H.R. 830 — SAFE Act

This section adds fentanyl-related substances (i.e., substances structurally related to fentanyl through specified modifications such as replacement or substitution on the phenethyl, piperidine, aniline, or N-propionyl groups) to Schedule I of the Controlled Substances Act. (As background, Schedule I substances have high abuse potential, no currently accepted medical use in the United States, and lack of accepted safety under medical supervision, subjecting them to the strictest federal controls, including no approved prescriptions.) This class scheduling applies to any quantity of such substances, salts, isomers, or salts of isomers (unless exempted or otherwise controlled), requires the Attorney General to publish a non-exhaustive list in the Federal Register within 60 days of determinations, and exempts these substances from quantity-based mandatory minimum penalties under specified provisions of the CSA and the Controlled Substances Import and Export Act.

This section revises mandatory minimum penalties under 21 U.S.C. 841(b)(1) for violations involving fentanyl by (1) in subparagraph (A) (10 years to life imprisonment), replacing clause (vi) with thresholds of 400 grams or more of a mixture containing fentanyl or 100 grams or more of a specified fentanyl analogue (excluding fentanyl-related substances as defined in schedule I(e) of 21 U.S.C. 202(c)); (2) in subparagraph (B) (5 to 40 years imprisonment), making a parallel replacement in clause (vi) for 40 grams or more of a mixture containing fentanyl or 10 grams or more of a specified fentanyl analogue (excluding such fentanyl-related substances); and (3) in subparagraph (C) (up to 20 years imprisonment), clarifying that penalties apply to fentanyl-related substances. (Thus, fentanyl-related substances are subject to subparagraph (C) penalties rather than the higher mandatory minimums for fentanyl analogues under subparagraphs (A) and (B).)

This section revises penalties under the Controlled Substances Import and Export Act (21 U.S.C. 960(b)) for offenses involving fentanyl by (1) replacing paragraph (1)(F) with provisions covering 400 grams or more of a mixture or substance containing fentanyl or 100 grams or more of specified fentanyl analogues (excluding fentanyl-related substances), which triggers a mandatory minimum of 10 years to life imprisonment; (2) replacing paragraph (2)(F) with provisions covering 40 grams or more of a fentanyl-containing mixture or substance or 10 grams or more of such analogues, which triggers 5 to 40 years imprisonment; and (3) clarifying that paragraph (3) penalties (generally up to 20 years for lesser quantities of schedule I or II substances) explicitly include fentanyl-related substances. (Thus, fentanyl-related substances are subject to lower-tier penalties than other fentanyl analogues.)

This section establishes a new process under the Controlled Substances Act for removing fentanyl-related substances from Schedule I or rescheduling them to Schedule III based on a determination by the HHS Secretary. Specifically, (1) if the Secretary determines—considering actual abuse potential, scientific evidence of pharmacological effects (e.g., mu opioid receptor studies), and other statutory factors—that a fentanyl-related substance has lower abuse potential than Schedule V drugs, the Secretary's binding scientific and medical evaluation requires the Attorney General to remove it from all schedules within 90 days; and (2) if the determination is lower abuse potential than Schedules I and II drugs, the Attorney General must reschedule it to Schedule III within 90 days. The section further requires 30 days' advance notice to the Attorney General; exceptions for international treaty obligations; procedures for DOJ to identify such substances and forward petitions to HHS; and a rule of construction preserving other scheduling authorities.

This section authorizes federal sentencing courts, on motion of the defendant, Bureau of Prisons, government attorney, or sua sponte and after considering 18 U.S.C. §3553(a) factors, to vacate or reduce (at their discretion) previously imposed sentences for past convictions under the Controlled Substances Act (21 U.S.C. §841(b), as added by new subsection (b)(8)) or Controlled Substances Import and Export Act (21 U.S.C. §960(b), as added by new subsection (b)(8)) involving a fentanyl-related substance (as defined in Schedule I(e) of 21 U.S.C. §812(c) at the time of the offense) that has since been rescheduled to Schedule III, IV, or V or removed from the controlled substances schedules. (Thus, such resentencing would apply the lower penalties associated with the substance's current scheduling as if it had been in effect at the time of the offense; defendants need not be present for hearings.)

This section establishes an alternative registration process under the Controlled Substances Act (CSA) for practitioners conducting specified research with Schedule I controlled substances (i.e., those with high abuse potential and no currently accepted medical use), notwithstanding existing CSA research registration requirements. Specifically, such research—either subject to an active FDA investigational new drug application (21 CFR 312.40) or conducted or funded by HHS, DOJ, or VA—may proceed if the practitioner (A) is already registered for Schedule I or II research and sends the Attorney General (AG) a notice (with chemical name, quantity, research details, and state authorization) 30 days in advance; (B) is unregistered, in which case the notice is treated as a registration application, with AG approval or denial within 45 days; or (C) receives verification of research details from HHS or VA, as needed. Practitioners are limited to notified quantities (supplemental notices allowed), must submit electronically if feasible, and remain subject to CSA import/export rules. This section further amends CSA registration renewal provisions to exempt additional agents or employees of a research institution from separate registration for the same-schedule controlled substances if acting in scope of practice, the institution has another registered researcher who notifies and authorizes the AG (affirming vicarious liability), and the AG does not refuse within 30 days for grounds specified in CSA section 304(a) (e.g., felony convictions or diversion risks). (Thus, this facilitates team-based research without multiple individual registrations.)

This section requires the Attorney General to issue rules implementing the Act and its amendments no later than one year after enactment and authorizes issuance as interim final rules. Such interim final rules take effect immediately without a good cause finding under APA §553(b)(B) (which normally requires notice-and-comment rulemaking or a good cause exception before skipping it); provides for post-issuance public comments and hearing requests; and requires a final rule thereafter in accordance with APA §553.

This section directs the Comptroller General of the United States to submit to the House Committees on Energy and Commerce and the Judiciary and the Senate Committee on the Judiciary, not more than four years after enactment, a report analyzing the implementation and impact of permanent class scheduling of fentanyl-related substances (as defined in new schedule I(e) of section 202(c) of the Controlled Substances Act). The report must include (1) the impact on research of such substances; (2) any actions taken to remove or reschedule any such substance; (3) the impact on unlawful importation, manufacture, trafficking, and use of such substances, including data on their proliferation since scheduling; (4) a comparison of sentences for criminal charges involving such substances to those for fentanyl and individually scheduled fentanyl analogues; and (5) the efficacy of class scheduling generally in reducing proliferation of new controlled substance analogues. In developing the report, the Comptroller General must consult the Secretary of Health and Human Services, the Attorney General, the Secretary of Homeland Security, the Secretary of State, the Director of the Office of National Drug Control Policy, the scientific and medical research community, state and local law enforcement, and civil rights and criminal justice reform communities, basing it to the greatest extent possible on reliable data and empirical information.