‘‘(A) provide for annual audits of the fi-
nancial condition of the Foundation; and
‘‘(B) make such audits, and all other
records, documents, and other papers of the
Foundation, available to the Secretary and the
Comptroller General of the United States for
examination or audit.
‘‘(4) REPORTS.—
‘‘(A) Not later than 5 months following the
end of each fiscal year, the Foundation shall
publish a report describing the activities of the
Foundation during the preceding fiscal year.
Each such report shall include for the fiscal
year involved a comprehensive statement of the
operations, activities, financial condition, and
accomplishments of the Foundation.
‘‘(B) With respect to the financial condi-
tion of the Foundation, each report under sub-
paragraph (A) shall include the source, and a
description of, all gifts or grants to the Founda-
tion of real or personal property, and the source
and amount of all gifts or grants to the Foun-
dation of money. Each such report shall include
a specification of any restrictions on the pur-
poses for which gifts or grants to the Founda-
tion may be used.
‘‘(C) The Foundation shall make copies of
each report submitted under subparagraph (A)
available for public inspection, and shall upon
request provide a copy of the report to any indi-
vidual for a charge not exceeding the cost of
providing the copy.
‘‘(D) The Board shall annually hold a pub-
lic meeting to summarize the activities of the
Foundation and distribute written reports con-
cerning such activities and the scientific results
derived from such activities.
‘‘(5) SERVICE OF FEDERAL EMPLOYEES.—Fed-
eral employees may serve on committees advisory to
the Foundation and otherwise cooperate with and
assist the Foundation in carrying out its function, so
long as the employees do not direct or control Foun-
dation activities.
‘‘(6) RELATIONSHIP
WITH
EXISTING
ENTI-
TIES.—The Foundation may, pursuant to appro-
priate agreements, acquire the resources of existing
nonprofit private corporations with missions similar
to the purposes of the Foundation.
‘‘(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
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
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—