114 S3225 IS: Opioid Quota Openness, Transparency, and Awareness Act of 2016 U.S. Senate 2016-07-14 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II 114th CONGRESS2d Session S. 3225 IN THE SENATE OF THE UNITED STATES July 14, 2016 Mr. Markey introduced the following bill; which was read twice and referred to the Committee on the Judiciary A BILL To amend the Controlled Substances Act to require the Attorney General to make procurement quotas for opioid analgesics publicly available, and for other purposes.

1.

Short title

This Act may be cited as the Opioid Quota Openness, Transparency, and Awareness Act of 2016 or the Opioid QuOTA Act.

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: (i)(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 Web site 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)Upon a request by a registered manufacturer asserting that a document or information described in clause (i) or (ii) of paragraph (2)(C) is exempt from disclosure under section 552(b)(4) of title 5, United States Code, and to the extent that the Attorney General determines that the document or information is exempt from disclosure under such section 552(b)(4), the document or information may be excluded from public disclosure under paragraph (2).. (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(i)(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 determined such a document or information was exempt from disclosure under section 552(b)(4) of title 5, United States Code; and (2)evaluates the extent of the independent evaluation conducted by the Attorney General of requests described in section 306(i)(3) of the Controlled Substances Act.