a request for proposals for 1 or more grants or con-
tracts to nonprofit consortia for demonstration 
projects to promote pediatric device development. 
(2) DETERMINATION
ON
GRANTS
OR
CON-
TRACTS.—Not later than 180 days after the date the 
Secretary of Health and Human Services issues a 
request for proposals under paragraph (1), the Sec-
retary shall make a determination on the grants or 
contracts under this section. 
(b) APPLICATION.—A nonprofit consortium that de-
sires to receive a grant or contract under this section shall 
submit an application to the Secretary of Health and 
Human Services at such time, in such manner, and con-
taining such information as the Secretary may require. 
(c) USE OF FUNDS.—A nonprofit consortium that re-
ceives a grant or contract under this section shall— 
(1) encourage innovation by connecting quali-
fied individuals with pediatric device ideas with po-
tential manufacturers; 
(2) mentor and manage pediatric device 
projects through the development process, including 
product identification, prototype design, device devel-
opment, and marketing; 
(3) connect innovators and physicians to exist-
ing Federal resources, including resources from the 
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Food and Drug Administration, the National Insti-
tutes of Health, the Small Business Administration, 
the Department of Energy, the Department of Edu-
cation, the National Science Foundation, the De-
partment of Veterans Affairs, the Agency for 
Healthcare Research and Quality, and the National 
Institute of Standards and Technology; 
(4) assess the scientific and medical merit of 
proposed pediatric device projects; 
(5) assess business feasibility and provide busi-
ness advice; 
(6) provide assistance with prototype develop-
ment; and 
(7) provide assistance with postmarket needs, 
including training, logistics, and reporting. 
(d) COORDINATION.— 
(1) NATIONAL INSTITUTES OF HEALTH.—Each 
consortium that receives a grant or contract under 
this section shall— 
(A) coordinate with the National Institutes 
of Health’s pediatric device contact point or of-
fice, designated under section 304; and 
(B) provide to the National Institutes of 
Health any identified pediatric device needs 
that the consortium lacks sufficient capacity to 
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address or those needs in which the consortium 
has been unable to stimulate manufacturer in-
terest. 
(2) FOOD AND DRUG ADMINISTRATION.—Each 
consortium that receives a grant or contract under 
this section shall coordinate with the Commissioner 
of Food and Drugs and device companies to facili-
tate the application for approval or clearance of de-
vices labeled for pediatric use. 
(e) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
$6,000,000 for each of fiscal years 2008 through 2012. 
SEC. 306. AMENDMENTS TO OFFICE OF PEDIATRIC THERA-
PEUTICS AND PEDIATRIC ADVISORY COM-
MITTEE. 
(a) OFFICE OF PEDIATRIC THERAPEUTICS.—Section 
6(b) of the Best Pharmaceuticals for Children Act (21 
U.S.C. 393a(b)) is amended by inserting ‘‘, including in-
creasing pediatric access to medical devices’’ after ‘‘pedi-
atric issues’’. 
(b) PEDIATRIC ADVISORY COMMITTEE.—Section 14 
of the Best Pharmaceuticals for Children Act (42 U.S.C. 
284m note) is amended— 
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(1) in subsection (a), by inserting ‘‘(including 
drugs and biological products) and medical devices’’ 
after ‘‘therapeutics’’; and 
(2) in subsection (b)— 
(A) in paragraph (1), by inserting ‘‘(in-
cluding drugs and biological products) and med-
ical devices’’ after ‘‘therapeutics’’; and 
(B) in paragraph (2)— 
(i) in subparagraph (A), by striking 
‘‘and 505B’’ and inserting ‘‘505B, 510(k), 
515, and 520(m)’’; 
(ii) by striking subparagraph (B) and 
inserting the following: 
‘‘(B) identification of research priorities re-
lated to therapeutics (including drugs and bio-
logical products) and medical devices for pedi-
atric populations and the need for additional 
diagnostics and treatments for specific pediatric 
diseases or conditions;’’; and 
(iii) in subparagraph (C), by inserting 
‘‘(including drugs and biological products) 
and medical devices’’ after ‘‘therapeutics’’. 
SEC. 307. POSTMARKET STUDIES. 
Section 522 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360l) is amended— 
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(1) in subsection (a)— 
(A) by inserting ‘‘, or as a condition to ap-
proval of an application (or a supplement to an 
application) or a product development protocol 
under section 515 or as a condition to clearance 
of a premarket notification under section 
510(k), for a pediatric population or pediatric 
subpopulation,’’ after ‘‘The Secretary may by 
order’’; and 
(B) by inserting ‘‘, or that is indicated for 
pediatric populations or subpopulations or is ex-
pected to have significant use in pediatric popu-
lations,’’ after ‘‘health consequences’’; and 
(2) in subsection (b)— 
(A) by striking ‘‘(b) SURVEILLANCE AP-
PROVAL.—Each’’ and inserting the following: 
‘‘(b) SURVEILLANCE APPROVAL.— 
‘‘(1) IN GENERAL.—Each’’; 
(B) by striking ‘‘The Secretary, in con-
sultation’’ and inserting ‘‘Except as provided in 
paragraph (2), the Secretary, in consultation’’; 
(C) by striking ‘‘Any determination’’ and 
inserting ‘‘Except as provided in paragraph (2), 
any determination’’; and 
(D) by adding at the end the following: 
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‘‘(2) LONGER
STUDIES
FOR
PEDIATRIC
DE-
VICES.—The Secretary may by order require a pro-
spective surveillance period of more than 36 months 
with respect to a device that is expected to have sig-
nificant use in pediatric populations if such period of 
more than 36 months is necessary in order to assess 
the impact of the device on growth and development, 
or the effects of growth, development, activity level, 
or other factors on the safety or efficacy of the de-
vice. 
‘‘(c) DISPUTE RESOLUTION.—A manufacturer may 
request review under section 562 of any order or condition 
requiring postmarket surveillance under this section. Dur-
ing the pendency of such review, the device subject to such 
a postmarket surveillance order or condition shall not be 
deemed misbranded under section 502(t) or otherwise in 
violation of such order or condition or a related require-
ment of this Act unless deemed necessary to protect the 
public health.’’. 
TITLE IV—PEDIATRIC 
RESEARCH EQUITY ACT OF 2007 
SEC. 401. SHORT TITLE. 
This title may be cited as the ‘‘Pediatric Research 
Equity Act of 2007’’. 
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