I 
113TH CONGRESS 
2D SESSION 
H. R. 4299 
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 
MARCH 26, 2014 
Mr. PITTS (for himself and Mr. PALLONE) introduced 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 deter-
mined by the Speaker, in each case for consideration of such provisions 
as fall within the jurisdiction of the committee concerned 
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. 
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’’. 
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SEC. 2. SCHEDULING OF SUBSTANCES INCLUDED IN NEW 
FDA-APPROVED DRUGS. 
Section 201 of the Controlled Substances Act (21 
U.S.C. 811) is amended by inserting after subsection (h) 
the following: 
‘‘(i) Within 45 days of receiving a recommendation 
from the Secretary to add a drug or substance that has 
never been marketed in the United States to a schedule 
under this title, the Attorney General shall, without regard 
to the findings required by subsection (a) of this section 
or section 202(b), issue an interim final rule, under the 
exception for good cause described in subparagraph (B) 
of section 553(b) of title 5, United States Code, placing 
the drug or substance into the schedule recommended by 
the Secretary. The interim final rule shall be made imme-
diately effective under section 553(d)(3) of title 5, United 
States Code.’’. 
SEC. 3. ENHANCING NEW DRUG DEVELOPMENT. 
Section 302 of the Controlled Substances Act (21 
U.S.C. 822) is amended by inserting after subsection (g) 
the following: 
‘‘(h)(1) A person who submits an application for reg-
istration to manufacture or distribute a controlled sub-
stance in accordance with this section may indicate on the 
registration application that the substance will be used 
only in connection with clinical trials of a drug in accord-
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ance with section 505(i) of the Federal Food, Drug, and 
Cosmetic Act. 
‘‘(2) When an application for registration to manu-
facture or distribute a controlled substance includes an in-
dication that the controlled substance will be used only 
in connection with clinical trials of a drug in accordance 
with section 505(i) of the Federal Food, Drug, and Cos-
metic Act, the Attorney General shall— 
‘‘(A) make a final decision on the application 
for registration within 180 days; or 
‘‘(B) provide notice to the applicant in writing 
of— 
‘‘(i) the outstanding issues that must be 
resolved in order to reach a final decision on 
the application; and 
‘‘(ii) the estimated date on which a final 
decision on the application will be made.’’. 
Æ 
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