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HHS/FDA RIN: 0910-AI11 Publication ID: Fall 2019 
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 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 
EO 13771 Designation: Deregulatory 
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  06/00/2020 
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:
Jenifer Stach
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 71, Room 7301,
Silver Spring, MD 20993
Phone:240 402-7911
Email: jenifer.stach@hhs.fda.gov