152 
‘‘(B) particular pediatric diseases, dis-
orders or conditions where more complete 
knowledge and testing of therapeutics, including 
drugs and biologics, may be beneficial in pedi-
atric populations; and 
‘‘(C) the adequacy of necessary infrastruc-
ture to conduct pediatric pharmacological re-
search, including research networks and trained 
pediatric investigators. 
‘‘(b) PEDIATRIC STUDIES
AND RESEARCH.—The 
Secretary, acting through the National Institutes of 
Health, shall award funds to entities that have the exper-
tise to conduct pediatric clinical trials or other research 
(including qualified universities, hospitals, laboratories, 
contract research organizations, practice groups, federally 
funded programs such as pediatric pharmacology research 
units, other public or private institutions, or individuals) 
to enable the entities to conduct the drug studies or other 
research on the issues described in subsection (a). The 
Secretary may use contracts, grants, or other appropriate 
funding mechanisms to award funds under this subsection. 
‘‘(c) PROCESS
FOR PROPOSED PEDIATRIC STUDY 
REQUESTS AND LABELING CHANGES.— 
‘‘(1) SUBMISSION
OF
PROPOSED
PEDIATRIC 
STUDY REQUEST.—The Director of the National In-
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stitutes of Health shall, as appropriate, submit pro-
posed pediatric study requests for consideration by 
the Commissioner of Food and Drugs for pediatric 
studies of a specific pediatric indication identified 
under subsection (a). Such a proposed pediatric 
study request shall be made in a manner equivalent 
to a written request made under subsection (b) or 
(c) of section 505A of the Federal Food, Drug, and 
Cosmetic Act, including with respect to the informa-
tion provided on the pediatric studies to be con-
ducted pursuant to the request. The Director of the 
National Institutes of Health may submit a pro-
posed pediatric study request for a drug for which— 
‘‘(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 mar-
ket exclusivity protection for at least one form 
of the drug under the Federal Food, Drug, and 
Cosmetic Act; and 
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154 
‘‘(C) additional studies are needed to as-
sess the safety and effectiveness of the use of 
the drug in the pediatric population. 
‘‘(2) WRITTEN REQUEST TO HOLDERS OF AP-
PROVED APPLICATIONS FOR DRUGS LACKING EXCLU-
SIVITY.—The Commissioner of Food and Drugs, in 
consultation with the Director of the National Insti-
tutes of Health, may issue a written request based 
on the proposed pediatric study request for the indi-
cation or indications submitted pursuant to para-
graph (1) (which shall include a timeframe for nego-
tiations for an agreement) for pediatric studies con-
cerning 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 subsection (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 ap-
propriate formulations for each age group for which 
the study is requested. 
‘‘(3) REQUESTS FOR PROPOSALS.—If the Com-
missioner of Food and Drugs does not receive a re-
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155 
sponse 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 con-
duct the pediatric studies described in the written 
request in accordance with subsection (b). 
‘‘(4) DISQUALIFICATION.—A holder that re-
ceives 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 
MECHANISMS.—A contract, grant, or other funding 
may be awarded under this section only if a proposal 
is submitted to the Secretary in such form and man-
ner, and containing such agreements, 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 Commis-
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sioner of Food and Drugs. The report shall in-
clude all data generated 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 (sub-
ject to section 505A(d)(4) of the Federal Food, 
Drug, and Cosmetic Act) and shall be assigned 
a docket number by the Commissioner of Food 
and Drugs. An interested person may submit 
written comments concerning 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 ap-
propriate action in response to the reports sub-
mitted under subparagraph (A) in accordance 
with paragraph (7). 
‘‘(7) REQUESTS FOR LABELING CHANGE.—Dur-
ing the 180-day period after the date on which a re-
port is submitted under paragraph (6)(A), the Com-
missioner of Food and Drugs shall— 
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