In the Senate of the United States, 

October 26, 2015. 

Resolved, That the bill from the House of Representatives (H.R. 639) entitled ‘‘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.’’, do pass with the following 

AMENDMENT: 

Strike all after the enacting clause and insert the 

following: 

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.—Sec8 tion 505 of the Federal Food, Drug, and Cosmetic Act 
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1 (21 U.S.C. 355) is amended by adding at the end the 

2 following: 

3 ‘‘(x) DATE OF APPROVAL IN THE CASE OF REC4 OMMENDED CONTROLS UNDER THE CSA.— 

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

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

7 the Secretary provides notice to the sponsor that the 

8 Secretary intends to issue a scientific and medical 

9 evaluation and recommend controls under the Con10 trolled Substances Act, approval of such application 

11 shall not take effect until the interim final rule con12 trolling the drug is issued in accordance with section 

13 201(j) of the Controlled Substances Act. 

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

15 section, with respect to an application described in 

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

17 the later of— 

18 ‘‘(A) the date an application under sub19 section (b) is approved under subsection (c); or 

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

21 final rule controlling the drug.’’. 

22 (2) EFFECTIVE DATE OF APPROVAL OF BIOLOGI23 CAL PRODUCTS.—Section 351 of the Public Health 

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

25 the end the following: 
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1 ‘‘(n) DATE OF APPROVAL IN THE CASE OF REC2 OMMENDED CONTROLS UNDER THE CSA.— 

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

4 under subsection (a) with respect to a biological prod5 uct for which the Secretary provides notice to the 

6 sponsor that the Secretary intends to issue a scientific 

7 and medical evaluation and recommend controls 

8 under the Controlled Substances Act, approval of such 

9 application shall not take effect until the interim 

10 final rule controlling the biological product is issued 

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

12 Substances Act. 

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

14 section, with respect to an application described in 

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

16 such application, or licensure of the product subject to 

17 such application, shall mean the later of— 

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

19 under subsection (a); or 

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

21 final rule controlling the biological product.’’. 

22 (3) EFFECTIVE DATE OF APPROVAL OF ANIMAL

23 DRUGS.— 

24 (A) IN GENERAL.—Section 512 of the Fed25 eral Food, Drug, and Cosmetic Act (21 U.S.C. 
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1 360b) is amended by adding at the end the fol2 lowing: 

3 ‘‘(q) DATE OF APPROVAL IN THE CASE OF REC4 OMMENDED CONTROLS UNDER THE CSA.— 

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

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

7 the Secretary provides notice to the sponsor that the 

8 Secretary intends to issue a scientific and medical 

9 evaluation and recommend controls under the Con10 trolled Substances Act, approval of such application 

11 shall not take effect until the interim final rule con12 trolling the drug is issued in accordance with section 

13 201(j) of the Controlled Substances Act. 

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

15 section, with respect to an application described in 

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

17 the later of— 

18 ‘‘(A) the date an application under sub19 section (b) is approved under subsection (c); or 

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

21 final rule controlling the drug.’’. 

22 (B) CONDITIONAL APPROVAL.—Section 

23 571(d) of the Federal Food, Drug, and Cosmetic 

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

25 at the end the following: 
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1 ‘‘(4)(A) In the case of an application under sub2 section (a) with respect to a drug for which the Sec3 retary provides notice to the sponsor that the Sec4 retary intends to issue a scientific and medical eval5 uation and recommend controls under the Controlled 

6 Substances Act, conditional approval of such applica7 tion shall not take effect until the interim final rule 

8 controlling the drug is issued in accordance with sec9 tion 201(j) of the Controlled Substances Act. 

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

11 an application described in subparagraph (A), the 

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

13 ‘‘(i) the date an application under sub14 section (a) is conditionally approved under sub15 section (b); or 

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

17 final rule controlling the drug.’’. 

18 (C) INDEXING OF LEGALLY MARKETED UN19 APPROVED NEW ANIMAL DRUGS.—Section 572 of 

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

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

22 end the following: 

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

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

25 to a drug for which the Secretary provides notice to the 
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1 person filing the request that the Secretary intends to issue 

2 a scientific and medical evaluation and recommend controls 

3 under the Controlled Substances Act, a determination to 

4 grant the request to add such drug to the index shall not 

5 take effect until the interim final rule controlling the drug 

6 is issued in accordance with section 201(j) of the Controlled 

7 Substances Act.’’. 

8 (4) DATE OF APPROVAL FOR DESIGNATED NEW

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

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

11 amended by adding at the end the following: 

12 ‘‘(3) For purposes of determining the 7-year pe13 riod of exclusivity under paragraph (1) for a drug for 

14 which the Secretary intends to issue a scientific and 

15 medical evaluation and recommend controls under the 

16 Controlled Substances Act, the drug shall not be con17 sidered approved or conditionally approved until the 

18 date that the interim final rule controlling the drug 

19 is issued in accordance with section 201(j) of the Con20 trolled Substances Act.’’. 

21 (b) SCHEDULING OF NEWLY APPROVED DRUGS.—Sec22 tion 201 of the Controlled Substances Act (21 U.S.C. 811) 

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

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

25 (f), if the Secretary of Health and Human Services rec-
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1 ommends that the Attorney General control the drug in 

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

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

4 the date described in paragraph (2), issue an interim final 

5 rule controlling the drug in accordance with such sub6 sections and section 202(b) using the procedures described 

7 in paragraph (3). 

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

9 later of— 

10 ‘‘(A) the date on which the Attorney General re11 ceives the scientific and medical evaluation and the 

12 scheduling recommendation from the Secretary of 

13 Health and Human Services in accordance with sub14 section (b); or 

15 ‘‘(B) the date on which the Attorney General re16 ceives notification from the Secretary of Health and 

17 Human Services that the Secretary has approved an 

18 application under section 505(c), 512, or 571 of the 

19 Federal Food, Drug, and Cosmetic Act or section 

20 351(a) of the Public Health Service Act, or indexed 

21 a drug under section 572 of the Federal Food, Drug, 

22 and Cosmetic Act, with respect to the drug described 

23 in paragraph (1). 

24 ‘‘(3) A rule issued by the Attorney General under para25 graph (1) shall become immediately effective as an interim 
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1 final rule without requiring the Attorney General to dem2 onstrate good cause therefor. The interim final rule shall 

3 give interested persons the opportunity to comment and to 

4 request a hearing. After the conclusion of such proceedings, 

5 the Attorney General shall issue a final rule in accordance 

6 with the scheduling criteria of subsections (b), (c), and (d) 

7 of this section and section 202(b).’’. 

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

9 title 35, United States Code, is amended— 

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

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

12 drug product described in subsection (i), within the 

13 sixty-day period beginning on the covered date (as de14 fined in subsection (i))’’ after ‘‘marketing or use’’; 

15 and 

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

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

18 of Health and Human Services provides notice to the spon19 sor of an application or request for approval, conditional 

20 approval, or indexing of a drug product for which the Sec21 retary intends to recommend controls under the Controlled 

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

23 product shall be considered to— 
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1 ‘‘(A) have been approved or indexed under the 

2 relevant provision of the Public Health Service Act or 

3 Federal Food, Drug, and Cosmetic Act; 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 Pub10 lic 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, and 

18 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 following: 
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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.’’. 

21 SEC. 4. RE-EXPORTATION AMONG MEMBERS OF THE EURO22 PEAN ECONOMIC AREA. 

23 Section 1003 of the Controlled Substances Import and 

24 Export Act (21 U.S.C. 953) is amended— 

25 (1) in subsection(f)— 
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1 (A) in paragraph (5)— 

2 (i) by striking ‘‘(5)’’ and inserting 

3 ‘‘(5)(A)’’; 

4 (ii) by inserting ‘‘, except that the con5 trolled substance may be exported from a 

6 second country that is a member of the Eu7 ropean Economic Area to another country 

8 that is a member of the European Economic 

9 Area, provided that the first country is also 

10 a member of the European Economic Area’’ 

11 before the period at the end; and 

12 (iii) by adding at the end the fol13 lowing: 

14 ‘‘(B) Subsequent to any re-exportation described 

15 in subparagraph (A), a controlled substance may con16 tinue to be exported from any country that is a mem17 ber of the European Economic Area to any other such 

18 country, if— 

19 ‘‘(i) the conditions applicable with respect 

20 to the first country under paragraphs (1), (2), 

21 (3), (4), (6), and (7) are met by each subsequent 

22 country from which the controlled substance is 

23 exported pursuant to this paragraph; and 

24 ‘‘(ii) the conditions applicable with respect 

25 to the second country under paragraphs (1), (2), 
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1 (3), (4), (6), and (7) are met by each subsequent 

2 country to which the controlled substance is ex3 ported pursuant to this paragraph.’’; and 

4 (B) in paragraph (6)— 

5 (i) by striking ‘‘(6)’’ and inserting 

6 ‘‘(6)(A)’’; and 

7 (ii) by adding at the end the following: 

8 ‘‘(B) In the case of re-exportation among mem9 bers of the European Economic Area, within 30 days 

10 after each re-exportation, the person who exported the 

11 controlled substance from the United States delivers to 

12 the Attorney General— 

13 ‘‘(i) documentation certifying that such re14 exportation has occurred; and 

15 ‘‘(ii) information concerning the consignee, 

16 country, and product.’’; and 

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

18 ‘‘(g) LIMITATION.—Subject to paragraphs (5) and (6) 

19 of subsection (f) in the case of any controlled substance in 

20 schedule I or II or any narcotic drug in schedule III or 

21 IV, the Attorney General shall not promulgate nor enforce 

22 any regulation, subregulatory guidance, or enforcement pol23 icy which impedes re-exportation of any controlled sub24 stance among European Economic Area countries, includ25 ing by promulgating or enforcing any requirement that— 
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1 ‘‘(1) re-exportation from the first country to the 

2 second country or re-exportation from the second 

3 country to another country occur within a specified 

4 period of time; or 

5 ‘‘(2) information concerning the consignee, coun6 try, and product be provided prior to exportation of 

7 the controlled substance from the United States or 

8 prior to each re-exportation among members of the 

9 European Economic Area.’’. 

Attest: 

Secretary. 
114TH CONGRESS 

1ST SESSION H.R. 639 

AMENDMENT