (b)(1)(C). Pub. L. 113–5, §202(a)(1), substituted "consortium of States" for "consortium of entities described in subparagraph (A)".

Subsec. (b)(2)(A)(i), (ii). Pub. L. 113–5, §202(a)(2)(A)(i), added cls. (i) and (ii) and struck out former cls. (i) and (ii) which read as follows:

"(i) a description of the activities such entity will carry out under the agreement to meet the goals identified under section 300hh–1 of this title;

"(ii) a pandemic influenza plan consistent with the requirements of paragraphs (2) and (5) of subsection (g);".

Subsec. (b)(2)(A)(vi) to (ix). Pub. L. 113–5, §202(a)(2)(A)(ii), (iii), added cls. (vi) to (ix).

Subsec. (b)(2)(C). Pub. L. 113–5, §202(a)(2)(B), inserted ", including addressing the needs of at-risk individuals," after "capabilities of such entity".

Subsec. (b)(2)(D). Pub. L. 113–5, §204(b), substituted "section 247d–4(c)(3)" for "section 247d–4(d)(3)".

Subsec. (f)(2) to (4). Pub. L. 113–5, §202(a)(3), inserted "and" at end of par. (2), substituted period for "; and" at end of par. (3), and struck out par. (4) which read as follows: "disseminate such recommendations and guidance, including through expanding existing lessons learned information systems to create a single Internet-based point of access for sharing and distributing medical and public health best practices and lessons learned from drills, exercises, disasters, and other emergencies."

Subsec. (g)(1)(A). Pub. L. 113–5, §202(a)(4)(A), added subpar. (A) and struck out former subpar. (A) which read as follows: "include outcome goals representing operational achievement of the National Preparedness Goals developed under section 300hh–1(b) of this title; and".

Subsec. (g)(2)(A). Pub. L. 113–5, §202(a)(4)(B), inserted at end "The Secretary shall periodically update, as necessary and appropriate, such pandemic influenza plan criteria and shall require the integration of such criteria into the benchmarks and standards described in paragraph (1)."

Subsec. (h). Pub. L. 113–5, §202(a)(5), (6), redesignated subsec. (i) as (h) and struck out former subsec. (h) which related to grants for real-time disease detection improvement.

Subsec. (h)(1)(A). Pub. L. 113–5, §202(a)(7)(A)(i), substituted "$641,900,000 for fiscal year 2014" for "$824,000,000 for fiscal year 2007, of which $35,000,000 shall be used to carry out subsection (h)," and "$641,900,000 for each of fiscal years 2015 through 2018" for "such sums as may be necessary for each of fiscal years 2008 through 2011".

Subsec. (h)(1)(B) to (D). Pub. L. 113–5, §202(a)(7)(A)(ii)–(iv), redesignated subpars. (C) and (D) as (B) and (C), respectively, substituted "subparagraph (B)" for "subparagraph (C)" in subpar. (C), and struck out former subpar. (B). Prior to amendment, text of subpar. (B) read as follows: "There are authorized to be appropriated, $10,000,000 for fiscal year 2007 to carry out subsection (f)(4) of this section and section 300hh–16 of this title."

Subsec. (h)(3)(C), (D). Pub. L. 113–5, §202(a)(7)(B), substituted "paragraph (1)(A)" for "paragraph (1)(A)(i)(I)" wherever appearing.

Subsec. (h)(4)(B). Pub. L. 113–5, §202(a)(7)(C), substituted "subsection (b)" for "subsection (c)".

Subsec. (h)(7). Pub. L. 113–5, §202(a)(7)(D), added par. (7).

Subsec. (i). Pub. L. 113–5, §202(a)(6), redesignated subsec. (j) as (i). Former subsec. (i) redesignated (h).

Subsec. (i)(1)(E). Pub. L. 113–5, §202(a)(8)(A), substituted "subsection (j)" for "subsection (k)".

Subsec. (i)(3). Pub. L. 113–5, §202(a)(8)(B), struck out par. (3) which related to maximum amount of an award under this section that may be carried over to the succeeding fiscal year.

Subsecs. (j), (k). Pub. L. 113–5, §202(a)(6), redesignated subsec. (k) as (j). Former subsec. (j) redesignated (i).

2006Pub. L. 109–417, §201(1), substituted "Improving State and local public health security" for "Grants to improve State, local, and hospital preparedness for and response to bioterrorism and other public health emergencies" in section catchline.

Subsecs. (a) to (h). Pub. L. 109–417, §201(2), added subsecs. (a) to (h) and struck out former subsecs. (a) to (h) which related to grants to improve State, local, and hospital preparedness for and response to bioterrorism and other public health emergencies.

Subsec. (i). Pub. L. 109–417, §201(3), redesignated subsec. (j) as (i).

Pub. L. 109–417, §201(2), struck out subsec. (i) which defined "eligible entity".

Subsec. (i)(1) to (3)(A). Pub. L. 109–417, §201(4)(A), added pars. (1) to (3)(A) and struck out former pars. (1) to (3)(A) which related to appropriations for fiscal years 2003 through 2006, use of amounts to supplement and not supplant other funds, and conditions for receipt of award in fiscal year 2003.

Subsec. (i)(4)(A). Pub. L. 109–417, §201(4)(B), substituted "fiscal year 2007" for "fiscal year 2003" and struck out "(A)(i)(I)" after "paragraph (1)".

Subsec. (i)(4)(D). Pub. L. 109–417, §201(4)(C), substituted "fiscal year 2006" for "fiscal year 2002".

Subsec. (i)(5)(A). Pub. L. 109–417, §201(4)(D), in introductory provisions, substituted "fiscal year 2007" for "fiscal year 2003" and struck out "(A)(i)(I)" after "paragraph (1)".

Subsec. (i)(6). Pub. L. 109–417, §201(4)(E), added par. (6) and struck out heading and text of former par. (6). Text read as follows: "For fiscal year 2003, the Secretary shall in making awards under this section ensure that appropriate portions of such awards are made available to political subdivisions, local departments of public health, hospitals (including children's hospitals), clinics, health centers, or primary care facilities, or consortia of such entities."

Subsec. (j). Pub. L. 109–417, §201(5), added subsec. (j).

Pub. L. 109–417, §201(3), redesignated subsec. (j) as (i).

Subsec. (k). Pub. L. 109–417, §201(5), added subsec. (k).

Effective Date of 2019 Amendment

Pub. L. 116–22, title II, §202(b)(2), June 24, 2019, 133 Stat. 909, provided that: "The amendments made by paragraph (1) [amending this section] shall apply with respect to cooperative agreements awarded on or after the date of enactment of this Act [June 24, 2019]."

Effective Date of 2015 Amendment

Amendment by Pub. L. 114–95 effective Dec. 10, 2015, except with respect to certain noncompetitive programs and competitive programs, see section 5 of Pub. L. 114–95, set out as a note under section 6301 of Title 20, Education.

Emergency Medical and Public Health Communications Pilot Projects

Pub. L. 110–53, title XXII, §2201(d), Aug. 3, 2007, 121 Stat. 541, provided that:

"(1) In general.—The Assistant Secretary of Commerce for Communications and Information may establish not more than 10 geographically dispersed project grants to emergency medical and public health care facilities to improve the capabilities of emergency communications systems in emergency medical care facilities.

"(2) Maximum amount.—The Assistant Secretary may not provide more than $2,000,000 in Federal assistance under the pilot program to any applicant.

"(3) Cost sharing.—The Assistant Secretary may not provide more than 20 percent of the cost, incurred during the period of the grant, of any project under the pilot program.

"(4) Maximum period of grants.—The Assistant Secretary may not fund any applicant under the pilot program for more than 3 years.

"(5) Deployment and distribution.—The Assistant Secretary shall seek to the maximum extent practicable to ensure a broad geographic distribution of project sites.

"(6) Transfer of information and knowledge.—The Assistant Secretary shall establish mechanisms to ensure that the information and knowledge gained by participants in the pilot program are transferred among the pilot program participants and to other interested parties, including other applicants that submitted applications."

1 See Codification note below.

§247d–3b. Partnerships for State and regional hospital preparedness to improve surge capacity

(a) In general

The Secretary, acting through the Assistant Secretary for Preparedness and Response, shall award competitive grants or cooperative agreements to eligible entities to enable such entities to improve surge capacity and enhance community and hospital preparedness for, and response to, public health emergencies in accordance with subsection (c), including, as appropriate, capacity and preparedness to address the needs of children and other at-risk individuals.

(b) Eligibility

To be eligible for an award under subsection (a), an entity shall—

(1)(A) be a coalition that includes—

(i) one or more hospitals, at least one of which shall be a designated trauma center, consistent with section 300d–13(c) of this title;

(ii) one or more other local health care facilities, including clinics, health centers, community health centers, primary care facilities, mental health centers, mobile medical assets, or nursing homes;

(iii)(I) one or more political subdivisions;

(II) one or more States; or

(III) one or more States and one or more political subdivisions; and

(iv) one or more emergency medical service organizations or emergency management organizations; and


(B) prepare, in consultation with the Chief Executive Officer and the lead health officials of the State, District, or territory in which the hospital and health care facilities described in subparagraph (A) are located, and submit to the Secretary, an application at such time, in such manner, and containing such information as the Secretary may require; or

(2)(A) be an entity described in section 247d–3a(b)(1) of this title; and

(B) submit an application at such time, in such manner, and containing such information as the Secretary may require, including the information or assurances required under section 247d–3a(b)(2) of this title and an assurance that the State will adhere to any applicable guidelines established by the Secretary.

(c) Use of funds

An award under subsection (a) shall be expended for activities to achieve the preparedness goals described under paragraphs (1), (3), (4), (5), and (6) of section 300hh–1(b) of this title with respect to all-hazards, including chemical, biological, radiological, or nuclear threats.

(d) Preferences

(1) Regional coordination

In making awards under subsection (a), the Secretary shall give preference to eligible entities that submit applications that, in the determination of the Secretary—

(A) will enhance coordination—

(i) among the entities described in subsection (b)(1)(A)(i);

(ii) among one or more facilities in a regional health care emergency system under section 247d–3c of this title; and

(iii) between such entities and the entities described in subsection (b)(1)(A)(ii); and


(B) include, in the coalition described in subsection (b)(1)(A), a significant percentage of the hospitals and health care facilities within the geographic area served by such coalition.

(2) Other preferences

In making awards under subsection (a), the Secretary shall give preference to eligible entities that, in the determination of the Secretary—

(A) include one or more hospitals that are participants in the National Disaster Medical System;

(B) are located in a geographic area that faces a high degree of risk, as determined by the Secretary in consultation with the Secretary of Homeland Security; or

(C) have a significant need for funds to achieve the preparedness and response goals described in section 300hh–1(b)(3) of this title.

(e) Consistency of planned activities

The Secretary may not award a cooperative agreement to an eligible entity described in subsection (b)(1) unless the application submitted by the entity is coordinated and consistent with an applicable State All-Hazards Public Health Emergency Preparedness and Response Plan and relevant local plans, as determined by the Secretary in consultation with relevant State health officials.

(f) Limitation on awards

A political subdivision shall not participate in more than one coalition described in subsection (b)(1).

(g) Coordination

(1) Local response capabilities

An eligible entity shall, to the extent practicable, ensure that activities carried out under an award under subsection (a) are coordinated with activities of relevant local Metropolitan Medical Response Systems, local Medical Reserve Corps, the local Cities Readiness Initiative, and local emergency plans.

(2) National collaboration

Coalitions consisting of one or more eligible entities under this section may, to the extent practicable, collaborate with other coalitions consisting of one or more eligible entities under this section for purposes of national coordination and collaboration with respect to activities to achieve the preparedness and response goals described under paragraphs (1), (3), (4), (5), and (6) of section 300hh–1(b) of this title.

(h) Maintenance of funding

(1) In general

An entity that receives an award under this section shall maintain expenditures for health care preparedness at a level that is not less than the average level of such expenditures maintained by the entity for the preceding 2 year period.

(2) Rule of construction

Nothing in this section shall be construed to prohibit the use of awards under this section to pay salary and related expenses of public health and other professionals employed by State, local, or tribal agencies who are carrying out activities supported by such awards (regardless of whether the primary assignment of such personnel is to carry out such activities).

(i) Performance and accountability

(1) In general

The requirements of section 247d–3a(g), (i), (j), and (k) of this title shall apply to entities receiving awards under this section (regardless of whether such entities are described under subsection (b)(1)(A) or (b)(2)(A)) in the same manner as such requirements apply to entities under section 247d–3a of this title. In submitting reports under this paragraph, a coalition shall include information on the progress that the coalition has made toward the implementation of section 247d–3c of this title (or barriers to progress, if any). A coalition described in subsection (b)(1)(A) shall make such reports available to the lead health official of the State in which such coalition is located.

(2) Meeting goals of National Health Security Strategy

The Secretary shall implement objective, evidence-based metrics to ensure that entities receiving awards under this section are meeting, to the extent practicable, the applicable goals of the National Health Security Strategy under section 300hh–1 of this title.

(j) Authorization of appropriations

(1) In general

(A) Authorization of appropriations

For purposes of carrying out this section and section 247d–3c of this title, in accordance with subparagraph (B), there is authorized to be appropriated $385,000,000 for each of fiscal years 2019 through 2023.

(B) Reservation of amounts for regional systems

(i) In general

Subject to clause (ii), of the amount appropriated under subparagraph (A) for a fiscal year, the Secretary may reserve up to 5 percent for the purpose of carrying out section 247d–3c of this title.

(ii) Reservation contingent on continued appropriations for this section

If for fiscal year 2019 or a subsequent fiscal year, the amount appropriated under subparagraph (A) is such that, after application of clause (i), the amount remaining for the purpose of carrying out this section would be less than the amount available for such purpose for the previous fiscal year, the amount that may be reserved under clause (i) shall be reduced such that the amount remaining for the purpose of carrying out this section is not less than the amount available for such purpose for the previous fiscal year.

(iii) Sunset

The authority to reserve amounts under clause (i) shall expire on September 30, 2023.

(2) Reservation of amounts for partnerships

Prior to making awards described in paragraph (3), the Secretary may reserve from the amount appropriated under paragraph (1)(A) for a fiscal year and not reserved for the purpose described in paragraph (1)(B)(i), an amount determined appropriate by the Secretary for making awards to entities described in subsection (b)(1)(A).

(3) Awards to States and political subdivisions

(A) In general

From amounts appropriated for a fiscal year under paragraph (1)(A) and not reserved under paragraph (1)(B)(i) or (2), the Secretary shall make awards to entities described in subsection (b)(2)(A) that have completed an application as described in subsection (b)(2)(B).

(B) Amount

The Secretary shall determine the amount of an award to each entity described in subparagraph (A) in the same manner as such amounts are determined under section 247d–3a(h) of this title.

(4) Availability of cooperative agreement funds

(A) In general

Amounts provided to an eligible entity under a cooperative agreement under subsection (a) for a fiscal year and remaining unobligated at the end of such year shall remain available to such entity for the next fiscal year for the purposes for which such funds were provided.

(B) Funds contingent on achieving benchmarks

The continued availability of funds under subparagraph (A) with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the pandemic influenza plan as required under subsection (i).

(July 1, 1944, ch. 373, title III, §319C–2, as added Pub. L. 107–188, title I, §131(a), June 12, 2002, 116 Stat. 624; amended Pub. L. 109–417, title III, §305, Dec. 19, 2006, 120 Stat. 2861; Pub. L. 110–85, title XI, §1104(1), Sept. 27, 2007, 121 Stat. 975; Pub. L. 113–5, title II, §§202(c)(2), 203(c), Mar. 13, 2013, 127 Stat. 175, 176; Pub. L. 116–22, title II, §§201(b), 202(c), (e), 203(c), (e)(2), June 24, 2019, 133 Stat. 908–910, 914.)

Amendments

2019—Subsec. (a). Pub. L. 116–22, §202(c)(1), inserted ", acting through the Assistant Secretary for Preparedness and Response," after "The Secretary" and substituted "preparedness for, and response to, public health emergencies in accordance with subsection (c)" for "preparedness for public health emergencies".

Subsec. (b)(1)(A). Pub. L. 116–22, §202(c)(2)(A), substituted "coalition that includes" for "partnership consisting of" in introductory provisions.

Subsec. (b)(1)(A)(iv). Pub. L. 116–22, §202(c)(2)(B), (C), added cl. (iv).

Subsec. (d)(1)(A)(ii), (iii). Pub. L. 116–22, §203(e)(2), added cl. (ii) and redesignated former cl. (ii) as (iii).

Subsec. (d)(1)(B). Pub. L. 116–22, §202(c)(3)(A), substituted "coalition" for "partnership" in two places.

Subsec. (d)(2)(C). Pub. L. 116–22, §202(c)(3)(B), substituted "preparedness and response" for "medical preparedness".

Subsec. (f). Pub. L. 116–22, §202(c)(4), substituted "coalition" for "partnership".

Subsec. (g)(2). Pub. L. 116–22, §202(c)(5), substituted "Coalitions" for "Partnerships" and "coalitions" for "partnerships" and inserted "and response" after "preparedness".

Subsec. (i)(1). Pub. L. 116–22, §203(c), inserted "In submitting reports under this paragraph, a coalition shall include information on the progress that the coalition has made toward the implementation of section 247d–3c of this title (or barriers to progress, if any)." after "under section 247d–3a of this title."

Pub. L. 116–22, §202(c)(6), substituted "A coalition" for "An entity" and "such coalition" for "such partnership".

Pub. L. 116–22, §201(b), substituted "section 247d–3a(g), (i), (j), and (k)" for "section 247d–3a(g), (i), and (j)".

Subsec. (j)(1). Pub. L. 116–22, §202(e)(1), amended par. (1) generally. Prior to amendment, text read as follows: "For purposes of carrying out this section, there is authorized to be appropriated $374,700,000 for each of fiscal years 2014 through 2018."

Subsec. (j)(2). Pub. L. 116–22, §202(e)(2), substituted "paragraph (1)(A) for a fiscal year and not reserved for the purpose described in paragraph (1)(B)(i)" for "paragraph (1) for a fiscal year".

Subsec. (j)(3)(A). Pub. L. 116–22, §202(e)(3), substituted "paragraph (1)(A) and not reserved under paragraph (1)(B)(i) or (2)" for "paragraph (1) and not reserved under paragraph (2)".

2013—Subsec. (a). Pub. L. 113–5, §203(c)(1), inserted ", including, as appropriate, capacity and preparedness to address the needs of children and other at-risk individuals" before period at end.

Subsec. (b)(1)(A)(ii). Pub. L. 113–5, §203(c)(2), substituted "centers, community health centers, primary" for "centers, primary".

Subsec. (c). Pub. L. 113–5, §203(c)(3), added subsec. (c) and struck out former subsec. (c). Prior to amendment, text read as follows: "An award under subsection (a) shall be expended for activities to achieve the preparedness goals described under paragraphs (1), (3), (4), (5), and (6) of section 300hh–1(b) of this title."

Subsec. (g). Pub. L. 113–5, §203(c)(4), added subsec. (g) and struck out former subsec. (g). Prior to amendment, text read as follows: "An eligible entity shall, to the extent practicable, ensure that activities carried out under an award under subsection (a) are coordinated with activities of relevant local Metropolitan Medical Response Systems, local Medical Reserve Corps, the Cities Readiness Initiative, and local emergency plans."

Subsec. (i). Pub. L. 113–5, §203(c)(5), designated existing provisions as par. (1), inserted heading, and added par. (2).

Pub. L. 113–5, §202(c)(2)(A), substituted "(i), and (j)" for "(j), and (k)".

Subsec. (j)(1). Pub. L. 113–5, §203(c)(6)(A), amended par. (1) generally. Prior to amendment, text read as follows: "For the purpose of carrying out this section, there is authorized to be appropriated $474,000,000 for fiscal year 2007, and such sums as may be necessary for each of fiscal years 2008 through 2011."

Subsec. (j)(3)(B). Pub. L. 113–5, §202(c)(2)(B), substituted "247d–3a(h)" for "247d–3a(i)".

Subsec. (j)(4). Pub. L. 113–5, §203(c)(6)(B), added par. (4).

2007—Subsec. (j)(3)(B). Pub. L. 110–85 substituted "section 247d–3a(i)" for "section 247d–3a(h)".

2006Pub. L. 109–417 amended section catchline and text generally. Prior to amendment, section consisted of subsecs. (a) to (i) relating to partnerships for community and hospital preparedness.

§247d–3c. Guidelines for regional health care emergency preparedness and response systems

(a) Purpose

It is the purpose of this section to identify and provide guidelines for regional systems of hospitals, health care facilities, and other public and private sector entities, with varying levels of capability to treat patients and increase medical surge capacity during, in advance of, and immediately following a public health emergency, including threats posed by one or more chemical, biological, radiological, or nuclear agents, including emerging infectious diseases.

(b) Guidelines

The Assistant Secretary for Preparedness and Response, in consultation with the Director of the Centers for Disease Control and Prevention, the Administrator of the Centers for Medicare & Medicaid Services, the Administrator of the Health Resources and Services Administration, the Commissioner of Food and Drugs, the Assistant Secretary for Mental Health and Substance Use, the Assistant Secretary of Labor for Occupational Safety and Health, the Secretary of Veterans Affairs, the heads of such other Federal agencies as the Secretary determines to be appropriate, and State, local, Tribal, and territorial public health officials, shall, not later than 2 years after June 24, 2019—

(1) identify and develop a set of guidelines relating to practices and protocols for all-hazards public health emergency preparedness and response for hospitals and health care facilities to provide appropriate patient care during, in advance of, or immediately following, a public health emergency, resulting from one or more chemical, biological, radiological, or nuclear agents, including emerging infectious diseases (which may include existing practices, such as trauma care and medical surge capacity and capabilities), with respect to—

(A) a regional approach to identifying hospitals and health care facilities based on varying capabilities and capacity to treat patients affected by such emergency, including—

(i) the manner in which the system will coordinate with and integrate the partnerships and health care coalitions established under section 247d–3b(b) of this title; and

(ii) informing and educating appropriate first responders and health care supply chain partners of the regional emergency preparedness and response capabilities and medical surge capacity of such hospitals and health care facilities in the community;


(B) physical and technological infrastructure, laboratory capacity, staffing, blood supply, and other supply chain needs, taking into account resiliency, geographic considerations, and rural considerations;

(C) protocols or best practices for the safety and personal protection of workers who handle human remains and health care workers (including with respect to protective equipment and supplies, waste management processes, and decontamination), sharing of specialized experience among the health care workforce, behavioral health, psychological resilience, and training of the workforce, as applicable;

(D) in a manner that allows for disease containment (within the meaning of section 300hh–1(b)(2)(B) of this title), coordinated medical triage, treatment, and transportation of patients, based on patient medical need (including patients in rural areas), to the appropriate hospitals or health care facilities within the regional system or, as applicable and appropriate, between systems in different States or regions; and

(E) the needs of children and other at-risk individuals;


(2) make such guidelines available on the internet website of the Department of Health and Human Services in a manner that does not compromise national security; and

(3) update such guidelines as appropriate, including based on input received pursuant to subsections (c) and (e) and information resulting from applicable reports required under the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (including any amendments made by such Act), to address new and emerging public health threats.

(c) Considerations

In identifying, developing, and updating guidelines under subsection (b), the Assistant Secretary for Preparedness and Response shall—

(1) include input from hospitals and health care facilities (including health care coalitions under section 247d–3b of this title), State, local, Tribal, and territorial public health departments, and health care or subject matter experts (including experts with relevant expertise in chemical, biological, radiological, or nuclear threats, including emerging infectious diseases), as the Assistant Secretary determines appropriate, to meet the goals under section 300hh–1(b)(3) of this title;

(2) consult and engage with appropriate health care providers and professionals, including physicians, nurses, first responders, health care facilities (including hospitals, primary care clinics, community health centers, mental health facilities, ambulatory care facilities, and dental health facilities), pharmacies, emergency medical providers, trauma care providers, environmental health agencies, public health laboratories, poison control centers, blood banks, tissue banks, and other experts that the Assistant Secretary determines appropriate, to meet the goals under section 300hh–1(b)(3) of this title;

(3) consider feedback related to financial implications for hospitals, health care facilities, public health agencies, laboratories, blood banks, tissue banks, and other entities engaged in regional preparedness planning to implement and follow such guidelines, as applicable; and

(4) consider financial requirements and potential incentives for entities to prepare for, and respond to, public health emergencies as part of the regional health care emergency preparedness and response system.

(d) Technical assistance

The Assistant Secretary for Preparedness and Response, in consultation with the Director of the Centers for Disease Control and Prevention and the Assistant Secretary of Labor for Occupational Safety and Health, may provide technical assistance and consultation toward meeting the guidelines described in subsection (b).

(e) Demonstration project for regional health care preparedness and response systems

(1) In general

The Assistant Secretary for Preparedness and Response may establish a demonstration project pursuant to the development and implementation of guidelines under subsection (b) to award grants to improve medical surge capacity for all hazards, build and integrate regional medical response capabilities, improve specialty care expertise for all-hazards response, and coordinate medical preparedness and response across State, local, Tribal, territorial, and regional jurisdictions.

(2) Sunset

The authority under this subsection shall expire on September 30, 2023.

(July 1, 1944, ch. 373, title III, §319C–3, as added Pub. L. 116–22, title II, §203(a), June 24, 2019, 133 Stat. 911.)

References in Text

The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, referred to in subsec. (b)(3), is Pub. L. 116–22, June 24, 2019, 133 Stat. 905. For complete classfication of this Act to the Code, see Short Title of 2019 Amendment note set out under section 201 of this title and Tables.

§247d–4. Facilities and capacities of the Centers for Disease Control and Prevention

(a) In general

(1) Findings

Congress finds that the Centers for Disease Control and Prevention has an essential role in defending against and combatting public health threats domestically and abroad and requires secure and modern facilities, and expanded, improved, and appropriately maintained capabilities related to bioterrorism and other public health emergencies, sufficient to enable such Centers to conduct this important mission.

(2) Facilities

(A) In general

The Director of the Centers for Disease Control and Prevention may design, construct, and equip new facilities, renovate existing facilities (including laboratories, laboratory support buildings, scientific communication facilities, transshipment complexes, secured and isolated parking structures, office buildings, and other facilities and infrastructure), and upgrade security of such facilities, in order to better conduct the capacities described in section 247d–1 of this title, and for supporting public health activities.

(B) Multiyear contracting authority

For any project of designing, constructing, equipping, or renovating any facility under subparagraph (A), the Director of the Centers for Disease Control and Prevention may enter into a single contract or related contracts that collectively include the full scope of the project, and the solicitation and contract shall contain the clause "availability of funds" found at section 52.232–18 of title 48, Code of Federal Regulations.

(3) Improving the capacities of the Centers for Disease Control and Prevention

The Secretary shall expand, improve, enhance, and appropriately maintain the capabilities of the Centers for Disease Control and Prevention relating to preparedness for and responding effectively to bioterrorism and other public health emergencies. Activities that may be carried out under the preceding sentence include—

(A) expanding or enhancing the training of personnel;

(B) improving communications facilities and networks, including delivery of necessary information to rural areas;

(C) improving capabilities for public health surveillance and reporting activities, taking into account the integrated system or systems of public health alert communications and surveillance networks under subsection (b); and

(D) improving laboratory facilities related to bioterrorism and other public health emergencies, including increasing the security of such facilities.

(4) Study of resources for facilities and capacities

Not later than June 1, 2022, the Comptroller General of the United States shall conduct a study on Federal spending in fiscal years 2013 through 2018 for activities authorized under this subsection. Such study shall include a review and assessment of obligations and expenditures directly related to each activity under paragraphs (2) and (3), including a specific accounting of, and delineation between, obligations and expenditures incurred for the construction, renovation, equipping, and security upgrades of facilities and associated contracts under this subsection, and the obligations and expenditures incurred to establish and improve the situational awareness and biosurveillance network under subsection (b), and shall identify the agency or agencies incurring such obligations and expenditures.

(b) Establishment of systems of public health communications and surveillance networks

(1) In general

The Secretary, directly or through awards of grants, contracts, or cooperative agreements, shall provide for the establishment of an integrated system or systems of public health alert communications and surveillance networks between and among—

(A) Federal, State, and local public health officials;

(B) public and private health-related laboratories, hospitals, poison control centers, immunization information systems, and other health care facilities; and

(C) any other entities determined appropriate by the Secretary.

(2) Requirements

The Secretary shall develop a plan to, and ensure that networks under paragraph (1) allow for the timely sharing and discussion, in a secure manner and in a form readily usable for analytical approaches, of essential information concerning bioterrorism or another public health emergency, or recommended methods for responding to such an attack or emergency, allowing for coordination to maximize all-hazards medical and public health preparedness and response and to minimize duplication of effort.

(3) Standards

(A) In general

Not later than 1 year after June 24, 2019, the Secretary, in cooperation with health care providers, State, local, Tribal, and territorial public health officials, and relevant Federal agencies (including the Office of the National Coordinator for Health Information Technology and the National Institute of Standards and Technology), shall, as necessary, adopt technical and reporting standards, including standards for interoperability as defined by section 300jj of this title, for networks under paragraph (1) and update such standards as necessary. Such standards shall be made available on the internet website of the Department of Health and Human Services, in a manner that does not compromise national security.

(B) Deference to standards development organizations

In adopting and implementing standards under this subsection and subsection (c), the Secretary shall give deference to standards published by standards development organizations and voluntary consensus-based standards entities.

(c) Modernizing public health situational awareness and biosurveillance

(1) In general

The Secretary, in collaboration with State, local, and tribal public health officials, shall establish, and improve as applicable and appropriate, a near real-time electronic nationwide public health situational awareness capability through an interoperable network of systems to share data and information to enhance early detection of, rapid response to, and management of, potentially catastrophic infectious disease outbreaks, novel emerging threats, and other public health emergencies that originate domestically or abroad. Such network shall be built on existing State situational awareness systems or enhanced systems that enable such interoperability.

(2) Coordination and consultation

In establishing and improving the network under paragraph (1), the Secretary shall—

(A) facilitate coordination among agencies within the Department of Health and Human Services that provide, or have the potential to provide, information and data to, and analyses for, the situational awareness and biosurveillance network under paragraph (1), including coordination among relevant agencies related to health care services, the facilitation of health information exchange (including the Office of the National Coordinator for Health Information Technology), and public health emergency preparedness and response; and

(B) consult with the Secretary of Agriculture, the Secretary of Commerce (and the Director of the National Institute of Standards and Technology), the Secretary of Defense, the Secretary of Homeland Security, the Secretary of Veterans Affairs, and the heads of other Federal agencies, as the Secretary determines appropriate.

(3) Elements

(A) In general

The network described in paragraph (1) shall include data and information transmitted in a standardized format from—

(i) State, local, and tribal public health entities, including public health laboratories;

(ii) Federal health agencies;

(iii) zoonotic disease monitoring systems;

(iv) public and private sector health care entities, hospitals, pharmacies, poison control centers or professional organizations in the field of poison control, immunization information systems, community health centers, health centers, clinical laboratories, and public environmental health agencies, to the extent practicable and provided that such data are voluntarily provided simultaneously to the Secretary and appropriate State, local, and tribal public health agencies; and

(v) such other sources as the Secretary may deem appropriate.

(B) Review

Not later than 2 years after June 24, 2019, and every 6 years thereafter, the Secretary shall conduct a review of the elements described in subparagraph (A). Such review shall include a discussion of the addition of any elements pursuant to clause (v), including elements added to advancing new technologies, and identify any challenges in the incorporation of elements under subparagraph (A). The Secretary shall provide such review to the congressional committees of jurisdiction.

(4) Rule of construction

Paragraph (3) shall not be construed as requiring separate reporting of data and information from each source listed.

(5) Required activities

(A) In general

In establishing and operating the network described in paragraph (1), the Secretary shall—

(i) utilize applicable interoperability standards as adopted by the Secretary, and in consultation with the Office of the National Coordinator for Health Information Technology and the National Institute of Standards and Technology, through a joint public and private sector process;

(ii) define minimal data elements for such network;

(iii) in collaboration with State, local, and tribal public health officials, integrate and build upon existing State, local, and tribal capabilities, ensuring simultaneous sharing of data, information, and analyses from the network described in paragraph (1) with State, local, and tribal public health agencies;

(iv) in collaboration with State, local, and tribal public health officials, develop procedures and standards for the collection, analysis, and interpretation of data that States, regions, or other entities collect and report to the network described in paragraph (1); and

(v) pilot test standards and implementation specifications, consistent with the process described in section 300jj–12(b)(3)(C) of this title, which State, local, Tribal, and territorial public health entities may utilize, on a voluntary basis, as a part of the network.

(B) Public meeting

(i) In general

Not later than 180 days after June 24, 2019, the Secretary shall convene a public meeting for purposes of discussing and providing input on the potential goals, functions, and uses of the network described in paragraph (1) and incorporating the elements described in paragraph (3)(A).

(ii) Experts

The public meeting shall include representatives of relevant Federal agencies (including representatives from the Office of the National Coordinator for Health Information Technology and the National Institute of Standards and Technology); State, local, Tribal, and territorial public health officials; stakeholders with expertise in biosurveillance and situational awareness; stakeholders with expertise in capabilities relevant to biosurveillance and situational awareness, such as experts in informatics and data analytics (including experts in prediction, modeling, or forecasting); and other representatives as the Secretary determines appropriate.

(iii) Topics

Such public meeting shall include a discussion of—

(I) data elements, including minimal or essential data elements, that are voluntarily provided for such network, which may include elements from public health and public and private health care entities, to the extent practicable;

(II) standards and implementation specifications that may improve the collection, analysis, and interpretation of data during a public health emergency;

(III) strategies to encourage the access, exchange, and use of information;

(IV) considerations for State, local, Tribal, and territorial capabilities and infrastructure related to data exchange and interoperability;

(V) privacy and security protections provided at the Federal, State, local, Tribal, and territorial levels, and by nongovernmental stakeholders; and

(VI) opportunities for the incorporation of innovative technologies to improve the network.

(6) Strategy and implementation plan

(A) In general

Not later than 18 months after June 24, 2019, the Secretary shall submit to the congressional committees of jurisdiction a coordinated strategy and an accompanying implementation plan that—

(i) is informed by the public meeting under paragraph (5)(B);

(ii) includes a review and assessment of existing capabilities of the network and related infrastructure, including input provided by the public meeting under paragraph (5)(B);

(iii) identifies and demonstrates the measurable steps the Secretary will carry out to—

(I) develop, implement, and evaluate the network described in paragraph (1), utilizing elements described in paragraph (3)(A);

(II) modernize and enhance biosurveillance activities, including strategies to include innovative technologies and analytical approaches (including prediction and forecasting for pandemics and all-hazards) from public and private entities;

(III) improve information sharing, coordination, and communication among disparate biosurveillance systems supported by the Department of Health and Human Services, including the identification of methods to improve accountability, better utilize resources and workforce capabilities, and incorporate innovative technologies within and across agencies; and

(IV) test and evaluate capabilities of the interoperable network of systems to improve situational awareness and biosurveillance capabilities;


(iv) includes performance measures and the metrics by which performance measures will be assessed with respect to the measurable steps under clause (iii); and

(v) establishes dates by which each measurable step under clause (iii) will be implemented.

(B) Annual budget plan

Not later than 2 years after June 24, 2019, and on an annual basis thereafter, in accordance with the strategy and implementation plan under this paragraph, the Secretary shall, taking into account recommendations provided by the National Biodefense Science Board, develop a budget plan based on the strategy and implementation plan under this section. Such budget plan shall include—

(i) a summary of resources previously expended to establish, improve, and utilize the nationwide public health situational awareness and biosurveillance network under paragraph (1);

(ii) estimates of costs and resources needed to establish and improve the network under paragraph (1) according to the strategy and implementation plan under subparagraph (A);

(iii) the identification of gaps and inefficiencies in nationwide public health situational awareness and biosurveillance capabilities, resources, and authorities needed to address such gaps; and

(iv) a strategy to minimize and address such gaps and improve inefficiencies.

(7) Consultation with the National Biodefense Science Board

In carrying out this section and consistent with section 247d–7g of this title, the National Biodefense Science Board shall provide expert advice and guidance, including recommendations, regarding the measurable steps the Secretary should take to modernize and enhance biosurveillance activities pursuant to the efforts of the Department of Health and Human Services to ensure comprehensive, real-time, all-hazards biosurveillance capabilities. In complying with the preceding sentence, the National Biodefense Science Board shall—

(A) identify the steps necessary to achieve a national biosurveillance system for human health (taking into account zoonotic disease, including gaps in scientific understanding of the interactions between human, animal, and environmental health), with international connectivity, where appropriate, that is predicated on State, regional, and community level capabilities and creates a networked system to allow for two-way information flow between and among Federal, State, and local government public health authorities and clinical health care providers;

(B) identify any duplicative surveillance programs and gaps in surveillance programs under the authority of the Secretary, or changes that are necessary to existing programs, in order to enhance and modernize such activities, minimize duplication, strengthen and streamline such activities under the authority of the Secretary, and achieve real-time and appropriate data that relate to disease activity, both human and zoonotic;

(C) coordinate with applicable existing advisory committees of the Director of the Centers for Disease Control and Prevention, including such advisory committees consisting of representatives from State, local, and tribal public health authorities and appropriate public and private sector health care entities, animal health organizations related to zoonotic disease, and academic institutions, in order to provide guidance on public health surveillance activities; and

(D) provide recommendations to the Secretary on policies and procedures to complete the steps described in this paragraph in a manner that is consistent with section 300hh–1 of this title.

(8) Situational awareness and biosurveillance as a national security priority

The Secretary, on a periodic basis as applicable and appropriate, shall meet with the Director of National Intelligence to inform the development and capabilities of the nationwide public health situational awareness and biosurveillance network.

(d) State and regional systems to enhance situational awareness in public health emergencies

(1) In general

To implement the network described in subsection (c), the Secretary may award grants to States or consortia of States to enhance the ability of such States or consortia of States to establish or operate a coordinated public health situational awareness system for regional or Statewide early detection of, rapid response to, and management of potentially catastrophic infectious disease outbreaks and public health emergencies, in collaboration with appropriate public health agencies, environmental health agencies, sentinel hospitals, clinical laboratories, pharmacies, poison control centers, immunization programs, other health care organizations, and animal health organizations within such States.

(2) Eligibility

To be eligible to receive a grant under paragraph (1), the State or consortium of States shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including an assurance that the State or consortium of States will submit to the Secretary—

(A) reports of such data, information, and metrics as the Secretary may require;

(B) a report on the effectiveness of the systems funded under the grant;

(C) a description of the manner in which grant funds will be used to enhance the timelines and comprehensiveness of efforts to detect, respond to, and manage potentially catastrophic infectious disease outbreaks and public health emergencies; and

(D) an implementation plan that may include measurable steps to achieve the purposes described in paragraph (1).

(3) Use of funds

A State or consortium of States that receives an award under this subsection—

(A) shall establish, enhance, or operate a coordinated public health situational awareness system for regional or Statewide early detection of, rapid response to, and management of potentially catastrophic infectious disease outbreaks and public health emergencies;

(B) may award grants or contracts to entities described in paragraph (1) within or serving such State to assist such entities in improving the operation of information technology systems, facilitating the secure exchange of data and information, and training personnel to enhance the operation of the system described in subparagraph (A); and

(C) may conduct a pilot program for the development of multi-State telehealth network test beds that build on, enhance, and securely link existing State and local telehealth programs to prepare for, monitor, respond to, and manage the events of public health emergencies, facilitate coordination and communication among medical, public health, and emergency response agencies, and provide medical services through telehealth initiatives within the States that are involved in such a multi-State telehealth network test bed.

(4) Limitation

Information technology systems acquired or implemented using grants awarded under this section must be compliant with—

(A) interoperability and other technological standards, as determined by the Secretary; and

(B) data collection and reporting requirements for the network described in subsection (c).

(5) Technical assistance

The Secretary may provide technical assistance to States, localities, Tribes, and territories or a consortium of States, localities, Tribes, and territories receiving an award under this subsection regarding interoperability and the technical standards set forth by the Secretary.

(e) Telehealth enhancements for emergency response

(1) Evaluation

The Secretary, in consultation with the Federal Communications Commission and other relevant Federal agencies, shall—

(A) conduct an inventory of telehealth initiatives in existence on December 19, 2006, including—

(i) the specific location of network components;

(ii) the medical, technological, and communications capabilities of such components;

(iii) the functionality of such components; and

(iv) the capacity and ability of such components to handle increased volume during the response to a public health emergency;


(B) identify methods to expand and interconnect the regional health information networks funded by the Secretary, the State and regional broadband networks funded through the rural health care support mechanism pilot program funded by the Federal Communications Commission, and other telehealth networks;

(C) evaluate ways to prepare for, monitor, respond rapidly to, or manage the events of, a public health emergency through the enhanced use of telehealth technologies, including mechanisms for payment or reimbursement for use of such technologies and personnel during public health emergencies;

(D) identify methods for reducing legal barriers that deter health care professionals from providing telemedicine services, such as by utilizing State emergency health care professional credentialing verification systems, encouraging States to establish and implement mechanisms to improve interstate medical licensure cooperation, facilitating the exchange of information among States regarding investigations and adverse actions, and encouraging States to waive the application of licensing requirements during a public health emergency;

(E) evaluate ways to integrate the practice of telemedicine within the National Disaster Medical System; and

(F) promote greater coordination among existing Federal interagency telemedicine and health information technology initiatives.

(2) Report

Not later than 12 months after December 19, 2006, the Secretary shall prepare and submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives regarding the findings and recommendations pursuant to subparagraphs (A) through (F) of paragraph (1).

(f) Personnel authorities

(1) Specially qualified personnel

In addition to any other personnel authorities, to carry out subsections (b) and (c), the Secretary may—

(A) appoint highly qualified individuals to scientific or professional positions at the Centers for Disease Control and Prevention, not to exceed 30 such employees at any time (specific to positions authorized by this subsection), with expertise in capabilities relevant to biosurveillance and situational awareness, such as experts in informatics and data analytics (including experts in prediction, modeling, or forecasting), and other related scientific or technical fields; and

(B) compensate individuals appointed under subparagraph (A) in the same manner and subject to the same terms and conditions in which individuals appointed under 9903 1 of title 5 are compensated, without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates.

(2) Limitations

The Secretary shall exercise the authority under paragraph (1) in a manner that is consistent with the limitations described in section 247d–6a(e)(2) of this title.

(g) Timeline

The Secretary shall accomplish the purposes under subsections (b) and (c) no later than September 30, 2023, and shall provide a justification to the congressional committees of jurisdiction for any missed or delayed implementation of measurable steps identified under subsection (c)(6)(A)(iii).

(h) Independent evaluation

Not later than 3 years after June 24, 2019, the Comptroller General of the United States shall conduct an independent evaluation and submit to the Secretary and the congressional committees of jurisdiction a report concerning the activities conducted under subsections (b) and (c), and provide recommendations, as applicable and appropriate, on necessary improvements to the biosurveillance and situational awareness network.

(i) Authorization of appropriations

There are authorized to be appropriated to carry out this section, $161,800,000 for each of fiscal years 2019 through 2023.

(j) Definition

For purposes of this section the term "biosurveillance" means the process of gathering near real-time biological data that relates to human and zoonotic disease activity and threats to human or animal health, in order to achieve early warning and identification of such health threats, early detection and prompt ongoing tracking of health events, and overall situational awareness of disease activity.

(July 1, 1944, ch. 373, title III, §319D, as added Pub. L. 106–505, title I, §102, Nov. 13, 2000, 114 Stat. 2318; amended Pub. L. 107–188, title I, §103, June 12, 2002, 116 Stat. 603; Pub. L. 109–417, title II, §§202, 204(b)(2), Dec. 19, 2006, 120 Stat. 2845, 2851; Pub. L. 113–5, title II, §204(a), Mar. 13, 2013, 127 Stat. 177; Pub. L. 116–22, title II, §205(a), (b), June 24, 2019, 133 Stat. 918, 924.)

Amendments

2019Pub. L. 116–22, §205(a)(1), substituted "Facilities and capacities of" for "Revitalizing" in section catchline.

Subsec. (a). Pub. L. 116–22, §205(a)(2)(A), substituted "In general" for "Facilities; capacities" in heading.

Subsec. (a)(1). Pub. L. 116–22, §205(a)(2)(B), substituted ", improved, and appropriately maintained" for "and improved".

Subsec. (a)(3). Pub. L. 116–22, §205(a)(2)(C), substituted "expand, improve, enhance, and appropriately maintain" for "expand, enhance, and improve" in introductory provisions.

Subsec. (a)(4). Pub. L. 116–22, §205(a)(2)(D), added par. (4).

Subsec. (b). Pub. L. 116–22, §205(a)(3)(A), substituted "Establishment of systems of public health" for "National" in heading.

Subsec. (b)(1)(B). Pub. L. 116–22, §205(a)(3)(B), inserted "immunization information systems," after "centers,".

Subsec. (b)(2). Pub. L. 116–22, §205(a)(3)(C), inserted "develop a plan to, and" after "The Secretary shall" and "and in a form readily usable for analytical approaches" after "in a secure manner".

Subsec. (b)(3). Pub. L. 116–22, §205(a)(3)(D), amended par. (3) generally. Prior to amendment, text read as follows: "Not later than one year after June 12, 2002, the Secretary, in cooperation with health care providers and State and local public health officials, shall establish any additional technical and reporting standards (including standards for interoperability) for networks under paragraph (1) and update such standards as necessary."

Subsec. (c)(1). Pub. L. 116–22, §205(a)(4)(A), substituted "The Secretary" for "Not later than 2 years after March 13, 2013, the Secretary" and "such interoperability" for "such connectivity" and inserted ", and improve as applicable and appropriate," after "shall establish" and a comma after "detection of".

Subsec. (c)(2). Pub. L. 116–22, §205(a)(4)(B), amended par. (2) generally. Prior to amendment, par. (2) related to a coordinated strategy and an accompanying implementation plan.

Subsec. (c)(3). Pub. L. 116–22, §205(a)(4)(C), designated existing provisions as subpar. (A) and inserted heading; redesignated former subpars. (A) to (E) as cls. (i) to (v), respectively, and realigned margins; in cl. (iv), inserted "immunization information systems," after "poison control," and substituted ", clinical laboratories, and public environmental health agencies" for "and clinical laboratories"; and added subpar. (B).

Subsec. (c)(5)(A). Pub. L. 116–22, §205(a)(4)(D)(i), (ii), designated existing provisions as subpar. (A), inserted heading, redesignated former subpars. (A) to (D) as (i) to (iv), respectively, and realigned margins.

Subsec. (c)(5)(A)(i). Pub. L. 116–22, §205(a)(4)(D)(iv)(I), substituted "as adopted" for "as determined" and inserted "and the National Institute of Standards and Technology" after "Office of the National Coordinator for Health Information Technology".

Subsec. (c)(5)(A)(v). Pub. L. 116–22, §205(a)(4)(D)(iv)(II)–(IV), added cl. (v).

Subsec. (c)(5)(B). Pub. L. 116–22, §205(a)(4)(D)(iii), added subpar. (B). Former subpar. (B) redesignated cl. (ii) of subpar. (A).

Subsec. (c)(6). Pub. L. 116–22, §205(a)(4)(F), added par. (6). Former par. (6) redesignated (7).

Subsec. (c)(7). Pub. L. 116–22, §205(a)(4)(E), redesignated par. (6) as (7).

Subsec. (c)(7)(A). Pub. L. 116–22, §205(a)(4)(G)(i), inserted "(taking into account zoonotic disease, including gaps in scientific understanding of the interactions between human, animal, and environmental health)" after "human health".

Subsec. (c)(7)(B). Pub. L. 116–22, §205(a)(4)(G)(ii), inserted "and gaps in surveillance programs" after "surveillance programs" and substituted "zoonotic;" for "zoonotic; and".

Subsec. (c)(7)(C). Pub. L. 116–22, §205(a)(4)(G)(iii), inserted ", animal health organizations related to zoonotic disease," after "health care entities" and substituted "activities; and" for "activities."

Subsec. (c)(7)(D). Pub. L. 116–22, §205(a)(4)(G)(iv), added subpar. (D).

Subsec. (c)(8). Pub. L. 116–22, §205(a)(4)(H), added par. (8).

Subsec. (d)(1). Pub. L. 116–22, §205(a)(5)(A), inserted "environmental health agencies," after "public health agencies," and "immunization programs," after "poison control centers,".

Subsec. (d)(2)(D). Pub. L. 116–22, §205(a)(5)(B), added subpar. (D).

Subsec. (d)(5). Pub. L. 116–22, §205(a)(5)(C), added par. (5) and struck out former par. (5) which required an independent evaluation and report from the Government Accountability Office no later than 3 years after Mar. 13, 2013.

Subsecs. (f) to (h). Pub. L. 116–22, §205(a)(7), added subsecs. (f) to (h). Former subsecs. (f) and (g) redesignated (i) and (j), respectively.

Subsec. (i). Pub. L. 116–22, §205(a)(6), (b), redesignated subsec. (f) as (i) and substituted "$161,800,000 for each of fiscal years 2019 through 2023" for "$138,300,000 for each of fiscal years 2014 through 2018".

Subsec. (j). Pub. L. 116–22, §205(a)(6), redesignated subsec. (g) as (j).

2013—Subsec. (b)(1)(B). Pub. L. 113–5, §204(a)(1)(A), inserted "poison control centers," after "hospitals,".

Subsec. (b)(2). Pub. L. 113–5, §204(a)(1)(B), inserted ", allowing for coordination to maximize all-hazards medical and public health preparedness and response and to minimize duplication of effort" before period at end.

Subsec. (b)(3). Pub. L. 113–5, §204(a)(1)(C), inserted "and update such standards as necessary" before period at end.

Subsec. (c). Pub. L. 113–5, §204(a)(4)(A), substituted "Modernizing public health situational awareness and biosurveillance" for "Public health situational awareness" in heading.

Pub. L. 113–5, §204(a)(2), (3), redesignated subsec. (d) as (c) and struck out former subsec. (c) which related to authorization of appropriations for fiscal years 2002 through 2006.

Subsec. (c)(1). Pub. L. 113–5, §204(a)(4)(B), substituted "March 13, 2013" for "December 19, 2006" and inserted ", novel emerging threats," after "disease outbreaks".

Subsec. (c)(2). Pub. L. 113–5, §204(a)(4)(C), added par. (2) and struck out former par. (2). Prior to amendment, text read as follows: "Not later than 180 days after December 19, 2006, the Secretary shall submit to the appropriate committees of Congress, a strategic plan that demonstrates the steps the Secretary will undertake to develop, implement, and evaluate the network described in paragraph (1), utilizing the elements described in paragraph (3)."

Subsec. (c)(3)(D). Pub. L. 113–5, §204(a)(4)(D), inserted "community health centers, health centers" after "of poison control,".

Subsec. (c)(5)(A). Pub. L. 113–5, §204(a)(4)(E), added subpar. (A) and struck out former subpar. (A) which read as follows: "utilize applicable interoperability standards as determined by the Secretary through a joint public and private sector process;".

Subsec. (c)(6). Pub. L. 113–5, §204(a)(4)(F), added par. (6).

Subsec. (d). Pub. L. 113–5, §204(a)(3), redesignated subsec. (e) as (d). Former subsec. (d) redesignated (c).

Subsec. (d)(1), (4)(B). Pub. L. 113–5, §204(a)(5)(A), (B), substituted "subsection (c)" for "subsection (d)".

Subsec. (d)(5). Pub. L. 113–5, §204(a)(5)(C), substituted "3 years after March 13, 2013" for "4 years after December 19, 2006" and "subsection (c)" for "subsection (d)".

Subsec. (e). Pub. L. 113–5, §204(a)(3), redesignated subsec. (f) as (e). Former subsec. (e) redesignated (d).

Subsec. (f). Pub. L. 113–5, §204(a)(3), (6), redesignated subsec. (g) as (f) and substituted "$138,300,000 for each of fiscal years 2014 through 2018" for "such sums as may be necessary in each of fiscal years 2007 through 2011". Former subsec. (f) redesignated (e).

Subsec. (g). Pub. L. 113–5, §204(a)(7), added subsec. (g). Former subsec. (g) redesignated (f).

2006—Subsec. (a)(1). Pub. L. 109–417, §202(1), inserted "domestically and abroad" after "public health threats".

Subsec. (a)(3). Pub. L. 109–417, §204(b)(2), struck out ", taking into account evaluations under section 247d–2(a) of this title," after "The Secretary" in introductory provisions.

Subsecs. (d) to (g). Pub. L. 109–417, §202(2), added subsecs. (d) to (g).

2002Pub. L. 107–188 reenacted section catchline without change and amended text generally, substituting detailed provisions relating to facilities, capacities, and national communications and surveillance networks for provisions relating to findings of need for secure and modern facilities.

Working Capital Fund

Pub. L. 113–76, div. H, title II, Jan. 17, 2014, 128 Stat. 368, provided in part: "That to facilitate the implementation of the permanent Working Capital Fund ('WCF') authorized under this heading [cdc-wide activities and program support] in division F of Public Law 112–74 [see note below], on or after enactment of this Act [Jan. 17, 2014], unobligated balances of amounts appropriated for business services for fiscal year 2013 shall be transferred to the WCF: Provided further, That on or after enactment of this Act, CDC shall transfer amounts available for business services to other CDC appropriations consistent with the benefit each appropriation received from the business services appropriation in fiscal year 2013: Provided further, That once the WCF is implemented in fiscal year 2014, assets purchased in any prior fiscal year with funds appropriated for or reimbursed to business services may be transferred to the WCF and customers billed for depreciation of those assets: Provided further, That CDC shall, consistent with the authorities provided in 42 U.S.C. 231, ensure that the WCF is used only for administrative support services and not for programmatic activities: Provided further, That CDC shall notify the Committees on Appropriations of the House of Representatives and the Senate not later than 15 days prior to any transfers made with funds provided under this heading."

Similar provisions were contained in the following prior appropriation act:

Pub. L. 113–6, div. F, title V, §1507, Mar. 26, 2013, 127 Stat. 423.

Pub. L. 112–74, div. F, title II, Dec. 23, 2011, 125 Stat. 1070, provided in part: "That CDC [Centers for Disease Control and Prevention] may establish a Working Capital Fund, with the authorities equivalent to those provided in 42 U.S.C. 231, to improve the provision of supplies and service."

1 So in original. Probably should be preceded by "section".

§247d–4a. Infectious Diseases Rapid Response Reserve Fund

There is established in the Treasury a reserve fund to be known as the "Infectious Diseases Rapid Response Reserve Fund" (the "Reserve Fund"): Provided, That of the funds provided under the heading "CDC-Wide Activities and Program Support" [132 Stat. 3073], $50,000,000, to remain available until expended, shall be available to the Director of the CDC for deposit in the Reserve Fund: Provided further, That amounts in the Reserve Fund shall be for carrying out titles II, III, and XVII of the PHS Act [42 U.S.C. 201 et seq., 241 et seq., 300u et seq.] to prevent, prepare for, or respond to an infectious disease emergency, including, in connection with such activities, to purchase or lease and provide for the insurance of passenger motor vehicles for official use in foreign countries: Provided further, That amounts in the Reserve Fund may only be provided for an infectious disease emergency if the infectious disease emergency (1) is declared by the Secretary of Health and Human Services under section 319 of the PHS Act [42 U.S.C. 247d] to be a public health emergency; or (2) as determined by the Secretary, has significant potential to imminently occur and potential, on occurrence, to affect national security or the health and security of United States citizens, domestically or internationally: Provided further, That amounts in the Reserve Fund may be transferred by the Director of the CDC to other accounts of the CDC, to accounts of the NIH, or to the Public Health and Social Services Emergency Fund, to be merged with such accounts or Fund for the purposes provided in this section: Provided further, That the Committees on Appropriations of the House of Representatives and the Senate shall be notified in advance of any transfer or obligation made under the authority provided in this section, including notification on the anticipated uses of such funds by program, project, or activity: Provided further, That not later than 15 days after notification of the planned use of the Reserve Fund, the Director shall provide a detailed spend plan of anticipated uses of funds, including estimated personnel and administrative costs, to the Committees on Appropriations of the House of Representatives and the Senate: Provided further, That such plans shall be updated and submitted every 90 days thereafter until funds have been fully expended which should include the unobligated balances in the Reserve Fund and all the actual obligations incurred to date: Provided further, That amounts in the Reserve Fund shall be in addition to amounts otherwise available to the Department of Health and Human Services for the purposes provided in this section: Provided further, That the transfer authorities in this section are in addition to any transfer authority otherwise available to the Department of Health and Human Services: Provided further, That products purchased using amounts in the Reserve Fund may, at the discretion of the Secretary of Health and Human Services, be deposited in the Strategic National Stockpile under section 319F–2 of the PHS Act [42 U.S.C. 247d–6b]: Provided further, That this section shall be in effect as of September 28, 2018, through each fiscal year hereafter.

(Pub. L. 115–245, div. B, title II, §231, Sept. 28, 2018, 132 Stat. 3095.)

References in Text

CDC and NIH, referred to in text, mean the Centers for Disease Control and Prevention and the National Institutes of Health, respectively.

The PHS Act, referred to in text, means the Public Health Service Act, act July 1, 1944, ch. 373, 58 Stat. 682. Titles II, III, and XVII of the Act are classified generally to subchapters I (§201 et seq.), II (§241 et seq.), and XV (§300u et seq.), respectively, of this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 201 of this title and Tables.

Codification

Section was enacted as part of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019, and not as part of the Public Health Service Act which comprises this chapter.

§247d–4b. Children's Preparedness Unit

(a) Enhancing emergency preparedness for children

The Secretary, acting through the Director of the Centers for Disease Control and Prevention (referred to in this subsection as the "Director"), shall maintain an internal team of experts, to be known as the Children's Preparedness Unit (referred to in this subsection as the "Unit"), to work collaboratively to provide guidance on the considerations for, and the specific needs of, children before, during, and after public health emergencies. The Unit shall inform the Director regarding emergency preparedness and response efforts pertaining to children at the Centers for Disease Control and Prevention.

(b) Expertise

The team described in subsection (a) shall include one or more pediatricians, which may be a developmental-behavioral pediatrician, and may also include behavioral scientists, child psychologists, epidemiologists, biostatisticians, health communications staff, and individuals with other areas of expertise, as the Secretary determines appropriate.

(c) Duties

The team described in subsection (a) may—

(1) assist State, local, Tribal, and territorial emergency planning and response activities related to children, which may include developing, identifying, and sharing best practices;

(2) provide technical assistance, training, and consultation to Federal, State, local, Tribal, and territorial public health officials to improve preparedness and response capabilities with respect to the needs of children, including providing such technical assistance, training, and consultation to eligible entities in order to support the achievement of measurable evidence-based benchmarks and objective standards applicable to sections 247d–3a and 247d–3b of this title;

(3) improve the utilization of methods to incorporate the needs of children in planning for and responding to a public health emergency, including public awareness of such methods;

(4) coordinate with, and improve, public-private partnerships, such as health care coalitions pursuant to sections 247d–3b and 247d–3c of this title, to address gaps and inefficiencies in emergency preparedness and response efforts for children;

(5) provide expertise and input during the development of guidance and clinical recommendations to address the needs of children when preparing for, and responding to, public health emergencies, including pursuant to section 247d–3c of this title; and

(6) carry out other duties related to preparedness and response activities for children, as the Secretary determines appropriate.

(July 1, 1944, ch. 373, title III, §319D–1, as added Pub. L. 116–22, title III, §304, June 24, 2019, 133 Stat. 936.)

§247d–5. Combating antimicrobial resistance

(a) Task force

(1) In general

The Secretary shall establish an Antimicrobial Resistance Task Force to provide advice and recommendations to the Secretary and coordinate Federal programs relating to antimicrobial resistance. The Secretary may appoint or select a committee, or other organization in existence as of November 13, 2000, to serve as such a task force, if such committee, or other organization meets the requirements of this section.

(2) Members of task force

The task force described in paragraph (1) shall be composed of representatives from such Federal agencies, and shall seek input from public health constituencies, manufacturers, veterinary and medical professional societies and others, as determined to be necessary by the Secretary, to develop and implement a comprehensive plan to address the public health threat of antimicrobial resistance.

(3) Agenda

(A) In general

The task force described in paragraph (1) shall consider factors the Secretary considers appropriate, including—

(i) public health factors contributing to increasing antimicrobial resistance;

(ii) public health needs to detect and monitor antimicrobial resistance;

(iii) detection, prevention, and control strategies for resistant pathogens;

(iv) the need for improved information and data collection;

(v) the assessment of the risk imposed by pathogens presenting a threat to the public health; and

(vi) any other issues which the Secretary determines are relevant to antimicrobial resistance.

(B) Detection and control

The Secretary, in consultation with the task force described in paragraph (1) and State and local public health officials, shall—

(i) develop, improve, coordinate or enhance participation in a surveillance plan to detect and monitor emerging antimicrobial resistance; and

(ii) develop, improve, coordinate or enhance participation in an integrated information system to assimilate, analyze, and exchange antimicrobial resistance data between public health departments.

(4) Meetings

The task force described under paragraph (1) shall convene not less than twice a year, or more frequently as the Secretary determines to be appropriate.

(b) Research and development of new antimicrobial drugs and diagnostics

The Secretary and the Director of Agricultural Research Services, consistent with the recommendations of the task force established under subsection (a), shall directly or through awards of grants or cooperative agreements to public or private entities provide for the conduct of research, investigations, experiments, demonstrations, and studies in the health sciences that are related to—

(1) the development of new therapeutics, including vaccines and antimicrobials, against resistant pathogens;

(2) the development or testing of medical diagnostics to detect pathogens resistant to antimicrobials;

(3) the epidemiology, mechanisms, and pathogenesis of antimicrobial resistance;

(4) the sequencing of the genomes, or other DNA analysis, or other comparative analysis, of priority pathogens (as determined by the Director of the National Institutes of Health in consultation with the task force established under subsection (a)), in collaboration and coordination with the activities of the Department of Defense and the Joint Genome Institute of the Department of Energy; and

(5) other relevant research areas.

(c) Education of medical and public health personnel

The Secretary, after consultation with the Assistant Secretary for Health, the Surgeon General, the Director of the Centers for Disease Control and Prevention, the Administrator of the Health Resources and Services Administration, the Director of the Agency for Healthcare Research and Quality, members of the task force described in subsection (a), professional organizations and societies, and such other public health officials as may be necessary, shall—

(1) develop and implement educational programs to increase the awareness of the general public with respect to the public health threat of antimicrobial resistance and the appropriate use of antibiotics;

(2) develop and implement educational programs to instruct health care professionals in the prudent use of antibiotics; and

(3) develop and implement programs to train laboratory personnel in the recognition or identification of resistance in pathogens.

(d) Grants

(1) In general

The Secretary shall award competitive grants to eligible entities to enable such entities to increase the capacity to detect, monitor, and combat antimicrobial resistance.

(2) Eligible entities

Eligible entities for grants under paragraph (1) shall be State or local public health agencies, Indian tribes or tribal organizations, or other public or private nonprofit entities.

(3) Use of funds

An eligible entity receiving a grant under paragraph (1) shall use funds from such grant for activities that are consistent with the factors identified by the task force under subsection (a)(3), which may include activities that—

(A) provide training to enable such entity to identify patterns of resistance rapidly and accurately;

(B) develop, improve, coordinate or enhance participation in information systems by which data on resistant infections can be shared rapidly among relevant national, State, and local health agencies and health care providers; and

(C) develop and implement policies to control the spread of antimicrobial resistance.

(e) Grants for demonstration programs

(1) In general

The Secretary shall award competitive grants to eligible entities to establish demonstration programs to promote judicious use of antimicrobial drugs or control the spread of antimicrobial-resistant pathogens.

(2) Eligible entities

Eligible entities for grants under paragraph (1) may include hospitals, clinics, institutions of long-term care, professional medical societies, schools or programs that train medical laboratory personnel, or other public or private nonprofit entities.

(3) Technical assistance

The Secretary shall provide appropriate technical assistance to eligible entities that receive grants under paragraph (1).

(f) Monitoring at Federal health care facilities

The Secretary shall encourage reporting on aggregate antimicrobial drug use and antimicrobial resistance to antimicrobial drugs and the implementation of antimicrobial stewardship programs by health care facilities of the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service and shall provide technical assistance to the Secretary of Defense and the Secretary of Veterans Affairs, as appropriate and upon request.

(g) Report on antimicrobial resistance in humans and use of antimicrobial drugs

Not later than 1 year after December 13, 2016, and annually thereafter, the Secretary shall prepare and make publicly available data and information concerning—

(1) aggregate national and regional trends of antimicrobial resistance in humans to antimicrobial drugs, including such drugs approved under section 356(h) of title 21;

(2) antimicrobial stewardship, which may include summaries of State efforts to address antimicrobial resistance in humans to antimicrobial drugs and antimicrobial stewardship; and

(3) coordination between the Director of the Centers for Disease Control and Prevention and the Commissioner of Food and Drugs with respect to the monitoring of—

(A) any applicable resistance under paragraph (1); and

(B) drugs approved under section 356(h) of title 21.

(h) Information related to antimicrobial stewardship programs

The Secretary shall, as appropriate, disseminate guidance, educational materials, or other appropriate materials related to the development and implementation of evidence-based antimicrobial stewardship programs or practices at health care facilities, such as nursing homes and other long-term care facilities, ambulatory surgical centers, dialysis centers, outpatient clinics, and hospitals, including community and rural hospitals.

(i) Supporting State-based activities to combat antimicrobial resistance

The Secretary shall continue to work with State and local public health departments on statewide or regional programs related to antimicrobial resistance. Such efforts may include activities to related to—

(1) identifying patterns of bacterial and fungal resistance in humans to antimicrobial drugs;

(2) preventing the spread of bacterial and fungal infections that are resistant to antimicrobial drugs; and

(3) promoting antimicrobial stewardship.

(j) Antimicrobial resistance and stewardship activities

(1) In general

For the purposes of supporting stewardship activities, examining changes in antimicrobial resistance, and evaluating the effectiveness of section 356(h) of title 21, the Secretary shall—

(A) provide a mechanism for facilities to report data related to their antimicrobial stewardship activities (including analyzing the outcomes of such activities); and

(B) evaluate—

(i) antimicrobial resistance data using a standardized approach; and

(ii) trends in the utilization of drugs approved under such section 356(h) of title 21 with respect to patient populations.

(2) Use of systems

The Secretary shall use available systems, including the National Healthcare Safety Network or other systems identified by the Secretary, to fulfill the requirements or conduct activities under this section.

(k) Antimicrobial

For purposes of subsections (f) through (j), the term "antimicrobial" includes any antibacterial or antifungal drugs, and may include drugs that eliminate or inhibit the growth of other microorganisms, as appropriate.

(l) Supplement not supplant

Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under this section.

(m) Authorization of appropriations

There are authorized to be appropriated to carry out this section, $40,000,000 for fiscal year 2001, $25,000,000 for each of the fiscal years 2002 and 2003, and such sums as may be necessary for each of the fiscal years 2004 through 2006.

(July 1, 1944, ch. 373, title III, §319E, as added Pub. L. 106–505, title I, §102, Nov. 13, 2000, 114 Stat. 2318; amended Pub. L. 107–188, title I, §109, June 12, 2002, 116 Stat. 610; Pub. L. 114–255, div. A, title III, §3041(a), Dec. 13, 2016, 130 Stat. 1111.)

Amendments

2016—Subsecs. (f) to (m). Pub. L. 114–255 added subsecs. (f) to (k) and redesignated former subsecs. (f) and (g) as (l) and (m), respectively.

2002—Subsec. (b). Pub. L. 107–188, §109(1)(A), in introductory provisions, substituted "shall directly or through awards of grants or cooperative agreements to public or private entities provide for the conduct of" for "shall conduct and support".

Subsec. (b)(4). Pub. L. 107–188, §109(1)(B), amended par. (4) generally. Prior to amendment, par. (4) read as follows: "the sequencing of the genomes of priority pathogens as determined by the Director of the National Institutes of Health in consultation with the task force established under subsection (a) of this section; and".

Subsec. (e)(2). Pub. L. 107–188, §109(2), inserted "schools or programs that train medical laboratory personnel," after "professional medical societies,".

Subsec. (g). Pub. L. 107–188, §109(3), substituted "$25,000,000 for each of the fiscal years 2002 and 2003, and such sums as may be necessary for each of the fiscal years 2004 through 2006" for "and such sums as may be necessary for each subsequent fiscal year through 2006".

Construction of 2016 Amendment

Nothing in amendment by Pub. L. 114–255 to be construed to restrict the prescribing of antimicrobial drugs or other products, including drugs approved under section 356(h) of Title 21, Food and Drugs, by health care professionals, or to limit the practice of health care, see section 3043 of Pub. L. 114–255, set out as a note under section 356 of Title 21.

Additional Strategies for Combating Antibiotic Resistance

Pub. L. 116–22, title V, §505, June 24, 2019, 133 Stat. 951, provided that:

"(a) Advisory Council.—The Secretary of Health and Human Services (referred to in this section as the 'Secretary') may continue the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, referred to in this section as the 'Advisory Council'.

"(b) Duties.—The Advisory Council shall advise and provide information and recommendations to the Secretary regarding programs and policies intended to reduce or combat antibiotic-resistant bacteria that may present a public health threat and improve capabilities to prevent, diagnose, mitigate, or treat such resistance. Such advice, information, and recommendations may be related to improving—

"(1) the effectiveness of antibiotics;

"(2) research and advanced research on, and the development of, improved and innovative methods for combating or reducing antibiotic resistance, including new treatments, rapid point-of-care diagnostics, alternatives to antibiotics, including alternatives to animal antibiotics, and antimicrobial stewardship activities;

"(3) surveillance of antibiotic-resistant bacterial infections, including publicly available and up-to-date information on resistance to antibiotics;

"(4) education for health care providers and the public with respect to up-to-date information on antibiotic resistance and ways to reduce or combat such resistance to antibiotics related to humans and animals;

"(5) methods to prevent or reduce the transmission of antibiotic-resistant bacterial infections, including stewardship programs; and

"(6) coordination with respect to international efforts in order to inform and advance United States capabilities to combat antibiotic resistance.

"(c) Meetings and Coordination.—

"(1) Meetings.—The Advisory Council shall meet not less than biannually and, to the extent practicable, in coordination with meetings of the Antimicrobial Resistance Task Force established in section 319E(a) of the Public Health Service Act [42 U.S.C. 247d–5(a)].

"(2) Coordination.—The Advisory Council shall, to the greatest extent practicable, coordinate activities carried out by the Council with the Antimicrobial Resistance Task Force established under section 319E(a) of the Public Health Service Act (42 U.S.C. 247d–5(a)).

"(d) FACA.—The Federal Advisory Committee Act (5 U.S.C. App.) shall apply to the activities and duties of the Advisory Council.

"(e) Extension of Advisory Council.—Not later than October 1, 2022, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a recommendation on whether the Advisory Council should be extended, and in addition, identify whether there are other committees, councils, or task forces that have overlapping or similar duties to that of the Advisory Council, and whether such committees, councils, or task forces should be combined, including with respect to section 319E(a) of the Public Health Service Act (42 U.S.C. 247d–5(a))."

Availability of Data

Pub. L. 114–255, div. A, title III, §3041(b), Dec. 13, 2016, 130 Stat. 1112, provided that: "The Secretary shall make the data collected pursuant to this subsection [probably refers to the amendments made to this section by section 3041(a) of Pub. L. 114–255] public. Nothing in this subsection shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code."

Ex. Ord. No. 13676. Combating Antibiotic-Resistant Bacteria

Ex. Ord. No. 13676, Sept. 18, 2014, 79 F.R. 56931, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, I hereby order as follows:

Section 1. Policy. The discovery of antibiotics in the early 20th century fundamentally transformed human and veterinary medicine. Antibiotics save millions of lives each year in the United States and around the world. The rise of antibiotic-resistant bacteria, however, represents a serious threat to public health and the economy. The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) estimates that annually at least two million illnesses and 23,000 deaths are caused by antibiotic-resistant bacteria in the United States alone.

Detecting, preventing, and controlling antibiotic resistance requires a strategic, coordinated, and sustained effort. It also depends on the engagement of governments, academia, industry, healthcare providers, the general public, and the agricultural community, as well as international partners. Success in this effort will require significant efforts to: minimize the emergence of antibiotic-resistant bacteria; preserve the efficacy of new and existing antibacterial drugs; advance research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship; strengthen surveillance efforts in public health and agriculture; develop and promote the use of new, rapid diagnostic technologies; accelerate scientific research and facilitate the development of new antibacterial drugs, vaccines, diagnostics, and other novel therapeutics; maximize the dissemination of the most up-to-date information on the appropriate and proper use of antibiotics to the general public and healthcare providers; work with the pharmaceutical industry to include information on the proper use of over-the-counter and prescription antibiotic medications for humans and animals; and improve international collaboration and capabilities for prevention, surveillance, stewardship, basic research, and drug and diagnostics development.

The Federal Government will work domestically and internationally to detect, prevent, and control illness and death related to antibiotic-resistant infections by implementing measures that reduce the emergence and spread of antibiotic-resistant bacteria and help ensure the continued availability of effective therapeutics for the treatment of bacterial infections.

Sec. 2. Oversight and Coordination. Combating antibiotic-resistant bacteria is a national security priority. The National Security Council staff, in collaboration with the Office of Science and Technology Policy, the Domestic Policy Council, and the Office of Management and Budget, shall coordinate the development and implementation of Federal Government policies to combat antibiotic-resistant bacteria, including the activities, reports, and recommendations of the Task Force for Combating Antibiotic-Resistant Bacteria established in section 3 of this order.

Sec. 3. Task Force for Combating Antibiotic-Resistant Bacteria. There is hereby established the Task Force for Combating Antibiotic-Resistant Bacteria (Task Force), to be co-chaired by the Secretaries of Defense, Agriculture, and HHS.

(a) Membership. In addition to the Co-Chairs, the Task Force shall consist of representatives from:

(i) the Department of State;

(ii) the Department of Justice;

(iii) the Department of Veterans Affairs;

(iv) the Department of Homeland Security;

(v) the Environmental Protection Agency;

(vi) the United States Agency for International Development;

(vii) the Office of Management and Budget;

(viii) the Domestic Policy Council;

(ix) the National Security Council staff;

(x) the Office of Science and Technology Policy;

(xi) the National Science Foundation; and

(xii) such executive departments, agencies, or offices as the Co-Chairs may designate.

Each executive department, agency, or office represented on the Task Force (Task Force agency) shall designate an employee of the Federal Government to perform the functions of the Task Force. In performing its functions, the Task Force may make use of existing interagency task forces on antibiotic resistance.

(b) Mission. The Task Force shall identify actions that will provide for the facilitation and monitoring of implementation of this order and the National Strategy for Combating Antibiotic-Resistant Bacteria (Strategy).

(c) Functions.

(i) By February 15, 2015, the Task Force shall submit a 5-year National Action Plan (Action Plan) to the President that outlines specific actions to be taken to implement the Strategy. The Action Plan shall include goals, milestones, and metrics for measuring progress, as well as associated timelines for implementation. The Action Plan shall address recommendations made by the President's Council of Advisors on Science and Technology regarding combating antibiotic resistance.

(ii) Within 180 days of the release of the Action Plan and each year thereafter, the Task Force shall provide the President with an update on Federal Government actions to combat antibiotic resistance consistent with this order, including progress made in implementing the Strategy and Action Plan, plans for addressing any barriers preventing full implementation of the Strategy and Action Plan, and recommendations for new or modified actions. Annual updates shall include specific goals, milestones, and metrics for all proposed actions and recommendations. The Task Force shall take Federal Government resources into consideration when developing these proposed actions and recommendations.

(iii) In performing its functions, the Task Force shall review relevant statutes, regulations, policies, and programs, and shall consult with relevant domestic and international organizations and experts, as necessary.

(iv) The Task Force shall conduct an assessment of progress made towards achieving the milestones and goals outlined in the Strategy in conjunction with the Advisory Council established pursuant to section 4 of this order.

Sec. 4. Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. (a) The Secretary of HHS (Secretary), in consultation with the Secretaries of Defense and Agriculture, shall establish the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The Advisory Council shall be composed of not more than 30 members to be appointed or designated by the Secretary.

(b) The Secretary shall designate a chairperson from among the members of the Advisory Council.

(c) The Advisory Council shall provide advice, information, and recommendations to the Secretary regarding programs and policies intended to: preserve the effectiveness of antibiotics by optimizing their use; advance research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship; strengthen surveillance of antibiotic-resistant bacterial infections; prevent the transmission of antibiotic-resistant bacterial infections; advance the development of rapid point-of-care and agricultural diagnostics; further research on new treatments for bacterial infections; develop alternatives to antibiotics for agricultural purposes; maximize the dissemination of up-to-date information on the appropriate and proper use of antibiotics to the general public and human and animal healthcare providers; and improve international coordination of efforts to combat antibiotic resistance. The Secretary shall provide the President with all written reports created by the Advisory Council.

(d) Task Force agencies shall, to the extent permitted by law, provide the Advisory Council with such information as it may require for purposes of carrying out its functions.

(e) To the extent permitted by law, and subject to the availability of appropriations, HHS shall provide the Advisory Council with such funds and support as may be necessary for the performance of its functions.

Sec. 5. Improved Antibiotic Stewardship. (a) By the end of calendar year 2016, HHS shall review existing regulations and propose new regulations or other actions, as appropriate, that require hospitals and other inpatient healthcare delivery facilities to implement robust antibiotic stewardship programs that adhere to best practices, such as those identified by the CDC. HHS shall also take steps to encourage other healthcare facilities, such as ambulatory surgery centers and dialysis facilities, to adopt antibiotic stewardship programs.

(b) Task Force agencies shall, as appropriate, define, promulgate, and implement stewardship programs in other healthcare settings, including office-based practices, outpatient settings, emergency departments, and institutional and long-term care facilities such as nursing homes, pharmacies, and correctional facilities.

(c) By the end of calendar year 2016, the Department of Defense (DoD) and the Department of Veterans Affairs (VA) shall review their existing regulations and, as appropriate, propose new regulations and other actions that require their hospitals and long-term care facilities to implement robust antibiotic stewardship programs that adhere to best practices, such as those defined by the CDC. DoD and the VA shall also take steps to encourage their other healthcare facilities, such as ambulatory surgery centers and outpatient clinics, to adopt antibiotic stewardship programs.

(d) Task Force agencies shall, as appropriate, monitor improvements in antibiotic use through the National Healthcare Safety Network and other systems.

(e) The Food and Drug Administration (FDA) in HHS, in coordination with the Department of Agriculture (USDA), shall continue taking steps to eliminate the use of medically important classes of antibiotics for growth promotion purposes in food-producing animals.

(f) USDA, the Environmental Protection Agency (EPA), and FDA shall strengthen coordination in common program areas, such as surveillance of antibiotic use and resistance patterns in food-producing animals, inter-species disease transmissibility, and research findings.

(g) DoD, HHS, and the VA shall review existing regulations and propose new regulations and other actions, as appropriate, to standardize the collection and sharing of antibiotic resistance data across all their healthcare settings.

Sec. 6. Strengthening National Surveillance Efforts for Resistant Bacteria. (a) The Task Force shall ensure that the Action Plan includes procedures for creating and integrating surveillance systems and laboratory networks to provide timely, high-quality data across healthcare and agricultural settings, including detailed genomic and other information, adequate to track resistant bacteria across diverse settings. The network-integrated surveillance systems and laboratory networks shall include common information requirements, repositories for bacteria isolates and other samples, a curated genomic database, rules for access to samples and scientific data, standards for electronic health record-based reporting, data transparency, budget coordination, and international coordination.

(b) Task Force agencies shall, as appropriate, link data from Federal Government sample isolate repositories for bacteria strains to an integrated surveillance system, and, where feasible, the repositories shall enhance their sample collections and further interoperable data systems with national surveillance efforts.

(c) USDA, EPA, and FDA shall work together with stakeholders to monitor and report on changes in antibiotic use in agriculture and their impact on the environment.

(d) Task Force agencies shall, as appropriate, monitor antibiotic resistance in healthcare settings through the National Healthcare Safety Network and related systems.

Sec. 7. Preventing and Responding to Infections and Outbreaks with Antibiotic-Resistant Organisms. (a) Task Force agencies shall, as appropriate, utilize the enhanced surveillance activities described in section 6 of this order to prevent antibiotic-resistant infections by: actively identifying and responding to antibiotic-resistant outbreaks; preventing outbreaks and transmission of antibiotic-resistant infections in healthcare, community, and agricultural settings through early detection and tracking of resistant organisms; and identifying and evaluating additional strategies in the healthcare and community settings for the effective prevention and control of antibiotic-resistant infections.

(b) Task Force agencies shall take steps to implement the measures and achieve the milestones outlined in the Strategy and Action Plan.

(c) DoD, HHS, and the VA shall review and, as appropriate, update their hospital and long-term care infectious disease protocols for identifying, isolating, and treating antibiotic-resistant bacterial infection cases.

Sec. 8. Promoting New and Next Generation Antibiotics and Diagnostics. (a) As part of the Action Plan, the Task Force shall describe steps that agencies can take to encourage the development of new and next-generation antibacterial drugs, diagnostics, vaccines, and novel therapeutics for both the public and agricultural sectors, including steps to develop infrastructure for clinical trials and options for attracting greater private investment in the development of new antibiotics and rapid point-of-care diagnostics. Task Force agency efforts shall focus on addressing areas of unmet medical need for individuals, including those antibiotic-resistant bacteria CDC has identified as public and agricultural health threats.

(b) Together with the countermeasures it develops for biodefense threats, the Biomedical Advanced Research Development Authority in HHS shall develop new and next-generation countermeasures that target antibiotic-resistant bacteria that present a serious or urgent threat to public health.

(c) The Public Health Emergency Medical Countermeasures Enterprise in HHS shall, as appropriate, coordinate with Task Force agencies' efforts to promote new and next-generation countermeasures to target antibiotic-resistant bacteria that present a serious or urgent threat to public health.

Sec. 9. International Cooperation. Within 30 days of the date of this order, the Secretaries of State, USDA, and HHS shall designate representatives to engage in international action to combat antibiotic-resistant bacteria, including the development of the World Health Organization (WHO) Global Action Plan for Antimicrobial Resistance with the WHO, Member States, and other relevant organizations. The Secretaries of State, USDA, and HHS shall conduct a review of international collaboration activities and partnerships, and identify and pursue opportunities for enhanced prevention, surveillance, research and development, and policy engagement. All Task Force agencies with research and development activities related to antibiotic resistance shall, as appropriate, expand existing bilateral and multilateral scientific cooperation and research pursuant to the Action Plan.

Sec. 10. General Provisions. (a) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(b) Nothing in this order shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

(d) Insofar as the Federal Advisory Committee Act, as amended (5 U.S.C. App.) (the "Act"), may apply to the Advisory Council, any functions of the President under the Act, except for that of reporting to the Congress, shall be performed by the Secretary in accordance with the guidelines issued by the Administrator of General Services.

Barack Obama.      

Extension of Term of Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria

Term of Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria extended until Sept. 30, 2019, by Ex. Ord. No. 13811, Sept. 29, 2017, 82 F.R. 46363, set out as a note under section 14 of the Federal Advisory Committee Act in the Appendix to Title 5, Government Organization and Employees.

Previous extension of term of Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria was contained in the following prior Executive Order:

Ex. Ord. No. 13708, Sept. 30, 2015, 80 F.R. 60271, extended term until Sept. 30, 2017.

§247d–5a. Repealed. Pub. L. 114–255, div. A, title III, §3044(b)(1), Dec. 13, 2016, 130 Stat. 1121

Section, Pub. L. 110–85, title XI, §1111, Sept. 27, 2007, 121 Stat. 975, related to identification of clinically susceptible concentrations of antimicrobials. See section 360a–2 of Title 21, Food and Drugs.

§247d–6. Public health countermeasures to a bioterrorist attack

(a) All-hazards public health and medical response curricula and training

(1) In general

The Secretary, in collaboration with the Secretary of Defense, and in consultation with relevant public and private entities, shall develop core health and medical response curricula and trainings by adapting applicable existing curricula and training programs to improve responses to public health emergencies.

(2) Curriculum

The public health and medical response training program may include course work related to—

(A) medical management of casualties, taking into account the needs of at-risk individuals;

(B) public health aspects of public health emergencies;

(C) mental health aspects of public health emergencies;

(D) national incident management, including coordination among Federal, State, local, tribal, international agencies, and other entities; and

(E) protecting health care workers and health care first responders from workplace exposures during a public health emergency.

(3) Peer review

On a periodic basis, products prepared as part of the program shall be rigorously tested and peer-reviewed by experts in the relevant fields.

(4) Credit

The Secretary and the Secretary of Defense shall—

(A) take into account continuing professional education requirements of public health and healthcare professions; and

(B) cooperate with State, local, and tribal accrediting agencies and with professional associations in arranging for students enrolled in the program to obtain continuing professional education credit for program courses.

(5) Dissemination and training

(A) In general

The Secretary may provide for the dissemination and teaching of the materials described in paragraphs (1) and (2) by appropriate means, as determined by the Secretary.

(B) Certain entities

The education and training activities described in subparagraph (A) may be carried out by Federal public health, medical, or dental entities, appropriate educational entities, professional organizations and societies, private accrediting organizations, and other nonprofit institutions or entities meeting criteria established by the Secretary.

(C) Grants and contracts

In carrying out this subsection, the Secretary may carry out activities directly or through the award of grants and contracts, and may enter into interagency agreements with other Federal agencies.

(b) Advice to the Federal Government

(1) Required advisory committees

In coordination with the working group under subsection (a), the Secretary shall establish advisory committees in accordance with paragraphs (2) and (3) to provide expert recommendations to assist such working groups in carrying out their respective responsibilities under subsections (a) and (b).

(2) National Advisory Committee on At-Risk Individuals and Public Health Emergencies

(A) In general

For purposes of paragraph (1), the Secretary shall establish an advisory committee to be known as the National Advisory Committee on At-Risk Individuals and Public Health Emergencies (referred to in this paragraph as the "Advisory Committee").

(B) Duties

The Advisory Committee shall provide recommendations regarding—

(i) the preparedness of the health care (including mental health care) system to respond to public health emergencies as they relate to at-risk individuals;

(ii) needed changes to the health care and emergency medical service systems and emergency medical services protocols to meet the special needs of at-risk individuals; and

(iii) changes, if necessary, to the national stockpile under section 300hh–12 of this title to meet the emergency health security of at-risk individuals.

(C) Composition

The Advisory Committee shall be composed of such Federal officials as may be appropriate to address the special needs of the diverse population groups of at-risk populations.

(D) Termination

The Advisory Committee terminates six years after June 12, 2002.

(3) Emergency Public Information and Communications Advisory Committee

(A) In general

For purposes of paragraph (1), the Secretary shall establish an advisory committee to be known as the Emergency Public Information and Communications Advisory Committee (referred to in this paragraph as the "EPIC Advisory Committee").

(B) Duties

The EPIC Advisory Committee shall make recommendations to the Secretary and report on appropriate ways to communicate public health information regarding bioterrorism and other public health emergencies to the public.

(C) Composition

The EPIC Advisory Committee shall be composed of individuals representing a diverse group of experts in public health, medicine, communications, behavioral psychology, and other areas determined appropriate by the Secretary.

(D) Dissemination

The Secretary shall review the recommendations of the EPIC Advisory Committee and ensure that appropriate information is disseminated to the public.

(E) Termination

The EPIC Advisory Committee terminates one year after June 12, 2002.

(c) Expansion of Epidemic Intelligence Service Program

The Secretary may establish 20 officer positions in the Epidemic Intelligence Service Program, in addition to the number of the officer positions offered under such Program in 2006, for individuals who agree to participate, for a period of not less than 2 years, in the Career Epidemiology Field Officer program in a State, local, or tribal health department that serves a health professional shortage area (as defined under section 254e(a) of this title), a medically underserved population (as defined under section 254b(b)(3) of this title), or a medically underserved area or area at high risk of a public health emergency as designated by the Secretary.

(d) Centers for Public Health Preparedness; core curricula and training

(1) In general

The Secretary may establish at accredited schools of public health, Centers for Public Health Preparedness (hereafter referred to in this section as the "Centers").

(2) Eligibility

To be eligible to receive an award under this subsection to establish a Center, an accredited school of public health shall agree to conduct activities consistent with the requirements of this subsection.

(3) Core curricula

The Secretary, in collaboration with the Centers and other public or private entities shall establish core curricula based on established competencies leading to a 4-year bachelor's degree, a graduate degree, a combined bachelor and master's degree, or a certificate program, for use by each Center. The Secretary shall disseminate such curricula to other accredited schools of public health and other health professions schools determined appropriate by the Secretary, for voluntary use by such schools.

(4) Core competency-based training program

The Secretary, in collaboration with the Centers and other public or private entities shall facilitate the development of a competency-based training program to train public health practitioners. The Centers shall use such training program to train public health practitioners. The Secretary shall disseminate such training program to other accredited schools of public health, health professions schools, and other public or private entities as determined by the Secretary, for voluntary use by such entities.

(5) Content of core curricula and training program

The Secretary shall ensure that the core curricula and training program established pursuant to this subsection respond to the needs of State, local, and tribal public health authorities and integrate and emphasize essential public health security capabilities consistent with section 300hh–1(b)(2) of this title.

(6) Academic-workforce communication

As a condition of receiving funding from the Secretary under this subsection, a Center shall collaborate with a State, local, or tribal public health department to—

(A) define the public health preparedness and response needs of the community involved;

(B) assess the extent to which such needs are fulfilled by existing preparedness and response activities of such school or health department, and how such activities may be improved;

(C) prior to developing new materials or trainings, evaluate and utilize relevant materials and trainings developed by others Centers; and

(D) evaluate community impact and the effectiveness of any newly developed materials or trainings.

(7) Public health systems research

In consultation with relevant public and private entities, the Secretary shall define the existing knowledge base for public health preparedness and response systems, and establish a research agenda based on Federal, State, local, and tribal public health preparedness priorities. As a condition of receiving funding from the Secretary under this subsection, a Center shall conduct public health systems research that is consistent with the agenda described under this paragraph.

(e) Accelerated research and development on priority pathogens and countermeasures

(1) In general

With respect to pathogens of potential use in a bioterrorist attack, and other agents that may cause a public health emergency, the Secretary, taking into consideration any recommendations of the working group under subsection (a), shall conduct, and award grants, contracts, or cooperative agreements for, research, investigations, experiments, demonstrations, and studies in the health sciences relating to—

(A) the epidemiology and pathogenesis of such pathogens;

(B) the sequencing of the genomes, or other DNA analysis, or other comparative analysis, of priority pathogens (as determined by the Director of the National Institutes of Health in consultation with the working group established in subsection (a)), in collaboration and coordination with the activities of the Department of Defense and the Joint Genome Institute of the Department of Energy;

(C) the development of priority countermeasures; and

(D) other relevant areas of research;


with consideration given to the needs of children and other vulnerable populations.

(2) Priority

The Secretary shall give priority under this section to the funding of research and other studies related to priority countermeasures.

(3) Role of Department of Veterans Affairs

In carrying out paragraph (1), the Secretary shall consider using the biomedical research and development capabilities of the Department of Veterans Affairs, in conjunction with that Department's affiliations with health-professions universities. When advantageous to the Government in furtherance of the purposes of such paragraph, the Secretary may enter into cooperative agreements with the Secretary of Veterans Affairs to achieve such purposes.

(4) Priority countermeasures

For purposes of this section, the term "priority countermeasure" means a drug, biological product, device, vaccine, vaccine adjuvant, antiviral, or diagnostic test that the Secretary determines to be—

(A) a priority to treat, identify, or prevent infection by a biological agent or toxin listed pursuant to section 262a(a)(1) of this title, or harm from any other agent that may cause a public health emergency; or

(B) a priority to treat, identify, or prevent conditions that may result in adverse health consequences or death and may be caused by the administering of a drug, biological product, device, vaccine, vaccine adjuvant, antiviral, or diagnostic test that is a priority under subparagraph (A).

(f) Authorization of appropriations

(1) Fiscal year 2007

There are authorized to be appropriated to carry out this section for fiscal year 2007—

(A) to carry out subsection (a)—

(i) $5,000,000 to carry out paragraphs (1) through (4); and

(ii) $7,000,000 to carry out paragraph (5);


(B) to carry out subsection (c), $3,000,000; and

(C) to carry out subsection (d), $31,000,000, of which $5,000,000 shall be used to carry out paragraphs (3) through (5) of such subsection.

(2) Subsequent fiscal years

There are authorized to be appropriated such sums as may be necessary to carry out this section for fiscal year 2008 and each subsequent fiscal year.

(July 1, 1944, ch. 373, title III, §319F, as added Pub. L. 106–505, title I, §102, Nov. 13, 2000, 114 Stat. 2321; amended Pub. L. 107–188, title I, §§104(a) 105, 108, 111(3), 125, June 12, 2002, 116 Stat. 605, 606, 609, 611, 614; Pub. L. 108–276, §2(d), July 21, 2004, 118 Stat. 842; Pub. L. 109–417, title III, §§301(d), (e), 304, Dec. 19, 2006, 120 Stat. 2854, 2855, 2859; Pub. L. 113–5, title II, §203(a), Mar. 13, 2013, 127 Stat. 175.)

Amendments

2013—Subsec. (a)(5)(B). Pub. L. 113–5 substituted "public health, medical, or dental" for "public health or medical".

2006—Subsec. (a). Pub. L. 109–417, §304(1), added subsec. (a) and struck out heading and text of former subsec. (a) which established a working group on bioterrorism and other public health emergencies.

Subsec. (b)(2). Pub. L. 109–417, §301(d)(1), substituted "At-Risk Individuals and Public Health Emergencies" for "Children and Terrorism" in heading.

Subsec. (b)(2)(A). Pub. L. 109–417, §301(d)(2), substituted "At-Risk Individuals and Public Health Emergencies" for "Children and Terrorism".

Subsec. (b)(2)(B)(i). Pub. L. 109–417, §301(d)(3)(A), substituted "public health emergencies as they relate to at-risk individuals" for "bioterrorism as it relates to children".

Subsec. (b)(2)(B)(ii), (iii). Pub. L. 109–417, §301(d)(3)(B), (C), substituted "at-risk individuals" for "children".

Subsec. (b)(2)(C). Pub. L. 109–417, §301(d)(4), substituted "at-risk populations" for "children, and child health experts on infectious disease, environmental health, toxicology, and other relevant professional disciplines".

Subsec. (b)(2)(D). Pub. L. 109–417, §301(d)(5), substituted "six years" for "one year".

Subsec. (b)(3)(B). Pub. L. 109–417, §301(e), struck out "and the working group under subsection (a) of this section" after "Secretary".

Subsecs. (c) to (h). Pub. L. 109–417, §304(2)–(4), added subsecs. (c), (d), and (f), redesignated subsec. (h) as (e), and struck out former subsecs. (c) to (g), which related to: in subsec. (c), development of communication strategy; in subsec. (d), Federal Internet site on bioterrorism; in subsec. (e), grants to increase capacity to detect, diagnose, and respond to acts of bioterrorism; in subsec. (f), assistance to State and local health agencies to enable effective response to attacks; and, in subsec. (g), education and training activities.

Subsecs. (i), (j). Pub. L. 109–417, §304(5), struck out subsecs. (i) and (j) which related to report to congressional committees on public health and medical consequences of a bioterrorist attack and the supplementary nature of funds appropriated under this section, respectively.

2004—Subsec. (a)(1). Pub. L. 108–276, §2(d)(1), inserted "the Secretary of Homeland Security," after "Management Agency," in introductory provisions.

Subsec. (h)(4)(B). Pub. L. 108–276, §2(d)(2), substituted "to treat, identify, or prevent conditions" for "to diagnose conditions".

2002—Subsec. (a). Pub. L. 107–188, §108, added subsec. (a) and struck out heading and text of former subsec. (a). Text read as follows: "The Secretary, in coordination with the Secretary of Defense, shall establish a joint interdepartmental working group on preparedness and readiness for the medical and public health effects of a bioterrorist attack on the civilian population. Such joint working group shall—

"(1) coordinate research on pathogens likely to be used in a bioterrorist attack on the civilian population as well as therapies to treat such pathogens;

"(2) coordinate research and development into equipment to detect pathogens likely to be used in a bioterrorist attack on the civilian population and protect against infection from such pathogens;

"(3) develop shared standards for equipment to detect and to protect against infection from pathogens likely to be used in a bioterrorist attack on the civilian population; and

"(4) coordinate the development, maintenance, and procedures for the release of, strategic reserves of vaccines, drugs, and medical supplies which may be needed rapidly after a bioterrorist attack upon the civilian population."

Subsec. (b). Pub. L. 107–188, §104(a)(1), (3), added subsec. (b) and struck out former subsec. (b) which related to establishment, functions, membership, and coordination of a working group on the public health and medical consequences of bioterrorism.

Subsecs. (c), (d). Pub. L. 107–188, §104(a)(3), added subsecs. (c) and (d). Former subsecs. (c) and (d) redesignated (e) and (f), respectively.

Subsec. (e). Pub. L. 107–188, §104(a)(2), redesignated subsec. (c) as (e). Former subsec. (e) redesignated (g).

Subsec. (e)(2). Pub. L. 107–188, §111(3), which directed the amendment of section 391F(e)(2) of the Public Health Service Act by striking out "or" after "clinic," and inserting before period ", professional organization or society, school or program that trains medical laboratory personnel, private accrediting organization, or other nonprofit private institution or entity meeting criteria established by the Secretary", was executed to subsec. (e)(2) of this section, which is section 319F(e)(2) of the Act, to reflect the probable intent of Congress.

Subsec. (f). Pub. L. 107–188, §104(a)(2), redesignated subsec. (d) as (f). Former subsec. (f) redesignated (h).

Subsec. (g). Pub. L. 107–188, §105, amended heading and text of subsec. (g) generally. Prior to amendment, text read as follows: "The Secretary, in collaboration with members of the working group described in subsection (b) of this section, and professional organizations and societies, shall—

"(1) develop and implement educational programs to instruct public health officials, medical professionals, and other personnel working in health care facilities in the recognition and care of victims of a bioterrorist attack; and

"(2) develop and implement programs to train laboratory personnel in the recognition and identification of a potential bioweapon."

Pub. L. 107–188, §104(a)(2), redesignated subsec. (e) as (g). Former subsec. (g) redesignated (i).

Subsec. (h). Pub. L. 107–188, §125, amended heading and text of subsec. (h) generally. Prior to amendment, text read as follows: "The Secretary shall consult with the working group described in subsection (a) of this section, to develop priorities for and conduct research, investigations, experiments, demonstrations, and studies in the health sciences related to—

"(1) the epidemiology and pathogenesis of potential bioweapons;

"(2) the development of new vaccines or other therapeutics against pathogens likely to be used in a bioterrorist attack;

"(3) the development of medical diagnostics to detect potential bioweapons; and

"(4) other relevant research areas."

Pub. L. 107–188, §104(a)(2), redesignated subsec. (f) as (h). Former subsec. (h) redesignated (j).

Subsec. (i). Pub. L. 107–188, §104(a)(1), (2), redesignated subsec. (g) as (i) and struck out heading and text of former subsec. (i). Text read as follows: "There are authorized to be appropriated to carry out this section $215,000,000 for fiscal year 2001, and such sums as may be necessary for each subsequent fiscal year through 2006."

Subsec. (j). Pub. L. 107–188, §104(a)(2), redesignated subsec. (h) as (j).

Other Reports

Pub. L. 107–188, title I, §101(b)(1), June 12, 2002, 116 Stat. 598, provided that:

"(1) In general.—Not later than one year after the date of the enactment of this Act [June 12, 2002], the Secretary of Health and Human Services (referred to in this subsection as the 'Secretary') shall submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report concerning—

"(A) the recommendations and findings of the National Advisory Committee on Children and Terrorism under section 319F(c)(2) of the Public Health Service Act [probably means section 319F(b)(2), 42 U.S.C. 247d–6(b)(2)];

"(B) the recommendations and findings of the EPIC Advisory Committee under section 319F(c)(3) of such Act [probably means section 319F(b)(3), 42 U.S.C. 247d–6(b)(3)];

"(C) the characteristics that may render a rural community uniquely vulnerable to a biological attack, including distance, lack of emergency transport, hospital or laboratory capacity, lack of integration of Federal or State public health networks, workforce deficits, or other relevant characteristics;

"(D) the characteristics that may render areas or populations designated as medically underserved populations (as defined in section 330 of such Act [42 U.S.C. 254b]) uniquely vulnerable to a biological attack, including significant numbers of low-income or uninsured individuals, lack of affordable and accessible health care services, insufficient public and primary health care resources, lack of integration of Federal or State public health networks, workforce deficits, or other relevant characteristics;

"(E) the recommendations of the Secretary with respect to additional legislative authority that the Secretary determines is necessary to effectively strengthen rural communities, or medically underserved populations (as defined in section 330 of such Act); and

"(F) the need for and benefits of a National Disaster Response Medical Volunteer Service that would be a private-sector, community-based rapid response corps of medical volunteers."

Study Regarding Communications Abilities of Public Health Agencies

Pub. L. 107–188, title I, §104(b), June 12, 2002, 116 Stat. 606, provided that: "The Secretary of Health and Human Services, in consultation with the Federal Communications Commission, the National Telecommunications and Information Administration, and other appropriate Federal agencies, shall conduct a study to determine whether local public health entities have the ability to maintain communications in the event of a bioterrorist attack or other public health emergency. The study shall examine whether redundancies are required in the telecommunications system, particularly with respect to mobile communications, for public health entities to maintain systems operability and connectivity during such emergencies. The study shall also include recommendations to industry and public health entities about how to implement such redundancies if necessary."

§247d–6a. Authority for use of certain procedures regarding qualified countermeasure research and development activities

(a) In general

(1) Authority

In conducting and supporting research and development activities regarding countermeasures under section 247d–6(e) of this title, the Secretary may conduct and support such activities in accordance with this section and, in consultation with the Director of the National Institutes of Health, as part of the program under section 285f of this title, if the activities concern qualified countermeasures.

(2) Definitions

In this section:

(A) Qualified countermeasure

The term "qualified countermeasure" means a drug (as that term is defined by section 321(g)(1) of title 21), biological product (as that term is defined by section 262(i) of this title), or device (as that term is defined by section 321(h) of title 21), that the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6)—

(i) to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security;

(ii) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device that is used as described in this subparagraph; or

(iii) is a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii).

(B) Infectious disease

The term "infectious disease" means a disease potentially caused by a pathogenic organism (including a bacteria, virus, fungus, or parasite) that is acquired by a person and that reproduces in that person.

(3) Interagency cooperation

(A) In general

In carrying out activities under this section, the Secretary is authorized, subject to subparagraph (B), to enter into interagency agreements and other collaborative undertakings with other agencies of the United States Government.

(B) Limitation

An agreement or undertaking under this paragraph shall not authorize another agency to exercise the authorities provided by this section.

(4) Availability of facilities to the Secretary

In any grant, contract, or cooperative agreement entered into under the authority provided in this section with respect to a biocontainment laboratory or other related or ancillary specialized research facility that the Secretary determines necessary for the purpose of performing, administering, or supporting qualified countermeasure research and development, the Secretary may provide that the facility that is the object of such grant, contract, or cooperative agreement shall be available as needed to the Secretary to respond to public health emergencies affecting national security.

(5) Transfers of qualified countermeasures

Each agreement for an award of a grant, contract, or cooperative agreement under section 247d–6(e) of this title for the development of a qualified countermeasure shall provide that the recipient of the award will comply with all applicable export-related controls with respect to such countermeasure.

(b) Expedited procurement authority

(1) Increased simplified acquisition threshold for qualified countermeasure procurements

(A) In general

For any procurement by the Secretary of property or services for use (as determined by the Secretary) in performing, administering, or supporting qualified countermeasure research or development activities under this section that the Secretary determines necessary to respond to pressing research and development needs under this section, the amount specified in section 134 of title 41, as applicable pursuant to section 3101(b)(1)(A) of title 41, shall be deemed to be $25,000,000 in the administration, with respect to such procurement, of—

(i) section 3305(a)(1) of title 41 and its implementing regulations; and

(ii) section 3101(b)(1)(B) of title 41 and its implementing regulations.

(B) Application of certain provisions

Notwithstanding subparagraph (A) and the provision of law and regulations referred to in such subparagraph, each of the following provisions shall apply to procurements described in this paragraph to the same extent that such provisions would apply to such procurements in the absence of subparagraph (A):

(i) Chapter 37 of title 40 (relating to contract work hours and safety standards).

(ii) Section 8703(a) of title 41.

(iii) Section 4706 of title 41 (relating to the examination of contractor records).

(iv) Section 3131 of title 40 (relating to bonds of contractors of public buildings or works).

(v) Section 3901 of title 41 (relating to contingent fees to middlemen).

(vi) Section 6962 of this title.

(vii) Section 1354 of title 31 (relating to the limitation on the use of appropriated funds for contracts with entities not meeting veterans employment reporting requirements).

(C) Internal controls to be instituted

The Secretary shall institute appropriate internal controls for procurements that are under this paragraph, including requirements with regard to documenting the justification for use of the authority in this paragraph with respect to the procurement involved.

(D) Authority to limit competition

In conducting a procurement under this paragraph, the Secretary may not use the authority provided for under subparagraph (A) to conduct a procurement on a basis other than full and open competition unless the Secretary determines that the mission of the BioShield Program under the Project BioShield Act of 2004 would be seriously impaired without such a limitation.

(2) Procedures other than full and open competition

(A) In general

In using the authority provided in section 3304(a)(1) of title 41 to use procedures other than competitive procedures in the case of a procurement described in paragraph (1) of this subsection, the phrase "available from only one responsible source" in such section 3304(a)(1) shall be deemed to mean "available from only one responsible source or only from a limited number of responsible sources".

(B) Relation to other authorities

The authority under subparagraph (A) is in addition to any other authority to use procedures other than competitive procedures.

(C) Applicable government-wide regulations

The Secretary shall implement this paragraph in accordance with government-wide regulations implementing such section 3304(a)(1) (including requirements that offers be solicited from as many potential sources as is practicable under the circumstances, that required notices be published, and that submitted offers be considered), as such regulations apply to procurements for which an agency has authority to use procedures other than competitive procedures when the property or services needed by the agency are available from only one responsible source or only from a limited number of responsible sources and no other type of property or services will satisfy the needs of the agency.

(3) Increased micropurchase threshold

(A) In general

For a procurement described by paragraph (1), the amount specified in subsections (a), (d), and (e) of section 1902 of title 41 shall be deemed to be $15,000 in the administration of that section with respect to such procurement.

(B) Internal controls to be instituted

The Secretary shall institute appropriate internal controls for purchases that are under this paragraph and that are greater than $2,500.

(C) Exception to preference for purchase card mechanism

No provision of law establishing a preference for using a Government purchase card method for purchases shall apply to purchases that are under this paragraph and that are greater than $2,500.

(4) Review

(A) Review allowed

Notwithstanding subsection (f), section 1491 of title 28, and section 3556 of title 31, review of a contracting agency decision relating to a procurement described in paragraph (1) may be had only by filing a protest—

(i) with a contracting agency; or

(ii) with the Comptroller General under subchapter V of chapter 35 of title 31.

(B) Override of stay of contract award or performance committed to agency discretion

Notwithstanding section 1491 of title 28 and section 3553 of title 31, the following authorizations by the head of a procuring activity are committed to agency discretion:

(i) An authorization under section 3553(c)(2) of title 31 to award a contract for a procurement described in paragraph (1) of this subsection.

(ii) An authorization under section 3553(d)(3)(C) of such title to perform a contract for a procurement described in paragraph (1) of this subsection.

(c) Authority to expedite peer review

(1) In general

The Secretary may, as the Secretary determines necessary to respond to pressing qualified countermeasure research and development needs under this section, employ such expedited peer review procedures (including consultation with appropriate scientific experts) as the Secretary, in consultation with the Director of NIH, deems appropriate to obtain assessment of scientific and technical merit and likely contribution to the field of qualified countermeasure research, in place of the peer review and advisory council review procedures that would be required under sections 241(a)(3), 284(b)(1)(B), 284(b)(2), 284a(a)(3)(A), 289a, and 289c of this title, as applicable to a grant, contract, or cooperative agreement—

(A) that is for performing, administering, or supporting qualified countermeasure research and development activities; and

(B) the amount of which is not greater than $1,500,000.

(2) Subsequent phases of research

The Secretary's determination of whether to employ expedited peer review with respect to any subsequent phases of a research grant, contract, or cooperative agreement under this section shall be determined without regard to the peer review procedures used for any prior peer review of that same grant, contract, or cooperative agreement. Nothing in the preceding sentence may be construed to impose any requirement with respect to peer review not otherwise required under any other law or regulation.

(d) Authority for personal services contracts

(1) In general

For the purpose of performing, administering, or supporting qualified countermeasure research and development activities, the Secretary may, as the Secretary determines necessary to respond to pressing qualified countermeasure research and development needs under this section, obtain by contract (in accordance with section 3109 of title 5, but without regard to the limitations in such section on the period of service and on pay) the personal services of experts or consultants who have scientific or other professional qualifications, except that in no case shall the compensation provided to any such expert or consultant exceed the daily equivalent of the annual rate of compensation for the President.

(2) Federal Tort Claims Act coverage

(A) In general

A person carrying out a contract under paragraph (1), and an officer, employee, or governing board member of such person, shall, subject to a determination by the Secretary, be deemed to be an employee of the Department of Health and Human Services for purposes of claims under sections 1346(b) and 2672 of title 28 for money damages for personal injury, including death, resulting from performance of functions under such contract.

(B) Exclusivity of remedy

The remedy provided by subparagraph (A) shall be exclusive of any other civil action or proceeding by reason of the same subject matter against the entity involved (person, officer, employee, or governing board member) for any act or omission within the scope of the Federal Tort Claims Act.

(C) Recourse in case of gross misconduct or contract violation

(i) In general

Should payment be made by the United States to any claimant bringing a claim under this paragraph, either by way of administrative determination, settlement, or court judgment, the United States shall have, notwithstanding any provision of State law, the right to recover against any entity identified in subparagraph (B) for that portion of the damages so awarded or paid, as well as interest and any costs of litigation, resulting from the failure of any such entity to carry out any obligation or responsibility assumed by such entity under a contract with the United States or from any grossly negligent or reckless conduct or intentional or willful misconduct on the part of such entity.

(ii) Venue

The United States may maintain an action under this subparagraph against such entity in the district court of the United States in which such entity resides or has its principal place of business.

(3) Internal controls to be instituted

(A) In general

The Secretary shall institute appropriate internal controls for contracts under this subsection, including procedures for the Secretary to make a determination of whether a person, or an officer, employee, or governing board member of a person, is deemed to be an employee of the Department of Health and Human Services pursuant to paragraph (2).

(B) Determination of employee status to be final

A determination by the Secretary under subparagraph (A) that a person, or an officer, employee, or governing board member of a person, is or is not deemed to be an employee of the Department of Health and Human Services shall be final and binding on the Secretary and the Attorney General and other parties to any civil action or proceeding.

(4) Number of personal services contracts limited

The number of experts and consultants whose personal services are obtained under paragraph (1) shall not exceed 30 at any time.

(e) Streamlined personnel authority

(1) In general

In addition to any other personnel authorities, the Secretary may, as the Secretary determines necessary to respond to pressing qualified countermeasure research and development needs under this section, without regard to those provisions of title 5 governing appointments in the competitive service, and without regard to the provisions of chapter 51 and subchapter III of