159 
under paragraph (9), does not agree to make a re-
quested labeling change, the Commissioner of 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 subsection 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 pre-
ceding sentence) shall preclude, delay, or serve as 
the basis to stay the other course of action. 
‘‘(d) DISSEMINATION
OF
PEDIATRIC
INFORMA-
TION.—Not later than one year after the date of the enact-
ment of the Best Pharmaceuticals 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 
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160 
‘‘(B) such sums as are necessary for each 
of the four succeeding fiscal years. 
‘‘(2) AVAILABILITY.—Any amount appropriated 
under paragraph (1) shall remain available to carry 
out this section until expended.’’. 
(c) FEES RELATING TO DRUGS.—Section 735(6) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379(6)) is amended by adding at the end the following 
new subparagraph: 
‘‘(G) Activities relating to the support of 
studies of drugs on pediatric populations under 
section 505A(n)(1).’’. 
(d) 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 sec-
tion 505A(d)(4)(C) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(a)(d)(4)(C))’’. 
(e) 
CONTINUATION
OF
OPERATION
OF
COM-
MITTEE.—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
COM-
MITTEE.—Notwithstanding section 14 of the Federal Ad-
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161 
visory Committee Act, the advisory committee shall con-
tinue to operate during the five-year period beginning on 
the date of the enactment of the Best Pharmaceuticals for 
Children Act of 2007.’’. 
(f) 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 fol-
lowing new subparagraph: 
‘‘(D) provide recommendations to the in-
ternal review committee created under section 
505A(f) of the Federal Food, Drug, and Cos-
metic Act regarding the implementation of 
amendments to sections 505A and 505B of the 
Federal Food, Drug, and Cosmetic Act with re-
spect to the treatment of pediatric cancers.’’; 
and 
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162 
(B) by adding at the end the following new 
paragraph: 
‘‘(3) CONTINUATION OF OPERATION OF SUB-
COMMITTEE.—Notwithstanding 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’’. 
(g) 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 ‘‘Administra-
tive Procedure Act’’) and any other provision of law, 
the proposed rule issued by the Commissioner of 
Food and Drugs entitled ‘‘Toll-Free Number for Re-
porting 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. 
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163 
(2) LIMITATION.—The proposed rule that takes 
effect under subsection (a), or the final rule de-
scribed under subsection (a), shall, notwithstanding 
section 17(a) of the Best Pharmaceuticals for Chil-
dren 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 re-
port complaints to the manufacturer or dis-
tributor of the drug. 
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 amend-
ed by adding at the end the following: 
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