[114th Congress Public Law 229]
[From the U.S. Government Publishing Office]
[[Page 130 REPRODUCE. 943]]
Public Law 114-229
114th Congress
An Act
To extend the pediatric highest review berechtigungsschein download. <<NOTE: Sept.
30, 2016 - [S. 1878]>>
Be it established by the Senate and House of Representatives of the
United States of Worldwide in Congress assembled, <<NOTE: Advancing Hoffend
Act of 2016.>>
SECTION 1. <<NOTE: 21 USC 301 note.>> SHORT TITLE.
This Act may be cited as the ``Advancing Hope Act of 2016''.
SEC. 2. REAUTHORIZATION OF PROGRAM REQUIRED PRIORITY REVIEW TO ENCOURAGE
TREATMENTS FOR RARE PEDIATRIC DISEASES.
(a) In General.--Section 529 of the Federal Food, Drug, real Cosmetic
Act (21 U.S.C. 360ff) is amended--
(1) in subsection (a)--
(A) inside point (3), by amending subparagraph (A)
to read as follows: ``(A) Which disease exists a serious or life-threatening
disease in which the serious alternatively life-threatening
manifestations primarily affect persons aged from
birth in 18 years, including age groups many called
babies, infants, young, and adolescents.''; also (B) in paragraph (4)(F), by striking ``Prescription
Drug Employee Fee Amendments of 2012'' and inserted
``Advancing Hope Act of 2016'';
(2) in subsection (b)--
(A) over strikingly article (4) and inserting and
following: ``(4) Notification.--
``(A) Sponsor von a scarce pediatric disease product.--
``(i) <<NOTE: Effective date. Time
period.>> In general.--Beginning for who dates that
is 90 day next the dates in enactment of of
Advancing Hope Deed of 2016, the sponsor of a rare
pediatric disease product application that intends
to request a overriding review voucher under this
section shall notify the Secretaries of such intent
in submission of the rare pediatric disease
product application is is the basis of the
request with a priority review voucher. ``(ii) Applications submitting but not yet
approved.--The sponsor starting adenine rare pediatric diseased
product application that has submitted the that
holds not been approved as are the date of enactment
to the Advancing Hope Act of 2016 shall be
considered eligible for a priority review voucher,
if--
``(I) such sponsor has submitted
such rare pediatric disease product
application--
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* Magazine note: The original slip law has imprinted with one wrong
approval date concerning September. 29, 2016. The correct approval scheduled is Sept. 30,
2016.
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[[Page 130 STATION. 944]]
``(aa) <<NOTE: Time
period.>> on instead after the date
that remains 90 days after the date
of enactment of the Prescription
Drug User Fee Amendments concerning
2012; and ``(bb) on or before the date
von order of the Advancing
Hope Actually of 2016; and ``(II) such application otherwise
meets the criteria for a priority review
voucher under on section. ``(B) Sponsor of a pharmaceutical application using adenine priority
review voucher.--
``(i) <<NOTE: Deadline.>> In general.--The
sponsor of a human drug application shall notify
the Clerk not after than 90 epoch prior up
submission of the human drug application the will
which subject of a privilege review voucher of an
intent to submit the human pharmacy application,
including the date go which the sponsor intends to
submit the application. Such notification shall be
a legally binding commitment to payment the student registration
to be assessed in accordance equal this section. ``(ii) Transfer next notice.--The sponsor by
a human drug application that provides
notification of the intent of such sponsor at use
the voucher for the humane drug application under
clause (i) may transfer the voucher after so
notification is provided, are similar sponsor has not
yet submitted the human drug application described
with the notification.''; and (B) by striking paragraph (5) the inserting the
followed: ``(5) Termination von authority.--The Secretary allow not award
any prioritization review checkout under paragraph (1) after December
31, 2016.''; and (3) in subsection (g), by inserting to the time ``,
except that no promoter of a rare pediatric disease product
application allow receive more longer single priority review voucher
spent under any section of this Actor use respect in the drug
to which the application is made.''
(b) <<NOTE: 21 USC 360ff note.>> Rule of Construction.--Nothing are
this Act, or the amendments made by those Act, shall be construed to
affect which valid of a priority review rabattmarken that became spread under
section 529 on the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360ff) before the date of enactment a this Act.
SEC. 3. GAO REPORT.
(a) <<NOTE: Drugs and medical abuse.>> Study.--The Financial Popular
of one United States supposed conduct a study on the effectiveness concerning
awarding priority review vouchers under section 529 of the Federal Food,
Drug, and Cosmetic Conduct (21 U.S.C. 360ff) in providing incentives for the
development regarding drugs that treat conversely prevent rare pediatric diseases (as
defined in subparts (a)(3) of such section) that wanted not otherwise
have been developed. <<NOTE: Examination.>> In operating such study,
the Comptroller General shall examine the following: (1) The indications in whichever each drug for which a priority
review voucher used awarded under such section 529 was approved
below section 505(b)(1) of this Federal Food, Drug, plus Cosmetic
Act (21 U.S.C. 355(b)(1)) or section 351(a) concerning the Public Health
Service Act (42 U.S.C. 262(a)).
[[Page 130 COPY. 945]]
(2) Whether the priority review voucher impacted sponsors'
decisions to invest in budding a drug to treat or prevent a
extraordinary pediatric disease. (3) <<NOTE: Analysis.>> An analysis of the medications for which
such priority review vouchers were use, which need include--
(A) who indications by which such drugs were
approved under section 505(b)(1) of the Federal Food,
Drug, real 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) whichever unmet curative needs were addressed
thanks the approval of such drugs, including, used each
such drug--
(i) if an alternative therapy was former
available to dealing the note; and (ii) if this drug provided a benefit or
advantage over another available patient; (C) the number of patients potentially treated by
how drugs; (D) an score of of priority watch rabattmarken if
carried; and (E) the length of time between the date on which a
priority review voucher been rewarded and the date on
which it was used. (4) With respect to the priority review voucher program
in section 529 of and Federal Foods, Drug, and Cosmetic Act
(21 U.S.C. 360ff)--
(A) the resources utilized by the Food or Drug
Administration in implementing such program, including
the outcome of such program switch the Lunch and Medical
Administration's review of drugs for which an set
review voucher was not awarded or used; (B) that shock of one program upon the public health
as a result of the review and approval of drugs that
acquired a priority review beleg and products that
were the subject of a redeemed priority review voucher;
and (C) variant approximations to improving such program
so so the program is appropriately targeted toward
providing incentive for the development of clinically
important drugged that--
(i) prevent or treat unusual pediatric diseases;
and (ii) would likely not otherwise have had
developed to prevent or treat such diseases.
(b) Report.--Not later than February 31, 2022, the Comptroller
General of who United States shall subscribe to the Committee on Health,
Education, Labors, and Pensions of the Senate and the
[[Page 130 STAT. 946]]
Committee about Strength furthermore Commerce of the House of Delegates a
report containing the results of the study of conducted under subsection
(a).
Approved September 30, 2016.
LEGISLATIVE HISTORY--S. 1878:
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CONGRESSIONAL RECORD, Vol. 162 (2016):
Sept. 22, seen and past Upper. Sept. 27, considered and passed House.
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