I 
114TH CONGRESS 
2D SESSION 
H. R. 5182 
To promote the development of safe drugs for neonates. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 10, 2016 
Mr. LONG (for himself and Mr. BEN RAY LUJA´N of New Mexico) introduced 
the following bill; which was referred to the Committee on Energy and 
Commerce 
A BILL 
To promote the development of safe drugs for neonates. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Promoting Life-Saving 
New Therapies for Neonates Act of 2016’’. 
SEC. 2. PROMOTING THE DEVELOPMENT OF SAFE AND EF-
FECTIVE THERAPIES FOR NEONATES. 
Subchapter B of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360aa et seq.) is 
amended by inserting after section 529 the following: 
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‘‘SEC. 530. EXCLUSIVITY TO ENCOURAGE DEVELOPMENT OF 
SAFE AND EFFECTIVE THERAPIES FOR NEO-
NATES. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) NEONATAL
DRUG.—The term ‘neonatal 
drug’ means a drug for the prevention or treatment 
of a disease or condition of a preterm or full-term 
neonate. 
‘‘(2) NEONATAL
DRUG
APPLICATION.—The 
term ‘neonatal drug 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 disease or condition listed 
on the Priority List of Critical Needs for 
Neonates described in subsection (c); and 
‘‘(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; 
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‘‘(B) NONTRANSFERABILITY.—A neonatal 
exclusivity voucher may not be transferred to, 
or used for, a drug with respect to which all 
patents and exclusivities have expired as of the 
date of the transfer. 
‘‘(C) 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 calendar 
days after such transfer. 
‘‘(D) 
PROHIBITION
ON
ADDITIONAL 
FEES.—The Secretary shall not apply a fee for 
the exercise of a voucher under this section. 
The preceding sentence shall not affect the au-
thority of the Secretary to apply fees with re-
spect to a neonatal drug application that are 
otherwise applicable under law. 
‘‘(E) REVOCATION
OF
VOUCHER.—The 
Secretary may revoke any neonatal exclusivity 
voucher if the neonatal drug product for which 
such voucher was awarded is not marketed in 
the United States within the 365-day period be-
ginning on the date of the approval of such 
drug under section 505 of this Act or section 
351 of the Public Health Service Act. 
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‘‘(3) LIMITATIONS.— 
‘‘(A) NO AWARD FOR PRIOR APPROVED AP-
PLICATION.—A sponsor of a neonatal drug may 
not receive a voucher under this section if the 
neonatal drug application was submitted to the 
Secretary prior to the date of enactment of this 
section. 
‘‘(B) REQUIRED PEDIATRIC RESEARCH.— 
The Secretary shall limit grants of exclusivity 
under this section to drugs that are not re-
quired to complete neonatal studies under sec-
tion 505B. 
‘‘(C) NO COMBINING VOUCHERS.—A spon-
sor may not use a neonatal exclusivity voucher 
on a product for which the sponsor also intends 
to use a voucher obtained or purchased pursu-
ant to section 524 or section 529. 
‘‘(4) NOTIFICATION OF INTENT TO USE VOUCH-
ER.— 
‘‘(A) NOTIFICATION
BY
SPONSOR.—The 
sponsor of a human drug application intending 
to use a voucher awarded or transferred under 
this section shall notify the Secretary not later 
than 15 months prior to loss of patent and 
exclusivities on the drug for which the voucher 
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will be redeemed, in such form as the Secretary 
may require. 
‘‘(B) NOTIFICATION
BY
SECRETARY.— 
Within 30 calendar days of such notification to 
the Secretary, the Secretary shall notify the 
sponsor of its eligibility to redeem a voucher for 
the intended drug. 
‘‘(c) PRIORITY LIST OF CRITICAL NEEDS FOR NEO-
NATES.— 
‘‘(1) IN GENERAL.—The Secretary, in consulta-
tion with the Pediatric Advisory Committee, the Na-
tional Institutes of Health, the International Neo-
natal Consortium sponsored by Critical Path Insti-
tute, and other stakeholders, shall, within one year 
of the date of enactment of the Promoting Life-Sav-
ing New Therapies for Neonates Act of 2016— 
‘‘(A) develop and publish a list of critical 
research priorities related to specific diseases or 
conditions common to the neonatal population 
(referred to as the ‘Priority List of Critical 
Needs for Neonates’); 
‘‘(B) issue guidance specific to the neo-
natal drug exclusivity voucher program; and 
‘‘(C) perform other activities necessary to 
support neonatal drug applications. 
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‘‘(2) PUBLIC COMMENT.—The Secretary shall 
provide a period of public notice and comment on 
the proposed list and shall hold public meetings to 
elicit input from patient advocacy and other organi-
zations prior to publishing the final list. 
‘‘(3) SUBSEQUENT
UPDATE.—The Secretary 
may revise, and publish in accordance with para-
graph (1)(A), the Priority List of Critical Needs for 
Neonates every 3 years, or as frequently as the Sec-
retary determines necessary. 
‘‘(4) RESTRICTION ON REMOVAL FROM LIST.— 
No disease or condition on the Priority List of Crit-
ical Needs for Neonates may be removed until after 
completion of the study and report under subsection 
(d). 
‘‘(d) GAO STUDY AND REPORT.— 
‘‘(1) STUDY.— 
‘‘(A) IN
GENERAL.—Beginning 8 years 
after the date of enactment of the Promoting 
Life-Saving New Therapies for Neonates Act of 
2016 or on the date that the Secretary awards 
the third neonatal exclusivity voucher under 
this section, whichever is earlier, the Comp-
troller General of the United Sates shall con-
duct a study of the effectiveness of the program 
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under this section for the development of 
human drugs to treat and prevent diseases or 
conditions in the neonatal population. 
‘‘(B) CONTENTS OF THE STUDY.—In con-
ducting the study under subparagraph (A), the 
Comptroller General shall examine the fol-
lowing: 
‘‘(i) The number of neonatal drug 
vouchers awarded under this section. 
‘‘(ii) The indications for each drug for 
which a neonatal exclusivity voucher was 
approved under section 505 or section 351 
of the Public Health Service Act, and 
whether any other drugs with indications 
for populations other than neonates were 
approved with an indication for neonates 
under those sections. 
‘‘(iii) Whether, and to what extent, an 
unmet need related to the treatment or 
prevention of a disease or condition that 
affects the neonatal population was met 
through the approval of a neonatal drug. 
‘‘(iv) The value of the neonatal exclu-
sivity voucher if transferred. 
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