IB 
Union Calendar No. 451 
113TH CONGRESS 
2D SESSION 
H. R. 4299 
[Report No. 113–565, Parts I and II] 
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 
JULY 29, 2014 
Reported from the Committee on Energy and Commerce 
JULY 29, 2014 
Referral to the Committee on the Judiciary extended for a period ending not 
later than September 19, 2014 
SEPTEMBER 19, 2014 
Additional sponsors: Mr. BURGESS, Mrs. MCMORRIS RODGERS, Mrs. BLACK-
BURN, Mr. GINGREY of Georgia, Mr. GRIFFITH of Virginia, Mr. GENE 
GREEN of Texas, Mr. LATTA, Mr. ENGEL, Ms. SHEA-PORTER, Mr. 
BUTTERFIELD, Mr. TONKO, Mr. JOHNSON of Ohio, Mr. HARPER, and 
Mr. COLLINS of Georgia 
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SEPTEMBER 19, 2014 
Reported from the Committee on the Judiciary with an amendment 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on March 26, 2014] 
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. 
Section 201(a) of the Controlled Substances Act (21 
U.S.C. 811(a)) is amended by adding at the end the fol-
lowing: ‘‘Any such proceedings initiated at the request of 
the Secretary under this subsection to control a drug or 
other substance not previously scheduled, where the Sec-
retary has recommended the drug or other substance be 
placed in schedule II, III, IV, or V, shall be commenced 
not later than 120 days after receipt of written rec-
ommendations from the Secretary. The final rule shall be 
issued not later than 60 days after the date on which both 
the public comment period has closed and the drug or other 
substance is the subject of an approved new drug applica-
tion under section 505 of the Federal Food, Drug, and Cos-
metic Act, unless a hearing on the proposed rule is granted 
by the Attorney General.’’. 
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 the purposes of registration to manufacture 
a controlled substance under subsection (d) of this section 
for use only in a clinical trial, the Attorney General shall 
register an applicant or serve an order to show cause upon 
an applicant pursuant to section 304(c) of this Act not later 
than 180 days after receipt of an application and all infor-
mation the Attorney General deems necessary to make a 
determination under subsection (d). 
‘‘(2) For the 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 regulations issued by the Attorney General, issue a no-
tice of application not later than 90 days after receipt of 
an application and all information the Attorney General 
deems necessary to issue a notice of application. Following 
the close of the comment period and receipt of all informa-
tion the Attorney General deems necessary to make a deter-
mination under subsection (a), the Attorney General shall 
register an applicant or serve an order to show cause upon 
an applicant pursuant to section 304(c) of this Act within 
180 days, unless a hearing on the application has been 
granted by the Attorney General pursuant to section 
1008(i) of the Controlled Substances Import and Export 
Act.’’. 
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Union Calendar No. 451 
113TH CONGRESS 
2D SESSION 
H. R. 4299 
[Report No. 113–565, Parts I and II] 
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. 
SEPTEMBER 19, 2014 
Reported from the Committee on the Judiciary with an 
amendment 
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