IB 
Union Calendar No. 26 
114TH CONGRESS 
1ST SESSION 
H. R. 639 
[Report No. 114–41, Part I] 
To amend the Controlled Substances Act with respect to drug scheduling 
recommendations by the Secretary of Health and Human Services, and 
with respect to registration of manufacturers and distributors seeking 
to conduct clinical testing. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 2, 2015 
Mr. PITTS (for himself, Mr. PALLONE, and Mr. GENE GREEN of Texas) intro-
duced the following bill; which was referred to the Committee on Energy 
and Commerce, and in addition to the Committee on the Judiciary, for 
a period to be subsequently determined by the Speaker, in each case for 
consideration of such provisions as fall within the jurisdiction of the com-
mittee concerned 
MARCH 16, 2015 
Additional sponsor: Mrs. MCMORRIS RODGERS 
MARCH 16, 2015 
Reported from the Committee on Energy and Commerce with amendments 
[Strike out all after the enacting clause and insert the part printed in italic] 
MARCH 16, 2015 
The Committee on the Judiciary discharged; committed to the Committee of 
the Whole House on the State of the Union and ordered to be printed 
[For text of introduced bill, see copy of bill as introduced on February 2, 2015] 
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A BILL 
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. 
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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 ‘‘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.—Sec-
tion 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 REC-
OMMENDED CONTROLS UNDER THE CSA.— 
‘‘(1) IN GENERAL.—In the case of an application 
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 applica-
tion shall not take effect until the interim final rule 
controlling the drug is issued in accordance with sec-
tion 201(j) of the Controlled Substances Act. 
‘‘(2) DATE OF APPROVAL.—For purposes of this 
section, with respect to an application described in 
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paragraph (1), the term ‘date of approval’ shall mean 
the later of— 
‘‘(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 BIOLOGI-
CAL 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 application 
under subsection (a) with respect to a biological prod-
uct for which the Secretary provides notice to the 
sponsor that the Secretary intends to recommend con-
trols under the Controlled Substances Act, approval 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 
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such application, or licensure of the product subject to 
such application, shall mean the later of— 
‘‘(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 application 
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 applica-
tion shall not take effect until the interim final rule 
controlling the drug is issued in accordance with sec-
tion 201(j) of the Controlled Substances Act. 
‘‘(2) DATE OF APPROVAL.—For purposes of this 
section, with respect to an application described in 
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paragraph (1), the term ‘date of approval’ shall mean 
the later of— 
‘‘(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 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 sub-
section (a) with respect to a drug for which the Sec-
retary provides notice to the sponsor that the Sec-
retary intends to recommend controls under the Con-
trolled Substances Act, conditional 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. 
‘‘(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 
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‘‘(ii) the date of issuance of the interim 
final rule controlling the drug.’’. 
(C) INDEXING OF LEGALLY MARKETED UN-
APPROVED 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 for which the Secretary provides notice to the 
person filing the request that the Secretary intends to rec-
ommend controls under the Controlled Substances Act, a de-
termination 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 control-
ling 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 controls 
under the Controlled Substances Act, the drug shall 
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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.—Sec-
tion 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 rec-
ommends that the Attorney General add the drug to sched-
ule 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 para-
graph (3). 
‘‘(2) The date described in this paragraph shall be the 
later of— 
‘‘(A) the date on which the Attorney General re-
ceives the scientific and medical evaluation and rec-
ommendations from the Secretary of Health and 
Human Services in accordance with subsection (b); or 
‘‘(B) the date on which the Attorney General re-
ceives notification from the Secretary of Health and 
Human Services that the Secretary has approved an 
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application under section 505(c), 512, 571, or 572 of 
the Federal Food, Drug, and Cosmetic 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 para-
graph (1) shall be in accordance with the procedures pro-
vided in subsection (a), except that the rule shall become 
immediately effective as an interim final rule without re-
quiring the Attorney General to demonstrate good cause 
therefor. After publication of the interim final rule, the At-
torney 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 preceding 
subparagraph (A), by inserting ‘‘, or in the case of a 
drug product described in subsection (i) within the 
sixty-day period beginning on the covered date (as de-
fined 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 spon-
sor of an application or request for approval, conditional 
approval, or indexing of a drug product for which the Sec-
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retary 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; 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 Pub-
lic 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.’’. 
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: 
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‘‘(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 ap-
plicant, 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 fil-
ing. 
‘‘(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 ap-
plication 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 appli-
cant, or serve an order to show cause upon the applicant 
in accordance with section 304(c), unless the Attorney Gen-
eral has granted a hearing on the application under section 
1008(i) of the Controlled Substances Import and Export 
Act.’’. 
Amend the title so as to read: ‘‘A bill to amend the 
Controlled Substances Act with respect to drug sched-
uling recommendations by the Secretary of Health and 
Human Services, and with respect to registration of man-
ufacturers and distributors seeking to conduct clinical 
testing, and for other purposes.’’. 
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Union Calendar No. 26 
114TH CONGRESS 
1ST SESSION 
H. R. 639 
[Report No. 114–41, Part I] 
A BILL 
To amend the Controlled Substances Act with re-
spect to drug scheduling recommendations by the 
Secretary of Health and Human Services, and 
with respect to registration of manufacturers and 
distributors seeking to conduct clinical testing. 
MARCH 16, 2015 
Reported from the Committee on Energy and Commerce 
with amendments 
MARCH 16, 2015 
The Committee on the Judiciary discharged; committed 
to the Committee of the Whole House on the State of 
the Union and ordered to be printed 
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