IIB 

114TH CONGRESS 

1ST SESSION H. R. 639 

IN THE SENATE OF THE UNITED STATES 

MARCH 17, 2015 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

AN ACT 

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, 

mstockstill on DSK4VPTVN1PROD with BILLS

2 

HR 639 RFS 

1 SECTION 1. SHORT TITLE. 

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

3 Transparency for New Medical Therapies Act’’. 

4 SEC. 2. SCHEDULING OF SUBSTANCES INCLUDED IN NEW 

5 FDA-APPROVED DRUGS. 

6 (a) EFFECTIVE DATE OF APPROVAL.— 

7 (1) EFFECTIVE DATE OF DRUG APPROVAL.— 

8 Section 505 of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 355) is amended by adding at 

10 the end the following: 

11 ‘‘(x) DATE OF APPROVAL IN THE CASE OF REC12 OMMENDED CONTROLS UNDER THE CSA.— 

13 ‘‘(1) IN GENERAL.—In the case of an applica14 tion under subsection (b) with respect to a drug for 

15 which the Secretary provides notice to the sponsor 

16 that the Secretary intends to recommend controls 

17 under the Controlled Substances Act, approval of 

18 such application shall not take effect until the in19 terim final rule controlling the drug is issued in ac20 cordance with section 201(j) of the Controlled Sub21 stances Act. 

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

23 this section, with respect to an application described 

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

25 mean the later of— 

mstockstill on DSK4VPTVN1PROD with BILLS

3 

HR 639 RFS 

1 ‘‘(A) the date an application under sub2 section (b) is approved under subsection (c); or 

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

4 final rule controlling the drug.’’. 

5 (2) EFFECTIVE DATE OF APPROVAL OF BIO6 LOGICAL PRODUCTS.—Section 351 of the Public 

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

8 adding at the end the following: 

9 ‘‘(n) DATE OF APPROVAL IN THE CASE OF REC10 OMMENDED CONTROLS UNDER THE CSA.— 

11 ‘‘(1) IN GENERAL.—In the case of an applica12 tion under subsection (a) with respect to a biological 

13 product for which the Secretary provides notice to 

14 the sponsor that the Secretary intends to rec15 ommend controls under the Controlled Substances 

16 Act, approval of such application shall not take ef17 fect until the interim final rule controlling the bio18 logical product is issued in accordance with section 

19 201(j) of the Controlled Substances Act. 

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

21 this section, with respect to an application described 

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

23 of such application, or licensure of the product sub24 ject to such application, shall mean the later of— 

mstockstill on DSK4VPTVN1PROD with BILLS

4 

HR 639 RFS 

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

2 under subsection (a); or 

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

4 final rule controlling the biological product.’’. 

5 (3) EFFECTIVE DATE OF APPROVAL OF ANIMAL

6 DRUGS.— 

7 (A) IN GENERAL.—Section 512 of the Fed8 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

9 360b) is amended by adding at the end the fol10 lowing: 

11 ‘‘(q) DATE OF APPROVAL IN THE CASE OF REC12 OMMENDED CONTROLS UNDER THE CSA.— 

13 ‘‘(1) IN GENERAL.—In the case of an applica14 tion under subsection (b) with respect to a drug for 

15 which the Secretary provides notice to the sponsor 

16 that the Secretary intends to recommend controls 

17 under the Controlled Substances Act, approval of 

18 such application shall not take effect until the in19 terim final rule controlling the drug is issued in ac20 cordance with section 201(j) of the Controlled Sub21 stances Act. 

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

23 this section, with respect to an application described 

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

25 mean the later of— 

mstockstill on DSK4VPTVN1PROD with BILLS

5 

HR 639 RFS 

1 ‘‘(A) the date an application under sub2 section (b) is approved under subsection (c); or 

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

4 final rule controlling the drug.’’. 

5 (B) CONDITIONAL APPROVAL.—Section 

6 571(d) of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 360ccc(d)) is amended by 

8 adding at the end the following: 

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

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

11 Secretary provides notice to the sponsor that the 

12 Secretary intends to recommend controls under the 

13 Controlled Substances Act, conditional 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 ‘‘(B) For purposes of this section, with respect 

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

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

21 ‘‘(i) the date an application under sub22 section (a) is conditionally approved under sub23 section (b); or 

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

25 final rule controlling the drug.’’. 

mstockstill on DSK4VPTVN1PROD with BILLS

6 

HR 639 RFS 

1 (C) INDEXING OF LEGALLY MARKETED

2 UNAPPROVED NEW ANIMAL DRUGS.—Section 

3 572 of the Federal Food, Drug, and Cosmetic 

4 Act (21 U.S.C. 360ccc–1) is amended by add5 ing at the end the following: 

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

7 to add a drug to the index under subsection (a) with re8 spect to a drug for which the Secretary provides notice 

9 to the person filing the request that the Secretary intends 

10 to recommend controls under the Controlled Substances 

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

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

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

14 controlling the drug is issued in accordance with section 

15 201(j) of the Controlled Substances Act.’’. 

16 (4) DATE OF APPROVAL FOR DESIGNATED NEW

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

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

19 2(c)) is amended by adding at the end the following: 

20 ‘‘(3) For purposes of determining the 7-year pe21 riod of exclusivity under paragraph (1) for a drug 

22 for which the Secretary intends to recommend con23 trols under the Controlled Substances Act, the drug 

24 shall not be considered approved or conditionally ap25 proved until the date that the interim final rule conmstockstill on DSK4VPTVN1PROD with BILLS

7 

HR 639 RFS 

1 trolling the drug is issued in accordance with section 

2 201(j) of the Controlled Substances Act.’’. 

3 (b) SCHEDULING OF NEWLY APPROVED DRUGS.— 

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

5 811) is amended by inserting after subsection (i) the fol6 lowing: 

7 ‘‘(j)(1) With respect to a drug referred to in sub8 section (f), if the Secretary of Health and Human Services 

9 recommends that the Attorney General add the drug to 

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

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

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

13 final rule controlling the drug in accordance with such 

14 subsections and section 202(b) using the procedures de15 scribed in paragraph (3). 

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

17 the later of— 

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

19 receives the scientific and medical evaluation and 

20 recommendations from the Secretary of Health and 

21 Human Services in accordance with subsection (b); 

22 or 

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

24 receives notification from the Secretary of Health 

25 and Human Services that the Secretary has apmstockstill on DSK4VPTVN1PROD with BILLS

8 

HR 639 RFS 

1 proved an application under section 505(c), 512, 

2 571, or 572 of the Federal Food, Drug, and Cos3 metic Act or section 351(a) of the Public Health 

4 Service Act with respect to the drug described in 

5 paragraph (1). 

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

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

8 provided in subsection (a), except that the rule shall be9 come immediately effective as an interim final rule without 

10 requiring the Attorney General to demonstrate good cause 

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

12 Attorney General shall issue a final rule in accordance 

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

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

15 title 35, United States Code, is amended— 

16 (1) in subsection (d)(1), in the matter pre17 ceding subparagraph (A), by inserting ‘‘, or in the 

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

19 within the 60-day period beginning on the covered 

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

21 or use’’; and 

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

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

24 of Health and Human Services provides notice to the 

25 sponsor of an application or request for approval, condimstockstill on DSK4VPTVN1PROD with BILLS

9 

HR 639 RFS 

1 tional approval, or indexing of a drug product for which 

2 the Secretary intends to recommend controls under the 

3 Controlled Substances Act, beginning on the covered date, 

4 the drug product shall be considered to— 

5 ‘‘(A) have been approved under the relevant 

6 provision of the Public Health Service Act or Fed7 eral Food, Drug, and Cosmetic Act; and 

8 ‘‘(B) have permission for commercial marketing 

9 or use. 

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

11 the later of— 

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

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

14 Public Health Service Act; or 

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

16 Federal Food, Drug, and Cosmetic Act; 

17 ‘‘(B) the date an application is conditionally ap18 proved under section 571(b) of the Federal Food, 

19 Drug, and Cosmetic Act; 

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

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

22 and Cosmetic Act; or 

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

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

25 Controlled Substances Act.’’. 

mstockstill on DSK4VPTVN1PROD with BILLS

10 

HR 639 RFS 

1 SEC. 3. ENHANCING NEW DRUG DEVELOPMENT. 

2 Section 303 of the Controlled Substances Act (21 

3 U.S.C. 823) is amended by adding at the end the fol4 lowing: 

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

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

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

8 applicant, or serve an order to show cause upon the appli9 cant in accordance with section 304(c), not later than 180 

10 days after the date on which the application is accepted 

11 for filing. 

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

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

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

15 with the regulations issued by the Attorney General, issue 

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

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

18 after the date on which the period for comment pursuant 

19 to such notice ends, the Attorney General shall register 

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

21 applicant in accordance with section 304(c), unless the At22 torney General has granted a hearing on the application 

mstockstill on DSK4VPTVN1PROD with BILLS

11 

HR 639 RFS 

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

2 and Export Act.’’. 

Passed the House of Representatives March 16, 

2015. 

Attest: KAREN L. HAAS, 

Clerk. 

mstockstill on DSK4VPTVN1PROD with BILLS