[USC04] 42 USC CHAPTER 6A, SUBCHAPTER III: NATIONAL RESEARCH INSTITUTES
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42 USC CHAPTER 6A, SUBCHAPTER III: NATIONAL RESEARCH INSTITUTES
From Title 42—THE PUBLIC HEALTH AND WELFARECHAPTER 6A—PUBLIC HEALTH SERVICE

SUBCHAPTER III—NATIONAL RESEARCH INSTITUTES

Codification

Title IV of the Public Health Service Act, comprising this subchapter, was originally enacted by act July 1, 1944, ch. 373, 58 Stat. 707, at which time title IV related solely to the National Cancer Institute. Because of the extensive amendments, reorganization of the subject matter, and expansion of title IV by the acts listed below, title IV is shown herein as having been added by Pub. L. 99–158, without reference to intervening amendments.

The provisions of title IV as originally enacted were subsequently redesignated as part A of title IV and amended, and parts B to I of title IV were added and amended by the following acts: June 16, 1948, ch. 481, 62 Stat. 464; June 24, 1948, ch. 621, 62 Stat. 598; Aug. 15, 1950, ch. 714, 64 Stat. 443; Oct. 5, 1961, Pub. L. 87–395, 75 Stat. 824; Oct. 17, 1962, Pub. L. 87–838, 76 Stat. 1072; Aug. 16, 1968, Pub. L. 90–489, 82 Stat. 771; Oct. 30, 1970, Pub. L. 91–515, 84 Stat. 1297; Dec. 23, 1971, Pub. L. 92–218, 85 Stat. 778; May 19, 1972, Pub. L. 92–305, 86 Stat. 162; Sept. 19, 1972, Pub. L. 92–423, 86 Stat. 679; Apr. 22, 1974, Pub. L. 93–270, 88 Stat. 90; May 14, 1974, Pub. L. 93–282, 88 Stat. 126; May 31, 1974, Pub. L. 93–296, 88 Stat. 184; July 12, 1974, Pub. L. 93–348, 88 Stat. 342; July 23, 1974, Pub. L. 93–352, 88 Stat. 358; July 23, 1974, Pub. L. 93–354, 88 Stat. 373; Jan. 4, 1975, Pub. L. 93–640, 88 Stat. 2217; July 29, 1975, Pub. L. 94–63, 89 Stat. 304; Nov. 28, 1975, Pub. L. 94–135, 89 Stat. 713; Apr. 21, 1976, Pub. L. 94–273, 90 Stat. 375; Apr. 22, 1976, Pub. L. 94–278, 90 Stat. 401; Oct. 19, 1976, Pub. L. 94–562, 90 Stat. 2645; Aug. 1, 1977, Pub. L. 95–83, 91 Stat. 383; Nov. 9, 1978, Pub. L. 95–622, 92 Stat. 3412; Nov. 9, 1978, Pub. L. 95–623, 92 Stat. 3443; July 10, 1979, Pub. L. 96–32, 93 Stat. 82; Oct. 7, 1980, Pub. L. 96–398, 94 Stat. 1564; Dec. 17, 1980, Pub. L. 96–538, 94 Stat. 3183; Aug. 13, 1981, Pub. L. 97–35, 95 Stat. 358; Apr. 26, 1984, Pub. L. 98–24, 97 Stat. 175.

Title IV was subsequently amended generally and completely reorganized by Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 822.

Part A—National Institutes of Health

§281. Organization of National Institutes of Health

(a) Relation to Public Health Service

The National Institutes of Health is an agency of the Service.

(b) National research institutes and national centers

The following agencies of the National Institutes of Health are national research institutes or national centers:

(1) The National Cancer Institute.

(2) The National Heart, Lung, and Blood Institute.

(3) The National Institute of Diabetes and Digestive and Kidney Diseases.

(4) The National Institute of Arthritis and Musculoskeletal and Skin Diseases.

(5) The National Institute on Aging.

(6) The National Institute of Allergy and Infectious Diseases.

(7) The Eunice Kennedy Shriver National Institute of Child Health and Human Development.

(8) The National Institute of Dental and Craniofacial Research.

(9) The National Eye Institute.

(10) The National Institute of Neurological Disorders and Stroke.

(11) The National Institute on Deafness and Other Communication Disorders.

(12) The National Institute on Alcohol Abuse and Alcoholism.

(13) The National Institute on Drug Abuse.

(14) The National Institute of Mental Health.

(15) The National Institute of General Medical Sciences.

(16) The National Institute of Environmental Health Sciences.

(17) The National Institute of Nursing Research.

(18) The National Institute of Biomedical Imaging and Bioengineering.

(19) The National Human Genome Research Institute.

(20) The National Library of Medicine.

(21) The National Center for Advancing Translational Sciences.

(22) The John E. Fogarty International Center for Advanced Study in the Health Sciences.

(23) The National Center for Complementary and Integrative Health.

(24) The National Institute on Minority Health and Health Disparities.

(25) Any other national center that, as an agency separate from any national research institute, was established within the National Institutes of Health as of the day before January 15, 2007.

(c) Division of Program Coordination, Planning, and Strategic Initiatives

(1) In general

Within the Office of the Director of the National Institutes of Health, there shall be a Division of Program Coordination, Planning, and Strategic Initiatives (referred to in this subsection as the "Division").

(2) Offices within Division

(A) Offices

The following offices are within the Division: The Office of AIDS Research, the Office of Research on Women's Health, the Office of Behavioral and Social Sciences Research, the Office of Disease Prevention, the Office of Dietary Supplements, and any other office located within the Office of the Director of NIH as of the day before January 15, 2007. In addition to such offices, the Director of NIH may establish within the Division such additional offices or other administrative units as the Director determines to be appropriate.

(B) Authorities

Each office in the Division—

(i) shall continue to carry out the authorities that were in effect for the office before January 15, 2007; and

(ii) shall, as determined appropriate by the Director of NIH, support the Division with respect to the authorities described in section 282(b)(7) of this title.

(d) Organization

(1) Number of institutes and centers

In the National Institutes of Health, the number of national research institutes and national centers may not exceed a total of 27, including any such institutes or centers established under authority of paragraph (2) or under authority of this subchapter as in effect on the day before January 15, 2007.

(2) Reorganization of institutes

(A) In general

The Secretary may establish in the National Institutes of Health one or more additional national research institutes to conduct and support research, training, health information, and other programs with respect to any particular disease or groups of diseases or any other aspect of human health if—

(i) the Secretary determines that an additional institute is necessary to carry out such activities; and

(ii) the additional institute is not established before the expiration of 180 days after the Secretary has provided the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate written notice of the determination made under clause (i) with respect to the institute.

(B) Additional authority

The Secretary may reorganize the functions of any national research institute and may abolish any national research institute if the Secretary determines that the institute is no longer required. A reorganization or abolition may not take effect under this paragraph before the expiration of 180 days after the Secretary has provided the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate written notice of the reorganization or abolition.

(3) Reorganization of Office of Director

Notwithstanding subsection (c), the Director of NIH may, after a series of public hearings, and with the approval of the Secretary, reorganize the offices within the Office of the Director, including the addition, removal, or transfer of functions of such offices, and the establishment or termination of such offices, if the Director determines that the overall management and operation of programs and activities conducted or supported by such offices would be more efficiently carried out under such a reorganization.

(4) Internal reorganization of institutes and centers

Notwithstanding any conflicting provisions of this subchapter, the director of a national research institute or a national center may, after a series of public hearings and with the approval of the Director of NIH, reorganize the divisions, centers, or other administrative units within such institute or center, including the addition, removal, or transfer of functions of such units, and the establishment or termination of such units, if the director of such institute or center determines that the overall management and operation of programs and activities conducted or supported by such divisions, centers, or other units would be more efficiently carried out under such a reorganization.

(e) Scientific Management Review Board for periodic organizational reviews

(1) In general

Not later than 60 days after January 15, 2007, the Secretary shall establish an advisory council within the National Institutes of Health to be known as the Scientific Management Review Board (referred to in this subsection as the "Board").

(2) Duties

(A) Reports on organizational issues

The Board shall provide advice to the appropriate officials under subsection (d) regarding the use of the authorities established in paragraphs (2), (3), and (4) of such subsection to reorganize the National Institutes of Health (referred to in this subsection as "organizational authorities"). Not less frequently than once each 7 years, the Board shall—

(i) determine whether and to what extent the organizational authorities should be used; and

(ii) issue a report providing the recommendations of the Board regarding the use of the authorities and the reasons underlying the recommendations.

(B) Certain responsibilities regarding reports

The activities of the Board with respect to a report under subparagraph (A) shall include the following:

(i) Reviewing the research portfolio of the National Institutes of Health (referred to in this subsection as "NIH") in order to determine the progress and effectiveness and value of the portfolio and the allocation among the portfolio activities of the resources of NIH.

(ii) Determining pending scientific opportunities, and public health needs, with respect to research within the jurisdiction of NIH.

(iii) For any proposal for organizational changes to which the Board gives significant consideration as a possible recommendation in such report—

(I) analyzing the budgetary and operational consequences of the proposed changes;

(II) taking into account historical funding and support for research activities at national research institutes and centers that have been established recently relative to national research institutes and centers that have been in existence for more than two decades;

(III) estimating the level of resources needed to implement the proposed changes;

(IV) assuming the proposed changes will be made and making a recommendation for the allocation of the resources of NIH among the national research institutes and national centers; and

(V) analyzing the consequences for the progress of research in the areas affected by the proposed changes.

(C) Consultation

In carrying out subparagraph (A), the Board shall consult with—

(i) the heads of national research institutes and national centers whose directors are not members of the Board;

(ii) other scientific leaders who are officers or employees of NIH and are not members of the Board;

(iii) advisory councils of the national research institutes and national centers;

(iv) organizations representing the scientific community; and

(v) organizations representing patients.

(3) Composition of Board

The Board shall consist of the Director of NIH, who shall be a permanent nonvoting member on an ex officio basis, and an odd number of additional members, not to exceed 21, all of whom shall be voting members. The voting members of the Board shall be the following:

(A) Not fewer than 9 officials who are directors of national research institutes or national centers. The Secretary shall designate such officials for membership and shall ensure that the group of officials so designated includes directors of—

(i) national research institutes whose budgets are substantial relative to a majority of the other institutes;

(ii) national research institutes whose budgets are small relative to a majority of the other institutes;

(iii) national research institutes that have been in existence for a substantial period of time without significant organizational change under subsection (d);

(iv) as applicable, national research institutes that have undergone significant organization changes under such subsection, or that have been established under such subsection, other than national research institutes for which such changes have been in place for a substantial period of time; and

(v) national centers.


(B) Members appointed by the Secretary from among individuals who are not officers or employees of the United States. Such members shall include—

(i) individuals representing the interests of public or private institutions of higher education that have historically received funds from NIH to conduct research; and

(ii) individuals representing the interests of private entities that have received funds from NIH to conduct research or that have broad expertise regarding how the National Institutes of Health functions, exclusive of private entities to which clause (i) applies.

(4) Chair

The Chair of the Board shall be selected by the Secretary from among the members of the Board appointed under paragraph (3)(B). The term of office of the Chair shall be 2 years.

(5) Meetings

(A) In general

The Board shall meet at the call of the Chair or upon the request of the Director of NIH, but not fewer than 5 times with respect to issuing any particular report under paragraph (2)(A). The location of the meetings of the Board is subject to the approval of the Director of NIH.

(B) Particular forums

Of the meetings held under subparagraph (A) with respect to a report under paragraph (2)(A)—

(i) one or more shall be directed toward the scientific community to address scientific needs and opportunities related to proposals for organizational changes under subsection (d), or as the case may be, related to a proposal that no such changes be made; and

(ii) one or more shall be directed toward consumer organizations to address the needs and opportunities of patients and their families with respect to proposals referred to in clause (i).

(C) Availability of information from forums

For each meeting under subparagraph (B), the Director of NIH shall post on the Internet site of the National Institutes of Health a summary of the proceedings.

(6) Compensation; term of office

The provisions of subsections (b)(4) and (c) of section 284a of this title apply with respect to the Board to the same extent and in the same manner as such provisions apply with respect to an advisory council referred to in such subsections, except that the reference in such subsection (c) to 4 years regarding the term of an appointed member is deemed to be a reference to 5 years.

(7) Reports

(A) Recommendations for changes

Each report under paragraph (2)(A) shall be submitted to—

(i) the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives;

(ii) the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate;

(iii) the Secretary; and

(iv) officials with organizational authorities, other than any such official who served as a member of the Board with respect to the report involved.

(B) Availability to public

The Director of NIH shall post each report under paragraph (2) on the Internet site of the National Institutes of Health.

(C) Report on Board activities

Not later than 18 months after January 15, 2007, the Board shall submit to the committees specified in subparagraph (A) a report describing the activities of the Board.

(f) Organizational changes per recommendation of Scientific Management Review Board

(1) In general

With respect to an official who has organizational authorities within the meaning of subsection (e)(2)(A), if a recommendation to the official for an organizational change is made in a report under such subsection, the official shall, except as provided in paragraphs (2), (3), and (4) of this subsection, make the change in accordance with the following:

(A) Not later than 100 days after the report is submitted under subsection (e)(7)(A), the official shall initiate the applicable public process required in subsection (d) toward making the change.

(B) The change shall be fully implemented not later than the expiration of the 3-year period beginning on the date on which such process is initiated.

(2) Inapplicability to certain reorganizations

Paragraph (1) does not apply to a recommendation made in a report under subsection (e)(2)(A) if the recommendation is for—

(A) an organizational change under subsection (d)(2) that constitutes the establishment, termination, or consolidation of one or more national research institutes or national centers; or

(B) an organizational change under subsection (d)(3).

(3) Objection by Director of NIH

(A) In general

Paragraph (1) does not apply to a recommendation for an organizational change made in a report under subsection (e)(2)(A) if, not later than 90 days after the report is submitted under subsection (e)(7)(A), the Director of NIH submits to the committees specified in such subsection a report providing that the Director objects to the change, which report includes the reasons underlying the objection.

(B) Scope of objection

For purposes of subparagraph (A), an objection by the Director of NIH may be made to the entirety of a recommended organizational change or to 1 or more aspects of the change. Any aspect of a change not objected to by the Director in a report under subparagraph (A) shall be implemented in accordance with paragraph (1).

(4) Congressional review

An organizational change under subsection (d)(2) that is initiated pursuant to paragraph (1) shall be carried out by regulation in accordance with the procedures for substantive rules under section 553 of title 5. A rule under the preceding sentence shall be considered a major rule for purposes of chapter 8 of such title (relating to congressional review of agency rulemaking).

(g) Definitions

For purposes of this subchapter:

(1) The term "Director of NIH" means the Director of the National Institutes of Health.

(2) The terms "national research institute" and "national center" mean an agency of the National Institutes of Health that is—

(A) listed in subsection (b) and not terminated under subsection (d)(2)(A); or

(B) established by the Director of NIH under such subsection.

(h) References to NIH

For purposes of this subchapter, a reference to the National Institutes of Health includes its agencies.

(July 1, 1944, ch. 373, title IV, §401, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 822; amended Pub. L. 100–553, §2(1), Oct. 28, 1988, 102 Stat. 2769; Pub. L. 100–607, title I, §101(1), Nov. 4, 1988, 102 Stat. 3048; Pub. L. 100–690, title II, §2613(b)(2), Nov. 18, 1988, 102 Stat. 4238; Pub. L. 102–321, title I, §121(a), July 10, 1992, 106 Stat. 358; Pub. L. 103–43, title XV, §§1501(1), 1511(b)(1), 1521(1), June 10, 1993, 107 Stat. 172, 179, 180; Pub. L. 103–417, §13(b), Oct. 25, 1994, 108 Stat. 4335; Pub. L. 105–277, div. A, §101(f) [title II, §212, title VI, §601(k)], Oct. 21, 1998, 112 Stat. 2681–337, 2681-359, 2681-388; Pub. L. 106–525, title I, §101(b)(1), Nov. 22, 2000, 114 Stat. 2501; Pub. L. 106–580, §3(e), Dec. 29, 2000, 114 Stat. 3091; Pub. L. 109–482, title I, §§101(a), (b), 108(a), Jan. 15, 2007, 120 Stat. 3675, 3676, 3697; Pub. L. 110–154, §1(b)(1), Dec. 21, 2007, 121 Stat. 1827; Pub. L. 111–148, title X, §10334(c)(3)(A), Mar. 23, 2010, 124 Stat. 974; Pub. L. 112–74, div. F, title II, §221(a)(2), (c)(2)(B), Dec. 23, 2011, 125 Stat. 1087, 1089; Pub. L. 113–235, div. G, title II, §224(1), Dec. 16, 2014, 128 Stat. 2490.)

Amendments

2014—Subsec. (b)(23). Pub. L. 113–235 substituted "National Center for Complementary and Integrative Health" for "National Center for Complementary and Alternative Medicine".

2011—Subsec. (b)(21). Pub. L. 112–74, §221(a)(2), substituted "National Center for Advancing Translational Sciences" for "National Center for Research Resources".

Subsec. (c)(2)(A). Pub. L. 112–74, §221(c)(2)(B), struck out "the Office of Rare Diseases," after "the Office of Dietary Supplements,".

2010—Subsec. (b)(24). Pub. L. 111–148 substituted "Institute" for "Center".

2007—Subsec. (b)(7). Pub. L. 110–154 substituted "Eunice Kennedy Shriver National Institute of Child Health and Human Development" for "National Institute of Child Health and Human Development".

Pub. L. 109–482, §101(a), reenacted section catchline without change and amended text generally, substituting provisions consisting of subsecs. (a) to (d)(1) for former subsecs. (a) to (d) which related to: in subsec. (a), relationship to Public Health Service; in subsec. (b), list of national research institutes that were agencies; in subsec. (c), establishment of additional institutes and reorganization or abolition of institutes; and, in subsec. (d), definition of "national research institute". See below.

Subsec. (d)(2). Pub. L. 109–482, §108(a), added after subsec. (d)(1) provisions identical to text of subsec. (c) prior to amendment by Pub. L. 109–482, §101(a), redesignated such provisions as par. (2), added par. heading, redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, added subpar. headings, in subpar. (A), redesignated former subpars. (A) and (B) as cls. (i) and (ii), respectively, in cl. (ii), substituted "Health, Education, Labor, and Pensions" for "Labor and Human Resources" and "clause (i)" for "subparagraph (A)", and, in subpar. (B), substituted "Health, Education, Labor, and Pensions" for "Labor and Human Resources".

Subsec. (d)(3), (4). Pub. L. 109–482, §101(b)(1), added pars. (3) and (4).

Subsecs. (e) to (h). Pub. L. 109–482, §101(b)(2), added subsecs. (e) to (h).

2000—Subsec. (b)(1)(R). Pub. L. 106–580 added subpar. (R).

Subsec. (b)(2)(F). Pub. L. 106–525, §101(b)(1)(A), realigned margins.

Subsec. (b)(2)(G). Pub. L. 106–525, §101(b)(1)(B), added subpar. (G).

1998—Subsec. (b)(1)(H). Pub. L. 105–277, §101(f) [title II, §212], substituted "National Institute of Dental and Craniofacial Research" for "National Institute of Dental Research".

Subsec. (b)(2)(F). Pub. L. 105–277, §101(f) [title VI, §601(k)], added subpar. (F).

1994—Subsec. (b)(2)(E). Pub. L. 103–417 added subpar. (E).

1993—Subsec. (b)(1)(Q). Pub. L. 103–43, §1511(b)(1)(A), added subpar. (Q).

Subsec. (b)(2)(B). Pub. L. 103–43, §1501(1), amended subpar. (B) generally, substituting "National Center for Research Resources" for "Division of Research Resources".

Subsec. (b)(2)(D). Pub. L. 103–43, §§1511(b)(1)(B), 1521(1), added subpar. (D) and struck out former subpar. (D) which read as follows: "The National Center for Nursing Research."

1992—Subsec. (b)(1)(N) to (P). Pub. L. 102–321 added subpars. (N) to (P).

1988—Subsec. (b)(1)(J), (M). Pub. L. 100–553 and Pub. L. 100–607 made identical amendments, striking out "and Communicative" after "Neurological" in subpar. (J), and adding subpar. (M). Pub. L. 100–690 amended subsec. (b)(1) to read as if the amendments by Pub. L. 100–607 had not been enacted.

Effective Date of 2007 Amendment

Pub. L. 109–482, title I, §109, Jan. 15, 2007, 120 Stat. 3697, provided that: "This title [see Tables for classification] and the amendments made by this title apply only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years."

Effective Date of 2000 Amendment

Pub. L. 106–525, title VI, §603, Nov. 22, 2000, 114 Stat. 2511, provided that: "This Act [enacting subpart 6 (§287c–31 et seq.) of part E of this subchapter and sections 293e, 296e–1, and 299a–1 of this title, amending sections 281, 296f, 299a, 299c–6, and 300u–6 of this title, repealing section 283b of this title, and enacting provisions set out as notes under sections 201, 287c–31, 293e, and 3501 of this title] and the amendments made by this Act take effect October 1, 2000, or upon the date of the enactment of this Act [Nov. 22, 2000], whichever occurs later."

Effective Date of 1992 Amendment

Amendment by Pub. L. 102–321 effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as a note under section 236 of this title.

Effective Date of 1988 Amendment

For effective date of amendment by Pub. L. 100–690, see section 2613(b)(1) of Pub. L. 100–690, set out as an Effect of Enactment of Similar Provisions note under section 285m of this title.

Construction of 2007 Amendment

Pub. L. 109–482, title I, §102(g), Jan. 15, 2007, 120 Stat. 3685, provided that: "This Act [see Tables for classification] and the amendments made by this Act may not be construed as affecting the authorities of the national research institutes and national centers that were in effect under the Public Health Service Act [42 U.S.C. 201 et seq.] on the day before the date of the enactment of this Act [Jan. 15, 2007], subject to the authorities of the Secretary of Health and Human Services and the Director of NIH under section 401 of the Public Health Service Act [42 U.S.C. 281] (as amended by section 101 of this Act). For purposes of the preceding sentence, the terms 'national research institute', 'national center', and 'Director of NIH' have the meanings given such terms in such section 401."

Study of the Use of Centers of Excellence at the National Institutes of Health

Pub. L. 107–84, §7, Dec. 18, 2001, 115 Stat. 829, required the Secretary of Health and Human Services to contract, not later than 60 days after Dec. 18, 2001, with the Institute of Medicine to conduct a study on the impact of, need for, and other issues associated with Centers of Excellence at the National Institutes of Health and complete the study and submit a report not later than one year after the date of the contract.

Report on Medical Uses of Biological Agents in Development of Defenses Against Biological Warfare

Pub. L. 103–43, title XIX, §1904, June 10, 1993, 107 Stat. 203, directed Secretary of Health and Human Services, in consultation with Secretary of Defense and with heads of other appropriate executive agencies, to report to Congress, not later than 12 months after June 10, 1993, on the appropriateness and impact of the National Institutes of Health assuming responsibility for the conduct of all Federal research, development, testing, and evaluation functions relating to medical countermeasures against biowarfare threat agents.

Research on Lupus Erythematosus

Pub. L. 99–158, §5, Nov. 20, 1985, 99 Stat. 880, as amended by Pub. L. 102–531, title III, §312(f), Oct. 27, 1992, 106 Stat. 3506, directed Secretary of Health and Human Resources to establish a Lupus Erythematosus Coordinating Committee to plan, develop, coordinate, and implement comprehensive Federal initiatives in research on Lupus Erythematosus, provided for composition of committee and meetings, and directed Committee to prepare a report for Congress on its activities, to be submitted not later than 18 months after Nov. 20, 1985, with Committee to terminate one month after the report was submitted.

Interagency Committee on Learning Disabilities

Pub. L. 99–158, §9, Nov. 20, 1985, 99 Stat. 882, directed Director of the National Institutes of Health, not later than 90 days after Nov. 20, 1985, to establish an Interagency Committee on Learning Disabilities to review and assess Federal research priorities, activities, and findings regarding learning disabilities (including central nervous system dysfunction in children), provided for composition of the Committee, directed Committee to report to Congress on its activities not later than 18 months after Nov. 20, 1985, and provided that the Committee terminate 90 days after submission of the report.

§282. Director of National Institutes of Health

(a) Appointment

The National Institutes of Health shall be headed by the Director of NIH who shall be appointed by the President by and with the advice and consent of the Senate. The Director of NIH shall perform functions as provided under subsection (b) and as the Secretary may otherwise prescribe.

(b) Duties and authority

In carrying out the purposes of section 241 of this title, the Secretary, acting through the Director of NIH—

(1) shall carry out this subchapter, including being responsible for the overall direction of the National Institutes of Health and for the establishment and implementation of general policies respecting the management and operation of programs and activities within the National Institutes of Health;

(2) shall coordinate and oversee the operation of the national research institutes, national centers, and administrative entities within the National Institutes of Health;

(3) shall, in consultation with the heads of the national research institutes and national centers, be responsible for program coordination across the national research institutes and national centers, including conducting priority-setting reviews, to ensure that the research portfolio of the National Institutes of Health is balanced and free of unnecessary duplication, and takes advantage of collaborative, cross-cutting research;

(4) shall assemble accurate data to be used to assess research priorities, including—

(A) information to better evaluate scientific opportunity, public health burdens, and progress in reducing health disparities; and

(B) data on study populations of clinical research, funded by or conducted at each national research institute and national center, which—

(i) specifies the inclusion of—

(I) women;

(II) members of minority groups;

(III) relevant age categories, including pediatric subgroups; and

(IV) other demographic variables as the Director of the National Institutes of Health determines appropriate;


(ii) is disaggregated by research area, condition, and disease categories; and

(iii) is to be made publicly available on the Internet website of the National Institutes of Health;


(5) shall ensure that scientifically based strategic planning is implemented in support of research priorities as determined by the agencies of the National Institutes of Health, and through the development, implementation, and updating of the strategic plan developed under subsection (m);

(6) shall ensure that the resources of the National Institutes of Health are sufficiently allocated for research projects identified in strategic plans;

(7)(A) shall, through the Division of Program Coordination, Planning, and Strategic Initiatives—

(i) identify research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis and would benefit from conducting or supporting additional research that involves collaboration between 2 or more national research institutes or national centers, or would otherwise benefit from strategic coordination and planning;

(ii) include information on such research in reports under section 283 of this title; and

(iii) in the case of such research supported with funds referred to in subparagraph (B)—

(I) require as appropriate that proposals include milestones and goals for the research;

(II) require that the proposals include timeframes for funding of the research; and

(III) ensure appropriate consideration of proposals for which the principal investigator is an individual who has not previously served as the principal investigator of research conducted or supported by the National Institutes of Health;


(B)(i) may, with respect to funds reserved under section 282a(c)(1) of this title for the Common Fund, allocate such funds to the national research institutes and national centers for conducting and supporting research that is identified under subparagraph (A); and

(ii) shall, with respect to funds appropriated to the Common Fund pursuant to section 282a(a)(2) of this title, allocate such funds to the national research institutes and national centers for making grants for pediatric research that is identified under subparagraph (A); and

(C) may assign additional functions to the Division in support of responsibilities identified in subparagraph (A), as determined appropriate by the Director;

(8) shall, in coordination with the heads of the national research institutes and national centers, ensure that such institutes and centers—

(A) preserve an emphasis on investigator-initiated research project grants, including with respect to research involving collaboration between 2 or more such institutes or centers;

(B) when appropriate, maximize investigator-initiated research project grants in their annual research portfolios;

(C) foster collaboration between clinical research projects funded by the respective national research institutes and national centers that—

(i) conduct research involving human subjects; and

(ii) collect similar data; and


(D) encourage the collaboration described in subparagraph (C) to—

(i) allow for an increase in the number of subjects studied; and

(ii) utilize diverse study populations, with special consideration to biological, social, and other determinants of health that contribute to health disparities;


(9) shall ensure that research conducted or supported by the National Institutes of Health is subject to review in accordance with section 289a of this title and that, after such review, the research is reviewed in accordance with section 289a–1(a)(2) of this title by the appropriate advisory council under section 284a of this title before the research proposals are approved for funding;

(10) shall have authority to review and approve the establishment of all centers of excellence recommended by the national research institutes;

(11)(A) shall oversee research training for all of the national research institutes and National Research Service Awards in accordance with section 288 of this title; and

(B) may conduct and support research training—

(i) for which fellowship support is not provided under section 288 of this title; and

(ii) that does not consist of residency training of physicians or other health professionals;


(12) may, from funds appropriated under section 282a(b) of this title, reserve funds to provide for research on matters that have not received significant funding relative to other matters, to respond to new issues and scientific emergencies, and to act on research opportunities of high priority;

(13) may, subject to appropriations Acts, collect and retain registration fees obtained from third parties to defray expenses for scientific, educational, and research-related conferences;

(14) for the national research institutes and administrative entities within the National Institutes of Health—

(A) may acquire, construct, improve, repair, operate, and maintain, at the site of such institutes and entities, laboratories, and other research facilities, other facilities, equipment, and other real or personal property, and

(B) may acquire, without regard to section 8141 of title 40, by lease or otherwise through the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of Columbia for use for a period not to exceed ten years;


(15) may secure resources for research conducted by or through the National Institutes of Health;

(16) may, without regard to the provisions of title 5 governing appointments in the competitive service, and 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, establish such technical and scientific peer review groups and scientific program advisory committees as are needed to carry out the requirements of this subchapter and appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups;

(17) may secure for the National Institutes of Health consultation services and advice of persons from the United States or abroad;

(18) may use, with their consent, the services, equipment, personnel, information, and facilities of other Federal, State, or local public agencies, with or without reimbursement therefor;

(19) may, for purposes of study, admit and treat at facilities of the National Institutes of Health individuals not otherwise eligible for such treatment;

(20) may accept voluntary and uncompensated services;

(21) may perform such other administrative functions as the Secretary determines are needed to effectively carry out this subchapter;

(22) may appoint physicians, dentists, and other health care professionals, subject to the provisions of title 5 relating to appointments and classifications in the competitive service, and may compensate such professionals subject to the provisions of chapter 74 of title 38;

(23) shall designate a contact point or office to help innovators and physicians identify sources of funding available for pediatric medical device development;

(24) implement the Cures Acceleration Network described in section 287a of this title; and

(25) may require recipients of National Institutes of Health awards to share scientific data, to the extent feasible, generated from such National Institutes of Health awards in a manner that is consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection of—

(A) human research participants, including with respect to privacy, security, informed consent, and protected health information; and

(B) proprietary interests, confidential commercial information, and the intellectual property rights of the funding recipient.


The Federal Advisory Committee Act shall not apply to the duration of a peer review group appointed under paragraph (16). The members of such a group shall be individuals who by virtue of their training or experience are eminently qualified to perform the review functions of such group. Not more than one-fourth of the members of any such group shall be officers or employees of the United States.

(c) Availability of substances and organisms for research

The Director of NIH may make available to individuals and entities, for biomedical and behavioral research, substances and living organisms. Such substances and organisms shall be made available under such terms and conditions (including payment for them) as the Secretary determines appropriate.

(d) Services of experts or consultants; number; payment of expenses, conditions, recovery

(1) The Director of NIH may obtain (in accordance with section 3109 of title 5, but without regard to the limitation in such section on the period of service) the services of not more than 220 experts or consultants, with scientific or other professional qualifications, for the National Institutes of Health.

(2)(A) Except as provided in subparagraph (B), experts and consultants whose services are obtained under paragraph (1) shall be paid or reimbursed, in accordance with title 5, for their travel to and from their place of service and for other expenses associated with their assignment.

(B) Expenses specified in subparagraph (A) shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (1) unless the expert or consultant has agreed in writing to complete the entire period of the assignment or one year of the assignment, whichever is shorter, unless separated or reassigned for reasons which are beyond the control of the expert or consultant and which are acceptable to the Secretary. If the expert or consultant violates the agreement, the money spent by the United States for such expenses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive in whole or in part a right of recovery under this subparagraph.

(e) Dissemination of research information

The Director of NIH shall—

(1) advise the agencies of the National Institutes of Health on medical applications of research;

(2) coordinate, review, and facilitate the systematic identification and evaluation of, clinically relevant information from research conducted by or through the national research institutes;

(3) promote the effective transfer of the information described in paragraph (2) to the health care community and to entities that require such information;

(4) monitor the effectiveness of the activities described in paragraph (3); and

(5) ensure that, after January 1, 1994, all new or revised health education and promotion materials developed or funded by the National Institutes of Health and intended for the general public are in a form that does not exceed a level of functional literacy, as defined in the National Literacy Act of 1991 (Public Law 102–73).

(f) Associate Director for Prevention; functions

There shall be in the National Institutes of Health an Associate Director for Prevention. The Director of NIH shall delegate to the Associate Director for Prevention the functions of the Director relating to the promotion of the disease prevention research programs of the national research institutes and the coordination of such programs among the national research institutes and between the national research institutes and other public and private entities, including elementary, secondary, and post-secondary schools. The Associate Director shall—

(1) annually review the efficacy of existing policies and techniques used by the national research institutes to disseminate the results of disease prevention and behavioral research programs; and

(2) recommend, coordinate, and oversee the modification or reconstruction of such policies and techniques to ensure maximum dissemination, using advanced technologies to the maximum extent practicable, of research results to such entities.

(g) Transferred

(h) Increased participation of women and disadvantaged individuals in biomedical and behavioral research

The Secretary, acting through the Director of NIH and the Directors of the agencies of the National Institutes of Health, shall, in conducting and supporting programs for research, research training, recruitment, and other activities, provide for an increase in the number of women and individuals from disadvantaged backgrounds (including racial and ethnic minorities) in the fields of biomedical and behavioral research.

(i) Data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions

(1)(A) The Secretary, acting through the Director of NIH, shall establish, maintain, and operate a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions (in this subsection referred to as the "data bank"). The activities of the data bank shall be integrated and coordinated with related activities of other agencies of the Department of Health and Human Services, and to the extent practicable, coordinated with other data banks containing similar information.

(B) The Secretary shall establish the data bank after consultation with the Commissioner of Food and Drugs, the directors of the appropriate agencies of the National Institutes of Health (including the National Library of Medicine), and the Director of the Centers for Disease Control and Prevention.

(2) In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the information described in such paragraph. The Secretary shall disseminate such information through information systems, which shall include toll-free telephone communications, available to individuals with serious or life-threatening diseases and conditions, to other members of the public, to health care providers, and to researchers.

(3) The data bank shall include the following:

(A) A registry of clinical trials (whether federally or privately funded) of experimental treatments for serious or life-threatening diseases and conditions under regulations promulgated pursuant to section 355(i) of title 21, which provides a description of the purpose of each experimental drug, either with the consent of the protocol sponsor, or when a trial to test effectiveness begins. Information provided shall consist of eligibility criteria for participation in the clinical trials, a description of the location of trial sites, a point of contact for those wanting to enroll in the trial, and a description of whether, and through what procedure, the manufacturer or sponsor of the investigation of a new drug will respond to requests for protocol exception, with appropriate safeguards, for single-patient and expanded protocol use of the new drug, particularly in children, and shall be in a form that can be readily understood by members of the public. Such information shall be forwarded to the data bank by the sponsor of the trial not later than 21 days after the approval of the protocol.

(B) Information pertaining to experimental treatments for serious or life-threatening diseases and conditions that may be available—

(i) under a treatment investigational new drug application that has been submitted to the Secretary under section 360bbb(c) of title 21; or

(ii) as a Group C cancer drug (as defined by the National Cancer Institute).


The data bank may also include information pertaining to the results of clinical trials of such treatments, with the consent of the sponsor, including information concerning potential toxicities or adverse effects associated with the use or administration of such experimental treatments.


(4) The data bank shall not include information relating to an investigation if the sponsor has provided a detailed certification to the Secretary that disclosure of such information would substantially interfere with the timely enrollment of subjects in the investigation, unless the Secretary, after the receipt of the certification, provides the sponsor with a detailed written determination that such disclosure would not substantially interfere with such enrollment.

(5) Fees collected under section 379h of title 21 shall not be used in carrying out this subsection.

(j) Expanded clinical trial registry data bank

(1) Definitions; requirement

(A) Definitions

In this subsection:

(i) Applicable clinical trial

The term "applicable clinical trial" means an applicable device clinical trial or an applicable drug clinical trial.

(ii) Applicable device clinical trial

The term "applicable device clinical trial" means—

(I) a prospective clinical study of health outcomes comparing an intervention with a device subject to section 360(k), 360e, or 360j(m) of title 21 against a control in human subjects (other than a small clinical trial to determine the feasibility of a device, or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); and

(II) a pediatric postmarket surveillance as required under section 360l of title 21.

(iii) Applicable drug clinical trial

(I) In general

The term "applicable drug clinical trial" means a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to section 355 of title 21 or to section 262 of this title.

(II) Clinical investigation

For purposes of subclause (I), the term "clinical investigation" has the meaning given that term in section 312.3 of title 21, Code of Federal Regulations (or any successor regulation).

(III) Phase I

For purposes of subclause (I), the term "phase I" has the meaning given that term in section 312.21 of title 21, Code of Federal Regulations (or any successor regulation).

(iv) Clinical trial information

The term "clinical trial information" means, with respect to an applicable clinical trial, those data elements that the responsible party is required to submit under paragraph (2) or under paragraph (3).

(v) Completion date

The term "completion date" means, with respect to an applicable clinical trial, the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated.

(vi) Device

The term "device" means a device as defined in section 321(h) of title 21.

(vii) Drug

The term "drug" means a drug as defined in section 321(g) of title 21 or a biological product as defined in section 262 of this title.

(viii) Ongoing

The term "ongoing" means, with respect to a clinical trial of a drug or a device and to a date, that—

(I) 1 or more patients is enrolled in the clinical trial; and

(II) the date is before the completion date of the clinical trial.

(ix) Responsible party

The term "responsible party", with respect to a clinical trial of a drug or device, means—

(I) the sponsor of the clinical trial (as defined in section 50.3 of title 21, Code of Federal Regulations (or any successor regulation)); or

(II) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this subsection for the submission of clinical trial information.

(B) Requirement

The Secretary shall develop a mechanism by which the responsible party for each applicable clinical trial shall submit the identity and contact information of such responsible party to the Secretary at the time of submission of clinical trial information under paragraph (2).

(2) Expansion of clinical trial registry data bank with respect to clinical trial information

(A) In general

(i) Expansion of data bank

To enhance patient enrollment and provide a mechanism to track subsequent progress of clinical trials, the Secretary, acting through the Director of NIH, shall expand, in accordance with this subsection, the clinical trials registry of the data bank described under subsection (i)(1) (referred to in this subsection as the "registry data bank"). The Director of NIH shall ensure that the registry data bank is made publicly available through the Internet.

(ii) Content

The clinical trial information required to be submitted under this paragraph for an applicable clinical trial shall include—

(I) descriptive information, including—

(aa) a brief title, intended for the lay public;

(bb) a brief summary, intended for the lay public;

(cc) the primary purpose;

(dd) the study design;

(ee) for an applicable drug clinical trial, the study phase;

(ff) study type;

(gg) the primary disease or condition being studied, or the focus of the study;

(hh) the intervention name and intervention type;

(ii) the study start date;

(jj) the expected completion date;

(kk) the target number of subjects; and

(ll) outcomes, including primary and secondary outcome measures;


(II) recruitment information, including—

(aa) eligibility criteria;

(bb) gender;

(cc) age limits;

(dd) whether the trial accepts healthy volunteers;

(ee) overall recruitment status;

(ff) individual site status; and

(gg) in the case of an applicable drug clinical trial, if the drug is not approved under section 355 of title 21 or licensed under section 262 of this title, specify whether or not there is expanded access to the drug under section 360bbb of title 21 for those who do not qualify for enrollment in the clinical trial and how to obtain information about such access;


(III) location and contact information, including—

(aa) the name of the sponsor;

(bb) the responsible party, by official title; and

(cc) the facility name and facility contact information (including the city, State, and zip code for each clinical trial location, or a toll-free number through which such location information may be accessed); and


(IV) administrative data (which the Secretary may make publicly available as necessary), including—

(aa) the unique protocol identification number;

(bb) other protocol identification numbers, if any; and

(cc) the Food and Drug Administration IND/IDE protocol number and the record verification date.

(iii) Modifications

The Secretary may by regulation modify the requirements for clinical trial information under this paragraph, if the Secretary provides a rationale for why such a modification improves and does not reduce such clinical trial information.

(B) Format and structure

(i) Searchable categories

The Director of NIH shall ensure that the public may, in addition to keyword searching, search the entries in the registry data bank by 1 or more of the following criteria:

(I) The disease or condition being studied in the clinical trial, using Medical Subject Headers (MeSH) descriptors.

(II) The name of the intervention, including any drug or device being studied in the clinical trial.

(III) The location of the clinical trial.

(IV) The age group studied in the clinical trial, including pediatric subpopulations.

(V) The study phase of the clinical trial.

(VI) The sponsor of the clinical trial, which may be the National Institutes of Health or another Federal agency, a private industry source, or a university or other organization.

(VII) The recruitment status of the clinical trial.

(VIII) The National Clinical Trial number or other study identification for the clinical trial.

(ii) Additional searchable category

Not later than 18 months after September 27, 2007, the Director of NIH shall ensure that the public may search the entries of the registry data bank by the safety issue, if any, being studied in the clinical trial as a primary or secondary outcome.

(iii) Other elements

The Director of NIH shall also ensure that the public may search the entries of the registry data bank by such other elements as the Director deems necessary on an ongoing basis.

(iv) Format

The Director of the NIH shall ensure that the registry data bank is easily used by the public, and that entries are easily compared.

(C) Data submission

The responsible party for an applicable clinical trial, including an applicable drug clinical trial for a serious or life-threatening disease or condition, that is initiated after, or is ongoing on the date that is 90 days after, September 27, 2007, shall submit to the Director of NIH for inclusion in the registry data bank the clinical trial information described in of 1 subparagraph (A)(ii) not later than the later of—

(i) 90 days after September 27, 2007;

(ii) 21 days after the first patient is enrolled in such clinical trial; or

(iii) in the case of a clinical trial that is not for a serious or life-threatening disease or condition and that is ongoing on September 27, 2007, 1 year after September 27, 2007.

(D) Posting of data

(i) Applicable drug clinical trial

The Director of NIH shall ensure that clinical trial information for an applicable drug clinical trial submitted in accordance with this paragraph is posted in the registry data bank not later than 30 days after such submission.

(ii) Applicable device clinical trial

The Director of NIH shall ensure that clinical trial information for an applicable device clinical trial submitted in accordance with this paragraph is posted publicly in the registry data bank—

(I) not earlier than the date of clearance under section 360(k) of title 21, or approval under section 360e or 360j(m) of title 21, as applicable, for a device that was not previously cleared or approved, and not later than 30 days after such date, unless the responsible party affirmatively requests that the Director of the National Institutes of Health publicly post such clinical trial information for an applicable device clinical trial prior to such date of clearance or approval; or

(II) for a device that was previously cleared or approved, not later than 30 days after the clinical trial information under paragraph (3)(C) is required to be posted by the Secretary.

(iii) Option to make certain clinical trial information available earlier

The Director of the National Institutes of Health shall inform responsible parties of the option to request that clinical trial information for an applicable device clinical trial be publicly posted prior to the date of clearance or approval, in accordance with clause (ii)(I).

(iv) Combination products

An applicable clinical trial for a product that is a combination of drug, device, or biological product shall be considered—

(I) an applicable drug clinical trial, if the Secretary determines under section 353(g) of title 21 that the primary mode of action of such product is that of a drug or biological product; or

(II) an applicable device clinical trial, if the Secretary determines under such section that the primary mode of action of such product is that of a device.

(3) Expansion of registry data bank to include results of clinical trials

(A) Linking registry data bank to existing results

(i) In general

Beginning not later than 90 days after September 27, 2007, for those clinical trials that form the primary basis of an efficacy claim or are conducted after the drug involved is approved or after the device involved is cleared or approved, the Secretary shall ensure that the registry data bank includes links to results information as described in clause (ii) for such clinical trial—

(I) not earlier than 30 days after the date of the approval of the drug involved or clearance or approval of the device involved; or

(II) not later than 30 days after the results information described in clause (ii) becomes publicly available.

(ii) Required information

(I) FDA information

The Secretary shall ensure that the registry data bank includes links to the following information:

(aa) If an advisory committee considered at a meeting an applicable clinical trial, any posted Food and Drug Administration summary document regarding such applicable clinical trial.

(bb) If an applicable drug clinical trial was conducted under section 355a or 355c of title 21, a link to the posted Food and Drug Administration assessment of the results of such trial.

(cc) Food and Drug Administration public health advisories regarding the drug or device that is the subject of the applicable clinical trial, if any.

(dd) For an applicable drug clinical trial, the Food and Drug Administration action package for approval document required under section 355(l)(2) of title 21.

(ee) For an applicable device clinical trial, in the case of a premarket application under section 360e of title 21, the detailed summary of information respecting the safety and effectiveness of the device required under section 360j(h)(1) of title 21, or, in the case of a report under section 360(k) of title 21, the section 360(k) summary of the safety and effectiveness data required under section 807.95(d) of title 21, Code of Federal Regulations (or any successor regulation).

(II) NIH information

The Secretary shall ensure that the registry data bank includes links to the following information:

(aa) Medline citations to any publications focused on the results of an applicable clinical trial.

(bb) The entry for the drug that is the subject of an applicable drug clinical trial in the National Library of Medicine database of structured product labels, if available.

(iii) Results for existing data bank entries

The Secretary may include the links described in clause (ii) for data bank entries for clinical trials submitted to the data bank prior to September 27, 2007, as available.

(B) Inclusion of results

The Secretary, acting through the Director of NIH, shall—

(i) expand the registry data bank to include the results of applicable clinical trials (referred to in this subsection as the "registry and results data bank");

(ii) ensure that such results are made publicly available through the Internet;

(iii) post publicly a glossary for the lay public explaining technical terms related to the results of clinical trials; and

(iv) in consultation with experts on risk communication, provide information with the information included under subparagraph (C) in the registry and results data bank to help ensure that such information does not mislead the patients or the public.

(C) Basic results

Not later than 1 year after September 27, 2007, the Secretary shall include in the registry and results data bank for each applicable clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title or a device that is cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21, the following elements:

(i) Demographic and baseline characteristics of patient sample

A table of the demographic and baseline data collected overall and for each arm of the clinical trial to describe the patients who participated in the clinical trial, including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any.

(ii) Primary and secondary outcomes

The primary and secondary outcome measures as submitted under paragraph (2)(A)(ii)(I)(ll), and a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial, including the results of scientifically appropriate tests of the statistical significance of such outcome measures.

(iii) Point of contact

A point of contact for scientific information about the clinical trial results.

(iv) Certain agreements

Whether there exists an agreement (other than an agreement solely to comply with applicable provisions of law protecting the privacy of participants) between the sponsor or its agent and the principal investigator (unless the sponsor is an employer of the principal investigator) that restricts in any manner the ability of the principal investigator, after the completion date of the trial, to discuss the results of the trial at a scientific meeting or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the trial.

(D) Expanded registry and results data bank

(i) Expansion by rulemaking

To provide more complete results information and to enhance patient access to and understanding of the results of clinical trials, not later than 3 years after September 27, 2007, the Secretary shall by regulation expand the registry and results data bank as provided under this subparagraph.

(ii) Clinical trials

(I) Approved products

The regulations under this subparagraph shall require the inclusion of the results information described in clause (iii) for—

(aa) each applicable drug clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title; and

(bb) each applicable device clinical trial for a device that is cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21.

(II) Unapproved products

The regulations under this subparagraph shall establish whether or not the results information described in clause (iii) shall be required for—

(aa) an applicable drug clinical trial for a drug that is not approved under section 355 of title 21 and not licensed under section 262 of this title (whether approval or licensure was sought or not); and

(bb) an applicable device clinical trial for a device that is not cleared under section 360(k) of title 21 and not approved under section 360e or section 360j(m) of title 21 (whether clearance or approval was sought or not).

(iii) Required elements

The regulations under this subparagraph shall require, in addition to the elements described in subparagraph (C), information within each of the following categories:

(I) A summary of the clinical trial and its results that is written in non-technical, understandable language for patients, if the Secretary determines that such types of summary can be included without being misleading or promotional.

(II) A summary of the clinical trial and its results that is technical in nature, if the Secretary determines that such types of summary can be included without being misleading or promotional.

(III) The full protocol or such information on the protocol for the trial as may be necessary to help to evaluate the results of the trial.

(IV) Such other categories as the Secretary determines appropriate.

(iv) Results submission

The results information described in clause (iii) shall be submitted to the Director of NIH for inclusion in the registry and results data bank as provided by subparagraph (E), except that the Secretary shall by regulation determine—

(I) whether the 1-year period for submission of clinical trial information described in subparagraph (E)(i) should be increased from 1 year to a period not to exceed 18 months;

(II) whether the clinical trial information described in clause (iii) should be required to be submitted for an applicable clinical trial for which the clinical trial information described in subparagraph (C) is submitted to the registry and results data bank before the effective date of the regulations issued under this subparagraph; and

(III) in the case when the clinical trial information described in clause (iii) is required to be submitted for the applicable clinical trials described in clause (ii)(II), the date by which such clinical trial information shall be required to be submitted, taking into account—

(aa) the certification process under subparagraph (E)(iii) when approval, licensure, or clearance is sought; and

(bb) whether there should be a delay of submission when approval, licensure, or clearance will not be sought.

(v) Additional provisions

The regulations under this subparagraph shall also establish—

(I) a standard format for the submission of clinical trial information under this paragraph to the registry and results data bank;

(II) additional information on clinical trials and results that is written in nontechnical, understandable language for patients;

(III) considering the experience under the pilot quality control project described in paragraph (5)(C), procedures for quality control, including using representative samples, with respect to completeness and content of clinical trial information under this subsection, to help ensure that data elements are not false or misleading and are non-promotional;

(IV) the appropriate timing and requirements for updates of clinical trial information, and whether and, if so, how such updates should be tracked;

(V) a statement to accompany the entry for an applicable clinical trial when the primary and secondary outcome measures for such clinical trial are submitted under paragraph (4)(A) after the date specified for the submission of such information in paragraph (2)(C); and

(VI) additions or modifications to the manner of reporting of the data elements established under subparagraph (C).

(vi) Consideration of World Health Organization data set

The Secretary shall consider the status of the consensus data elements set for reporting clinical trial results of the World Health Organization when issuing the regulations under this subparagraph.

(vii) Public meeting

The Secretary shall hold a public meeting no later than 18 months after September 27, 2007, to provide an opportunity for input from interested parties with regard to the regulations to be issued under this subparagraph.

(E) Submission of results information

(i) In general

Except as provided in clauses (iii), (iv), (v), and (vi) the responsible party for an applicable clinical trial that is described in clause (ii) shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraph (C) not later than 1 year, or such other period as may be provided by regulation under subparagraph (D), after the earlier of—

(I) the estimated completion date of the trial as described in paragraph (2)(A)(ii)(I)(jj)); 2 or

(II) the actual date of completion.

(ii) Clinical trials described

An applicable clinical trial described in this clause is an applicable clinical trial subject to—

(I) paragraph (2)(C); and

(II)(aa) subparagraph (C); or

(bb) the regulations issued under subparagraph (D).

(iii) Delayed submission of results with certification

If the responsible party for an applicable clinical trial submits a certification that clause (iv) or (v) applies to such clinical trial, the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) as required under the applicable clause.

(iv) Seeking initial approval of a drug or device

With respect to an applicable clinical trial that is completed before the drug is initially approved under section 355 of title 21 or initially licensed under section 262 of this title, or the device is initially cleared under section 360(k) or initially approved under section 360e or 360j(m) of title 21, the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) not later than 30 days after the drug or device is approved under such section 355, licensed under such section 262, cleared under such section 360(k), or approved under such section 360e or 360j(m), as applicable.

(v) Seeking approval of a new use for the drug or device

(I) In general

With respect to an applicable clinical trial where the manufacturer of the drug or device is the sponsor of an applicable clinical trial, and such manufacturer has filed, or will file within 1 year, an application seeking approval under section 355 of title 21, licensing under section 262 of this title, or clearance under section 360(k), or approval under section 360e or 360j(m) of title 21 for the use studied in such clinical trial (which use is not included in the labeling of the approved drug or device), then the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) on the earlier of the date that is 30 days after the date—

(aa) the new use of the drug or device is approved under such section 355, licensed under such section 262, cleared under such section 360(k), or approved under such section 360e or 360j(m);

(bb) the Secretary issues a letter, such as a complete response letter, not approving the submission or not clearing the submission, a not approvable letter, or a not substantially equivalent letter for the new use of the drug or device under such section 355, 262, 360(k), 360e, or 360j(m); or

(cc) except as provided in subclause (III), the application or premarket notification under such section 355, 262, 360(k), 360e, or 360j(m) is withdrawn without resubmission for no less than 210 days.

(II) Requirement that each clinical trial in application be treated the same

If a manufacturer makes a certification under clause (iii) that this clause applies with respect to a clinical trial, the manufacturer shall make such a certification with respect to each applicable clinical trial that is required to be submitted in an application or report for licensure, approval, or clearance (under section 262 of this title or section 355, 360(k), 360e, or 360j(m) of title 21, as applicable) of the use studied in the clinical trial.

(III) Two-year limitation

The responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information subject to subclause (I) on the date that is 2 years after the date a certification under clause (iii) was made to the Director of NIH, if an action referred to in item (aa), (bb), or (cc) of subclause (I) has not occurred by such date.

(vi) Extensions

The Director of NIH may provide an extension of the deadline for submission of clinical trial information under clause (i) if the responsible party for the trial submits to the Director a written request that demonstrates good cause for the extension and provides an estimate of the date on which the information will be submitted. The Director of NIH may grant more than one such extension for a clinical trial.

(F) Notice to Director of NIH

The Commissioner of Food and Drugs shall notify the Director of NIH when there is an action described in subparagraph (E)(iv) or item (aa), (bb), or (cc) of subparagraph (E)(v)(I) with respect to an application or a report that includes a certification required under paragraph (5)(B) of such action not later than 30 days after such action.

(G) Posting of data

The Director of NIH shall ensure that the clinical trial information described in subparagraphs (C) and (D) for an applicable clinical trial submitted in accordance with this paragraph is posted publicly in the registry and results database not later than 30 days after such submission.

(H) Waivers regarding certain clinical trial results

The Secretary may waive any applicable requirements of this paragraph for an applicable clinical trial, upon a written request from the responsible party, if the Secretary determines that extraordinary circumstances justify the waiver and that providing the waiver is consistent with the protection of public health, or in the interest of national security. Not later than 30 days after any part of a waiver is granted, the Secretary shall notify, in writing, the appropriate committees of Congress of the waiver and provide an explanation for why the waiver was granted.

(I) Adverse events

(i) Regulations

Not later than 18 months after September 27, 2007, the Secretary shall by regulation determine the best method for including in the registry and results data bank appropriate results information on serious adverse and frequent adverse events for applicable clinical trials described in subparagraph (C) in a manner and form that is useful and not misleading to patients, physicians, and scientists.

(ii) Default

If the Secretary fails to issue the regulation required by clause (i) by the date that is 24 months after September 27, 2007, clause (iii) shall take effect.

(iii) Additional elements

Upon the application of clause (ii), the Secretary shall include in the registry and results data bank for applicable clinical trials described in subparagraph (C), in addition to the clinical trial information described in subparagraph (C), the following elements:

(I) Serious adverse events

A table of anticipated and unanticipated serious adverse events grouped by organ system, with number and frequency of such event in each arm of the clinical trial.

(II) Frequent adverse events

A table of anticipated and unanticipated adverse events that are not included in the table described in subclause (I) that exceed a frequency of 5 percent within any arm of the clinical trial, grouped by organ system, with number and frequency of such event in each arm of the clinical trial.

(iv) Posting of other information

In carrying out clause (iii), the Secretary shall, in consultation with experts in risk communication, post with the tables information to enhance patient understanding and to ensure such tables do not mislead patients or the lay public.

(v) Relation to subparagraph (C)

Clinical trial information included in the registry and results data bank pursuant to this subparagraph is deemed to be clinical trial information included in such data bank pursuant to subparagraph (C).

(4) Additional submissions of clinical trial information

(A) Voluntary submissions

A responsible party for a clinical trial that is not an applicable clinical trial, or that is an applicable clinical trial that is not subject to paragraph (2)(C), may submit complete clinical trial information described in paragraph (2) or paragraph (3) provided the responsible party submits clinical trial information for each applicable clinical trial that is required to be submitted under section 262 of this title or under section 355, 360(k), 360e, or 360j(m) of title 21 in an application or report for licensure, approval, or clearance of the drug or device for the use studied in the clinical trial.

(B) Required submissions

(i) In general

Notwithstanding paragraphs (2) and (3) and subparagraph (A), in any case in which the Secretary determines for a specific clinical trial described in clause (ii) that posting in the registry and results data bank of clinical trial information for such clinical trial is necessary to protect the public health—

(I) the Secretary may require by notification that such information be submitted to the Secretary in accordance with paragraphs (2) and (3) except with regard to timing of submission;

(II) unless the responsible party submits a certification under paragraph (3)(E)(iii), such information shall be submitted not later than 30 days after the date specified by the Secretary in the notification; and

(III) failure to comply with the requirements under subclauses (I) and (II) shall be treated as a violation of the corresponding requirement of such paragraphs.

(ii) Clinical trials described

A clinical trial described in this clause is—

(I) an applicable clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title or for a device that is cleared under section 360(k) of title 21 or approved under section 360e or section 360j(m) of title 21, whose completion date is on or after the date 10 years before September 27, 2007; or

(II) an applicable clinical trial that is described by both by 3 paragraph (2)(C) and paragraph (3)(D)(ii)(II)).4

(C) Updates to clinical trial data bank

(i) Submission of updates

The responsible party for an applicable clinical trial shall submit to the Director of NIH for inclusion in the registry and results data bank updates to reflect changes to the clinical trial information submitted under paragraph (2). Such updates—

(I) shall be provided not less than once every 12 months, unless there were no changes to the clinical trial information during the preceding 12-month period;

(II) shall include identification of the dates of any such changes;

(III) not later than 30 days after the recruitment status of such clinical trial changes, shall include an update of the recruitment status; and

(IV) not later than 30 days after the completion date of the clinical trial, shall include notification to the Director that such clinical trial is complete.

(ii) Public availability of updates

The Director of NIH shall make updates submitted under clause (i) publicly available in the registry data bank. Except with regard to overall recruitment status, individual site status, location, and contact information, the Director of NIH shall ensure that updates to elements required under subclauses (I) to (V) of paragraph (2)(A)(ii) do not result in the removal of any information from the original submissions or any preceding updates, and information in such databases is presented in a manner that enables users to readily access each original element submission and to track the changes made by the updates. The Director of NIH shall provide a link from the table of primary and secondary outcomes required under paragraph (3)(C)(ii) to the tracked history required under this clause of the primary and secondary outcome measures submitted under paragraph (2)(A)(ii)(I)(ll).

(5) Coordination and compliance

(A) Clinical trials supported by grants from Federal agencies

(i) Grants from certain Federal agencies

If an applicable clinical trial is funded in whole or in part by a grant from any agency of the Department of Health and Human Services, including the Food and Drug Administration, the National Institutes of Health, or the Agency for Healthcare Research and Quality, any grant or progress report forms required under such grant shall include a certification that the responsible party has made all required submissions to the Director of NIH under paragraphs (2) and (3).

(ii) Verification by Federal agencies

The heads of the agencies referred to in clause (i), as applicable, shall verify that the clinical trial information for each applicable clinical trial for which a grantee is the responsible party has been submitted under paragraphs (2) and (3) before releasing any remaining funding for a grant or funding for a future grant to such grantee.

(iii) Notice and opportunity to remedy

If the head of an agency referred to in clause (i), as applicable, verifies that a grantee has not submitted clinical trial information as described in clause (ii), such agency head shall provide notice to such grantee of such non-compliance and allow such grantee 30 days to correct such non-compliance and submit the required clinical trial information.

(iv) Consultation with other Federal agencies

The Secretary shall—

(I) consult with other agencies that conduct research involving human subjects in accordance with any section of part 46 of title 45, Code of Federal Regulations (or any successor regulations), to determine if any such research is an applicable clinical trial; and

(II) develop with such agencies procedures comparable to those described in clauses (i), (ii), and (iii) to ensure that clinical trial information for such applicable clinical trial is submitted under paragraphs (2) and (3).

(B) Certification to accompany drug, biological product, and device submissions

At the time of submission of an application under section 355 of title 21, section 360e of title 21, section 360j(m) of title 21, or section 262 of this title, or submission of a report under section 360(k) of title 21, such application or submission shall be accompanied by a certification that all applicable requirements of this subsection have been met. Where available, such certification shall include the appropriate National Clinical Trial control numbers.

(C) Quality control

(i) Pilot quality control project

Until the effective date of the regulations issued under paragraph (3)(D), the Secretary, acting through the Director of NIH and the Commissioner of Food and Drugs, shall conduct a pilot project to determine the optimal method of verification to help to ensure that the clinical trial information submitted under paragraph (3)(C) is non-promotional and is not false or misleading in any particular under subparagraph (D). The Secretary shall use the publicly available information described in paragraph (3)(A) and any other information available to the Secretary about applicable clinical trials to verify the accuracy of the clinical trial information submitted under paragraph (3)(C).

(ii) Notice of compliance

If the Secretary determines that any clinical trial information was not submitted as required under this subsection, or was submitted but is false or misleading in any particular, the Secretary shall notify the responsible party and give such party an opportunity to remedy such noncompliance by submitting the required revised clinical trial information not later than 30 days after such notification.

(D) Truthful clinical trial information

(i) In general

The clinical trial information submitted by a responsible party under this subsection shall not be false or misleading in any particular.

(ii) Effect

Clause (i) shall not have the effect of—

(I) requiring clinical trial information with respect to an applicable clinical trial to include information from any source other than such clinical trial involved; or

(II) requiring clinical trial information described in paragraph (3)(D) to be submitted for purposes of paragraph (3)(C).

(E) Public notices

(i) Notice of violations

If the responsible party for an applicable clinical trial fails to submit clinical trial information for such clinical trial as required under paragraphs (2) or (3), the Director of NIH shall include in the registry and results data bank entry for such clinical trial a notice—

(I) that the responsible party is not in compliance with this chapter by—

(aa) failing to submit required clinical trial information; or

(bb) submitting false or misleading clinical trial information;


(II) of the penalties imposed for the violation, if any; and

(III) whether the responsible party has corrected the clinical trial information in the registry and results data bank.

(ii) Notice of failure to submit primary and secondary outcomes

If the responsible party for an applicable clinical trial fails to submit the primary and secondary outcomes as required under section 2(A)(ii)(I)(ll),5 the Director of NIH shall include in the registry and results data bank entry for such clinical trial a notice that the responsible party is not in compliance by failing to register the primary and secondary outcomes in accordance with this chapter, and that the primary and secondary outcomes were not publicly disclosed in the database before conducting the clinical trial.

(iii) Failure to submit statement

The notice under clause (i) for a violation described in clause (i)(I)(aa) shall include the following statement: "The entry for this clinical trial was not complete at the time of submission, as required by law. This may or may not have any bearing on the accuracy of the information in the entry.".

(iv) Submission of false information statement

The notice under clause (i) for a violation described in clause (i)(I)(bb) shall include the following statement: "The entry for this clinical trial was found to be false or misleading and therefore not in compliance with the law.".

(v) Non-submission of statement

The notice under clause (ii) for a violation described in clause (ii) shall include the following statement: "The entry for this clinical trial did not contain information on the primary and secondary outcomes at the time of submission, as required by law. This may or may not have any bearing on the accuracy of the information in the entry.".

(vi) Compliance searches

The Director of NIH shall provide that the public may easily search the registry and results data bank for entries that include notices required under this subparagraph.

(6) Limitation on disclosure of clinical trial information

(A) In general

Nothing in this subsection (or under section 552 of title 5) shall require the Secretary to publicly disclose, by any means other than the registry and results data bank, information described in subparagraph (B).

(B) Information described

Information described in this subparagraph is—

(i) information submitted to the Director of NIH under this subsection, or information of the same general nature as (or integrally associated with) the information so submitted; and

(ii) information not otherwise publicly available, including because it is protected from disclosure under section 552 of title 5.

(7) Authorization of appropriations

There are authorized to be appropriated to carry out this subsection $10,000,000 for each fiscal year.

(k) Day care for children of employees

(1) The Director of NIH may establish a program to provide day care services for the employees of the National Institutes of Health similar to those services provided by other Federal agencies (including the availability of day care service on a 24-hour-a-day basis).

(2) Any day care provider at the National Institutes of Health shall establish a sliding scale of fees that takes into consideration the income and needs of the employee.

(3) For purposes regarding the provision of day care services, the Director of NIH may enter into rental or lease purchase agreements.

(l) Council of Councils

(1) Establishment

Not later than 90 days after January 15, 2007, the Director of NIH shall establish within the Office of the Director an advisory council to be known as the "Council of Councils" (referred to in this subsection as the "Council") for the purpose of advising the Director on matters related to the policies and activities of the Division of Program Coordination, Planning, and Strategic Initiatives, including making recommendations with respect to the conduct and support of research described in subsection (b)(7).

(2) Membership

(A) In general

The Council shall be composed of 27 members selected by the Director of NIH with approval from the Secretary from among the list of nominees under subparagraph (C).

(B) Certain requirements

In selecting the members of the Council, the Director of NIH shall ensure—

(i) the representation of a broad range of disciplines and perspectives; and

(ii) the ongoing inclusion of at least 1 representative from each national research institute whose budget is substantial relative to a majority of the other institutes.

(C) Nomination

The Director of NIH shall maintain an updated list of individuals who have been nominated to serve on the Council, which list shall consist of the following:

(i) For each national research institute and national center, 3 individuals nominated by the head of such institute or center from among the members of the advisory council of the institute or center, of which—

(I) two shall be scientists; and

(II) one shall be from the general public or shall be a leader in the field of public policy, law, health policy, economics, or management.


(ii) For each office within the Division of Program Coordination, Planning, and Strategic Initiatives, 1 individual nominated by the head of such office.

(iii) Members of the Council of Public Representatives.

(3) Terms

(A) In general

The term of service for a member of the Council shall be 6 years, except as provided in subparagraphs (B) and (C).

(B) Terms of initial appointees

Of the initial members selected for the Council, the Director of NIH shall designate—

(i) nine for a term of 6 years;

(ii) nine for a term of 4 years; and

(iii) nine for a term of 2 years.

(C) Vacancies

Any member appointed to fill a vacancy occurring before the expiration of the term for which the member's predecessor was appointed shall be appointed only for the remainder of that term. A member may serve after the expiration of that member's term until a successor has taken office.

(m) National Institutes of Health Strategic Plan

(1) In general

Not later than 2 years after December 13, 2016, and at least every 6 years thereafter, the Director of the National Institutes of Health shall develop and submit to the appropriate committees of Congress and post on the Internet website of the National Institutes of Health, a coordinated strategy (to be known as the "National Institutes of Health Strategic Plan") to provide direction to the biomedical research investments made by the National Institutes of Health, to facilitate collaboration across the institutes and centers, to leverage scientific opportunity, and to advance biomedicine.

(2) Requirements

The strategy under paragraph (1) shall—

(A) identify strategic research priorities and objectives across biomedical research, including—

(i) an assessment of the state of biomedical and behavioral research, including areas of opportunity with respect to basic, clinical, and translational research;

(ii) priorities and objectives to advance the treatment, cure, and prevention of health conditions;

(iii) emerging scientific opportunities, rising public health challenges, and scientific knowledge gaps; and

(iv) the identification of near-, mid-, and long-term scientific needs;


(B) consider, in carrying out subparagraph (A)—

(i) disease burden in the United States and the potential for return on investment to the United States;

(ii) rare diseases and conditions;

(iii) biological, social, and other determinants of health that contribute to health disparities; and

(iv) other factors the Director of National Institutes of Health determines appropriate;


(C) include multi-institute priorities, including coordination of research among institutes and centers;

(D) include strategic priorities for funding research through the Common Fund, in accordance with section 282a(c)(1)(C) of this title;

(E) address the National Institutes of Health's proposed and ongoing activities related to training and the biomedical workforce; and

(F) describe opportunities for collaboration with other agencies and departments, as appropriate.

(3) Use of plans

Strategic plans developed and updated by the national research institutes and national centers of the National Institutes of Health shall be prepared regularly and in such a manner that such plans will be informed by the strategic plans developed and updated under this subsection. Such plans developed by and updated by the national research institutes and national centers shall have a common template.

(4) Consultation

The Director of National Institutes of Health shall develop the strategic plan under paragraph (1) in consultation with the directors of the national research institutes and national centers, researchers, patient advocacy groups, and industry leaders.

(n) Unique research initiatives

(1) In general

The Director of NIH may approve, after consideration of a proposal under paragraph (2)(A), requests by the national research institutes and centers, or program officers within the Office of the Director to engage in transactions other than a contract, grant, or cooperative agreement with respect to projects that carry out—

(A) the Precision Medicine Initiative under section 289g–5 of this title; or

(B) subsection (b)(7), except that not more than 50 percent of the funds available for a fiscal year through the Common Fund under section 282a(c)(1) of this title for purposes of carrying out such subsection (b)(7) may be used to engage in such other transactions.

(2) Requirements

The authority provided under this subsection may be used to conduct or support high impact cutting-edge research described in paragraph (1) using the other transactions authority described in such paragraph if the institute, center, or office—

(A) submits a proposal to the Director of NIH for the use of such authority before conducting or supporting the research, including why the use of such authority is essential to promoting the success of the project;

(B) receives approval for the use of such authority from the Director of NIH; and

(C) for each year in which the institute, center, or office has used such authority in accordance with this subsection, submits a report to the Director of NIH on the activities of the institute, center, or office relating to such research.

(July 1, 1944, ch. 373, title IV, §402, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 823; amended Pub. L. 100–607, title I, §111, Nov. 4, 1988, 102 Stat. 3052; Pub. L. 102–321, title I, §163(b)(3), July 10, 1992, 106 Stat. 376; Pub. L. 103–43, title I, §141(b), title II, §§201, 202, 206, 208, 210(b), (c), title III, §303(b), June 10, 1993, 107 Stat. 139, 144, 148-150, 153; Pub. L. 105–115, title I, §113(a), Nov. 21, 1997, 111 Stat. 2310; Pub. L. 105–362, title VI, §601(a)(1)(A), Nov. 10, 1998, 112 Stat. 3285; Pub. L. 105–392, title IV, §409, Nov. 13, 1998, 112 Stat. 3589; Pub. L. 107–109, §15(c)(2), Jan. 4, 2002, 115 Stat. 1420; Pub. L. 109–482, title I, §§102(a)–(d), (f)(1)(A), 103(b)(1), Jan. 15, 2007, 120 Stat. 3681, 3683, 3684, 3687; Pub. L. 110–85, title III, §304(a), title VIII, §801(a), title XI, §1104(2), Sept. 27, 2007, 121 Stat. 863, 904, 975; Pub. L. 110–316, title III, §302, Aug. 14, 2008, 122 Stat. 3524; Pub. L. 111–148, title X, §10409(b), Mar. 23, 2010, 124 Stat. 978; Pub. L. 112–74, div. F, title II, §221(b)(5)(B), (d)(1), Dec. 23, 2011, 125 Stat. 1089, 1090; Pub. L. 113–94, §3(a), Apr. 3, 2014, 128 Stat. 1086; Pub. L. 114–255, div. A, title II, §§2014(a), 2031(a), 2036(a), 2038(a), 2051, Dec. 13, 2016, 130 Stat. 1051, 1054, 1062, 1064, 1074.)

References in Text

The Federal Advisory Committee Act, referred to in subsec. (b), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770, which is set out in the Appendix to Title 5, Government Organization and Employees.

The General Schedule, referred to in subsec. (b)(16), is set out under section 5332 of Title 5, Government Organization and Employees.

The National Literacy Act of 1991, referred to in subsec. (e)(5), is Pub. L. 102–73, July 25, 1991, 105 Stat. 333, which was repealed by Pub. L. 105–220, title II, §251(a)(2), Aug. 7, 1998, 112 Stat. 1079. For complete classification of this Act to the Code, see Tables.

Codification

In subsec. (b)(14)(B), "section 8141 of title 40" substituted for "the Act of March 3, 1877 (40 U.S.C. 34)" on authority of Pub. L. 107–217, §5(c), Aug. 21, 2002, 116 Stat. 1303, the first section of which enacted Title 40, Public Buildings, Property, and Works.

Amendments

2016—Subsec. (b)(4). Pub. L. 114–255, §2038(a)(1), amended par. (4) generally. Prior to amendment, text read as follows: "shall assemble accurate data to be used to assess research priorities, including information to better evaluate scientific opportunity, public health burdens, and progress in reducing minority and other health disparities;".

Subsec. (b)(5). Pub. L. 114–255, §2031(a)(1), inserted ", and through the development, implementation, and updating of the strategic plan developed under subsection (m)" before semicolon.

Subsec. (b)(8)(C), (D). Pub. L. 114–255, §2038(a)(2), added subpars. (C) and (D).

Subsec. (b)(25). Pub. L. 114–255, §2014(a), added par. (25).

Subsec. (j)(2)(D)(ii)(I). Pub. L. 114–255, §2051(1), inserted ", unless the responsible party affirmatively requests that the Director of the National Institutes of Health publicly post such clinical trial information for an applicable device clinical trial prior to such date of clearance or approval" before semicolon.

Subsec. (j)(2)(D)(iii), (iv). Pub. L. 114–255, §2051(2), added cls. (iii) and (iv).

Subsec. (m). Pub. L. 114–255, §2031(a)(2), added subsec. (m).

Subsec. (n). Pub. L. 114–255, §2036(a), added subsec. (n).

2014—Subsec. (b)(7). Pub. L. 113–94 amended par. (7) generally, enacting similar provisions and adding provisions relating to allocating funds appropriated pursuant to section 282a(a)(2) of this title for making grants for pediatric research.

2011—Subsec. (b)(24). Pub. L. 112–74, §221(d)(1), substituted "287a" for "282d".

Subsec. (g). Pub. L. 112–74, §221(b)(5)(B), redesignated and transferred subsec. (g) of this section to subsec. (b) of section 285k of this title.

2010—Subsec. (b)(24). Pub. L. 111–148 added par. (24).

2008—Subsec. (j)(3)(C). Pub. L. 110–316, §302(1), in introductory provisions, substituted "for each applicable clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title or a device that is cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21, the following elements:" for "the following elements for drugs that are approved under section 355 of title 21 or licensed under section 262 of this title and devices that are cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21:".

Subsec. (j)(3)(I)(i), (iii). Pub. L. 110–316, §302(2), substituted "applicable clinical trials described in subparagraph (C)" for "drugs described in subparagraph (C)".

2007—Subsec. (a). Pub. L. 109–482, §102(f)(1)(A), substituted "Director of NIH who shall" for "Director of the National Institutes of Health (hereafter in this subchapter referred to as the 'Director of NIH') who shall".

Subsec. (b). Pub. L. 109–482, §102(a)(5), substituted "paragraph (16)" for "paragraph (6)" in concluding provisions.

Subsec. (b)(1). Pub. L. 109–482, §102(a)(6), added par. (1) and struck out former par. (1) which read as follows: "shall be responsible for the overall direction of the National Institutes of Health and for the establishment and implementation of general policies respecting the management and operation of programs and activities within the National Institutes of Health;".

Subsec. (b)(2), (3). Pub. L. 109–482, §102(b), added pars. (2) and (3) and struck out former pars. (2) and (3) which read as follows:

"(2) shall coordinate and oversee the operation of the national research institutes and administrative entities within the National Institutes of Health;

"(3) shall assure that research at or supported by the National Institutes of Health is subject to review in accordance with section 289a of this title;".

Subsec. (b)(4). Pub. L. 110–85, §1104(2), inserted "minority and other" after "reducing".

Pub. L. 109–482, §102(b), added par. (4). Former par. (4) redesignated (14).

Subsec. (b)(5) to (22). Pub. L. 109–482, §102(a)(1)–(4), (b), added pars. (5) to (13), redesignated former pars. (4) to (11) and (14) as (14) to (22), respectively, in par. (21) inserted "and" at end, and struck out former pars. (12) and (13) which read as follows:

"(12) after consultation with the Director of the Office of Research on Women's Health, shall ensure that resources of the National Institutes of Health are sufficiently allocated for projects of research on women's health that are identified under section 287d(b) of this title;

"(13) may conduct and support research training—

"(A) for which fellowship support is not provided under section 288 of this title; and

"(B) which does not consist of residency training of physicians or other health professionals; and".

Subsec. (b)(23). Pub. L. 110–85, §304(a), added par. (23).

Subsec. (i). Pub. L. 109–482, §102(c), redesignated subsec. (j) as (i) and struck out former subsec. (i) which related to discretionary fund for use by the Director of NIH to carry out activities authorized in this chapter.

Subsec. (i)(5). Pub. L. 109–482, §103(b)(1), struck out first sentence which read as follows: "For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary."

Subsecs. (j), (k). Pub. L. 110–85, §801(a), added subsec. (j) and redesignated former subsec. (j) as (k). Former subsec. (k) redesignated (l).

Pub. L. 109–482, §102(c)(2), (d), added subsec. (k) and redesignated former subsec. (k) as (j).

Subsec. (l). Pub. L. 110–85, §801(a)(1), redesignated subsec. (k) as (l).

Pub. L. 109–482, §102(c)(1), struck out subsec. (l) which read as follows: "The Director of NIH shall carry out the program established in part F of subchapter X of this chapter (relating to interagency research on trauma)."

2002—Subsec. (j)(3)(A). Pub. L. 107–109, which directed the amendment of the first sentence of subsec. (j)(3)(A) by substituting "trial sites," for "trial sites, and" and "in the trial, and a description of whether, and through what procedure, the manufacturer or sponsor of the investigation of a new drug will respond to requests for protocol exception, with appropriate safeguards, for single-patient and expanded protocol use of the new drug, particularly in children," for "in the trial,", was executed by making the substitutions in the second sentence, to reflect the probable intent of Congress.

1998—Subsec. (b)(13), (14). Pub. L. 105–392 added pars. (13) and (14).

Subsec. (f). Pub. L. 105–362 inserted "and" at end of par. (1), substituted a period for "; and" at end of par. (2), and struck out par. (3) which read as follows: "annually prepare and submit to the Director of NIH a report concerning the prevention and dissemination activities undertaken by the Associate Director, including—

"(A) a summary of the Associate Director's review of existing dissemination policies and techniques together with a detailed statement concerning any modification or restructuring, or recommendations for modification or restructuring, of such policies and techniques; and

"(B) a detailed statement of the expenditures made for the prevention and dissemination activities reported on and the personnel used in connection with such activities."

1997—Subsecs. (j) to (l). Pub. L. 105–115 added subsec. (j) and redesignated former subsecs. (j) and (k) as (k) and (l), respectively.

1993—Subsec. (b)(12). Pub. L. 103–43, §141(b), added par. (12).

Subsec. (e)(5). Pub. L. 103–43, §210(b), added par. (5).

Subsec. (f). Pub. L. 103–43, §201, substituted "other public and private entities, including elementary, secondary, and post-secondary schools. The Associate Director shall—" and pars. (1) to (3) for "other public and private entities. The Associate Director shall annually report to the Director of NIH on the prevention activities undertaken by the Associate Director. The report shall include a detailed statement of the expenditures made for the activities reported on and the personnel used in connection with such activities".

Subsec. (g). Pub. L. 103–43, §202, added subsec. (g).

Subsec. (h). Pub. L. 103–43, §206, added subsec. (h).

Subsec. (i). Pub. L. 103–43, §208, added subsec. (i).

Subsec. (j). Pub. L. 103–43, §210(c), added subsec. (j).

Subsec. (k). Pub. L. 103–43, §303(b), added subsec. (k).

1992—Subsec. (d)(1). Pub. L. 102–321 substituted "220" for "two hundred".

1988—Subsec. (b)(6). Pub. L. 100–607 inserted "and scientific program advisory committees" after "peer review groups".

Effective Date of 2007 Amendment

Amendment 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 a note under section 281 of this title.

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of Title 21, Food and Drugs.

Effective Date of 1992 Amendment

Amendment by Pub. L. 102–321 effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as a note under section 236 of this title.

Rule of Construction Regarding Continuation of Programs

Pub. L. 109–482, title I, §103(c), Jan. 15, 2007, 120 Stat. 3689, provided that: "The amendment of a program by a provision of subsection (b) [amending this section and sections 283a, 283d, 283g to 283i, 284e to 284j, 284l, 284m, 285a–9, 285a–10, 285b–7a, 285b–7b, 285c–9, 285d–6a, 285d–8, 285e–10, 285e–10a, 285f–2, 285f–3, 285g–5, 285g–9, 285g–10, 285n, 285o, 285o–2, 285o–4, 285p, 285r, 286a–1, 287a–2, 287a–3, 287a–4, 287c–11, 287c–31 to 287c–33, 288, 288–1, and former 288–5a of this title and repealing sections 285a–8, 285b–8, 285e–11, and 286a–2 of this title] may not be construed as terminating the authority of the Federal agency involved to carry out the program."

Confidentiality

Pub. L. 114–255, div. A, title II, §2014(b), Dec. 13, 2016, 130 Stat. 1051, provided that: "Nothing in the amendments made by subsection (a) [amending this section] authorizes the Secretary of Health and Human Services to disclose any information that is a trade secret, or other privileged or confidential information, described in section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code, or [shall] be construed to require recipients of grants or cooperative agreements through the National Institutes of Health to share such information."

Appropriate Age Groupings in Clinical Research

Pub. L. 114–255, div. A, title II, §2038(i), Dec. 13, 2016, 130 Stat. 1067, provided that:

"(1) Input from experts.—Not later than 180 days after the date of enactment of this Act [Dec. 13, 2016], the Director of the National Institutes of Health shall convene a workshop of experts on pediatric and older populations to provide input on—

"(A) appropriate age groups to be included in research studies involving human subjects; and

"(B) acceptable justifications for excluding participants from a range of age groups from human subjects research studies.

"(2) Policy updates.—Not later than 180 days after the conclusion of the workshop under paragraph (1), the Director of the National Institutes of Health shall make a determination with respect to whether the policies of the National Institutes of Health on the inclusion of relevant age groups in clinical studies need to be updated, and shall update such policies as appropriate. In making the determination, the Director of the National Institutes of Health shall take into consideration whether such policies—

"(A) address the consideration of age as an inclusion variable in research involving human subjects; and

"(B) identify the criteria for justification for any age-related exclusions in such research.

"(3) Public availability of findings and conclusions.—The Director of the National Institutes of Health shall—

"(A) make the findings and conclusions resulting from the workshop under paragraph (1) and updates to policies in accordance with paragraph (2), as applicable, available to the public on the Internet website of the National Institutes of Health; and

"(B) ensure that age-related data reported in the triennial report under section 403 of the Public Health Service Act (42 U.S.C. 283) (as amended by section 2032 [of Pub. L. 114–255]) are made available to the public on the Internet website of the National Institutes of Health."

Enhancing the Rigor and Reproducibility of Scientific Research

Pub. L. 114–255, div. A, title II, §2039, Dec. 13, 2016, 130 Stat. 1068, provided that:

"(a) Establishment.—Not later than 1 year after the date of enactment of this Act [Dec. 13, 2016], the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall convene a working group under the Advisory Committee to the Director of the National Institutes of Health (referred to in this section as the 'Advisory Committee'), appointed under section 222 of the Public Health Service Act (42 U.S.C. 217a), to develop and issue recommendations through the Advisory Committee for a formal policy, which may incorporate or be informed by relevant existing and ongoing activities, to enhance rigor and reproducibility of scientific research funded by the National Institutes of Health.

"(b) Considerations.—In developing and issuing recommendations through the Advisory Committee under subsection (a), the working group established under such subsection shall consider, as appropriate—

"(1) preclinical experiment design, including analysis of sex as a biological variable;

"(2) clinical experiment design, including—

"(A) the diversity of populations studied for clinical research, with respect to biological, social, and other determinants of health that contribute to health disparities;

"(B) the circumstances under which summary information regarding biological, social, and other factors that contribute to health disparities should be reported; and

"(C) the circumstances under which clinical studies, including clinical trials, should conduct an analysis of the data collected during the study on the basis of biological, social, and other factors that contribute to health disparities;

"(3) applicable levels of rigor in statistical methods, methodology, and analysis;

"(4) data and information sharing in accordance with applicable privacy laws and regulations; and

"(5) any other matter the working group determines relevant.

"(c) Policies.—Not later than 18 months after the date of enactment of this Act, the Director of the National Institutes of Health shall consider the recommendations developed by the working group and issued by the Advisory Committee under subsection (a) and develop or update policies as appropriate.

"(d) Report.—Not later than 2 years after the date of enactment of this Act, the Director of the National Institutes of Health shall issue a report to the Secretary of Health and Human Services, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives regarding recommendations developed under subsection (a) and any subsequent policy changes implemented, to enhance rigor and reproducibility in scientific research funded by the National Institutes of Health.

"(e) Confidentiality.—Nothing in this section authorizes the Secretary of Health and Human Services to disclose any information that is a trade secret, or other privileged or confidential information, described in section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code."

Demonstration Grants for Improving Pediatric Device Availability

Pub. L. 110–85, title III, §305, Sept. 27, 2007, 121 Stat. 863, as amended by Pub. L. 112–144, title VI, §620(a), July 9, 2012, 126 Stat. 1064; Pub. L. 115–52, title V, §502(c), Aug. 18, 2017, 131 Stat. 1037, provided that:

"(a) In General.—

"(1) Request for proposals.—Not later than 90 days after the date of the enactment of this Act [Sept. 27, 2007], the Secretary of Health and Human Services shall issue a request for proposals for 1 or more grants or contracts to nonprofit consortia for demonstration projects to promote pediatric device development.

"(2) Determination on grants or contracts.—Not later than 180 days after the date the Secretary of Health and Human Services issues a request for proposals under paragraph (1), the Secretary shall make a determination on the grants or contracts under this section.

"(b) Application.—A nonprofit consortium that desires to receive a grant or contract under this section shall submit an application to the Secretary of Health and Human Services at such time, in such manner, and containing such information as the Secretary may require.

"(c) Use of Funds.—A nonprofit consortium that receives a grant or contract under this section shall facilitate the development, production, and distribution of pediatric medical devices by—

"(1) encouraging innovation and connecting qualified individuals with pediatric device ideas with potential manufacturers;

"(2) mentoring and managing pediatric device projects through the development process, including product identification, prototype design, device development, and marketing;

"(3) connecting innovators and physicians to existing Federal and non-Federal resources, including resources from the Food and Drug Administration, the National Institutes of Health, the Small Business Administration, the Department of Energy, the Department of Education, the National Science Foundation, the Department of Veterans Affairs, the Agency for Healthcare Research and Quality, and the National Institute of Standards and Technology;

"(4) assessing the scientific and medical merit of proposed pediatric device projects;

"(5) providing assistance and advice as needed on business development, personnel training, prototype development, postmarket needs, and other activities consistent with the purposes of this section; and

"(6) providing regulatory consultation to device sponsors in support of the submission of an application for a pediatric device, where appropriate.

"(d) Coordination.—

"(1) National institutes of health.—Each consortium that receives a grant or contract under this section shall—

"(A) coordinate with the National Institutes of Health's pediatric device contact point or office, designated under section 402(b)(23) of the Public Health Service Act [42 U.S.C. 282(b)(23)], as added by section 304(a) of this Act; and

"(B) provide to the National Institutes of Health any identified pediatric device needs that the consortium lacks sufficient capacity to address or those needs in which the consortium has been unable to stimulate manufacturer interest.

"(2) Food and drug administration.—Each consortium that receives a grant or contract under this section shall coordinate with the Commissioner of Food and Drugs and device companies to facilitate the application for approval or clearance of devices labeled for pediatric use.

"(3) Effectiveness and outcomes.—Each consortium that receives a grant or contract under this section shall annually report to the Secretary of Health and Human Services on the status of pediatric device development, production, and distribution that has been facilitated by the consortium.

"(e) Authorization of Appropriations.—There are authorized to be appropriated to carry out this section $5,250,000 for each of fiscal years 2018 through 2022."

Surveillances

Pub. L. 110–85, title VIII, §801(c), Sept. 27, 2007, 121 Stat. 921, provided that: "Not later than 12 months after the date of the enactment of this Act [Sept. 27, 2007], the Secretary of Health and Human Services shall issue guidance on how the requirements of section 402(j) of the Public Health Service Act [42 U.S.C. 282(j)], as added by this section, apply to a pediatric postmarket surveillance described in paragraph (1)(A)(ii)(II) of such section 402(j) that is not a clinical trial."

Preemption

Pub. L. 110–85, title VIII, §801(d), Sept. 27, 2007, 121 Stat. 922, provided that:

"(1) In general.—Upon the expansion of the registry and results data bank under section 402(j)(3)(D) of the Public Health Service Act [42 U.S.C. 282(j)(3)(D)], as added by this section, no State or political subdivision of a State may establish or continue in effect any requirement for the registration of clinical trials or for the inclusion of information relating to the results of clinical trials in a database.

"(2) Rule of construction.—The fact of submission of clinical trial information, if submitted in compliance with subsection (j) of section 402 of the Public Health Service Act (as amended by this section), that relates to a use of a drug or device not included in the official labeling of the approved drug or device shall not be construed by the Secretary of Health and Human Services or in any administrative or judicial proceeding, as evidence of a new intended use of the drug or device that is different from the intended use of the drug or device set forth in the official labeling of the drug or device. The availability of clinical trial information through the registry and results data bank under such subsection (j), if submitted in compliance with such subsection, shall not be considered as labeling, adulteration, or misbranding of the drug or device under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)."

Collaboration and Report

Pub. L. 105–115, title I, §113(b), Nov. 21, 1997, 111 Stat. 2312, directed the Secretary of Health and Human Services, the Director of the National Institutes of Health, and the Commissioner of Food and Drugs to collaborate to determine the feasibility of including device investigations within the scope of the data bank under subsec. (j) of this section, with the Secretary to report to Congress, not later than two years after Nov. 21, 1997, on the public health need, if any, for inclusion of device investigations within the scope of the data bank under subsec. (j), and on the adverse impact, if any, on device innovation and research in the United States if information relating to such device investigations was required to be publicly disclosed.

Chronic Fatigue Syndrome; Experts and Research Representatives on Advisory Committees and Boards

Pub. L. 103–43, title IX, §902(c), June 10, 1993, 107 Stat. 164, provided that: "The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall ensure that appropriate individuals with expertise in chronic fatigue syndrome or neuromuscular diseases and representative of a variety of disciplines and fields within the research community are appointed to appropriate National Institutes of Health advisory committees and boards."

Third-Party Payments Regarding Certain Clinical Trials and Certain Life-Threatening Illnesses

Pub. L. 103–43, title XIX, §1901(a), June 10, 1993, 107 Stat. 200, provided that: "The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall conduct a study for the purpose of—

"(1) determining the policies of third-party payors regarding the payment of the costs of appropriate health services that are provided incident to the participation of individuals as subjects in clinical trials conducted in the development of drugs with respect to acquired immune deficiency syndrome, cancer, and other life-threatening illnesses; and

"(2) developing recommendations regarding such policies."

Personnel Study of Recruitment, Retention and Turnover

Pub. L. 103–43, title XIX, §1905, June 10, 1993, 107 Stat. 203, directed Secretary of Health and Human Services, acting through Director of National Institutes of Health, to conduct a study to review the retention, recruitment, vacancy and turnover rates of support staff, including firefighters, law enforcement, procurement officers, technicians, nurses and clerical employees, to ensure that National Institutes of Health is adequately supporting conduct of efficient, effective and high quality research for the American public, and to submit a report to Congress on results of such study not later than 1 year after June 10, 1993.

Chronic Pain Conditions

Pub. L. 103–43, title XIX, §1907, June 10, 1993, 107 Stat. 204, directed Director of the National Institutes of Health to submit to Congress, not later than 2 years after June 10, 1993, a report and study on the incidence in the United States of cases of chronic pain, including chronic pain resulting from back injuries, reflex sympathetic dystrophy syndrome, temporomandibular joint disorder, post-herpetic neuropathy, painful diabetic neuropathy, phantom pain, and post-stroke pain, and the effect of such cases on the costs of health care in the United States.

Support for Bioengineering Research

Pub. L. 103–43, title XIX, §1912, June 10, 1993, 107 Stat. 206, directed Secretary of Health and Human Services, acting through Director of the National Institutes of Health, to conduct a study for the purpose of determining the sources and amounts of public and private funding devoted to basic research in bioengineering, including biomaterials sciences, cellular bioprocessing, tissue and rehabilitation engineering, evaluating whether that commitment is sufficient to maintain the innovative edge that the United States has in these technologies, evaluating the role of the National Institutes of Health or any other Federal agency to achieve a greater commitment to innovation in bioengineering, and evaluating the need for better coordination and collaboration among Federal agencies and between the public and private sectors, and, not later than 1 year after June 10, 1993, to prepare and submit to Committee on Labor and Human Resources of Senate, and Committee on Energy and Commerce of House of Representatives, a report containing the findings of the study together with recommendations concerning the enactment of legislation to implement the results of such study.

Master Plan for Physical Infrastructure for Research

Pub. L. 103–43, title XX, §2002, June 10, 1993, 107 Stat. 208, directed Secretary of Health and Human Services, acting through Director of the National Institutes of Health, not later than June 1, 1994, to present to Congress a master plan to provide for replacement or refurbishment of less than adequate buildings, utility equipment and distribution systems (including the resources that provide electrical and other utilities, chilled water, air handling, and other services that the Secretary, acting through the Director, deemed necessary), roads, walkways, parking areas, and grounds that underpin the laboratory and clinical facilities of the National Institutes of Health, and provided that the plan could make recommendations for the undertaking of new projects that are consistent with the objectives of this section, such as encircling the National Institutes of Health Federal enclave with an adequate chilled water conduit.

1 So in original. The word "of" probably should not appear.

2 So in original. The second closing parenthesis probably should not appear.

3 So in original.

4 So in original. The second closing parenthesis probably should not appear.

5 So in original. Probably should be "paragraph (2)(A)(ii)(I)(ll),".

§282a. Authorization of appropriations

(a) In general

(1) This subchapter

For purposes of carrying out this subchapter, there are authorized to be appropriated—

(A) $30,331,309,000 for fiscal year 2007;

(B) $32,831,309,000 for fiscal year 2008;

(C) such sums as may be necessary for fiscal year 2009;

(D) $34,851,000,000 for fiscal year 2018;

(E) $35,585,871,000 for fiscal year 2019; and

(F) $36,472,442,775 for fiscal year 2020.

(2) Funding for 10-year pediatric research initiative through Common Fund

For the purpose of carrying out section 282(b)(7)(B)(ii) of this title, there is authorized to be appropriated to the Common Fund, out of the 10-Year Pediatric Research Initiative Fund described in section 9008 of title 26, and in addition to amounts otherwise made available under paragraph (1) of this subsection and reserved under subsection (c)(1)(B)(i) of this section, $12,600,000 for each of fiscal years 2014 through 2023.

(b) Office of the Director

Of the amount authorized to be appropriated under subsection (a) for a fiscal year, there are authorized to be appropriated for programs and activities under this subchapter carried out through the Office of the Director of NIH such sums as may be necessary for each of the fiscal years 2007 through 2009.

(c) Trans-NIH research

(1) Common Fund

(A) Account

For the purpose of allocations under section 282(b)(7)(B) of this title (relating to research identified by the Division of Program Coordination, Planning, and Strategic Initiatives), there is established an account to be known as the Common Fund.

(B) Reservation

(i) In general

Of the total amount appropriated under subsection (a)(1) for fiscal year 2007 or any subsequent fiscal year, the Director of NIH shall reserve an amount for the Common Fund, subject to any applicable provisions in appropriations Acts.

(ii) Minimum amount

For each fiscal year, the percentage constituted by the amount reserved under clause (i) relative to the total amount appropriated under subsection (a)(1) for such year may not be less than the percentage constituted by the amount so reserved for the preceding fiscal year relative to the total amount appropriated under subsection (a)(1) for such preceding fiscal year, subject to any applicable provisions in appropriations Acts.

(C) Common Fund strategic planning report

As part of the National Institutes of Health Strategic Plan required under section 282(m) of this title, the Secretary, acting through the Director of NIH, shall submit a report to the Congress containing a strategic plan for funding research described in section 282(b)(7)(A)(i) of this title (including personnel needs) through the Common Fund. Each such plan shall include the following:

(i) An estimate of the amounts determined by the Director of NIH to be appropriate for maximizing the potential of such research.

(ii) An estimate of the amounts determined by the Director of NIH to be sufficient only for continuing to fund research activities previously identified by the Division of Program Coordination, Planning, and Strategic Initiatives.

(iii) An estimate of the amounts determined by the Director of NIH to be necessary to fund research described in section 282(b)(7)(A)(i) of this title

(I) that is in addition to the research activities described in clause (ii); and

(II) for which there is the most substantial need.

(D) Evaluation

During the 6-month period following the end of the first fiscal year for which the total amount reserved under subparagraph (B) is equal to 5 percent of the total amount appropriated under subsection (a)(1) for such fiscal year, the Secretary, acting through the Director of NIH, in consultation with the advisory council established under section 282(k) of this title, shall submit recommendations to the Congress for changes regarding amounts for the Common Fund.

(2) Trans-NIH research reporting

(A) Limitation

With respect to the total amount appropriated under subsection (a) for fiscal year 2008 or any subsequent fiscal year, if the head of a national research institute or national center fails to submit the report required by subparagraph (B) for the preceding fiscal year, the amount made available for the institute or center for the fiscal year involved may not exceed the amount made available for the institute or center for fiscal year 2006.

(B) Reporting

Not later than 2 years after December 13, 2016, the head of each national research institute or national center shall submit to the Director of the National Institutes of Health a report, to be included in the triennial report under section 283 of this title, on the amount made available by the institute or center for conducting or supporting research that involves collaboration between the institute or center and 1 or more other national research institutes or national centers.

(C) Determination

For purposes of determining the amount or percentage of funds to be reported under subparagraph (B), any amounts made available to an institute or center under section 282(b)(7)(B) of this title shall be included.

(D) Verification of amounts

Upon receipt of each report submitted under subparagraph (B), the Director of NIH shall review and, in cases of discrepancy, verify the accuracy of the amounts specified in the report.

(E) Waiver

At the request of any national research institute or national center, the Director of NIH may waive the application of this paragraph to such institute or center if the Director finds that the conduct or support of research described in subparagraph (B) is inconsistent with the mission of such institute or center.

(d) Transfer authority

Of the total amount appropriated under subsection (a)(1) for a fiscal year, the Director of NIH may (in addition to the reservation under subsection (c)(1) for such year) transfer not more than 1 percent for programs or activities that are authorized in this subchapter and identified by the Director to receive funds pursuant to this subsection. In making such transfers, the Director may not decrease any appropriation account under subsection (a)(1) by more than 1 percent.

(e) Rule of construction

This section may not be construed as affecting the authorities of the Director of NIH under section 281 of this title.

(July 1, 1944, ch. 373, title IV, §402A, as added Pub. L. 109–482, title I, §103(a), Jan. 15, 2007, 120 Stat. 3685; amended Pub. L. 113–94, §3(b), Apr. 3, 2014, 128 Stat. 1087; Pub. L. 114–255, div. A, title II, §§2001, 2031(b), 2042(a), Dec. 13, 2016, 130 Stat. 1047, 1056, 1073.)

Amendments

2016—Subsec. (a)(1)(D) to (F). Pub. L. 114–255, §2001, added subpars. (D) to (F).

Subsec. (c)(1)(C). Pub. L. 114–255, §2031(b), substituted "As part of the National Institutes of Health Strategic Plan required under section 282(m) of this title," for "Not later than June 1, 2007, and every 2 years thereafter,".

Subsec. (c)(2)(B). Pub. L. 114–255, §2042(a)(1), amended subpar. (B) generally. Prior to amendment, text read as follows: "Not later than January 1, 2008, and each January 1st thereafter—

"(i) the head of each national research institute or national center shall submit to the Director of NIH a report on the amount made available by the institute or center for conducting or supporting research that involves collaboration between the institute or center and 1 or more other national research institutes or national centers; and

"(ii) the Secretary shall submit a report to the Congress identifying the percentage of funds made available by each national research institute and national center with respect to such fiscal year for conducting or supporting research described in clause (i)."

Subsec. (c)(2)(D), (E). Pub. L. 114–255, §2042(a)(2), substituted "(B)" for "(B)(i)".

2014—Subsec. (a). Pub. L. 113–94, §3(b)(1)(B), which directed amendment of subsec. (a) by striking "For purposes of carrying out this subchapter" and inserting par. (1) designation, heading, and "For purposes of carrying out this subchapter", was executed by striking "For the purpose of carrying out this subchapter" and making the insertions as directed, to reflect the probable intent of Congress.

Pub. L. 113–94, §3(b)(1)(A), redesignated pars. (1) to (3) as subpars. (A) to (C), respectively, and realigned margins.

Subsec. (a)(2). Pub. L. 113–94, §3(b)(1)(C), added par. (2). Former par. (2) redesignated subpar. (B) of par. (1).

Subsecs. (c)(1)(B), (D), (d). Pub. L. 113–94, §3(b)(2), substituted "subsection (a)(1)" for "subsection (a)" wherever appearing.

Effective Date

Section 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.

Supplement, Not Supplant; Prohibition Against Transfer

Pub. L. 113–94, §3(c), Apr. 3, 2014, 128 Stat. 1087, provided that: "Funds appropriated pursuant to section 402A(a)(2) of the Public Health Service Act [42 U.S.C. 282a(a)(2)], as added by subsection (b)—

"(1) shall be used to supplement, not supplant, the funds otherwise allocated by the National Institutes of Health for pediatric research; and

"(2) notwithstanding any transfer authority in any appropriation Act, shall not be used for any purpose other than allocating funds for making grants as described in section 402(b)(7)(B)(ii) of the Public Health Service Act [42 U.S.C. 282(b)(7)(B)(ii)], as added by subsection (a)."

§282b. Electronic coding of grants and activities

The Secretary, acting through the Director of NIH, shall establish an electronic system to uniformly code research grants and activities of the Office of the Director and of all the national research institutes and national centers. The electronic system shall be searchable by a variety of codes, such as the type of research grant, the research entity managing the grant, and the public health area of interest. When permissible, the Secretary, acting through the Director of NIH, shall provide information on relevant literature and patents that are associated with research activities of the National Institutes of Health.

(July 1, 1944, ch. 373, title IV, §402B, as added Pub. L. 109–482, title I, §104(a)(3), Jan. 15, 2007, 120 Stat. 3689.)

Effective Date

Section 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.

§282c. Public access to funded investigators' final manuscripts

The Director of the National Institutes of Health ("NIH") shall require in the current fiscal year and thereafter that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine's PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law.

(Pub. L. 111–8, div. F, title II, §217, Mar. 11, 2009, 123 Stat. 782.)

Codification

Section was enacted as part of the Department of Health and Human Services Appropriations Act, 2009, and also as part of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2009, and the Omnibus Appropriations Act, 2009, and not as part of the Public Health Service Act which comprises this chapter.

§282d. Transferred

Codification

Section, act July 1, 1944, ch. 373, title IV, §402C, as added Pub. L. 111–148, title X, §10409(d), Mar. 23, 2010, 124 Stat. 978, which related to the Cures Acceleration Network, was renumbered section 480 of act July 1, 1944, by Pub. L. 112–74, div. F, title II, §221(c)(1)(A), Dec. 23, 2011, 125 Stat. 1089, and transferred to section 287a of this title.

§283. Triennial reports of Director of NIH

(a) In general

The Director of NIH shall submit to the Congress on a triennial basis a report in accordance with this section. The first report shall be submitted not later than 1 year after January 15, 2007. Each such report shall include the following information:

(1) An assessment of the state of biomedical and behavioral research.

(2) A description of the activities conducted or supported by the agencies of the National Institutes of Health and policies respecting the programs of such agencies.

(3) A description of intra-National Institutes of Health activities, including—

(A) identification of the percentage of funds made available by each national research institute and national center with respect to each applicable fiscal year for conducting or supporting research that involves collaboration between the institute or center and 1 or more other national research institutes or national centers; and

(B) recommendations for promoting coordination of information among the centers of excellence.


(4) A catalog of all the research activities of the agencies, prepared in accordance with the following:

(A) The catalog shall, for each such activity—

(i) identify the agency or agencies involved;

(ii) state whether the activity was carried out directly by the agencies or was supported by the agencies and describe to what extent the agency was involved; and

(iii) identify whether the activity was carried out through a center of excellence.


(B) In the case of clinical research, the catalog shall, as appropriate, identify study populations by demographic variables, including biological and social variables and relevant age categories (such as pediatric subgroups), and determinants of health, that contribute to research on minority health and health disparities.

(C) Research activities listed in the catalog shall include, where applicable, the following:

(i) Epidemiological studies and longitudinal studies.

(ii) Disease registries, information clearinghouses, and other data systems.

(iii) Public education and information campaigns.

(iv) Training activities, including—

(I) National Research Service Awards and Clinical Transformation Science Awards;

(II) graduate medical education programs, including information on the number and type of graduate degrees awarded during the period in which the programs received funding under this subchapter;

(III) investigator-initiated awards for postdoctoral training and postdoctoral training funded through research grants;

(IV) a breakdown by demographic variables and other appropriate categories; and

(V) an evaluation and comparison of outcomes and effectiveness of various training programs.


(v) Clinical trials, including a breakdown of participation by study populations and demographic variables, including relevant age categories (such as pediatric subgroups), information submitted by each national research institute and national center to the Director of National Institutes of Health under section 289a–2(f) of this title, and such other information as may be necessary to demonstrate compliance with section 289a–2 of this title and other applicable requirements regarding inclusion of demographic groups.

(vi) Translational research activities with other agencies of the Public Health Service.


(5) A summary of the research activities throughout the agencies, which summary shall be organized by the following categories, where applicable:

(A) Cancer.

(B) Neurosciences.

(C) Life stages, human development, and rehabilitation.

(D) Organ systems.

(E) Autoimmune diseases.

(F) Genomics.

(G) Molecular biology and basic science.

(H) Technology development.

(I) Chronic diseases, including pain and palliative care.

(J) Infectious diseases and bioterrorism.

(K) Minority health and health disparities.

(L) Such additional categories as the Director determines to be appropriate.


(6) A review of each entity receiving funding under this subchapter in its capacity as a center of excellence (in this paragraph referred to as a "center of excellence"), including the following—

(A) an evaluation of the performance and research outcomes of each center of excellence; and

(B) recommendations for improving the effectiveness, efficiency, and outcomes of the centers of excellence.

(b) Requirement regarding disease-specific research activities

In a report under subsection (a), the Director of NIH, when reporting on research activities relating to a specific disease, disorder, or other adverse health condition, shall—

(1) present information in a standardized format;

(2) identify the actual dollar amounts obligated for such activities; and

(3) include a plan for research on the specific disease, disorder, or other adverse health condition, including a statement of objectives regarding the research, the means for achieving the objectives, a date by which the objectives are expected to be achieved, and justifications for revisions to the plan.

(c) Additional reports

In addition to reports required by subsections (a) and (b), the Director of NIH or the head of a national research institute or national center may submit to the Congress such additional reports as the Director or the head of such institute or center determines to be appropriate.

(July 1, 1944, ch. 373, title IV, §403, as added Pub. L. 109–482, title I, §104(a)(3), Jan. 15, 2007, 120 Stat. 3689; amended Pub. L. 110–85, title XI, §1104(3), Sept. 27, 2007, 121 Stat. 975; Pub. L. 114–255, div. A, title II, §2032, Dec. 13, 2016, 130 Stat. 1056.)

Prior Provisions

A prior section 283, act July 1, 1944, ch. 373, title IV, §403, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 826; amended Pub. L. 100–607, title I, §112, Nov. 4, 1988, 102 Stat. 3052, required a biennial report by the Director to the President and Congress, prior to repeal by Pub. L. 109–482, title I, §104(a)(3), Jan. 15, 2007, 120 Stat. 3689.

Amendments

2016Pub. L. 114–255, §2032(1), substituted "Triennial" for "Biennial" in section catchline.

Subsec. (a). Pub. L. 114–255, §2032(2)(A), substituted "triennial" for "biennial" in introductory provisions.

Subsec. (a)(3). Pub. L. 114–255, §2032(2)(B), amended par. (3) generally. Prior to amendment, par. (3) read as follows: "Classification and justification for the priorities established by the agencies, including a strategic plan and recommendations for future research initiatives to be carried out under section 282(b)(7) of this title through the Division of Program Coordination, Planning, and Strategic Initiatives."

Subsec. (a)(4)(B). Pub. L. 114–255, §2032(2)(C)(i), substituted "demographic variables, including biological and social variables and relevant age categories (such as pediatric subgroups), and determinants of health," for "demographic variables and other variables".

Subsec. (a)(4)(C)(v). Pub. L. 114–255, §2032(2)(C)(ii), substituted "demographic variables, including relevant age categories (such as pediatric subgroups), information submitted by each national research institute and national center to the Director of National Institutes of Health under section 289a–2(f) of this title, and such" for "demographic variables and such" and "and other applicable requirements regarding inclusion of demographic groups" for "(regarding inclusion of women and minorities in clinical research)".

Subsec. (a)(6). Pub. L. 114–255, §2032(2)(D), substituted "the following—" for "the following:" in introductory provisions, "an evaluation" for "An evaluation" and "; and" for the period in subpar. (A), redesignated subpar. (C) as (B) and substituted "recommendations" for "Recommendations", and struck out former subpars. (B) and (D), which read as follows:

"(B) Recommendations for promoting coordination of information among the centers of excellence.

"(D) If no additional centers of excellence have been funded under this subchapter since the previous report under this section, an explanation of the reasons for not funding any additional centers."

2007—Subsec. (a)(4)(C)(iv)(III). Pub. L. 110–85 inserted "and postdoctoral training funded through research grants" before semicolon at end.

Effective Date

Section 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.

§283a. Annual reporting to increase interagency collaboration and coordination

(a) Collaboration with other HHS agencies

On an annual basis, the Director of NIH shall submit to the Secretary a report on the activities of the National Institutes of Health involving collaboration with other agencies of the Department of Health and Human Services.

(b) Clinical trials

Each calendar year, the Director of NIH shall submit to the Commissioner of Food and Drugs a report that identifies each clinical trial that is registered during such calendar year in the databank of information established under section 282(i) of this title.

(c) Human tissue samples

On an annual basis, the Director of NIH shall submit to the Congress a report that describes how the National Institutes of Health and its agencies store and track human tissue samples.

(d) First report

The first report under subsections (a), (b), and (c) shall be submitted not later than 1 year after January 15, 2007.

(July 1, 1944, ch. 373, title IV, §403A, as added Pub. L. 109–482, title I, §104(a)(3), Jan. 15, 2007, 120 Stat. 3691.)

Prior Provisions

A prior section 403A of act July 1, 1944, was renumbered section 403D and is classified to section 283a–3 of this title.

Effective Date

Section 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.

§283a–1. Annual reporting to prevent fraud and abuse

(a) Whistleblower complaints

(1) In general

On an annual basis, the Director of NIH shall submit to the Inspector General of the Department of Health and Human Services, the Secretary, the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate a report summarizing the activities of the National Institutes of Health relating to whistleblower complaints.

(2) Contents

For each whistleblower complaint pending during the year for which a report is submitted under this subsection, the report shall identify the following:

(A) Each agency of the National Institutes of Health involved.

(B) The status of the complaint.

(C) The resolution of the complaint to date.

(b) First report

The first report under subsection (a) shall be submitted not later than 1 year after January 15, 2007.

(July 1, 1944, ch. 373, title IV, §403B, as added Pub. L. 109–482, title I, §104(a)(3), Jan. 15, 2007, 120 Stat. 3691; amended Pub. L. 114–255, div. A, title II, §2042(b), Dec. 13, 2016, 130 Stat. 1073.)

Amendments

2016—Subsecs. (b), (c). Pub. L. 114–255 redesignated subsec. (c) as (b), substituted "subsection (a)" for "subsections (a) and (b)", and struck out former subsec. (b), which related to annual report by the Director of NIH on experts and consultants whose services were obtained by the National Institutes of Health or its agencies.

Effective Date

Section 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.

§283a–2. Annual reporting regarding training of graduate students for doctoral degrees

(a) In general

Each institution receiving an award under this subchapter for the training of graduate students for doctoral degrees shall annually report to the Director of NIH, with respect to graduate students supported by the National Institutes of Health at such institution—

(1) the percentage of such students admitted for study who successfully attain a doctoral degree; and

(2) for students described in paragraph (1), the average time between the beginning of graduate study and the receipt of a doctoral degree.

(3) 1 Provision of information to applicants

Each institution described in subsection (a) shall provide to each student submitting an application for a program of graduate study at such institution the information described in paragraphs (1) and (2) of such subsection with respect to the program or programs to which such student has applied.

(July 1, 1944, ch. 373, title IV, §403C, as added Pub. L. 109–482, title I, §104(a)(3), Jan. 15, 2007, 120 Stat. 3692; amended Pub. L. 110–85, title XI, §1104(5), Sept. 27, 2007, 121 Stat. 975; Pub. L. 114–255, div. A, title II, §2042(c), Dec. 13, 2016, 130 Stat. 1073.)

Prior Provisions

A prior section 403C of act July 1, 1944, was renumbered section 403D and is classified to section 283a–3 of this title.

Amendments

2016—Subsec. (a)(2). Pub. L. 114–255 struck out "(not including any leaves of absence)" after "time".

2007—Subsec. (a). Pub. L. 110–85, §1104(5)(A), substituted "graduate students supported by the National Institutes of Health" for "each degree-granting program" in introductory provisions.

Subsec. (a)(1). Pub. L. 110–85, §1104(5)(B), inserted "such" after "percentage of".

Subsec. (a)(2). Pub. L. 110–85, §1104(5)(C), inserted "(not including any leaves of absence)" after "average time".

Effective Date

Section 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.

1 So in original. Probably should be "(b)".

§283a–3. Establishment of program regarding DES

(a) In general

The Director of NIH shall establish a program for the conduct and support of research and training, the dissemination of health information, and other programs with respect to the diagnosis and treatment of conditions associated with exposure to the drug diethylstilbestrol (in this section referred to as "DES").

(b) Education programs

In carrying out subsection (a), the Director of NIH, after consultation with nonprofit private entities representing individuals who have been exposed to DES, shall conduct or support programs to educate health professionals and the public on the drug, including the importance of identifying and treating individuals who have been exposed to the drug.

(c) Longitudinal studies

After consultation with the Office of Research on Women's Health, the Director of NIH, acting through the appropriate national research institutes, shall in carrying out subsection (a) conduct or support one or more longitudinal studies to determine the incidence of the following diseases or disorders in the indicated populations and the relationship of DES to the diseases or disorders:

(1) In the case of women to whom (on or after January 1, 1938) DES was administered while the women were pregnant, the incidence of all diseases and disorders (including breast cancer, gynecological cancers, and impairments of the immune system, including autoimmune disease).

(2) In the case of women exposed to DES in utero, the incidence of clear cell cancer (including recurrences), the long-term health effects of such cancer, and the effects of treatments for such cancer.

(3) In the case of men and women exposed to DES in utero, the incidence of all diseases and disorders (including impairments of the reproductive and autoimmune systems).

(4) In the case of children of men or women exposed to DES in utero, the incidence of all diseases and disorders.

(d) Exposure to DES in utero

For purposes of this section, an individual shall be considered to have been exposed to DES in utero if, during the pregnancy that resulted in the birth of such individual, DES was (on or after January 1, 1938) administered to the biological mother of the individual.

(July 1, 1944, ch. 373, title IV, §403D, formerly §403A, as added Pub. L. 102–409, §2, Oct. 13, 1992, 106 Stat. 2092; amended Pub. L. 105–340, title I, §101(a), Oct. 31, 1998, 112 Stat. 3191; renumbered §403C and amended Pub. L. 109–482, title I, §§103(b)(2), 104(a)(1), Jan. 15, 2007, 120 Stat. 3687, 3689; renumbered §403D, Pub. L. 110–85, title XI, §1104(4), Sept. 27, 2007, 121 Stat. 975.)

Codification

Section was formerly classified to section 283a of this title prior to renumbering by Pub. L. 109–482.

Amendments

2007—Subsec. (e). Pub. L. 109–482, §103(b)(2), struck out subsec. (e) which read as follows: "In addition to any other authorization of appropriations available for the purpose of carrying out this section, there are authorized to be appropriated for such purpose such sums as may be necessary for each of the fiscal years 1993 through 2003."

1998—Subsec. (e). Pub. L. 105–340 substituted "2003" for "1996".

Effective Date of 2007 Amendment

Amendment 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 a note under section 281 of this title.

§283b. Repealed. Pub. L. 106–525, title I, §101(b)(2), Nov. 22, 2000, 114 Stat. 2501

Section, act July 1, 1944, ch. 373, title IV, §404, as added Pub. L. 103–43, title I, §151, June 10, 1993, 107 Stat. 139, related to the establishment and purpose of the Office of Research on Minority Health.

§283c. Office of Behavioral and Social Sciences Research

(a) There is established within the Office of the Director of NIH an office to be known as the Office of Behavioral and Social Sciences Research (in this section referred to as the "Office"). The Office shall be headed by a director, who shall be appointed by the Director of NIH.

(b)(1) With respect to research on the relationship between human behavior and the development, treatment, and prevention of medical conditions, the Director of the Office shall—

(A) coordinate research conducted or supported by the agencies of the National Institutes of Health; and

(B) identify projects of behavioral and social sciences research that should be conducted or supported by the national research institutes, and develop such projects in cooperation with such institutes.


(2) Research authorized under paragraph (1) includes research on teen pregnancy, infant mortality, violent behavior, suicide, and homelessness. Such research does not include neurobiological research, or research in which the behavior of an organism is observed for the purpose of determining activity at the cellular or molecular level.

(July 1, 1944, ch. 373, title IV, §404A, as added Pub. L. 103–43, title II, §203(a), June 10, 1993, 107 Stat. 145.)

Effective Date

Pub. L. 103–43, title II, §203(c), June 10, 1993, 107 Stat. 146, provided that: "The amendment described in subsection (a) [enacting this section] is made upon the date of the enactment of this Act [June 10, 1993] and takes effect July 1, 1993. Subsection (b) [107 Stat. 145] takes effect on such date."

§283d. Children's Vaccine Initiative

The Secretary, in consultation with the Director of the National Vaccine Program under subchapter XIX and acting through the Directors of the National Institute for Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute for Aging, and other public and private programs, shall carry out activities, which shall be consistent with the global Children's Vaccine Initiative, to develop affordable new and improved vaccines to be used in the United States and in the developing world that will increase the efficacy and efficiency of the prevention of infectious diseases. In carrying out such activities, the Secretary shall, to the extent practicable, develop and make available vaccines that require fewer contacts to deliver, that can be given early in life, that provide long lasting protection, that obviate refrigeration, needles and syringes, and that protect against a larger number of diseases.

(July 1, 1944, ch. 373, title IV, §404B, as added Pub. L. 103–43, title II, §204, June 10, 1993, 107 Stat. 146; amended Pub. L. 109–482, title I, §103(b)(3), Jan. 15, 2007, 120 Stat. 3687; Pub. L. 110–154, §1(b)(2), Dec. 21, 2007, 121 Stat. 1827; Pub. L. 114–255, div. A, title II, §2042(d), Dec. 13, 2016, 130 Stat. 1073.)

Amendments

2016Pub. L. 114–255 struck out subsec. (a) designation and heading "Development of New Vaccines" and subsec. (b). Prior to amendment, text of subsec. (b) read as follows: "In the report required in section 300aa–4 of this title, the Secretary, acting through the Director of the National Vaccine Program under subchapter XIX, shall include information with respect to activities and the progress made in implementing the provisions of this section and achieving its goals."

2007—Subsec. (a). Pub. L. 110–154 substituted "Eunice Kennedy Shriver National Institute of Child Health and Human Development" for "National Institute for Child Health and Human Development".

Subsec. (c). Pub. L. 109–482 struck out heading and text of subsec. (c). Text read as follows: "In addition to any other amounts authorized to be appropriated for activities of the type described in this section, there are authorized to be appropriated to carry out this section $20,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 and 1996."

Effective Date of 2007 Amendment

Amendment 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 a note under section 281 of this title.

§283e. Plan for use of animals in research

(a) Preparation

The Director of NIH, after consultation with the committee established under subsection (e), shall prepare a plan—

(1) for the National Institutes of Health to conduct or support research into—

(A) methods of biomedical research and experimentation that do not require the use of animals;

(B) methods of such research and experimentation that reduce the number of animals used in such research;

(C) methods of such research and experimentation that produce less pain and distress in such animals; and

(D) methods of such research and experimentation that involve the use of marine life (other than marine mammals);


(2) for establishing the validity and reliability of the methods described in paragraph (1);

(3) for encouraging the acceptance by the scientific community of such methods that have been found to be valid and reliable; and

(4) for training scientists in the use of such methods that have been found to be valid and reliable.

(b) Submission to Congressional committees

Not later than October 1, 1993, the Director of NIH 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, the plan required in subsection (a) and shall begin implementation of the plan.

(c) Periodic review and revision

The Director of NIH shall periodically review, and as appropriate, make revisions in the plan required under subsection (a). A description of any revision made in the plan shall be included in the first biennial report under section 283 of this title that is submitted after the revision is made.

(d) Dissemination of information

The Director of NIH shall take such actions as may be appropriate to convey to scientists and others who use animals in biomedical or behavioral research or experimentation information respecting the methods found to be valid and reliable under subsection (a)(2).

(e) Interagency Coordinating Committee on the Use of Animals in Research

(1) The Director of NIH shall establish within the National Institutes of Health a committee to be known as the Interagency Coordinating Committee on the Use of Animals in Research (in this subsection referred to as the "Committee").

(2) The Committee shall provide advice to the Director of NIH on the preparation of the plan required in subsection (a).

(3) The Committee shall be composed of—

(A) the Directors of each of the national research institutes (or the designees of such Directors); and

(B) representatives of the Environmental Protection Agency, the Food and Drug Administration, the Consumer Product Safety Commission, the National Science Foundation, and such additional agencies as the Director of NIH determines to be appropriate, which representatives shall include not less than one veterinarian with expertise in laboratory-animal medicine.

(July 1, 1944, ch. 373, title IV, §404C, as added Pub. L. 103–43, title II, §205(a), June 10, 1993, 107 Stat. 146; amended Pub. L. 112–74, div. F, title II, §221(d)(2), Dec. 23, 2011, 125 Stat. 1090.)

Amendments

2011—Subsec. (e)(3)(A). Pub. L. 112–74 struck out "and the Director of the Center for Research Resources" after "institutes".

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.

§283f. Requirements regarding surveys of sexual behavior

With respect to any survey of human sexual behavior proposed to be conducted or supported through the National Institutes of Health, the survey may not be carried out unless—

(1) the proposal has undergone review in accordance with any applicable requirements of sections 289 and 289a of this title; and

(2) the Secretary, in accordance with section 289a–1 of this title, makes a determination that the information expected to be obtained through the survey will assist—

(A) in reducing the incidence of sexually transmitted diseases, the incidence of infection with the human immunodeficiency virus, or the incidence of any other infectious disease; or

(B) in improving reproductive health or other conditions of health.

(July 1, 1944, ch. 373, title IV, §404D, as added Pub. L. 103–43, title II, §207, June 10, 1993, 107 Stat. 148.)

Prohibition Against SHARP Adult Sex Survey and American Teenage Sex Survey

Pub. L. 103–43, title XX, §2015, June 10, 1993, 107 Stat. 217, provided that: "The Secretary of Health and Human Services may not during fiscal year 1993 or any subsequent fiscal year conduct or support the SHARP survey of adult sexual behavior or the American Teenage Study of adolescent sexual behavior. This section becomes effective on the date of the enactment of this Act [June 10, 1993]."

§283g. Muscular dystrophy; initiative through Director of National Institutes of Health

(a) Expansion, intensification, and coordination of activities

(1) In general

The Director of NIH, in coordination with the Directors of the National Institute of Neurological Disorders and Stroke, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Heart, Lung, and Blood Institute, and the other national research institutes as appropriate, shall expand and intensify programs of such Institutes with respect to research and related activities concerning various forms of muscular dystrophy, including Duchenne, Becker, congenital muscular dystrophy, limb-girdle muscular dystrophy, myotonic, facioscapulohumeral muscular dystrophy (referred to in this section as "FSHD") and other forms of muscular dystrophy.

(2) Coordination

The Directors referred to in paragraph (1) shall jointly coordinate the programs referred to in such paragraph and consult with the Muscular Dystrophy Interagency Coordinating Committee established under section 6 of the MD–CARE Act.1

(3) Allocations by Director of NIH

The Director of NIH shall allocate the amounts appropriated to carry out this section for each fiscal year among the national research institutes referred to in paragraph (1).

(b) Centers of excellence

(1) In general

The Director of NIH shall award grants and contracts under subsection (a)(1) to public or nonprofit private entities to pay all or part of the cost of planning, establishing, improving, and providing basic operating support for centers of excellence regarding research on various forms of muscular dystrophy. Such centers of excellence shall be known as the "Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers".

(2) Research

Each center under paragraph (1) shall supplement but not replace the establishment of a comprehensive research portfolio in all the muscular dystrophies. As a whole, the centers shall conduct basic and clinical research in all forms of muscular dystrophy including early detection, diagnosis, prevention, and treatment, including the fields of muscle biology, genetics, noninvasive imaging, cardiac and pulmonary function, and pharmacological and other therapies.

(3) Coordination of centers

The Director of NIH shall, as appropriate, provide for the coordination of information among centers under paragraph (1) and ensure regular communication and sharing of data between such centers.

(4) Organization of centers

Each center under paragraph (1) shall use the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may be prescribed by the Director of NIH.

(5) Duration of support

Support for a center established under paragraph (1) may be provided under this section for a period of not to exceed 5 years. Such period may be extended for 1 or more additional periods not exceeding 5 years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director of NIH and if such group has recommended to the Director that such period should be extended.

(c) Facilitation of research

The Director of NIH shall provide for a program under subsection (a)(1) under which samples of tissues and genetic materials that are of use in research on muscular dystrophy are donated, collected, preserved, and made available for such research. The program shall be carried out in accordance with accepted scientific and medical standards for the donation, collection, and preservation of such samples.

(d) Coordinating Committee

(1) In general

The Secretary shall establish the Muscular Dystrophy Coordinating Committee (referred to in this section as the "Coordinating Committee") to coordinate activities across the National Institutes and with other Federal health programs and activities relating to the various forms of muscular dystrophy.

(2) Composition

The Coordinating Committee shall consist of not more than 18 members to be appointed by the Secretary, of which—

(A) 2/3 of such members shall represent governmental agencies, including the directors or their designees of each of the national research institutes involved in research with respect to muscular dystrophy and representatives of all other Federal departments and agencies whose programs involve health functions or responsibilities relevant to such diseases, including the Centers for Disease Control and Prevention, the Health Resources and Services Administration, the Food and Drug Administration, and the Administration for Community Living and representatives of other governmental agencies that serve children and adults with muscular dystrophy, including the Department of Education and the Social Security Administration; and

(B) 1/3 of such members shall be public members, including a broad cross section of persons affected with muscular dystrophies including parents or legal guardians, affected individuals, researchers, and clinicians.


Members appointed under subparagraph (B) shall serve for a term of 3 years, and may serve for an unlimited number of terms if reappointed.

(3) Chair

(A) In general

With respect to muscular dystrophy, the Chair of the Coordinating Committee shall serve as the principal advisor to the Secretary, the Assistant Secretary for Health, and the Director of NIH, and shall provide advice to the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and Drugs, and to the heads of other relevant agencies. The Coordinating Committee shall select the Chair for a term not to exceed 2 years.

(B) Appointment

The Chair of the Committee shall be appointed by and be directly responsible to the Secretary.

(4) Administrative support; terms of service; other provisions

The following shall apply with respect to the Coordinating Committee:

(A) The Coordinating Committee shall receive necessary and appropriate administrative support from the Department of Health and Human Services.

(B) The Coordinating Committee shall meet as appropriate as determined by the Secretary, in consultation with the chair,2 but shall meet no fewer than two times per calendar year.

(e) Plan for HHS activities

(1) In general

Not later than 1 year after December 18, 2001, the Coordinating Committee shall develop a plan for conducting and supporting research and education on muscular dystrophy through the agencies represented on the Coordinating Committee pursuant to subsection (d)(2)(A) and shall periodically review and revise the plan. The plan shall—

(A) provide for a broad range of research and education activities relating to biomedical, epidemiological, psychosocial, public services, and rehabilitative issues, including studies of the impact of such diseases in rural and underserved communities, studies to demonstrate the cost-effectiveness of providing independent living resources and support to patients with various forms of muscular dystrophy, and studies to determine optimal clinical care interventions for adults with various forms of muscular dystrophy;

(B) identify priorities among the programs and activities of the National Institutes of Health regarding such diseases; and

(C) reflect input from a broad range of scientists, patients, and advocacy groups.

(2) Certain elements of plan

The plan under paragraph (1) shall, with respect to each form of muscular dystrophy, provide for the following as appropriate:

(A) Research to determine the reasons underlying the incidence and prevalence of various forms of muscular dystrophy.

(B) Basic research concerning the etiology and genetic links of the disease and potential causes of mutations.

(C) The development of improved screening techniques.

(D) Basic and clinical research for the development and evaluation of new treatments, including new biological agents and new clinical interventions to improve the health of those with muscular dystrophy.

(E) Information and education programs for health care professionals and the public.

(f) Public input

The Secretary shall, under subsection (a)(1), provide for a means through which the public can obtain information on the existing and planned programs and activities of the Department of Health and Human Services with respect to various forms of muscular dystrophy and through which the Secretary can receive comments from the public regarding such programs and activities.

(g) Clinical research

The Coordinating Committee may evaluate the potential need to enhance the clinical research infrastructure required to test emerging therapies for the various forms of muscular dystrophy by prioritizing the achievement of the goals related to this topic in the plan under subsection (e)(1).

(July 1, 1944, ch. 373, title IV, §404E, as added Pub. L. 107–84, §3, Dec. 18, 2001, 115 Stat. 824; amended Pub. L. 109–482, title I, §§103(b)(4), 104(b)(1)(A), Jan. 15, 2007, 120 Stat. 3687, 3692; Pub. L. 110–154, §1(b)(3), Dec. 21, 2007, 121 Stat. 1827; Pub. L. 110–361, §2, Oct. 8, 2008, 122 Stat. 4010; Pub. L. 113–166, §2, Sept. 26, 2014, 128 Stat. 1879.)

References in Text

Section 6 of the MD–CARE Act, referred to in subsec. (a)(2), is section 6 of Pub. L. 107–84, which was formerly set out as a note under section 247b–18 of this title and does not relate to establishment of a coordinating committee. However, subsec. (d) of this section contains provisions relating to the establishment of the Muscular Dystrophy Coordinating Committee.

Prior Provisions

A prior section 283g, act July 1, 1944, ch. 373, title IV, §404E, as added Pub. L. 103–43, title II, §209, June 10, 1993, 107 Stat. 149, related to Office of Alternative Medicine, prior to repeal by Pub. L. 105–277, div. A, §101(f) [title VI, §601(1)], Oct. 21, 1998, 112 Stat. 2681–337, 2681-387.

Amendments

2014—Subsec. (a)(1). Pub. L. 113–166, §2(1), substituted "Musculoskeletal" for "Muscoskeletal" and inserted "Becker, congenital muscular dystrophy, limb-girdle muscular dystrophy," after "Duchenne,".

Subsec. (b)(2). Pub. L. 113–166, §2(2)(A), substituted "cardiac and pulmonary function, and pharmacological" for "genetics, pharmacological".

Subsec. (b)(3). Pub. L. 113–166, §2(2)(B), inserted "and sharing of data" after "regular communication".

Subsec. (d)(2). Pub. L. 113–166, §2(3)(A)(i), substituted "18" for "15" in introductory provisions.

Subsec. (d)(2)(A). Pub. L. 113–166, §2(3)(A)(ii), substituted ", the Food and Drug Administration, and the Administration for Community Living" for "and the Food and Drug Administration" and "including the Department of Education and the Social Security Administration" for "such as the Department of Education" and inserted "and adults" after "children".

Subsec. (d)(4)(B). Pub. L. 113–166, §2(3)(B), inserted ", but shall meet no fewer than two times per calendar year" before period at end.

Subsec. (e)(1). Pub. L. 113–166, §2(4)(A)(i), substituted "through the agencies represented on the Coordinating Committee pursuant to subsection (d)(2)(A)" for "through the national research institutes" in introductory provisions.

Subsec. (e)(1)(A). Pub. L. 113–166, §2(4)(A)(ii), inserted "public services," after "psychosocial," and ", studies to demonstrate the cost-effectiveness of providing independent living resources and support to patients with various forms of muscular dystrophy, and studies to determine optimal clinical care interventions for adults with various forms of muscular dystrophy" after "including studies of the impact of such diseases in rural and underserved communities".

Subsec. (e)(2)(D). Pub. L. 113–166, §2(4)(B), inserted "and new clinical interventions to improve the health of those with muscular dystrophy" after "including new biological agents".

2008—Subsec. (a)(1). Pub. L. 110–361, §2(b)(1), inserted "the National Heart, Lung, and Blood Institute," after "the Eunice Kennedy Shriver National Institute of Child Health and Human Development,".

Subsec. (b)(1). Pub. L. 110–361, §2(b)(2), inserted at end "Such centers of excellence shall be known as the 'Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers'."

Subsec. (f). Pub. L. 110–361, §2(a), redesignated subsec. (g) as (f) and struck out former subsec. (f) which related to reports.

Subsec. (g). Pub. L. 110–361, §2(a), (b)(3), added subsec. (g) and redesignated former subsec. (g) as (f).

2007Pub. L. 109–482, §104(b)(1)(A)(ii), which directed amendment of subsec. (b) by striking subsec. (f) and redesignating subsec. (g) as (f), could not literally be executed and was not executed in view of amendments by Pub. L. 110–361. See 2008 Amendment notes above.

Subsec. (a)(1). Pub. L. 110–154 substituted "Eunice Kennedy Shriver National Institute of Child Health and Human Development" for "National Institute of Child Health and Human Development".

Subsec. (b)(3). Pub. L. 109–482, §104(b)(1)(A)(i), amended heading and text of par. (3) generally. Text read as follows: "The Director of NIH—

"(A) shall, as appropriate, provide for the coordination of information among centers under paragraph (1) and ensure regular communication between such centers; and

"(B) shall require the periodic preparation of reports on the activities of the centers and the submission of the reports to the Director."

Subsec. (h). Pub. L. 109–482, §103(b)(4), struck out heading and text of subsec. (h). Text read as follows: "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 2002 through 2006. The authorization of appropriations established in the preceding sentence is in addition to any other authorization of appropriations that is available for conducting or supporting through the National Institutes of Health research and other activities with respect to muscular dystrophy."

Effective Date of 2007 Amendment

Amendment 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 a note under section 281 of this title.

1 See References in Text note below.

2 So in original. Probably should be capitalized.

§§283h, 283i. Transferred

Codification

Section 283h, act July 1, 1944, ch. 373, title IV, §404F, as added Pub. L. 107–280, §3, Nov. 6, 2002, 116 Stat. 1989; amended Pub. L. 109–482, title I, §§103(b)(5), 104(b)(1)(B), Jan. 15, 2007, 120 Stat. 3687, 3693, which related to the Office of Rare Diseases, was renumbered section 481 of act July 1, 1944, by Pub. L. 112–74, div. F, title II, §221(c)(2)(A)(i), Dec. 23, 2011, 125 Stat. 1089, and transferred to section 287a–1 of this title.

Section 283i, act July 1, 1944, ch. 373, title IV, §404G, as added Pub. L. 107–280, §4, Nov. 6, 2002, 116 Stat. 1990; amended Pub. L. 109–482, title I, §103(b)(6), Jan. 15, 2007, 120 Stat. 3687, which related to rare disease regional centers of excellence, was renumbered section 481A of act July 1, 1944, by Pub. L. 112–74, div. F, title II, §221(c)(3), Dec. 23, 2011, 125 Stat. 1089, and transferred to section 287a–2 of this title.

§283j. Repealed. Pub. L. 114–255, div. A, title II, §2042(f)(1), Dec. 13, 2016, 130 Stat. 1073

Section, July 1, 1944, ch. 373, title IV, §404H, as added Pub. L. 109–416, §2(b), Dec. 19, 2006, 120 Stat. 2821, required review and report on centers of excellence funded under this subchapter.

§283k. Biomedical and behavioral research facilities

(a) Modernization and construction of facilities

(1) In general

The Director of NIH, acting through the Office of the Director of NIH or the Director of the National Institute of Allergy and Infectious Diseases, may make grants or contracts to public and nonprofit private entities to expand, remodel, renovate, or alter existing research facilities or construct new research facilities, subject to the provisions of this section.

(2) Construction and cost of construction

For purposes of this section, the terms "construction" and "cost of construction" include the construction of new buildings and the expansion, renovation, remodeling, and alteration of existing buildings, including architects' fees, but do not include the cost of acquisition of land or off-site improvements.

(b) Scientific and technical review boards for merit-based review of proposals

(1) In general: approval as precondition to grants

(A) Establishment

There is established a Scientific and Technical Review Board on Biomedical and Behavioral Research Facilities (referred to in this section as the "Board").

(B) Requirement

The Director of NIH, acting through the Office of the Director of NIH, may approve an application for a grant under subsection (a) only if the Board has under paragraph (2) recommended the application for approval.

(2) Duties

(A) Advice

The Board shall provide advice to the Director of NIH and the Council of Councils established under section 282(l) of this title (in this section referred to as the "Council") in carrying out this section.

(B) Determination of merit

In carrying out subparagraph (A), the Board shall make a determination of the merit of each application submitted for a grant under subsection (a), after consideration of the requirements established in subsection (c), and shall report the results of the determination to the Director of NIH and the Council. Such determinations shall be conducted in a manner consistent with procedures established under section 289a of this title.

(C) Amount

In carrying out subparagraph (A), the Board shall, in the case of applications recommended for approval, make recommendations to the Director and the Council on the amount that should be provided under the grant.

(D) Annual report

In carrying out subparagraph (A), the Board shall prepare an annual report for the Director of NIH and the Council describing the activities of the Board in the fiscal year for which the report is made. Each such report shall be available to the public, and shall—

(i) summarize and analyze expenditures made under this section;

(ii) provide a summary of the types, numbers, and amounts of applications that were recommended for grants under subsection (a) but that were not approved by the Director of NIH; and

(iii) contain the recommendations of the Board for any changes in the administration of this section.

(3) Membership

(A) In general

Subject to subparagraph (B), the Board shall be composed of 15 members to be appointed by the Director of NIH, acting through the Office of the Director of NIH, and such ad-hoc or temporary members as the Director of NIH, acting through the Office of the Director of NIH, determines to be appropriate. All members of the Board, including temporary and ad-hoc members, shall be voting members.

(B) Limitation

Not more than three individuals who are officers or employees of the Federal Government may serve as members of the Board.

(4) Certain requirements regarding membership

In selecting individuals for membership on the Board, the Director of NIH, acting through the Office of the Director of NIH, shall ensure that the members are individuals who, by virtue of their training or experience, are eminently qualified to perform peer review functions. In selecting such individuals for such membership, the Director of NIH, acting through the Office of the Director of NIH, shall ensure that the members of the Board collectively—

(A) are experienced in the planning, construction, financing, and administration of entities that conduct biomedical or behavioral research sciences;

(B) are knowledgeable in making determinations of the need of entities for biomedical or behavioral research facilities, including such facilities for the dentistry, nursing, pharmacy, and allied health professions;

(C) are knowledgeable in evaluating the relative priorities for applications for grants under subsection (a) in view of the overall research needs of the United States; and

(D) are experienced with emerging centers of excellence, as described in subsection (c)(2).

(5) Certain authorities

(A) Workshops and conferences

In carrying out paragraph (2), the Board may convene workshops and conferences, and collect data as the Board considers appropriate.

(B) Subcommittees

In carrying out paragraph (2), the Board may establish subcommittees within the Board. Such subcommittees may hold meetings as determined necessary to enable the subcommittee to carry out its duties.

(6) Terms

(A) In general

Except as provided in subparagraph (B), each appointed member of the Board shall hold office for a term of 4 years. Any member appointed to fill a vacancy occurring prior to the expiration of the term for which such member's predecessor was appointed shall be appointed for the remainder of the term of the predecessor.

(B) Staggered terms

Members appointed to the Board shall serve staggered terms as specified by the Director of NIH, acting through the Office of the Director of NIH, when making the appointments.

(C) Reappointment

No member of the Board shall be eligible for reappointment to the Board until 1 year has elapsed after the end of the most recent term of the member.

(7) Compensation

Members of the Board who are not officers or employees of the United States shall receive for each day the members are engaged in the performance of the functions of the Board compensation at the same rate received by members of other national advisory councils established under this subchapter.

(c) Requirements for grants

(1) In general

The Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases, may make a grant under subsection (a) only if the applicant for the grant meets the following conditions:

(A) The applicant is determined by such Director to be competent to engage in the type of research for which the proposed facility is to be constructed.

(B) The applicant provides assurances satisfactory to the Director that—

(i) for not less than 20 years after completion of the construction involved, the facility will be used for the purposes of the research for which it is to be constructed;

(ii) sufficient funds will be available to meet the non-Federal share of the cost of constructing the facility;

(iii) sufficient funds will be available, when construction is completed, for the effective use of the facility for the research for which it is being constructed; and

(iv) the proposed construction will expand the applicant's capacity for research, or is necessary to improve or maintain the quality of the applicant's research.


(C) The applicant meets reasonable qualifications established by the Director with respect to—

(i) the relative scientific and technical merit of the applications, and the relative effectiveness of the proposed facilities, in expanding the capacity for biomedical or behavioral research and in improving the quality of such research;

(ii) the quality of the research or training, or both, to be carried out in the facilities involved;

(iii) the congruence of the research activities to be carried out within the facility with the research and investigator manpower needs of the United States; and

(iv) the age and condition of existing research facilities.


(D) The applicant has demonstrated a commitment to enhancing and expanding the research productivity of the applicant.

(2) Institutions of emerging excellence

From the amount appropriated to carry out this section for a fiscal year up to $50,000,000, the Director of NIH, acting through the Office of the Director of NIH, shall make available 25 percent of such amount, and from the amount appropriated to carry out this section for a fiscal year that is over $50,000,000, the Director of NIH, acting through the Office of the Director of NIH, shall make available up to 25 percent of such amount, for grants under subsection (a) to applicants that in addition to meeting the requirements established in paragraph (1), have demonstrated emerging excellence in biomedical or behavioral research, as follows:

(A) The applicant has a plan for research or training advancement and possesses the ability to carry out the plan.

(B) The applicant carries out research and research training programs that have a special relevance to a problem, concern, or unmet health need of the United States.

(C) The applicant has been productive in research or research development and training.

(D) The applicant—

(i) has been designated as a center of excellence under section 293c 1 of this title;

(ii) is located in a geographic area whose population includes a significant number of individuals with health status deficit, and the applicant provides health services to such individuals; or

(iii) is located in a geographic area in which a deficit in health care technology, services, or research resources may adversely affect the health status of the population of the area in the future, and the applicant is carrying out activities with respect to protecting the health status of such population.

(d) Requirement of application

The Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases, may make a grant under subsection (a) only if an application for the grant is submitted to the Director and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Director determines to be necessary to carry out this section.

(e) Amount of grant; payments

(1) Amount

The amount of any grant awarded under subsection (a) shall be determined by the Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases,,2 except that such amount shall not exceed—

(A) 50 percent (or, in the case of the Institute, 75 percent) of the necessary cost of the construction of a proposed facility as determined by the Director; or

(B) in the case of a multipurpose facility, 40 percent (or, in the case of the Institute, 75 percent) of that part of the necessary cost of construction that the Director determines to be proportionate to the contemplated use of the facility.

(2) Reservation of amounts

On the approval of any application for a grant under subsection (a), the Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases, shall reserve, from any appropriation available for such grants, the amount of such grant, and shall pay such amount, in advance or by way of reimbursement, and in such installments consistent with the construction progress, as the Director may determine appropriate. The reservation of any amount by the Director under this paragraph may be amended by the Director, either on the approval of an amendment of the application or on the revision of the estimated cost of construction of the facility.

(3) Exclusion of certain costs

In determining the amount of any grant under subsection (a), there shall be excluded from the cost of construction an amount equal to the sum of—

(A) the amount of any other Federal grant that the applicant has obtained, or is assured of obtaining, with respect to construction that is to be financed in part by a grant authorized under this section; and

(B) the amount of any non-Federal funds required to be expended as a condition of such other Federal grant.

(4) Waiver of limitations

The limitations imposed under paragraph (1) may be waived at the discretion of the Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases, for applicants meeting the conditions described in subsection (c).

(f) Recapture of payments

If, not later than 20 years after the completion of construction for which a grant has been awarded under subsection (a)—

(1) in the case of an award by the Director of NIH, acting through the Office of the Director of NIH, the applicant or other owner of the facility shall cease to be a public or non profit 3 private entity; or

(2) the facility shall cease to be used for the research purposes for which it was constructed (unless the Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases, determines, in accordance with regulations, that there is good cause for releasing the applicant or other owner from obligation to do so),


the United States shall be entitled to recover from the applicant or other owner of the facility the amount bearing the same ratio to the current value (as determined by an agreement between the parties or by action brought in the United States District Court for the district in which such facility is situated) of the facility as the amount of the Federal participation bore to the cost of the construction of such facility.

(g) Guidelines

Not later than 6 months after June 10, 1993, the Director of NIH, acting through the Office of the Director of NIH, after consultation with the Council, shall issue guidelines with respect to grants under subsection (a).

(July 1, 1944, ch. 373, title IV, §404I, formerly §481A, as added Pub. L. 103–43, title XV, §1502, June 10, 1993, 107 Stat. 173; amended Pub. L. 105–392, title I, §101(c), Nov. 13, 1998, 112 Stat. 3537; Pub. L. 106–505, title III, §303, Nov. 13, 2000, 114 Stat. 2330; Pub. L. 108–276, §2(b), July 21, 2004, 118 Stat. 841; Pub. L. 109–482, title I, §§103(b)(40), 104(b)(1)(M), Jan. 15, 2007, 120 Stat. 3688, 3693; renumbered §404I and amended Pub. L. 112–74, div. F, title II, §221(b)(1), Dec. 23, 2011, 125 Stat. 1087.)

References in Text

Section 293c of this title, referred to in subsec. (c)(2)(D)(i), does not contain provisions relating to designation as a center of excellence. See section 293 of this title.

Codification

Section was formerly classified to section 287a–2 of this title.

Amendments

2011—Subsec. (a)(1). Pub. L. 112–74, §221(b)(1)(B)(i), substituted "acting through the Office of the Director of NIH or the Director of the National Institute of Allergy and Infectious Diseases" for "acting through the Director of the Center or the Director of the National Institute of Allergy and Infectious Diseases".

Subsec. (b)(1)(A). Pub. L. 112–74, §221(b)(1)(B)(vi)(I), struck out "within the Center" after "established".

Subsec. (b)(1)(B). Pub. L. 112–74, §221(b)(1)(B)(v), substituted "Director of NIH, acting through the Office of the Director of NIH," for "Director of the Center".

Subsec. (b)(2)(A). Pub. L. 112–74, §221(b)(1)(B)(vi)(II)(aa), substituted "and the Council of Councils established under section 282(l) of this title (in this section referred to as the 'Council')" for "and the advisory council established under section 287a of this title (in this section referred to as the 'Advisory Council')".

Pub. L. 112–74, §221(b)(1)(B)(iii), substituted "Director of NIH" for "Director of the Center".

Subsec. (b)(2)(B). Pub. L. 112–74, §221(b)(1)(B)(vi)(II)(bb), struck out "Advisory" before "Council".

Pub. L. 112–74, §221(b)(1)(B)(iii), substituted "Director of NIH" for "Director of the Center".

Subsec. (b)(2)(C). Pub. L. 112–74, §221(b)(1)(B)(vi)(II)(bb), struck out "Advisory" before "Council".

Subsec. (b)(2)(D). Pub. L. 112–74, §221(b)(1)(B)(vi)(II)(bb), struck out "Advisory" before "Council".

Pub. L. 112–74, §221(b)(1)(B)(iii), substituted "Director of NIH" for "Director of the Center" in introductory provisions and cl. (ii).

Subsec. (b)(3)(A). Pub. L. 112–74, §221(b)(1)(B)(v), substituted "Director of NIH, acting through the Office of the Director of NIH," for "Director of the Center" in two places.

Pub. L. 112–74, §221(b)(1)(B)(iv), struck out comma after "Director of the Center" the first place appearing.

Subsec. (b)(4). Pub. L. 112–74, §221(b)(1)(B)(v), substituted "Director of NIH, acting through the Office of the Director of NIH," for "Director of the Center" in two places in introductory provisions.

Subsec. (b)(6)(B). Pub. L. 112–74, §221(b)(1)(B)(v), substituted "Director of NIH, acting through the Office of the Director of NIH," for "Director of the Center".

Subsec. (c)(1). Pub. L. 112–74, §221(b)(1)(B)(ii), substituted "Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases," for "Director of the Center or the Director of the National Institute of Allergy and Infectious Diseases" in introductory provisions.

Subsec. (c)(2). Pub. L. 112–74, §221(b)(1)(B)(v), substituted "Director of NIH, acting through the Office of the Director of NIH," for "Director of the Center" in two places in introductory provisions.

Subsec. (d). Pub. L. 112–74, §221(b)(1)(B)(ii), substituted "Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases," for "Director of the Center or the Director of the National Institute of Allergy and Infectious Diseases".

Subsec. (e). Pub. L. 112–74, §221(b)(1)(B)(ii), substituted "Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases," for "Director of the Center or the Director of the National Institute of Allergy and Infectious Diseases" wherever appearing.

Subsec. (f)(1). Pub. L. 112–74, §221(b)(1)(B)(v), substituted "Director of NIH, acting through the Office of the Director of NIH," for "Director of the Center".

Pub. L. 112–74, §221(b)(1)(B)(iv), struck out comma after "Director of the Center".

Subsec. (f)(2). Pub. L. 112–74, §221(b)(1)(B)(ii), substituted "Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases," for "Director of the Center or the Director of the National Institute of Allergy and Infectious Diseases".

Subsec. (g). Pub. L. 112–74, §221(b)(1)(B)(vii), substituted "after consultation with the Council" for "after consultation with the Advisory Council".

Pub. L. 112–74, §221(b)(1)(B)(v), substituted "Director of NIH, acting through the Office of the Director of NIH," for "Director of the Center".

Pub. L. 112–74, §221(b)(1)(B)(iv), struck out comma after "Director of the Center".

2007—Subsec. (c)(2). Pub. L. 109–482, §103(b)(40)(A), in introductory provisions, substituted "to carry out this section for a fiscal year up to" for "under subsection (i)(1) of this section for a fiscal year up to" and "to carry out this section for a fiscal year that" for "under such subsection for a fiscal year that".

Subsec. (h). Pub. L. 109–482, §104(b)(1)(M), struck out subsec. (h) which required biennial report concerning the status of biomedical and behavioral research facilities and the availability and condition of laboratory equipment.

Subsec. (i). Pub. L. 109–482, §103(b)(40)(B), struck out subsec. (i) which authorized appropriations for the National Center for Research Resources and the National Institute of Allergy and Infectious Diseases.

2004—Subsec. (a)(1). Pub. L. 108–276, §2(b)(1), inserted "or the Director of the National Institute of Allergy and Infectious Diseases" after "Director of the Center".

Subsec. (c)(1). Pub. L. 108–276, §2(b)(2)(A), inserted "or the Director of the National Institute of Allergy and Infectious Diseases" after "Director of the Center".

Subsec. (c)(2). Pub. L. 108–276, §2(b)(2)(B), substituted "subsection (i)(1)" for "subsection (i)" in introductory provisions.

Subsec. (d). Pub. L. 108–276, §2(b)(3), inserted "or the Director of the National Institute of Allergy and Infectious Diseases" after "Director of the Center".

Subsec. (e)(1). Pub. L. 108–276, §2(b)(4)(A)(i), inserted "or the Director of the National Institute of Allergy and Infectious Diseases" after "Director of the Center" in introductory provisions.

Subsec. (e)(1)(A). Pub. L. 108–276, §2(b)(4)(A)(ii), inserted "(or, in the case of the Institute, 75 percent)" after "50 percent".

Subsec. (e)(1)(B). Pub. L. 108–276, §2(b)(4)(A)(iii), inserted "(or, in the case of the Institute, 75 percent)" after "40 percent".

Subsec. (e)(2). Pub. L. 108–276, §2(b)(4)(B), inserted "or the Director of the National Institute of Allergy and Infectious Diseases" after "Director of the Center".

Subsec. (e)(4). Pub. L.108–276, §2(b)(4)(C), inserted "of the Center or the Director of the National Institute of Allergy and Infectious Diseases" after "Director".

Subsec. (f)(1). Pub. L. 108–276, §2(b)(5)(A), inserted "in the case of an award by the Director of the Center," before "the applicant".

Subsec. (f)(2). Pub. L. 108–276, §2(b)(5)(B), inserted "of the Center or the Director of the National Institute of Allergy and Infectious Diseases" after "Director".

Subsec. (i). Pub. L. 108–276, §2(b)(6), designated existing provisions as par. (1), inserted heading, substituted "For the purpose of carrying out this section with respect to the Center," for "For the purpose of carrying out this section,", and added par. (2).

2000Pub. L. 106–505 amended section generally, adding provisions requiring the Director to provide Congress with biennial status reports.

1998—Subsec. (c)(3)(D)(i). Pub. L. 105–392 substituted "part B of subchapter V of this chapter" for "section 293c of this title".

Effective Date of 2007 Amendment

Amendment 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 a note under section 281 of this title.

Findings

Pub. L. 106–505, title III, §302, Nov. 13, 2000, 114 Stat. 2330, provided that: "Congress finds that—

"(1) the National Institutes of Health is the principal source of Federal funding for medical research at universities and other research institutions in the United States;

"(2) the National Institutes of Health has received a substantial increase in research funding from Congress for the purpose of expanding the national investment of the United States in behavioral and biomedical research;

"(3) the infrastructure of our research institutions is central to the continued leadership of the United States in medical research;

"(4) as Congress increases the investment in cutting-edge basic and clinical research, it is critical that Congress also examine the current quality of the laboratories and buildings where research is being conducted, as well as the quality of laboratory equipment used in research;

"(5) many of the research facilities and laboratories in the United States are outdated and inadequate;

"(6) the National Science Foundation found, in a 1998 report on the status of biomedical research facilities, that over 60 percent of research-performing institutions indicated that they had an inadequate amount of medical research space;

"(7) the National Science Foundation reports that academic institutions have deferred nearly $11,000,000,000 in renovation and construction projects because of a lack of funds; and

"(8) future increases in Federal funding for the National Institutes of Health must include increased support for the renovation and construction of extramural research facilities in the United States and the purchase of state-of-the-art laboratory instrumentation."

1 See References in Text note below.

2 So in original.

3 So in original. Probably should be "nonprofit".

§283l. Construction of regional centers for research on primates

(a) With respect to activities carried out by the Director of NIH, acting through the Office of the Director of NIH, to support regional centers for research on primates, the Director of NIH may, for each of the fiscal years 2000 through 2002, reserve from the amounts appropriated to carry out section 283k of this title such sums as necessary for the purpose of making awards of grants and contracts to public or nonprofit private entities to construct, renovate, or otherwise improve such regional centers. The reservation of such amounts for any fiscal year is subject to the availability of qualified applicants for such awards.

(b) The Director of NIH may not make a grant or enter into a contract under subsection (a) unless the applicant for such assistance agrees, with respect to the costs to be incurred by the applicant in carrying out the purpose described in such subsection, to make available (directly or through donations from public or private entities) non-Federal contributions in cash toward such costs in an amount equal to not less than $1 for each $4 of Federal funds provided in such assistance.

(July 1, 1944, ch. 373, title IV, §404J, formerly §481B, as added Pub. L. 103–43, title XV, §1503, June 10, 1993, 107 Stat. 178; amended Pub. L. 105–392, title IV, §411, Nov. 13, 1998, 112 Stat. 3590; Pub. L. 106–505, title III, §304, Nov. 13, 2000, 114 Stat. 2335; Pub. L. 109–482, title I, §103(b)(41), Jan. 15, 2007, 120 Stat. 3688; renumbered §404J and amended Pub. L. 112–74, div. F, title II, §221(b)(2), Dec. 23, 2011, 125 Stat. 1088.)

Codification

Section was formerly classified to section 287a–3 of this title.

Amendments

2011—Subsec. (a). Pub. L. 112–74, §221(b)(2)(B), substituted "by the Director of NIH, acting through the Office of the Director of NIH," for "by the National Center for Research Resources" and "283k" for "287a–2".

2007—Subsec. (a). Pub. L. 109–482, which directed the substitution of "to carry out section 287a–2" for "under section 287a–2(h)", was executed by making substitution for "under section 287a–2(i)", to reflect the probable intent of Congress.

2000—Subsec. (a). Pub. L. 106–505, which directed the amendment of subsec. (a) by substituting "2000 through 2002, reserve from the amounts appropriated under section 287a–2(i) of this title such sums as necessary" for " '1994' and all that follows through '$5,000,000' ", was executed by making the substitution for "1994 through 1996, reserve from the amounts appropriated under section 287a–2(h) of this title up to $2,500,000", to reflect the probable intent of Congress and the amendment by Pub. L. 105–392. See 1998 Amendment note below.

1998—Subsec. (a). Pub. L. 105–392, in first sentence, substituted "may" for "shall" and "up to $2,500,000" for "$5,000,000".

Effective Date of 2007 Amendment

Amendment 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 a note under section 281 of this title.

§283m. Sanctuary system for surplus chimpanzees

(a) In general

The Secretary shall provide for the establishment and operation in accordance with this section of a system to provide for the lifetime care of chimpanzees that have been used, or were bred or purchased for use, in research conducted or supported by the National Institutes of Health, the Food and Drug Administration, or other agencies of the Federal Government, and with respect to which it has been determined by the Secretary that the chimpanzees are not needed for such research (in this section referred to as "surplus chimpanzees").

(b) Administration of sanctuary system

The Secretary shall carry out this section, including the establishment of regulations under subsection (d), in consultation with the board of directors of the nonprofit private entity that receives the contract under subsection (e) (relating to the operation of the sanctuary system).

(c) Acceptance of chimpanzees into system

All surplus chimpanzees owned by the Federal Government shall be accepted into the sanctuary system. Subject to standards under subsection (d)(4), any chimpanzee that is not owned by the Federal Government can be accepted into the system if the owner transfers to the sanctuary system title to the chimpanzee.

(d) Standards for permanent retirement of surplus chimpanzees

(1) In general

Not later than 180 days after December 20, 2000, the Secretary shall by regulation establish standards for operating the sanctuary system to provide for the permanent retirement of surplus chimpanzees. In establishing the standards, the Secretary shall consider the recommendations of the board of directors of the nonprofit private entity that receives the contract under subsection (e), and shall consider the recommendations of the National Research Council applicable to surplus chimpanzees that are made in the report published in 1997 and entitled "Chimpanzees in Research—Strategies for Their Ethical Care, Management, and Use".

(2) Chimpanzees accepted into system

With respect to chimpanzees that are accepted into the sanctuary system, standards under paragraph (1) shall include the following:

(A) A prohibition that the chimpanzees may not be used for research, except as authorized under paragraph (3).

(B) Provisions regarding the housing of the chimpanzees.

(C) Provisions regarding the behavioral well-being of the chimpanzees.

(D) A requirement that the chimpanzees be cared for in accordance with the Animal Welfare Act [7 U.S.C. 2131 et seq.].

(E) A requirement that the chimpanzees be prevented from breeding.

(F) A requirement that complete histories be maintained on the health and use in research of the chimpanzees.

(G) A requirement that the chimpanzees be monitored for the purpose of promptly detecting the presence in the chimpanzees of any condition that may be a threat to the public health or the health of other chimpanzees.

(H) A requirement that chimpanzees posing such a threat be contained in accordance with applicable recommendations of the Director of the Centers for Disease Control and Prevention.

(I) A prohibition that none of the chimpanzees may be subjected to euthanasia, except as in the best interests of the chimpanzee involved, as determined by the system and an attending veterinarian.

(J) A prohibition that the chimpanzees may not be discharged from the system.

(K) A provision that the Secretary may, in the discretion of the Secretary, accept into the system chimpanzees that are not surplus chimpanzees.

(L) Such additional standards as the Secretary determines to be appropriate.

(3) Restrictions regarding research

(A) In general

For purposes of paragraph (2)(A), standards under paragraph (1) shall provide that a chimpanzee accepted into the sanctuary system may not be used for studies or research, except that the chimpanzee may be used for noninvasive behavioral studies or medical studies based on information collected during the course of normal veterinary care that is provided for the benefit of the chimpanzee, provided that any such study involves minimal physical and mental harm, pain, distress, and disturbance to the chimpanzee and the social group in which the chimpanzee lives.

(B) Additional restriction

For purposes of paragraph (2)(A), a condition for the use in studies or research of a chimpanzee accepted into the sanctuary system is (in addition to conditions under subparagraph (A) of this paragraph) that the applicant for such use has not been fined for, or signed a consent decree for, any violation of the Animal Welfare Act [7 U.S.C. 2131 et seq.].

(4) Non-Federal chimpanzees offered for acceptance into system

With respect to a chimpanzee that is not owned by the Federal Government and is offered for acceptance into the sanctuary system, standards under paragraph (1) shall include the following:

(A) A provision that the Secretary may authorize the imposition of a fee for accepting such chimpanzee into the system, except as follows:

(i) Such a fee may not be imposed for accepting the chimpanzee if, on the day before December 20, 2000, the chimpanzee was owned by the nonprofit private entity that receives the contract under subsection (e) or by any individual sanctuary facility receiving a subcontract or grant under subsection (e)(1).

(ii) Such a fee may not be imposed for accepting the chimpanzee if the chimpanzee is owned by an entity that operates a primate center, and if the chimpanzee is housed in the primate center pursuant to the program for regional centers for research on primates that is carried out by the Director of NIH, acting through the Office of the Director of NIH,.1


Any fees collected under this subparagraph are available to the Secretary for the costs of operating the system. Any other fees received by the Secretary for the long-term care of chimpanzees (including any Federal fees that are collected for such purpose and are identified in the report under section 3 of the Chimpanzee Health Improvement, Maintenance, and Protection Act) are available for operating the system, in addition to availability for such other purposes as may be authorized for the use of the fees.

(B) A provision that the Secretary may deny such chimpanzee acceptance into the system if the capacity of the system is not sufficient to accept the chimpanzee, taking into account the physical capacity of the system; the financial resources of the system; the number of individuals serving as the staff of the system, including the number of professional staff; the necessity of providing for the safety of the staff and of the public; the necessity of caring for accepted chimpanzees in accordance with the standards under paragraph (1); and such other factors as may be appropriate.

(C) A provision that the Secretary may deny such chimpanzee acceptance into the system if a complete history of the health and use in research of the chimpanzee is not available to the Secretary.

(D) Such additional standards as the Secretary determines to be appropriate.

(e) Award of contract for operation of system

(1) In general

Subject to the availability of funds pursuant to subsection (g), the Secretary shall make an award of a contract to a nonprofit private entity under which the entity has the responsibility of operating (and establishing, as applicable) the sanctuary system and awarding subcontracts or grants to individual sanctuary facilities that meet the standards under subsection (d).

(2) Requirements

The Secretary may make an award under paragraph (1) to a nonprofit private entity only if the entity meets the following requirements:

(A) The entity has a governing board of directors that is composed and appointed in accordance with paragraph (3) and is satisfactory to the Secretary.

(B) The terms of service for members of such board are in accordance with paragraph (3).

(C) The members of the board serve without compensation. The members may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the duties of the board.

(D) The entity has an executive director meeting such requirements as the Secretary determines to be appropriate.

(E) The entity makes the agreement described in paragraph (4) (relating to non-Federal contributions).

(F) The entity agrees to comply with standards under subsection (d).

(G) The entity agrees to make necropsy reports on chimpanzees in the sanctuary system available on a reasonable basis to persons who conduct biomedical or behavioral research, with priority given to such persons who are Federal employees or who receive financial support from the Federal Government for research.

(H) Such other requirements as the Secretary determines to be appropriate.

(3) Board of directors

For purposes of subparagraphs (A) and (B) of paragraph (2):

(A) The governing board of directors of the nonprofit private entity involved is composed and appointed in accordance with this paragraph if the following conditions are met:

(i) Such board is composed of not more than 13 voting members.

(ii) Such members include individuals with expertise and experience in the science of managing captive chimpanzees (including primate veterinary care), appointed from among individuals endorsed by organizations that represent individuals in such field.

(iii) Such members include individuals with expertise and experience in the field of animal protection, appointed from among individuals endorsed by organizations that represent individuals in such field.

(iv) Such members include individuals with expertise and experience in the zoological field (including behavioral primatology), appointed from among individuals endorsed by organizations that represent individuals in such field.

(v) Such members include individuals with expertise and experience in the field of the business and management of nonprofit organizations, appointed from among individuals endorsed by organizations that represent individuals in such field.

(vi) Such members include representatives from entities that provide accreditation in the field of laboratory animal medicine.

(vii) Such members include individuals with expertise and experience in the field of containing biohazards.

(viii) Such members include an additional member who serves as the chair of the board, appointed from among individuals who have been endorsed for purposes of clause (ii), (iii), (iv), or (v).

(ix) None of the members of the board has been fined for, or signed a consent decree for, any violation of the Animal Welfare Act [7 U.S.C. 2131 et seq.].


(B) The terms of service for members of the board of directors are in accordance with this paragraph if the following conditions are met:

(i) The term of the chair of the board is 3 years.

(ii) The initial members of the board select, by a random method, one member from each of the six fields specified in subparagraph (A) to serve a term of 2 years and (in addition to the chair) one member from each of such fields to serve a term of 3 years.

(iii) After the initial terms under clause (ii) expire, each member of the board (other than the chair) is appointed to serve a term of 2 years.

(iv) An individual whose term of service expires may be reappointed to the board.

(v) A vacancy in the membership of the board is filled in the manner in which the original appointment was made.

(vi) If a member of the board does not serve the full term applicable to the member, the individual appointed to fill the resulting vacancy is appointed for the remainder of the term of the predecessor member.

(4) Requirement of matching funds

The agreement required in paragraph (2)(E) for a nonprofit private entity (relating to the award of the contract under paragraph (1)) is an agreement that, with respect to the costs to be incurred by the entity in establishing and operating the sanctuary system, the entity will make available (directly or through donations from public or private entities) non-Federal contributions toward such costs, in cash or in kind, in an amount not less than the following, as applicable:

(A) For expenses associated with establishing the sanctuary system (as determined by the Secretary), 10 percent of such costs ($1 for each $9 of Federal funds provided under the contract under paragraph (1)).

(B) For expenses associated with operating the sanctuary system (as determined by the Secretary), 25 percent of such costs ($1 for each $3 of Federal funds provided under such contract).

(5) Establishment of contract entity

If the Secretary determines that an entity meeting the requirements of paragraph (2) does not exist, not later than 60 days after December 20, 2000, the Secretary shall, for purposes of paragraph (1), make a grant for the establishment of such an entity, including paying the cost of incorporating the entity under the law of one of the States.

(f) Definitions

For purposes of this section:

(1) Permanent retirement

The term "permanent retirement", with respect to a chimpanzee that has been accepted into the sanctuary system, means that under subsection (a) the system provides for the lifetime care of the chimpanzee, that under subsection (d)(2) the system does not permit the chimpanzee to be used in research (except as authorized under subsection (d)(3)) or to be euthanized (except as provided in subsection (d)(2)(I)), that under subsection (d)(2) the system will not discharge the chimpanzee from the system, and that under such subsection the system otherwise cares for the chimpanzee.

(2) Sanctuary system

The term "sanctuary system" means the system described in subsection (a).

(3) Secretary

The term "Secretary" means the Secretary of Health and Human Services.

(4) Surplus chimpanzees

The term "surplus chimpanzees" has the meaning given that term in subsection (a).

(g) Funding

(1) In general

Of the amount appropriated for the National Institutes of Health, there are authorized to be appropriated to carry out this section and for the care, maintenance, and transportation of all chimpanzees otherwise under the ownership or control of the National Institutes of Health, and to enable the National Institutes of Health to operate more efficiently and economically by decreasing the overall Federal cost of providing for the care, maintenance, and transportation of chimpanzees—

(A) for fiscal year 2014, $12,400,000;

(B) for fiscal year 2015, $11,650,000;

(C) for fiscal year 2016, $10,900,000;

(D) for fiscal year 2017, $10,150,000; and

(E) for fiscal year 2018, $9,400,000.

(2) Use of funds for other compliant facilities

With respect to amounts authorized to be appropriated by paragraph (1) for a fiscal year, the Secretary may use a portion of such amounts to make awards of grants or contracts to public or private entities operating facilities that, as determined by the Secretary in consultation with the board of directors of the nonprofit private entity that receives the contract under subsection (e), provide for the retirement of chimpanzees in accordance with the same standards that apply to the sanctuary system pursuant to regulations under subsection (d). Such an award may be expended for the expenses of operating the facilities involved.

(3) Biennial report

Not later than 180 days after November 27, 2013, the Director of the National Institutes of Health shall submit 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 in the House of Representatives a report, to be updated biennially, regarding—

(A) the care, maintenance, and transportation of the chimpanzees under the ownership or control of the National Institutes of Health;

(B) costs related to such care, maintenance, and transportation, and any other related costs; and

(C) the research status of such chimpanzees.

(July 1, 1944, ch. 373, title IV, §404K, formerly §481C, as added Pub. L. 106–551, §2, Dec. 20, 2000, 114 Stat. 2752; amended Pub. L. 110–170, §2(a), Dec. 26, 2007, 121 Stat. 2465; renumbered §404K and amended Pub. L. 112–74, div. F, title II, §221(b)(3), Dec. 23, 2011, 125 Stat. 1088; Pub. L. 113–55, title III, §302(a), (c), Nov. 27, 2013, 127 Stat. 646, 647.)

References in Text

The Animal Welfare Act, referred to in subsecs. (d)(2)(D), (3)(B) and (e)(3)(A)(ix), is Pub. L. 89–544, Aug. 24, 1966, 80 Stat. 350, as amended, which is classified generally to chapter 54 (§2131 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 2131 of Title 7 and Tables.

Section 3 of the Chimpanzee Health Improvement, Maintenance, and Protection Act, referred to in subsec. (d)(4)(A), is section 3 of Pub. L. 106–551, which is set out as a note below.

Codification

Section was formerly classified to section 287a–3a of this title.

November 27, 2013, referred to in subsec. (g)(3), was in the original "the date enactment of this Act" (sic), which was translated as meaning the date of enactment of Pub. L. 113–55, which enacted par. (3), to reflect the probable intent of Congress.

Amendments

2013—Subsec. (g)(1). Pub. L. 113–55, §302(a)(1), amended par. (1) generally. Prior to amendment, text read as follows: "Of the amount appropriated under this chapter for fiscal year 2001 and each subsequent fiscal year, the Secretary, subject to paragraph (2), shall reserve a portion for purposes of the operation (and establishment, as applicable) of the sanctuary system and for purposes of paragraph (3), except that the Secretary may not for such purposes reserve any further funds from such amount after the aggregate total of the funds so reserved for such fiscal years reaches $30,000,000. The purposes for which funds reserved under the preceding sentence may be expended include the construction and renovation of facilities for the sanctuary system."

Subsec. (g)(2). Pub. L. 113–55, §302(a)(4), substituted "With respect to amounts authorized to be appropriated by paragraph (1)" for "With respect to amounts reserved under paragraph (1)" and "Secretary in consultation with the board of directors" for "board of directors".

Pub. L. 113–55, §302(a)(2), (3), redesignated par. (3) as (2) and struck out former par. (2). Prior to amendment, text of par. (2) read as follows: "Funds may not be reserved for a fiscal year under paragraph (1) unless the amount appropriated under this chapter for such year equals or exceeds the amount appropriated under this chapter for fiscal year 1999."

Subsec. (g)(3). Pub. L. 113–55, §302(c), added par. (3). Former par. (3) redesignated (2).

Pub. L. 113–55, §302(a)(3), redesignated par. (3) as (2).

2011—Subsec. (d)(4)(A)(ii). Pub. L. 112–74, §221(b)(3)(B), substituted "that is carried out by the Director of NIH, acting through the Office of the Director of NIH," for "that is carried out by the National Center for Research Resources".

2007—Subsec. (d)(2)(J). Pub. L. 110–170, §2(a)(1), struck out at end "If any chimpanzee is removed from a sanctuary facility for purposes of research authorized under paragraph (3)(A)(ii), the chimpanzee shall be returned immediately upon the completion of that research. All costs associated with the removal of the chimpanzee from the facility, with the care of the chimpanzee during such absence from the facility, and with the return of the chimpanzee to the facility shall be the responsibility of the entity that obtains approval under such paragraph regarding use of the chimpanzee and removes the chimpanzee from the sanctuary facility."

Subsec. (d)(3)(A). Pub. L. 110–170, §2(a)(2)(A), substituted "except that the chimpanzee may be used for noninvasive behavioral studies" for "except as provided in clause (i) or (ii), as follows:

"(i) The chimpanzee may be used for noninvasive behavioral studies"

and struck out cl. (ii) which related to findings necessary before a chimpanzee may be used in research.

Subsec. (d)(3)(B), (C). Pub. L. 110–170, §2(a)(2)(B)–(D), redesignated subpar. (C) as (B), substituted "under subparagraph (A)" for "under subparagraphs (A) and (B)", and struck out former subpar. (B) which related to approval of research design.

Report to Congress Regarding Number of Chimpanzees and Funding for Care of Chimpanzees

Pub. L. 106–551, §3, Dec. 20, 2000, 114 Stat. 2759, required the Secretary of Health and Human Services to submit a report to Congress, not later than 365 days after Dec. 20, 2000, about the chimpanzees that had been used, or bred or purchased for use, in research conducted or supported by the National Institutes of Health, the Food and Drug Administration, or other agencies of the Federal Government.

1 So in original. Comma probably should not appear.

§283n. Shared Instrumentation Grant Program

(a) Requirements for grants

In determining whether to award a grant to an applicant under the Shared Instrumentation Grant Program, the Director of NIH, acting through the Office of the Director of NIH, shall consider—

(1) the extent to which an award for the specific instrument involved would meet the scientific needs and enhance the planned research endeavors of the major users by providing an instrument that is unavailable or to which availability is highly limited;

(2) with respect to the instrument involved, the availability and commitment of the appropriate technical expertise within the major user group or the applicant institution for use of the instrumentation;

(3) the adequacy of the organizational plan for the use of the instrument involved and the internal advisory committee for oversight of the applicant, including sharing arrangements if any;

(4) the applicant's commitment for continued support of the utilization and maintenance of the instrument; and

(5) the extent to which the specified instrument will be shared and the benefit of the proposed instrument to the overall research community to be served.

(b) Peer review

In awarding grants under the program described in subsection (a), the Director of NIH, acting through the Office of the Director of NIH, shall comply with the peer review requirements in section 289a of this title.

(July 1, 1944, ch. 373, title IV, §404L, formerly Pub. L. 106–505, title III, §305, Nov. 13, 2000, 114 Stat. 2335; renumbered July 1, 1944, ch. 373, title IV, §404L, and amended Pub. L. 112–74, div. F, title II, §221(b)(4), Dec. 23, 2011, 125 Stat. 1088.)

Codification

Section was formerly set out as a note under section 287 of this title, prior to renumbering by Pub. L. 112–74.

Amendments

2011Pub. L. 112–74, §221(b)(4)(B)(iii), substituted "Director of NIH, acting through the Office of the Director of NIH," for "Director of the National Center for Research Resources" in subsecs. (a) and (b).

Subsec. (a). Pub. L. 112–74, §221(b)(4)(B)(ii), substituted "under the Shared Instrumentation Grant Program" for "under the program described in subsection (a)" in introductory provisions.

Pub. L. 112–74, §221(b)(4)(B)(i), redesignated subsec. (b) as (a) and struck out former subsec. (a). Prior to amendment, text of subsec. (a) read as follows: "There is authorized to be appropriated $100,000,000 for fiscal year 2000, and such sums as may be necessary for each subsequent fiscal year, to enable the Secretary of Health and Human Services, acting through the Director of the National Center for Research Resources, to provide for the continued operation of the Shared Instrumentation Grant Program (initiated in fiscal year 1992 under the authority of section 287 of this title)."

Subsec. (b). Pub. L. 112–74, §221(b)(4)(B)(iv), substituted "in subsection (a), the" for "in subsection (a)" and made technical amendment to reference in original act which appears in text as reference to section 289a of this title.

Pub. L. 112–74, §221(b)(4)(B)(i), redesignated subsec. (c) as (b). Former subsec. (b) redesignated (a).

Subsec. (c). Pub. L. 112–74, §221(b)(4)(B)(i), redesignated subsec. (c) as (b).

§283o. Next generation of researchers

(a) Next generation of researchers initiative

There shall be established within the Office of the Director of the National Institutes of Health, the Next Generation of Researchers Initiative (referred to in this section as the "Initiative"), through which the Director shall coordinate all policies and programs within the National Institutes of Health that are focused on promoting and providing opportunities for new researchers and earlier research independence.

(b) Activities

The Director of the National Institutes of Health, through the Initiative shall—

(1) promote policies and programs within the National Institutes of Health that are focused on improving opportunities for new researchers and promoting earlier research independence, including existing policies and programs, as appropriate;

(2) develop, modify, or prioritize policies, as needed, within the National Institutes of Health to promote opportunities for new researchers and earlier research independence, such as policies to increase opportunities for new researchers to receive funding, enhance training and mentorship programs for researchers, and enhance workforce diversity;

(3) coordinate, as appropriate, with relevant agencies, professional and academic associations, academic institutions, and others, to improve and update existing information on the biomedical research workforce in order to inform programs related to the training, recruitment, and retention of biomedical researchers; and

(4) carry out other activities, including evaluation and oversight of existing programs, as appropriate, to promote the development of the next generation of researchers and earlier research independence.

(July 1, 1944, ch. 373, title IV, §404M, as added Pub. L. 114–255, div. A, title II, §2021(a), Dec. 13, 2016, 130 Stat. 1051.)

§283p. Population focused research

The Director of the National Institutes of Health shall, as appropriate, encourage efforts to improve research related to the health of sexual and gender minority populations, including by—

(1) facilitating increased participation of sexual and gender minority populations in clinical research supported by the National Institutes of Health, and reporting on such participation, as applicable;

(2) facilitating the development of valid and reliable methods for research relevant to sexual and gender minority populations; and

(3) addressing methodological challenges.

(July 1, 1944, ch. 373, title IV, §404N, as added Pub. L. 114–255, div. A, title II, §2038(d), Dec. 13, 2016, 130 Stat. 1065.)

Reporting

Pub. L. 114–255, div. A, title II, §2038(e), Dec. 13, 2016, 130 Stat. 1065, provided that:

"(1) In general.—The Secretary, in collaboration with the Director of the National Institutes of Health, shall as appropriate—

"(A) continue to support research for the development of appropriate measures related to reporting health information about sexual and gender minority populations; and

"(B) not later than 2 years after the date of enactment of this Act [Dec. 13, 2016], disseminate and make public such measures.

"(2) National academy of medicine recommendations.—In developing the measures described in paragraph (1)(A), the Secretary shall take into account recommendations made by the National Academy of Medicine."

§283q. Eureka prize competitions

(a) In general

Pursuant to the authorities and processes established under section 3719 of title 15, the Director of the National Institutes of Health shall support prize competitions for one or both of the following goals:

(1) Identifying and funding areas of biomedical science that could realize significant advancements through a prize competition.

(2) Improving health outcomes, particularly with respect to human diseases and conditions—

(A) for which public and private investment in research is disproportionately small relative to Federal Government expenditures on prevention and treatment activities with respect to such diseases and conditions, such that Federal expenditures on health programs would be reduced;

(B) that are serious and represent a significant disease burden in the United States; or

(C) for which there is potential for significant return on investment to the United States.

(b) Tracking; reporting

The Director of the National Institutes of Health shall—

(1) collect information on—

(A) the effect of innovations funded through the prize competitions under this section in advancing biomedical science or improving health outcomes pursuant to subsection (a); and

(B) the effect of the innovations on Federal expenditures; and


(2) include the information collected under paragraph (1) in the triennial report under section 283 of this title (as amended by section 2032).

(Pub. L. 114–255, div. A, title II, §2002, Dec. 13, 2016, 130 Stat. 1047.)

References in Text

Section 2032, referred to in subsec. (b)(2), means section 2032 of Pub. L. 114–255.

Codification

Section was enacted as part of the 21st Century Cures Act, and not as part of the Public Health Service Act which comprises this chapter.

Part B—General Provisions Respecting National Research Institutes

§284. Directors of national research institutes

(a) Appointment

(1) In general

The Director of the National Cancer Institute shall be appointed by the President, and the Directors of the other national research institutes and national centers shall be appointed by the Secretary, acting through the Director of National Institutes of Health. Each Director of a national research institute or national center shall report directly to the Director of National Institutes of Health.

(2) Appointment

(A) Term

A Director of a national research institute or national center who is appointed by the Secretary, acting through the Director of National Institutes of Health, shall be appointed for 5 years.

(B) Reappointment

At the end of the term of a Director of a national research institute or national center, the Director may be reappointed in accordance with standards applicable to the relevant appointment mechanism. There shall be no limit on the number of terms that a Director may serve.

(C) Vacancies

If the office of a Director of a national research institute or national center becomes vacant before the end of such Director's term, the Director appointed to fill the vacancy shall be appointed for a 5-year term starting on the date of such appointment.

(D) Current directors

Each Director of a national research institute or national center who is serving on December 13, 2016, shall be deemed to be appointed for a 5-year term under this subsection beginning on such date.

(E) Rule of construction

Nothing in this subsection shall be construed to limit the authority of the Secretary or the Director of National Institutes of Health to terminate the appointment of a director referred to in subparagraph (A) before the expiration of such director's 5-year term.

(F) Nature of appointment

Appointments and reappointments under this subsection shall be made on the basis of ability and experience as it relates to the mission of the National Institutes of Health and its components, including compliance with any legal requirement that the Secretary or Director of National Institutes of Health determines relevant.

(3) Nonapplication of certain provision

The restrictions contained in section 202 of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1993 (Public Law 102–394; 42 U.S.C. 238f note) related to consultants and individual scientists appointed for limited periods of time shall not apply to Directors appointed under this subsection.

(b) Duties and authority; grants, contracts, and cooperative agreements

(1) In carrying out the purposes of section 241 of this title with respect to human diseases or disorders or other aspects of human health for which the national research institutes were established, the Secretary, acting through the Director of each national research institute—

(A) shall encourage and support research, investigations, experiments, demonstrations, and studies in the health sciences related to—

(i) the maintenance of health,

(ii) the detection, diagnosis, treatment, and prevention of human diseases and disorders,

(iii) the rehabilitation of individuals with human diseases, disorders, and disabilities, and

(iv) the expansion of knowledge of the processes underlying human diseases, disorders, and disabilities, the processes underlying the normal and pathological functioning of the body and its organ systems, and the processes underlying the interactions between the human organism and the environment;


(B) may, subject to the peer review prescribed under section 289a(b) of this title and any advisory council review under section 284a(a)(3)(A)(i) of this title, conduct the research, investigations, experiments, demonstrations, and studies referred to in subparagraph (A);

(C) shall, as appropriate, conduct and support research that has the potential to transform the scientific field, has inherently higher risk, and that seeks to address major current challenges;

(D) may conduct and support research training (i) for which fellowship support is not provided under section 288 of this title, and (ii) which is not residency training of physicians or other health professionals;

(E) may develop, implement, and support demonstrations and programs for the application of the results of the activities of the institute to clinical practice and disease prevention activities;

(F) may develop, conduct, and support public and professional education and information programs;

(G) may secure, develop and maintain, distribute, and support the development and maintenance of resources needed for research;

(H) may make available the facilities of the institute to appropriate entities and individuals engaged in research activities and cooperate with and assist Federal and State agencies charged with protecting the public health;

(I) may accept unconditional gifts made to the institute for its activities, and, in the case of gifts of a value in excess of $50,000, establish suitable memorials to the donor;

(J) may secure for the institute consultation services and advice of persons from the United States or abroad;

(K) may use, with their consent, the services, equipment, personnel, information, and facilities of other Federal, State, or local public agencies, with or without reimbursement therefor;

(L) may accept voluntary and uncompensated services; and

(M) may perform such other functions as the Secretary determines are needed to carry out effectively the purposes of the institute.


The indemnification provisions of section 2354 of title 10 shall apply with respect to contracts entered into under this subsection and section 282(b) of this title.

(2) Support for an activity or program under this subsection may be provided through grants, contracts, and cooperative agreements. The Secretary, acting through the Director of each national research institute—

(A) may enter into a contract for research, training, or demonstrations only if the contract has been recommended after technical and scientific peer review required by regulations under section 289a of this title;

(B) may make grants and cooperative agreements under paragraph (1) for research, training, or demonstrations, except that—

(i) if the direct cost of the grant or cooperative agreement to be made does not exceed $50,000, such grant or cooperative agreement may be made only if such grant or cooperative agreement has been recommended after technical and scientific peer review required by regulations under section 289a of this title, and

(ii) if the direct cost of the grant or cooperative agreement to be made exceeds $50,000, such grant or cooperative agreement may be made only if such grant or cooperative agreement has been recommended after technical and scientific peer review required by regulations under section 289a of this title and is recommended under section 284a(a)(3)(A)(ii) of this title by the advisory council for the national research institute involved; and


(C) shall, subject to section 300cc–40c(d)(2) of this title, receive from the President and the Office of Management and Budget directly all funds appropriated by the Congress for obligation and expenditure by the Institute.


(3) Before an award is made by a national research institute or by a national center for a grant for a research program or project (commonly referred to as an "R-series grant"), other than an award constituting a noncompetitive renewal of such a grant, or a noncompetitive administrative supplement to such a grant, the Director of such national research institute or national center shall, consistent with the peer review process—

(A) review and make the final decision with respect to making the award; and

(B) take into consideration, as appropriate—

(i) the mission of the national research institute or national center and the scientific priorities identified in the strategic plan under section 282(m) of this title;

(ii) programs or projects funded by other agencies on similar research topics; and

(iii) advice by staff and the advisory council or board of such national research institute or national center.

(c) Coordination with other public and private entities; cooperation with other national research institutes; appointment of additional peer review groups

In carrying out subsection (b), each Director of a national research institute—

(1) shall coordinate, as appropriate, the activities of the institute with similar programs of other public and private entities;

(2) shall cooperate with the Directors of the other national research institutes in the development and support of multidisciplinary research and research that involves more than one institute;

(3) may, in consultation with the advisory council for the Institute and with the approval of the Director of NIH—

(A) establish technical and scientific peer review groups in addition to those appointed under section 282(b)(16) of this title; and

(B) appoint the members of peer review groups established under subparagraph (A); and


(4) may publish, or arrange for the publication of, information with respect to the purpose of the Institute without regard to section 501 of title 44.


The Federal Advisory Committee Act shall not apply to the duration of a peer review group appointed under paragraph (3).

(July 1, 1944, ch. 373, title IV, §405, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 826; amended Pub. L. 100–607, title I, §116, Nov. 4, 1988, 102 Stat. 3053; Pub. L. 100–690, title II, §2613(c), Nov. 18, 1988, 102 Stat. 4239; Pub. L. 103–43, title III, §301(a)(1), (b), June 10, 1993, 107 Stat. 150; Pub. L. 109–482, title I, §102(f)(1)(B), Jan. 15, 2007, 120 Stat. 3685; Pub. L. 114–255, div. A, title II, §§2033(a), (b), 2036(c), Dec. 13, 2016, 130 Stat. 1057, 1058, 1063.)

References in Text

The Federal Advisory Committee Act, referred to in subsec. (c), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770, as amended, which is set out in the Appendix to Title 5, Government Organization and Employees.

Amendments

2016—Subsec. (a). Pub. L. 114–255, §2033(a), amended subsec. (a) generally. Prior to amendment, text read as follows: "The Director of the National Cancer Institute shall be appointed by the President and the Directors of the other national research institutes shall be appointed by the Secretary. Each Director of a national research institute shall report directly to the Director of NIH.".

Subsec. (b)(1)(C) to (M). Pub. L. 114–255, §2036(c), added par. (C) and redesignated former pars. (C) to (L) as (D) to (M), respectively.

Subsec. (b)(3). Pub. L. 114–255, §2033(b), added par. (3).

2007—Subsec. (c)(3)(A). Pub. L. 109–482 substituted "section 282(b)(16)" for "section 282(b)(6)".

1993—Subsec. (b)(2)(C). Pub. L. 103–43, §301(a)(1), added subpar. (C).

Subsec. (c). Pub. L. 103–43, §301(b)(2), inserted concluding provisions relating to Federal Advisory Committee Act.

Subsec. (c)(3). Pub. L. 103–43, §301(b)(1), amended par. (3) generally. Prior to amendment, par. (3) read as follows: "may, in consultation with the advisory council for the Institute and the approval of the Director of NIH, establish and appoint technical and scientific peer review groups in addition to those established and appointed under section 282(b)(6) of this title; and".

1988—Subsec. (b)(1). Pub. L. 100–607, §116(1), struck out "the" after "with respect to" in introductory provisions.

Subsec. (c)(3). Pub. L. 100–690 substituted "establish and appoint" and "established and appointed" for "establish" and "established", respectively.

Pub. L. 100–607, §116(2)(A), amended par. (3) generally. Prior to amendment, par. (3) read as follows: "may, with the approval of the advisory council for the institute and the Director of NIH, appoint technical and scientific peer review groups in addition to those appointed under section 282(b)(6) of this title."

Subsec. (c)(4). Pub. L. 100–607, §116(2)(C), added par. (4).

Effective Date of 2007 Amendment

Amendment 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 a note under section 281 of this title.

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–690 effective immediately after enactment of Pub. L. 100–607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out as a note under section 242m of this title.

Enhancing the Clinical and Translational Science Award

Pub. L. 109–482, title I, §106, Jan. 15, 2007, 120 Stat. 3696, provided that:

"(a) In General.—In administering the Clinical and Translational Science Award, the Director of NIH shall establish a mechanism to preserve independent funding and infrastructure for pediatric clinical research centers by—

"(1) allowing the appointment of a secondary principal investigator under a single Clinical and Translational Science Award, such that a pediatric principal investigator may be appointed with direct authority over a separate budget and infrastructure for pediatric clinical research; or

"(2) otherwise securing institutional independence of pediatric clinical research centers with respect to finances, infrastructure, resources, and research agenda.

"(b) Report.—As part of the biennial report under section 403 of the Public Health Service Act [42 U.S.C. 283], the Director of NIH shall provide an evaluation and comparison of outcomes and effectiveness of training programs under subsection (a).

"(c) Definition.—For purposes of this section, the term 'Director of NIH' has the meaning given such term in section 401 of the Public Health Service Act [42 U.S.C. 281]."

§284a. Advisory councils

(a) Establishment; acceptance of conditional gifts; functions

(1) Except as provided in subsection (h), the Secretary shall appoint an advisory council for each national research institute which (A) shall advise, assist, consult with, and make recommendations to the Secretary and the Director of such institute on matters related to the activities carried out by and through the institute and the policies respecting such activities, and (B) shall carry out the special functions prescribed by part C.

(2) Each advisory council for a national research institute may recommend to the Secretary acceptance, in accordance with section 238 of this title, of conditional gifts for study, investigation, or research respecting the diseases, disorders, or other aspect of human health with respect to which the institute was established, for the acquisition of grounds, or for the construction, equipping, or maintenance of facilities for the institute.

(3) Each advisory council for a national research institute—

(A)(i) may on the basis of the materials provided under section 289a(b)(2) of this title respecting research conducted at the institute, make recommendations to the Director of the institute respecting such research,

(ii) may review applications for grants and cooperative agreements for research or training and for which advisory council approval is required under section 284(b)(2) of this title and recommend for approval applications for projects which show promise of making valuable contributions to human knowledge, and

(iii) may review any grant, contract, or cooperative agreement proposed to be made or entered into by the institute;

(B) may collect, by correspondence or by personal investigation, information as to studies which are being carried on in the United States or any other country as to the diseases, disorders, or other aspect of human health with respect to which the institute was established and with the approval of the Director of the institute make available such information through appropriate publications for the benefit of public and private health entities and health professions personnel and scientists and for the information of the general public; and

(C) may appoint subcommittees and convene workshops and conferences.

(b) Membership; compensation

(1) Each advisory council shall consist of ex officio members and not more than eighteen members appointed by the Secretary. The ex officio members shall be nonvoting members.

(2) The ex officio members of an advisory council shall consist of—

(A) the Secretary, the Director of NIH, the Director of the national research institute for which the council is established, the Under Secretary for Health of the Department of Veterans Affairs or the Chief Dental Director of the Department of Veterans Affairs, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers), and

(B) such additional officers or employees of the United States as the Secretary determines necessary for the advisory council to effectively carry out its functions.


(3) The members of an advisory council who are not ex officio members shall be appointed as follows:

(A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of the health and scientific disciplines (including not less than two individuals who are leaders in the fields of public health and the behavioral or social sciences) relevant to the activities of the national research institute for which the advisory council is established.

(B) One-third of the members shall be appointed by the Secretary from the general public and shall include leaders in fields of public policy, law, health policy, economics, and management.


(4) Members of an advisory council who are officers or employees of the United States shall not receive any compensation for service on the advisory council. The other members of an advisory council shall receive, for each day (including traveltime) they are engaged in the performance of the functions of the advisory council, compensation at rates not to exceed the daily equivalent of the annual rate in effect for grade GS–18 of the General Schedule.

(c) Term of office; reappointment; vacancy

The term of office of an appointed member of an advisory council is four years, except that any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term and the Secretary shall make appointments to an advisory council in such a manner as to ensure that the terms of the members do not all expire in the same year. A member may serve after the expiration of the member's term for 180 days after the date of such expiration. A member who has been appointed for a term of four years may not be reappointed to an advisory council before two years from the date of expiration of such term of office. If a vacancy occurs in the advisory council among the appointed members, the Secretary shall make an appointment to fill the vacancy within 90 days from the date the vacancy occurs.

(d) Chairman; term of office

The chairman of an advisory council shall be selected by the Secretary from among the appointed members, except that the Secretary may select the Director of the national research institute for which the advisory council is established to be the chairman of the advisory council. The term of office of the chairman shall be two years.

(e) Meetings

The advisory council shall meet at the call of the chairman or upon the request of the Director of the national research institute for which it was established, but at least three times each fiscal year. The location of the meetings of each advisory council is subject to the approval of the Director of the national research institute for which the advisory council was established.

(f) Appointment of executive secretary; training and orientation for new members

The Director of the national research institute for which an advisory council is established shall designate a member of the staff of the institute to serve as the executive secretary of the advisory council. The Director of such institute shall make available to the advisory council such staff, information, and other assistance as it may require to carry out its functions. The Director of such institute shall provide orientation and training for new members of the advisory council to provide them with such information and training as may be appropriate for their effective participation in the functions of the advisory council.

(g) Comments and recommendations for inclusion in biennial report; additional reports

Each advisory council may prepare, for inclusion in the biennial report made under section 284b 1 of this title, (1) comments respecting the activities of the advisory council in the fiscal years respecting which the report is prepared, (2) comments on the progress of the national research institute for which it was established in meeting its objectives, and (3) recommendations respecting the future directions and program and policy emphasis of the institute. Each advisory council may prepare such additional reports as it may determine appropriate.

(h) Advisory councils in existence; application of section to National Cancer Advisory Board and advisory council to National Heart, Lung, and Blood Institute

(1) Except as provided in paragraph (2), this section does not terminate the membership of any advisory council for a national research institute which was in existence on November 20, 1985. After November 20, 1985—

(A) the Secretary shall make appointments to each such advisory council in such a manner as to bring about as soon as practicable the composition for such council prescribed by this section;

(B) each advisory council shall organize itself in accordance with this section and exercise the functions prescribed by this section; and

(C) the Director of each national research institute shall perform for such advisory council the functions prescribed by this section.


(2)(A) The National Cancer Advisory Board shall be the advisory council for the National Cancer Institute. This section applies to the National Cancer Advisory Board, except that—

(i) appointments to such Board shall be made by the President;

(ii) the term of office of an appointed member shall be 6 years;

(iii) of the members appointed to the Board not less than five members shall be individuals knowledgeable in environmental carcinogenesis (including carcinogenesis involving occupational and dietary factors);

(iv) the chairman of the Board shall be selected by the President from the appointed members and shall serve as chairman for a term of two years;

(v) the ex officio members of the Board shall be nonvoting members and shall be the Secretary, the Director of the Office of Science and Technology Policy, the Director of NIH, the Under Secretary for Health of the Department of Veterans Affairs, the Director of the National Institute for Occupational Safety and Health, the Director of the National Institute of Environmental Health Sciences, the Secretary of Labor, the Commissioner of the Food and Drug Administration, the Administrator of the Environmental Protection Agency, the Chairman of the Consumer Product Safety Commission, the Assistant Secretary of Defense for Health Affairs, and the Director of the Office of Science of the Department of Energy (or the designees of such officers); and

(vi) the Board shall meet at least four times each fiscal year.


(B) This section applies to the advisory council to the National Heart, Lung, and Blood Institute, except that the advisory council shall meet at least four times each fiscal year.

(July 1, 1944, ch. 373, title IV, §406, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 828; amended Pub. L. 100–607, title I, §117, Nov. 4, 1988, 102 Stat. 3053; Pub. L. 101–381, title I, §102(1), Aug. 18, 1990, 104 Stat. 585; Pub. L. 102–405, title III, §302(e)(1), Oct. 9, 1992, 106 Stat. 1985; Pub. L. 103–43, title II, §210(a), title XX, §§2008(b)(1), 2010(b)(2), June 10, 1993, 107 Stat. 149, 210, 214; Pub. L. 105–245, title III, §309(b)(2)(C), Oct. 7, 1998, 112 Stat. 1853.)

References in Text

Section 284b of this title, referred to in subsec. (g), was repealed by Pub. L. 109–482, title I, §104(b)(1)(C), Jan. 15, 2007, 120 Stat. 3693.

Amendments

1998—Subsec. (h)(2)(A)(v). Pub. L. 105–245 substituted "Science of the Department of Energy" for "Energy Research of the Department of Energy".

1993—Subsec. (a)(2). Pub. L. 103–43, §2010(b)(2), substituted "section 238" for "section 300aaa".

Subsec. (b)(2)(A). Pub. L. 103–43, §2008(b)(1)(A), substituted "Department of Veterans Affairs" for "Veterans' Administration" in two places.

Subsec. (c). Pub. L. 103–43, §210(a), substituted "for 180 days after the date of such expiration" for "until a successor has taken office".

Subsec. (h)(2)(A)(v). Pub. L. 103–43, §2008(b)(1)(B), substituted "Department of Veterans Affairs" for "Veterans' Administration".

1992—Subsecs. (b)(2)(A), (h)(2)(A)(v). Pub. L. 102–405 substituted "Under Secretary for Health" for "Chief Medical Director".

1990—Subsec. (a)(2). Pub. L. 101–381 made technical amendment to reference to section 300aaa of this title to reflect renumbering of corresponding section of original act.

1988—Subsec. (b)(1). Pub. L. 100–607, §117(a), inserted at end "The ex officio members shall be nonvoting members."

Subsec. (b)(3)(A). Pub. L. 100–607, §117(b), inserted "not less than two individuals who are leaders in the fields of" after "(including".

Subsec. (h)(2)(A)(v). Pub. L. 100–607, §117(c), inserted "shall be nonvoting members and" after "Board" and substituted "the Assistant Secretary of Defense for Health Affairs, and the Director of the Office of Energy Research of the Department of Energy" for "and the Assistant Secretary of Defense for Health Affairs".

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 the 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.

References in Other Laws to GS–16, 17, or 18 Pay Rates

References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.

1 See References in Text note below.

§284b. Repealed. Pub. L. 109–482, title I, §104(b)(1)(C), Jan. 15, 2007, 120 Stat. 3693

Section, act July 1, 1944, ch. 373, title IV, §407, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 831, related to biennial report and its contents.

Effective Date of Repeal

Repeal 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.

§284c. Certain uses of funds

(a)(1) Except as provided in paragraph (2), the sum of the amounts obligated in any fiscal year for administrative expenses of the National Institutes of Health may not exceed an amount which is 5.5 percent of the total amount appropriated for such fiscal year for the National Institutes of Health.

(2) Paragraph (1) does not apply to the National Library of Medicine, the National Center for Nursing Research, the John E. Fogarty International Center for Advanced Study in the Health Sciences, the Warren G. Magnuson Clinical Center, and the Office of Medical Applications of Research.

(3) For purposes of paragraph (1), the term "administrative expenses" means expenses incurred for the support of activities relevant to the award of grants, contracts, and cooperative agreements and expenses incurred for general administration of the scientific programs and activities of the National Institutes of Health.

(b) For fiscal year 1989 and subsequent fiscal years, amounts made available to the National Institutes of Health shall be available for payment of nurses and allied health professionals in accordance with payment authorities, scheduling options, benefits, and other authorities provided under chapter 73 of title 38 for nurses of the Department of Veterans Affairs.

(July 1, 1944, ch. 373, title IV, §408, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 831; amended Pub. L. 100–607, title I, §118, Nov. 4, 1988, 102 Stat. 3053; Pub. L. 100–690, title II, §2613(d), Nov. 18, 1988, 102 Stat. 4239; Pub. L. 103–43, title IV, §403(b)(1), title XX, §2008(b)(2), June 10, 1993, 107 Stat. 158, 211; Pub. L. 104–316, title I, §122(a), Oct. 19, 1996, 110 Stat. 3836; Pub. L. 105–362, title VI, §601(a)(1)(B), Nov. 10, 1998, 112 Stat. 3285.)

Amendments

1998—Subsec. (a)(4). Pub. L. 105–362 struck out par. (4) which read as follows: "Not later than December 31, 1987, and December 31 of each succeeding year, the Secretary shall report to the Congress the amount obligated in the fiscal year preceding such date for administrative expenses of the National Institutes of Health and the total amount appropriated for the National Institutes of Health for such fiscal year. The Secretary shall consult with the Comptroller General of the United States in preparing each report."

1996—Subsec. (a)(3). Pub. L. 104–316 struck out at end "In identifying expenses incurred for such support and administration the Secretary shall consult with the Comptroller General of the United States."

1993Pub. L. 103–43 amended section catchline generally, redesignated subsec. (b) as (a) and par. (5) of subsec. (a) as (b), struck out former subsec. (a) which authorized appropriations in addition to amounts otherwise appropriated under this subchapter for the National Cancer Institute for programs other than under section 285a–1 of this title and for its program under section 285a–1 of this title and for the National Heart, Lung, and Blood Institute for programs other than under section 285b–1 of this title and for its program under section 285b–1 of this title, and substituted "Department of Veterans Affairs" for "Veterans' Administration" in subsec. (b).

1988—Subsec. (a)(1), (2). Pub. L. 100–607, §118(a), amended pars. (1) and (2) generally. Prior to amendment, pars. (1) and (2) read as follows:

"(1)(A) For the National Cancer Institute (other than its programs under section 285a–1 of this title), there are authorized to be appropriated $1,194,000,000 for fiscal year 1986, $1,270,000,000 for fiscal year 1987, and $1,344,000,000 for fiscal year 1988.

"(B) For the programs under section 285a–1 of this title, there are authorized to be appropriated $68,000,000 for fiscal year 1986, $74,000,000 for fiscal year 1987, and $80,000,000 for fiscal year 1988.

"(2)(A) For the National Heart, Lung, and Blood Institute (other than its programs under section 285b–1 of this title), there are authorized to be appropriated $809,000,000 for fiscal year 1986, $871,000,000 for fiscal year 1987, and $927,000,000 for fiscal year 1988. Of the amount appropriated under this subsection for such fiscal year, not less than 15 percent of such amount shall be reserved for programs respecting diseases of the lung and not less than 15 percent of such amount shall be reserved for programs respecting blood diseases and blood resources.

"(B) For the programs under section 285b–1 of this title, there are authorized to be appropriated $82,000,000 for fiscal year 1986, $90,000,000 for fiscal year 1987, and $98,000,000 for fiscal year 1988."

Subsec. (a)(2)(B). Pub. L. 100–690 inserted a comma after "section 285b–1 of this title".

Subsec. (b)(5). Pub. L. 100–607, §118(b), added par. (5).

Change of Name

National Center for Nursing Research changed to National Institute of Nursing Research by Pub. L. 103–43, title XV, §1511, June 10, 1993, 107 Stat. 178.

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–690 effective immediately after enactment of Pub. L. 100–607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out as a note under section 242m of this title.

Warren G. Magnuson Clinical Center; Availability of Funds for Payment of Nurses; Rate of Pay and Options and Benefits

Pub. L. 99–349, title I, July 2, 1986, 100 Stat. 738, provided that: "Funds made available for fiscal year 1986 and hereafter to the Warren G. Magnuson Clinical Center of the National Institutes of Health shall be available for payment of nurses at the rates of pay and with schedule options and benefits authorized for the Veterans Administration pursuant to 38 U.S.C. 4107."

§284d. Definitions

(a) Health service research

For purposes of this subchapter, the term "health services research" means research endeavors that study the impact of the organization, financing and management of health services on the quality, cost, access to and outcomes of care. Such term does not include research on the efficacy of services to prevent, diagnose, or treat medical conditions.

(b) Clinical research

As used in this subchapter, the term "clinical research" means patient oriented clinical research conducted with human subjects, or research on the causes and consequences of disease in human populations involving material of human origin (such as tissue specimens and cognitive phenomena) for which an investigator or colleague directly interacts with human subjects in an outpatient or inpatient setting to clarify a problem in human physiology, pathophysiology or disease, or epidemiologic or behavioral studies, outcomes research or health services research, or developing new technologies, therapeutic interventions, or clinical trials.

(July 1, 1944, ch. 373, title IV, §409, as added Pub. L. 102–321, title I, §121(b), July 10, 1992, 106 Stat. 358; amended Pub. L. 103–43, title XX, §2016(a), June 10, 1993, 107 Stat. 218; Pub. L. 106–505, title II, §206, Nov. 13, 2000, 114 Stat. 2329.)

Amendments

2000Pub. L. 106–505 designated existing provisions as subsec. (a), inserted heading, and added subsec. (b).

1993Pub. L. 103–43 inserted at end "Such term does not include research on the efficacy of services to prevent, diagnose, or treat medical conditions."

Effective Date

Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as an Effective Date of 1992 Amendment note under section 236 of this title.

§284e. Research on osteoporosis, Paget's disease, and related bone disorders

(a) Establishment

The Directors of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Aging, the National Institute of Dental Research, and the National Institute of Diabetes and Digestive and Kidney Diseases, shall expand and intensify the programs of such Institutes with respect to research and related activities concerning osteoporosis, Paget's disease, and related bone disorders.

(b) Coordination

The Directors referred to in subsection (a) shall jointly coordinate the programs referred to in such subsection and consult with the Arthritis and Musculoskeletal Diseases Interagency Coordinating Committee and the Interagency Task Force on Aging Research.

(c) Information clearinghouse

(1) In general

In order to assist in carrying out the purpose described in subsection (a), the Director of NIH shall provide for the establishment of an information clearinghouse on osteoporosis and related bone disorders to facilitate and enhance knowledge and understanding on the part of health professionals, patients, and the public through the effective dissemination of information.

(2) Establishment through grant or contract

For the purpose of carrying out paragraph (1), the Director of NIH shall enter into a grant, cooperative agreement, or contract with a nonprofit private entity involved in activities regarding the prevention and control of osteoporosis and related bone disorders.

(July 1, 1944, ch. 373, title IV, §409A, as added Pub. L. 103–43, title III, §302, June 10, 1993, 107 Stat. 151; amended Pub. L. 105–340, title I, §102, Oct. 31, 1998, 112 Stat. 3192; Pub. L. 109–482, title I, §103(b)(7), Jan. 15, 2007, 120 Stat. 3687.)

Amendments

2007—Subsec. (d). Pub. L. 109–482 struck out heading and text of subsec. (d). Text read as follows: "For the purpose of carrying out this section, there are authorized to be appropriated $40,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 2003."

1998—Subsec. (d). Pub. L. 105–340 substituted "through 2003" for "and 1996".

Effective Date of 2007 Amendment

Amendment 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 a note under section 281 of this title.

§284f. Parkinson's disease

(a) In general

The Director of NIH shall establish a program for the conduct and support of research and training with respect to Parkinson's disease (subject to the extent of amounts appropriated to carry out this section).

(b) Inter-institute coordination

(1) In general

The Director of NIH shall provide for the coordination of the program established under subsection (a) among all of the national research institutes conducting Parkinson's disease research.

(2) Conference

Coordination under paragraph (1) shall include the convening of a research planning conference not less frequently than once every 2 years. Each such conference shall prepare and submit to the Committee on Appropriations and the Committee on Labor and Human Resources of the Senate and the Committee on Appropriations and the Committee on Commerce of the House of Representatives a report concerning the conference.

(c) Morris K. Udall research centers

(1) In general

The Director of NIH is authorized to award Core Center Grants to encourage the development of innovative multidisciplinary research and provide training concerning Parkinson's disease. The Director is authorized to award not more than 10 Core Center Grants and designate each center funded under such grants as a Morris K. Udall Center for Research on Parkinson's Disease.

(2) Requirements

(A) In general

With respect to Parkinson's disease, each center assisted under this subsection shall—

(i) use the facilities of a single institution or a consortium of cooperating institutions, and meet such qualifications as may be prescribed by the Director of the NIH; and

(ii) conduct basic and clinical research.

(B) Discretionary requirements

With respect to Parkinson's disease, each center assisted under this subsection may—

(i) conduct training programs for scientists and health professionals;

(ii) conduct programs to provide information and continuing education to health professionals;

(iii) conduct programs for the dissemination of information to the public;

(iv) separately or in collaboration with other centers, establish a nationwide data system derived from patient populations with Parkinson's disease, and where possible, comparing relevant data involving general populations;

(v) separately or in collaboration with other centers, establish a Parkinson's Disease Information Clearinghouse to facilitate and enhance knowledge and understanding of Parkinson's disease; and

(vi) separately or in collaboration with other centers, establish a national education program that fosters a national focus on Parkinson's disease and the care of those with Parkinson's disease.

(3) Stipends regarding training programs

A center may use funds provided under paragraph (1) to provide stipends for scientists and health professionals enrolled in training programs under paragraph (2)(B).

(4) Duration of support

Support of a center under this subsection may be for a period not exceeding five years. Such period may be extended by the Director of NIH for one or more additional periods of not more than five years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended.

(d) Morris K. Udall Awards for Excellence in Parkinson's Disease Research

The Director of NIH is authorized to establish a grant program to support investigators with a proven record of excellence and innovation in Parkinson's disease research and who demonstrate potential for significant future breakthroughs in the understanding of the pathogensis,1 diagnosis, and treatment of Parkinson's disease. Grants under this subsection shall be available for a period of not to exceed 5 years.

(July 1, 1944, ch. 373, title IV, §409B, as added Pub. L. 105–78, title VI, §603(c), Nov. 13, 1997, 111 Stat. 1520; amended Pub. L. 109–482, title I, §103(b)(8), Jan. 15, 2007, 120 Stat. 3687.)

Amendments

2007—Subsec. (a). Pub. L. 109–482, §103(b)(8)(A), substituted "to carry out this section" for "under subsection (e) of this section".

Subsec. (e). Pub. L. 109–482, §103(b)(8)(B), struck out heading and text of subsec. (e). Text read as follows: "For the purpose of carrying out this section and section 241 of this title and this subchapter with respect to research focused on Parkinson's disease, there are authorized to be appropriated up to $100,000,000 for fiscal year 1998, and such sums as may be necessary for each of the fiscal years 1999 and 2000."

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.

Effective Date of 2007 Amendment

Amendment 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 a note under section 281 of this title.

Additional Grants

Pub. L. 108–199, div. E, title II, §217, Jan. 23, 2004, 118 Stat. 255, provided that: "Notwithstanding section 409B(c) of the Public Health Service Act [42 U.S.C. 284f(c)] regarding a limitation on the number of such grants, funds appropriated in this Act [div. E of Pub. L. 108–199, see Tables for classification] and Acts in fiscal years thereafter may be expended by the Director of the National Institutes of Health to award Core Center Grants to encourage the development of innovative multidisciplinary research and provide training concerning Parkinson's disease. Each center funded under such grants shall be designated as a Morris K. Udall Center for Research on Parkinson's Disease."

Similar provisions were contained in Pub. L. 108–7, div. G, title II, §218, Feb. 20, 2003, 117 Stat. 326.

Finding and Purpose

Pub. L. 105–78, title VI, §603(b), Nov. 13, 1997, 111 Stat. 1519, provided that:

"(1) Finding.—Congress finds that to take full advantage of the tremendous potential for finding a cure or effective treatment, the Federal investment in Parkinson's disease must be expanded, as well as the coordination strengthened among the National Institutes of Health research institutes.

"(2) Purpose.—It is the purpose of this section [enacting this section] to provide for the expansion and coordination of research regarding Parkinson's disease, and to improve care and assistance for afflicted individuals and their family caregivers."

1 So in original. Probably should be "pathogenesis,".

§284g. Expansion, intensification, and coordination of activities of National Institutes of Health with respect to research on autism spectrum disorder

(a) In general

(1) Expansion of activities

The Director of NIH (in this section referred to as the "Director") shall, subject to the availability of appropriations, expand, intensify, and coordinate the activities of the National Institutes of Health with respect to research on autism spectrum disorder, including basic and clinical research in fields including pathology, developmental neurobiology, genetics, epigenetics, pharmacology, nutrition, immunology, neuroimmunology, neurobehavioral development, endocrinology, gastroenterology, and toxicology. Such research shall investigate the cause (including possible environmental causes), diagnosis or rule out, early detection, prevention, services, supports, intervention, and treatment of autism spectrum disorder.

(2) Consolidation

The Director may consolidate program activities under this section if such consolidation would improve program efficiencies and outcomes.

(3) Administration of program; collaboration among agencies

The Director shall carry out this section acting through the Director of the National Institute of Mental Health and in collaboration with any other agencies that the Director determines appropriate.

(b) Centers of excellence

(1) In general

The Director shall under subsection (a)(1) make awards of grants and contracts to public or nonprofit private entities to pay all or part of the cost of planning, establishing, improving, and providing basic operating support for centers of excellence regarding research on autism spectrum disorder.

(2) Research

Each center under paragraph (1) shall conduct basic and clinical research into autism spectrum disorder. Such research should include investigations into the cause, diagnosis, early detection, prevention, control, and treatment of autism spectrum disorder. The centers, as a group, shall conduct research including the fields of developmental neurobiology, genetics, and psychopharmacology.

(3) Services for patients

(A) In general

A center under paragraph (1) may expend amounts provided under such paragraph to carry out a program to make individuals aware of opportunities to participate as subjects in research conducted by the centers.

(B) Referrals and costs

A program under subparagraph (A) may, in accordance with such criteria as the Director may establish, provide to the subjects described in such subparagraph, referrals for health and other services, and such patient care costs as are required for research.

(C) Availability and access

The extent to which a center can demonstrate availability and access to clinical services shall be considered by the Director in decisions about awarding grants to applicants which meet the scientific criteria for funding under this section.

(4) Organization of centers

Each center under paragraph (1) shall use the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may be prescribed by the Director.

(5) Number of centers; duration of support

(A) In general

The Director shall provide for the establishment of not less than five centers under paragraph (1).

(B) Duration

Support for a center established under paragraph (1) may be provided under this section for a period of not to exceed 5 years. Such period may be extended for one or more additional periods not exceeding 5 years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended.

(c) Facilitation of research

The Director shall under subsection (a)(1) provide for a program under which samples of tissues and genetic materials that are of use in research on autism spectrum disorder are donated, collected, preserved, and made available for such research. The program shall be carried out in accordance with accepted scientific and medical standards for the donation, collection, and preservation of such samples.

(d) Public input

The Director shall under subsection (a)(1) provide for means through which the public can obtain information on the existing and planned programs and activities of the National Institutes of Health with respect to autism spectrum disorder and through which the Director can receive comments from the public regarding such programs and activities.

(July 1, 1944, ch. 373, title IV, §409C, as added Pub. L. 106–310, div. A, title I, §101, Oct. 17, 2000, 114 Stat. 1105; amended Pub. L. 109–416, §§2(a), 4(b), Dec. 19, 2006, 120 Stat. 2821, 2830; Pub. L. 109–482, title I, §§103(b)(9), 104(b)(1)(D), Jan. 15, 2007, 120 Stat. 3687, 3693.)

Codification

Another section 409C of act July 1, 1944, was renumbered section 409G and is classified to section 284k of this title.

Amendments

2007—Subsec. (b)(4) to (6). Pub. L. 109–482, §104(b)(1)(D), redesignated pars. (5) and (6) as (4) and (5), respectively, and struck out heading and text of former par. (4). Text read as follows: "The Director shall, as appropriate, provide for the coordination of information among centers under paragraph (1) and ensure regular communication between such centers, and may require the periodic preparation of reports on the activities of the centers and the submission of the reports to the Director."

Subsec. (e). Pub. L. 109–482, §103(b)(9), which directed the striking of subsec. (e), could not be executed because of prior amendment by Pub. L. 109–416. See 2006 Amendment note below.

2006Pub. L. 109–416, §2(a)(1), substituted "autism spectrum disorder" for "autism" in section catchline.

Subsec. (a). Pub. L. 109–416, §2(a)(3), added pars. (1) and (2), redesignated former par. (2) as (3), and struck out heading and text of former par. (1). Text read as follows: "The Director of NIH (in this section referred to as the 'Director') shall expand, intensify, and coordinate the activities of the National Institutes of Health with respect to research on autism."

Subsec. (b)(1), (2). Pub. L. 109–416, §2(a)(2), substituted "autism spectrum disorder" for "autism" in par. (1) and in two places in par. (2).

Subsecs. (c), (d). Pub. L. 109–416, §2(a)(2), substituted "autism spectrum disorder" for "autism".

Subsec. (e). Pub. L. 109–416, §4(b), struck out heading and text of subsec. (e). Text read as follows: "There are authorized to be appropriated such sums as may be necessary to carry out this section. Amounts appropriated under this subsection are in addition to any other amounts appropriated for such purpose."

Effective Date of 2007 Amendment

Amendment 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 a note under section 281 of this title.

§284h. Pediatric Research Initiative

(a) Establishment

The Secretary shall establish within the Office of the Director of NIH a Pediatric Research Initiative (referred to in this section as the "Initiative") to conduct and support research that is directly related to diseases, disorders, and other conditions in children. The Initiative shall be headed by the Director of NIH.

(b) Purpose

The purpose of the Initiative is to provide funds to enable the Director of NIH—

(1) to increase support for pediatric biomedical research within the National Institutes of Health to realize the expanding opportunities for advancement in scientific investigations and care for children;

(2) to enhance collaborative efforts among the Institutes to conduct and support multidisciplinary research in the areas that the Director deems most promising; and

(3) in coordination with the Food and Drug Administration, to increase the development of adequate pediatric clinical trials and pediatric use information to promote the safer and more effective use of prescription drugs in the pediatric population.

(c) Duties

In carrying out subsection (b), the Director of NIH shall—

(1) consult with the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the other national research institutes, in considering their requests for new or expanded pediatric research efforts, and consult with the Administrator of the Health Resources and Services Administration and other advisors as the Director determines to be appropriate;

(2) have broad discretion in the allocation of any Initiative assistance among the Institutes, among types of grants, and between basic and clinical research so long as the assistance is directly related to the illnesses and conditions of children; and

(3) be responsible for the oversight of any newly appropriated Initiative funds and annually report to Congress and the public on the extent of the total funds obligated to conduct or support pediatric research across the National Institutes of Health, including the specific support and research awards allocated through the Initiative.

(d) National Pediatric Research Network

(1) Network

In carrying out the Initiative, the Director of NIH, in collaboration with the national research institutes and national centers that carry out activities involving pediatric research, shall support a National Pediatric Research Network in order to more effectively support pediatric research and optimize the use of Federal resources. Such National Pediatric Research Network may be comprised of, as appropriate—

(A) the pediatric research consortia receiving awards under paragraph (2); or

(B) other consortia, centers, or networks focused on pediatric research that are recognized by the Director of NIH and established pursuant to the authorities vested in the National Institutes of Health by other sections of this chapter.

(2) Pediatric research consortia

(A) In general

The Director of NIH shall award funding, including through grants, contracts, or other mechanisms, to public or private nonprofit entities for providing support for pediatric research consortia, including with respect to—

(i) basic, clinical, behavioral, or translational research to meet unmet needs for pediatric research; and

(ii) training researchers in pediatric research techniques in order to address unmet pediatric research needs.

(B) Research

The Director of NIH shall, as appropriate, ensure that—

(i) each consortium receiving an award under subparagraph (A) conducts or supports at least one category of research described in subparagraph (A)(i) and collectively such consortia conduct or support such categories of research; and

(ii) one or more such consortia provide training described in subparagraph (A)(ii).

(C) Organization of consortium

Each consortium receiving an award under subparagraph (A) shall—

(i) be formed from a collaboration of cooperating institutions;

(ii) be coordinated by a lead institution or institutions;

(iii) agree to disseminate scientific findings, including from clinical trials, rapidly and efficiently, as appropriate, to—

(I) other consortia;

(II) the National Institutes of Health;

(III) the Food and Drug Administration;

(IV) and 1 other relevant agencies; and


(iv) meet such requirements as may be prescribed by the Director of NIH.

(D) Supplement, not supplant

Any support received by a consortium under subparagraph (A) shall be used to supplement, and not supplant, other public or private support for activities authorized to be supported under this paragraph.

(E) Duration of support

Support of a consortium under subparagraph (A) shall be for a period of not to exceed 5 years. Such period may be extended at the discretion of the Director of NIH.

(3) Coordination of consortia activities

The Director of NIH shall, as appropriate—

(A) provide for the coordination of activities (including the exchange of information and regular communication) among the consortia established pursuant to paragraph (2); and

(B) require the periodic preparation and submission to the Director of reports on the activities of each such consortium.

(4) Assistance with registries

Each consortium receiving an award under paragraph (2)(A) may provide assistance, as appropriate, to the Centers for Disease Control and Prevention for activities related to patient registries and other surveillance systems upon request by the Director of the Centers for Disease Control and Prevention.

(e) Research on pediatric rare diseases or conditions

In making awards under subsection (d)(2) for pediatric research consortia, the Director of NIH shall ensure that an appropriate number of such awards are awarded to such consortia that agree to—

(1) consider pediatric rare diseases or conditions, or those related to birth defects; and

(2) conduct or coordinate one or more multisite clinical trials of therapies for, or approaches to, the prevention, diagnosis, or treatment of one or more pediatric rare diseases or conditions.

(f) Transfer of funds

The Director of NIH may transfer amounts appropriated under this section to any of the Institutes for a fiscal year to carry out the purposes of the Initiative under this section.

(July 1, 1944, ch. 373, title IV, §409D, as added Pub. L. 106–310, div. A, title X, §1001, Oct. 17, 2000, 114 Stat. 1127; amended Pub. L. 109–482, title I, §103(b)(10), Jan. 15, 2007, 120 Stat. 3687; Pub. L. 110–154, §1(b)(4), Dec. 21, 2007, 121 Stat. 1827; Pub. L. 113–55, title II, §202, Nov. 27, 2013, 127 Stat. 644; Pub. L. 114–255, div. A, title II, §2071, Dec. 13, 2016, 130 Stat. 1083.)

Codification

Another section 409D of act July 1, 1944, was renumbered section 409H and is classified to section 284l of this title.

Amendments

2016—Subsec. (d)(1). Pub. L. 114–255, §2071(1), substituted "in collaboration with the national research institutes and national centers that carry out activities involving pediatric research, shall support" for "in consultation with the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and in collaboration with other appropriate national research institutes and national centers that carry out activities involving pediatric research, may provide for the establishment of" in introductory provisions.

Subsec. (d)(2)(A), (E). Pub. L. 114–255, §2071(2), substituted "shall" for "may" in introductory provisions of par. (2)(A) and in first sentence of par. (2)(E).

2013—Subsecs. (d) to (f). Pub. L. 113–55 added subsecs. (d) and (e) and redesignated former subsec. (d) as (f).

2007—Subsec. (c)(1). Pub. L. 110–154 substituted "Eunice Kennedy Shriver National Institute of Child Health and Human Development" for "National Institute of Child Health and Human Development".

Subsecs. (d), (e). Pub. L. 109–482 redesignated subsec. (e) as (d) and struck out heading and text of former subsec. (d). Text read as follows: "For the purpose of carrying out this section, there are authorized to be appropriated $50,000,000 for fiscal year 2001, and such sums as may be necessary for each of the fiscal years 2002 through 2005."

Effective Date of 2007 Amendment

Amendment 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 a note under section 281 of this title.

1 So in original. The word "and" probably should appear at end of subcl. (III).

§284i. Autoimmune diseases

(a) Expansion, intensification, and coordination of activities

(1) In general

The Director of NIH shall expand, intensify, and coordinate research and other activities of the National Institutes of Health with respect to autoimmune diseases.

(2) Allocations by Director of NIH

With respect to amounts appropriated to carry out this section for a fiscal year, the Director of NIH shall allocate the amounts among the national research institutes that are carrying out paragraph (1).

(3) Definition

The term "autoimmune disease" includes, for purposes of this section such diseases or disorders with evidence of autoimmune pathogensis 1 as the Secretary determines to be appropriate.

(b) Coordinating Committee

(1) In general

The Secretary shall ensure that the Autoimmune Diseases Coordinating Committee (referred to in this section as the "Coordinating Committee") coordinates activities across the National Institutes and with other Federal health programs and activities relating to such diseases.

(2) Composition

The Coordinating Committee shall be composed of the directors or their designees of each of the national research institutes involved in research with respect to autoimmune diseases and representatives of all other Federal departments and agencies whose programs involve health functions or responsibilities relevant to such diseases, including the Centers for Disease Control and Prevention and the Food and Drug Administration.

(3) Chair

(A) In general

With respect to autoimmune diseases, the Chair of the Committee shall serve as the principal advisor to the Secretary, the Assistant Secretary for Health, and the Director of NIH, and shall provide advice to the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and Drugs, and other relevant agencies.

(B) Director of NIH

The Chair of the Committee shall be directly responsible to the Director of NIH.

(c) Plan for NIH activities

(1) In general

Not later than 1 year after October 17, 2000, the Coordinating Committee shall develop a plan for conducting and supporting research and education on autoimmune diseases through the national research institutes and shall periodically review and revise the plan. The plan shall—

(A) provide for a broad range of research and education activities relating to biomedical, psychosocial, and rehabilitative issues, including studies of the disproportionate impact of such diseases on women;

(B) identify priorities among the programs and activities of the National Institutes of Health regarding such diseases; and

(C) reflect input from a broad range of scientists, patients, and advocacy groups.

(2) Certain elements of plan

The plan under paragraph (1) shall, with respect to autoimmune diseases, provide for the following as appropriate:

(A) Research to determine the reasons underlying the incidence and prevalence of the diseases.

(B) Basic research concerning the etiology and causes of the diseases.

(C) Epidemiological studies to address the frequency and natural history of the diseases, including any differences among the sexes and among racial and ethnic groups.

(D) The development of improved screening techniques.

(E) Clinical research for the development and evaluation of new treatments, including new biological agents.

(F) Information and education programs for health care professionals and the public.

(3) Implementation of plan

The Director of NIH shall ensure that programs and activities of the National Institutes of Health regarding autoimmune diseases are implemented in accordance with the plan under paragraph (1).

(July 1, 1944, ch. 373, title IV, §409E, as added Pub. L. 106–310, div. A, title XIX, §1901, Oct. 17, 2000, 114 Stat. 1153; amended Pub. L. 109–482, title I, §§103(b)(11), 104(b)(1)(E), Jan. 15, 2007, 120 Stat. 3687, 3693.)

Amendments

2007—Subsec. (d). Pub. L. 109–482, §104(b)(1)(E), struck out heading and text of subsec. (d). Text read as follows: "The Coordinating Committee under subsection (b)(1) of this section shall biennially submit to the Committee on Commerce of the House of Representatives, and the Committee on Health, Education, Labor and Pensions of the Senate, a report that describes the research, education, and other activities on autoimmune diseases being conducted or supported through the national research institutes, and that in addition includes the following:

"(1) The plan under subsection (c)(1) of this section (or revisions to the plan, as the case may be).

"(2) Provisions specifying the amounts expended by the National Institutes of Health with respect to each of the autoimmune diseases included in the plan.

"(3) Provisions identifying particular projects or types of projects that should in the future be considered by the national research institutes or other entities in the field of research on autoimmune diseases."

Subsec. (e). Pub. L. 109–482, §103(b)(11), struck out heading and text of subsec. (e). Text read as follows: "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. The authorization of appropriations established in the preceding sentence is in addition to any other authorization of appropriations that is available for conducting or supporting through the National Institutes of Health research and other activities with respect to autoimmune diseases."

Effective Date of 2007 Amendment

Amendment 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 a note under section 281 of this title.

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

§284j. Muscular dystrophy research

(a) Coordination of activities

The Director of NIH shall expand and increase coordination in the activities of the National Institutes of Health with respect to research on muscular dystrophies, including Duchenne muscular dystrophy.

(b) Administration of program; collaboration among agencies

The Director of NIH shall carry out this section through the appropriate institutes, including the National Institute of Neurological Disorders and Stroke and in collaboration with any other agencies that the Director determines appropriate.

(July 1, 1944, ch. 373, title IV, §409F, as added Pub. L. 106–310, div. A, title XXII, §2201, Oct. 17, 2000, 114 Stat. 1157; amended Pub. L. 109–482, title I, §103(b)(12), Jan. 15, 2007, 120 Stat. 3687.)

Amendments

2007—Subsec. (c). Pub. L. 109–482 struck out heading and text of subsec. (c). Text read as follows: "There are authorized to be appropriated such sums as may be necessary to carry out this section for each of the fiscal years 2001 through 2005. Amounts appropriated under this subsection shall be in addition to any other amounts appropriated for such purpose."

Effective Date of 2007 Amendment

Amendment 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 a note under section 281 of this title.

§284k. Clinical research

(a) In general

The Director of National Institutes of Health shall undertake activities to support and expand the involvement of the National Institutes of Health in clinical research.

(b) Requirements

In carrying out subsection (a), the Director of National Institutes of Health shall—

(1) consider the recommendations of the Division of Research Grants Clinical Research Study Group and other recommendations for enhancing clinical research; and

(2) establish intramural and extramural clinical research fellowship programs directed specifically at medical and dental students and a continuing education clinical research training program at the National Institutes of Health.

(c) Support for the diverse needs of clinical research

The Director of National Institutes of Health, in cooperation with the Directors of the Institutes, Centers, and Divisions of the National Institutes of Health, shall support and expand the resources available for the diverse needs of the clinical research community, including inpatient, outpatient, and critical care clinical research.

(d) Peer review

The Director of National Institutes of Health shall establish peer review mechanisms to evaluate applications for the awards and fellowships provided for in subsection (b)(2) and section 284l of this title. Such review mechanisms shall include individuals who are exceptionally qualified to appraise the merits of potential clinical research training and research grant proposals.

(July 1, 1944, ch. 373, title IV, §409G, formerly §409C, as added Pub. L. 106–505, title II, §203, Nov. 13, 2000, 114 Stat. 2326; renumbered §409G, Pub. L. 107–109, §3(1), Jan. 4, 2002, 115 Stat. 1408.)

References in Text

Section 284l of this title, referred to in subsec. (d), was in the original "section 409D", and was translated as meaning section 409D of act July 1, 1944, ch. 373, as added by section 204(b) of Pub. L. 106–505. Such section 409D was renumbered section 409H of act July 1, 1944, ch. 373, by Pub. L. 107–109, §3(2), Jan. 4, 2002, 115 Stat. 1408. Another section 409D of act July 1, 1944, ch. 373, as added by section 1001 of Pub. L. 106–310, is classified to section 284h of this title.

Findings and Purpose

Pub. L. 106–505, title II, §202, Nov. 13, 2000, 114 Stat. 2325, provided that:

"(a) Findings.—Congress makes the following findings:

"(1) Clinical research is critical to the advancement of scientific knowledge and to the development of cures and improved treatment for disease.

"(2) Tremendous advances in biology are opening doors to new insights into human physiology, pathophysiology and disease, creating extraordinary opportunities for clinical research.

"(3) Clinical research includes translational research which is an integral part of the research process leading to general human applications. It is the bridge between the laboratory and new methods of diagnosis, treatment, and prevention and is thus essential to progress against cancer and other diseases.

"(4) The United States will spend more than $1,200,000,000,000 on health care in 1999, but the Federal budget for health research at the National Institutes of Health was $15,600,000,000 only 1 percent of that total.

"(5) Studies at the Institute of Medicine, the National Research Council, and the National Academy of Sciences have all addressed the current problems in clinical research.

"(6) The Director of the National Institutes of Health has recognized the current problems in clinical research and appointed a special panel, which recommended expanded support for existing National Institutes of Health clinical research programs and the creation of new initiatives to recruit and retain clinical investigators.

"(7) The current level of training and support for health professionals in clinical research is fragmented, undervalued, and underfunded.

"(8) Young investigators are not only apprentices for future positions but a crucial source of energy, enthusiasm, and ideas in the day-to-day research that constitutes the scientific enterprise. Serious questions about the future of life-science research are raised by the following:

"(A) The number of young investigators applying for grants dropped by 54 percent between 1985 and 1993.

"(B) The number of physicians applying for first-time National Institutes of Health research project grants fell from 1226 in 1994 to 963 in 1998, a 21 percent reduction.

"(C) Newly independent life-scientists are expected to raise funds to support their new research programs and a substantial proportion of their own salaries.

"(9) The following have been cited as reasons for the decline in the number of active clinical researchers, and those choosing this career path:

"(A) A medical school graduate incurs an average debt of $85,619, as reported in the Medical School Graduation Questionnaire by the Association of American Medical Colleges (AAMC).

"(B) The prolonged period of clinical training required increases the accumulated debt burden.

"(C) The decreasing number of mentors and role models.

"(D) The perceived instability of funding from the National Institutes of Health and other Federal agencies.

"(E) The almost complete absence of clinical research training in the curriculum of training grant awardees.

"(F) Academic Medical Centers are experiencing difficulties in maintaining a proper environment for research in a highly competitive health care marketplace, which are compounded by the decreased willingness of third party payers to cover health care costs for patients engaged in research studies and research procedures.

"(10) In 1960, general clinical research centers were established under the Office of the Director of the National Institutes of Health with an initial appropriation of $3,000,000.

"(11) Appropriations for general clinical research centers in fiscal year 1999 equaled $200,500,000.

"(12) Since the late 1960s, spending for general clinical research centers has declined from approximately 3 percent to 1 percent of the National Institutes of Health budget.

"(13) In fiscal year 1999, there were 77 general clinical research centers in operation, supplying patients in the areas in which such centers operate with access to the most modern clinical research and clinical research facilities and technologies.

"(b) Purpose.—It is the purpose of this title [see Short Title of 2000 Amendments note set out under section 201 of this title] to provide additional support for and to expand clinical research programs."

Oversight by GAO

Pub. L. 106–505, title II, §207, Nov. 13, 2000, 114 Stat. 2330, provided that, not later than 18 months after Nov. 13, 2000, the Comptroller General was to submit to Congress a report describing the extent to which the National Institutes of Health had complied with the amendments made by title II of Pub. L. 106–505.

§284l. Enhancement awards

(a) Mentored Patient-Oriented Research Career Development Awards

(1) Grants

(A) In general

The Director of the National Institutes of Health shall make grants (to be referred to as "Mentored Patient-Oriented Research Career Development Awards") to support individual careers in clinical research at general clinical research centers or at other institutions that have the infrastructure and resources deemed appropriate for conducting patient-oriented clinical research.

(B) Use

Grants under subparagraph (A) shall be used to support clinical investigators in the early phases of their independent careers by providing salary and such other support for a period of supervised study.

(2) Applications

An application for a grant under this subsection shall be submitted by an individual scientist at such time as the Director may require.

(b) Mid-Career Investigator Awards in Patient-Oriented Research

(1) Grants

(A) In general

The Director of the National Institutes of Health shall make grants (to be referred to as "Mid-Career Investigator Awards in Patient-Oriented Research") to support individual clinical research projects at general clinical research centers or at other institutions that have the infrastructure and resources deemed appropriate for conducting patient-oriented clinical research.

(B) Use

Grants under subparagraph (A) shall be used to provide support for mid-career level clinicians to allow such clinicians to devote time to clinical research and to act as mentors for beginning clinical investigators.

(2) Applications

An application for a grant under this subsection shall be submitted by an individual scientist at such time as the Director requires.

(c) Graduate Training in Clinical Investigation Award

(1) In general

The Director of the National Institutes of Health shall make grants (to be referred to as "Graduate Training in Clinical Investigation Awards") to support individuals pursuing master's or doctoral degrees in clinical investigation.

(2) Applications

An application for a grant under this subsection shall be submitted by an individual scientist at such time as the Director may require.

(3) Limitations

Grants under this subsection shall be for terms of 2 years or more and shall provide stipend, tuition, and institutional support for individual advanced degree programs in clinical investigation.

(4) Definition

As used in this subsection, the term "advanced degree programs in clinical investigation" means programs that award a master's or Ph.D. degree in clinical investigation after 2 or more years of training in areas such as the following:

(A) Analytical methods, biostatistics, and study design.

(B) Principles of clinical pharmacology and pharmacokinetics.

(C) Clinical epidemiology.

(D) Computer data management and medical informatics.

(E) Ethical and regulatory issues.

(F) Biomedical writing.

(d) Clinical Research Curriculum Awards

(1) In general

The Director of the National Institutes of Health shall make grants (to be referred to as "Clinical Research Curriculum Awards") to institutions for the development and support of programs of core curricula for training clinical investigators, including medical students. Such core curricula may include training in areas such as the following:

(A) Analytical methods, biostatistics, and study design.

(B) Principles of clinical pharmacology and pharmacokinetics.

(C) Clinical epidemiology.

(D) Computer data management and medical informatics.

(E) Ethical and regulatory issues.

(F) Biomedical writing.

(2) Applications

An application for a grant under this subsection shall be submitted by an individual institution or a consortium of institutions at such time as the Director may require. An institution may submit only one such application.

(3) Limitations

Grants under this subsection shall be for terms of up to 5 years and may be renewable.

(July 1, 1944, ch. 373, title IV, §409H, formerly §409D, as added Pub. L. 106–505, title II, §204(b), Nov. 13, 2000, 114 Stat. 2327; renumbered §409H, Pub. L. 107–109, §3(2), Jan. 4, 2002, 115 Stat. 1408; Pub. L. 109–482, title I, §103(b)(13), Jan. 15, 2007, 120 Stat. 3687.)

Amendments

2007—Subsec. (a)(3). Pub. L. 109–482, §103(b)(13)(A), struck out heading and text of par. (3). Text read as follows: "For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary for each fiscal year."

Subsec. (b)(3). Pub. L. 109–482, §103(b)(13)(B), struck out heading and text of par. (3). Text read as follows: "For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary for each fiscal year."

Subsec. (c)(5). Pub. L. 109–482, §103(b)(13)(C), struck out heading and text of par. (5). Text read as follows: "For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary for each fiscal year."

Subsec. (d)(4). Pub. L. 109–482, §103(b)(13)(D), struck out heading and text of par. (4). Text read as follows: "For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary for each fiscal year."

Effective Date of 2007 Amendment

Amendment 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 a note under section 281 of this title.

§284m. Program for pediatric studies of drugs

(a) List of priority issues in pediatric therapeutics

(1) In general

Not later than one year after September 27, 2007, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs and experts in pediatric research, shall develop and publish a priority list of needs in pediatric therapeutics, including drugs, biological products, or indications that require study. The list shall be revised every three years.

(2) Consideration of available information

In developing and prioritizing the list under paragraph (1), the Secretary—

(A) shall consider—

(i) therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials;

(ii) particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, and identification of biomarkers for such diseases, disorders, or conditions, may be beneficial in pediatric populations; and

(iii) the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators; and


(B) may consider the availability of qualified countermeasures (as defined in section 247d–6a of this title), security countermeasures (as defined in section 247d–6b of this title), and qualified pandemic or epidemic products (as defined in section 247d–6d of this title) to address the needs of pediatric populations, in consultation with the Assistant Secretary for Preparedness and Response, consistent with the purposes of this section.

(b) Pediatric studies and research

The Secretary, acting through the National Institutes of Health, shall award funds to entities that have the expertise to conduct pediatric clinical trials or other research (including qualified universities, hospitals, laboratories, contract research organizations, practice groups, federally funded programs such as pediatric pharmacology research units, other public or private institutions, or individuals) to enable the entities to conduct the drug studies or other research on the issues described in paragraphs (1) and (2)(A) of subsection (a). The Secretary may use contracts, grants, or other appropriate funding mechanisms to award funds under this subsection.

(c) Process for proposed pediatric study requests and labeling changes

(1) Submission of proposed pediatric study request

The Director of the National Institutes of Health shall, as appropriate, submit proposed pediatric study requests for consideration by the Commissioner of Food and Drugs for pediatric studies of a specific pediatric indication identified under subsection (a). Such a proposed pediatric study request shall be made in a manner equivalent to a written request made under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a], or section 262(m) of this title, including with respect to the information provided on the pediatric studies to be conducted pursuant to the request. The Director of the National Institutes of Health may submit a proposed pediatric study request for a drug for which—

(A)(i) there is an approved application under section 505(j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)] or section 262(k) of this title; or

(ii) there is a submitted application that could be approved under the criteria of such section; and

(B) there remains no patent listed pursuant to section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(b)(1)], and every three-year and five-year period referred to in subsection (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv), (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355], or applicable twelve-year period referred to in section 262(k)(7) of this title, and any seven-year period referred to in section 527 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360cc] has ended for at least one form of the drug; and

(C) additional studies are needed to assess the safety and effectiveness of the use of the drug in the pediatric population.

(2) Written request to holders of approved applications

The Commissioner of Food and Drugs, in consultation with the Director of the National Institutes of Health, may issue a written request based on the proposed pediatric study request for the indication or indications submitted pursuant to paragraph (1) (which shall include a timeframe for negotiations for an agreement) for pediatric studies concerning a drug identified under subsection (a) to all holders of an approved application for the drug. Such a written request shall be made in a manner equivalent to the manner in which a written request is made under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a] or section 262(m) of this title, including with respect to information provided on the pediatric studies to be conducted pursuant to the request and using appropriate formulations for each age group for which the study is requested.

(3) Requests for proposals

If the Commissioner of Food and Drugs does not receive a response to a written request issued under paragraph (2) not later than 30 days after the date on which a request was issued, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs, shall publish a request for proposals to conduct the pediatric studies described in the written request in accordance with subsection (b).

(4) Disqualification

A holder that receives a first right of refusal shall not be entitled to respond to a request for proposals under paragraph (3).

(5) Contracts, grants, or other funding mechanisms

A contract, grant, or other funding may be awarded under this section only if a proposal is submitted to the Secretary in such form and manner, and containing such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.

(6) Reporting of studies

(A) In general

On completion of a pediatric study in accordance with an award under this section, a report concerning the study shall be submitted to the Director of the National Institutes of Health and the Commissioner of Food and Drugs. The report shall include all data generated in connection with the study, including a written request if issued.

(B) Availability of reports

(i) In general

Each report submitted under subparagraph (A) shall be considered to be in the public domain (subject to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a(d)(4)]) and not later than 90 days after submission of such report, shall be—

(I) posted on the internet website of the National Institutes of Health in a manner that is accessible and consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection of—

(aa) human research participants, including with respect to privacy, security, informed consent, and protected health information; and

(bb) proprietary interests, confidential commercial information, and intellectual property rights; and


(II) assigned a docket number by the Commissioner of Food and Drugs and made available for the submission of public comments.

(ii) Submission of comments

An interested person may submit written comments concerning such pediatric studies to the Commissioner of Food and Drugs, and the submitted comments shall become part of the docket file with respect to each of the drugs.

(C) Action by Commissioner

The Commissioner of Food and Drugs shall take action in a timely and appropriate manner in response to the reports submitted under subparagraph (A), and shall begin such action upon receipt of the report under subparagraph (A), in accordance with paragraph (7).

(7) Requests for labeling change

Within the 180-day period after the date on which a report is submitted under paragraph (6)(A), the Commissioner of Food and Drugs shall—

(A) review the report and such other data as are available concerning the safe and effective use in the pediatric population of the drug studied;

(B) negotiate with the holders of approved applications for the drug studied for any labeling changes that the Commissioner of Food and Drugs determines to be appropriate and requests the holders to make; and

(C)(i) include in the public docket file a reference to the location of the report on the internet website of the National Institutes of Health and a copy of any requested labeling changes; and

(ii) publish through a posting on the Web site of the Food and Drug Administration a summary of the report and a copy of any requested labeling changes.

(8) Dispute resolution

(A) Referral to Pediatric Advisory Committee

If, not later than the end of the 180-day period specified in paragraph (7), the holder of an approved application for the drug involved does not agree to any labeling change requested by the Commissioner of Food and Drugs under that paragraph, the Commissioner of Food and Drugs shall refer the request to the Pediatric Advisory Committee.

(B) Action by the Pediatric Advisory Committee

Not later than 90 days after receiving a referral under subparagraph (A), the Pediatric Advisory Committee shall—

(i) review the available information on the safe and effective use of the drug in the pediatric population, including study reports submitted under this section; and

(ii) make a recommendation to the Commissioner of Food and Drugs as to appropriate labeling changes, if any.

(9) FDA determination

Not later than 30 days after receiving a recommendation from the Pediatric Advisory Committee under paragraph (8)(B)(ii) with respect to a drug, the Commissioner of Food and Drugs shall consider the recommendation and, if appropriate, make a request to the holders of approved applications for the drug to make any labeling change that the Commissioner of Food and Drugs determines to be appropriate.

(10) Failure to agree

If a holder of an approved application for a drug, within 30 days after receiving a request to make a labeling change under paragraph (9), does not agree to make a requested labeling change, the Commissioner of Food and Drugs may deem the drug to be misbranded under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].

(11) No effect on authority

Nothing in this subsection limits the authority of the United States to bring an enforcement action under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] when a drug lacks appropriate pediatric labeling. Neither course of action (the Pediatric Advisory Committee process or an enforcement action referred to in the preceding sentence) shall preclude, delay, or serve as the basis to stay the other course of action.

(d) Authorization of appropriations

(1) In general

There are authorized to be appropriated to carry out this section, $25,000,000 for each of fiscal years 2018 through 2022.

(2) Availability

Any amount appropriated under paragraph (1) shall remain available to carry out this section until expended.

(July 1, 1944, ch. 373, title IV, §409I, as added Pub. L. 107–109, §3(3), Jan. 4, 2002, 115 Stat. 1408; amended Pub. L. 108–155, §3(b)(6), Dec. 3, 2003, 117 Stat. 1942; Pub. L. 109–482, title I, §103(b)(14), Jan. 15, 2007, 120 Stat. 3687; Pub. L. 110–85, title V, §502(b), Sept. 27, 2007, 121 Stat. 886; Pub. L. 111–148, title VII, §7002(g)(2)(A), Mar. 23, 2010, 124 Stat. 820; Pub. L. 112–144, title V, §§507(d), 509(d), July 9, 2012, 126 Stat. 1045, 1049; Pub. L. 113–5, title III, §307(b), Mar. 13, 2013, 127 Stat. 192; Pub. L. 115–52, title V, §501, Aug. 18, 2017, 131 Stat. 1036.)

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (c)(10), (11), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.

Amendments

2017—Subsec. (a)(2)(A)(ii). Pub. L. 115–52, §501(1), inserted "and identification of biomarkers for such diseases, disorders, or conditions," after "biologics,".

Subsec. (c)(6)(B). Pub. L. 115–52, §501(2)(A)(i), amended subpar. (B) generally. Prior to amendment, text read as follows: "Each report submitted under subparagraph (A) shall be considered to be in the public domain (subject to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act) and shall be assigned a docket number by the Commissioner of Food and Drugs. An interested person may submit written comments concerning such pediatric studies to the Commissioner of Food and Drugs, and the written comments shall become part of the docket file with respect to each of the drugs."

Subsec. (c)(6)(C). Pub. L. 115–52, §501(2)(A)(ii), substituted "action in a timely and appropriate manner in response to the reports submitted under subparagraph (A), and shall begin such action upon receipt of the report under subparagraph (A), in accordance with paragraph (7)." for "appropriate action in response to the reports submitted under subparagraph (A) in accordance with paragraph (7)."

Subsec. (c)(7). Pub. L. 115–52, §501(2)(B)(i), substituted "Within" for "During" in introductory provisions.

Subsec. (c)(7)(C)(i). Pub. L. 115–52, §501(2)(B)(ii), substituted "include in the public docket file a reference to the location of the report on the internet website of the National Institutes of Health and a copy of" for "place in the public docket file a copy of the report and of".

Subsec. (c)(7)(C)(ii). Pub. L. 115–52, §501(2)(B)(iii), struck out "in the Federal Register and" after "publish".

Subsec. (d). Pub. L. 115–52, §501(3), (4), redesignated subsec. (e) as (d) and struck out former subsec. (d). Prior to amendment, text of subsec. (d) read as follows: "Not later than one year after September 27, 2007, the Secretary, acting through the Director of the National Institutes of Health, shall study the feasibility of establishing a compilation of information on pediatric drug use and report the findings to Congress."

Subsec. (d)(1). Pub. L. 115–52, §501(5), substituted "2018 through 2022" for "2013 through 2017".

Subsec. (e). Pub. L. 115–52, §501(4), redesignated subsec. (e) as (d).

2013—Subsec. (a)(2). Pub. L. 113–5, §307(b)(1), added par. (2) and struck out former par. (2). Prior to amendment, text read as follows: "In developing and prioritizing the list under paragraph (1), the Secretary shall consider—

"(A) therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials;

"(B) particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, may be beneficial in pediatric populations; and

"(C) the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators."

Subsec. (b). Pub. L. 113–5, §307(b)(2), substituted "paragraphs (1) and (2)(A) of subsection (a)" for "subsection (a)".

2012—Subsec. (c)(1). Pub. L. 112–144, §509(d)(1)(A), inserted "or section 262(m) of this title," after "Cosmetic Act,".

Subsec. (c)(1)(A)(i). Pub. L. 112–144, §509(d)(1)(B), inserted "or section 262(k) of this title" after "Cosmetic Act".

Subsec. (c)(1)(B). Pub. L. 112–144, §509(d)(1)(C), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "there is no patent protection or market exclusivity protection for at least one form of the drug under the Federal Food, Drug, and Cosmetic Act; and".

Subsec. (c)(2). Pub. L. 112–144, §509(d)(2), struck out "for drugs lacking exclusivity" after "applications" in heading, and in text struck out "under section 505 of the Federal Food, Drug, and Cosmetic Act" after "for the drug" and substituted "505A of the Federal Food, Drug, and Cosmetic Act or section 262(m) of this title" for "505A of such Act".

Subsec. (e)(1). Pub. L. 112–144, §507(d), substituted "to carry out this section, $25,000,000 for each of fiscal years 2013 through 2017." for "to carry out this section—

"(A) $200,000,000 for fiscal year 2008; and

"(B) such sums as are necessary for each of the four succeeding fiscal years."

2010—Subsec. (a)(1). Pub. L. 111–148 inserted ", biological products," after "including drugs".

2007Pub. L. 110–85 amended section generally. Prior to amendment, section related to development of list of drugs for which pediatric studies are needed, award of contracts for pediatric studies, process for requesting contract proposals to conduct certain pediatric studies, reporting of completed studies, requests for labeling changes and dispute resolution, and recommendation by the Secretary for formulation changes.

Subsec. (d). Pub. L. 109–482 struck out subsec. (d) which related to authorization and availability of appropriations.

2003—Subsec. (c)(8), (9), (11). Pub. L. 108–155 struck out "Advisory Subcommittee of the Anti-Infective Drugs" before "Advisory Committee" wherever appearing.

Effective Date of 2007 Amendment

Amendment 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 a note under section 281 of this title.

Effective Date of 2003 Amendment

Amendment by Pub. L. 108–155 effective Dec. 3, 2003, except as otherwise provided, see section 4 of Pub. L. 108–155, set out as an Effective Date note under section 355c of Title 21, Food and Drugs.

§284m–1. Pediatric Advisory Committee

(a) In general

The Secretary of Health and Human Services shall, under section 217a of this title or other appropriate authority, convene and consult an advisory committee on pediatric therapeutics (including drugs and biological products) and medical devices (referred to in this section as the "advisory committee").

(b) Purpose

(1) In general

The advisory committee shall advise and make recommendations to the Secretary, through the Commissioner of Food and Drugs, on matters relating to pediatric therapeutics (including drugs and biological products) and medical devices.

(2) Matters included

The matters referred to in paragraph (1) include—

(A) pediatric research conducted under sections 262, 284m, and 290b of this title and sections 351, 352, 355, 355a, 355c, 360(k), 360e, and 360j(m) of title 21;

(B) identification of research priorities related to therapeutics (including drugs and biological products) and medical devices for pediatric populations and the need for additional diagnostics and treatments for specific pediatric diseases or conditions;

(C) the ethics, design, and analysis of clinical trials related to pediatric therapeutics (including drugs and biological products) and medical devices; and

(D) the development of countermeasures (as defined in section 360bbb–4(a) of title 21) for pediatric populations.

(c) Composition

The advisory committee shall include representatives of pediatric health organizations, pediatric researchers, relevant patient and patient-family organizations, and other experts selected by the Secretary.

(d) Continuation of Operation of Committee

Notwithstanding section 14 of the Federal Advisory Committee Act, the advisory committee shall continue to operate to carry out the advisory committee's responsibilities under sections 355a, 355c, and 360j(m) of title 21.

(Pub. L. 107–109, §14, Jan. 4, 2002, 115 Stat. 1419, as amended by Pub. L. 108–155, §3(b)(2), Dec. 3, 2003, 117 Stat. 1941; Pub. L. 110–85, title III, §306(b), title V, §502(d), Sept. 27, 2007, 121 Stat. 865, 889; Pub. L. 112–144, title V, §507(a), July 9, 2012, 126 Stat. 1045; Pub. L. 113–5, title III, §307(c), Mar. 13, 2013, 127 Stat. 192.)

References in Text

Section 14 of the Federal Advisory Committee Act, referred to in subsec. (d), is section 14 of Pub. L. 92–463, which is set out in the Appendix to Title 5, Government Organization and Employees.

Codification

Section was formerly set out as a note under section 284m of this title.

Section was enacted as part of the Best Pharmaceuticals for Children Act, and not as part of the Public Health Service Act which comprises this chapter.

Amendments

2013—Subsec. (b)(2)(D). Pub. L. 113–5 added subpar. (D).

2012—Subsec. (d). Pub. L. 112–144 substituted "to carry out the advisory committee's responsibilities under sections 355a, 355c, and 360j(m) of title 21" for "during the five-year period beginning on September 27, 2007".

2007—Subsec. (a). Pub. L. 110–85, §306(b)(1), inserted "(including drugs and biological products) and medical devices" after "therapeutics".

Subsec. (b)(1). Pub. L. 110–85, §306(b)(2)(A), inserted "(including drugs and biological products) and medical devices" after "therapeutics".

Subsec. (b)(2)(A). Pub. L. 110–85, §306(b)(2)(B)(i), substituted "355c, 360(k), 360e, and 360j(m)" for "and 355c".

Subsec. (b)(2)(B). Pub. L. 110–85, §306(b)(2)(B)(ii), added subpar. (B) and struck out former subpar. (B) which read as follows: "identification of research priorities related to pediatric therapeutics and the need for additional treatments of specific pediatric diseases or conditions; and".

Subsec. (b)(2)(C). Pub. L. 110–85, §306(b)(2)(B)(iii), inserted "(including drugs and biological products) and medical devices" after "therapeutics".

Subsec. (d). Pub. L. 110–85, §502(d), added subsec. (d).

2003Pub. L. 108–155, §3(b)(2)(A), struck out "Pharmacology" after "Pediatric" in section catchline.

Subsec. (a). Pub. L. 108–155, §3(b)(2)(D), substituted "therapeutics" for "pharmacology".

Pub. L. 108–155, §3(b)(2)(B), inserted "or other appropriate authority" after "217a of this title".

Subsec. (b)(1). Pub. L. 108–155, §3(b)(2)(D), substituted "therapeutics" for "pharmacology".

Pub. L. 108–155, §3(b)(2)(C)(i), struck out "and in consultation with the Director of the National Institutes of Health" after "Commissioner of Food and Drugs".

Subsec. (b)(2). Pub. L. 108–155, §3(b)(2)(C)(ii), substituted "355a, and 355c" for "and 355a".

Subsec. (b)(2)(B), (C). Pub. L. 108–155, §3(b)(2)(D), substituted "therapeutics" for "pharmacology".

Effective Date of 2003 Amendment

Amendment by Pub. L. 108–155 effective Dec. 3, 2003, except as otherwise provided, see section 4 of Pub. L. 108–155, set out as an Effective Date note under section 355c of Title 21, Food and Drugs.

§284n. Certain demonstration projects

(a) Bridging the sciences

(1) In general

From amounts to be appropriated under section 282a(b) of this title, the Secretary of Health and Human Services, acting through the Director of NIH, (in this subsection referred to as the "Secretary") in consultation with the Director of the National Science Foundation, the Secretary of Energy, and other agency heads when necessary, may allocate funds for the national research institutes and national centers to make grants for the purpose of improving the public health through demonstration projects for biomedical research at the interface between the biological, behavioral, and social sciences and the physical, chemical, mathematical, and computational sciences.

(2) Goals, priorities, and methods; interagency collaboration

The Secretary shall establish goals, priorities, and methods of evaluation for research under paragraph (1), and shall provide for interagency collaboration with respect to such research. In developing such goals, priorities, and methods, the Secretary shall ensure that—

(A) the research reflects the vision of innovation and higher risk with long-term payoffs; and

(B) the research includes a wide spectrum of projects, funded at various levels, with varying timeframes.

(3) Peer review

A grant may be made under paragraph (1) only if the application for the grant has undergone technical and scientific peer review under section 289a of this title and has been reviewed by the advisory council under section 282(k) of this title or has been reviewed by an advisory council composed of representatives from appropriate scientific disciplines who can fully evaluate the applicant.

(b) High-risk, high-reward research

(1) In general

From amounts to be appropriated under section 282a(b) of this title, the Secretary, acting through the Director of NIH, may allocate funds for the national research institutes and national centers to make awards of grants or contracts or to engage in other transactions for demonstration projects for high-impact, cutting-edge research that fosters scientific creativity and increases fundamental biological understanding leading to the prevention, diagnosis, and treatment of diseases and disorders. The head of a national research institute or national center may conduct or support such high-impact, cutting-edge research (with funds allocated under the preceding sentence or otherwise available for such purpose) if the institute or center gives notice to the Director of NIH beforehand and submits a report to the Director of NIH on an annual basis on the activities of the institute or center relating to such research.

(2) Special consideration

In carrying out the program under paragraph (1), the Director of NIH shall give special consideration to coordinating activities with national research institutes whose budgets are substantial relative to a majority of the other institutes.

(3) Administration of program

Activities relating to research described in paragraph (1) shall be designed by the Director of NIH or the head of a national research institute or national center, as applicable, to enable such research to be carried out with maximum flexibility and speed.

(4) Public-private partnerships

In providing for research described in paragraph (1), the Director of NIH or the head of a national research institute or national center, as applicable, shall seek to facilitate partnerships between public and private entities and shall coordinate when appropriate with the Foundation for the National Institutes of Health.

(5) Peer review

A grant for research described in paragraph (1) may be made only if the application for the grant has undergone technical and scientific peer review under section 289a of this title and has been reviewed by the advisory council under section 282(k) of this title.

(c) Report to Congress

Not later than the end of fiscal year 2009, the Secretary, acting through the Director of NIH, shall conduct an evaluation of the activities under this section and submit a report to the Congress on the results of such evaluation.

(d) Definitions

For purposes of this section, the terms "Director of NIH", "national research institute", and "national center" have the meanings given such terms in section 281 of this title.

(Pub. L. 109–482, title I, §105, Jan. 15, 2007, 120 Stat. 3694.)

Codification

Section was enacted as part of the National Institutes of Health Reform Act of 2006, and not as part of the Public Health Service Act which comprises this chapter.

Effective Date

Section 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.

§284o. Activities of the National Institutes of Health with respect to research on paralysis

(a) Coordination

The Director of the National Institutes of Health (referred to in this section and sections 280g–9 and 284p of this title as the "Director"), pursuant to the general authority of the Director, may develop mechanisms to coordinate the paralysis research and rehabilitation activities of the Institutes and Centers of the National Institutes of Health in order to further advance such activities and avoid duplication of activities.

(b) Christopher and Dana Reeve Paralysis Research Consortia

(1) In general

The Director may make awards of grants to public or private entities to pay all or part of the cost of planning, establishing, improving, and providing basic operating support for consortia in paralysis research. The Director shall designate each consortium funded through such grants as a Christopher and Dana Reeve Paralysis Research Consortium.

(2) Research

Each consortium under paragraph (1)—

(A) may conduct basic, translational, and clinical paralysis research;

(B) may focus on advancing treatments and developing therapies in paralysis research;

(C) may focus on one or more forms of paralysis that result from central nervous system trauma or stroke;

(D) may facilitate and enhance the dissemination of clinical and scientific findings; and

(E) may replicate the findings of consortia members or other researchers for scientific and translational purposes.

(3) Coordination of consortia; reports

The Director may, as appropriate, provide for the coordination of information among consortia under paragraph (1) and ensure regular communication among members of the consortia, and may require the periodic preparation of reports on the activities of the consortia and the submission of the reports to the Director.

(4) Organization of consortia

Each consortium under paragraph (1) may use the facilities of a single lead institution, or be formed from several cooperating institutions, meeting such requirements as may be prescribed by the Director.

(c) Public input

The Director may provide for a mechanism to educate and disseminate information on the existing and planned programs and research activities of the National Institutes of Health with respect to paralysis and through which the Director can receive comments from the public regarding such programs and activities.

(Pub. L. 111–11, title XIV, §14101, Mar. 30, 2009, 123 Stat. 1452.)

Codification

Section was enacted as part of the Christopher and Dana Reeve Paralysis Act, and also as part of the Omnibus Public Land Management Act of 2009, and not as part of the Public Health Service Act which comprises this chapter.

§284p. Activities of the National Institutes of Health with respect to research with implications for enhancing daily function for persons with paralysis

(a) In general

The Director, pursuant to the general authority of the Director, may make awards of grants to public or private entities to pay all or part of the costs of planning, establishing, improving, and providing basic operating support to multicenter networks of clinical sites that will collaborate to design clinical rehabilitation intervention protocols and measures of outcomes on one or more forms of paralysis that result from central nervous system trauma, disorders, or stroke, or any combination of such conditions.

(b) Research

A multicenter network of clinical sites funded through this section may—

(1) focus on areas of key scientific concern, including—

(A) improving functional mobility;

(B) promoting behavioral adaptation to functional losses, especially to prevent secondary complications;

(C) assessing the efficacy and outcomes of medical rehabilitation therapies and practices and assisting technologies;

(D) developing improved assistive technology to improve function and independence; and

(E) understanding whole body system responses to physical impairments, disabilities, and societal and functional limitations; and


(2) replicate the findings of network members or other researchers for scientific and translation purposes.

(c) Coordination of clinical trials networks; reports

The Director may, as appropriate, provide for the coordination of information among networks funded through this section and ensure regular communication among members of the networks, and may require the periodic preparation of reports on the activities of the networks and submission of reports to the Director.

(Pub. L. 111–11, title XIV, §14201, Mar. 30, 2009, 123 Stat. 1453.)

Codification

Section was enacted as part of the Christopher and Dana Reeve Paralysis Act, and also as part of the Omnibus Public Land Management Act of 2009, and not as part of the Public Health Service Act which comprises this chapter.

Definition of "Director"

"Director" as meaning the Director of the National Institutes of Health, see section 284o(a) of this title.

§284q. Pain research

(a) Research initiatives

(1) In general

The Director of NIH is encouraged to continue and expand, through the Pain Consortium, an aggressive program of basic and clinical research on the causes of and potential treatments for pain.

(2) Annual recommendations

Not less than annually, the Pain Consortium, in consultation with the Division of Program Coordination, Planning, and Strategic Initiatives, shall develop and submit to the Director of NIH recommendations on appropriate pain research initiatives that could be undertaken with funds reserved under section 282a(c)(1) of this title for the Common Fund or otherwise available for such initiatives.

(3) Definition

In this subsection, the term "Pain Consortium" means the Pain Consortium of the National Institutes of Health or a similar trans-National Institutes of Health coordinating entity designated by the Secretary for purposes of this subsection.

(b) Interagency Pain Research Coordinating Committee

(1) Establishment

The Secretary shall establish not later than 1 year after March 23, 2010, and as necessary maintain a committee, to be known as the Interagency Pain Research Coordinating Committee (in this section referred to as the "Committee"), to coordinate all efforts within the Department of Health and Human Services and other Federal agencies that relate to pain research.

(2) Membership

(A) In general

The Committee shall be composed of the following voting members:

(i) Not more than 7 voting Federal representatives appoint 1 by the Secretary from agencies that conduct pain care research and treatment.

(ii) 12 additional voting members appointed under subparagraph (B).

(B) Additional members

The Committee shall include additional voting members appointed by the Secretary as follows:

(i) 6 non-Federal members shall be appointed from among scientists, physicians, and other health professionals.

(ii) 6 members shall be appointed from members of the general public, who are representatives of leading research, advocacy, and service organizations for individuals with pain-related conditions.

(C) Nonvoting members

The Committee shall include such nonvoting members as the Secretary determines to be appropriate.

(3) Chairperson

The voting members of the Committee shall select a chairperson from among such members. The selection of a chairperson shall be subject to the approval of the Director of NIH.

(4) Meetings

The Committee shall meet at the call of the chairperson of the Committee or upon the request of the Director of NIH, but in no case less often than once each year.

(5) Duties

The Committee shall—

(A) develop a summary of advances in pain care research supported or conducted by the Federal agencies relevant to the diagnosis, prevention, and treatment of pain and diseases and disorders associated with pain;

(B) identify critical gaps in basic and clinical research on the symptoms and causes of pain;

(C) make recommendations to ensure that the activities of the National Institutes of Health and other Federal agencies are free of unnecessary duplication of effort;

(D) make recommendations on how best to disseminate information on pain care; and

(E) make recommendations on how to expand partnerships between public entities and private entities to expand collaborative, cross-cutting research.

(6) Review

The Secretary shall review the necessity of the Committee at least once every 2 years.

(July 1, 1944, ch. 373, title IV, §409J, as added Pub. L. 111–148, title IV, §4305(b), Mar. 23, 2010, 124 Stat. 585.)

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

§284q–1. NIH opioid research

(a) In general

The Director of the National Institutes of Health (referred to in this section as the "NIH") may intensify and coordinate fundamental, translational, and clinical research of the NIH with respect to—

(1) the understanding of pain;

(2) the discovery and development of therapies for chronic pain; and

(3) the development of alternatives to opioids for effective pain treatments.

(b) Priority and direction

The prioritization and direction of the Federally funded portfolio of pain research studies shall consider recommendations made by the Interagency Pain Research Coordinating Committee in concert with the Pain Management Best Practices Inter-Agency Task Force, and in accordance with the National Pain Strategy, the Federal Pain Research Strategy, and the NIH-Wide Strategic Plan for Fiscal Years 2016–2020, the latter of which calls for the relative burdens of individual diseases and medical disorders to be regarded as crucial considerations in balancing the priorities of the Federal research portfolio.

(Pub. L. 114–198, title I, §108, July 22, 2016, 130 Stat. 705.)

Codification

Section was enacted as part of the Comprehensive Addiction and Recovery Act of 2016, and not as part of the Public Health Service Act which comprises this chapter.

§284r. Basic research

(1) Developing policies

Not later than 2 years after December 13, 2016, the Director of the National Institutes of Health (referred to in this section as the "Director of the National Institutes of Health"), taking into consideration the recommendations developed under section 2039,1 shall develop policies for projects of basic research funded by National Institutes of Health to assess—

(A) relevant biological variables including sex, as appropriate; and

(B) how differences between male and female cells, tissues, or animals may be examined and analyzed.

(2) Revising policies

The Director of the National Institutes of Health may update or revise the policies developed under paragraph (1) as appropriate.

(3) Consultation and outreach

In developing, updating, or revising the policies under this section, the Director of the National Institutes of Health shall—

(A) consult with—

(i) the Office of Research on Women's Health;

(ii) the Office of Laboratory Animal Welfare; and

(iii) appropriate members of the scientific and academic communities; and


(B) conduct outreach to solicit feedback from members of the scientific and academic communities on the influence of sex as a variable in basic research, including feedback on when it is appropriate for projects of basic research involving cells, tissues, or animals to include both male and female cells, tissues, or animals.

(4) Additional requirements

The Director of the National Institutes of Health shall—

(A) ensure that projects of basic research funded by the National Institutes of Health are conducted in accordance with the policies developed, updated, or revised under this section, as applicable; and

(B) encourage that the results of such research, when published or reported, be disaggregated as appropriate with respect to the analysis of any sex differences.

(Pub. L. 114–255, div. A, title II, §2038(g), Dec. 13, 2016, 130 Stat. 1066.)

References in Text

Section 2039, referred to in par. (1), is section 2039 of Pub. L. 114–255, which is set out as a note under section 282 of this title.

Codification

Section was enacted as part of the 21st Century Cures Act, and not as part of the Public Health Service Act which comprises this chapter.

1 See References in Text note below.

§284s. Tick-borne diseases

(a) In general

The Secretary of Health and Human Services (referred to in this section as "the Secretary") shall continue to conduct or support epidemiological, basic, translational, and clinical research related to vector-borne diseases, including tick-borne diseases.

(b) Reports

The Secretary shall ensure that each triennial report under section 283 of this title (as amended by section 2032) includes information on actions undertaken by the National Institutes of Health to carry out subsection (a) with respect to tick-borne diseases.

(c) Tick-Borne Diseases Working Group

(1) Establishment

The Secretary shall establish a working group, to be known as the Tick-Borne Disease Working Group (referred to in this section as the "Working Group"), comprised of representatives of appropriate Federal agencies and other non-Federal entities, to provide expertise and to review all efforts within the Department of Health and Human Services related to all tick-borne diseases, to help ensure interagency coordination and minimize overlap, and to examine research priorities.

(2) Responsibilities

The working group shall—

(A) not later than 2 years after December 13, 2016, develop or update a summary of—

(i) ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for individuals with tick-borne diseases;

(ii) advances made pursuant to such research;

(iii) Federal activities related to tick-borne diseases, including—

(I) epidemiological activities related to tick-borne diseases; and

(II) basic, clinical, and translational tick-borne disease research related to the pathogenesis, prevention, diagnosis, and treatment of tick-borne diseases;


(iv) gaps in tick-borne disease research described in clause (iii)(II);

(v) the Working Group's meetings required under paragraph (4); and

(vi) the comments received by the Working Group;


(B) make recommendations to the Secretary regarding any appropriate changes or improvements to such activities and research; and

(C) solicit input from States, localities, and nongovernmental entities, including organizations representing patients, health care providers, researchers, and industry regarding scientific advances, research questions, surveillance activities, and emerging strains in species of pathogenic organisms.

(3) Membership

The members of the working group shall represent a diversity of scientific disciplines and views and shall be composed of the following members:

(A) Federal members

Seven Federal members, consisting of one or more representatives of each of the following:

(i) The Office of the Assistant Secretary for Health.

(ii) The Food and Drug Administration.

(iii) The Centers for Disease Control and Prevention.

(iv) The National Institutes of Health.

(v) Such other agencies and offices of the Department of Health and Human Services as the Secretary determines appropriate.

(B) Non–Federal public members

Seven non–Federal public members, consisting of representatives of the following categories:

(i) Physicians and other medical providers with experience in diagnosing and treating tick-borne diseases.

(ii) Scientists or researchers with expertise.

(iii) Patients and their family members.

(iv) Nonprofit organizations that advocate for patients with respect to tick-borne diseases.

(v) Other individuals whose expertise is determined by the Secretary to be beneficial to the functioning of the Working Group.

(4) Meetings

The Working Group shall meet not less than twice each year.

(5) Reporting

Not later than 2 years after December 13, 2016, and every 2 years thereafter until termination of the Working Group pursuant to paragraph (7), the Working Group shall—

(A) submit a report on its activities under paragraph (2)(A) and any recommendations under paragraph (2)(B) to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate; and

(B) make such report publicly available on the Internet website of the Department of Health and Human Services.

(6) Applicability of FACA

The Working Group shall be treated as an advisory committee subject to the Federal Advisory Committee Act (5 U.S.C. App.).

(7) Sunset

The Working Group under this section shall terminate 6 years after December 13, 2016.

(Pub. L. 114–255, div. A, title II, §2062, Dec. 13, 2016, 130 Stat. 1079.)

References in Text

Section 2032, referred to in subsec. (b), means section 2032 of Pub. L. 114–255.

The Federal Advisory Committee Act, referred to in subsec. (c)(6), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770, which is set out in the Appendix to Title 5, Government Organization and Employees.

Codification

Section was enacted as part of the 21st Century Cures Act, and not as part of the Public Health Service Act which comprises this chapter.

Part C—Specific Provisions Respecting National Research Institutes

subpart 1—national cancer institute

§285. Purpose of Institute

The general purpose of the National Cancer Institute (hereafter in this subpart referred to as the "Institute") is the conduct and support of research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.

(July 1, 1944, ch. 373, title IV, §410, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 832; amended Pub. L. 100–607, title I, §121, Nov. 4, 1988, 102 Stat. 3054.)

Amendments

1988Pub. L. 100–607 inserted ", rehabilitation from cancer," after "treatment of cancer".

White House Cancer Moonshot Task Force

Memorandum of President of the United States, Jan. 28, 2016, 81 F.R. 5361, provided:

Memorandum for the Heads of Executive Departments and Agencies

Cancer is a leading cause of death, and cancer incidence is expected to increase worldwide in the coming decades. But today, cancer research is on the cusp of major breakthroughs. It is of critical national importance that we accelerate progress towards prevention, treatment, and a cure—to double the rate of progress in the fight against cancer—and put ourselves on a path to achieve in just 5 years research and treatment gains that otherwise might take a decade or more. To that end, I hereby direct the following:

Section 1. White House Cancer Moonshot Task Force. There is established, within the Office of the Vice President, a White House Cancer Moonshot Task Force (Task Force), which will focus on making the most of Federal investments, targeted incentives, private sector efforts from industry and philanthropy, patient engagement initiatives, and other mechanisms to support cancer research and enable progress in treatment and care. The Vice President shall serve as Chair of the Task Force.

(a) Membership of the Task Force. In addition to the Vice President, the Task Force shall consist of the heads of the executive branch departments, agencies, and offices listed below:

(i) the Department of Defense;

(ii) the Department of Commerce;

(iii) the Department of Health and Human Services;

(iv) the Department of Energy;

(v) the Department of Veterans Affairs;

(vi) the Office of Management and Budget;

(vii) the National Economic Council;

(viii) the Domestic Policy Council;

(ix) the Office of Science and Technology Policy;

(x) the Food and Drug Administration;

(xi) the National Cancer Institute (NCI);

(xii) the National Institutes of Health (NIH);

(xiii) the National Science Foundation; and

(xiv) such other executive branch departments, agencies, or offices as the President may designate.

A member of the Task Force may designate, to perform the Task Force functions of the member, any person who is a part of the member's department, agency, or office, and who is a full time officer or employee of the Federal Government. At the direction of the Chair, the Task Force may establish subgroups consisting exclusively of Task Force members or their designees under this section, as appropriate.

(b) Administration of the Task Force. The NIH shall provide funding and administrative support for the Task Force to the extent permitted by law and within existing appropriations. The Vice President shall designate an officer or employee of the executive branch as the Executive Director of the Task Force, who shall coordinate the work of the Task Force.

Sec. 2. Mission and Functions of the Task Force. The Task Force shall work with a wide array of executive departments and agencies that have responsibility for key issues related to basic, translational, and clinical research, therapy development, regulation of medical products, and medical care related to cancer. Consistent with applicable law, the Task Force also will consult with external experts from relevant scientific sectors, including the Presidentially appointed National Cancer Advisory Board (NCAB). The NCAB shall advise the Director of NCI on its recommendations respecting the future direction and program and policy emphasis of NCI as it relates to the work of the Task Force. To assist the NCAB in providing this advice, the NCAB is strongly encouraged to establish a working group consisting of a Blue Ribbon Panel of scientific experts. The Director shall relay the advice of the NCAB to the Task Force, as appropriate. The functions of the Task Force are advisory only and shall include, but shall not be limited to, producing a detailed set of findings and recommendations to:

(a) accelerate our understanding of cancer, and its prevention, early detection, treatment, and cure;

(b) improve patient access and care;

(c) support greater access to new research, data, and computational capabilities;

(d) encourage development of cancer treatments;

(e) identify and address any unnecessary regulatory barriers and consider ways to expedite administrative reforms;

(f) ensure optimal investment of Federal resources; and

(g) identify opportunities to develop public-private partnerships and increase coordination of the Federal Government's efforts with the private sector, as appropriate.

Sec. 3. Outreach. Consistent with the objectives set out in section 2 of this memorandum, the Task Force, in accordance with applicable law, in addition to regular meetings, shall conduct outreach with representatives of the cancer patient community, academia, business, nonprofit organizations, State and local government agencies, the research community, and other interested persons that will assist with the Task Force's development of a detailed set of recommendations.

Sec. 4. Transparency and Reports. The Task Force shall facilitate the posting on the Internet of reports and engage in an open, reciprocal dialogue with the American people. The Task Force shall present to the President a report before December 31, 2016, on its findings and recommendations, which shall be made available to the public and posted on the Internet.

Sec. 5. General Provisions. (a) The heads of executive departments and agencies shall assist and provide information to the Task Force, consistent with applicable law, as may be necessary to carry out the functions of the Task Force. Each executive department and agency shall bear its own expense for participating in the Task Force.

(b) Nothing in this memorandum shall be construed to impair or otherwise affect:

(i) authority granted by law to an executive department, agency, or the head thereof; or

(ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(c) This memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations.

(d) This memorandum 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.

Sec. 6. Publication. The Secretary of Health and Human Services is authorized and directed to publish this memorandum in the Federal Register.

Barack Obama.      

§285a. National Cancer Program

The National Cancer Program shall consist of (1) an expanded, intensified, and coordinated cancer research program encompassing the research programs conducted and supported by the Institute and the related research programs of the other national research institutes, including an expanded and intensified research program for the prevention of cancer caused by occupational or environmental exposure to carcinogens, and (2) the other programs and activities of the Institute.

(July 1, 1944, ch. 373, title IV, §411, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 832.)

§285a–1. Cancer control programs

The Director of the Institute shall establish and support demonstration, education, and other programs for the detection, diagnosis, prevention, and treatment of cancer and for rehabilitation and counseling respecting cancer. Programs established and supported under this section shall include—

(1) locally initiated education and demonstration programs (and regional networks of such programs) to transmit research results and to disseminate information respecting—

(A) the detection, diagnosis, prevention, and treatment of cancer,

(B) the continuing care of cancer patients and the families of cancer patients, and

(C) rehabilitation and counseling respecting cancer,


to physicians and other health professionals who provide care to individuals who have cancer;

(2) the demonstration of and the education of students of the health professions and health professionals in—

(A) effective methods for the prevention and early detection of cancer and the identification of individuals with a high risk of developing cancer, and

(B) improved methods of patient referral to appropriate centers for early diagnosis and treatment of cancer; and


(3) the demonstration of new methods for the dissemination of information to the general public concerning the prevention, early detection, diagnosis, and treatment and control of cancer and information concerning unapproved and ineffective methods, drugs, and devices for the diagnosis, prevention, treatment, and control of cancer.

(July 1, 1944, ch. 373, title IV, §412, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 832.)

§285a–2. Special authorities of Director

(a) Information and education program

(1) The Director of the Institute shall establish an information and education program to collect, identify, analyze, and disseminate on a timely basis, through publications and other appropriate means, to cancer patients and their families, physicians and other health professionals, and the general public, information on cancer research, diagnosis, prevention, and treatment (including information respecting nutrition programs for cancer patients and the relationship between nutrition and cancer). The Director of the Institute may take such action as may be necessary to insure that all channels for the dissemination and exchange of scientific knowledge and information are maintained between the Institute and the public and between the Institute and other scientific, medical, and biomedical disciplines and organizations nationally and internationally.

(2) In carrying out paragraph (1), the Director of the Institute shall—

(A) provide public and patient information and education programs, providing information that will help individuals take personal steps to reduce their risk of cancer, to make them aware of early detection techniques and to motivate appropriate utilization of those techniques, to help individuals deal with cancer if it strikes, and to provide information to improve long-term survival;

(B) continue and expand programs to provide physicians and the public with state-of-the-art information on the treatment of particular forms of cancers, and to identify those clinical trials that might benefit patients while advancing knowledge of cancer treatment;

(C) assess the incorporation of state-of-the-art cancer treatments into clinical practice and the extent to which cancer patients receive such treatments and include the results of such assessments in the biennial reports required under section 284b 1 of this title;

(D) maintain and operate the International Cancer Research Data Bank, which shall collect, catalog, store, and disseminate insofar as feasible the results of cancer research and treatment undertaken in any country for the use of any person involved in cancer research and treatment in any country; and

(E) to the extent practicable, in disseminating the results of such cancer research and treatment, utilize information systems available to the public.

(b) National Cancer Program

The Director of the Institute in carrying out the National Cancer Program—

(1) shall establish or support the large-scale production or distribution of specialized biological materials and other therapeutic substances for cancer research and set standards of safety and care for persons using such materials;

(2) shall, in consultation with the advisory council for the Institute, support (A) research in the cancer field outside the United States by highly qualified foreign nationals which can be expected to benefit the American people, (B) collaborative research involving American and foreign participants, and (C) the training of American scientists abroad and foreign scientists in the United States;

(3) shall, in consultation with the advisory council for the Institute, support appropriate programs of education and training (including continuing education and laboratory and clinical research training);

(4) shall encourage and coordinate cancer research by industrial concerns where such concerns evidence a particular capability for such research;

(5) may obtain (after consultation with the advisory council for the Institute and in accordance with section 3109 of title 5, but without regard to the limitation in such section on the period of service) the services of not more than one hundred and fifty-one experts or consultants who have scientific or professional qualifications;

(6)(A) may, in consultation with the advisory council for the Institute, acquire, construct, improve, repair, operate, and maintain laboratories, other research facilities, equipment, and such other real or personal property as the Director determines necessary;

(B) may, in consultation with the advisory council for the Institute, make grants for construction or renovation of facilities; and

(C) may, in consultation with the advisory council for the Institute, acquire, without regard to section 8141 of title 40, by lease or otherwise through the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of Columbia for the use of the Institute for a period not to exceed ten years;

(7) may, in consultation with the advisory council for the Institute, appoint one or more advisory committees composed of such private citizens and officials of Federal, State, and local governments to advise the Director with respect to the Director's functions;

(8) may, subject to section 284(b)(2) of this title and without regard to section 3324 of title 31 and section 6101 of title 41, enter into such contracts, leases, cooperative agreements, as may be necessary in the conduct of functions of the Director, with any public agency, or with any person, firm, association, corporation, or educational institution; and

(9) shall, notwithstanding section 284(a) of this title, prepare and submit, directly to the President for review and transmittal to Congress, an annual budget estimate (including an estimate of the number and type of personnel needs for the Institute) for the National Cancer Program, after reasonable opportunity for comment (but without change) by the Secretary, the Director of NIH, and the Institute's advisory council.


Except as otherwise provided, experts and consultants whose services are obtained under paragraph (5) shall be paid or reimbursed, in accordance with title 5 for their travel to and from their place of service and for other expenses associated with their assignment. Such expenses shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (5) unless the expert or consultant has agreed in writing to complete the entire period of the assignment or one year of the assignment, whichever is shorter, unless separated or reassigned for reasons which are beyond the control of the expert or consultant and which are acceptable to the Director of the Institute. If the expert or consultant violates the agreement, the money spent by the United States for such expenses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive in whole or in part a right of recovery under the preceding sentence.

(c) Pre-clinical models to evaluate promising pediatric cancer therapies

(1) Expansion and coordination of activities

The Director of the National Cancer Institute shall expand, intensify, and coordinate the activities of the Institute with respect to research on the development of preclinical models to evaluate which therapies are likely to be effective for treating pediatric cancer.

(2) Coordination with other institutes

The Director of the Institute shall coordinate the activities under paragraph (1) with similar activities conducted by other national research institutes and agencies of the National Institutes of Health to the extent that those Institutes and agencies have responsibilities that are related to pediatric cancer.

(July 1, 1944, ch. 373, title IV, §413, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 833; amended Pub. L. 100–607, title I, §122, Nov. 4, 1988, 102 Stat. 3054; Pub. L. 101–93, §5(c), Aug. 16, 1989, 103 Stat. 611; Pub. L. 103–43, title III, §301(a)(2), June 10, 1993, 107 Stat. 150; Pub. L. 107–109, §15(b), Jan. 4, 2002, 115 Stat. 1420.)

References in Text

Section 284b of this title, referred to in subsec. (a)(2)(C), was repealed by Pub. L. 109–482, title I, §104(b)(1)(C), Jan. 15, 2007, 120 Stat. 3693.

Codification

In subsec. (b)(6)(C), "section 8141 of title 40" substituted for "the Act of March 3, 1877 (40 U.S.C. 34)" on authority of Pub. L. 107–217, §5(c), Aug. 21, 2002, 116 Stat. 1303, the first section of which enacted Title 40, Public Buildings, Property, and Works.

In subsec. (b)(8), "section 6101 of title 41" substituted for "section 3709 of the Revised Statutes (41 U.S.C. 5)" on authority of Pub. L. 111–350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

Amendments

2002—Subsec. (c). Pub. L. 107–109 added subsec. (c).

1993—Subsec. (b)(9). Pub. L. 103–43 struck out subpar. (A) designation and subpar. (B) which permitted Director to receive from President and Office of Management and Budget directly all funds appropriated by Congress for obligation and expenditure by Institute.

1989—Subsec. (a)(1). Pub. L. 101–93 substituted "Institute and" for "Institute and and".

1988—Subsec. (a). Pub. L. 100–607, §122(1), designated existing provisions as par. (1), substituted "education program" for "education center", inserted "and the public and between the Institute and" after "between the Institute", and added par. (2).

Subsec. (b)(5). Pub. L. 100–607, §122(2)(A), substituted "after consultation with" for "with the approval of".

Subsec. (b)(8) to (10). Pub. L. 100–607, §122(2)(B), inserted "and" after "or educational institution;" in par. (8), redesignated par. (10) as (9), and struck out former par. (9) which related to International Cancer Research Data Bank.

1 See References in Text note below.

§285a–3. National cancer research and demonstration centers

(a) Cooperative agreements and grants for establishing and supporting

(1) The Director of the Institute may enter into cooperative agreements with and make grants to public or private nonprofit entities to pay all or part of the cost of planning, establishing, or strengthening, and providing basic operating support for centers for basic and clinical research into, training in, and demonstration of advanced diagnostic, prevention, control, and treatment methods for cancer.

(2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies established by the Director of NIH and after consultation with the Institute's advisory council.

(b) Uses for Federal payments under cooperative agreements or grants

Federal payments made under a cooperative agreement or grant under subsection (a) may be used for—

(1) construction (notwithstanding any limitation under section 289e of this title);

(2) staffing and other basic operating costs, including such patient care costs as are required for research;

(3) clinical training, including training for allied health professionals, continuing education for health professionals and allied health professions personnel, and information programs for the public respecting cancer; and

(4) demonstration purposes.


As used in this paragraph, the term "construction" does not include the acquisition of land, and the term "training" does not include research training for which Ruth L. Kirschstein National Research Service Awards may be provided under section 288 of this title.

(c) Period of support; additional periods

Support of a center under subsection (a) may be for a period of not to exceed five years. Such period may be extended by the Director for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended.

(d) Construction

Research centers under this section may not be considered centers of excellence for purposes of section 282(b)(10) of this title.

(July 1, 1944, ch. 373, title IV, §414, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 835; amended Pub. L. 100–607, title I, §123, Nov. 4, 1988, 102 Stat. 3055; Pub. L. 107–206, title I, §804(c), Aug. 2, 2002, 116 Stat. 874; Pub. L. 109–482, title I, §108(b), Jan. 15, 2007, 120 Stat. 3697.)

Amendments

2007—Subsec. (d). Pub. L. 109–482 added subsec. (d).

2002—Subsec. (b). Pub. L. 107–206 substituted "Ruth L. Kirschstein National Research Service Awards" for "National Research Service Awards" in concluding provisions.

1988—Subsec. (a)(1). Pub. L. 100–607 inserted "control," after "prevention,".

Effective Date of 2007 Amendment

Amendment 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 a note under section 281 of this title.

§285a–4. President's Cancer Panel; establishment, membership, etc., functions

(a)(1) The President's Cancer Panel (hereafter in this section referred to as the "Panel") shall be composed of three persons appointed by the President who by virtue of their training, experience, and background are exceptionally qualified to appraise the National Cancer Program. At least two members of the Panel shall be distinguished scientists or physicians.

(2)(A) Members of the Panel shall be appointed for three-year terms, except that (i) any member appointed to fill a vacancy occurring prior to the expiration of the term for which the member's predecessor was appointed shall be appointed only for the remainder of such term, and (ii) a member may serve until the member's successor has taken office. If a vacancy occurs in the Panel, the President shall make an appointment to fill the vacancy not later than 90 days after the date the vacancy occurred.

(B) The President shall designate one of the members to serve as the chairman of the Panel for a term of one year.

(C) Members of the Panel shall each be entitled to receive the daily equivalent of the annual rate of basic pay in effect for grade GS–18 of the General Schedule for each day (including traveltime) during which they are engaged in the actual performance of duties as members of the Panel and shall be paid or reimbursed, in accordance with title 5, for their travel to and from their place of service and for other expenses associated with their assignment.

(3) The Panel shall meet at the call of the chairman, but not less often than four times a year. A transcript shall be kept of the proceedings of each meeting of the Panel, and the chairman shall make such transcript available to the public.

(b) The Panel shall monitor the development and execution of the activities of the National Cancer Program, and shall report directly to the President. Any delays or blockages in rapid execution of the Program shall immediately be brought to the attention of the President. The Panel shall submit to the President periodic progress reports on the National Cancer Program and shall submit to the President, the Secretary, and the Congress an annual evaluation of the efficacy of the Program and suggestions for improvements, and shall submit such other reports as the President shall direct.

(July 1, 1944, ch. 373, title IV, §415, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 835.)

Termination of Reporting Requirements

For termination, effective May 15, 2000, of provisions in subsec. (b) of this section relating to the requirement that the Panel submit to Congress an annual evaluation of the efficacy of the Program and suggestions for improvements, see section 3003 of Pub. L. 104–66, as amended, set out as a note under section 1113 of Title 31, Money and Finance, and page 189 of House Document No. 103–7.

Termination of Advisory Panels

Advisory panels 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 panel established by the President or an officer of the Federal Government, such panel is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a panel established by the 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.

References in Other Laws to GS–16, 17, or 18 Pay Rates

References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.

§285a–5. Associate Director for Prevention; appointment; function

(a) There shall be in the Institute an Associate Director for Prevention to coordinate and promote the programs in the Institute concerning the prevention of cancer. The Associate Director shall be appointed by the Director of the Institute from individuals who because of their professional training or experience are experts in public health or preventive medicine.

(b) The Associate Director for Prevention shall prepare for inclusion in the biennial report made under section 284b 1 of this title a description of the prevention activities of the Institute, including a description of the staff and resources allocated to those activities.

(July 1, 1944, ch. 373, title IV, §416, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 836.)

References in Text

Section 284b of this title, referred to in subsec. (b), was repealed by Pub. L. 109–482, title I, §104(b)(1)(C), Jan. 15, 2007, 120 Stat. 3693.

1 See References in Text note below.

§285a–6. Breast and gynecological cancers

(a) Expansion and coordination of activities

The Director of the Institute, in consultation with the National Cancer Advisory Board, shall expand, intensify, and coordinate the activities of the Institute with respect to research on breast cancer, ovarian cancer, and other cancers of the reproductive system of women.

(b) Coordination with other institutes

The Director of the Institute shall coordinate the activities of the Director under subsection (a) with similar activities conducted by other national research institutes and agencies of the National Institutes of Health to the extent that such Institutes 1 and agencies have responsibilities that are related to breast cancer and other cancers of the reproductive system of women.

(c) Programs for breast cancer

(1) In general

In carrying out subsection (a), the Director of the Institute shall conduct or support research to expand the understanding of the cause of, and to find a cure for, breast cancer. Activities under such subsection shall provide for an expansion and intensification of the conduct and support of—

(A) basic research concerning the etiology and causes of breast cancer;

(B) clinical research and related activities concerning the causes, prevention, detection and treatment of breast cancer;

(C) control programs with respect to breast cancer in accordance with section 285a–1 of this title, including community-based programs designed to assist women who are members of medically underserved populations, low-income populations, or minority groups;

(D) information and education programs with respect to breast cancer in accordance with section 285a–2 of this title; and

(E) research and demonstration centers with respect to breast cancer in accordance with section 285a–3 of this title, including the development and operation of centers for breast cancer research to bring together basic and clinical, biomedical and behavioral scientists to conduct basic, clinical, epidemiological, psychosocial, prevention and treatment research and related activities on breast cancer.


Not less than six centers shall be operated under subparagraph (E). Activities of such centers should include supporting new and innovative research and training programs for new researchers. Such centers shall give priority to expediting the transfer of research advances to clinical applications.

(2) Implementation of plan for programs

(A) The Director of the Institute shall ensure that the research programs described in paragraph (1) are implemented in accordance with a plan for the programs. Such plan shall include comments and recommendations that the Director of the Institute considers appropriate, with due consideration provided to the professional judgment needs of the Institute as expressed in the annual budget estimate prepared in accordance with section 285a–2(9) 2 of this title. The Director of the Institute, in consultation with the National Cancer Advisory Board, shall periodically review and revise such plan.

(B) Not later than October 1, 1993, the Director of the Institute shall submit a copy of the plan to the President's Cancer Panel, the Secretary and the Director of NIH.

(C) The Director of the Institute shall submit any revisions of the plan to the President's Cancer Panel, the Secretary, and the Director of NIH.

(D) The Secretary shall provide a copy of the plan submitted under subparagraph (A), and any revisions submitted under subparagraph (C), to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate.

(d) Other cancers

In carrying out subsection (a), the Director of the Institute shall conduct or support research on ovarian cancer and other cancers of the reproductive system of women. Activities under such subsection shall provide for the conduct and support of—

(1) basic research concerning the etiology and causes of ovarian cancer and other cancers of the reproductive system of women;

(2) clinical research and related activities into the causes, prevention, detection and treatment of ovarian cancer and other cancers of the reproductive system of women;

(3) control programs with respect to ovarian cancer and other cancers of the reproductive system of women in accordance with section 285a–1 of this title;

(4) information and education programs with respect to ovarian cancer and other cancers of the reproductive system of women in accordance with section 285a–2 of this title; and

(5) research and demonstration centers with respect to ovarian cancer and cancers of the reproductive system in accordance with section 285a–3 of this title.

(e) Report

The Director of the Institute shall prepare, for inclusion in the biennial report submitted under section 284b 3 of this title, a report that describes the activities of the National Cancer Institute under the research programs referred to in subsection (a), that shall include—

(1) a description of the research plan with respect to breast cancer prepared under subsection (c);

(2) an assessment of the development, revision, and implementation of such plan;

(3) a description and evaluation of the progress made, during the period for which such report is prepared, in the research programs on breast cancer and cancers of the reproductive system of women;

(4) a summary and analysis of expenditures made, during the period for which such report is made, for activities with respect to breast cancer and cancers of the reproductive system of women conducted and supported by the National Institutes of Health; and

(5) such comments and recommendations as the Director considers appropriate.

(July 1, 1944, ch. 373, title IV, §417, as added Pub. L. 103–43, title IV, §401, June 10, 1993, 107 Stat. 153.)

References in Text

Section 284b of this title, referred to in subsec. (e), was repealed by Pub. L. 109–482, title I, §104(b)(1)(C), Jan. 15, 2007, 120 Stat. 3693.

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.

1 So in original. Probably should not be capitalized.

2 So in original. Probably should be section "285a–2(b)(9)".

3 See References in Text note below.

§285a–7. Prostate cancer

(a) Expansion and coordination of activities

The Director of the Institute, in consultation with the National Cancer Advisory Board, shall expand, intensify, and coordinate the activities of the Institute with respect to research on prostate cancer.

(b) Coordination with other institutes

The Director of the Institute shall coordinate the activities of the Director under subsection (a) with similar activities conducted by other national research institutes and agencies of the National Institutes of Health to the extent that such Institutes 1 and agencies have responsibilities that are related to prostate cancer.

(c) Programs

(1) In general

In carrying out subsection (a), the Director of the Institute shall conduct or support research to expand the understanding of the cause of, and to find a cure for, prostate cancer. Activities under such subsection shall provide for an expansion and intensification of the conduct and support of—

(A) basic research concerning the etiology and causes of prostate cancer;

(B) clinical research and related activities concerning the causes, prevention, detection and treatment of prostate cancer;

(C) prevention and control and early detection programs with respect to prostate cancer in accordance with section 285a–1 of this title, particularly as it relates to intensifying research on the role of prostate specific antigen for the screening and early detection of prostate cancer;

(D) an Inter-Institute Task Force, under the direction of the Director of the Institute, to provide coordination between relevant National Institutes of Health components of research efforts on prostate cancer;

(E) control programs with respect to prostate cancer in accordance with section 285a–1 of this title;

(F) information and education programs with respect to prostate cancer in accordance with section 285a–2 of this title; and

(G) research and demonstration centers with respect to prostate cancer in accordance with section 285a–3 of this title, including the development and operation of centers for prostate cancer research to bring together basic and clinical, biomedical and behavioral scientists to conduct basic, clinical, epidemiological, psychosocial, prevention and control, treatment, research, and related activities on prostate cancer.


Not less than six centers shall be operated under subparagraph (G). Activities of such centers should include supporting new and innovative research and training programs for new researchers. Such centers shall give priority to expediting the transfer of research advances to clinical applications.

(2) Implementation of plan for programs

(A) The Director of the Institute shall ensure that the research programs described in paragraph (1) are implemented in accordance with a plan for the programs. Such plan shall include comments and recommendations that the Director of the Institute considers appropriate, with due consideration provided to the professional judgment needs of the Institute as expressed in the annual budget estimate prepared in accordance with section 285a–2(9) 2 of this title. The Director of the Institute, in consultation with the National Cancer Advisory Board, shall periodically review and revise such plan.

(B) Not later than October 1, 1993, the Director of the Institute shall submit a copy of the plan to the President's Cancer Panel, the Secretary, and the Director of NIH.

(C) The Director of the Institute shall submit any revisions of the plan to the President's Cancer Panel, the Secretary, and the Director of NIH.

(D) The Secretary shall provide a copy of the plan submitted under subparagraph (A), and any revisions submitted under subparagraph (C), to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate.

(July 1, 1944, ch. 373, title IV, §417A, as added Pub. L. 103–43, title IV, §402, June 10, 1993, 107 Stat. 155.)

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.

1 So in original. Probably should not be capitalized.

2 So in original. Probably should be section "285a–2(b)(9)".

§285a–8. Repealed. Pub. L. 109–482, title I, §103(b)(15), Jan. 15, 2007, 120 Stat. 3687

Section, act July 1, 1944, ch. 373, title IV, §417B, as added Pub. L. 103–43, title IV, §403(a), June 10, 1993, 107 Stat. 157; amended Pub. L. 105–340, title I, §103, Oct. 31, 1998, 112 Stat. 3192; Pub. L. 106–505, title VI, §602(b), Nov. 13, 2000, 114 Stat. 2346, related to authorization of appropriations.

Effective Date of Repeal

Repeal 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.

§285a–9. Grants for education, prevention, and early detection of radiogenic cancers and diseases

(a) Definition

In this section the term "entity" means any—

(1) National Cancer Institute-designated cancer center;

(2) Department of Veterans Affairs hospital or medical center;

(3) Federally Qualified Health Center, community health center, or hospital;

(4) agency of any State or local government, including any State department of health; or

(5) nonprofit organization.

(b) In general

The Secretary, acting through the Administrator of the Health Resources and Services Administration in consultation with the Director of the National Institutes of Health and the Director of the Indian Health Service, may make competitive grants to any entity for the purpose of carrying out programs to—

(1) screen individuals described under section 4(a)(1)(A)(i) or 5(a)(1)(A) of the Radiation Exposure Compensation Act (42 U.S.C. 2210 note) for cancer as a preventative health measure;

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

(3) develop and disseminate public information and education programs for the detection, prevention, and treatment of radiogenic cancers and diseases; and

(4) facilitate putative applicants in the documentation of claims as described in section 5(a) of the Radiation Exposure Compensation Act (42 U.S.C. 2210 note).

(c) Indian Health Service

The programs under subsection (a) shall include programs provided through the Indian Health Service or through tribal contracts, compacts, grants, or cooperative agreements with the Indian Health Service and which are determined appropriate to raising the health status of Indians.

(d) Grant and contract authority

Entities receiving a grant under subsection (b) may expend the grant to carry out the purpose described in such subsection.

(e) Health coverage unaffected

Nothing in this section shall be construed to affect any coverage obligation of a governmental or private health plan or program relating to an individual referred to under subsection (b)(1).

(July 1, 1944, ch. 373, title IV, §417C, as added Pub. L. 106–245, §4, July 10, 2000, 114 Stat. 508; amended Pub. L. 109–482, title I, §§103(b)(16), 104(b)(1)(F), Jan. 15, 2007, 120 Stat. 3687, 3693.)

References in Text

Sections 4 and 5 of the Radiation Exposure Compensation Act, referred to in subsec. (b)(1) and (4), are sections 4 and 5 of Pub. L. 101–426, which are set out as a note under section 2210 of this title.

Amendments

2007—Subsec. (f). Pub. L. 109–482, §104(b)(1)(F), struck out heading and text of subsec. (f). Text read as follows: "Beginning on October 1 of the year following the date on which amounts are first appropriated to carry out this section and annually on each October 1 thereafter, the Secretary shall submit a report to the Committee on the Judiciary and the Committee on Health, Education, Labor, and Pensions of the Senate and to the Committee on the Judiciary and the Committee on Commerce of the House of Representatives. Each report shall summarize the expenditures and programs funded under this section as the Secretary determines to be appropriate."

Subsec. (g). Pub. L. 109–482, §103(b)(16), struck out heading and text of subsec. (g). Text read as follows: "There are authorized to be appropriated for the purpose of carrying out this section $20,000,000 for fiscal year 1999 and such sums as may be necessary for each of the fiscal years 2000 through 2009."

Effective Date of 2007 Amendment

Amendment 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 a note under section 281 of this title.

§285a–10. Research, information, and education with respect to blood cancer

(a) Joe Moakley Research Excellence Program

(1) In general

The Director of NIH shall expand, intensify, and coordinate programs for the conduct and support of research with respect to blood cancer, and particularly with respect to leukemia, lymphoma, and multiple myeloma.

(2) Administration

The Director of NIH shall carry out this subsection through the Director of the National Cancer Institute and in collaboration with any other agencies that the Director determines to be appropriate.

(b) Geraldine Ferraro Cancer Education Program

(1) In general

The Secretary shall direct the appropriate agency within the Department of Health and Human Services, in collaboration with the Director of NIH, to establish and carry out a program to provide information and education for patients and the general public with respect to blood cancer, and particularly with respect to the treatment of leukemia, lymphoma, and multiple myeloma.

(2) Administration

The Agency determined by the Secretary under paragraph (1) shall carry out this subsection in collaboration with private health organizations that have national education and patient assistance programs on blood-related cancers.

(July 1, 1944, ch. 373, title IV, §417D, as added Pub. L. 107–172, §3, May 14, 2002, 116 Stat. 541; amended Pub. L. 109–482, title I, §103(b)(17), Jan. 15, 2007, 120 Stat. 3688.)

Codification

Section 3 of Pub. L. 107–172, which directed that section 417D (this section) be inserted after section 419C of part C of title IV of the Public Health Service Act, was executed by adding section 417D to part C of title IV of the Public Health Service Act, to reflect the probable intent of Congress, notwithstanding that part C does not contain a section 419C.

Amendments

2007—Subsec. (a)(3). Pub. L. 109–482, §103(b)(17)(A), struck out heading and text of par. (3). Text read as follows: "For the purpose of carrying out this subsection, there is authorized to be appropriated such sums as may be necessary for fiscal year 2002 and each subsequent fiscal year. Such authorizations of appropriations are in addition to other authorizations of appropriations that are available for such purpose."

Subsec. (b)(3). Pub. L. 109–482, §103(b)(17)(B), struck out heading and text of par. (3). Text read as follows: "For the purpose of carrying out this subsection, there is authorized to be appropriated such sums as may be necessary for fiscal year 2002 and each subsequent fiscal year. Such authorizations of appropriations are in addition to other authorizations of appropriations that are available for such purpose."

Effective Date of 2007 Amendment

Amendment 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 a note under section 281 of this title.

Congressional Findings

Pub. L. 107–172, §2, May 14, 2002, 116 Stat. 541, provided that: "Congress finds that:

"(1) An estimated 109,500 people in the United States will be diagnosed with leukemia, lymphoma, and multiple myeloma in 2001.

"(2) New cases of the blood cancers described in paragraph (1) account for 8.6 percent of new cancer cases.

"(3) Those devastating blood cancers will cause the deaths of an estimated 60,300 persons in the United States in 2001. Every 9 minutes, a person in the United States dies from leukemia, lymphoma, or multiple myeloma.

"(4) While less than 5 percent of Federal funds for cancer research are spent on those blood cancers, those blood cancers cause 11 percent of all cancer deaths in the United States.

"(5) Increased Federal support of research into leukemia, lymphoma, and multiple myeloma has resulted and will continue to result in significant advances in the treatment, and ultimately the cure, of those blood cancers as well as other cancers."

§285a–11. Pediatric cancer research and awareness

(a) Pediatric cancer research

(1) Programs of research excellence in pediatric cancer

The Secretary, in collaboration with the Director of NIH and other Federal agencies with interest in prevention and treatment of pediatric cancer, shall continue to enhance, expand, and intensify pediatric cancer research and other activities related to pediatric cancer, including therapeutically applicable research to generate effective treatments, pediatric preclinical testing, and pediatric clinical trials through National Cancer Institute-supported pediatric cancer clinical trial groups and their member institutions. In enhancing, expanding, and intensifying such research and other activities, the Secretary is encouraged to take into consideration the application of such research and other activities for minority, health disparity, and medically underserved communities. For purposes of this section, the term "pediatric cancer research" means research on the causes, prevention, diagnosis, recognition, treatment, and long-term effects of pediatric cancer.

(2) Peer review requirements

All grants awarded under this subsection shall be awarded in accordance with section 289a of this title.

(b) Public awareness of pediatric cancers and available treatments and research

(1) In general

The Secretary may award grants to childhood cancer professional and direct service organizations for the expansion and widespread implementation of—

(A) activities that provide available information on treatment protocols to ensure early access to the best available therapies and clinical trials for pediatric cancers;

(B) activities that provide available information on the late effects of pediatric cancer treatment to ensure access to necessary long-term medical and psychological care; and

(C) direct resource services such as educational outreach for parents, peer-to-peer and parent-to-parent support networks, information on school re-entry and postsecondary education, and resource directories or referral services for financial assistance, psychological counseling, and other support services.


In awarding grants under this paragraph, the Secretary is encouraged to take into consideration the extent to which an entity would use such grant for purposes of making activities and services described in this paragraph available to minority, health disparity, and medically underserved communities.

(2) Performance measurement, transparency, and accountability

For each grant awarded under this subsection, the Secretary shall develop and implement metrics-based performance measures to assess the effectiveness of activities funded under such grant.

(3) Informational requirements

Any information made available pursuant to a grant awarded under paragraph (1) shall be—

(A) culturally and linguistically appropriate as needed by patients and families affected by childhood cancer; and

(B) approved by the Secretary.

(c) Rule of construction

Nothing in this section shall be construed as being inconsistent with the goals and purposes of the Minority Health and Health Disparities Research and Education Act of 2000 (42 U.S.C. 202 note).1

(d) Authorization of appropriations

For purposes of carrying out this section and section 280e–3a of this title, there are authorized to be appropriated $30,000,000 for each of fiscal years 2009 through 2013. Such authorization of appropriations is in addition to the authorization of appropriations established in section 282a of this title with respect to such purpose. Funds appropriated under this subsection shall remain available until expended.

(July 1, 1944, ch. 373, title IV, §417E, as added Pub. L. 110–285, §4(a), July 29, 2008, 122 Stat. 2629.)

References in Text

The Minority Health and Health Disparities Research and Education Act of 2000, referred to in subsec. (c), is Pub. L. 106–525, Nov. 22, 2000, 114 Stat. 2495. For complete classification of this Act to the Code, see Short Title of 2000 Amendments note set out under section 201 of this title and Tables.

1 So in original. See References in Text note below.

§285a–12. Interagency Breast Cancer and Environmental Research Coordinating Committee

(a) Interagency Breast Cancer and Environmental Research Coordinating Committee

(1) Establishment

Not later than 6 months after October 8, 2008, the Secretary shall establish a committee, to be known as the Interagency Breast Cancer and Environmental Research Coordinating Committee (in this section referred to as the "Committee").

(2) Duties

The Committee shall—

(A) share and coordinate information on existing research activities, and make recommendations to the National Institutes of Health and other Federal agencies regarding how to improve existing research programs, that are related to breast cancer research;

(B) develop a comprehensive strategy and advise the National Institutes of Health and other Federal agencies in the solicitation of proposals for collaborative, multidisciplinary research, including proposals to evaluate environmental and genomic factors that may be related to the etiology of breast cancer that would—

(i) result in innovative approaches to study emerging scientific opportunities or eliminate knowledge gaps in research to improve the research portfolio;

(ii) outline key research questions, methodologies, and knowledge gaps;

(iii) expand the number of research proposals that involve collaboration between 2 or more national research institutes or national centers, including proposals for Common Fund research described in section 282(b)(7) of this title to improve the research portfolio; and

(iv) expand the number of collaborative, multidisciplinary, and multi-institutional research grants;


(C) develop a summary of advances in breast cancer research supported or conducted by Federal agencies relevant to the diagnosis, prevention, and treatment of cancer and other diseases and disorders; and

(D) not later than 2 years after the date of the establishment of the Committee, make recommendations to the Secretary—

(i) regarding any appropriate changes to research activities, including recommendations to improve the research portfolio of the National Institutes of Health to ensure that scientifically-based strategic planning is implemented in support of research priorities that impact breast cancer research activities;

(ii) to ensure that the activities of the National Institutes of Health and other Federal agencies, including the Department of Defense, are free of unnecessary duplication of effort;

(iii) regarding public participation in decisions relating to breast cancer research to increase the involvement of patient advocacy and community organizations representing a broad geographical area;

(iv) on how best to disseminate information on breast cancer research progress; and

(v) on how to expand partnerships between public entities, including Federal agencies, and private entities to expand collaborative, cross-cutting research.

(3) Rule of construction

For the purposes of the Committee, when focusing on research to evaluate environmental and genomic factors that may be related to the etiology of breast cancer, nothing in this section shall be construed to restrict the Secretary from including other forms of cancer, as appropriate, when doing so may advance research in breast cancer or advance research in other forms of cancer.

(4) Membership

(A) In general

The Committee shall be composed of the following voting members:

(i) Not more than 7 voting Federal representatives as follows:

(I) The Director of the Centers for Disease Control and Prevention.

(II) The Director of the National Institutes of Health and the directors of such national research institutes and national centers (which may include the National Institute of Environmental Health Sciences) as the Secretary determines appropriate.

(III) One representative from the National Cancer Institute Board of Scientific Advisors, appointed by the Director of the National Cancer Institute.

(IV) The heads of such other agencies of the Department of Health and Human Services as the Secretary determines appropriate.

(V) Representatives of other Federal agencies that conduct or support cancer research, including the Department of Defense.


(ii) 12 additional voting members appointed under subparagraph (B).

(B) Additional members

The Committee shall include additional voting members appointed by the Secretary as follows:

(i) 6 members shall be appointed from among scientists, physicians, and other health professionals, who—

(I) are not officers or employees of the United States;

(II) represent multiple disciplines, including clinical, basic, and public health sciences;

(III) represent different geographical regions of the United States;

(IV) are from practice settings, academia, or other research settings; and

(V) are experienced in scientific peer review process.


(ii) 6 members shall be appointed from members of the general public, who represent individuals with breast cancer.

(C) Nonvoting members

The Committee shall include such nonvoting members as the Secretary determines to be appropriate.

(5) Chairperson

The voting members of the Committee shall select a chairperson from among such members. The selection of a chairperson shall be subject to the approval of the Director of NIH.

(6) Meetings

The Committee shall meet at the call of the chairperson of the Committee or upon the request of the Director of NIH, but in no case less often than once each year.

(b) Review

The Secretary shall review the necessity of the Committee in calendar year 2011 and, thereafter, at least once every 2 years.

(July 1, 1944, ch. 373, title IV, §417F, as added Pub. L. 110–354, §2(a), Oct. 8, 2008, 122 Stat. 3984.)

§285a–13. Scientific framework for recalcitrant cancers

(a) Development of scientific framework

(1) In general

For each recalcitrant cancer identified under subsection (b), the Director of the Institute shall develop (in accordance with subsection (c)) a scientific framework for the conduct or support of research on such cancer.

(2) Contents

The scientific framework with respect to a recalcitrant cancer shall include the following:

(A) Current status

(i) Review of literature

A summary of findings from the current literature in the areas of—

(I) the prevention, diagnosis, and treatment of such cancer;

(II) the fundamental biologic processes that regulate such cancer (including similarities and differences of such processes from the biological processes that regulate other cancers); and

(III) the epidemiology of such cancer.

(ii) Scientific advances

The identification of relevant emerging scientific areas and promising scientific advances in basic, translational, and clinical science relating to the areas described in subclauses (I) and (II) of clause (i).

(iii) Researchers

A description of the availability of qualified individuals to conduct scientific research in the areas described in clause (i).

(iv) Coordinated research initiatives

The identification of the types of initiatives and partnerships for the coordination of intramural and extramural research of the Institute in the areas described in clause (i) with research of the relevant national research institutes, Federal agencies, and non-Federal public and private entities in such areas.

(v) Research resources

The identification of public and private resources, such as patient registries and tissue banks, that are available to facilitate research relating to each of the areas described in clause (i).

(B) Identification of research questions

The identification of research questions relating to basic, translational, and clinical science in the areas described in subclauses (I) and (II) of subparagraph (A)(i) that have not been adequately addressed with respect to such recalcitrant cancer.

(C) Recommendations

Recommendations for appropriate actions that should be taken to advance research in the areas described in subparagraph (A)(i) and to address the research questions identified in subparagraph (B), as well as for appropriate benchmarks to measure progress on achieving such actions, including the following:

(i) Researchers

Ensuring adequate availability of qualified individuals described in subparagraph (A)(iii).

(ii) Coordinated research initiatives

Promoting and developing initiatives and partnerships described in subparagraph (A)(iv).

(iii) Research resources

Developing additional public and private resources described in subparagraph (A)(v) and strengthening existing resources.

(3) Timing

(A) Initial development and subsequent update

For each recalcitrant cancer identified under subsection (b)(1), the Director of the Institute shall—

(i) develop a scientific framework under this subsection not later than 18 months after January 2, 2013; and

(ii) review and update the scientific framework not later than 5 years after its initial development.

(B) Other updates

The Director of the Institute may review and update each scientific framework developed under this subsection as necessary.

(4) Public notice

With respect to each scientific framework developed under subsection (a), not later than 30 days after the date of completion of the framework, the Director of the Institute shall—

(A) submit such framework to the Committee on Energy and Commerce and Committee on Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and Committee on Appropriations of the Senate; and

(B) make such framework publically 1 available on the Internet website of the Department of Health and Human Services.

(b) Identification of recalcitrant cancer

(1) In general

Not later than 6 months after January 2, 2013, the Director of the Institute shall identify two or more recalcitrant cancers that each—

(A) have a 5-year relative survival rate of less than 20 percent; and

(B) are estimated to cause the death of at least 30,000 individuals in the United States per year.

(2) Additional cancers

The Director of the Institute may, at any time, identify other recalcitrant cancers for purposes of this section. In identifying a recalcitrant cancer pursuant to the previous sentence, the Director may consider additional metrics of progress (such as incidence and mortality rates) against such type of cancer.

(c) Working groups

For each recalcitrant cancer identified under subsection (b), the Director of the Institute shall convene a working group comprised of representatives of appropriate Federal agencies and other non-Federal entities to provide expertise on, and assist in developing, a scientific framework under subsection (a). The Director of the Institute (or the Director's designee) shall participate in the meetings of each such working group.

(d) Reporting

(1) Biennial reports

The Director of NIH shall ensure that each biennial report under section 283 of this title includes information on actions undertaken to carry out each scientific framework developed under subsection (a) with respect to a recalcitrant cancer, including the following:

(A) Information on research grants awarded by the National Institutes of Health for research relating to such cancer.

(B) An assessment of the progress made in improving outcomes (including relative survival rates) for individuals diagnosed with such cancer.

(C) An update on activities pertaining to such cancer under the authority of section 285a–2(b)(7) of this title.

(2) Additional one-time report for certain frameworks

For each recalcitrant cancer identified under subsection (b)(1), the Director of the Institute shall, not later than 6 years after the initial development of a scientific framework under subsection (a), submit a report to the Congress on the effectiveness of the framework (including the update required by subsection (a)(3)(A)(ii)) in improving the prevention, detection, diagnosis, and treatment of such cancer.

(e) Recommendations for exception funding

The Director of the Institute shall consider each relevant scientific framework developed under subsection (a) when making recommendations for exception funding for grant applications.

(f) Definition

In this section, the term "recalcitrant cancer" means a cancer for which the five-year relative survival rate is below 50 percent.

(July 1, 1944, ch. 373, title IV, §417G, as added Pub. L. 112–239, div. A, title X, §1083, Jan. 2, 2013, 126 Stat. 1960.)

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

subpart 2—national heart, lung, and blood institute

§285b. Purpose of Institute

The general purpose of the National Heart, Lung, and Blood Institute (hereafter in this subpart referred to as the "Institute") is the conduct and support of research, training, health information dissemination, and other programs with respect to heart, blood vessel, lung, and blood diseases and with respect to the use of blood and blood products and the management of blood resources.

(July 1, 1944, ch. 373, title IV, §418, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 836.)

§285b–1. Heart, blood vessel, lung, and blood disease prevention and control programs

(a) The Director of the Institute shall conduct and support programs for the prevention and control of heart, blood vessel, lung, and blood diseases. Such programs shall include community-based and population-based programs carried out in cooperation with other Federal agencies, with public health agencies of State or local governments, with nonprofit private entities that are community-based health agencies, or with other appropriate public or nonprofit private entities.

(b) In carrying out programs under subsection (a), the Director of the Institute shall give special consideration to the prevention and control of heart, blood vessel, lung, and blood diseases in children, and in populations that are at increased risk with respect to such diseases.

(July 1, 1944, ch. 373, title IV, §419, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 836; amended Pub. L. 103–43, title V, §505, June 10, 1993, 107 Stat. 160.)

Amendments

1993Pub. L. 103–43 substituted subsecs. (a) and (b) for former section which read as follows: "The Director of the Institute, under policies established by the Director of NIH and after consultation with the advisory council for the Institute, shall establish programs as necessary for cooperation with other Federal health agencies, State, local, and regional public health agencies, and nonprofit private health agencies in the diagnosis, prevention, and treatment (including the provision of emergency medical services) of heart, blood vessel, lung, and blood diseases, appropriately emphasizing the prevention, diagnosis, and treatment of such diseases of children."

§285b–2. Information and education

The Director of the Institute shall collect, identify, analyze, and disseminate on a timely basis, through publications and other appropriate means, to patients, families of patients, physicians and other health professionals, and the general public, information on research, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases, the maintenance of health to reduce the incidence of such diseases, and on the use of blood and blood products and the management of blood resources. In carrying out this section, the Director of the Institute shall place special emphasis upon the utilization of collaborative efforts with both the public and private sectors to—

(1) increase the awareness and knowledge of health care professionals and the public regarding the prevention of heart and blood vessel, lung, and blood diseases and the utilization of blood resources; and

(2) develop and disseminate to health professionals, patients and patient families, and the public information designed to encourage adults and children to adopt healthful practices concerning the prevention of such diseases.

(July 1, 1944, ch. 373, title IV, §420, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 837; amended Pub. L. 100–607, title I, §126, Nov. 4, 1988, 102 Stat. 3055.)

Amendments

1988Pub. L. 100–607 amended second sentence generally. Prior to amendment, second sentence read as follows: "In carrying out this section the Director of the Institute shall place special emphasis upon—

"(1) the dissemination of information regarding diet and nutrition, environmental pollutants, exercise, stress, hypertension, cigarette smoking, weight control, and other factors affecting the prevention of arteriosclerosis and other cardiovascular diseases and of pulmonary and blood diseases; and

"(2) the dissemination of information designed to encourage children to adopt healthful habits respecting the risk factors related to the prevention of such diseases."

§285b–3. National Heart, Blood Vessel, Lung, and Blood Diseases and Blood Resources Program; administrative provisions

(a)(1) The National Heart, Blood Vessel, Lung, and Blood Diseases and Blood Resources Program (hereafter in this subpart referred to as the "Program") may provide for—

(A) investigation into the epidemiology, etiology, and prevention of all forms and aspects of heart, blood vessel, lung, and blood diseases, including investigations into the social, environmental, behavioral, nutritional, biological, and genetic determinants and influences involved in the epidemiology, etiology, and prevention of such diseases;

(B) studies and research into the basic biological processes and mechanisms involved in the underlying normal and abnormal heart, blood vessel, lung, and blood phenomena;

(C) research into the development, trial, and evaluation of techniques, drugs, and devices (including computers) used in, and approaches to, the diagnosis, treatment (including the provision of emergency medical services), and prevention of heart, blood vessel, lung, and blood diseases and the rehabilitation of patients suffering from such diseases;

(D) establishment of programs that will focus and apply scientific and technological efforts involving the biological, physical, and engineering sciences to all facets of heart, blood vessel, lung, and blood diseases with emphasis on the refinement, development, and evaluation of technological devices that will assist, replace, or monitor vital organs and improve instrumentation for detection, diagnosis, and treatment of and rehabilitation from such diseases;

(E) establishment of programs for the conduct and direction of field studies, large-scale testing and evaluation, and demonstration of preventive, diagnostic, therapeutic, and rehabilitative approaches to, and emergency medical services for, such diseases;

(F) studies and research into blood diseases and blood, and into the use of blood for clinical purposes and all aspects of the management of blood resources in the United States, including the collection, preservation, fractionation, and distribution of blood and blood products;

(G) the education (including continuing education) and training of scientists, clinical investigators, and educators, in fields and specialties (including computer sciences) requisite to the conduct of clinical programs respecting heart, blood vessel, lung, and blood diseases and blood resources;

(H) public and professional education relating to all aspects of such diseases, including the prevention of such diseases, and the use of blood and blood products and the management of blood resources;

(I) establishment of programs for study and research into heart, blood vessel, lung, and blood diseases of children (including cystic fibrosis, hyaline membrane, hemolytic diseases such as sickle cell anemia and Cooley's anemia, and hemophilic diseases) and for the development and demonstration of diagnostic, treatment, and preventive approaches to such diseases; and

(J) establishment of programs for study, research, development, demonstrations and evaluation of emergency medical services for people who become critically ill in connection with heart, blood vessel, lung, or blood diseases.


(2) The Program shall be coordinated with other national research institutes to the extent that they have responsibilities respecting such diseases and shall give special emphasis to the continued development in the Institute of programs related to the causes of stroke and to effective coordination of such programs with related stroke programs in the National Institute of Neurological and Communicative Disorders and Stroke. The Director of the Institute, with the advice of the advisory council for the Institute, shall revise annually the plan for the Program and shall carry out the Program in accordance with such plan.

(b) In carrying out the Program, the Director of the Institute, under policies established by the Director of NIH—

(1) may, after consultation with the advisory council for the Institute, obtain (in accordance with section 3109 of title 5, but without regard to the limitation in such section on the period of such service) the services of not more than one hundred experts or consultants who have scientific or professional qualifications;

(2)(A) may, in consultation with the advisory council for the Institute, acquire and construct, improve, repair, operate, alter, renovate, and maintain, heart, blood vessel, lung, and blood disease and blood resource laboratories, research, training, and other facilities, equipment, and such other real or personal property as the Director determines necessary;

(B) may, in consultation with the advisory council for the Institute, make grants for construction or renovation of facilities; and

(C) may, in consultation with the advisory council for the Institute, acquire, without regard to section 8141 of title 40, by lease or otherwise, through the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of Columbia for the use of the Institute for a period not to exceed ten years;

(3) subject to section 284(b)(2) of this title and without regard to section 3324 of title 31 and section 6101 of title 41, may enter into such contracts, leases, cooperative agreements, or other transactions, as may be necessary in the conduct of the Director's functions, with any public agency, or with any person, firm, association, corporation, or educational institutions;

(4) may make grants to public and nonprofit private entities to assist in meeting the cost of the care of patients in hospitals, clinics, and related facilities who are participating in research projects; and

(5) shall, in consultation with the advisory council for the Institute, conduct appropriate intramural training and education programs, including continuing education and laboratory and clinical research training programs.


Except as otherwise provided, experts and consultants whose services are obtained under paragraph (1) shall be paid or reimbursed, in accordance with title 5, for their travel to and from their place of service and for other expenses associated with their assignment. Such expenses shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (1) unless the expert or consultant has agreed in writing to complete the entire period of the assignment or one year of the assignment, whichever is shorter, unless separated or reassigned for reasons which are beyond the control of the expert or consultant and which are acceptable to the Director of the Institute. If the expert or consultant violates the agreement, the money spent by the United States for such expenses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive in whole or in part a right of recovery under the preceding sentence.

(July 1, 1944, ch. 373, title IV, §421, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 837; amended Pub. L. 100–607, title I, §127, Nov. 4, 1988, 102 Stat. 3055; Pub. L. 103–43, title V, §501, title XX, §2008(b)(3), June 10, 1993, 107 Stat. 158, 211.)

Codification

In subsec. (b)(2)(C), "section 8141 of title 40" substituted for "the Act of March 3, 1877 (40 U.S.C. 34)" on authority of Pub. L. 107–217, §5(c), Aug. 21, 2002, 116 Stat. 1303, the first section of which enacted Title 40, Public Buildings, Property, and Works.

In subsec. (b)(3), "section 6101 of title 41" substituted for "section 3709 of the Revised Statutes (41 U.S.C. 5)" on authority of Pub. L. 111–350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

Amendments

1993—Subsec. (b)(1). Pub. L. 103–43, §2008(b)(3), inserted comma after "may".

Subsec. (b)(5). Pub. L. 103–43, §501, added par. (5).

1988—Subsec. (a)(1)(D). Pub. L. 100–607, §127(1), inserted "and rehabilitation from" after "and treatment of".

Subsec. (b)(1). Pub. L. 100–607, §127(2), substituted "after consultation with" for ", after approval of".

§285b–4. National research and demonstration centers

(a) Heart, blood vessel, lung, blood diseases, and blood resources; utilization of centers for prevention programs

(1) The Director of the Institute may provide, in accordance with subsection (c), for the development of—

(A) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment and rehabilitation methods (including methods of providing emergency medical services) for heart and blood vessel diseases;

(B) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment and rehabilitation methods (including methods of providing emergency medical services) for lung diseases (including bronchitis, emphysema, asthma, cystic fibrosis, and other lung diseases of children);

(C) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment methods (including methods of providing emergency medical services) for blood diseases and research into blood, in the use of blood products and in the management of blood resources; and

(D) three centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment (including genetic studies, intrauterine environment studies, postnatal studies, heart arrhythmias, and acquired heart disease and preventive cardiology) for cardiovascular diseases in children.


(2) The centers developed under paragraph (1) shall, in addition to being utilized for research, training, and demonstrations, be utilized for the following prevention programs for cardiovascular, pulmonary, and blood diseases:

(A) Programs to develop improved methods of detecting individuals with a high risk of developing cardiovascular, pulmonary, and blood diseases.

(B) Programs to develop improved methods of intervention against those factors which cause individuals to have a high risk of developing such diseases.

(C) Programs to develop health professions and allied health professions personnel highly skilled in the prevention of such diseases.

(D) Programs to develop improved methods of providing emergency medical services for persons with such diseases.

(E) Programs of continuing education for health and allied health professionals in the diagnosis, prevention, and treatment of such diseases and the maintenance of health to reduce the incidence of such diseases and information programs for the public respecting the prevention and early diagnosis and treatment of such diseases and the maintenance of health.


(3) The research, training, and demonstration activities carried out through any such center may relate to any one or more of the diseases referred to in paragraph (1) of this subsection.

(b) Sickle cell anemia

The Director of the Institute shall provide, in accordance with subsection (c), for the development of ten centers for basic and clinical research into the diagnosis, treatment, and control of sickle cell anemia.

(c) Cooperative agreements and grants for establishing and supporting; uses for Federal payments; period of support, additional periods

(1) The Director of the Institute may enter into cooperative agreements with and make grants to public or private nonprofit entities to pay all or part of the cost of planning, establishing, or strengthening, and providing basic operating support for centers for basic and clinical research into, training in, and demonstration of the management of blood resources and advanced diagnostic, prevention, and treatment methods for heart, blood vessel, lung, or blood diseases.

(2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies established by the Director of NIH and after consultation with the Institute's advisory council.

(3) Federal payments made under a cooperative agreement or grant under paragraph (1) may be used for—

(A) construction (notwithstanding any limitation under section 289e of this title);

(B) staffing and other basic operating costs, including such patient care costs as are required for research;

(C) training, including training for allied health professionals; and

(D) demonstration purposes.


As used in this subsection, the term "construction" does not include the acquisition of land, and the term "training" does not include research training for which Ruth L. Kirschstein National Research Service Awards may be provided under section 288 of this title.

(4) Support of a center under paragraph (1) may be for a period of not to exceed five years. Such period may be extended by the Director for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended.

(July 1, 1944, ch. 373, title IV, §422, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 839; amended Pub. L. 100–607, title I, §128, Nov. 4, 1988, 102 Stat. 3055; Pub. L. 103–43, title V, §502, June 10, 1993, 107 Stat. 158; Pub. L. 107–206, title I, §804(c), Aug. 2, 2002, 116 Stat. 874.)

Amendments

2002—Subsec. (c)(3). Pub. L. 107–206 substituted "Ruth L. Kirschstein National Research Service Awards" for "National Research Service Awards" in concluding provisions.

1993—Subsec. (a)(1)(D). Pub. L. 103–43 added subpar. (D).

1988—Subsec. (a)(1)(A), (B). Pub. L. 100–607 inserted "and rehabilitation" after "prevention, and treatment".

§285b–5. Repealed. Pub. L. 100–607, title I, §129, Nov. 4, 1988, 102 Stat. 3055

Section, act July 1, 1944, ch. 373, title IV, §423, as added Nov. 20, 1985, Pub. L. 99–158, §2, 99 Stat. 841, directed Secretary to establish an Interagency Technical Committee on Heart, Blood Vessel, Lung, and Blood Diseases and Blood Resources.

§285b–6. Associate Director for Prevention; appointment; function

(a) There shall be in the Institute an Associate Director for Prevention to coordinate and promote the programs in the Institute concerning the prevention of heart, blood vessel, lung, and blood diseases. The Associate Director shall be appointed by the Director of the Institute from individuals who because of their professional training or experience are experts in public health or preventive medicine.

(b) The Associate Director for Prevention shall prepare for inclusion in the biennial report made under section 284b 1 of this title a description of the prevention activities of the Institute, including a description of the staff and resources allocated to those activities.

(July 1, 1944, ch. 373, title IV, §423, formerly §424, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 841; renumbered §423, Pub. L. 100–607, title I, §129, Nov. 4, 1988, 102 Stat. 3055.)

References in Text

Section 284b of this title, referred to in subsec. (b), was repealed by Pub. L. 109–482, title I, §104(b)(1)(C), Jan. 15, 2007, 120 Stat. 3693.

Prior Provisions

A prior section 423 of act July 1, 1944, was classified to section 285b–5 of this title prior to repeal by Pub. L. 100–607.

1 See References in Text note below.

§285b–7. National Center on Sleep Disorders Research

(a) Establishment

Not later than 1 year after June 10, 1993, the Director of the Institute shall establish the National Center on Sleep Disorders Research (in this section referred to as the "Center"). The Center shall be headed by a director, who shall be appointed by the Director of the Institute.

(b) Purpose

The general purpose of the Center is—

(1) the conduct and support of research, training, health information dissemination, and other activities with respect to sleep disorders, including biological and circadian rhythm research, basic understanding of sleep, chronobiological and other sleep related research; and

(2) to coordinate the activities of the Center with similar activities of other Federal agencies, including the other agencies of the National Institutes of Health, and similar activities of other public entities and nonprofit entities.

(c) Sleep Disorders Research Advisory Board

(1) The Director of the National Institutes of Health shall establish a board to be known as the Sleep Disorders Research Advisory Board (in this section referred to as the "Advisory Board").

(2) The Advisory Board shall advise, assist, consult with, and make recommendations to the Director of the National Institutes of Health, through the Director of the Institute, and the Director of the Center concerning matters relating to the scientific activities carried out by and through the Center and the policies respecting such activities, including recommendations with respect to the plan required in subsection (c).1

(3)(A) The Director of the National Institutes of Health shall appoint to the Advisory Board 12 appropriately qualified representatives of the public who are not officers or employees of the Federal Government. Of such members, eight shall be representatives of health and scientific disciplines with respect to sleep disorders and four shall be individuals representing the interests of individuals with or undergoing treatment for sleep disorders.

(B) The following officials shall serve as ex officio members of the Advisory Board:

(i) The Director of the National Institutes of Health.

(ii) The Director of the Center.

(iii) The Director of the National Heart, Lung and Blood Institute.

(iv) The Director of the National Institute of Mental Health.

(v) The Director of the National Institute on Aging.

(vi) The Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

(vii) The Director of the National Institute of Neurological Disorders and Stroke.

(viii) The Assistant Secretary for Health.

(ix) The Assistant Secretary of Defense (Health Affairs).

(x) The Chief Medical Director of the Veterans' Administration.


(4) The members of the Advisory Board shall, from among the members of the Advisory Board, designate an individual to serve as the chair of the Advisory Board.

(5) Except as inconsistent with, or inapplicable to, this section, the provisions of section 284a of this title shall apply to the advisory board 2 established under this section in the same manner as such provisions apply to any advisory council established under such section.

(d) Development of comprehensive research plan; revision

(1) After consultation with the Director of the Center and the advisory board 2 established under subsection (c), the Director of the National Institutes of Health shall develop a comprehensive plan for the conduct and support of sleep disorders research.

(2) The plan developed under paragraph (1) shall identify priorities with respect to such research and shall provide for the coordination of such research conducted or supported by the agencies of the National Institutes of Health.

(3) The Director of the National Institutes of Health (after consultation with the Director of the Center and the advisory board 2 established under subsection (c)) shall revise the plan developed under paragraph (1) as appropriate.

(e) Collection and dissemination of information

The Director of the Center, in cooperation with the Centers for Disease Control and Prevention, is authorized to coordinate activities with the Department of Transportation, the Department of Defense, the Department of Education, the Department of Labor, and the Department of Commerce to collect data, conduct studies, and disseminate public information concerning the impact of sleep disorders and sleep deprivation.

(July 1, 1944, ch. 373, title IV, §424, as added Pub. L. 103–43, title V, §503, June 10, 1993, 107 Stat. 159; amended Pub. L. 110–154, §1(b)(5), Dec. 21, 2007, 121 Stat. 1827.)

Amendments

2007—Subsec. (c)(3)(B)(vi). Pub. L. 110–154 substituted "Eunice Kennedy Shriver National Institute of Child Health and Human Development" for "National Institute of Child Health and Human Development".

Change of Name

Reference to Chief Medical Director of Department of Veterans Affairs deemed to refer to Under Secretary for Health of Department of Veterans Affairs pursuant to section 302(e) of Pub. L. 102–405, set out as a note under section 305 of Title 38, Veterans' Benefits.

Reference to Chief Medical Director of Veterans' Administration deemed to refer to Chief Medical Director of Department of Veterans Affairs pursuant to section 10 of Pub. L. 100–527, set out as a Department of Veterans Affairs Act note under section 201 of Title 38.

Termination of Advisory Boards

Advisory boards 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 board established by the President or an officer of the Federal Government, such board is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a board 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 So in original. Probably should be subsection "(d)".

2 So in original. Probably should be capitalized.

§285b–7a. Heart attack, stroke, and other cardiovascular diseases in women

(a) In general

The Director of the Institute shall expand, intensify, and coordinate research and related activities of the Institute with respect to heart attack, stroke, and other cardiovascular diseases in women.

(b) Coordination with other institutes

The Director of the Institute shall coordinate activities under subsection (a) with similar activities conducted by the other national research institutes and agencies of the National Institutes of Health to the extent that such Institutes and agencies have responsibilities that are related to heart attack, stroke, and other cardiovascular diseases in women.

(c) Certain programs

In carrying out subsection (a), the Director of the Institute shall conduct or support research to expand the understanding of the causes of, and to develop methods for preventing, cardiovascular diseases in women. Activities under such subsection shall include conducting and supporting the following:

(1) Research to determine the reasons underlying the prevalence of heart attack, stroke, and other cardiovascular diseases in women, including African-American women and other women who are members of racial or ethnic minority groups.

(2) Basic research concerning the etiology and causes of cardiovascular diseases in women.

(3) Epidemiological studies to address the frequency and natural history of such diseases and the differences among men and women, and among racial and ethnic groups, with respect to such diseases.

(4) The development of safe, efficient, and cost-effective diagnostic approaches to evaluating women with suspected ischemic heart disease.

(5) Clinical research for the development and evaluation of new treatments for women, including rehabilitation.

(6) Studies to gain a better understanding of methods of preventing cardiovascular diseases in women, including applications of effective methods for the control of blood pressure, lipids, and obesity.

(7) Information and education programs for patients and health care providers on risk factors associated with heart attack, stroke, and other cardiovascular diseases in women, and on the importance of the prevention or control of such risk factors and timely referral with appropriate diagnosis and treatment. Such programs shall include information and education on health-related behaviors that can improve such important risk factors as smoking, obesity, high blood cholesterol, and lack of exercise.