Improving Regulatory Transparency for New Medical Therapies Act
PL 114-89 (H.R.639), enacted 11/25/2015

129 STAT. 698 
PUBLIC LAW 114–89—NOV. 25, 2015 
Public Law 114–89 
114th Congress 
An Act 
To amend the Controlled Substances Act with respect to drug scheduling rec-
ommendations by the Secretary of Health and Human Services, and with respect 
to registration of manufacturers and distributors seeking to conduct clinical test-
ing. 
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 ‘‘Improving Regulatory Trans-
parency for New Medical Therapies Act’’. 
SEC. 2. SCHEDULING OF SUBSTANCES INCLUDED IN NEW FDA- 
APPROVED DRUGS. 
(a) EFFECTIVE DATE OF APPROVAL.— 
(1) EFFECTIVE DATE OF DRUG APPROVAL.—Section 505 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
is amended by adding at the end the following: 
‘‘(x) DATE OF APPROVAL IN THE CASE OF RECOMMENDED CON-
TROLS UNDER THE CSA.— 
‘‘(1) IN GENERAL.—In the case of an application under sub-
section (b) with respect to a drug for which the Secretary 
provides notice to the sponsor that the Secretary intends to 
issue a scientific and medical evaluation and recommend con-
trols under the Controlled Substances Act, approval of such 
application shall not take effect until the interim final rule 
controlling the drug is issued in accordance with section 201(j) 
of the Controlled Substances Act. 
‘‘(2) DATE OF APPROVAL.—For purposes of this section, with 
respect to an application described in paragraph (1), the term 
‘date of approval’ shall mean the later of— 
‘‘(A) the date an application under subsection (b) is 
approved under subsection (c); or 
‘‘(B) the date of issuance of the interim final rule 
controlling the drug.’’. 
(2) EFFECTIVE
DATE
OF
APPROVAL
OF
BIOLOGICAL
PROD-
UCTS.—Section 351 of the Public Health Service Act (42 U.S.C. 
262) is amended by adding at the end the following: 
‘‘(n) DATE OF APPROVAL IN THE CASE OF RECOMMENDED CON-
TROLS UNDER THE CSA.— 
‘‘(1) IN GENERAL.—In the case of an application under sub-
section (a) with respect to a biological product for which the 
Secretary provides notice to the sponsor that the Secretary 
intends to issue a scientific and medical evaluation and rec-
ommend controls under the Controlled Substances Act, approval 
Definition. 
Improving 
Regulatory 
Transparency for 
New Medical 
Therapies Act. 
Nov. 25, 2015 
[H.R. 639] 
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129 STAT. 699 
PUBLIC LAW 114–89—NOV. 25, 2015 
of such application shall not take effect until the interim final 
rule controlling the biological product is issued in accordance 
with section 201(j) of the Controlled Substances Act. 
‘‘(2) DATE OF APPROVAL.—For purposes of this section, with 
respect to an application described in paragraph (1), references 
to the date of approval of such application, or licensure of 
the product subject to such application, shall mean the later 
of— 
‘‘(A) the date an application is approved under sub-
section (a); or 
‘‘(B) the date of issuance of the interim final rule 
controlling the biological product.’’. 
(3) EFFECTIVE DATE OF APPROVAL OF ANIMAL DRUGS.— 
(A) IN
GENERAL.—Section 512 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360b) is amended by 
adding at the end the following: 
‘‘(q) DATE OF APPROVAL IN THE CASE OF RECOMMENDED CON-
TROLS UNDER THE CSA.— 
‘‘(1) IN GENERAL.—In the case of an application under sub-
section (b) with respect to a drug for which the Secretary 
provides notice to the sponsor that the Secretary intends to 
issue a scientific and medical evaluation and recommend con-
trols under the Controlled Substances Act, approval of such 
application shall not take effect until the interim final rule 
controlling the drug is issued in accordance with section 201(j) 
of the Controlled Substances Act. 
‘‘(2) DATE OF APPROVAL.—For purposes of this section, with 
respect to an application described in paragraph (1), the term 
‘date of approval’ shall mean the later of— 
‘‘(A) the date an application under subsection (b) is 
approved under subsection (c); or 
‘‘(B) the date of issuance of the interim final rule 
controlling the drug.’’. 
(B) CONDITIONAL APPROVAL.—Section 571(d) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc(d)) 
is amended by adding at the end the following: 
‘‘(4)(A) In the case of an application under subsection (a) 
with respect to a drug for which the Secretary provides notice 
to the sponsor that the Secretary intends to issue a scientific 
and medical evaluation and recommend controls under the 
Controlled Substances Act, conditional approval of such applica-
tion shall not take effect until the interim final rule controlling 
the drug is issued in accordance with section 201(j) of the 
Controlled Substances Act. 
‘‘(B) For purposes of this section, with respect to an applica-
tion described in subparagraph (A), the term ‘date of approval’ 
shall mean the later of— 
‘‘(i) the date an application under subsection (a) is 
conditionally approved under subsection (b); or 
‘‘(ii) the date of issuance of the interim final rule 
controlling the drug.’’. 
(C) INDEXING OF LEGALLY MARKETED UNAPPROVED NEW 
ANIMAL DRUGS.—Section 572 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360ccc–1) is amended by 
adding at the end the following: 
‘‘(k) In the case of a request under subsection (d) to add a 
drug to the index under subsection (a) with respect to a drug 
Determination. 
Definition. 
Definition. 
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129 STAT. 700 
PUBLIC LAW 114–89—NOV. 25, 2015 
for which the Secretary provides notice to the person filing the 
request that the Secretary intends to issue a scientific and medical 
evaluation and recommend controls under the Controlled Sub-
stances Act, a determination to grant the request to add such 
drug to the index shall not take effect until the interim final 
rule controlling the drug is issued in accordance with section 201(j) 
of the Controlled Substances Act.’’. 
(4) DATE
OF
APPROVAL
FOR
DESIGNATED
NEW
ANIMAL 
DRUGS.—Section 573(c) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360ccc–2(c)) is amended by adding at the end 
the following: 
‘‘(3) For purposes of determining the 7-year period of exclu-
sivity under paragraph (1) for a drug for which the Secretary 
intends to issue a scientific and medical evaluation and rec-
ommend controls under the Controlled Substances Act, the 
drug shall not be considered approved or conditionally approved 
until the date that the interim final rule controlling the drug 
is issued in accordance with section 201(j) of the Controlled 
Substances Act.’’. 
(b) SCHEDULING OF NEWLY APPROVED DRUGS.—Section 201 of 
the Controlled Substances Act (21 U.S.C. 811) is amended by 
inserting after subsection (i) the following: 
‘‘(j)(1) With respect to a drug referred to in subsection (f), 
if the Secretary of Health and Human Services recommends that 
the Attorney General control the drug in schedule II, III, IV, or 
V pursuant to subsections (a) and (b), the Attorney General shall, 
not later than 90 days after the date described in paragraph (2), 
issue an interim final rule controlling the drug in accordance with 
such subsections and section 202(b) using the procedures described 
in paragraph (3). 
‘‘(2) The date described in this paragraph shall be the later 
of— 
‘‘(A) the date on which the Attorney General receives the 
scientific and medical evaluation and the scheduling rec-
ommendation from the Secretary of Health and Human Services 
in accordance with subsection (b); or 
‘‘(B) the date on which the Attorney General receives 
notification from the Secretary of Health and Human Services 
that the Secretary has approved an application under section 
505(c), 512, or 571 of the Federal Food, Drug, and Cosmetic 
Act or section 351(a) of the Public Health Service Act, or 
indexed a drug under section 572 of the Federal Food, Drug, 
and Cosmetic Act, with respect to the drug described in para-
graph (1). 
‘‘(3) A rule issued by the Attorney General under paragraph 
(1) shall become immediately effective as an interim final rule 
without requiring the Attorney General to demonstrate good cause 
therefor. The interim final rule shall give interested persons the 
opportunity to comment and to request a hearing. After the conclu-
sion of such proceedings, the Attorney General shall issue a final 
rule in accordance with the scheduling criteria of subsections (b), 
(c), and (d) of this section and section 202(b).’’. 
(c) EXTENSION OF PATENT TERM.—Section 156 of title 35, United 
States Code, is amended— 
(1) in subsection (d)(1), in the matter preceding subpara-
graph (A), by inserting ‘‘, or in the case of a drug product 
Comments. 
Hearing. 
Deadline. 
Regulations. 
Time period. 
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129 STAT. 701 
PUBLIC LAW 114–89—NOV. 25, 2015 
described in subsection (i), within the sixty-day period begin-
ning on the covered date (as defined in subsection (i))’’ after 
‘‘marketing or use’’; and 
(2) by adding at the end the following: 
‘‘(i)(1) For purposes of this section, if the Secretary of Health 
and Human Services provides notice to the sponsor of an application 
or request for approval, conditional approval, or indexing of a drug 
product for which the Secretary intends to recommend controls 
under the Controlled Substances Act, beginning on the covered 
date, the drug product shall be considered to— 
‘‘(A) have been approved or indexed under the relevant 
provision of the Public Health Service Act or Federal Food, 
Drug, and Cosmetic Act; and 
‘‘(B) have permission for commercial marketing or use. 
‘‘(2) In this subsection, the term ‘covered date’ means the later 
of— 
‘‘(A) the date an application is approved— 
‘‘(i) under section 351(a)(2)(C) of the Public Health 
Service Act; or 
‘‘(ii) under section 505(b) or 512(c) of the Federal Food, 
Drug, and Cosmetic Act; 
‘‘(B) the date an application is conditionally approved under 
section 571(b) of the Federal Food, Drug, and Cosmetic Act; 
‘‘(C) the date a request for indexing is granted under section 
572(d) of the Federal Food, Drug, and Cosmetic Act; or 
‘‘(D) the date of issuance of the interim final rule controlling 
the drug under section 201(j) of the Controlled Substances 
Act.’’. 
SEC. 3. ENHANCING NEW DRUG DEVELOPMENT. 
Section 303 of the Controlled Substances Act (21 U.S.C. 823) 
is amended by adding at the end the following: 
‘‘(i)(1) For purposes of registration to manufacture a controlled 
substance under subsection (d) for use only in a clinical trial, 
the Attorney General shall register the applicant, or serve an order 
to show cause upon the applicant in accordance with section 304(c), 
not later than 180 days after the date on which the application 
is accepted for filing. 
‘‘(2) For purposes of registration to manufacture a controlled 
substance under subsection (a) for use only in a clinical trial, 
the Attorney General shall, in accordance with the regulations 
issued by the Attorney General, issue a notice of application not 
later than 90 days after the application is accepted for filing. 
Not later than 90 days after the date on which the period for 
comment pursuant to such notice ends, the Attorney General shall 
register the applicant, or serve an order to show cause upon the 
applicant in accordance with section 304(c), unless the Attorney 
General has granted a hearing on the application under section 
1008(i) of the Controlled Substances Import and Export Act.’’. 
SEC. 4. RE-EXPORTATION AMONG MEMBERS OF THE EUROPEAN ECO-
NOMIC AREA. 
Section 1003 of the Controlled Substances Import and Export 
Act (21 U.S.C. 953) is amended— 
(1) in subsection (f)— 
(A) in paragraph (5)— 
(i) by striking ‘‘(5)’’ and inserting ‘‘(5)(A)’’; 
Notification. 
Deadlines. 
Definition. 
Notification. 
Effective date. 
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129 STAT. 702 
PUBLIC LAW 114–89—NOV. 25, 2015 
(ii) by inserting ‘‘, except that the controlled sub-
stance may be exported from a second country that 
is a member of the European Economic Area to another 
country that is a member of the European Economic 
Area, provided that the first country is also a member 
of the European Economic Area’’ before the period at 
the end; and 
(iii) by adding at the end the following: 
‘‘(B) Subsequent to any re-exportation described in subpara-
graph (A), a controlled substance may continue to be exported 
from any country that is a member of the European Economic 
Area to any other such country, if— 
‘‘(i) the conditions applicable with respect to the first 
country under paragraphs (1), (2), (3), (4), (6), and (7) 
are met by each subsequent country from which the con-
trolled substance is exported pursuant to this paragraph; 
and 
‘‘(ii) the conditions applicable with respect to the second 
country under paragraphs (1), (2), (3), (4), (6), and (7) 
are met by each subsequent country to which the controlled 
substance is exported pursuant to this paragraph.’’; and 
(B) in paragraph (6)— 
(i) by striking ‘‘(6)’’ and inserting ‘‘(6)(A)’’; and 
(ii) by adding at the end the following: 
‘‘(B) In the case of re-exportation among members of the 
European Economic Area, within 30 days after each re-expor-
tation, the person who exported the controlled substance from 
the United States delivers to the Attorney General— 
‘‘(i) documentation certifying that such re-exportation 
has occurred; and 
‘‘(ii) information concerning the consignee, country, and 
product.’’; and 
(2) by adding at the end the following: 
‘‘(g) LIMITATION.—Subject to paragraphs (5) and (6) of sub-
section (f) in the case of any controlled substance in schedule 
I or II or any narcotic drug in schedule III or IV, the Attorney 
General shall not promulgate nor enforce any regulation, subregu-
latory guidance, or enforcement policy which impedes re-exportation 
of any controlled substance among European Economic Area coun-
tries, including by promulgating or enforcing any requirement 
that— 
‘‘(1) re-exportation from the first country to the second 
country or re-exportation from the second country to another 
country occur within a specified period of time; or 
Certification. 
Deadline. 
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129 STAT. 703 
PUBLIC LAW 114–89—NOV. 25, 2015 
LEGISLATIVE HISTORY—H.R. 639: 
HOUSE REPORTS: No. 114–41, Pt. 1 (Comm. on Energy and Commerce). 
CONGRESSIONAL RECORD, Vol. 161 (2015): 
Mar. 16, considered and passed House. 
Oct. 26, considered and passed Senate, amended. 
Nov. 16, House concurred in Senate amendment. 
‘‘(2) information concerning the consignee, country, and 
product be provided prior to exportation of the controlled sub-
stance from the United States or prior to each re-exportation 
among members of the European Economic Area.’’. 
Approved November 25, 2015. 
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