H. R. 3580—65 
‘‘(A)(i) there is an approved application under section 
505(j) of the Federal Food, Drug, and Cosmetic Act; or 
‘‘(ii) there is a submitted application that could be 
approved under the criteria of such section; and 
‘‘(B) there is no patent protection or market exclusivity 
protection for at least one form of the drug under the 
Federal Food, Drug, and Cosmetic Act; and 
‘‘(C) additional studies are needed to assess the safety 
and effectiveness of the use of the drug in the pediatric 
population. 
‘‘(2) WRITTEN REQUEST TO HOLDERS OF APPROVED APPLICA-
TIONS
FOR
DRUGS
LACKING
EXCLUSIVITY.—The Commissioner 
of Food and Drugs, in consultation with the Director of the 
National Institutes of Health, may issue a written request 
based on the proposed pediatric study request for the indication 
or indications submitted pursuant to paragraph (1) (which shall 
include a timeframe for negotiations for an agreement) for 
pediatric studies concerning a drug identified under 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 (b) or (c) of section 505A of such Act, including with 
respect to information provided on the pediatric studies to 
be conducted pursuant to the request and using appropriate 
formulations for each age group for which the study is 
requested. 
‘‘(3) REQUESTS
FOR
PROPOSALS.—If the Commissioner of 
Food and Drugs does not receive a response to a written request 
issued under paragraph (2) not later than 30 days after the 
date on which a request was issued, the Secretary, acting 
through the Director of the National Institutes of Health and 
in consultation with the Commissioner of Food and Drugs, 
shall publish a request for proposals to conduct the pediatric 
studies described in the written request in accordance with 
subsection (b). 
‘‘(4) DISQUALIFICATION.—A holder that receives a first right 
of refusal shall not be entitled to respond to a request for 
proposals under paragraph (3). 
‘‘(5) CONTRACTS, GRANTS, OR
OTHER
FUNDING
MECHA-
NISMS.—A contract, grant, or other funding may be awarded 
under this section only if a proposal is submitted to the Sec-
retary in such form and manner, and containing such agree-
ments, assurances, and information as the Secretary determines 
to be necessary to carry out this section. 
‘‘(6) REPORTING OF STUDIES.— 
‘‘(A) IN GENERAL.—On completion of a pediatric study 
in accordance with an award under this section, a report 
concerning the study shall be submitted to the Director 
of the National Institutes of Health and the Commissioner 
of Food and Drugs. The report shall include all data gen-
erated in connection with the study, including a written 
request if issued. 
‘‘(B) AVAILABILITY OF REPORTS.—Each report submitted 
under subparagraph (A) shall be considered to be in the 
public domain (subject to section 505A(d)(4) of the Federal 
Food, Drug, and Cosmetic Act) and shall be assigned a
H. R. 3580—66 
docket number by the Commissioner of Food and Drugs. 
An interested person may submit written comments con-
cerning such pediatric studies to the Commissioner of Food 
and Drugs, and the written comments 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 appropriate action in response 
to the reports submitted under subparagraph (A) in accord-
ance with paragraph (7). 
‘‘(7) REQUESTS FOR LABELING CHANGE.—During the 180- 
day period after the date on which a report is submitted under 
paragraph (6)(A), the Commissioner of Food and Drugs shall— 
‘‘(A) review the report and such other data as are 
available concerning the safe and effective use in the pedi-
atric population of the drug studied; 
‘‘(B) negotiate with the holders of approved applications 
for the drug studied for any labeling changes that the 
Commissioner of Food and Drugs determines to be appro-
priate and requests 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 
‘‘(ii) publish in the Federal Register and through a 
posting on the Web site of the Food and Drug Administra-
tion a summary of the report and a copy of any requested 
labeling changes. 
‘‘(8) DISPUTE RESOLUTION.— 
‘‘(A) REFERRAL TO PEDIATRIC ADVISORY COMMITTEE.— 
If, not later than the end of the 180-day period specified 
in paragraph (7), the holder of an approved application 
for the drug involved does not agree to any labeling change 
requested by the Commissioner of Food and Drugs under 
that paragraph, the Commissioner of Food and Drugs shall 
refer the request to the Pediatric Advisory Committee. 
‘‘(B) ACTION BY THE PEDIATRIC ADVISORY COMMITTEE.— 
Not later than 90 days after receiving a referral under 
subparagraph (A), the Pediatric Advisory Committee 
shall— 
‘‘(i) review the available information on the safe 
and effective use of the drug in the pediatric popu-
lation, including study reports submitted under this 
section; and 
‘‘(ii) make a recommendation to the Commissioner 
of Food and Drugs as to appropriate labeling changes, 
if any. 
‘‘(9) FDA DETERMINATION.—Not later than 30 days after 
receiving a recommendation from the Pediatric Advisory Com-
mittee under paragraph (8)(B)(ii) with respect to a drug, the 
Commissioner of Food and Drugs shall consider the rec-
ommendation and, if appropriate, 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. 
‘‘(10) 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 (9), does not agree 
to make a requested labeling change, the Commissioner of
H. R. 3580—67 
Food and Drugs may deem the drug to be misbranded under 
the Federal Food, Drug, and Cosmetic Act. 
‘‘(11) NO
EFFECT
ON
AUTHORITY.—Nothing in this sub-
section limits the authority of the United States to bring an 
enforcement action under the Federal Food, Drug, and Cosmetic 
Act when a drug lacks appropriate pediatric labeling. Neither 
course of action (the Pediatric Advisory Committee process 
or an enforcement action referred to in the preceding sentence) 
shall preclude, delay, or serve as the basis to stay the other 
course of action. 
‘‘(d) DISSEMINATION
OF PEDIATRIC INFORMATION.—Not later 
than one year after the date of the enactment of the Best Pharma-
ceuticals for Children Act of 2007, the Secretary, acting through 
the Director of the National Institutes of Health, shall study the 
feasibility of establishing a compilation of information on pediatric 
drug use and report the findings to Congress. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(1) IN GENERAL.—There are authorized to be appropriated 
to carry out this section— 
‘‘(A) $200,000,000 for fiscal year 2008; and 
‘‘(B) such sums as are necessary for each of the four 
succeeding fiscal years. 
‘‘(2) AVAILABILITY.—Any amount appropriated under para-
graph (1) shall remain available to carry out this section until 
expended.’’. 
(c) FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH.— 
Section 499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 
290b(c)(1)(C)) is amended by striking ‘‘and studies listed by the 
Secretary pursuant to section 409I(a)(1)(A) of this Act and referred 
under section 505A(d)(4)(C) of the Federal Food, Drug and Cosmetic 
Act (21 U.S.C. 355(a)(d)(4)(C)’ ’’ and inserting ‘‘and studies for which 
the Secretary issues a certification in the affirmative under section 
505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic Act’’. 
(d) CONTINUATION OF OPERATION OF COMMITTEE.—Section 14 
of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m 
note) is amended by adding at the end the following new subsection: 
‘‘(d) CONTINUATION OF OPERATION OF COMMITTEE.—Notwith-
standing section 14 of the Federal Advisory Committee Act, the 
advisory committee shall continue to operate during the five-year 
period beginning on the date of the enactment of the Best Pharma-
ceuticals for Children Act of 2007.’’. 
(e) PEDIATRIC
SUBCOMMITTEE
OF
THE
ONCOLOGIC
DRUGS 
ADVISORY COMMITTEE.—Section 15 of the Best Pharmaceuticals 
for Children Act (42 U.S.C. 284m note) is amended— 
(1) in subsection (a)— 
(A) in paragraph (1)— 
(i) in subparagraph (B), by striking ‘‘and’’ after 
the semicolon; 
(ii) in subparagraph (C), by striking the period 
at the end and inserting ‘‘; and’’; and 
(iii) by adding at the end the following new 
subparagraph: 
‘‘(D) provide recommendations to the internal review 
committee created under section 505B(f) of the Federal 
Food, Drug, and Cosmetic Act regarding the implementa-
tion of amendments to sections 505A and 505B of the
H. R. 3580—68 
Federal Food, Drug, and Cosmetic Act with respect to 
the treatment of pediatric cancers.’’; and 
(B) by adding at the end the following new paragraph: 
‘‘(3) CONTINUATION OF OPERATION OF SUBCOMMITTEE.—Not-
withstanding section 14 of the Federal Advisory Committee 
Act, the Subcommittee shall continue to operate during the 
five-year period beginning on the date of the enactment of 
the Best Pharmaceuticals for Children Act of 2007.’’; and 
(2) in subsection (d), by striking ‘‘2003’’ and inserting 
‘‘2009’’. 
(f) EFFECTIVE DATE AND LIMITATION FOR RULE RELATING TO 
TOLL-FREE NUMBER FOR ADVERSE EVENTS ON LABELING FOR HUMAN 
DRUG PRODUCTS.— 
(1) IN GENERAL.—Notwithstanding subchapter II of chapter 
5, and chapter 7, of title 5, United States Code (commonly 
known as the ‘‘Administrative Procedure Act’’) and any other 
provision of law, the proposed rule issued by the Commissioner 
of Food and Drugs entitled ‘‘Toll-Free Number for Reporting 
Adverse Events on Labeling for Human Drug Products,’’ 69 
Fed. Reg. 21778, (April 22, 2004) shall take effect on January 
1, 2008, unless such Commissioner issues the final rule before 
such date. 
(2) LIMITATION.—The proposed rule that takes effect under 
subsection (a), or the final rule described under subsection 
(a), shall, notwithstanding section 17(a) of the Best Pharma-
ceuticals for Children Act (21 U.S.C. 355b(a)), not apply to 
a drug— 
(A) for which an application is approved under section 
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355); 
(B) that is not described under section 503(b)(1) of 
such Act (21 U.S.C. 353(b)(1)); and 
(C) the packaging of which includes a toll-free number 
through which consumers can report complaints to the 
manufacturer or distributor of the drug. 
SEC. 503. TRAINING OF PEDIATRIC PHARMACOLOGISTS. 
(a) INVESTMENT IN TOMORROW’S PEDIATRIC RESEARCHERS.—Sec-
tion 452G(2) of the Public Health Service Act (42 U.S.C. 285g– 
10(2)) is amended by adding before the period at the end the 
following: ‘‘, including pediatric pharmacological research’’. 
(b) PEDIATRIC RESEARCH LOAN REPAYMENT PROGRAM.—Section 
487F(a)(1) of the Public Health Service Act (42 U.S.C. 288–6(a)(1)) 
is amended by inserting ‘‘including pediatric pharmacological 
research,’’ after ‘‘pediatric research,’’. 
TITLE VI—REAGAN-UDALL 
FOUNDATION 
SEC. 601. THE REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG 
ADMINISTRATION. 
(a) IN GENERAL.—Chapter VII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at 
the end the following:
H. R. 3580—69 
‘‘Subchapter I—Reagan-Udall Foundation for the Food and 
Drug Administration 
‘‘SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUNDATION. 
‘‘(a) IN GENERAL.—A nonprofit corporation to be known as 
the Reagan-Udall Foundation for the Food and Drug Administration 
(referred to in this subchapter as the ‘Foundation’) shall be estab-
lished in accordance with this section. The Foundation shall be 
headed by an Executive Director, appointed by the members of 
the Board of Directors under subsection (e). The Foundation shall 
not be an agency or instrumentality of the United States Govern-
ment. 
‘‘(b) PURPOSE OF FOUNDATION.—The purpose of the Foundation 
is to advance the mission of the Food and Drug Administration 
to modernize medical, veterinary, food, food ingredient, and cosmetic 
product development, accelerate innovation, and enhance product 
safety. 
‘‘(c) DUTIES OF THE FOUNDATION.—The Foundation shall— 
‘‘(1) taking into consideration the Critical Path reports 
and priorities published by the Food and Drug Administration, 
identify unmet needs in the development, manufacture, and 
evaluation of the safety and effectiveness, including post-
approval, of devices, including diagnostics, biologics, and drugs, 
and the safety of food, food ingredients, and cosmetics, and 
including the incorporation of more sensitive and predictive 
tools and devices to measure safety; 
‘‘(2) establish goals and priorities in order to meet the 
unmet needs identified in paragraph (1); 
‘‘(3) in consultation with the Secretary, identify existing 
and proposed Federal intramural and extramural research and 
development programs relating to the goals and priorities estab-
lished under paragraph (2), coordinate Foundation activities 
with such programs, and minimize Foundation duplication of 
existing efforts; 
‘‘(4) award grants to, or enter into contracts, memoranda 
of understanding, or cooperative agreements with, scientists 
and entities, which may include the Food and Drug Administra-
tion, university consortia, public-private partnerships, institu-
tions of higher education, entities described in section 501(c)(3) 
of the Internal Revenue Code (and exempt from tax under 
section 501(a) of such Code), and industry, to efficiently and 
effectively advance the goals and priorities established under 
paragraph (2); 
‘‘(5) recruit meeting participants and hold or sponsor (in 
whole or in part) meetings as appropriate to further the goals 
and priorities established under paragraph (2); 
‘‘(6) release and publish information and data and, to the 
extent practicable, license, distribute, and release material, re-
agents, and techniques to maximize, promote, and coordinate 
the availability of such material, reagents, and techniques for 
use by the Food and Drug Administration, nonprofit organiza-
tions, and academic and industrial researchers to further the 
goals and priorities established under paragraph (2); 
‘‘(7) ensure that— 
‘‘(A) action is taken as necessary to obtain patents 
for inventions developed by the Foundation or with funds 
from the Foundation;
H. R. 3580—70 
‘‘(B) action is taken as necessary to enable the licensing 
of inventions developed by the Foundation or with funds 
from the Foundation; and 
‘‘(C) executed licenses, memoranda of understanding, 
material transfer agreements, contracts, and other such 
instruments, promote, to the maximum extent practicable, 
the broadest conversion to commercial and noncommercial 
applications of licensed and patented inventions of the 
Foundation to further the goals and priorities established 
under paragraph (2); 
‘‘(8) provide objective clinical and scientific information to 
the Food and Drug Administration and, upon request, to other 
Federal agencies to assist in agency determinations of how 
to ensure that regulatory policy accommodates scientific 
advances and meets the agency’s public health mission; 
‘‘(9) conduct annual assessments of the unmet needs identi-
fied in paragraph (1); and 
‘‘(10) carry out such other activities consistent with the 
purposes of the Foundation as the Board determines appro-
priate. 
‘‘(d) BOARD OF DIRECTORS.— 
‘‘(1) ESTABLISHMENT.— 
‘‘(A) IN GENERAL.—The Foundation shall have a Board 
of Directors (referred to in this subchapter as the ‘Board’), 
which shall be composed of ex officio and appointed mem-
bers in accordance with this subsection. All appointed mem-
bers of the Board shall be voting members. 
‘‘(B) EX
OFFICIO
MEMBERS.—The ex officio members 
of the Board shall be the following individuals or their 
designees: 
‘‘(i) The Commissioner. 
‘‘(ii) The Director of the National Institutes of 
Health. 
‘‘(iii) The Director of the Centers for Disease Con-
trol and Prevention. 
‘‘(iv) The Director of the Agency for Healthcare 
Research and Quality. 
‘‘(C) APPOINTED MEMBERS.— 
‘‘(i) IN GENERAL.—The ex officio members of the 
Board under subparagraph (B) shall, by majority vote, 
appoint to the Board 14 individuals, of which 9 shall 
be from a list of candidates to be provided by the 
National Academy of Sciences and 5 shall be from 
lists of candidates provided by patient and consumer 
advocacy groups, professional scientific and medical 
societies, and industry trade organizations. Of such 
appointed members— 
‘‘(I) 4 shall be representatives of the general 
pharmaceutical, device, food, cosmetic, and bio-
technology industries; 
‘‘(II) 3 shall be representatives of academic 
research organizations; 
‘‘(III) 2 shall be representatives of patient or 
consumer advocacy organizations; 
‘‘(IV) 1 shall be a representative of health care 
providers; and
H. R. 3580—71 
‘‘(V) 4 shall be at-large members with expertise 
or experience relevant to the purpose of the 
Foundation. 
‘‘(ii) REQUIREMENTS.— 
‘‘(I) EXPERTISE.—The ex officio members shall 
ensure the Board membership includes individuals 
with expertise in areas including the sciences of 
developing, manufacturing, and evaluating the 
safety and effectiveness of devices, including 
diagnostics, biologics, and drugs, and the safety 
of food, food ingredients, and cosmetics. 
‘‘(II) FEDERAL
EMPLOYEES.—No employee of 
the Federal Government shall be appointed as a 
member of the Board under this subparagraph 
or under paragraph (3)(B). 
‘‘(D) INITIAL MEETING.— 
‘‘(i) IN
GENERAL.—Not later than 30 days after 
the date of the enactment of this subchapter, the Sec-
retary shall convene a meeting of the ex officio mem-
bers of the Board to— 
‘‘(I) incorporate the Foundation; and 
‘‘(II) appoint the members of the Board in 
accordance with subparagraph (C). 
‘‘(ii) SERVICE OF EX OFFICIO MEMBERS.—Upon the 
appointment of the members of the Board under clause 
(i)(II)— 
‘‘(I) the terms of service of the Director of 
the Centers for Disease Control and Prevention 
and of the Director of the Agency for Healthcare 
Research and Quality as ex officio members of 
the Board shall terminate; and 
‘‘(II) the Commissioner and the Director of 
the National Institutes of Health shall continue 
to serve as ex officio members of the Board, but 
shall be nonvoting members. 
‘‘(iii) CHAIR.—The ex officio members of the Board 
under subparagraph (B) shall designate an appointed 
member of the Board to serve as the Chair of the 
Board. 
‘‘(2) DUTIES OF BOARD.—The Board shall— 
‘‘(A) establish bylaws for the Foundation that— 
‘‘(i) are published in the Federal Register and 
available for public comment; 
‘‘(ii) establish policies for the selection of the offi-
cers, employees, agents, and contractors of the Founda-
tion; 
‘‘(iii) establish policies, including ethical standards, 
for the acceptance, solicitation, and disposition of dona-
tions and grants to the Foundation and for the disposi-
tion of the assets of the Foundation, including appro-
priate limits on the ability of donors to designate, 
by stipulation or restriction, the use or recipient of 
donated funds; 
‘‘(iv) establish policies that would subject all 
employees, fellows, and trainees of the Foundation to 
the conflict of interest standards under section 208 
of title 18, United States Code;
H. R. 3580—72 
‘‘(v) establish licensing, distribution, and publica-
tion policies that support the widest and least restric-
tive use by the public of information and inventions 
developed by the Foundation or with Foundation funds 
to carry out the duties described in paragraphs (6) 
and (7) of subsection (c), and may include charging 
cost-based fees for published material produced by the 
Foundation; 
‘‘(vi) specify principles for the review of proposals 
and awarding of grants and contracts that include 
peer review and that are consistent with those of the 
Foundation for the National Institutes of Health, to 
the extent determined practicable and appropriate by 
the Board; 
‘‘(vii) specify a cap on administrative expenses for 
recipients of a grant, contract, or cooperative agree-
ment from the Foundation; 
‘‘(viii) establish policies for the execution of memo-
randa of understanding and cooperative agreements 
between the Foundation and other entities, including 
the Food and Drug Administration; 
‘‘(ix) establish policies for funding training fellow-
ships, whether at the Foundation, academic or sci-
entific institutions, or the Food and Drug Administra-
tion, for scientists, doctors, and other professionals who 
are not employees of regulated industry, to foster 
greater understanding of and expertise in new sci-
entific tools, diagnostics, manufacturing techniques, 
and potential barriers to translating basic research 
into clinical and regulatory practice; 
‘‘(x) specify a process for annual Board review of 
the operations of the Foundation; and 
‘‘(xi) establish specific duties of the Executive 
Director; 
‘‘(B) prioritize and provide overall direction to the 
activities of the Foundation; 
‘‘(C) evaluate the performance of the Executive 
Director; and 
‘‘(D) carry out any other necessary activities regarding 
the functioning of the Foundation. 
‘‘(3) TERMS AND VACANCIES.— 
‘‘(A) TERM.—The term of office of each member of the 
Board appointed under paragraph (1)(C) shall be 4 years, 
except that the terms of offices for the initial appointed 
members of the Board shall expire on a staggered basis 
as determined by the ex officio members. 
‘‘(B) VACANCY.—Any vacancy in the membership of 
the Board— 
‘‘(i) shall not affect the power of the remaining 
members to execute the duties of the Board; and 
‘‘(ii) shall be filled by appointment by the appointed 
members described in paragraph (1)(C) by majority 
vote. 
‘‘(C) PARTIAL TERM.—If a member of the Board does 
not serve the full term applicable under subparagraph (A), 
the individual appointed under subparagraph (B) to fill
H. R. 3580—73 
the resulting vacancy shall be appointed for the remainder 
of the term of the predecessor of the individual. 
‘‘(D) SERVING
PAST
TERM.—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. 
‘‘(e) INCORPORATION.—The ex officio members of the Board shall 
serve as incorporators and shall take whatever actions necessary 
to incorporate the Foundation. 
‘‘(f) NONPROFIT STATUS.—In carrying out subsection (b), the 
Board shall establish such policies and bylaws under subsection 
(d), and the Executive Director shall carry out such activities under 
subsection (g), as may be necessary to ensure that the Foundation 
maintains status as an organization that— 
‘‘(1) is described in subsection (c)(3) of section 501 of the 
Internal Revenue Code of 1986; and 
‘‘(2) is, under subsection (a) of such section, exempt from 
taxation. 
‘‘(g) EXECUTIVE DIRECTOR.— 
‘‘(1) IN GENERAL.—The Board shall appoint an Executive 
Director who shall serve at the pleasure of the Board. The 
Executive Director shall be responsible for the day-to-day oper-
ations of the Foundation and shall have such specific duties 
and responsibilities as the Board shall prescribe. 
‘‘(2) COMPENSATION.—The compensation of the Executive 
Director shall be fixed by the Board but shall not be greater 
than the compensation of the Commissioner. 
‘‘(h) ADMINISTRATIVE POWERS.—In carrying out this subchapter, 
the Board, acting through the Executive Director, may— 
‘‘(1) adopt, alter, and use a corporate seal, which shall 
be judicially noticed; 
‘‘(2) hire, promote, compensate, and discharge 1 or more 
officers, employees, and agents, as may be necessary, and define 
their duties; 
‘‘(3) prescribe the manner in which— 
‘‘(A) real or personal property of the Foundation is 
acquired, held, and transferred; 
‘‘(B) general operations of the Foundation are to be 
conducted; and 
‘‘(C) the privileges granted to the Board by law are 
exercised and enjoyed; 
‘‘(4) with the consent of the applicable executive department 
or independent agency, use the information, services, and facili-
ties of such department or agencies in carrying out this section; 
‘‘(5) enter into contracts with public and private organiza-
tions for the writing, editing, printing, and publishing of books 
and other material; 
‘‘(6) hold, administer, invest, and spend any gift, devise, 
or bequest of real or personal property made to the Foundation 
under subsection (i); 
‘‘(7) enter into such other contracts, leases, cooperative 
agreements, and other transactions as the Board considers 
appropriate to conduct the activities of the Foundation;