Acting Associate Director for Policy

0910-AJ15 202510 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Update 21 CFR 610.13(b) (Rabbit Pyrogen Testing)

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.

]]> Substantive, Nonsignificant First Time Published in The Unified Agenda Proposed Rule Stage No No Deregulatory 21 CFR 610.13 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 No NPRM 09/00/2026 No None No No No Phillip Kurs Acting Associate Director for Policy 0910 Food and Drug Administration FDA 240 402-0467 phillip.kurs@fda.hhs.gov 10903 New Hampshire Avenue, WO Building 71, Room 7217, Silver Spring MD 20993