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 determined 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. BLACKBURN, 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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•HR 4299 RH

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 registration of manufacturers and distributors seeking to 

conduct clinical testing. 


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•HR 4299 RH

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Improving Regulatory 

5 Transparency for New Medical Therapies Act’’. 

6 SEC. 2. SCHEDULING OF SUBSTANCES INCLUDED IN NEW 

7 FDA-APPROVED DRUGS. 

8 Section 201(a) of the Controlled Substances Act (21 

9 U.S.C. 811(a)) is amended by adding at the end the fol10 lowing: ‘‘Any such proceedings initiated at the request of 

11 the Secretary under this subsection to control a drug or 

12 other substance not previously scheduled, where the Sec13 retary has recommended the drug or other substance be 

14 placed in schedule II, III, IV, or V, shall be commenced 

15 not later than 120 days after receipt of written rec16 ommendations from the Secretary. The final rule shall be 

17 issued not later than 60 days after the date on which both 

18 the public comment period has closed and the drug or other 

19 substance is the subject of an approved new drug applica20 tion under section 505 of the Federal Food, Drug, and Cos21 metic Act, unless a hearing on the proposed rule is granted 

22 by the Attorney General.’’. 

23 SEC. 3. ENHANCING NEW DRUG DEVELOPMENT. 

24 Section 303 of the Controlled Substances Act (21 

25 U.S.C. 823) is amended by adding at the end the following: 


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•HR 4299 RH

1 ‘‘(i)(1) For the purposes of registration to manufacture 

2 a controlled substance under subsection (d) of this section 

3 for use only in a clinical trial, the Attorney General shall 

4 register an applicant or serve an order to show cause upon 

5 an applicant pursuant to section 304(c) of this Act not later 

6 than 180 days after receipt of an application and all infor7 mation the Attorney General deems necessary to make a 

8 determination under subsection (d). 

9 ‘‘(2) For the purposes of registration to manufacture 

10 a controlled substance under subsection (a) for use only in 

11 a clinical trial, the Attorney General shall, in accordance 

12 with regulations issued by the Attorney General, issue a no13 tice of application not later than 90 days after receipt of 

14 an application and all information the Attorney General 

15 deems necessary to issue a notice of application. Following 

16 the close of the comment period and receipt of all informa17 tion the Attorney General deems necessary to make a deter18 mination under subsection (a), the Attorney General shall 

19 register an applicant or serve an order to show cause upon 

20 an applicant pursuant to section 304(c) of this Act within 

21 180 days, unless a hearing on the application has been 

22 granted by the Attorney General pursuant to section 

23 1008(i) of the Controlled Substances Import and Export 

24 Act.’’. 


tkelley on DSK3SPTVN1PROD with BILLS

tkelley on DSK3SPTVN1PROD with BILLS
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 redistributors seeking to conduct clinical testing. with respect to registration of manufacturers and Secretary of Health and Human Services, and spect to drug scheduling recommendations by the 

SEPTEMBER 19, 2014 

Reported from the Committee on the Judiciary with an 

amendment 


tkelley on DSK3SPTVN1PROD with BILLS