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[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5228 Introduced in House (IH)]

<DOC>

115th CONGRESS
  2d Session
                                H. R. 5228

 To strengthen the authorities of the Food and Drug Administration to 
 address counterfeit drugs, illegal and synthetic opioids, and opioid-
                like substances, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             March 8, 2018

 Mr. Pallone introduced the following bill; which was referred to the 
 Committee on Energy and Commerce, and in addition to the Committee on 
the Budget, for a period to be subsequently determined by the Speaker, 
 in each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL

 
 To strengthen the authorities of the Food and Drug Administration to 
 address counterfeit drugs, illegal and synthetic opioids, and opioid-
                like substances, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Stop Counterfeit 
Drugs by Regulating and Enhancing Enforcement Now Act'' or the ``SCREEN 
Act''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Detention, refusal, and destruction of drugs offered for 
                            importation.
Sec. 3. Notification, nondistribution, and recall of adulterated or 
                            misbranded drug products.
Sec. 4. Seizure.
Sec. 5. Single source pattern of shipments of adulterated or misbranded 
                            drugs.
Sec. 6. Debarring violative individuals or companies.
Sec. 7. Account to strengthen efforts of FDA to combat the opioid and 
                            substance use epidemic.

SEC. 2. DETENTION, REFUSAL, AND DESTRUCTION OF DRUGS OFFERED FOR 
              IMPORTATION.

    (a) Certain Imported Products Deemed To Be Drugs.--Section 201(g) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) is 
amended by adding at the end the following:
    ``(3) An article being imported or offered for import is deemed to 
be a drug if it--
            ``(A) is or contains an active ingredient that is contained 
        within--
                    ``(i) a drug for which an approval is in effect 
                under section 505 of this Act; or
                    ``(ii) biological product for which a license is in 
                effect under section 351 of the Public Health Service 
                Act;
            ``(B) is or contains an active ingredient that is contained 
        within a drug or biological product for which an 
        investigational use exemption is in effect under section 505(i) 
        of this Act or section 351(a) of the Public Health Service Act, 
        for which substantial clinical investigations have been 
        instituted, and for which the existence of such investigations 
        has been made public; or
            ``(C) is a chemical analog of a drug or biological product 
        described in clause (A) or (B).''.
    (b) Articles of Concern.--
            (1) Delivery by treasury to hhs.--The first sentence of 
        section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 381(a)) is amended by striking ``and cosmetics'' and 
        inserting ``cosmetics, and potential articles of concern (as 
        defined in subsection (t)), and controlled substances described 
        paragraph (6) in the third sentence of this subsection''.
            (2) Repeal of antiquated review process.--
                    (A) Repeal.--The second sentence of section 801(a) 
                of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                381(a)) is repealed.
                    (B) Technical change to keep numbering of sentences 
                the same.--The first sentence of section 801(a) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) 
                is amended by striking ``the owner or consignee, who 
                may appear'' and inserting ``the owner or consignee. 
                The owner or consignee may appear''.
            (3) Refused admission.--
                    (A) In general.--The third sentence of section 
                801(a) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 381(a)) is amended--
                            (i) by striking ``If it appears from the 
                        examination'' and inserting ``Subject to 
                        subsection (b), if it appears from the 
                        examination''; and
                            (ii) by striking ``then such article shall 
                        be refused admission, except as provided in 
                        subsection (b) of this section'' and inserting 
                        ``or (5) such article is an article of concern 
                        (as defined in subsection (t)), or (6) such 
                        article is a controlled substance (as defined 
                        in section 102 of the Controlled Substances 
                        Act) for which a listing in any schedule is in 
                        effect (on a temporary or permanent basis) 
                        under section 201 of the Controlled Substances 
                        Act, or (7) such article is being imported or 
                        offered for import in violation of section 
                        301(cc), then such article may be refused 
                        admission, and if it appears such article may 
                        not be imported into the United States pursuant 
                        to subsection (d) or it appears that the 
                        article is a counterfeit drug, then such 
                        article shall be refused admission''.
                    (B) Definition of article of concern.--Section 801 
                of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                381) is amended by adding at the end the following:
    ``(t) Article of Concern Defined.--For purposes of subsection (a), 
the term `article of concern' means an article that is or contains a 
drug or other substance--
            ``(1) for which, during the 24-month period prior to the 
        article being imported or offered for import, the Secretary of 
        Health and Human Services--
                    ``(A) has requested that, based on a determination 
                that the drug or other substance appears to meet the 
                requirements for temporary or permanent scheduling 
                pursuant to section 201 of the Controlled Substances 
                Act, the Attorney General initiate the process to 
                control the drug or other substance in accordance with 
                such Act; or
                    ``(B) has made a determination, following the 
                publication by the Attorney General of a notice in the 
                Federal Register of the intention to issue an order 
                temporarily or permanently scheduling such drug or 
                substance in schedule I of section 202 of the 
                Controlled Substances Act, that such article presents 
                an imminent risk to the public health; and
            ``(2) with respect to which the Attorney General has not--
                    ``(A) scheduled the drug or other substance under 
                section 201 of such Act; or
                    ``(B) notified the Secretary of Health and Human 
                Services that the Attorney General has made a 
                determination not to schedule the drug or other 
                substance under such section.''.
    (c) Increasing the Maximum Dollar Amount of Drugs Subject to 
Destruction.--The sixth sentence in section 801(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended by striking 
``except that the Secretary'' and all that follows through the two 
periods at the end and inserting ``except that the Secretary of Health 
and Human Services may destroy, without the opportunity for export, any 
drug refused admission under this section, if such drug is valued at an 
amount that is $2,500 or less (or such higher amount as the Secretary 
of the Treasury may set by regulation pursuant to section 498(a)(1) of 
the Tariff Act of 1930 or such higher amount as the Commissioner of 
Food and Drugs may set based on a finding by the Commissioner that the 
higher amount is in the interest of public health) and was not brought 
into compliance as described under subsection (b).''.
    (d) Destruction of Articles of Concern.--The sixth sentence of 
section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381(a)), as amended by subsection (c), is further amended by inserting 
before the period at the end the following: ``; and the Secretary of 
Health and Human Services may destroy, without the opportunity for 
export, any article refused admission under clause (6) of the third 
sentence of this subsection.''.
    (e) Technical Amendments.--The seventh, eighth, and ninth sentences 
of section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 381(a)) are amended--
            (1) by striking ``a drug'' each place it appears and 
        inserting ``an article''; and
            (2) by striking ``the drug'' each place it appears and 
        inserting ``the article''.
    (f) Rule of Construction.--The last sentence in section 801(a) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended 
to read as follows: ``Clauses (2), (5), and (6) of the third sentence 
of this subsection shall not be construed to prohibit the admission of 
narcotic or nonnarcotic drugs or other substances, the importation of 
which is permitted under the Controlled Substances Import and Export 
Act.''.

SEC. 3. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR 
              MISBRANDED DRUG PRODUCTS.

    (a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(eee) The failure to comply with any order issued under section 
569D.''.
    (b) Notification, Nondistribution, and Recall of Adulterated or 
Misbranded Drugs.--Subchapter E of chapter V of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding at the 
end the following:

``SEC. 569D. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED 
              OR MISBRANDED DRUGS.

    ``(a) Order To Cease Distribution.--
            ``(1) In general.--If the Secretary has reason to believe 
        that the use or consumption of, or exposure to, a drug may 
        cause serious adverse health consequences or death to humans, 
        the Secretary may issue an order requiring any person who 
        distributes such drug to immediately cease distribution of such 
        drug.
            ``(2) Action following order.--Any person who is subject to 
        an order under paragraph (1) shall immediately cease 
        distribution of such drug and provide notification as required 
        by such order, and may appeal to the Secretary within 24 hours 
        of the issuance of such order. Such appeal may include a 
        request for an informal hearing and a description of any 
        efforts to recall such drug undertaken voluntarily by the 
        person, including after a request under subsection (b). Except 
        as provided in subsection (c), an informal hearing shall be 
        held as soon as practicable, but not later than 5 calendar 
        days, or less as determined by the Secretary, after such an 
        appeal is filed, unless the parties jointly agree to an 
        extension. After affording an opportunity for an informal 
        hearing, the Secretary shall determine whether the order should 
        be amended to require a recall of such drug. If, after 
        providing an opportunity for such a hearing, the Secretary 
        determines that inadequate grounds exist to support the actions 
        required by the order, the Secretary shall vacate the order.
    ``(b) Emergency Recall Order.--
            ``(1) In general.--If the Secretary has credible evidence 
        or information that a drug subject to an order under subsection 
        (a) presents an imminent threat of serious adverse health 
        consequences or death to humans, the Secretary may issue an 
        order requiring any person who distributes such drug--
                    ``(A) to immediately recall such drug; and
                    ``(B) to provide for notice, including to 
                individuals as appropriate, to persons who may be 
                affected by the recall.
            ``(2) Action following order.--Any person who is subject to 
        an emergency recall order under this subsection shall 
        immediately recall such drug and provide notification as 
        required by such order, and may appeal to the Secretary within 
        24 hours after issuance of such order. The person subject to an 
        emergency recall order shall conduct the recall notwithstanding 
        the pendency of any such appeal. An informal hearing shall be 
        held as soon as practicable but not later than 5 calendar days, 
        or less as determined by the Secretary, after such an appeal is 
        filed, unless the parties jointly agree to an extension. After 
        affording an opportunity for an informal hearing, the Secretary 
        shall determine whether the order should be amended pursuant to 
        subsection (d)(1). If, after providing an opportunity for such 
        a hearing, the Secretary determines that inadequate grounds 
        exist to support the actions required by the order, the 
        Secretary shall vacate the order.
    ``(c) Notice to Consumers and Health Officials.--The Secretary 
shall, as the Secretary determines to be necessary, provide notice of a 
recall order under this section to--
            ``(1) consumers to whom the drug was, or may have been, 
        distributed; and
            ``(2) appropriate State and local health officials.
    ``(d) Order To Recall.--
            ``(1) Amendment.--Except as provided under subsection (e), 
        if after providing an opportunity for an informal hearing under 
        subsection (a) or (b), the Secretary determines that an order 
        issued under subsection (a) or (b) should be amended to include 
        a recall of the drug with respect to which the order was 
        issued, the Secretary shall amend the order to require a 
        recall.
            ``(2) Contents.--An amended order under paragraph (1) 
        shall--
                    ``(A) specify a timetable in which the recall will 
                occur;
                    ``(B) require periodic reports to the Secretary 
                describing the progress of the recall; and
                    ``(C) provide for notice, including to individuals 
                as appropriate, to persons who may be affected by the 
                recall.
            ``(3) Assistance allowed.--In providing for notice under 
        paragraph (2)(C), the Secretary may allow for the assistance of 
        health professionals, State or local officials, or other 
        individuals designated by the Secretary.
            ``(4) Nondelegation.--An amended order under this 
        subsection shall be ordered by the Secretary or an official 
        designated by the Secretary. An official may not be so 
        designated under this section unless the official is the 
        director of the district in which the drug involved is located, 
        or is an official senior to such director.
    ``(e) Savings Clause.--Nothing contained in this section shall be 
construed as limiting--
            ``(1) the authority of the Secretary to issue an order to 
        cease distribution of, or to recall, an drug under any other 
        provision of this Act or the Public Health Service Act; or
            ``(2) the ability of the Secretary to request any person to 
        perform a voluntary activity related to any drug subject to 
        this Act or the Public Health Service Act.''.
    (c) Drugs Subject to Refusal.--The third sentence of subsection (a) 
of section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381), as amended by section 2(b)(C), is further amended by inserting 
``or (8) in the case of a drug, such drug is subject to an order under 
section 568 to cease distribution of or recall the drug,'' before 
``then such article shall be refused admission''.
    (d) Application.--Sections 301(eee) and 569D of the Federal Food, 
Drug, and Cosmetic Act, as added by subsections (a) and (b), shall 
apply with respect to a drug as of such date, not later than 1 year 
after the date of the enactment of this Act, as the Secretary of Health 
and Human Services shall specify.

SEC. 4. SEIZURE.

    Section 304(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 334(b)) is amended by striking the first sentence and inserting 
the following: ``The article, equipment, or other thing proceeded 
against shall be liable to seizure by process pursuant to the libel, 
and the procedure in cases under this section shall conform, as nearly 
as may be, to the procedure in admiralty rather than the procedure used 
for civil asset forfeiture proceedings set forth in section 983 of 
title 18, United States Code. On demand of either party any issue of 
fact joined in any such a case brought under this section shall be 
tried by jury. A seizure brought under this section is not governed by 
Rule G of the Supplemental Rules of Admiralty or Maritime Claims and 
Asset Forfeiture Actions. Exigent circumstances shall be deemed to 
exist for all seizures brought under this section, and in such cases, 
the summons and arrest warrant shall be issued by the clerk of the 
court without court review.''.

SEC. 5. SINGLE SOURCE PATTERN OF SHIPMENTS OF ADULTERATED OR MISBRANDED 
              DRUGS.

    Section 801 of the Federal Food, Drug, and Cosmetic Act is amended 
by adding at the end the following:
    ``(u) Single Source Pattern of Shipments of Adulterated or 
Misbranded Drugs.--If the Secretary identifies a pattern of adulterated 
or misbranded drugs being offered for import from the same 
manufacturer, distributor, or importer, the Secretary may by order 
choose to treat all drugs being offered for import from such 
manufacturer, distributor, or importer as adulterated or misbranded 
unless otherwise demonstrated.''.

SEC. 6. DEBARRING VIOLATIVE INDIVIDUALS OR COMPANIES.

    (a) Prohibited Act.--Section 301(cc) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(cc)) is amended to read as follows:
    ``(cc) The importing or offering for import into the United States 
of an article by, with the assistance of, or at the direction of, a 
person debarred from such activity under section 306(b)(3).''.
    (b) Debarment.--Section 306(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 335a(b)) is amended--
            (1) in paragraph (1)--
                    (A) in the matter preceding subparagraph (A), by 
                striking ``paragraph (2)'' and inserting ``paragraph 
                (2) or (3)'';
                    (B) in subparagraph (B), by striking ``or'' at the 
                end;
                    (C) in subparagraph (C), by striking the period at 
                the end and inserting ``, or''; and
                    (D) by adding at the end the following:
                    ``(D) a person from importing or offering to import 
                into the United States--
                            ``(i) a controlled substance as defined in 
                        section 102(6) of the Controlled Substances 
                        Act; or
                            ``(ii) any article that is regulated by the 
                        Food and Drug Administration that is valued at 
                        $2500 or less (or such higher amount as the 
                        Secretary of the Treasury may set by regulation 
                        pursuant to section 498(a)(1) of the Tariff Act 
                        of 1930).''; and
            (2) by striking paragraph (3) and inserting the following:
            ``(3) Persons subject to permissive debarment; 
        importation.--
                    ``(A) Food.--A person is subject to debarment under 
                paragraph (1)(C) if--
                            ``(i) the person has been convicted of a 
                        felony for conduct relating to the importation 
                        into the United States of any food; or
                            ``(ii) the person has engaged in a pattern 
                        of importing or offering for import adulterated 
                        food that presents a threat of serious adverse 
                        health consequences or death to humans or 
                        animals.
                    ``(B) Importation of drugs.--A person is subject to 
                debarment under paragraph (1)(D) if--
                            ``(i) the person has been convicted of a 
                        felony for conduct relating to the importation 
                        into the United States of any drug or 
                        controlled substance (as defined in section 102 
                        of the Controlled Substances Act); or
                            ``(ii) the person has engaged in a pattern 
                        of importing or offering for import drugs that 
                        are--
                                    ``(I) adulterated, misbranded, or 
                                in violation of section 505; or
                                    ``(II) controlled substances whose 
                                importation is prohibited pursuant to 
                                section 401(m) of the Tariff Act of 
                                1930.''.

SEC. 7. ACCOUNT TO STRENGTHEN EFFORTS OF FDA TO COMBAT THE OPIOID AND 
              SUBSTANCE USE EPIDEMIC.

    (a) In General.--The Commissioner of Food and Drugs (referred to in 
this section as the ``Commissioner'') shall use any funds appropriated 
pursuant to the authorization of appropriations under subsection (c) to 
carry out the programs and activities described in subsection (d) to 
strengthen and facilitate the Food and Drug Administration's efforts to 
address the opioid and substance use epidemic. Such funds shall be in 
addition to any funds which are otherwise available to carry out such 
programs and activities.
    (b) FDA Opioid and Substance Use Epidemic Response Fund.--
            (1) Establishment of fund.--There is established in the 
        Treasury an account, to be known as the FDA Opioid and 
        Substance Use Epidemic Response Fund (referred to in this 
        subsection as the ``Fund''), for purposes of funding the 
        programs and activities described in subsection (d).
            (2) Transfer.--For the period of fiscal years 2019 through 
        2023, $110,000,000 shall be transferred to the Fund from the 
        general fund of the Treasury.
            (3) Amounts deposited.--Any amounts transferred under 
        paragraph (2) shall remain unavailable in the Fund until such 
        amounts are appropriated pursuant to subsection (c).
    (c) Appropriations.--
            (1) Authorization of appropriations.--For the period of 
        fiscal years 2019 through 2023, there is authorized to be 
        appropriated from the Account to the Food and Drug 
        Administration, for the purpose of carrying out the programs 
        and activities described in subsection (d), an amount not to 
        exceed the total amount transferred to the Account under 
        subsection (b)(2). Notwithstanding subsection (g), such funds 
        shall remain available until expended.
            (2) Offsetting future appropriations.--For any of fiscal 
        years 2019 through 2023, for any discretionary appropriation 
        out of the Account to the Food and Drug Administration pursuant 
        to the authorization of appropriations under paragraph (1) for 
        the purpose of carrying out the programs and activities 
        described in subsection (d), the total amount of such 
        appropriations for the applicable fiscal year (not to exceed 
        the total amount remaining in the Account) shall be subtracted 
        from the estimate of discretionary budget authority and the 
        resulting outlays for any estimate under the Congressional 
        Budget and Impoundment Control Act of 1974 or the Balanced 
        Budget and Emergency Deficit Control Act of 1985, and the 
        amount transferred to the Account shall be reduced by the same 
        amount.
    (d) Food and Drug Administration.--The entirety of the funds made 
available pursuant to subsection (c)(1) shall be for the Commissioner 
of Food and Drugs, pursuant to applicable authorities in the Public 
Health Service Act (42 U.S.C. 201 et seq.) or the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.) and other applicable law, to 
support widespread innovation in non-opioid and non-addictive medical 
products for pain treatment, access to opioid addiction treatments, 
appropriate use of approved opioids, and efforts to reduce illicit 
importation of opioids. Such support may include the following programs 
and activities:
            (1) Obligating contract funds beginning in fiscal year 2019 
        for an educational campaign that will--
                    (A) educate patients and their families to 
                differentiate opioid medications;
                    (B) raise awareness about preferred storage and 
                disposal methods; and
                    (C) inform patients, families, and communities 
                about medication-assisted treatment options.
            (2) Building the Food and Drug Administration's presence in 
        international mail facilities, including through--
                    (A) improvements in equipment and information 
                technology enhancements to identify unapproved, 
                counterfeit, or other unlawful pharmaceuticals for 
                destruction;
                    (B) increased and improved surveillance;
                    (C) renovations at international mail facility 
                locations; and
                    (D) the purchase of laboratory equipment.
            (3) Enhancing the identification and targeting of firms and 
        products being offered for import into the United States 
        through review and analysis of websites, imports data, and 
        other sources of intelligence thereby making best use of the 
        Food and Drug Administration's inspectional and analytical 
        resources.
            (4) Increasing the number of staff to increase the number 
        of packages being examined, ensuring the safety of the staff 
        undertaking this work, and ensuring that packages identified as 
        illegal, counterfeit, misbranded, or adulterated are removed 
        from commerce through available authorities, including 
        administrative destruction.
            (5) Enhancing criminal investigations resources (including 
        full-time equivalent employees and equipment), imports 
        surveillance, and international work.
            (6) Obtaining equipment and full-time equivalent employees 
        needed to efficiently screen and analyze products offered for 
        import, including by building data libraries of new substances 
        and analogues to facilitate identification and evaluation of 
        pharmaceutical-based agents and by purchasing screening 
        technologies for use at international mail facilities.
            (7) Operating the Food and Drug Administration's forensic 
        laboratory facility to ensure adequate laboratory space and 
        functionality for additional work and full-time equivalent 
        employees.
    (e) Accountability and Oversight.--
            (1) Work plan.--
                    (A) In general.--Not later than 180 days after the 
                date of enactment of this Act, the Commissioner of Food 
                and Drugs shall submit to the Committee on Health, 
                Education, Labor, and Pensions of the Senate and the 
                Committee on Energy and Commerce of the House of 
                Representatives, a work plan including the proposed 
                allocation of funds appropriated pursuant to the 
                authorization of appropriations under subsection (c) 
                for each of fiscal years 2019 through 2023 and the 
                contents described in subparagraph (B).
                    (B) Contents.--The work plan submitted under 
                subparagraph (A) shall include--
                            (i) the amount of money to be obligated or 
                        expended out of the Account in each fiscal year 
                        for each program and activity described in 
                        subsection (d); and
                            (ii) a description and justification of 
                        each such program and activity.
            (2) Reports.--
                    (A) Annual reports.--Not later than October 1 of 
                each of fiscal years 2020 through 2024, the Secretary 
                of Health and Human Services shall submit to the 
                Committee on Health, Education, Labor, and Pensions of 
                the Senate and the Committee on Energy and Commerce of 
                the House of Representatives, a report including--
                            (i) the amount of money obligated or 
                        expended out of the Account in the prior fiscal 
                        year for each program and activity described in 
                        subsection (d);
                            (ii) a description of all programs and 
                        activities using funds provided pursuant to the 
                        authorization of appropriations under 
                        subsection (c); and
                            (iii) how the programs and activities are 
                        advancing public health.
                    (B) Additional reports.--At the request of the 
                Committee on Health, Education, Labor, and Pensions of 
                the Senate, or the Committee on Energy and Commerce of 
                the House of Representatives, the Commissioner shall 
                provide an update in the form of testimony and any 
                additional reports to the respective congressional 
                committee regarding the allocation of funding under 
                this section or the description of the programs and 
                activities undertaken with such funding.
    (f) Limitations.--Notwithstanding any transfer authority authorized 
by this Act or any appropriations Act, any funds made available 
pursuant to the authorization of appropriations under subsection (c) 
may not be used for any purpose other than the programs and activities 
described in subsection (d) strengthen and facilitate the Food and Drug 
Administration's efforts to address the opioid and substance use 
epidemic.
    (g) Sunset.--This section shall expire on September 30, 2022, 
except that--
            (1) this subsection does not apply to reporting under 
        subsection (e)(2); and
            (2) this section shall remain in effect until such time, 
        and to such extent, as may be necessary for the funds 
        transferred by subsection (b)(2) to be fully expended.
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