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HHS/FDA RIN: 0910-AI11 Publication ID: Spring 2023 
Title: Requirements for Determining Donor Eligibility and Donation Suitability of Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use 
Abstract:

FDA is proposing to revise certain regulations applicable to establishments that collect blood or blood components, including blood or blood components intended solely for autologous use. The proposed rule would revise and permit limited exceptions to certain donor eligibility and donation suitability requirements. The proposed rule would provide more flexibility to accommodate advancing technology, while continuing to help ensure the safety of the nation’s blood supply and donor health.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 42 U.S.C. 216    42 U.S.C. 262    42 U.S.C. 264    21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351 to 352    21 U.S.C. 355    21 U.S.C. 360    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  04/00/2024 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Karen Fikes
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Room 7301,
Silver Spring, MD 20993
Phone:240 402-7911
Email: karen.fikes@fda.hhs.gov