Opioid QuOTA Act of 2021
Bill: S.3327 | Sponsor: Sen. Markey, Edward J. (D-MA)
Policy area: Crime and Law Enforcement

Summary:
Opioid Quota Openness, Transparency, and Awareness Act of 2021 or the Opioid QuOTA Act of 2021
This bill requires the Drug Enforcement Administration to make publicly available on its website certain information regarding opioid procurement quotas.
The term opioid procurement quota means the maximum quantity of opioid analgesics that a registered manufacturer may procure.

To amend the Controlled Substances Act to require the Attorney General 
 to make procurement quotas for opioid analgesics publicly available, 
                        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.

    This Act may be cited as the ``Opioid Quota Openness, Transparency, 
and Awareness Act of 2021'' or the ``Opioid QuOTA Act of 2021''.

SEC. 2. PUBLIC REPORTING OF PROCUREMENT QUOTAS FOR OPIOID ANALGESICS.

    (a) In General.--Section 306 of the Controlled Substances Act (21 
U.S.C. 826) is amended by adding at the end the following:
    ``(j)(1) In this subsection, the term `opioid procurement quota' 
means a quota established by the Attorney General for the quantity of 
opioid analgesics that a registered manufacturer may procure for 
purposes of manufacturing dosage forms or other substances.
    ``(2) The Attorney General shall make publicly available, including 
through the website of the Drug Enforcement Administration--
            ``(A) the quantity of the opioid procurement quota for each 
        registered manufacturer for each year;
            ``(B) the quantity of opioid analgesics procured by each 
        registered manufacturer for each year; and
            ``(C) except as provided under paragraph (3)--
                    ``(i) a copy of the form or other application, 
                including any attachments or exhibits, submitted by 
                each registered manufacturer requesting an opioid 
                procurement quota; and
                    ``(ii) a copy of each year-end or annual report 
                relating to the procurement or use of opioid analgesics 
                submitted to the Attorney General by a registered 
                manufacturer to whom the Attorney General has issued an 
                opioid procurement quota.
    ``(3)(A) Upon request by a registered manufacturer, the Attorney 
General may redact information identified in clause (i) or (ii) of 
paragraph (2)(C) from the publication required under paragraph (2) if 
the Attorney General determines that public disclosure of that 
information is likely to cause substantial harm to the competitive 
position of the registered manufacturer. For purposes of a 
determination under this subparagraph, adverse publicity or 
embarrassment shall not constitute competitive harm.
    ``(B) A determination of the Attorney General under subparagraph 
(A) shall be subject to judicial review in accordance with chapter 7 of 
title 5, United States Code.
    ``(C) The Attorney General shall annually publish a report on the 
website of the Department of Justice containing an accounting of each 
declination determination made under subparagraph (A), including the 
reason for the declination, during the time period covered by the 
report.''.
    (b) GAO Report.--The Comptroller General of the United States shall 
submit to Congress a report that, for the 1-year period beginning on 
the date of enactment of this Act--
            (1) details--
                    (A) the number of instances in which a registered 
                manufacturer made a request described in section 
                306(j)(3) of the Controlled Substances Act, as added by 
                subsection (a), with respect to a document or 
                information; and
                    (B) the number of instances in which the Attorney 
                General redacted information described in clause (i) or 
                (ii) of subsection (j)(2)(C) of the Controlled 
                Substances Act, as added by subsection (a), from the 
                publication required under such subsection (j)(2); and
            (2) evaluates, in a fair, compliant, and transparent 
        manner, the extent of the independent evaluation conducted by 
        the Attorney General of requests described in section 306(j)(3) 
        of the Controlled Substances Act, as added by subsection (a).
                                 <all>