240 
(ii) only if no certification under para-
graph (2)(A)(vii)(IV) of such section 
505(j) was made before such day with re-
spect to the listed drug (as such term is 
used in such section 505(j)). 
(B) CERTAIN APPLICATIONS.—If an appli-
cation was filed under section 505(j) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)) prior to the day specified in sub-
paragraph (A)(i) and, on such day, contained a 
certification 
described 
in 
paragraph 
(2)(A)(vii)(IV), the application shall be subject 
to paragraph (5)(D)(i)(IV) of such section 
505(j) as in effect on the day before the date 
of the enactment of this Act. 
(b) INCREMENTAL REDUCTION OF EXTENDED PE-
RIOD.— 
(1) PERIOD DURATION.— 
(A) Effective on October 1, 2013, sub-
clause (IV) of section 505(j)(5)(D)(i) (21 
U.S.C. 355(j)(5)(D)(i)), as amended by sub-
section (a)(1) of this section, is amended by 
striking ‘‘45 months’’ and inserting ‘‘42 
months’’. 
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(B) Effective on October 1, 2014, sub-
clause (IV) of section 505(j)(5)(D)(i) (21 
U.S.C. 355(j)(5)(D)(i)), as amended by sub-
paragraph (A) of this paragraph, is amended by 
striking ‘‘42 months’’ and inserting ‘‘39 
months’’. 
(C) Effective on October 1, 2015, sub-
clause (IV) of section 505(j)(5)(D)(i) (21 
U.S.C. 355(j)(5)(D)(i)), as amended by sub-
paragraph (B) of this paragraph, is amended by 
striking ‘‘39 months’’ and inserting ‘‘36 
months’’. 
(D) Effective on October 1, 2016, sub-
clause (IV) of section 505(j)(5)(D)(i) (21 
U.S.C. 355(j)(5)(D)(i)), as amended by sub-
paragraph (C) of this paragraph, is amended by 
striking ‘‘36 months’’ and inserting ‘‘33 
months’’. 
(E) Effective on October 1, 2017, sub-
clause (IV) of section 505(j)(5)(D)(i) (21 
U.S.C. 355(j)(5)(D)(i)), as amended by sub-
paragraph (D) of this paragraph, is amended 
by striking ‘‘33 months’’ and inserting ‘‘30 
months’’. 
(2) APPLICABILITY.— 
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(A) The amendments made by subpara-
graphs (A), (B), (C), and (D) of paragraph (1) 
apply only with respect to an application under 
section 505(j) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)) that— 
(i) is filed and initially contains a cer-
tification 
described 
in 
paragraph 
(2)(A)(vii)(IV) during the period of one 
fiscal year beginning on the effective date 
of the respective amendment; or 
(ii) is amended to initially contain 
such a certification during such period. 
(B) The amendment made by paragraph 
(1)(E) applies only with respect to an applica-
tion under section 505(j) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)) 
that— 
(i) is filed and initially contains a cer-
tification 
described 
in 
paragraph 
(2)(A)(vii)(IV) on or after October 1, 
2017; or 
(ii) is amended to initially contain 
such a certification on or after October 1, 
2017. 
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(c) CONFORMING AMENDMENT.—Subparagraph (G) 
of section 505(q)(1) (21 U.S.C. 355(q)(1)) is amended— 
(1) in the subparagraph heading, by striking 
‘‘30-MONTH PERIOD’’ and inserting ‘‘PERIOD’’; and 
(2) by striking ‘‘the 30-month period’’ and in-
serting ‘‘the period’’. 
SEC. 863. FINAL AGENCY ACTION RELATING TO PETITIONS 
AND CIVIL ACTIONS. 
Section 505(q) (21 U.S.C. 355(q)) is amended— 
(1) in paragraph (1)(F), by striking ‘‘180 
days’’ and inserting ‘‘150 days’’; and 
(2) in paragraph (2)(A)— 
(A) in the subparagraph heading, by strik-
ing ‘‘180’’ and inserting ‘‘150’’; and 
(B) in clause (i), by striking ‘‘180-day’’ 
and inserting ‘‘150-day’’. 
SEC. 864. DEADLINE FOR DETERMINATION ON CERTAIN PE-
TITIONS. 
(a) IN GENERAL.—Section 505 (21 U.S.C. 355) is 
amended by adding at the end the following: 
‘‘(w) DEADLINE FOR DETERMINATION ON CERTAIN 
PETITIONS.—The Secretary shall issue a final, substantive 
determination on a petition submitted pursuant to sub-
section (b) of section 314.161 of title 21, Code of Federal 
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Regulations (or any successor regulations), no later than 
270 days after the date the petition is submitted.’’. 
(b) APPLICATION.—The amendment made by sub-
section (a) shall apply to any petition that is submitted 
pursuant to subsection (b) of section 314.161 of title 21, 
Code of Federal Regulations (or any successor regula-
tions), on or after the date of enactment of this Act. 
SEC. 865. RARE PEDIATRIC DISEASE PRIORITY REVIEW 
VOUCHER INCENTIVE PROGRAM. 
Subchapter B of Chapter V (21 U.S.C. 360aa et seq.) 
is amended by adding at the end the following: 
‘‘SEC. 529. PRIORITY REVIEW TO ENCOURAGE TREATMENTS 
FOR RARE PEDIATRIC DISEASES. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) PRIORITY REVIEW.—The term ‘priority re-
view’, with respect to a human drug application as 
defined in section 735(1), means review and action 
by the Secretary on such application not later than 
6 months after receipt by the Secretary of such ap-
plication, as described in the Manual of Policies and 
Procedures of the Food and Drug Administration 
and goals identified in the letters described in sec-
tion 101(b) of the Prescription Drug User Fee 
Amendments of 2012. 
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‘‘(2) PRIORITY REVIEW VOUCHER.—The term 
‘priority review voucher’ means a voucher issued by 
the Secretary to the sponsor of a rare pediatric dis-
ease product application that entitles the holder of 
such voucher to priority review of a single human 
drug application submitted under section 505(b)(1) 
or section 351(a) of the Public Health Service Act 
after the date of approval of the rare pediatric dis-
ease product application. 
‘‘(3) RARE
PEDIATRIC
DISEASE.—The term 
‘rare pediatric disease’ means a disease that meets 
each of the following criteria: 
‘‘(A) The disease primarily affects individ-
uals aged from birth to 18 years, including age 
groups often called neonates, infants, children, 
and adolescents. 
‘‘(B) The disease is a rare disease or con-
dition, within the meaning of section 526. 
‘‘(4) RARE PEDIATRIC DISEASE PRODUCT AP-
PLICATION.—The term ‘rare pediatric disease prod-
uct application’ means a human drug application, as 
defined in section 735(1), that— 
‘‘(A) is for a drug or biological product— 
‘‘(i) that is for the prevention or 
treatment of a rare pediatric disease; 
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‘‘(ii) that contains no active ingredient 
(including any ester or salt of the active 
ingredient) that has been previously ap-
proved in any other application under sec-
tion 505(b)(1), 505(b)(2), or 505(j) of this 
Act or section 351(a) or 351(k) of the 
Public Health Service Act; 
‘‘(B) is submitted under section 505(b)(1) 
of this Act or section 351(a) of the Public 
Health Service Act; 
‘‘(C) the Secretary deems eligible for pri-
ority review; 
‘‘(D) that relies on clinical data derived 
from studies examining a pediatric population 
and dosages of the drug intended for that popu-
lation; 
‘‘(E) that does not seek approval for an 
adult indication in the original rare pediatric 
disease product application; and 
‘‘(F) is approved after the date of the en-
actment of the Prescription Drug User Fee 
Amendments of 2012. 
‘‘(b) PRIORITY REVIEW VOUCHER.— 
‘‘(1) IN GENERAL.—The Secretary shall award 
a priority review voucher to the sponsor of a rare pe-
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diatric disease product application upon approval by 
the Secretary of such rare pediatric disease product 
application. 
‘‘(2) TRANSFERABILITY.— 
‘‘(A) IN GENERAL.—The sponsor of a rare 
pediatric disease product application that re-
ceives a priority review voucher under this sec-
tion may transfer (including by sale) the enti-
tlement to such voucher. There is no limit on 
the number of times a priority review voucher 
may be transferred before such voucher is used. 
‘‘(B) NOTIFICATION OF TRANSFER.—Each 
person to whom a voucher is transferred shall 
notify the Secretary of such change in owner-
ship of the voucher not later than 30 days after 
such transfer. 
‘‘(3) LIMITATION.—A sponsor of a rare pedi-
atric disease product application may not receive a 
priority review voucher under this section if the rare 
pediatric disease product application was submitted 
to the Secretary prior to the date that is 90 days 
after the date of enactment of the Prescription Drug 
User Fee Amendments of 2012. 
‘‘(4) NOTIFICATION.— 
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‘‘(A) IN
GENERAL.—The sponsor of a 
human drug application shall notify the Sec-
retary not later than 90 days prior to submis-
sion of the human drug application that is the 
subject of a priority review voucher of an intent 
to submit the human drug application, includ-
ing the date on which the sponsor intends to 
submit the application. Such notification shall 
be a legally binding commitment to pay for the 
user fee to be assessed in accordance with this 
section. 
‘‘(B) TRANSFER
AFTER
NOTICE.—The 
sponsor of a human drug application that pro-
vides notification of the intent of such sponsor 
to use the voucher for the human drug applica-
tion under subparagraph (A) may transfer the 
voucher after such notification is provided, if 
such sponsor has not yet submitted the human 
drug application described in the notification. 
‘‘(5) TERMINATION OF AUTHORITY.—The Sec-
retary may not award any priority review vouchers 
under paragraph (1) after the last day of the 1-year 
period that begins on the date that the Secretary 
awards the third rare pediatric disease priority 
voucher under this section. 
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‘‘(c) PRIORITY REVIEW USER FEE.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish a user fee program under which a sponsor of a 
human drug application that is the subject of a pri-
ority review voucher shall pay to the Secretary a fee 
determined under paragraph (2). Such fee shall be 
in addition to any fee required to be submitted by 
the sponsor under chapter VII. 
‘‘(2) FEE AMOUNT.—The amount of the pri-
ority review user fee shall be determined each fiscal 
year by the Secretary, based on the difference be-
tween— 
‘‘(A) the average cost incurred by the Food 
and Drug Administration in the review of a 
human drug application subject to priority re-
view in the previous fiscal year; and 
‘‘(B) the average cost incurred by the 
Food and Drug Administration in the review of 
a human drug application that is not subject to 
priority review in the previous fiscal year. 
‘‘(3) ANNUAL
FEE
SETTING.—The Secretary 
shall establish, before the beginning of each fiscal 
year beginning after September 30, 2012, the 
amount of the priority review user fee for that fiscal 
year. 
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‘‘(4) PAYMENT.— 
‘‘(A) IN
GENERAL.—The priority review 
user fee required by this subsection shall be due 
upon the notification by a sponsor of the intent 
of such sponsor to use the voucher, as specified 
in subsection (b)(4)(A). All other user fees as-
sociated with the human drug application shall 
be due as required by the Secretary or under 
applicable law. 
‘‘(B) COMPLETE APPLICATION.—An appli-
cation described under subparagraph (A) for 
which the sponsor requests the use of a priority 
review voucher shall be considered incomplete if 
the fee required by this subsection and all other 
applicable user fees are not paid in accordance 
with the Secretary’s procedures for paying such 
fees. 
‘‘(C) NO WAIVERS, EXEMPTIONS, REDUC-
TIONS, OR REFUNDS.—The Secretary may not 
grant a waiver, exemption, reduction, or refund 
of any fees due and payable under this section. 
‘‘(5) OFFSETTING
COLLECTIONS.—Fees col-
lected pursuant to this subsection for any fiscal 
year— 
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‘‘(A) shall be deposited and credited as off-
setting collections to the account providing ap-
propriations to the Food and Drug Administra-
tion; and 
‘‘(B) shall not be collected for any fiscal 
year except to the extent provided in advance in 
appropriation Acts. 
‘‘(d) DESIGNATION PROCESS.— 
‘‘(1) IN GENERAL.—Upon the request of the 
manufacturer or the sponsor of a new drug, the Sec-
retary may designate— 
‘‘(A) the new drug as a drug for a rare pe-
diatric disease; and 
‘‘(B) the application for the new drug as a 
rare pediatric disease product application. 
‘‘(2) REQUEST
FOR
DESIGNATION.—The re-
quest for a designation under paragraph (1), shall 
be made at the same time a request for designation 
of orphan disease status under section 526 or fast- 
track designation under section 506 is made. Re-
questing designation under this subsection is not a 
prerequisite to receiving a priority review voucher 
under this section. 
‘‘(3) DETERMINATION
BY
SECRETARY.—Not 
later than 60 days after a request is submitted 
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