H. R. 639 

One Hundred Fourteenth Congress 

of the 

United States of America 

AT THE FIRST SESSION 

Begun and held at the City of Washington on Tuesday, 

the sixth day of January, two thousand and fifteen 

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. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘Improving Regulatory Transparency for New Medical Therapies Act’’. 

SEC. 2. SCHEDULING OF SUBSTANCES INCLUDED IN NEW FDAAPPROVED DRUGS. 

(a) EFFECTIVE DATE OF APPROVAL.— (1) EFFECTIVE DATE OF DRUG APPROVAL.—Section 505 of 

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 

is amended by adding at the end the following: 

‘‘(x) DATE OF APPROVAL IN THE CASE OF RECOMMENDED CONTROLS UNDER THE CSA.— 

‘‘(1) IN GENERAL.—In the case of an application under subsection (b) with respect to a drug for which the Secretary 

provides notice to the sponsor that the Secretary intends to 

issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act, approval of such 

application shall not take effect until the interim final rule 

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

of the Controlled Substances Act. 

‘‘(2) DATE OF APPROVAL.—For purposes of this section, with 

respect to an application described in paragraph (1), the term 

‘date of approval’ shall mean the later of— 

‘‘(A) the date an application under subsection (b) is 

approved under subsection (c); or 

‘‘(B) the date of issuance of the interim final rule 

controlling the drug.’’. 

(2) EFFECTIVE DATE OF APPROVAL OF BIOLOGICAL PROD- UCTS.—Section 351 of the Public Health Service Act (42 U.S.C. 

262) is amended by adding at the end the following: 

‘‘(n) DATE OF APPROVAL IN THE CASE OF RECOMMENDED CON- TROLS UNDER THE CSA.— 

‘‘(1) IN GENERAL.—In the case of an application under subsection (a) with respect to a biological product for which the 

Secretary provides notice to the sponsor that the Secretary 

intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act, approval 
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of such application shall not take effect until the interim final 

rule controlling the biological product is issued in accordance 

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

‘‘(2) DATE OF APPROVAL.—For purposes of this section, with 

respect to an application described in paragraph (1), references 

to the date of approval of such application, or licensure of 

the product subject to such application, shall mean the later 

of— 

‘‘(A) the date an application is approved under subsection (a); or 

‘‘(B) the date of issuance of the interim final rule 

controlling the biological product.’’. 

(3) EFFECTIVE DATE OF APPROVAL OF ANIMAL DRUGS.— 

(A) IN GENERAL.—Section 512 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 360b) is amended by 

adding at the end the following: 

‘‘(q) DATE OF APPROVAL IN THE CASE OF RECOMMENDED CONTROLS UNDER THE CSA.— 

‘‘(1) IN GENERAL.—In the case of an application under subsection (b) with respect to a drug for which the Secretary 

provides notice to the sponsor that the Secretary intends to 

issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act, approval of such 

application shall not take effect until the interim final rule 

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

of the Controlled Substances Act. 

‘‘(2) DATE OF APPROVAL.—For purposes of this section, with 

respect to an application described in paragraph (1), the term 

‘date of approval’ shall mean the later of— 

‘‘(A) the date an application under subsection (b) is 

approved under subsection (c); or 

‘‘(B) the date of issuance of the interim final rule 

controlling the drug.’’. 

(B) CONDITIONAL APPROVAL.—Section 571(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc(d)) 

is amended by adding at the end the following: 

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

with respect to a drug for which the Secretary provides notice 

to the sponsor that the Secretary intends to issue a scientific 

and medical evaluation and recommend controls under the 

Controlled Substances Act, conditional approval of such application shall not take effect until the interim final rule controlling 

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

Controlled Substances Act. 

‘‘(B) For purposes of this section, with respect to an application described in subparagraph (A), the term ‘date of approval’ 

shall mean the later of— 

‘‘(i) the date an application under subsection (a) is 

conditionally approved under subsection (b); or 

‘‘(ii) the date of issuance of the interim final rule 

controlling the drug.’’. 

(C) INDEXING OF LEGALLY MARKETED UNAPPROVED NEW

ANIMAL DRUGS.—Section 572 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 360ccc–1) is amended by 

adding at the end the following: 

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

drug to the index under subsection (a) with respect to a drug 
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for which the Secretary provides notice to the person filing the 

request that the Secretary intends to issue a scientific and medical 

evaluation and recommend controls under the Controlled Substances Act, a determination to grant the request to add such 

drug to the index shall not take effect until the interim final 

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

of the Controlled Substances Act.’’. 

(4) DATE OF APPROVAL FOR DESIGNATED NEW ANIMAL

DRUGS.—Section 573(c) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 360ccc–2(c)) is amended by adding at the end 

the following: 

‘‘(3) For purposes of determining the 7-year period of exclusivity under paragraph (1) for a drug for which the Secretary 

intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act, the 

drug shall not be considered approved or conditionally approved 

until the date that the interim final rule controlling the drug 

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

Substances Act.’’. 

(b) SCHEDULING OF NEWLY APPROVED DRUGS.—Section 201 of 

the Controlled Substances Act (21 U.S.C. 811) is amended by 

inserting after subsection (i) the following: 

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

if the Secretary of Health and Human Services recommends that 

the Attorney General control the drug in schedule II, III, IV, or 

V pursuant to subsections (a) and (b), the Attorney General shall, 

not later than 90 days after the date described in paragraph (2), 

issue an interim final rule controlling the drug in accordance with 

such subsections and section 202(b) using the procedures described 

in paragraph (3). 

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

of— 

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

scientific and medical evaluation and the scheduling recommendation from the Secretary of Health and Human Services 

in accordance with subsection (b); or 

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

notification from the Secretary of Health and Human Services 

that the Secretary has approved an application under section 

505(c), 512, or 571 of the Federal Food, Drug, and Cosmetic 

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

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

and Cosmetic Act, with respect to the drug described in paragraph (1). 

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

(1) shall become immediately effective as an interim final rule 

without requiring the Attorney General to demonstrate good cause 

therefor. The interim final rule shall give interested persons the 

opportunity to comment and to request a hearing. After the conclusion of such proceedings, the Attorney General shall issue a final 

rule in accordance with the scheduling criteria of subsections (b), 

(c), and (d) of this section and section 202(b).’’. 

(c) EXTENSION OF PATENT TERM.—Section 156 of title 35, United 

States Code, is amended— 

(1) in subsection (d)(1), in the matter preceding subparagraph (A), by inserting ‘‘, or in the case of a drug product 
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described in subsection (i), within the sixty-day period beginning on the covered date (as defined in subsection (i))’’ after 

‘‘marketing or use’’; and 

(2) by adding at the end the following: 

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

and Human Services provides notice to the sponsor of an application 

or request for approval, conditional approval, or indexing of a drug 

product for which the Secretary intends to recommend controls 

under the Controlled Substances Act, beginning on the covered 

date, the drug product shall be considered to— 

‘‘(A) have been approved or indexed under the relevant 

provision of the Public Health Service Act or Federal Food, 

Drug, and Cosmetic Act; and 

‘‘(B) have permission for commercial marketing or use. 

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

of— 

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

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

Service Act; or 

‘‘(ii) under section 505(b) or 512(c) of the Federal Food, 

Drug, and Cosmetic Act; 

‘‘(B) the date an application is conditionally approved under 

section 571(b) of the Federal Food, Drug, and Cosmetic Act; 

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

572(d) of the Federal Food, Drug, and Cosmetic Act; or 

‘‘(D) the date of issuance of the interim final rule controlling 

the drug under section 201(j) of the Controlled Substances 

Act.’’. 

SEC. 3. ENHANCING NEW DRUG DEVELOPMENT. 

Section 303 of the Controlled Substances Act (21 U.S.C. 823) 

is amended by adding at the end the following: 

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

substance under subsection (d) for use only in a clinical trial, 

the Attorney General shall register the applicant, or serve an order 

to show cause upon the applicant in accordance with section 304(c), 

not later than 180 days after the date on which the application 

is accepted for filing. 

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

substance under subsection (a) for use only in a clinical trial, 

the Attorney General shall, in accordance with the regulations 

issued by the Attorney General, issue a notice of application not 

later than 90 days after the application is accepted for filing. 

Not later than 90 days after the date on which the period for 

comment pursuant to such notice ends, the Attorney General shall 

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

applicant in accordance with section 304(c), unless the Attorney 

General has granted a hearing on the application under section 

1008(i) of the Controlled Substances Import and Export Act.’’. 

SEC. 4. RE-EXPORTATION AMONG MEMBERS OF THE EUROPEAN ECONOMIC AREA. 

Section 1003 of the Controlled Substances Import and Export 

Act (21 U.S.C. 953) is amended— 

(1) in subsection (f)— 

(A) in paragraph (5)— 

(i) by striking ‘‘(5)’’ and inserting ‘‘(5)(A)’’; 
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(ii) by inserting ‘‘, except that the controlled substance may be exported from a second country that 

is a member of the European Economic Area to another 

country that is a member of the European Economic 

Area, provided that the first country is also a member 

of the European Economic Area’’ before the period at 

the end; and 

(iii) by adding at the end the following: 

‘‘(B) Subsequent to any re-exportation described in subparagraph (A), a controlled substance may continue to be exported 

from any country that is a member of the European Economic 

Area to any other such country, if— 

‘‘(i) the conditions applicable with respect to the first 

country under paragraphs (1), (2), (3), (4), (6), and (7) 

are met by each subsequent country from which the controlled substance is exported pursuant to this paragraph; 

and 

‘‘(ii) the conditions applicable with respect to the second 

country under paragraphs (1), (2), (3), (4), (6), and (7) 

are met by each subsequent country to which the controlled 

substance is exported pursuant to this paragraph.’’; and 

(B) in paragraph (6)— 

(i) by striking ‘‘(6)’’ and inserting ‘‘(6)(A)’’; and 

(ii) by adding at the end the following: 

‘‘(B) In the case of re-exportation among members of the 

European Economic Area, within 30 days after each re-exportation, the person who exported the controlled substance from 

the United States delivers to the Attorney General— 

‘‘(i) documentation certifying that such re-exportation 

has occurred; and 

‘‘(ii) information concerning the consignee, country, and 

product.’’; and 

(2) by adding at the end the following: 

‘‘(g) LIMITATION.—Subject to paragraphs (5) and (6) of subsection (f) in the case of any controlled substance in schedule 

I or II or any narcotic drug in schedule III or IV, the Attorney 

General shall not promulgate nor enforce any regulation, subregulatory guidance, or enforcement policy which impedes re-exportation 

of any controlled substance among European Economic Area countries, including by promulgating or enforcing any requirement 

that— 

‘‘(1) re-exportation from the first country to the second 

country or re-exportation from the second country to another 

country occur within a specified period of time; or 
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‘‘(2) information concerning the consignee, country, and 

product be provided prior to exportation of the controlled substance from the United States or prior to each re-exportation 

among members of the European Economic Area.’’. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.