0910-AH57 201810 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 Definition of the Term "Biological Product"

The Food and Drug Administration (FDA) proposes to amend its regulation that defines biological product to conform to the statutory definition (21 U.S.C. 262) adopted in the Biologics Price Competition and Innovation Act of 2009.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No Deregulatory 21 CFR 600.3 42 U.S.C. 216 42 U.S.C. 262 42 U.S.C. 263 42 U.S.C. 263a 42 U.S.C. 264 42 U.S.C. 300aa-25 Pub. L. 111–148, title VII, sec. 7002(e), Mar. 23, 2010, 124 Stat. 817 ... No NPRM 10/00/2018 No No None No No No Janice Weiner L. Principal Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3475 301 847-8440 janice.weiner@fda.hhs.gov Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6270, Silver Spring MD 20993-0002