‘‘(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 PREVALENCE
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 im-
munodeficiency 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 demographic
characteristics of such cases, both for the State in gen-
eral and for specific geographic areas in the State.
(2) A determination of whether such information
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 surveillance
system does not provide adequate and reliable infor-
mation 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 INDIVIDUALS
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 Secretary
shall ensure that the study under paragraph (1) con-
siders the following:
(A) The availability and utility of health
outcomes measures and data for HIV primary
care and support services and the extent to which
those measures and data could be used to meas-
ure the quality of such funded services.
(B) The effectiveness and efficiency of serv-
ice delivery (including the quality of services,
health outcomes, and resource use) within the
context of a changing health care and thera-
peutic environment, as well as the changing epi-
demiology of the epidemic, including deter-
mining the actual costs, potential savings, and
overall financial impact of modifying the pro-
gram 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 pro-
viding such assistance only if the infection has
progressed to acquired immune deficiency syn-
drome.
(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 relevant
to assessing an individual’s or community’s abil-
ity to gain and sustain access to quality HIV
services.
(c) OTHER ENTITIES.—If the Institute of Medicine de-
clines to conduct a study under this section, the Secretary
shall enter into an agreement with another appropriate
public or nonprofit private entity to conduct the study.
(d) REPORT.—The Secretary shall ensure that—
(1) not later than three 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 appro-
priate committees of the Congress; and
(2) not later than two 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 com-
mittees.
SEC. 502. DEVELOPMENT OF RAPID HIV TEST.
(a) EXPANSION, INTENSIFICATION, AND COORDINATION
OF RESEARCH AND OTHER ACTIVITIES.—
(1) IN GENERAL.—The Director of NIH shall ex-
pand, intensify, and coordinate research and other
activities of the National Institutes of Health with re-
spect to the development of reliable and affordable
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 appro-
priate committees of the Congress a report describing
the progress made towards, and barriers to, the pre-
market 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, includ-
ing 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 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 un-
necessary application of requirements—
(i) necessary to ensure the efficacy of
devices for donor screening to rapid HIV
tests intended for use in other screening sit-
uations; 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 distribu-
tion 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 appro-
priate entities regarding the ready availability of such tests
Calendar No. 455
106TH CONGRESS
2D SESSION
H. R. 4807
[Report No. 106–788]
A BILL
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 25, 2000
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union,
and ordered to be printed