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HHS/FDA RIN: 0910-AJ15 Publication ID: 2026 
Title: ●Update 21 CFR 610.13(b) (Rabbit Pyrogen Testing) 
Abstract:

The Food and Drug Administration is updating 21 CFR 610.13(b) to include established in vitro general standards for the detection of pyrogens including bacterial endotoxin in drug products.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 14192 Designation: Deregulatory 
CFR Citation: 21 CFR 610.13   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351, 352, and 353    21 U.S.C. 355    21 U.S.C. 360    21 U.S.C. 360c and d    21 U.S.C. 360h and i    21 U.S.C. 371 and 372    21 U.S.C. 374    21 U.S.C. 381    42 U.S.C. 216    42 U.S.C. 262 and 263    42 U.S.C. 263a    42 U.S.C. 264   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/00/2026 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Phillip Kurs
Acting Associate Director for Policy
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, WO Building 71, Room 7217,
Silver Spring, MD 20993
Phone:240 402-0467
Email: phillip.kurs@fda.hhs.gov