IIB 
114TH CONGRESS 
1ST SESSION 
H. R. 639 
IN THE SENATE OF THE UNITED STATES 
MARCH 17, 2015 
Received; read twice and referred to the Committee on Health, Education, 
Labor, and Pensions 
AN ACT 
To amend the Controlled Substances Act with respect to 
drug scheduling recommendations by the Secretary of 
Health and Human Services, and with respect to reg-
istration of manufacturers and distributors seeking to 
conduct clinical testing. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Improving Regulatory 
Transparency 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 Cos-
metic Act (21 U.S.C. 355) is amended by adding at 
the end the following: 
‘‘(x) DATE OF APPROVAL IN THE CASE OF REC-
OMMENDED CONTROLS UNDER THE CSA.— 
‘‘(1) IN GENERAL.—In the case of an applica-
tion under subsection (b) with respect to a drug for 
which the Secretary provides notice to the sponsor 
that the Secretary intends to recommend controls 
under the Controlled Substances Act, approval of 
such application shall not take effect until the in-
terim final rule controlling the drug is issued in ac-
cordance with section 201(j) of the Controlled Sub-
stances 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— 
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‘‘(A) the date an application under sub-
section (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 BIO-
LOGICAL
PRODUCTS.—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 REC-
OMMENDED CONTROLS UNDER THE CSA.— 
‘‘(1) IN GENERAL.—In the case of an applica-
tion under subsection (a) with respect to a biological 
product for which the Secretary provides notice to 
the sponsor that the Secretary intends to rec-
ommend controls under the Controlled Substances 
Act, approval of such application shall not take ef-
fect until the interim final rule controlling the bio-
logical 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 sub-
ject to such application, shall mean the later of— 
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‘‘(A) the date an application is approved 
under subsection (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 Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360b) is amended by adding at the end the fol-
lowing: 
‘‘(q) DATE OF APPROVAL IN THE CASE OF REC-
OMMENDED CONTROLS UNDER THE CSA.— 
‘‘(1) IN GENERAL.—In the case of an applica-
tion under subsection (b) with respect to a drug for 
which the Secretary provides notice to the sponsor 
that the Secretary intends to recommend controls 
under the Controlled Substances Act, approval of 
such application shall not take effect until the in-
terim final rule controlling the drug is issued in ac-
cordance with section 201(j) of the Controlled Sub-
stances 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— 
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‘‘(A) the date an application under sub-
section (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 Federal Food, Drug, and Cos-
metic 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 recommend controls under the 
Controlled Substances Act, conditional approval of 
such application shall not take effect until the in-
terim final rule controlling the drug is issued in ac-
cordance with section 201(j) of the Controlled Sub-
stances Act. 
‘‘(B) For purposes of this section, with respect 
to an application described in subparagraph (A), the 
term ‘date of approval’ shall mean the later of— 
‘‘(i) the date an application under sub-
section (a) is conditionally approved under sub-
section (b); or 
‘‘(ii) the date of issuance of the interim 
final rule controlling the drug.’’. 
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(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 add-
ing 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 re-
spect to a drug for which the Secretary provides notice 
to the person filing the request that the Secretary intends 
to recommend controls under the Controlled Substances 
Act, a determination to grant the request to add such drug 
to the index shall not take effect, and the Secretary shall 
not list the drug on such index, 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 pe-
riod of exclusivity under paragraph (1) for a drug 
for which the Secretary intends to recommend con-
trols under the Controlled Substances Act, the drug 
shall not be considered approved or conditionally ap-
proved until the date that the interim final rule con-
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trolling 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 fol-
lowing: 
‘‘(j)(1) With respect to a drug referred to in sub-
section (f), if the Secretary of Health and Human Services 
recommends that the Attorney General add the drug to 
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 de-
scribed 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 
recommendations 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 ap-
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proved an application under section 505(c), 512, 
571, or 572 of the Federal Food, Drug, and Cos-
metic Act or section 351(a) of the Public Health 
Service Act with respect to the drug described in 
paragraph (1). 
‘‘(3) A rule issued by the Attorney General under 
paragraph (1) shall be in accordance with the procedures 
provided in subsection (a), except that the rule shall be-
come immediately effective as an interim final rule without 
requiring the Attorney General to demonstrate good cause 
therefor. After publication of the interim final rule, the 
Attorney General shall issue a final rule in accordance 
with the procedures provided in subsection (a).’’. 
(c) EXTENSION OF PATENT TERM.—Section 156 of 
title 35, United States Code, is amended— 
(1) in subsection (d)(1), in the matter pre-
ceding subparagraph (A), by inserting ‘‘, or in the 
case of a drug product described in subsection (i) 
within the 60-day period beginning 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, condi-
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tional 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 under the relevant 
provision of the Public Health Service Act or Fed-
eral 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 ap-
proved 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.’’. 
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under section 1008(i) of the Controlled Substances Import 
and Export Act.’’. 
Passed the House of Representatives March 16, 
2015. 
Attest: 
KAREN L. HAAS, 
Clerk. 
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