[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 639 Engrossed Amendment Senate (EAS)]
<DOC>
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:
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.--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 products.--
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 Controls 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 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 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 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)'';
(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
``(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.''.
Attest:
Secretary.
114th CONGRESS
1st Session
H.R. 639
_______________________________________________________________________
AMENDMENT