Part A—Administration of Research Programs
§300cc. Requirement of annual comprehensive report on all expenditures by Secretary with respect to acquired immune deficiency syndrome
(a) In general
Not later than December 1 of each fiscal year, the Secretary shall prepare and submit to the Congress a report on the expenditures by the Secretary of amounts appropriated for the preceding fiscal year with respect to acquired immune deficiency syndrome.
(b) Inclusion of certain information
The report required in subsection (a) of this section shall, with respect to acquired immune deficiency syndrome, include—
(1) for each program, project, or activity with respect to such syndrome, a specification of the amount obligated by each office and agency of the Department of Health and Human Services;
(2) a summary description of each such program, project, or activity;
(3) a list of such programs, projects, or activities that are directed towards members of minority groups;
(4) a description of the extent to which programs, projects, and activities described in paragraph (3) have been coordinated between the Director of the Office of Minority Health and the Director of the Centers for Disease Control and Prevention;
(5) a summary of the progress made by each such program, project, or activity with respect to the prevention and control of acquired immune deficiency syndrome;
(6) a summary of the evaluations conducted under this subchapter; and
(7) any report required in this chapter to be submitted to the Secretary for inclusion in the report required in subsection (a) of this section.
(July 1, 1944, ch. 373, title XXIII, §2301, as added
Prior Provisions
A prior section 300cc, act July 1, 1944, §2301, was successively renumbered by subsequent acts and transferred, see
Amendments
1992—Subsec. (b)(4).
Limitation on Expenditures for AIDS and HIV Activities
Vaccines for Human Immunodeficiency Virus
"(1)
"(2)
"(3)
"(4)
Requirement of Certain Research Studies
Section 203 of
National Commission on Acquired Immune Deficiency Syndrome
Subtitle D (§§241–249) of title II of
Ex. Ord. No. 12963. Presidential Advisory Council on HIV/AIDS
Ex. Ord. No. 12963, June 14, 1995, 60 F.R. 31905, as amended by Ex. Ord. No. 13009, June 14, 1996, 61 F.R. 39799 [30799], provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, I hereby direct the Secretary of Health and Human Services to exercise her discretion as follows:
(b) The Secretary shall designate a Chairperson from among the members of the Advisory Council.
(b) Any members of the Advisory Council that receive compensation shall be compensated in accordance with Federal law. Committee members may be allowed travel expenses, including per diem in lieu of subsistence, to the extent permitted by law for persons serving intermittently in the Government service (
(c) To the extent permitted by law, and subject to the availability of appropriations, the Department of Health and Human Services shall provide the Advisory Council with such funds and support as may be necessary for the performance of its functions.
(b) This order is intended only to improve the internal management of the executive branch, and it is not intended to create any right, benefit, or trust responsibility, substantive or procedural, enforceable at law or equity by a party against the United States, its agencies, it officers, or any person.
William J. Clinton.
Section Referred to in Other Sections
This section is referred to in
§300cc–1. Requirement of expediting awards of grants and contracts for research
(a) In general
The Secretary shall expedite the award of grants, contracts, and cooperative agreements for research projects relating to acquired immune deficiency syndrome (including such research projects initiated independently of any solicitation by the Secretary for proposals for such research projects).
(b) Time limitations with respect to certain applications
(1) With respect to programs of grants, contracts, and cooperative agreements described in subsection (a) of this section, any application submitted in response to a solicitation by the Secretary for proposals pursuant to such a program—
(A) may not be approved if the application is submitted after the expiration of the 3-month period beginning on the date on which the solicitation is issued; and
(B) shall be awarded, or otherwise finally acted upon, not later than the expiration of the 6-month period beginning on the expiration of the period described in subparagraph (A).
(2) If the Secretary makes a determination that it is not practicable to administer a program referred to in paragraph (1) in accordance with the time limitations described in such paragraph, the Secretary may adjust the time limitations accordingly.
(c) Requirements with respect to adjustments in time limitations
With respect to any program for which a determination described in subsection (b)(2) of this section is made, the Secretary shall—
(1) if the determination is made before the Secretary issues a solicitation for proposals pursuant to the program, ensure that the solicitation describes the time limitations as adjusted by the determination; and
(2) if the determination is made after the Secretary issues such a solicitation for proposals, issue a statement describing the time limitations as adjusted by the determination and individually notify, with respect to the determination, each applicant whose application is submitted before the expiration of the 3-month period beginning on the date on which the solicitation was issued.
(d) Annual reports to Congress
Except as provided in subsection (e) of this section, the Secretary shall annually prepare, for inclusion in the comprehensive report required in
(A) summarizing programs for which the Secretary has made a determination described in subsection (b)(2) of this section, including a description of the time limitations as adjusted by the determination and including a summary of the solicitation issued by the Secretary for proposals pursuant to the program; and
(B) summarizing applications that—
(i) were submitted pursuant to a program of grants, contracts, or cooperative agreements referred to in paragraph (1) of subsection (b) of this section for which a determination described in paragraph (2) of such subsection has not been made; and
(ii) were not processed in accordance with the time limitations described in such paragraph (1).
(e) Quarterly reports for fiscal year 1989
For fiscal year 1989, the report required in subsection (d) of this section shall, not less than quarterly, be prepared and submitted 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 XXIII, §2302, as added
Prior Provisions
A prior section 300cc–1, act July 1, 1944, §2302, was successively renumbered by subsequent acts and transferred, see
Change of Name
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
§300cc–2. Requirements with respect to processing of requests for personnel and administrative support
(a) In general
The Director of the Office of Personnel Management or the Administrator of General Services, as the case may be, shall respond to any priority request made by the Administrator of the Substance Abuse and Mental Health Services Administration, the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and Drugs, or the Director of the National Institutes of Health, not later than 21 days after the date on which such request is made. If the Director of the Office of Personnel Management or the Administrator of General Services, as the case may be, does not disapprove a priority request during the 21-day period, the request shall be deemed to be approved.
(b) Notice to Secretary and to Assistant Secretary for Health
The Administrator of the Substance Abuse and Mental Health Services Administration, the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and Drugs, and the Director of the National Institutes of Health, shall, respectively, transmit to the Secretary and the Assistant Secretary for Health a copy of each priority request made under this section by the agency head involved. The copy shall be transmitted on the date on which the priority request involved is made.
(c) "Priority request" defined
For purposes of this section, the term "priority request" means any request that—
(1) is designated as a priority request by the Administrator of the Substance Abuse and Mental Health Services Administration, the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and Drugs, or the Director of the National Institutes of Health; and
(2)(A) is made to the Director of the Office of Personnel Management for the allocation of personnel to carry out activities with respect to acquired immune deficiency syndrome; or
(B) is made to the Administrator of General Services for administrative support or space in carrying out such activities.
(July 1, 1944, ch. 373, title XXIII, §2303, as added
Prior Provisions
A prior section 300cc–2, act July 1, 1944, §2303, was successively renumbered by subsequent acts and transferred, see
Amendments
1992—Subsec. (a).
Subsec. (b).
Subsec. (c)(1).
Effective Date of 1992 Amendment
Amendment by
§300cc–3. Establishment of Research Advisory Committee
(a) In general
After consultation with the Commissioner of Food and Drugs, the Secretary, acting through the Director of the National Institute of Allergy and Infectious Diseases, shall establish within such Institute an advisory committee to be known as the AIDS Research Advisory Committee (hereafter in this section referred to as the "Committee").
(b) Composition
The Committee shall be composed of physicians whose clinical practice includes a significant number of patients with acquired immune deficiency syndrome.
(c) Duties
The Committee shall—
(1) advise the Director of such Institute (and may provide advice to the Directors of other agencies of the National Institutes of Health, as appropriate) on appropriate research activities to be undertaken with respect to clinical treatment of such syndrome, including advice with respect to—
(A) research on drugs for preventing or minimizing the development of symptoms or conditions arising from infection with the etiologic agent for such syndrome, including recommendations on the projects of research with respect to diagnosing immune deficiency and with respect to predicting, diagnosing, preventing, and treating opportunistic cancers and infectious diseases; and
(B) research on the effectiveness of treating such symptoms or conditions with drugs that—
(i) are not approved by the Commissioner of Food and Drugs for the purpose of treating such symptoms or conditions; and
(ii) are being utilized for such purpose by individuals infected with such etiologic agent;
(2)(A) review ongoing publicly and privately supported research on clinical treatment for acquired immune deficiency syndrome, including research on drugs described in paragraph (1); and
(B) periodically issue, and make available to health care professionals, reports describing and evaluating such research;
(3) conduct studies and convene meetings for the purpose of determining the recommendations among physicians in clinical practice on clinical treatment of acquired immune deficiency syndrome, including treatment with the drugs described in paragraph (1); and
(4) conduct a study for the purpose of developing, with respect to individuals infected with the etiologic agent for acquired immune deficiency syndrome, a consensus among health care professionals on clinical treatments for preventing or minimizing the development of symptoms or conditions arising from infection with such etiologic agent.
(July 1, 1944, ch. 373, title XXIII, §2304, as added
Prior Provisions
A prior section 300cc–3, acts July 1, 1944, ch. 373, title XXIII, §2304, formerly title V, §504,
A prior section 300cc–4, acts July 1, 1944, ch. 373, title XXI, §2105, formerly title V, §505,
Prior sections 300cc–5 to 300cc–10, act July 1, 1944, §§2306 to 2311, respectively, were successively renumbered by subsequent acts and transferred, see
Amendments
1993—
Subsec. (a).
Subsec. (c)(1).
1988—Subsec. (c)(2)(B).
Effective Date of 1988 Amendment
Amendment by
Termination of Advisory Committees
Advisory committees 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 committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by the Congress, its duration is otherwise provided by law. See section 14 of
Section Referred to in Other Sections
This section is referred to in