In the Senate of the United States, 
October 26, 2015. 
Resolved, That the bill from the House of Representa-
tives (H.R. 639) entitled ‘‘An Act to amend the Controlled 
Substances Act with respect to drug scheduling recommenda-
tions 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 fol-
lowing 
AMENDMENT: 
Strike all after the enacting clause and insert the 
following: 
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 
FDA-APPROVED DRUGS. 
(a) EFFECTIVE DATE OF APPROVAL.— 
(1) EFFECTIVE DATE OF DRUG APPROVAL.—Sec-
tion 505 of the Federal Food, Drug, and Cosmetic Act
† HR 639 EAS 
(21 U.S.C. 355) is amended by adding at the end the 
following: 
‘‘(x) DATE
OF APPROVAL
IN
THE CASE
OF REC-
OMMENDED 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 Con-
trolled Substances Act, approval of such application 
shall not take effect until the interim final rule con-
trolling 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 sub-
section (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 BIOLOGI-
CAL PRODUCTS.—Section 351 of the Public Health 
Service Act (42 U.S.C. 262) is amended by adding at 
the end the following:
† HR 639 EAS 
‘‘(n) DATE
OF APPROVAL
IN
THE CASE
OF REC-
OMMENDED CONTROLS UNDER THE CSA.— 
‘‘(1) IN GENERAL.—In the case of an application 
under subsection (a) with respect to a biological prod-
uct 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 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 Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C.
† HR 639 EAS 
360b) is amended by adding at the end the fol-
lowing: 
‘‘(q) DATE
OF APPROVAL
IN
THE CASE
OF REC-
OMMENDED 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 Con-
trolled Substances Act, approval of such application 
shall not take effect until the interim final rule con-
trolling 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 sub-
section (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:
† HR 639 EAS 
‘‘(4)(A) In the case of an application under sub-
section (a) with respect to a drug for which the Sec-
retary provides notice to the sponsor that the Sec-
retary intends to issue a scientific and medical eval-
uation and recommend controls under the Controlled 
Substances Act, conditional approval of such applica-
tion shall not take effect until the interim final rule 
controlling the drug is issued in accordance with sec-
tion 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 sub-
section (a) is conditionally approved under sub-
section (b); or 
‘‘(ii) the date of issuance of the interim 
final rule controlling the drug.’’. 
(C) INDEXING OF LEGALLY MARKETED UN-
APPROVED 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 for which the Secretary provides notice to the
† HR 639 EAS 
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 pe-
riod 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 con-
sidered 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 Con-
trolled Substances Act.’’. 
(b) SCHEDULING OF NEWLY APPROVED DRUGS.—Sec-
tion 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 rec-
† HR 639 EAS 
ommends 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 sub-
sections 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 re-
ceives the scientific and medical evaluation and the 
scheduling recommendation from the Secretary of 
Health and Human Services in accordance with sub-
section (b); or 
‘‘(B) the date on which the Attorney General re-
ceives 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 para-
graph (1) shall become immediately effective as an interim
† HR 639 EAS 
final rule without requiring the Attorney General to dem-
onstrate 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 described in subsection (i), within the 
sixty-day period beginning on the covered date (as de-
fined 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 spon-
sor of an application or request for approval, conditional 
approval, or indexing of a drug product for which the Sec-
retary intends to recommend controls under the Controlled 
Substances Act, beginning on the covered date, the drug 
product shall be considered to—
† HR 639 EAS 
‘‘(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 Pub-
lic 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 ap-
proved 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:
† HR 639 EAS 
‘‘(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 ap-
plicant, 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 fil-
ing. 
‘‘(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 ap-
plication 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 appli-
cant, or serve an order to show cause upon the applicant 
in accordance with section 304(c), unless the Attorney Gen-
eral 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 EURO-
PEAN ECONOMIC AREA. 
Section 1003 of the Controlled Substances Import and 
Export Act (21 U.S.C. 953) is amended— 
(1) in subsection(f)—
† HR 639 EAS 
(A) in paragraph (5)— 
(i) by striking ‘‘(5)’’ and inserting 
‘‘(5)(A)’’; 
(ii) by inserting ‘‘, except that the con-
trolled substance may be exported from a 
second country that is a member of the Eu-
ropean 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 fol-
lowing: 
‘‘(B) Subsequent to any re-exportation described 
in subparagraph (A), a controlled substance may con-
tinue to be exported from any country that is a mem-
ber 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),
† HR 639 EAS 
(3), (4), (6), and (7) are met by each subsequent 
country to which the controlled substance is ex-
ported 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 mem-
bers 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 pol-
icy which impedes re-exportation of any controlled sub-
stance among European Economic Area countries, includ-
ing by promulgating or enforcing any requirement that—