IB 

Union Calendar No. 26 

114TH CONGRESS 

1ST SESSION H. R. 639 

[Report No. 114–41, Part I] 

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 

MARCH 16, 2015 

Additional sponsor: Mrs. MCMORRIS RODGERS

MARCH 16, 2015 

Reported from the Committee on Energy and Commerce with amendments 

[Strike out all after the enacting clause and insert the part printed in italic] 

MARCH 16, 2015 

The Committee on the Judiciary discharged; committed to the Committee of 

the Whole House on the State of the Union and ordered to be printed 

[For text of introduced bill, see copy of bill as introduced on February 2, 2015] 


smartinez on DSK4TPTVN1PROD with BILLS
2 

•HR 639 RH

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. 


smartinez on DSK4TPTVN1PROD with BILLS
3 

•HR 639 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 (a) EFFECTIVE DATE OF APPROVAL.— 

9 (1) EFFECTIVE DATE OF DRUG APPROVAL.—Sec10 tion 505 of the Federal Food, Drug, and Cosmetic Act 

11 (21 U.S.C. 355) is amended by adding at the end the 

12 following: 

13 ‘‘(x) DATE OF APPROVAL IN THE CASE OF REC14 OMMENDED CONTROLS UNDER THE CSA.— 

15 ‘‘(1) IN GENERAL.—In the case of an application 

16 under subsection (b) with respect to a drug for which 

17 the Secretary provides notice to the sponsor that the 

18 Secretary intends to recommend controls under the 

19 Controlled Substances Act, approval of such applica20 tion shall not take effect until the interim final rule 

21 controlling the drug is issued in accordance with sec22 tion 201(j) of the Controlled Substances Act. 

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

24 section, with respect to an application described in 


smartinez on DSK4TPTVN1PROD with BILLS
4 

•HR 639 RH

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

2 the later of— 

3 ‘‘(A) the date an application under sub4 section (b) is approved under subsection (c); or 

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

6 final rule controlling the drug.’’. 

7 (2) EFFECTIVE DATE OF APPROVAL OF BIOLOGI8 CAL PRODUCTS.—Section 351 of the Public Health 

9 Service Act (42 U.S.C. 262) is amended by adding at 

10 the end the following: 

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

13 ‘‘(1) IN GENERAL.—In the case of an application 

14 under subsection (a) with respect to a biological prod15 uct for which the Secretary provides notice to the 

16 sponsor that the Secretary intends to recommend con17 trols under the Controlled Substances Act, approval of 

18 such application shall not take effect until the interim 

19 final rule controlling the biological product is issued 

20 in accordance with section 201(j) of the Controlled 

21 Substances Act. 

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

23 section, with respect to an application described in 

24 paragraph (1), references to the date of approval of 


smartinez on DSK4TPTVN1PROD with BILLS
5 

•HR 639 RH

1 such application, or licensure of the product subject to 

2 such application, shall mean the later of— 

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

4 under subsection (a); or 

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

6 final rule controlling the biological product.’’. 

7 (3) EFFECTIVE DATE OF APPROVAL OF ANIMAL

8 DRUGS.— 

9 (A) IN GENERAL.—Section 512 of the Fed10 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

11 360b) is amended by adding at the end the fol12 lowing: 

13 ‘‘(q) DATE OF APPROVAL IN THE CASE OF REC14 OMMENDED CONTROLS UNDER THE CSA.— 

15 ‘‘(1) IN GENERAL.—In the case of an application 

16 under subsection (b) with respect to a drug for which 

17 the Secretary provides notice to the sponsor that the 

18 Secretary intends to recommend controls under the 

19 Controlled Substances Act, approval of such applica20 tion shall not take effect until the interim final rule 

21 controlling the drug is issued in accordance with sec22 tion 201(j) of the Controlled Substances Act. 

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

24 section, with respect to an application described in 


smartinez on DSK4TPTVN1PROD with BILLS
6 

•HR 639 RH

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

2 the later of— 

3 ‘‘(A) the date an application under sub4 section (b) is approved under subsection (c); or 

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

6 final rule controlling the drug.’’. 

7 (B) CONDITIONAL APPROVAL.—Section 

8 571(d) of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 360ccc(d)) is amended by adding 

10 at the end the following: 

11 ‘‘(4)(A) In the case of an application under sub12 section (a) with respect to a drug for which the Sec13 retary provides notice to the sponsor that the Sec14 retary intends to recommend controls under the Con15 trolled Substances Act, conditional approval of such 

16 application shall not take effect until the interim 

17 final rule controlling the drug is issued in accordance 

18 with section 201(j) of the Controlled Substances Act. 

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

20 an application described in subparagraph (A), the 

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

22 ‘‘(i) the date an application under sub23 section (a) is conditionally approved under sub24 section (b); or 


smartinez on DSK4TPTVN1PROD with BILLS
7 

•HR 639 RH

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

2 final rule controlling the drug.’’. 

3 (C) INDEXING OF LEGALLY MARKETED UN4 APPROVED NEW ANIMAL DRUGS.—Section 572 of 

5 the Federal Food, Drug, and Cosmetic Act (21 

6 U.S.C. 360ccc–1) is amended by adding at the 

7 end the following: 

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

9 add a drug to the index under subsection (a) with respect 

10 to a drug for which the Secretary provides notice to the 

11 person filing the request that the Secretary intends to rec12 ommend controls under the Controlled Substances Act, a de13 termination to grant the request to add such drug to the 

14 index shall not take effect, and the Secretary shall not list 

15 the drug on such index, until the interim final rule control16 ling the drug is issued in accordance with section 201(j) 

17 of the Controlled Substances Act.’’. 

18 (4) DATE OF APPROVAL FOR DESIGNATED NEW

19 ANIMAL DRUGS.—Section 573(c) of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 360ccc–2(c)) is 

21 amended by adding at the end the following: 

22 ‘‘(3) For purposes of determining the 7-year pe23 riod of exclusivity under paragraph (1) for a drug for 

24 which the Secretary intends to recommend controls 

25 under the Controlled Substances Act, the drug shall 


smartinez on DSK4TPTVN1PROD with BILLS
8 

•HR 639 RH

1 not be considered approved or conditionally approved 

2 until the date that the interim final rule controlling 

3 the drug is issued in accordance with section 201(j) 

4 of the Controlled Substances Act.’’. 

5 (b) SCHEDULING OF NEWLY APPROVED DRUGS.—Sec6 tion 201 of the Controlled Substances Act (21 U.S.C. 811) 

7 is amended by inserting after subsection (i) the following: 

8 ‘‘(j)(1) With respect to a drug referred to in subsection 

9 (f), if the Secretary of Health and Human Services rec10 ommends that the Attorney General add the drug to sched11 ule II, III, IV, or V pursuant to subsections (a) and (b), 

12 the Attorney General shall, not later than 90 days after the 

13 date described in paragraph (2), issue an interim final rule 

14 controlling the drug in accordance with such subsections 

15 and section 202(b) using the procedures described in para16 graph (3). 

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

18 later of— 

19 ‘‘(A) the date on which the Attorney General re20 ceives the scientific and medical evaluation and rec21 ommendations from the Secretary of Health and 

22 Human Services in accordance with subsection (b); or 

23 ‘‘(B) the date on which the Attorney General re24 ceives notification from the Secretary of Health and 

25 Human Services that the Secretary has approved an 


smartinez on DSK4TPTVN1PROD with BILLS
9 

•HR 639 RH

1 application under section 505(c), 512, 571, or 572 of 

2 the Federal Food, Drug, and Cosmetic Act or section 

3 351(a) of the Public Health Service Act with respect 

4 to the drug described in paragraph (1). 

5 ‘‘(3) A rule issued by the Attorney General under para6 graph (1) shall be in accordance with the procedures pro7 vided in subsection (a), except that the rule shall become 

8 immediately effective as an interim final rule without re9 quiring the Attorney General to demonstrate good cause 

10 therefor. After publication of the interim final rule, the At11 torney General shall issue a final rule in accordance with 

12 the procedures provided in subsection (a).’’. 

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

14 title 35, United States Code, is amended— 

15 (1) in subsection (d)(1), in the matter preceding 

16 subparagraph (A), by inserting ‘‘, or in the case of a 

17 drug product described in subsection (i) within the 

18 sixty-day period beginning on the covered date (as de19 fined in subsection (i))’’ after ‘‘marketing or use’’; 

20 and 

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

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

23 of Health and Human Services provides notice to the spon24 sor of an application or request for approval, conditional 

25 approval, or indexing of a drug product for which the SecVerDate Sep 11 2014 00:28 Mar 17, 2015 Jkt 049200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6203 E:\BILLS\H639.RH H639

smartinez on DSK4TPTVN1PROD with BILLS
10 

•HR 639 RH

1 retary intends to recommend controls under the Controlled 

2 Substances Act, beginning on the covered date, the drug 

3 product shall be considered to— 

4 ‘‘(A) have been approved; and 

5 ‘‘(B) have permission for commercial marketing 

6 or use. 

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

8 the later of— 

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

10 ‘‘(i) under section 351(a)(2)(C) of the Pub11 lic Health Service Act; or 

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

13 Federal Food, Drug, and Cosmetic Act; 

14 ‘‘(B) the date an application is conditionally ap15 proved under section 571(b) of the Federal Food, 

16 Drug, and Cosmetic Act; 

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

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

19 Cosmetic Act; or 

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

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

22 Controlled Substances Act.’’. 

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: 


smartinez on DSK4TPTVN1PROD with BILLS
11 

•HR 639 RH

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

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

3 a clinical trial, the Attorney General shall register the ap4 plicant, or serve an order to show cause upon the applicant 

5 in accordance with section 304(c), not later than 180 days 

6 after the date on which the application is accepted for fil7 ing. 

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 ap13 plication is accepted for filing. Not later than 90 days after 

14 the date on which the period for comment pursuant to such 

15 notice ends, the Attorney General shall register the appli16 cant, or serve an order to show cause upon the applicant 

17 in accordance with section 304(c), unless the Attorney Gen18 eral has granted a hearing on the application under section 

19 1008(i) of the Controlled Substances Import and Export 

20 Act.’’. 

Amend the title so as to read: ‘‘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, and for other purposes.’’. 


smartinez on DSK4TPTVN1PROD with BILLS
Union Calendar No. 26 

114TH CONGRESS 

1ST SESSION H. R. 639 

[Report No. 114–41, Part I] 

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 

MARCH 16, 2015 

Reported from the Committee on Energy and Commerce 

M

with amendments 

ARCH 16, 2015 

The Committee on the Judiciary discharged; committed 

the Union and ordered to be printed to the Committee of the Whole House on the State of 


smartinez on DSK4TPTVN1PROD with BILLS