42 U.S.C. § 300cc–1. Requirement of expediting awards of grants and contracts for research
- (a)(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)(b)
Time limitations with respect to certain applications
- (1)(b)(1)
With respect to programs of grants, contracts, and cooperative agreements described in subsection (a), any application submitted in response to a solicitation by the Secretary for proposals pursuant to such a program—
- (A)(b)(1)(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)(b)(1)(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)(b)(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)(c)
Requirements with respect to adjustments in time limitations
With respect to any program for which a determination described in subsection (b)(2) is made, the Secretary shall—
- (1)(c)(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)(c)(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)(d)
Annual reports to Congress
Except as provided in subsection (e), the Secretary shall annually prepare, for inclusion in the comprehensive report required in section 300cc 1 of this title, a report—
- (A)(d)(A)summarizing programs for which the Secretary has made a determination described in subsection (b)(2), 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)(d)(B)
summarizing applications that—
- (i)(d)(B)(i)were submitted pursuant to a program of grants, contracts, or cooperative agreements referred to in paragraph (1) of subsection (b) for which a determination described in paragraph (2) of such subsection has not been made; and
- (ii)(d)(B)(ii)were not processed in accordance with the time limitations described in such paragraph (1).
- (e)(e)
Quarterly reports for fiscal year 1989
For fiscal year 1989, the report required in subsection (d) 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.
- “(a)
Expansion, Intensification, and Coordination of Research and Other 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 the development of reliable and affordable tests for HIV disease that can rapidly be administered and whose results can rapidly be obtained (in this section referred to as ‘rapid HIV test’). - “(2)
Authorization of appropriations.—
For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
- “(b)
Premarket Review of Rapid HIV Tests.—
- “(1)
[sic] In general.—
Not later than 90 days after the date of the enactment of this Act [Oct. 20, 2000], the Secretary, in consultation with the Director of the Centers for Disease Control and Prevention and the Commissioner of Food and Drugs, shall submit to the appropriate committees of the Congress a report describing the progress made towards, and barriers to, the premarket review and commercial distribution of rapid HIV tests. The report shall—
- “(A)assess the public health need for and public health benefits of rapid HIV tests, including the minimization of false positive results through the availability of multiple rapid HIV tests;
- “(B)make recommendations regarding the need for the expedited review of rapid HIV test applications submitted to the Center for Biologics Evaluation and Research and, if such recommendations are favorable, specify criteria and procedures for such expedited review; and
- “(C)
specify whether the barriers to the premarket review of rapid HIV tests include the unnecessary application of requirements—
- “(i)necessary to ensure the efficacy of devices for donor screening to rapid HIV tests intended for use in other screening situations; or
- “(ii)for identifying antibodies to HIV subtypes of rare incidence in the United States to rapid HIV tests intended for use in screening situations other than donor screening.
- “(c)
Guidelines of Centers for Disease Control and Prevention.—
Promptly after commercial distribution of a rapid HIV test begins, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish or update guidelines that include recommendations for States, hospitals, and other appropriate entities regarding the ready availability of such tests for administration to pregnant women who are in labor or in the late stage of pregnancy and whose HIV status is not known to the attending obstetrician.”
- “(1)
In general.—
The Secretary of Health and Human Services, acting through the National Institutes of Health, shall develop a plan for the appropriate inclusion of HIV-infected women, including pregnant women, HIV-infected infants, and HIV-infected children in studies conducted by or through the National Institutes of Health concerning the safety and efficacy of HIV vaccines for the treatment and prevention of HIV infection. Such plan shall ensure the full participation of other Federal agencies currently conducting HIV vaccine studies and require that such studies conform fully to the requirements of part 46 of title 45, Code of Federal Regulations. - “(2)
Report.—
Not later than 180 days after the date of the enactment of this Act [June 10, 1993], the Secretary of Health and Human Services shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Labor and Human Resources [now Committee on Health, Education, Labor, and Pensions] of the Senate, a report concerning the plan developed under paragraph (1). - “(3)
Implementation.—
Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall implement the plan developed under paragraph (1), including measures for the full participation of other Federal agencies currently conducting HIV vaccine studies. - “(4)
Authorization of appropriations.—
For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1994 through 1996.”