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(3) by inserting after subsection (b) the fol-
lowing subsection:
‘‘(b) REPORT.—The Secretary shall biennially pre-
pare and submit to the appropriate committees of the Con-
gress a report concerning the coordination efforts at the
Federal, State, and local levels described in this section,
including a description of Federal barriers to HIV pro-
gram integration and a strategy for eliminating such bar-
riers and enhancing the continuity of care and prevention
services for individuals with HIV disease or those at risk
of such disease.’’; and
(4) in each of subsections (c) and (d) (as redes-
ignated by paragraph (2) of this section), by insert-
ing ‘‘and prevention services’’ after ‘‘continuity of
care’’ each place such term appears.
SEC. 414. PLAN REGARDING RELEASE OF PRISONERS WITH
HIV DISEASE.
Section 2675A of the Public Health Service Act, as
amended by section 413(2) of this Act, is amended by add-
ing at the end the following subsection:
‘‘(e) RECOMMENDATIONS REGARDING RELEASE OF
PRISONERS.—After consultation with the Attorney Gen-
eral and the Director of the Bureau of Prisons, with
States, with eligible areas under part A, and with entities
that receive amounts from grants under part A or B, the
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Secretary, consistent with the coordination required in
subsection (a), shall develop a plan for the medical case
management of and the provision of support services to
individuals who were Federal or State prisoners and had
HIV disease as of the date on which the individuals were
released from the custody of the penal system. The Sec-
retary shall submit the plan to the Congress not later than
2 years after the date of the enactment of the Ryan White
CARE Act Amendments of 2000.’’.
SEC. 415. AUDITS.
Part D of title XXVI of the Public Health Service
Act, as amended by section 412 of this Act, is amended
by inserting after section 2675A the following section:
‘‘SEC. 2675B. AUDITS.
‘‘For fiscal year 2002 and subsequent fiscal years,
the Secretary may reduce the amounts of grants under
this title to a State or political subdivision of a State for
a fiscal year if, with respect to such grants for the second
preceding fiscal year, the State or subdivision fails to pre-
pare audits in accordance with the procedures of section
7502 of title 31, United States Code. The Secretary shall
annually select representative samples of such audits, pre-
pare summaries of the selected audits, and submit the
summaries to the Congress.’’.
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SEC. 416. ADMINISTRATIVE SIMPLIFICATION.
Part D of title XXVI of the Public Health Service
Act, as amended by section 415 of this Act, is amended
by inserting after section 2675B the following section:
‘‘SEC. 2675C. ADMINISTRATIVE SIMPLIFICATION REGARD-
ING PARTS A AND B.
‘‘(a) COORDINATED
DISBURSEMENT.—After con-
sultation with the States, with eligible areas under part
A, and with entities that receive amounts from grants
under part A or B, the Secretary shall develop a plan for
coordinating the disbursement of appropriations for
grants under part A with the disbursement of appropria-
tions for grants under part B in order to assist grantees
and other recipients of amounts from such grants in com-
plying with the requirements of such parts. The Secretary
shall submit the plan to the Congress not later than 18
months after the date of the enactment of the Ryan White
CARE Act Amendments of 2000. Not later than 2 years
after the date on which the plan is so submitted, the Sec-
retary shall complete the implementation of the plan, not-
withstanding any provision of this title that is inconsistent
with the plan.
‘‘(b) BIENNIAL APPLICATIONS.—After consultation
with the States, with eligible areas under part A, and with
entities that receive amounts from grants under part A
or B, the Secretary shall make a determination of whether
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the administration of parts A and B by the Secretary, and
the efficiency of grantees under such parts in complying
with the requirements of such parts, would be improved
by requiring that applications for grants under such parts
be submitted biennially rather than annually. The Sec-
retary shall submit such determination to the Congress
not later than 2 years after the date of the enactment of
the Ryan White CARE Act Amendments of 2000.
‘‘(c) APPLICATION SIMPLIFICATION.—After consulta-
tion with the States, with eligible areas under part A, and
with entities that receive amounts from grants under part
A or B, the Secretary shall develop a plan for simplifying
the process for applications under parts A and B. The Sec-
retary shall submit the plan to the Congress not later than
18 months after the date of the enactment of the Ryan
White CARE Act Amendments of 2000. Not later than
2 years after the date on which the plan is so submitted,
the Secretary shall complete the implementation of the
plan, notwithstanding any provision of this title that is
inconsistent with the plan.’’.
SEC. 
417. 
AUTHORIZATION 
OF 
APPROPRIATIONS 
FOR
PARTS A AND B.
Section 2677 of the Public Health Service Act (42
U.S.C. 300ff–77) is amended to read as follows:
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‘‘SEC. 2677. AUTHORIZATION OF APPROPRIATIONS.
‘‘(a) PART A.—For the purpose of carrying out part
A, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 2001 through
2005.
‘‘(b) PART B.—For the purpose of carrying out part
B, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 2001 through
2005.’’.
TITLE V—GENERAL PROVISIONS
SEC. 501. STUDIES BY INSTITUTE OF MEDICINE.
(a) STATE SURVEILLANCE SYSTEMS
ON PREVA-
LENCE OF HIV.—The Secretary of Health and Human
Services (referred to in this section as the ‘‘Secretary’’)
shall request the Institute of Medicine to enter into an
agreement with the Secretary under which such Institute
conducts a study to provide the following:
(1) A determination of whether the surveillance
system of each of the States regarding the human
immunodeficiency virus provides for the reporting of
cases of infection with the virus in a manner that is
sufficient to provide adequate and reliable informa-
tion on the number of such cases and the demo-
graphic characteristics of such cases, both for the
State in general and for specific geographic areas in
the State.
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(2) A determination of whether such informa-
tion is sufficiently accurate for purposes of formula
grants under parts A and B of title XXVI of the
Public Health Service Act.
(3) With respect to any State whose surveil-
lance system does not provide adequate and reliable
information on cases of infection with the virus, rec-
ommendations regarding the manner in which the
State can improve the system.
(b) RELATIONSHIP
BETWEEN
EPIDEMIOLOGICAL
MEASURES AND HEALTH CARE FOR CERTAIN INDIVID-
UALS WITH HIV DISEASE.—
(1) IN GENERAL.—The Secretary shall request
the Institute of Medicine to enter into an agreement
with the Secretary under which such Institute con-
ducts a study concerning the appropriate epidemio-
logical measures and their relationship to the financ-
ing and delivery of primary care and health-related
support services for low-income, uninsured, and
under-insured individuals with HIV disease.
(2) ISSUES
TO
BE
CONSIDERED.—The Sec-
retary shall ensure that the study under paragraph
(1) considers the following:
(A) The availability and utility of health
outcomes measures and data for HIV primary
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care and support services and the extent to
which those measures and data could be used to
measure the quality of such funded services.
(B) The effectiveness and efficiency of
service delivery (including the quality of serv-
ices, health outcomes, and resource use) within
the context of a changing health care and
therapeutic environment, as well as the chang-
ing epidemiology of the epidemic, including de-
termining the actual costs, potential savings,
and overall financial impact of modifying the
program under title XIX of the Social Security
Act to establish eligibility for medical assistance
under such title on the basis of infection with
the human immunodeficiency virus rather than
providing such assistance only if the infection
has progressed to acquired immune deficiency
syndrome.
(C) Existing and needed epidemiological
data and other analytic tools for resource plan-
ning and allocation decisions, specifically for es-
timating severity of need of a community and
the relationship to the allocations process.
(D) Other factors determined to be rel-
evant to assessing an individual’s or commu-
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nity’s ability to gain and sustain access to qual-
ity HIV services.
(c) OTHER ENTITIES.—If the Institute of Medicine
declines to conduct a study under this section, the Sec-
retary shall enter into an agreement with another appro-
priate public or nonprofit private entity to conduct the
study.
(d) REPORT.—The Secretary shall ensure that—
(1) not later than 3 years after the date of the
enactment of this Act, the study required in sub-
section (a) is completed and a report describing the
findings made in the study is submitted to the ap-
propriate committees of the Congress; and
(2) not later than 2 years after the date of the
enactment of this Act, the study required in sub-
section (b) is completed and a report describing the
findings made in the study is submitted to such
committees.
SEC. 502. DEVELOPMENT OF RAPID HIV TEST.
(a) EXPANSION, INTENSIFICATION, AND COORDINA-
TION 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
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tests for HIV disease that can rapidly be adminis-
tered and whose results can rapidly be obtained (in
this section referred to a ‘‘rapid HIV test’’).
(2) REPORT TO CONGRESS.—The Director of
NIH shall periodically submit to the appropriate
committees of Congress a report describing the re-
search and other activities conducted or supported
under paragraph (1).
(3) 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) IN GENERAL.—Not later than 90 days after
the date of the enactment of this Act, the Secretary,
in consultation with the Director of the Centers for
Disease Control and Prevention and the Commis-
sioner of Food and Drugs, shall submit to the ap-
propriate committees of the Congress a report de-
scribing 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, in-
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cluding the minimization of false positive re-
sults 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 Bio-
logics Evaluation and Research and, if such rec-
ommendations are favorable, specify criteria
and procedures for such expedited review; and
(C) specify whether the barriers to the pre-
market 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 CON-
TROL AND PREVENTION.—Promptly after commercial dis-
tribution of a rapid HIV test begins, the Secretary, acting
through the Director of the Centers for Disease Control
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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.
TITLE VI—EFFECTIVE DATE
SEC. 601. EFFECTIVE DATE.
This Act and the amendments made by this Act take
effect October 1, 2000, or upon the date of the enactment
of this Act, whichever occurs later.
Passed the House of Representatives July 26 (legis-
lative day, July 25), 2000.
Attest:
JEFF TRANDAHL,
Clerk.
Calendar No. 716
106TH CONGRESS
2D SESSION
H. R. 4807
AN ACT
To amend the Public Health Service Act to revise
and extend programs established under the Ryan
White Comprehensive AIDS Resources Emer-
gency Act of 1990, and for other purposes.
JULY 26, 2000
Received; read twice and placed on the calendar