Regulatory Counsel

0910-AH21 201410 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 Revocation of the General Safety Test Regulations That Are Duplicative of Requirements in Biologic License Applications

The Food and Drug Administration (FDA) is proposing to amend its regulations by removing the general safety test (GST) requirements for biological products. FDA is taking this action because these regulations are duplicative and obsolete.

]]> Substantive, Nonsignificant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 610.11 21 CFR 610.11a 21 CFR 680.3 21 USC 321 21 USC 331 21 USC 351 21 USC 352 21 USC 353 21 USC 355 21 USC 360 21 USC 360c 21 USC 360d 21 USC 360h 21 USC 360i 21 USC 371 21 USC 372 21 USC 374 21 USC 381 42 USC 216 42 USC 262 42 USC 263 42 USC 263a 42 USC 264 No NPRM 08/22/2014 79 FR 49727 NPRM Comment Period End 11/20/2014 No None No No No Lori Churchyard Jo Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-7911 lori.olsenchurchyard@fda.hhs.gov Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Building 71, Room 7301, Silver Spring MD 20993