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‘‘(7) INTELLECTUAL PROPERTY RIGHTS.—The
Board may adopt written standards with respect to
the ownership of any intellectual property rights de-
rived from the collaborative efforts of the Founda-
tion prior to the commencement of such efforts.
‘‘(8) 
NATIONAL
INSTITUTES
OF
HEALTH
AMENDMENTS OF 1990.—The activities conducted in
support of the National Institutes of Health Amend-
ments of 1990 (Public Law 101–613), and the
amendments made by such Act, shall not be nullified
by the enactment of this section.
‘‘(9) LIMITATION OF ACTIVITIES.—The Foun-
dation shall exist solely as an entity to collect funds
and award grants for research on drugs listed by the
Secretary pursuant to section 409I(a)(1)(A).
‘‘(10) TRANSFER OF FUNDS.—The Foundation
may transfer funds to the National Institutes of
Health. Any funds transferred under this paragraph
shall be subject to all Federal limitations relating to
federally-funded research.
‘‘(k) DUTIES OF THE DIRECTOR.—
‘‘(1) APPLICABILITY OF CERTAIN STANDARDS
TO NON-FEDERAL EMPLOYEES.—In the case of any
individual who is not an employee of the Federal
Government and who serves in association with the
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National Institutes of Health, with respect to finan-
cial assistance received from the Foundation, the
Foundation may not provide the assistance of, or
otherwise permit the work at the National Institutes
of Health to begin until a memorandum of under-
standing between the individual and the Director of
NIH, or the designee of such Director, has been exe-
cuted specifying that the individual shall be subject
to such ethical and procedural standards of conduct
relating to duties performed at the National Insti-
tutes of Health, as the Director of NIH determines
is appropriate.
‘‘(2) SUPPORT
SERVICES.—The Director of
NIH shall provide facilities, utilities and support
services to the Foundation.
‘‘(l) REPORTS OF STUDIES; LABELING CHANGES.—
‘‘(1) IN GENERAL.—Upon completion of a pedi-
atric study conducted pursuant to this section, a re-
port concerning the study shall be submitted to the
Director of National Institutes of Health and the
Commissioner of Food and Drugs. The report shall
include all data generated in connection with the
study.
‘‘(2) AVAILABILITY
OF
REPORTS; ACTION
BY
FOOD
AND
DRUG
ADMINISTRATION; 
LABELING
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CHANGES.—With respect to a report submitted
under paragraph (1), the provisions of paragraphs
(3)(B) through (8) of section 409I(c) apply to such
report to the same extent and in the same manner
as such provision apply to a report submitted under
section 409I(c)(3)(A).
‘‘(m) FUNDING.—
‘‘(1) AUTHORIZATION
OF
APPROPRIATIONS.—
For the purpose of carrying out this part, there are
authorized to be appropriated such sums as may be
necessary for fiscal year 2002 and each subsequent
fiscal year.
‘‘(2) LIMITATION REGARDING OTHER FUNDS.—
Amounts appropriated under any provision of law
other than paragraph (1) may not be expended to
establish or operate the Foundation.’’.
SEC. 14. STUDY CONCERNING RESEARCH INVOLVING CHIL-
DREN.
(a) CONTRACT WITH INSTITUTE OF MEDICINE.—The
Secretary of Health and Human Services shall enter into
a contract with the Institute of Medicine for—
(1) the conduct, in accordance with subsection
(b), of a review of—
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(A) Federal regulations in effect on the
date of the enactment of this Act relating to re-
search involving children;
(B) federally-prepared or supported reports
relating to research involving children; and
(C) federally-supported evidence-based re-
search involving children; and
(2) the submission to the appropriate commit-
tees of Congress, by not later than 2 years after the
date of enactment of this Act, of a report concerning
the review conducted under paragraph (1) that in-
cludes recommendations on best practices relating to
research involving children.
(b) AREAS OF REVIEW.—In conducting the review
under subsection (a)(1), the Institute of Medicine shall
consider the following:
(1) The written and oral process of obtaining
and defining ‘‘assent’’, ‘‘permission’’ and ‘‘informed
consent’’ with respect to child clinical research par-
ticipants and the parents, guardians, and the indi-
viduals who may serve as the legally authorized rep-
resentatives of such children (as defined in subpart
A of part 46 of title 45, Code of Federal Regula-
tions).
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(2) The expectations and comprehension of
child research participants and the parents, guard-
ians, or legally authorized representatives of such
children, for the direct benefits and risks of the
child’s research involvement, particularly in terms of
research versus therapeutic treatment.
(3) The definition of ‘‘minimal risk’’ with re-
spect to a healthy child or a child with an illness.
(4) The appropriateness of the regulations ap-
plicable to children of differing ages and maturity
levels, including regulations relating to legal status.
(5) Whether payment (financial or otherwise)
may be provided to a child or his or her parent,
guardian, or legally authorized representative for the
participation of the child in research, and if so, the
amount and type of payment that may be made.
(6) Compliance with the regulations referred to
in subsection (a)(1)(A), the monitoring of such com-
pliance (including the role of institutional review
boards), and the enforcement actions taken for viola-
tions of such regulations.
(7) The unique roles and responsibilities of in-
stitutional review boards in reviewing research in-
volving children, including composition of member-
ship on institutional review boards.
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(c) REQUIREMENTS OF EXPERTISE.—The Institute
of Medicine shall conduct the review under subsection
(a)(1) and make recommendations under subsection (a)(2)
in conjunction with experts in pediatric medicine, pediatric
research, and the ethical conduct of research involving
children.
SEC. 15. STUDY ON EFFECTS OF THIS ACT.
Not later than October 1, 2006, the Comptroller Gen-
eral of the United States shall submit to the Congress and
the Secretary of Health and Human Services a report that
describes the following:
(1) The effectiveness of the amendments made
by this Act in ensuring that all drugs used by chil-
dren are tested and properly labeled, including—
(A) the number and importance for chil-
dren of drugs that are being tested as a result
of such amendments, and the importance for
children, health care providers, parents, and
others of labeling changes made as a result of
such testing;
(B) the number and importance for chil-
dren of drugs that are not being tested for their
use notwithstanding the amendments, and pos-
sible reason for this; and
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(C) the number of drugs for which pedi-
atric testing has been done, for which a period
of market exclusivity has been granted, and for
which labeling changes required the use of the
dispute resolution process established pursuant
to the amendments, together with a description
of the outcomes of such process, including a de-
scription of the disputes and the recommenda-
tions of the advisory committee.
(2) The economic impact of the amendments
made by this Act, including an estimate of—
(A) costs to taxpayers in the form of high-
er expenditures by Medicaid and other govern-
ment programs;
(B) costs to consumers as a result of any
delay in the availability of lower cost generic
equivalents of drugs tested and granted exclu-
sivity pursuant to such amendments, and loss
of revenue by the generic drug industry and any
other affected industry as a result of any such
delay; and
(C) benefits to the government, to private
insurers, and to consumers resulting from de-
creased health care costs, including—
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(i) decreased hospitalizations, due to
more appropriate and more effective use of
medications in children as a result of test-
ing and re-labeling because of such amend-
ments;
(ii) direct and indirect benefits associ-
ated with fewer physician visits not related
to hospitalization;
(iii) benefits to children from missing
less time at school and being less affected
by chronic illnesses, thereby allowing a bet-
ter quality of life;
(iv) benefits to consumers from lower
health insurance premiums due to lower
treatment costs and hospitalization rates;
and
(v) benefits to employers from reduced
need for employees to care for family mem-
bers.
(3) The nature and types of studies in children
of drugs granted a period of market exclusivity pur-
suant to the amendments made by this Act, includ-
ing a description of the complexity of such studies,
the number of study sites necessary to obtain appro-
priate data, and the numbers of children involved in
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any clinical studies, and the cost of such studies for
each type of study identified.
(4) The increased pediatric research capability,
both private and government-funded, associated with
the amendments made by this Act.
SEC. 16. MINORITY CHILDREN AND PEDIATRIC-EXCLU-
SIVITY PROGRAM.
(a) PROTOCOLS FOR PEDIATRIC STUDIES.—Section
505A of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a) is amended in subsection (c)(2) (as redesig-
nated by section 2(a)(2) of this Act) by inserting after
the first sentence the following: ‘‘In reaching an agree-
ment regarding written protocols, the Secretary shall take
into account adequate representation of children of ethnic
and racial minorities.’’.
(b) STUDY BY GENERAL ACCOUNTING OFFICE.—
(1) IN GENERAL.—The Comptroller General of
the United States shall conduct a study for the pur-
pose of determining the following:
(A) The extent to which children of ethnic
and racial minorities are adequately represented
in studies under section 505A of the Federal
Food, Drug, and Cosmetic Act; and to the ex-
tent ethnic and racial minorities are not ade-
quately represented, the reasons for such under
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representation and recommendations to increase
such representation.
(B) Whether the Food and Drug Adminis-
tration has appropriate management systems to
monitor the representation of the children of
ethnic and racial minorities in such studies.
(C) Whether drugs used to address dis-
eases that disproportionately affect racial and
ethnic minorities are being studied for their
safety and effectiveness under section 505A of
the Federal Food, Drug, and Cosmetic Act.
(2) DATE CERTAIN FOR COMPLETING STUDY.—
Not later than January 10, 2003, the Comptroller
General shall complete the study required in para-
graph (1) and submit to the Congress a report de-
scribing the findings of the study.
SEC. 17. TECHNICAL AND CONFORMING AMENDMENTS.
Section 505A of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355a) is amended—
(1)(A) by striking ‘‘(j)(4)(D)(ii)’’ each place
such term appears and inserting ‘‘(j)(5)(D)(ii)’’; and
(B) by striking ‘‘(j)(4)(D)’’ each place such
term appears and inserting ‘‘(j)(5)(D)’’; and
(2)(A) in subsection (c) (as redesignated by sec-
tion 2(a)(2) of this Act), in each of paragraphs (1)
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through (3), by striking ‘‘subsection (a) or (c)’’ and
inserting ‘‘subsection (a) or (b)’’; and
(B) in subsection (d) (as so redesignated), in
the last sentence, by striking ‘‘subsection (a) or (c)’’
and inserting ‘‘subsection (a) or (b)’’.
Passed the House of Representatives November 15,
2001.
Attest:
JEFF TRANDAHL,
Clerk.
Calendar No. 228
107TH CONGRESS
1ST SESSION
H. R. 2887
AN ACT
To amend the Federal Food, Drug, and Cosmetic
Act to improve the safety and efficacy of phar-
maceuticals for children.
NOVEMBER 16, 2001
Received; read twice and placed on the calendar