157 
‘‘(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; 
‘‘(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 
‘‘(ii) publish in the Federal Register and 
through a posting on the website of the Food 
and Drug Administration a summary of the re-
port 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 
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158 
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 re-
ceiving 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 population, including study 
reports submitted under this section; and 
‘‘(ii) make a recommendation to the 
Commissioner of Food and Drugs as to ap-
propriate labeling changes, if any. 
‘‘(9) FDA DETERMINATION.—Not later than 30 
days after receiving a recommendation from the Pe-
diatric 
Advisory 
Committee 
under 
paragraph 
(8)(B)(ii) with respect to a drug, the Commissioner 
of Food and Drugs shall consider the recommenda-
tion and, if appropriate, make a request to the hold-
ers 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 
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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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