Advancing Hope Act of 2016
PL 114-229 (S.1878), enacted 09/30/2016

130 STAT. 943 
PUBLIC LAW 114–229—SEPT. 30, 2016 
Public Law 114–229 
114th Congress 
An Act 
To extend the pediatric priority review voucher program. 
Be it enacted by the Senate and House of Representatives of 
the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Advancing Hope Act of 2016’’. 
SEC. 2. REAUTHORIZATION OF PROGRAM FOR PRIORITY REVIEW TO 
ENCOURAGE TREATMENTS FOR RARE PEDIATRIC DIS-
EASES. 
(a) IN GENERAL.—Section 529 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360ff) is amended— 
(1) in subsection (a)— 
(A) in paragraph (3), by amending subparagraph (A) 
to read as follows: 
‘‘(A) The disease is a serious or life-threatening disease 
in which the serious or life-threatening manifestations pri-
marily affect individuals aged from birth to 18 years, 
including age groups often called neonates, infants, chil-
dren, and adolescents.’’; and 
(B) in paragraph (4)(F), by striking ‘‘Prescription Drug 
User Fee Amendments of 2012’’ and inserting ‘‘Advancing 
Hope Act of 2016’’; 
(2) in subsection (b)— 
(A) by striking paragraph (4) and inserting the fol-
lowing: 
‘‘(4) NOTIFICATION.— 
‘‘(A) SPONSOR OF A RARE PEDIATRIC DISEASE PRODUCT.— 
‘‘(i) IN GENERAL.—Beginning on the date that is 
90 days after the date of enactment of the Advancing 
Hope Act of 2016, the sponsor of a rare pediatric dis-
ease product application that intends to request a pri-
ority review voucher under this section shall notify 
the Secretary of such intent upon submission of the 
rare pediatric disease product application that is the 
basis of the request for a priority review voucher. 
‘‘(ii) APPLICATIONS
SUBMITTED
BUT
NOT
YET 
APPROVED.—The sponsor of a rare pediatric disease 
product application that was submitted and that has 
not been approved as of the date of enactment of the 
Advancing Hope Act of 2016 shall be considered eligible 
for a priority review voucher, if— 
‘‘(I) such sponsor has submitted such rare pedi-
atric disease product application— 
Effective date. 
Time period. 
21 USC 301 note. 
Advancing Hope 
Act of 2016. 
Sept. 30, 2016 
[S. 1878] 
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130 STAT. 944 
PUBLIC LAW 114–229—SEPT. 30, 2016 
‘‘(aa) on or after the date that is 90 days 
after the date of enactment of the Prescription 
Drug User Fee Amendments of 2012; and 
‘‘(bb) on or before the date of enactment 
of the Advancing Hope Act of 2016; and 
‘‘(II) such application otherwise meets the cri-
teria for a priority review voucher under this sec-
tion. 
‘‘(B) SPONSOR OF A DRUG APPLICATION USING A PRIORITY 
REVIEW VOUCHER.— 
‘‘(i) IN GENERAL.—The sponsor of a human drug 
application shall notify the Secretary not later than 
90 days prior to submission of the human drug applica-
tion that is the subject of a priority review voucher 
of an intent to submit the human drug application, 
including the date on which the sponsor intends to 
submit the application. Such notification shall be a 
legally binding commitment to pay the user fee to 
be assessed in accordance with this section. 
‘‘(ii) TRANSFER AFTER NOTICE.—The sponsor of a 
human drug application that provides notification of 
the intent of such sponsor to use the voucher for the 
human drug application under clause (i) may transfer 
the voucher after such notification is provided, if such 
sponsor has not yet submitted the human drug applica-
tion described in the notification.’’; and 
(B) by striking paragraph (5) and inserting the fol-
lowing: 
‘‘(5) TERMINATION OF AUTHORITY.—The Secretary may not 
award any priority review vouchers under paragraph (1) after 
December 31, 2016.’’; and 
(3) in subsection (g), by inserting before the period ‘‘, except 
that no sponsor of a rare pediatric disease product application 
may receive more than one priority review voucher issued under 
any section of this Act with respect to the drug for which 
the application is made.’’ 
(b) RULE
OF CONSTRUCTION.—Nothing in this Act, or the 
amendments made by this Act, shall be construed to affect the 
validity of a priority review voucher that was issued under section 
529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff) 
before the date of enactment of this Act. 
SEC. 3. GAO REPORT. 
(a) STUDY.—The Comptroller General of the United States shall 
conduct a study on the effectiveness of awarding priority review 
vouchers under section 529 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360ff) in providing incentives for the development 
of drugs that treat or prevent rare pediatric diseases (as defined 
in subsection (a)(3) of such section) that would not otherwise have 
been developed. In conducting such study, the Comptroller General 
shall examine the following: 
(1) The indications for which each drug for which a priority 
review voucher was awarded under such section 529 was 
approved under section 505(b)(1) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(b)(1)) or section 351(a) of 
the Public Health Service Act (42 U.S.C. 262(a)). 
Examination. 
Drugs and drug 
abuse. 
21 USC 360ff 
note. 
Deadline. 
Time period. 
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130 STAT. 945 
PUBLIC LAW 114–229—SEPT. 30, 2016 
(2) Whether the priority review voucher impacted sponsors’ 
decisions to invest in developing a drug to treat or prevent 
a rare pediatric disease. 
(3) An analysis of the drugs for which such priority review 
vouchers were used, which shall include— 
(A) the indications for which such drugs were approved 
under section 505(b)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(b)(1)) or section 351(a) of 
the Public Health Service Act (42 U.S.C. 262(a)); 
(B) whether unmet medical needs were addressed 
through the approval of such drugs, including, for each 
such drug— 
(i) if an alternative therapy was previously avail-
able to treat the indication; and 
(ii) if the drug provided a benefit or advantage 
over another available therapy; 
(C) the number of patients potentially treated by such 
drugs; 
(D) the value of the priority review voucher if trans-
ferred; and 
(E) the length of time between the date on which 
a priority review voucher was awarded and the date on 
which it was used. 
(4) With respect to the priority review voucher program 
under section 529 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360ff)— 
(A) the resources used by the Food and Drug Adminis-
tration in implementing such program, including the effect 
of such program on the Food and Drug Administration’s 
review of drugs for which a priority review voucher was 
not awarded or used; 
(B) the impact of the program on the public health 
as a result of the review and approval of drugs that received 
a priority review voucher and products that were the sub-
ject of a redeemed priority review voucher; and 
(C) alternative approaches to improving such program 
so that the program is appropriately targeted toward pro-
viding incentives for the development of clinically impor-
tant drugs that— 
(i) prevent or treat rare pediatric diseases; and 
(ii) would likely not otherwise have been developed 
to prevent or treat such diseases. 
(b) REPORT.—Not later than January 31, 2022, the Comptroller 
General of the United States shall submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the 
Analysis. 
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130 STAT. 946 
PUBLIC LAW 114–229—SEPT. 30, 2016 
LEGISLATIVE HISTORY—S. 1878: 
CONGRESSIONAL RECORD, Vol. 162 (2016): 
Sept. 22, considered and passed Senate. 
Sept. 27, considered and passed House. 
Committee on Energy and Commerce of the House of Representa-
tives a report containing the results of the study of conducted 
under subsection (a). 
Approved September 30, 2016. 
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