118 S2809 IS: Halting the Epidemic of Addiction and Loss Act of 2023 U.S. Senate 2023-09-14 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.

II118th CONGRESS1st SessionS. 2809IN THE SENATE OF THE UNITED STATESSeptember 14, 2023Mr. Cornyn (for himself and Ms. Hassan) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo ensure references to opioid overdose reversal agents in certain grant programs of the Department of Health and Human Services are not limited to naloxone.

1.

Short title

This Act may be cited as the Halting the Epidemic of Addiction and Loss Act of 2023 or the HEAL Act of 2023.

2.

References to opioid overdose reversal agents in HHS grant programs

(a)

In general

In promulgating regulations or issuing guidance or other documents for any grant program of the Department of Health and Human Services that addresses opioid misuse or use disorders, the Secretary of Health and Human Services (referred to in this section as the Secretary) shall ensure that any reference to an opioid overdose reversal agent—(1) shall be a reference to any drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) for emergency treatment of known or suspected opioid overdose; and (2)shall not be limited to a reference to naloxone.(b)

Existing references

(1)

Update

Not later than December 31, 2023, the Secretary shall update each regulation, guidance, and other document described in paragraph (2) such that any reference to an opioid overdose reversal agent, including any reference to naloxone, is a reference to any drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) for emergency treatment of known or suspected opioid overdose. (2)

Regulations, guidance, documents described

A regulation, guidance, or other document described in this paragraph is any regulation, guidance, or other document of the Department of Health and Human Services that—(A)was issued before the date of enactment of this Act; and(B)is for—(i)the grant program for State and Tribal response to opioid use disorders under section 1003 of the 21st Century Cures Act (42 U.S.C. 290ee–3a; commonly referred to as State Opioid Response Grants and Tribal Opioid Response Grants); or(ii)the grant program for priority substance use disorder prevention needs of regional and national significance under section 516 of the Public Health Service Act (42 U.S.C. 290bb–22).