I 

114TH CONGRESS 

1ST SESSION H. R. 639 

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) 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 

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. 

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’’. 


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1 SEC. 2. SCHEDULING OF SUBSTANCES INCLUDED IN NEW 

2 FDA-APPROVED DRUGS. 

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

4 U.S.C. 811(a)) is amended by adding at the end the fol5 lowing: ‘‘Any such proceedings initiated at the request of 

6 the Secretary under this subsection to control a drug or 

7 other substance not previously scheduled, where the Sec8 retary has recommended the drug or other substance be 

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

10 not later than 120 days after receipt of written rec11 ommendations from the Secretary. The final rule shall be 

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

13 the public comment period has closed and the drug or 

14 other substance is the subject of an approved new drug 

15 application under section 505 of the Federal Food, Drug, 

16 and Cosmetic Act, unless a hearing on the proposed rule 

17 is granted by the Attorney General.’’. 

18 SEC. 3. ENHANCING NEW DRUG DEVELOPMENT. 

19 Section 303 of the Controlled Substances Act (21 

20 U.S.C. 823) is amended by adding at the end the fol21 lowing: 

22 ‘‘(i)(1) For the purposes of registration to manufac23 ture a controlled substance under subsection (d) of this 

24 section for use only in a clinical trial, the Attorney General 

25 shall register an applicant or serve an order to show cause 

26 upon an applicant pursuant to section 304(c) of this Act 


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1 not later than 180 days after receipt of an application and 

2 all information the Attorney General deems necessary to 

3 make a determination under subsection (d). 

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

5 a controlled substance under subsection (a) for use only 

6 in a clinical trial, the Attorney General shall, in accord7 ance with regulations issued by the Attorney General, 

8 issue a notice of application not later than 90 days after 

9 receipt of an application and all information the Attorney 

10 General deems necessary to issue a notice of application. 

11 Following the close of the comment period and receipt of 

12 all information the Attorney General deems necessary to 

13 make a determination under subsection (a), the Attorney 

14 General shall register an applicant or serve an order to 

15 show cause upon an applicant pursuant to section 304(c) 

16 of this Act within 180 days, unless a hearing on the appli17 cation has been granted by the Attorney General pursuant 

18 to section 1008(i) of the Controlled Substances Import 

19 and Export Act.’’. 

Æ 


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