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[114th Congress Public Law 89]
[From the U.S. Government Publishing Office]

[[Page 697]]

     IMPROVING REGULATORY TRANSPARENCY FOR NEW MEDICAL THERAPIES ACT

[[Page 129 STAT. 698]]

Public Law 114-89
114th Congress

                                 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. <<NOTE: Nov. 25, 2015 -  [H.R. 639]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Improving 
Regulatory Transparency for New Medical Therapies Act.>> 
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) <<NOTE: Definition.>>  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

[[Page 129 STAT. 699]]

        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) <<NOTE: Definition.>>  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) <<NOTE: Definition.>>  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) <<NOTE: Determination.>>  In the case of a request under 
subsection (d) to add a drug to the index under subsection (a) with 
respect to a drug

[[Page 129 STAT. 700]]

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) <<NOTE: Time period.>>  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) <<NOTE: Deadline. Regulations.>>  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 <<NOTE: Comments. Hearing.>>  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

[[Page 129 STAT. 701]]

        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) <<NOTE: Notification. Effective date.>>  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) <<NOTE: Definition.>>  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) <<NOTE: Deadlines.>>  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) <<NOTE: Notification.>>  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)'';

[[Page 129 STAT. 702]]

                          (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) <<NOTE: Deadline.>>  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) <<NOTE: Certification.>>  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

[[Page 129 STAT. 703]]

            ``(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.''.

    Approved November 25, 2015.

LEGISLATIVE HISTORY--H.R. 639:
---------------------------------------------------------------------------

HOUSE REPORTS: No. 114-41, Pt. 1 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD, Vol. 161 (2015):
            Mar. 16, considered and passed House.
            Oct. 26, considered and passed Senate, amended.
            Nov. 16, House concurred in Senate amendment.

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