0910-AG16 200904 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Amendments to Sterility Testing Requirements for Biological Products Substantive, Nonsignificant First Time Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 610.12 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 12/00/2009 No None No No No Laura Rich 0910 Food and Drug Administration FDA 877 287-1373 ctpregulations@fda.hhs.gov Center for Tobacco Products, 10903 New Hampshire Avenue, Building 71, Room G335, Silver Spring MD 20993