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 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 of the Controlled Substances Act (21 

4 U.S.C. 811) is amended by inserting after subsection (h) 

5 the following: 

6 ‘‘(i) Within 45 days of receiving a recommendation 

7 from the Secretary to add a drug or substance that has 

8 never been marketed in the United States to a schedule 

9 under this title, the Attorney General shall, without regard 

10 to the findings required by subsection (a) of this section 

11 or section 202(b), issue an interim final rule, under the 

12 exception for good cause described in subparagraph (B) 

13 of section 553(b) of title 5, United States Code, placing 

14 the drug or substance into the schedule recommended by 

15 the Secretary. The interim final rule shall be made imme16 diately effective under section 553(d)(3) of title 5, United 

17 States Code.’’. 

18 SEC. 3. ENHANCING NEW DRUG DEVELOPMENT. 

19 Section 302 of the Controlled Substances Act (21 

20 U.S.C. 822) is amended by inserting after subsection (g) 

21 the following: 

22 ‘‘(h)(1) A person who submits an application for reg23 istration to manufacture or distribute a controlled sub24 stance in accordance with this section may indicate on the 

25 registration application that the substance will be used 

26 only in connection with clinical trials of a drug in accordVerDate Mar 15 2010 03:53 Mar 28, 2014 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4299.IH H4299

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1 ance with section 505(i) of the Federal Food, Drug, and 

2 Cosmetic Act. 

3 ‘‘(2) When an application for registration to manu4 facture or distribute a controlled substance includes an in5 dication that the controlled substance will be used only 

6 in connection with clinical trials of a drug in accordance 

7 with section 505(i) of the Federal Food, Drug, and Cos8 metic Act, the Attorney General shall— 

9 ‘‘(A) make a final decision on the application 

10 for registration within 180 days; or 

11 ‘‘(B) provide notice to the applicant in writing 

12 of— 

13 ‘‘(i) the outstanding issues that must be 

14 resolved in order to reach a final decision on 

15 the application; and 

16 ‘‘(ii) the estimated date on which a final 

17 decision on the application will be made.’’. 

Æ 


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