§ 300cc–1. Requirement of expediting awards of grants and contracts for research

§ 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), 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) 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), the Secretary shall annually prepare, for inclusion in the comprehensive report required in section 300cc 11 See References in Text note below. of this title, a report—

(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) summarizing applications that—

(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) 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) 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 Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102 Stat. 3063.)

Editorial Notes

References in Text

Section 300cc of this title, referred to in subsec. (d), was repealed by Pub. L. 109–482, title I, § 104(b)(2)(C), Jan. 15, 2007, 120 Stat. 3693.

Prior Provisions

A prior section 300cc–1, act July 1, 1944, § 2302, was successively renumbered by subsequent acts and transferred, see section 238a of this title.

Statutory Notes and Related Subsidiaries

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.

Development of Rapid HIV Test

Pub. L. 106–345, title V, § 502, Oct. 20, 2000, 114 Stat. 1353, as amended by Pub. L. 114–255, div. A, title II, § 2042(g), Dec. 13, 2016, 130 Stat. 1073, provided that: “(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.”

Limitation on Expenditures for AIDS and HIV Activities

Pub. L. 104–146, § 11, May 20, 1996, 110 Stat. 1373, provided that: “Notwithstanding any other provision of law, the total amounts of Federal funds expended in any fiscal year for AIDS and HIV activities may not exceed the total amounts expended in such fiscal year for activities related to cancer.”

Vaccines for Human Immunodeficiency Virus

Pub. L. 103–43, title XIX, § 1901(b), June 10, 1993, 107 Stat. 200, provided that: “(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.”

Executive Documents

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:

Section 1. Establishment. (a) The Secretary of Health and Human Services (the “Secretary”) shall establish an HIV/AIDS Advisory Council (the “Advisory Council” or the “Council”), to be known as the Presidential Advisory Council on HIV/AIDS. The Advisory Council shall be composed of not more than 35 members to be appointed or designated by the Secretary. The Advisory Council shall comply with the Federal Advisory Committee Act, as amended ([former] 5 U.S.C. App.) [see 5 U.S.C. 1001 et seq.].

(b) The Secretary shall designate a Chairperson from among the members of the Advisory Council.

Sec. 2. Functions. The Advisory Council shall provide advice, information, and recommendations to the Secretary regarding programs and policies intended to (a) promote effective prevention of HIV disease, (b) advance research on HIV and AIDS, and (c) promote quality services to persons living with HIV disease and AIDS. The functions of the Advisory Council shall be solely advisory in nature. The Secretary shall provide the President with copies of all written reports provided to the Secretary by the Advisory Council.

Sec. 3. Administration. (a) The heads of executive departments and agencies shall, to the extent permitted by law, provide the Advisory Council with such information as it may require for purposes of carrying out its functions.

(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 (5 U.S.C. section 5701–5707).

(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.

Sec. 4. General Provisions. (a) Notwithstanding the provisions of any other Executive order, any functions of the President under the Federal Advisory Committee Act that are applicable to the Advisory Council, except that of reporting annually to the Congress, shall be performed by the Department of Health and Human Services, in accordance with the guidelines and procedures established by the Administrator of General Services.

(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.

Extension of Term of Presidential Advisory Council on HIV/AIDS

Term of Presidential Advisory Council on HIV/AIDS extended until Sept. 30, 2025, by Ex. Ord. No. 14109, Sept. 29, 2023, 88 F.R. 68447, set out as a note under section 1013 of Title 5, Government Organization and Employees.

Previous extensions of term of Presidential Advisory Council on HIV/AIDS were contained in the following prior Executive Orders:

Ex. Ord. No. 14048, Sept. 30, 2021, 86 F.R. 55465, extended term until Sept. 30, 2023.

Ex. Ord. No. 13889, Sept. 27, 2019, 84 F.R. 52743 extended term until Sept. 30, 2021.

Ex. Ord. No. 13811, Sept. 29, 2017, 82 F.R. 46363, extended term until Sept. 30, 2019.

Ex. Ord. No. 13708, Sept. 30, 2015, 80 F.R. 60271, extended term until Sept. 30, 2017.

Ex. Ord. No. 13649. Accelerating Improvements in HIV Prevention and Care in the United States Through the HIV Care Continuum Initiative

Ex. Ord. No. 13649, July 15, 2013, 78 F.R. 43057, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, and in order to further strengthen the capacity of the Federal Government to effectively respond to the ongoing domestic HIV epidemic, it is hereby ordered as follows:

Section 1. Policy. Addressing the domestic HIV epidemic is a priority of my Administration. In 2010, the White House released the first comprehensive National HIV/AIDS Strategy (Strategy), setting quantitative goals for reducing new HIV infections, improving health outcomes for people living with HIV, and reducing HIV-related health disparities. The Strategy will continue to serve as the blueprint for our national response to the domestic epidemic. It has increased coordination, collaboration, and accountability across executive departments and agencies (agencies) with regard to addressing the epidemic. It has also focused our Nation’s collective efforts on increasing the use of evidence-based approaches to prevention and care among populations and in regions where HIV is most concentrated.

Since the release of the Strategy, additional scientific discoveries have greatly enhanced our understanding of how to prevent and treat HIV. Accordingly, further Federal action is appropriate in response to these new developments. For example, a breakthrough research trial supported by the National Institutes of Health showed that initiating HIV treatment when the immune system was relatively healthy reduced HIV transmission by 96 percent. In addition, evidence suggests that early treatment may reduce HIV-related complications. These findings highlight the importance of prompt HIV diagnosis, and because of recent advances in HIV testing technology, HIV can be detected sooner and more rapidly than ever before.

Based on these and other data, recommendations for HIV testing and treatment have changed. The U.S. Preventive Services Task Force now recommends that clinicians screen all individuals ages 15 to 65 years for HIV, and the Department of Health and Human Services Guidelines for Use of Antiretroviral Agents now recommends offering treatment to all adolescents and adults diagnosed with HIV.

Furthermore, ongoing implementation of the Affordable Care Act provides a historic opportunity for Americans to access affordable, quality health care. The Act is expanding access to recommended preventive services with no out-of-pocket costs, including HIV testing, and, beginning in 2014, insurance companies will not be able to deny coverage based on pre-existing conditions, including HIV. Starting October 1, 2013, Americans can select the coverage that best suits them through the new Health Insurance Marketplace, and coverage will begin January 1, 2014.

Despite progress in combating HIV, important work remains. Since the publication of the Strategy, data released by the Centers for Disease Control and Prevention show that there are significant gaps along the HIV care continuum—the sequential stages of care from being diagnosed to receiving optimal treatment. Nearly one-fifth of the estimated 1.1 million people living with HIV in the United States are undiagnosed; one-third are not linked to medical care; nearly two-thirds are not engaged in ongoing care; and only one-quarter have the virus effectively controlled, which is necessary to maintain long-term health and reduce risk of transmission to others.

In light of these data, we must further clarify and focus our national efforts to prevent and treat HIV infection. It is the policy of my Administration that agencies implementing the Strategy prioritize addressing the continuum of HIV care, including by accelerating efforts to increase HIV testing, services, and treatment along the continuum. This acceleration will enable us to meet the goals of the Strategy and move closer to an AIDS-free generation.

Sec. 2. Establishment of the HIV Care Continuum Initiative. There is established the HIV Care Continuum Initiative (Initiative), to be overseen by the Director of the Office of National AIDS Policy. The Initiative will mobilize and coordinate Federal efforts in response to recent advances regarding how to prevent and treat HIV infection. The Initiative will support further integration of HIV prevention and care efforts; promote expansion of successful HIV testing and service delivery models; encourage innovative approaches to addressing barriers to accessing testing and treatment; and ensure that Federal resources are appropriately focused on implementing evidence-based interventions that improve outcomes along the HIV care continuum.