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.
SEC. 3. RESEARCH FUND FOR THE STUDY OF DRUGS LACK-
ING EXCLUSIVITY.
Part B of title IV of the Public Health Service Act
(42 U.S.C. 284 et seq.) is amended—
(1) by redesignating the second section 409C
(relating to clinical research) as section 409G;
(2) by redesignating the second section 409D
(relating to enhancement awards) as section 409H;
and
(3) by adding at the end the following:
‘‘SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS
LACKING EXCLUSIVITY.
‘‘(a) LIST OF DRUGS LACKING EXCLUSIVITY FOR
WHICH PEDIATRIC STUDIES ARE NEEDED.—
‘‘(1) IN GENERAL.—Not later than 1 year after
the date of enactment of this section, the Secretary,
acting through the Director of the National Insti-
tutes of Health and in consultation with the Com-
missioner of Food and Drugs and experts in pedi-
atric research, shall develop, prioritize, and publish
an annual list of approved drugs for which—
‘‘(A)(i) there is an approved application
under section 505(j) of the Federal Food,
Drug, and Cosmetic Act;
‘‘(ii) there is a submitted application that
could be approved under the criteria of section
505(j) of the Federal Food, Drug, and Cos-
metic Act;
‘‘(iii) there is no patent protection or mar-
ket exclusivity protection under the Federal
Food, Drug, and Cosmetic Act; or
‘‘(iv) there is, under section 505A(c)(4)(C)
of the Federal Food, Drug, and Cosmetic Act,
a referral for inclusion on such list; and
‘‘(B) additional studies are needed to as-
sess the safety and effectiveness of the use of
the drug in the pediatric population.
‘‘(2) CONSIDERATION OF AVAILABLE INFORMA-
TION.—In developing the list under paragraph (1),
the Secretary shall consider, for each drug on the
list—
‘‘(A) the availability of information con-
cerning the safe and effective use of the drug
in the pediatric population;
‘‘(B) whether additional information is
needed;
‘‘(C) whether new pediatric studies con-
cerning the drug may produce health benefits in
the pediatric population; and
‘‘(D) whether reformulation of the drug is
necessary;
‘‘(b) CONTRACTS
FOR PEDIATRIC STUDIES.—The
Secretary shall award contracts to entities that have the
expertise to conduct pediatric clinical trials (including
qualified universities, hospitals, laboratories, contract re-
search organizations, federally funded programs such as
pediatric pharmacology research units, other public or pri-
vate institutions, or individuals) to enable the entities to
conduct pediatric studies concerning one or more drugs
identified in the list described in subsection (a).
‘‘(c) PROCESS
FOR
CONTRACTS
AND
LABELING
CHANGES.—
‘‘(1) WRITTEN REQUEST TO HOLDERS OF AP-
PROVED APPLICATIONS FOR DRUGS LACKING EXCLU-
SIVITY.—
‘‘(A) IN GENERAL.—The Commissioner of
Food and Drugs, in consultation with the Di-
rector of National Institutes of Health, may
issue a written request (which shall include a
timeframe for negotiations for an agreement)
for pediatric studies concerning a drug identi-
fied in the list described in subsection (a) to all
holders of an approved application for the drug
under section 505 of the Federal Food, Drug,
and Cosmetic Act. Such a written request shall
be made in a manner equivalent to the manner
in which a written request is made under sub-
section (a) or (b) of section 505A of the Fed-
eral Food, Drug, and Cosmetic Act, including
with respect to information provided on the pe-
diatric studies to be conducted pursuant to the
request.
‘‘(B) PUBLICATION OF REQUEST.—If the
Commissioner of Food and Drugs does not re-
ceive a response to a written request issued
under subparagraph (A) within 30 days of the
date on which a request was issued, the Sec-
retary, acting through the Director of National
Institutes of Health and in consultation with
the Commissioner of Food and Drugs, shall
publish a request for contract proposals to con-
duct the pediatric studies described in the writ-
ten request.
‘‘(C) DISQUALIFICATION.—A holder that
receives a first right of refusal shall not be enti-
tled to respond to a request for contract pro-
posals under subparagraph (B).
‘‘(D) GUIDANCE.—Not later than 270 days
after the date of enactment of this section, the
Commissioner of Food and Drugs shall promul-
gate guidance to establish the process for the
submission of responses to written requests
under subparagraph (A).
‘‘(2) CONTRACTS.—A contract under this sec-
tion may be awarded only if a proposal for the con-
tract is submitted to the Secretary in such form and
manner, and containing such agreements, assur-
ances, and information as the Secretary determines
to be necessary to carry out this section.
‘‘(3) REPORTING OF STUDIES.—
‘‘(A) Upon completion of a pediatric study
in accordance with a contract awarded under
this section, a report concerning the study shall
be submitted to the Director of National Insti-
tutes of Health and the Commissioner of Food
and Drugs. The report shall include all data
generated in connection with the study.
‘‘(B) AVAILABILITY
OF
REPORTS.—Each
report submitted under subparagraph (A) shall
be considered to be in the public domain, and
shall be assigned a docket number by the Com-
missioner of Food and Drugs. An interested
person may submit written comments con-
cerning such pediatric studies to the Commis-
sioner of Food and Drugs, and the written com-
ments shall become part of the docket file with
respect to each of the drugs.
‘‘(C) ACTION
BY
COMMISSIONER.—The
Commissioner of Food and Drugs shall take ap-
propriate action in response to the reports sub-
mitted under subparagraph (A) in accordance
with paragraph (4).
‘‘(4) REQUEST FOR LABELING CHANGES.—Dur-
ing the 180-day period after the date on which a re-
port is submitted under paragraph (3)(A), the Com-
missioner of Food and Drugs shall—
‘‘(A) review the report and such other data
as are available concerning the safe and effec-
tive use in the pediatric population of the drug
studied; and
‘‘(B) negotiate with the holders of ap-
proved applications for the drug studied for any
labeling changes that the Commissioner of Food
and Drugs determines to be appropriate and re-
quests the holders to make; and
‘‘(C)(i) place in the public docket file a
copy of the report and of any requested labeling
changes; and
spect to a drug, the Commissioner of Food and
Drugs shall consider the recommendation and, if ap-
propriate, make a request to the holders of approved
applications for the drug to make any labeling
change that the Commissioner of Food and Drugs
determines to be appropriate.
‘‘(7) FAILURE TO AGREE.—If a holder of an
approved application for a drug, within 30 days
after receiving a request to make a labeling change
under paragraph (6), does not agree to make a re-
quested labeling change, the Commissioner may
deem the drug to be misbranded under the Federal
Food, Drug, and Cosmetic Act.
‘‘(8) RECOMMENDATION
FOR
FORMULATION
CHANGES.—If a pediatric study completed under
public contract indicates that a formulation change
is necessary and the Secretary agrees, the Secretary
shall send a nonbinding letter of recommendation re-
garding that change to each holder of an approved
application.
‘‘(d) CONFIDENTIAL
COMMERCIAL
INFORMATION;
TRADE SECRETS.—Nothing in this section requires or au-
thorizes the use or disclosure of confidential commercial
information or trade secrets.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—
‘‘(1) IN
GENERAL.—For the purpose of car-
rying out this section, there are authorized to be ap-
propriated $200,000,000 for fiscal year 2002, and
such sums as may be necessary for each of the fiscal
years 2003 through 2007.
‘‘(2) AVAILABILITY.—Any amount appropriated
under paragraph (1) shall remain available to carry
out this section until expended.’’.
SEC. 4. WRITTEN REQUEST TO HOLDERS OF APPROVED AP-
PLICATIONS FOR DRUGS THAT HAVE MAR-
KET EXCLUSIVITY.
Section 505A of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355a) is amended in subsection (c)
(as redesignated by section 2(a)(2) of this Act) by adding
at the end the following:
‘‘(4) WRITTEN REQUEST TO HOLDERS OF AP-
PROVED
APPLICATIONS
FOR
DRUGS
THAT
HAVE
MARKET EXCLUSIVITY.—
‘‘(A) REQUEST
AND
RESPONSE.—If the
Secretary makes a written request for pediatric
studies under subsection (b) to the holder of an
application approved under section 505(b)(1),
the holder, not later than 180 days after receiv-
ing the written request, shall respond to the
Secretary as to the intention of the holder to
act on the request by—
‘‘(i) indicating when the pediatric
studies will be initiated, if the holder
agrees to the request; or
‘‘(ii) indicating that the holder does
not agree to the request.
‘‘(B) NO AGREEMENT TO REQUEST.—
‘‘(i) REFERRAL.—If the holder does
not agree to a written request within the
time period specified in subparagraph (A),
and if the Secretary determines that there
is a continuing need for information relat-
ing to the use of the drug in the pediatric
population (including neonates as appro-
priate), the Secretary shall refer the drug
to the Foundation for Pediatric Research
established under section 499A of the Pub-
lic Health Service Act (referred to in this
paragraph as the ‘Foundation’) for consid-
eration for the conduct of the pediatric
studies described in the written request.
‘‘(ii) PUBLIC NOTICE.—The Secretary
shall give public notice of a referral under
clause (i), including notice of the name of
the drug, the name of the manufacturer,
and the indication to be studied.
‘‘(C) LACK OF FUNDS.—If, on referral of
a drug under subparagraph (B)(i), the Founda-
tion certifies to the Secretary that the Founda-
tion does not have funds available to conduct
the requested studies, the Secretary shall refer
the drug for inclusion on the list established
under section 409I of the Public Health Service
Act for the conduct of the studies.
‘‘(D) CONFIDENTIAL COMMERCIAL INFOR-
MATION; TRADE
SECRETS.—Nothing in this
paragraph requires or authorizes the use or dis-
closure of confidential commercial information
or trade secrets.
‘‘(E) NO
REQUIREMENT
TO
REFER.—
Nothing in this subsection shall be construed to
require that every declined written request shall
be referred to the Foundation.’’.
SEC. 5. TIMELY LABELING CHANGES FOR DRUGS GRANTED
EXCLUSIVITY; DRUG FEES.
(a) ELIMINATION OF USER FEE WAIVER FOR PEDI-
ATRIC SUPPLEMENTS.—Section 736(a)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)(1)) is
amended—
(1) by striking subparagraph (F); and
(2) by redesignating subparagraph (G) as sub-
paragraph (F).
(b) LABELING CHANGES.—
(1) DEFINITION OF PRIORITY SUPPLEMENT.—
Section 201 of the Federal Food Drug, and Cos-
metic Act (21 U.S.C. 321) is amended by adding at
the end the following:
‘‘(kk) PRIORITY SUPPLEMENT.—The term ‘priority
supplement’ means a drug application referred to in sec-
tion 101(4) of the Food and Drug Administration Mod-
ernization Act of 1997 (111 Stat. 2298).’’.
(2) 
TREATMENT
AS
PRIORITY
SUPPLE-
MENTS.—Section 505A of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355a), as amended by
section 2(a)(2) of this Act, is amended by adding at
the end the following:
‘‘(k) LABELING SUPPLEMENTS.—
‘‘(1) PRIORITY
STATUS
FOR
PEDIATRIC
SUP-
PLEMENTS.—Any supplement to an application
under section 505 proposing a labeling change pur-
suant to a report on a pediatric study under this
section—
‘‘(A) shall be considered to be a priority
supplement; and
‘‘(B) shall be subject to the performance
goals established by the Commissioner for pri-
ority drugs.
‘‘(2) DISPUTE RESOLUTION.—If the Commis-
sioner determines that an application with respect to
which a pediatric study is conducted under this sec-
tion is approvable and that the only open issue for
final action on the application is the reaching of an
agreement between the sponsor of the application
and the Commissioner on appropriate changes to the
labeling for the drug that is the subject of the
application—
‘‘(A) not later than 180 days after the date
of submission of the application—
‘‘(i) the Commissioner shall request
that the sponsor of the application make
any labeling change that the Commissioner
determines to be appropriate; and
‘‘(ii) if the sponsor of the application
does not agree to make a labeling change
requested by the Commissioner by that
date, the Commissioner shall immediately
refer the matter to the Pediatric Advisory
Subcommittee of the Anti-Infective Drugs
Advisory Committee;
‘‘(B) not later than 90 days after receiving
the referral, the Pediatric Advisory Sub-
committee of the Anti-Infective Drugs Advisory
Committee shall—
‘‘(i) review the pediatric study reports;
and
‘‘(ii) make a recommendation to the
Commissioner concerning appropriate la-
beling changes, if any;
‘‘(C) the Commissioner shall consider the
recommendations of the Pediatric Advisory
Subcommittee of the Anti-Infective Drugs Advi-
sory Committee and, if appropriate, not later
than 30 days after receiving the recommenda-
tion, make a request to the sponsor of the ap-
plication to make any labeling change that the
Commissioner determines to be appropriate;
and
‘‘(D) if the sponsor of the application,
within 30 days after receiving a request under
subparagraph (C), does not agree to make a la-
beling change requested by the Commissioner,
the Commissioner may deem the drug that is
the subject of the application to be mis-
branded.’’.
SEC. 6. OFFICE OF PEDIATRIC THERAPEUTICS.
(a) ESTABLISHMENT.—The Secretary of Health and
Human Services shall establish an Office of Pediatric
Therapeutics within the Office of the Commissioner of
Food and Drugs.
(b) DUTIES.—The Office of Pediatric Therapeutics
shall be responsible for oversight and coordination of all
activities of the Food and Drug Administration that may
have any effect on a pediatric population or the practice
of pediatrics or may in any other way involve pediatric
issues.
(c) STAFF.—The staff of the Office of Pediatric
Therapeutics shall include—
(1) employees of the Department of Health and
Human Services who, as of the date of enactment of
this Act, exercise responsibilities relating to pediatric
therapeutics;
(2) 1 or more additional individuals with exper-
tise concerning ethical issues presented by the con-
duct of clinical research in the pediatric population;
and
(3) 1 or more additional individuals with exper-
tise in pediatrics who shall consult and collaborate
with all components of the Food and Drug Adminis-
tration concerning activities described in subsection
(b).
SEC. 7. NEONATES.
Section 505A of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355a) is amended in subsection (f)
(as redesignated by section 2(a)(2) of this Act) by insert-
ing ‘‘(including neonates in appropriate cases)’’ after ‘‘pe-
diatric age groups’’.
SEC. 8. SUNSET.
Section 505A of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355a) is amended by striking sub-
section (i) (as redesignated by section 2(a)(2) of this Act)
and inserting the following:
‘‘(i) SUNSET.—A drug may not receive any 6-month
period under subsection (a) or (b) unless—
‘‘(1) on or before October 1, 2007, the Sec-
retary makes a written request for pediatric studies
of the drug;
‘‘(2) on or before October 1, 2007, an approv-
able application for the drug is submitted under sec-
tion 505(b)(1); and
‘‘(3) all requirements of this section are met.’’.
SEC. 9. DISSEMINATION OF PEDIATRIC INFORMATION.
Section 505A of the Federal Food, Drug, and Cos-
metic Act, as amended by section 5(b)(2) of this Act, is
amended by adding at the end the following:
‘‘(l) DISSEMINATION OF PEDIATRIC INFORMATION.—
‘‘(1) IN GENERAL.—Not later than 180 days
after the date of submission of a report on a pedi-
atric study under this section, the Commissioner
shall make available to the public a summary of the
medical and clinical pharmacology reviews of pedi-
atric studies conducted for the supplement, including
by publication in the Federal Register.
‘‘(2) EFFECT OF SUBSECTION.—Nothing in this
subsection alters or amends in any way section 552
of title 5 or section 1905 of title 18, United States
Code.’’.
SEC. 10. CLARIFICATION OF INTERACTION OF MARKET EX-
CLUSIVITY UNDER SECTION 505A OF THE
FEDERAL FOOD, DRUG, AND COSMETIC ACT
AND MARKET EXCLUSIVITY AWARDED TO AN
APPLICANT FOR APPROVAL OF A DRUG
UNDER SECTION 505(j) OF THAT ACT.
Section 505A of the Federal Food, Drug, and Cos-
metic Act, as amended by section 9 of this Act, is amended
by adding at the end the following:
‘‘(m) CLARIFICATION OF INTERACTION OF MARKET
EXCLUSIVITY UNDER THIS SECTION AND MARKET EX-
CLUSIVITY AWARDED TO AN APPLICANT FOR APPROVAL
OF A DRUG UNDER SECTION 505(j).—
‘‘(1) IN GENERAL.—If a 180-day period under
section 505(j)(5)(B)(iv) overlaps with a 6-month ex-
tension under this section, so that the applicant for
approval of a drug under section 505(j) entitled to
the 180-day period under that section loses a portion
of the 180-day period to which the applicant is enti-
tled for the drug, the 180-day period shall be
extended—
‘‘(A) if the 180-day period would, but for
this subsection, expire after the 6-month exten-
sion, by the number of days of the overlap; or
‘‘(B) if the 180-day period would, but for
this subsection, expire during the 6-month ex-
tension, by 6 months.
‘‘(2) EFFECT OF SUBSECTION.—Under no cir-
cumstances shall application of this section result in
an applicant for approval of a drug under section
505(j) being enabled to commercially market the
drug to the exclusion of a subsequent applicant for
approval of a drug under section 505(j) for more
than 180 days.’’.
SEC. 11. PROMPT APPROVAL OF GENERIC DRUGS WHEN
PEDIATRIC INFORMATION ADDED TO LABEL-
ING.
(a) IN GENERAL.—Section 505A of the Federal
Food, Drug, and Cosmetic Act, as amended by section 10
of this Act, is amended by adding at the end the following
subsection:
‘‘(n) PROMPT APPROVAL OF GENERIC DRUGS WHEN
PEDIATRIC INFORMATION ADDED TO LABELING.—
‘‘(1) IN GENERAL.—A drug for which an appli-
cation has been submitted or approved under section
505(j) and which otherwise meets all other applica-
ble requirements under that section shall be consid-
ered eligible for approval and shall not be considered
misbranded under section 502 even when its labeling
omits a pediatric indication or other aspect of label-
ing pertaining to pediatric use that is protected by
patent or by market exclusivity pursuant to clause
(iii) or (iv) of section 505(j)(5)(D).
‘‘(2) LABELING OF GENERIC DRUG.—Notwith-
standing the provisions of clause (iii) or (iv) of sec-
tion 505(j)(5)(D), the Secretary may require that
the labeling of a drug approved under section 505(j)
that omits pediatric labeling pursuant to paragraph
(1) include—
‘‘(A) a statement that the drug is not la-
beled for the protected pediatric use; and
‘‘(B) any warnings against unsafe pediatric
use that the Secretary considers necessary.
‘‘(3) RULE OF CONSTRUCTION.—Paragraphs 1
and 2 of this subsection do not affect—
‘‘(A) the availability or scope of exclusivity
under this section;
‘‘(B) the availability or scope of exclusivity
under section 505 for pediatric formulations; or
‘‘(C) except as expressly provided in para-
graph (1) and (2), the operation of section
505.’’.
(b) EFFECTIVE DATE.—The amendments made by
subsection (a) take effect on the date of the enactment
of this Act, including with respect to applications under
section 505(j) of the Federal Food, Drug, and Cosmetic
Act that are approved or pending on that date.
SEC. 12. ADVERSE-EVENT REPORTING.
(a) TOLL-FREE NUMBER IN LABELING.—Not later
than one year after the date of the enactment of this Act,
the Secretary of Health and Human Services shall promul-
gate a final rule requiring that the labeling of each drug
for which an application is approved under section 505
of the Federal Food, Drug, and Cosmetic Act (regardless
of the date on which approved) include the toll-free num-
ber maintained by the Secretary for the purpose of receiv-
ing reports of adverse events regarding drugs. With re-
spect to the final rule:
(1) The rule shall provide for the implementa-
tion of such labeling requirement in a manner that
the Secretary considers to be most likely to reach
the broadest consumer audience.
(2) In promulgating the rule, the Secretary
shall seek to minimize the cost of the rule on the
pharmacy profession.
(3) The rule shall take effect not later than 60
days after the date on which the rule is promul-
gated.
(b) DRUGS
WITH
PEDIATRIC
MARKET
EXCLU-
SIVITY.—
(1) IN GENERAL.—During the one-year begin-
ning on the date on which a drug receives a period
of market exclusivity under 505A of the Federal
Food, Drug, and Cosmetic Act, any report of an ad-
verse event regarding the drug that the Secretary of
Health and Human Services receives shall be re-
ferred to the Office of Pediatric Therapeutics estab-
lished under section 6 of this Act. In considering the
report, the Director of such Office shall provide for
the review of the report by the Pediatric Advisory
Subcommittee of the Anti-Infective Drugs Advisory
Committee, including obtaining any recommenda-
tions of such Subcommittee regarding whether the
Secretary should take action under the Federal
Food, Drug, and Cosmetic Act in response to the re-
port.
(2) RULE OF CONSTRUCTION.—Paragraph (1)
may not be construed as restricting the authority of
the Secretary of Health and Human Services to con-
tinue carrying out the activities described in such
paragraph regarding a drug after the one-year pe-
riod described in such paragraph regarding the drug
has expired.
SEC. 13. FOUNDATION FOR PEDIATRIC RESEARCH.
Title IV of the Public Health Service Act (42 U.S.C.
281 et seq.) is amended by adding at the end the following
part:
‘‘PART J—FOUNDATION FOR PEDIATRIC
RESEARCH
‘‘SEC. 499A. ESTABLISHMENT AND DUTIES OF FOUNDATION.
‘‘(a) IN GENERAL.—The Secretary, acting through
the Director of NIH and in consultation with the Commis-
sioner of Food and Drugs, shall establish a nonprofit cor-
poration to be known as the Foundation for Pediatric Re-
search (hereafter in this section referred to as the ‘Foun-
dation’). The Foundation shall not be an agency or instru-
mentality of the United States Government.
‘‘(b) PURPOSE OF FOUNDATION.—The purpose of
the Foundation shall be to collect funds and award grants
for research on drugs listed by the Secretary pursuant to
section 409I(a)(1)(A).
‘‘(c) CERTAIN ACTIVITIES OF FOUNDATION.—
‘‘(1) IN GENERAL.—In carrying out subsection
(b), the Foundation may solicit and accept gifts,
grants, and other donations, establish accounts, and
invest and expend funds in support of a program to
encourage donations for the conduct of studies of
drugs referred to in subsection (b).
‘‘(2) FEES.—The Foundation may assess fees
for the provision of professional, administrative and
management services by the Foundation in amounts
determined reasonable and appropriate by the Exec-
utive Director.
‘‘(3) AUTHORITY OF FOUNDATION.—The Foun-
dation shall be the sole entity responsible for car-
rying out the activities described in this subsection.
‘‘(d) BOARD OF DIRECTORS.—
‘‘(1) COMPOSITION.—
‘‘(A) The Foundation shall have a Board
of Directors (hereafter referred to in this sec-
tion as the ‘Board’), which shall be composed of
ex officio and appointed members in accordance
with this subsection. Appointed members of the
Board shall be the voting members.
‘‘(B) The ex officio members of the Board
shall be—
‘‘(i) the Chairman and ranking minor-
ity member of the Subcommittee on Health
(Committee on Energy and Commerce) or
their designees, in the case of the House of
Representatives;
‘‘(ii) the Chairman and ranking mi-
nority member of the Committee on
Health, Education, Labor and Pensions or
their designees, in the case of the Senate;
‘‘(iii) the Director of NIH; and
‘‘(iv) the Commissioner of Food and
Drugs.
‘‘(C) The ex officio members of the Board
under subparagraph (B) shall appoint to the
Board 11 individuals from among a list of can-
didates to be provided by the National Academy
of Science. Of such appointed members—
‘‘(i) 5 shall be representative of the
experts in pediatric medicine and research
field;
‘‘(ii) 1 shall be a biomedical ethicist;
and
‘‘(iii) 5 shall be representatives of the
general public, which may include rep-
resentatives of affected industries.
‘‘(D)(i) Not later than 30 days after the
date of the enactment of the Best Pharma-
ceuticals for Children Act, the Director of NIH
shall convene a meeting of the ex officio mem-
bers of the Board to—
‘‘(I) incorporate the Foundation and
establish the general policies of the Foun-
dation for carrying out the purposes of
subsection (b), including the establishment
of the bylaws of the Foundation; and
‘‘(II) appoint the members of the
Board in accordance with subparagraph
(C).
‘‘(ii) Upon the appointment of the mem-
bers of the Board under clause (i)(II), the
terms of service of the ex officio members of the
Board as members of the Board shall termi-
nate.
‘‘(E) The agreement of not less than three-
fifths of the members of the ex officio members
of the Board shall be required for the appoint-
ment of each member to the initial Board.
‘‘(F) No employee of the National Insti-
tutes of Health shall be appointed as a member
of the Board.
‘‘(2) CHAIR.—
‘‘(A) The ex officio members of the Board
under paragraph (1)(B) shall designate an indi-
vidual to serve as the initial Chair of the Board.
‘‘(B) Upon the termination of the term of
service of the initial Chair of the Board, the ap-
pointed members of the Board shall elect a
member of the Board to serve as the Chair of
the Board.
‘‘(3) TERMS AND VACANCIES.—
‘‘(A) The term of office of each member of
the Board appointed under paragraph (1)(C)
shall be 5 years, except that the terms of offices
for the initial appointed members of the Board
shall expire as determined by the ex officio
members and the Chair.
‘‘(B) Any vacancy in the membership of
the Board shall be filled in the manner in which
the original position was made and shall not af-
fect the power of the remaining members to
execute the duties of the Board.
‘‘(C) If a member of the Board does not
serve the full term applicable under subpara-
graph (A), the individual appointed to fill the
resulting vacancy shall be appointed for the re-
mainder of the term of the predecessor of the
individual.
‘‘(D) A member of the Board may continue
to serve after the expiration of the term of the
member until a successor is appointed.
‘‘(4) COMPENSATION.—Members of the Board
may not receive compensation for service on the
Board. Such members may be reimbursed for travel,
subsistence, and other necessary expenses incurred
in carrying out the duties of the Board, as set forth
in the bylaws issued by the Board.
‘‘(5) MEETINGS AND QUORUM.—A majority of
the members of the Board shall constitute a quorum
for purposes of conducting the business of the
Board.
‘‘(6) CERTAIN BYLAWS.—
‘‘(A) In establishing bylaws under this sub-
section, the Board shall ensure that the fol-
lowing are provided for:
‘‘(i) Policies for the selection of the
officers, employees, and agents of the
Foundation.
‘‘(ii) Policies, including ethical stand-
ards, for the acceptance, solicitation, and
disposition of donations and grants to the
Foundation and for the disposition of the
assets of the Foundation. Policies with re-
spect to ethical standards shall ensure that
officers, employees and agents of the
Foundation (including members of the
Board) avoid encumbrances that would re-
sult in a conflict of interest, including a fi-
nancial conflict of interest or a divided al-
legiance. Such policies shall include re-
quirements for the provision of information
concerning any ownership or controlling in-
terest in entities related to the activities of
the Foundation by such officers, employees
and agents and their spouses and relatives.
‘‘(iii) Policies for the conduct of the
general operations of the Foundation.
‘‘(B) In establishing bylaws under this sub-
section, the Board shall ensure that such by-
laws (and activities carried out under the by-
laws) do not—
‘‘(i) reflect unfavorably upon the abil-
ity of the Foundation to carry out its re-
sponsibilities or official duties in a fair and
objective manner; or
‘‘(ii) compromise, or appear to com-
promise, the integrity of any governmental
agency or program, or any officer or em-
ployee involved in such program.
‘‘(e) INCORPORATION.—The initial members of the
Board shall serve as incorporators and shall take whatever
actions necessary to incorporate the Foundation.
‘‘(f) NONPROFIT STATUS.—The Foundation shall be
considered to be a corporation under section 501(c) of the
Internal Revenue Code of 1986, and shall be subject to
the provisions of such section.
‘‘(g) EXECUTIVE DIRECTOR.—
‘‘(1) IN GENERAL.—The Foundation shall have
an Executive Director who shall be appointed by the
Board and shall serve at the pleasure of the Board.
The Executive Director shall be responsible for the
day-to-day operations of the Foundation and shall
have such specific duties and responsibilities as the
Board shall prescribe.
‘‘(2) COMPENSATION.—The rate of compensa-
tion of the Executive Director shall be fixed by the
Board.
‘‘(h) POWERS.—In carrying out subsection (b), the
Foundation shall operate under the direction of its Board,
and may—
‘‘(1) adopt, alter, and use a corporate seal,
which shall be judicially noticed;
‘‘(2) provide for 1 or more officers, employees,
and agents, as may be necessary, define their duties,
and require surety bonds or make other provisions
against losses occasioned by acts of such persons;
‘‘(3) hire, promote, compensate, and discharge
officers and employees of the Foundation, and define
the duties of the officers and employees;
‘‘(4) with the consent of any executive depart-
ment or independent agency, use the information,
services, staff, and facilities of such in carrying out
this section;
‘‘(5) sue and be sued in its corporate name, and
complain and defend in courts of competent jurisdic-
tion;
‘‘(6) modify or consent to the modification of
any contract or agreement to which it is a party or
in which it has an interest under this part;
‘‘(7) establish a process for the selection of can-
didates for positions under subsection (c);
‘‘(8) solicit, accept, hold, administer, invest, and
spend any gift, devise, or bequest of real or personal
property made to the Foundation;
‘‘(9) enter into such other contracts, leases, co-
operative agreements, and other transactions as the
Executive Director considers appropriate to conduct
the activities of the Foundation; and
‘‘(10) exercise other powers as set forth in this
section, and such other incidental powers as are nec-
essary to carry out its powers, duties, and functions
in accordance with this part.
‘‘(i) ADMINISTRATIVE CONTROL.—No participant in
the program established under this part shall exercise any
administrative control over any Federal employee, nor
shall the Foundation attempt to influence an executive
branch agency or employee.
‘‘(j) GENERAL PROVISIONS.—
‘‘(1) FOUNDATION INTEGRITY.—The members
of the Board shall be accountable for the integrity
of the operations of the Foundation and shall ensure
such integrity through the development and enforce-
ment of criteria and procedures relating to stand-
ards of conduct (including those developed under
subsection (d)(6)(A)(ii), financial disclosure state-
ments, conflict of interest rules, recusal and waiver
rules, audits and other matter determined appro-
priate by the Board.
‘‘(2) FINANCIAL
CONFLICTS
OF
INTEREST.—
Any individual who is an officer, employee, or mem-
ber of the Board of the Foundation may not (in ac-
cordance with policies and requirements developed
under subsection (d)(6)(A)(ii) personally or substan-
tially participate in the consideration or determina-
tion by the Foundation of any matter that would di-
rectly or predictably affect any financial interest of
the individual or a relative (as such term is defined
in section 109(16) of the Ethics in Government Act
of 1978) of the individual, of any business organiza-
tion or other entity, or of which the individual is an
officer or employee, or is negotiating for employ-
ment, or in which the individual has any other finan-
cial interest.
‘‘(3) AUDITS; AVAILABILITY OF RECORDS.—The
Foundation shall—
(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).
(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.
(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