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HHS/FDA RIN: 0910-AI94 Publication ID: Spring 2024 
Title: ●Drug Establishment Registration Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments 
Abstract:

The proposed rulemaking will revise the registration regulations at 21 CFR 207 to: (1) Clarify that the drug establishment registration and drug listing requirements are applicable to foreign drug manufacturing establishments that do not directly import or offer for import drugs into the United States, but are still involved in the manufacture of drugs that are imported or offered for import into the United States following the passage of section 2511 of the PREVENT Pandemics Act; and (2) establish drug establishment registration requirements specific to establishments engaging in distributed manufacturing.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 207   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 353    21 U.S.C. 355    21 U.S.C. 360    21 U.S.C. 360b    21 U.S.C. 371    21 U.S.C. 374    21 U.S.C. 379    21 U.S.C. 381    21 U.S.C. 393    42 U.S.C. 262    42 U.S.C. 264    42 U.S.C. 271   
Legal Deadline:
Action Source Description Date
NPRM  Statutory  Section 2511 Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act).  12/29/2024 
Timetable:
Action Date FR Cite
NPRM  12/00/2024 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No 
Agency Contact:
Ashley Boam
Health Science Administrator
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, Building 51, Room 4192, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6341
Email: ashley.boam@fda.hhs.gov