(D) in paragraph (4), by striking ‘‘in para-
graph (2)’’ in both places it appears and insert-
ing ‘‘in subparagraphs (2)(A) or (2)(B)’’. 
(3) CONFORMING AMENDMENTS.— 
(A) TITLE
28.—Section 2201(b) of title 
28, United States Code, is amended by insert-
ing before the period the following: ‘‘, or section 
351 of the Public Health Service Act’’. 
(B) PUBLIC HEALTH SERVICE ACT.—Sub-
jection (j) of section 351 of the Public Health 
Service Act (42 U.S.C. 262) is amended by in-
serting ‘‘or subsection (k)’’ after ‘‘subsection 
(a)’’. 
(c) REVIEW OF APPLICATIONS SUBMITTED DURING 
EXCLUSIVITY PERIODS.— 
(1) USER FEE GOALS.— 
(A) REVISION.—Within 180 days after the 
date of the enactment of this Act, the Secretary 
of Health and Human Services, in consultation 
with the relevant stakeholders, shall revise the 
PDUFA reauthorization performance goals and 
procedures with respect to the user fee goals for 
abbreviated 
biological 
product 
applications 
under section 351(k) of the Public Health Serv-
ice Act, as added by subsection (a) of this sec-
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tion, that are submitted more than 2 years in 
advance of the expiration of any period of exclu-
sive marketing to which the reference drug is 
entitled under subsection (k)(10) or subsection 
(l) of section 351 of the Public Health Service 
Act, as added by subsection (a) of this section 
and section 4 respectively. 
(B) CONSIDERATIONS.—In revising the 
user fee goals for applications described in sub-
paragraph (A), the Secretary shall consider— 
(i) the need to provide sufficient time 
so that a decision on whether to approve 
the application can be made in advance of 
the expiration of any exclusivity, and con-
sidering the possibility that amendments 
will be necessary after the initial decision 
and prior to approval; and 
(ii) the importance of conserving 
agency resources. 
(2) REVIEW PRIORITIES.—In setting priorities 
with respect to the review of applications described 
in paragraph (1)(A), the Secretary shall take into 
account the number of years in advance of the expi-
ration of any exclusivity granted to the reference 
drug that an application was submitted. 
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(3) SUBMISSION
OF
REVISED
PERFORMANCE 
GOALS TO CONGRESS.—The Secretary shall, within 
30 days after revising the PDUFA reauthorization 
performance goals and procedures under this sub-
section, submit to the Committee on Energy and 
Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate a letter describing the revised 
goals and the basis for such revisions. 
(4) DEFINITIONS.—In this subsection: 
(A) The terms ‘‘abbreviated biological 
product application’’ and ‘‘reference product’’ 
have the meanings given to those terms in sec-
tion 351(i) of the Public Health Service Act, as 
amended by section 2(a). 
(B) The term ‘‘PDUFA reauthorization 
performance goals and procedures’’ means the 
performance goals and procedures of the Food 
and Drug Administration, agreed to for pur-
poses of the reauthorization of part 2 of sub-
chapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 279g et 
seq.; relating to the prescription drug user fee 
program) for fiscal year 2008 and succeeding 
fiscal years. 
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SEC. 4. PEDIATRIC STUDIES OF BIOLOGICAL PRODUCTS. 
Section 351 of the Public Health Service Act (42 
U.S.C. 262), as amended by section 3, is further amended 
by adding at the end the following: 
‘‘(l) PEDIATRIC STUDIES.— 
‘‘(1) APPLICATION OF CERTAIN PROVISIONS.— 
The provisions of section 505A of the Federal Food, 
Drug, and Cosmetic Act shall, except as inconsistent 
with this section, apply to biological products ap-
proved under subsection (a) or (k) of this section to 
the same extent and in the same manner as such 
provisions apply to drugs approved under subsection 
(c) or (j), respectively, of section 505 of the Federal 
Food, Drug, and Cosmetic Act. 
‘‘(2) MARKET EXCLUSIVELY FOR NEW BIOLOGI-
CAL PRODUCTS.—If, prior to approval of an applica-
tion that is submitted under subsection (a) of this 
section, the Secretary determines that information 
relating to the use of a new biological product in the 
pediatric population may produce health benefits in 
that population, the Secretary makes a written re-
quest for pediatric studies (which shall include a 
timeframe for completing such studies), the appli-
cant agrees to the request, such studies are com-
pleted using appropriate formulations for each age 
group for which the study is requested within any 
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such timeframe, and the reports thereof are sub-
mitted and accepted in accordance with section 
505A(d)(3) of the Federal Food, Drug, and Cos-
metic Act— 
‘‘(A) the period for such biological product 
referred to in subparagraph (A) of subsection 
(k)(10), including any extension under subpara-
graph (D) of such subsection, is extended by 6 
months; and 
‘‘(B) if the biological product is designated 
under section 526 for a rare disease or condi-
tion, the period for such biological product re-
ferred to in section 527(a) is deemed to be 7 
years and 6 months rather than 7 years. 
‘‘(3) MARKET EXCLUSIVITY FOR ALREADY-MAR-
KETED
BIOLOGICAL
PRODUCTS.—If the Secretary 
determines that information relating to the use of a 
licensed biological product in the pediatric popu-
lation may produce health benefits in that popu-
lation and makes a written request to the holder of 
an approved application under subsection (a) of this 
section for pediatric studies (which shall include a 
timeframe for completing such studies), the holder 
agrees to the request, such studies are completed 
using appropriate formulations for each age group 
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for which the study is requested within any such 
timeframe, and the reports thereof are submitted 
and accepted in accordance with section 505A(d)(3) 
of the Federal Food, Drug, and Cosmetic Act— 
‘‘(A) the period for such biological product 
referred to in subparagraph (A) of subsection 
(k)(10), including any extension under subpara-
graph (D) of such subsection, is extended by 6 
months; and 
‘‘(B) if the biological product is designated 
under section 526 for a rare disease or condi-
tion, the period for such biological product re-
ferred to in section 527(a) is deemed to be 7 
years and 6 months rather than 7 years. 
‘‘(4) EXCEPTION.—The Secretary shall not ex-
tend the period referred to in paragraph (2)(A), 
(2)(B), (3)(A), or (3)(B) if the determination under 
section 505A(d)(3) is made later than 9 months 
prior to the expiration of such period.’’. 
Æ 
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