II 

114TH CONGRESS 

1ST SESSION S. 481 

To amend the Controlled Substances Act and the Federal Food, Drug, and 

Cosmetic 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, 

and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 12, 2015 

Mr. HATCH (for himself and Mr. WHITEHOUSE) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Controlled Substances Act and the Federal 

Food, Drug, and Cosmetic 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, and for other purposes. 

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 (a) EFFECTIVE DATE OF APPROVAL.— 

4 (1) EFFECTIVE DATE OF DRUG APPROVAL.— 

5 Section 505 of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 355) is amended by adding at 

7 the end the following: 

8 ‘‘(x) DATE OF APPROVAL IN THE CASE OF REC9 OMMENDED CONTROLS UNDER THE CSA.— 

10 ‘‘(1) IN GENERAL.—In the case of an applica11 tion under subsection (b) with respect to a drug for 

12 which the Secretary provides notice to the sponsor 

13 that the Secretary intends to recommend controls 

14 under the Controlled Substances Act, approval of 

15 such application shall not take effect until the in16 terim final rule controlling the drug is issued in ac17 cordance with section 201(j) of the Controlled Sub18 stances Act. 

19 ‘‘(2) DATE OF APPROVAL.—For purposes of 

20 this section, with respect to an application described 

21 in paragraph (1), the term ‘date of approval’ shall 

22 mean the later of— 

23 ‘‘(A) the date an application under sub24 section (b) is approved under subsection (c); or 

25 ‘‘(B) the date of issuance of the interim 

26 final rule controlling the drug.’’. 


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1 (2) EFFECTIVE DATE OF APPROVAL OF BIO2 LOGICAL PRODUCTS.—Section 351 of the Public 

3 Health Service Act (42 U.S.C. 262) is amended by 

4 adding at the end the following: 

5 ‘‘(n) DATE OF APPROVAL IN THE CASE OF REC6 OMMENDED CONTROLS UNDER THE CSA.— 

7 ‘‘(1) IN GENERAL.—In the case of an applica8 tion under subsection (a) with respect to a biological 

9 product for which the Secretary provides notice to 

10 the sponsor that the Secretary intends to rec11 ommend controls under the Controlled Substances 

12 Act, approval of such application shall not take ef13 fect until the interim final rule controlling the bio14 logical product is issued in accordance with section 

15 201(j) of the Controlled Substances Act. 

16 ‘‘(2) DATE OF APPROVAL.—For purposes of 

17 this section, with respect to an application described 

18 in paragraph (1), references to the date of approval 

19 of such application, or licensure of the product sub20 ject to such application, shall mean the later of— 

21 ‘‘(A) the date an application is approved 

22 under subsection (a); or 

23 ‘‘(B) the date of issuance of the interim 

24 final rule controlling the biological product.’’. 


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1 (3) EFFECTIVE DATE OF APPROVAL OF ANIMAL

2 DRUGS.— 

3 (A) IN GENERAL.—Section 512 of the Fed4 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

5 360b) is amended by adding at the end the fol6 lowing: 

7 ‘‘(q) DATE OF APPROVAL IN THE CASE OF REC8 OMMENDED CONTROLS UNDER THE CSA.— 

9 ‘‘(1) IN GENERAL.—In the case of an applica10 tion under subsection (b) with respect to a drug for 

11 which the Secretary provides notice to the sponsor 

12 that the Secretary intends to recommend controls 

13 under the Controlled Substances Act, approval of 

14 such application shall not take effect until the in15 terim final rule controlling the drug is issued in ac16 cordance with section 201(j) of the Controlled Sub17 stances Act. 

18 ‘‘(2) DATE OF APPROVAL.—For purposes of 

19 this section, with respect to an application described 

20 in paragraph (1), the term ‘date of approval’ shall 

21 mean the later of— 

22 ‘‘(A) the date an application under sub23 section (b) is approved under subsection (c); or 

24 ‘‘(B) the date of issuance of the interim 

25 final rule controlling the drug.’’. 


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1 (B) CONDITIONAL APPROVAL.—Section 

2 571(d) of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 360ccc(d)) is amended by 

4 adding at the end the following: 

5 ‘‘(4)(A) In the case of an application under 

6 subsection (a) with respect to a drug for which the 

7 Secretary provides notice to the sponsor that the 

8 Secretary intends to recommend controls under the 

9 Controlled Substances Act, conditional approval of 

10 such application shall not take effect until the in11 terim final rule controlling the drug is issued in ac12 cordance with section 201(j) of the Controlled Sub13 stances Act. 

14 ‘‘(B) For purposes of this section, with respect 

15 to an application described in subparagraph (A), the 

16 term ‘date of approval’ shall mean the later of— 

17 ‘‘(i) the date an application under sub18 section (a) is conditionally approved under sub19 section (b); or 

20 ‘‘(ii) the date of issuance of the interim 

21 final rule controlling the drug.’’. 

22 (C) INDEXING OF LEGALLY MARKETED

23 UNAPPROVED NEW ANIMAL DRUGS.—Section 

24 572 of the Federal Food, Drug, and Cosmetic 


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1 Act (21 U.S.C. 360ccc–1) is amended by add2 ing at the end the following: 

3 ‘‘(k) In the case of a request under subsection (d) 

4 to add a drug to the index under subsection (a) with re5 spect to a drug for which the Secretary provides notice 

6 to the person filing the request that the Secretary intends 

7 to recommend controls under the Controlled Substances 

8 Act, a determination to grant the request to add such drug 

9 to the index shall not take effect, and the Secretary shall 

10 not list the drug on such index, until the interim final rule 

11 controlling the drug is issued in accordance with section 

12 201(j) of the Controlled Substances Act.’’. 

13 (4) DATE OF APPROVAL FOR DESIGNATED NEW

14 ANIMAL DRUGS.—Section 573(c) of the Federal 

15 Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc– 

16 2(c)) is amended by adding at the end the following: 

17 ‘‘(3) For purposes of determining the 7-year pe18 riod of exclusivity under paragraph (1) for a drug 

19 for which the Secretary intends to recommend con20 trols under the Controlled Substances Act, the drug 

21 shall not be considered approved or conditionally ap22 proved until the date that the interim final rule con23 trolling the drug is issued in accordance with section 

24 201(j) of the Controlled Substances Act.’’. 


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1 (b) SCHEDULING OF NEWLY APPROVED DRUGS.— 

2 Section 201 of the Controlled Substances Act (21 U.S.C. 

3 811) is amended by inserting after subsection (i) the fol4 lowing: 

5 ‘‘(j)(1) With respect to a drug referred to in sub6 section (f), if the Secretary of Health and Human Services 

7 recommends that the Attorney General add the drug to 

8 schedule II, III, IV, or V pursuant to subsections (a) and 

9 (b), the Attorney General shall, not later than 90 days 

10 after the date described in paragraph (2), issue an interim 

11 final rule controlling the drug in accordance with such 

12 subsections and section 202(b) using the procedures de13 scribed in paragraph (3). 

14 ‘‘(2) The date described in this paragraph shall be 

15 the later of— 

16 ‘‘(A) the date on which the Attorney General 

17 receives the scientific and medical evaluation and 

18 recommendations from the Secretary of Health and 

19 Human Services in accordance with subsection (b); 

20 or 

21 ‘‘(B) the date on which the Attorney General 

22 receives notification from the Secretary of Health 

23 and Human Services that the Secretary has ap24 proved an application under section 505(c), 512, 

25 571, or 572 of the Federal Food, Drug, and CosVerDate Sep 11 2014 00:05 Feb 24, 2015 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S481.IS S481

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1 metic Act or section 351(a) of the Public Health 

2 Service Act with respect to the drug described in 

3 paragraph (1). 

4 ‘‘(3) A rule issued by the Attorney General under 

5 paragraph (1) shall be in accordance with the procedures 

6 provided in subsection (a), except that the rule shall be7 come immediately effective as an interim final rule without 

8 requiring the Attorney General to demonstrate good cause 

9 therefor. After publication of the interim final rule, the 

10 Attorney General shall issue a final rule in accordance 

11 with the procedures provided in subsection (a).’’. 

12 (c) EXTENSION OF PATENT TERM.—Section 156 of 

13 title 35, United States Code, is amended— 

14 (1) in subsection (d)(1), in the matter pre15 ceding subparagraph (A), by inserting ‘‘, or in the 

16 case of a drug product described in subsection (i) 

17 within the sixty-day period beginning on the covered 

18 date (as defined in subsection (i))’’ after ‘‘marketing 

19 or use’’; and 

20 (2) by adding at the end the following: 

21 ‘‘(i)(1) For purposes of this section, if the Secretary 

22 of Health and Human Services provides notice to the 

23 sponsor of an application or request for approval, condi24 tional approval, or indexing of a drug product for which 

25 the Secretary intends to recommend controls under the 


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1 Controlled Substances Act, beginning on the covered date, 

2 the drug product shall be considered to— 

3 ‘‘(A) have been approved; and 

4 ‘‘(B) have permission for commercial marketing 

5 or use. 

6 ‘‘(2) In this subsection, the term ‘covered date’ means 

7 the later of— 

8 ‘‘(A) the date an application is approved— 

9 ‘‘(i) under section 351(a)(2)(C) of the 

10 Public Health Service Act; or 

11 ‘‘(ii) under section 505(b) or 512(c) of the 

12 Federal Food, Drug, and Cosmetic Act; 

13 ‘‘(B) the date an application is conditionally ap14 proved under section 571(b) of the Federal Food, 

15 Drug, and Cosmetic Act; 

16 ‘‘(C) the date a request for indexing is granted 

17 under section 572(d) of the Federal Food, Drug, 

18 and Cosmetic Act; or 

19 ‘‘(D) the date of issuance of the interim final 

20 rule controlling the drug under section 201(j) of the 

21 Controlled Substances Act.’’. 

22 SEC. 3. ENHANCING NEW DRUG DEVELOPMENT. 

23 Section 303 of the Controlled Substances Act (21 

24 U.S.C. 823) is amended by adding at the end the fol25 lowing: 


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

2 a controlled substance under subsection (d) for use only 

3 in a clinical trial, the Attorney General shall register the 

4 applicant, or serve an order to show cause upon the appli5 cant in accordance with section 304(c), not later than 180 

6 days after the date on which the application is accepted 

7 for filing. 

8 ‘‘(2) For purposes of registration to manufacture a 

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

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

11 with the regulations issued by the Attorney General, issue 

12 a notice of application not later than 90 days after the 

13 application is accepted for filing. Not later than 90 days 

14 after the date on which the period for comment pursuant 

15 to such notice ends, the Attorney General shall register 

16 the applicant, or serve an order to show cause upon the 

17 applicant in accordance with section 304(c), unless the At18 torney General has granted a hearing on the application 

19 under section 1008(i) of the Controlled Substances Import 

20 and Export Act.’’. 

Æ 


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