I 
114TH CONGRESS 
2D SESSION 
H. R. 5127 
To amend the Federal Food, Drug, and Cosmetic Act to extend the exclusivity 
period for certain drug products developed or labeled so as to reduce 
drug abuse, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 29, 2016 
Mr. GRIFFITH (for himself, Mr. CONNOLLY, and Mr. BILIRAKIS) introduced 
the following bill; which was referred to the Committee on Energy and 
Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
extend the exclusivity period for certain drug products 
developed or labeled so as to reduce drug abuse, and 
for other purposes. 
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 ‘‘Curb Opioid Misuse 
By Advancing Technology Act of 2016’’. 
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SEC. 2. EXTENDED EXCLUSIVITY FOR CERTAIN DRUG 
PRODUCTS 
TO 
PROTECT 
THE 
PUBLIC 
HEALTH. 
(a) 
NEW
DRUG
APPLICATIONS.—Section 
505(c)(3)(E) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(c)(3)(E)) is amended by adding at 
the end the following: 
‘‘(vi) With respect to an application 
described in clause (iii) or a supplement to 
an application described in clause (iv), if 
such application or supplement is approved 
on or after the date of enactment of the 
Curb Opioid Misuse By Advancing Tech-
nology Act of 2016, the 3-year period spec-
ified in each such clause shall be extended 
for an additional period of 12 months if 
the person submitting such application or 
supplement provides documentation to the 
Secretary demonstrating that the drug 
that is the subject of the application or 
supplement— 
‘‘(I) is approved, in whole or in 
part, on the basis of one or more new 
clinical abuse potential studies; and 
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‘‘(II) is approved with labeling 
that characterizes the abuse-deterrent 
properties of the drug product.’’. 
(b) ABBREVIATED NEW DRUG APPLICATIONS.—Sec-
tion 505(j)(5) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)(5)) is amended— 
(1) in subparagraph (B), by adding at the end 
the following: 
‘‘(v) With respect to an abbreviated 
application described in clause (iv), if such 
application is approved on or after the date 
of enactment of the Curb Opioid Misuse 
By Advancing Technology Act of 2016, the 
180-day period specified in such clause 
shall be extended for an additional period 
of 60 days if the first applicant submitting 
the abbreviated application provides docu-
mentation to the Secretary demonstrating 
that the listed drug referred to paragraph 
(2)(A)(i) and referenced in the abbreviated 
application— 
‘‘(I) is approved, in whole or in 
part, on the basis of one or more new 
clinical abuse potential studies; and 
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‘‘(II) is approved with labeling 
that characterizes the abuse-deterrent 
properties of the drug product.’’; and 
(2) in subparagraph (F), by adding at the end 
the following: 
‘‘(vi) With respect to an application 
described in clause (iii) or a supplement to 
an application described in clause (iv), if 
such application or supplement is approved 
on or after the date of enactment of the 
Curb Opioid Misuse By Advancing Tech-
nology Act of 2016, the 3-year period spec-
ified in each such clause shall be extended 
for an additional period of 12 months if 
the person submitting such application or 
supplement provides documentation to the 
Secretary demonstrating that the drug 
that is the subject of the application or 
supplement— 
‘‘(I) is approved, in whole or in 
part, on the basis of one or more new 
clinical abuse potential studies; and 
‘‘(II) is approved with labeling 
that characterizes the abuse-deterrent 
properties of that drug product.’’. 
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(c) REGULATIONS.— 
(1) IN GENERAL.—Not later than 2 years after 
the date of the enactment of this Act, the Secretary 
of Health and Human Services (referred to in this 
section as ‘‘the Secretary’’) shall adopt final regula-
tions, which shall have been promulgated in accord-
ance with section 553 of title 5, United States Code, 
to carry out the amendments made by this section. 
(2) RESTRICTIONS.—Notwithstanding any other 
provision of law, the Secretary shall promulgate reg-
ulations implementing this section only as described 
in paragraph (1), except that the Secretary may 
issue interim guidance for persons claiming eligi-
bility for the extension provided by clause (vi) of 
subsection (c)(3)(E) or (j)(5)(F) of section 505 of 
the Federal Food, Drug, and Cosmetic Act (as 
added by subsections (a) and (b)) prior to the pro-
mulgation of such regulations. 
(3) EXCLUSIVITY
PRIOR
TO
REGULATIONS.— 
The Secretary shall award the extensions provided 
by clause (vi) of subsection (c)(3)(E) or (j)(5)(F) 
and by clause (v) of subsection (j)(5)(B) of section 
505 of the Federal Food, Drug, and Cosmetic Act 
(as added by subsections (a) and (b)) prior to the 
promulgation of regulations under this subsection, if 
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an application, supplement, or abbreviated applica-
tion meets the requirements for the applicable exten-
sion. 
(d) DEFINITIONS.— 
(1) The term ‘‘new clinical investigations’’ in 
subsections 
(c)(3)(E)(iii), 
(c)(3)(E)(iv), 
(j)(5)(F)(iii), and (j)(5)(F)(iv) of section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) shall include new clinical abuse potential stud-
ies intended to assess the impact of potentially 
abuse-deterrent properties of drug products in 
human subjects. 
(2) The terms ‘‘conditions of approval’’ and 
‘‘change approved in the supplement’’ in subsections 
(c)(3)(E)(iii) and (c)(3)(E)(iv) of section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) shall include any abuse-deterrent properties of 
a drug product subject to the extension provided by 
subsection (c)(3)(E)(vi) of such section 505 (as 
added by subsection (a)), such that the Secretary 
may not make the approval of an application sub-
mitted under subsection (b)(2) of such section 505 
effective before the expiration of 4 years from the 
date of the approval of the application or supple-
ment under subsection (b) of such section 505, in-
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cluding the extension under subsection (c)(3)(E)(vi) 
of such section 505, unless the application submitted 
under subsection (b)(2) of such section 505— 
(A) is approved, in whole or in part, on the 
basis of one or more new clinical abuse poten-
tial studies; and 
(B) is approved with labeling that charac-
terizes the abuse-deterrent properties of the 
drug product. 
(3) The terms ‘‘conditions of approval’’ and 
‘‘change approved in the supplement’’ in subsections 
(j)(5)(F)(iii) and (j)(5)(F)(iv) of section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) shall include any abuse-deterrent properties of 
a drug product subject to the extension provided by 
subsection (j)(5)(F)(vi) of such section 505 (as 
added by subsection (b)), such that the Secretary 
may not make the approval of an abbreviated appli-
cation for a drug product submitted under sub-
section (j) of such section 505 effective before the 
expiration of 4 years from the date of the approval 
of the application or supplement under subsection 
(b) of such section 505, including the extension 
under subsection (j)(5)(F)(vi) of such section 505. 
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