0910-AC23 200904 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Requirements for Submission of In Vivo Bioequivalence Data Substantive, Nonsignificant Previously Published in The Unified Agenda Completed Actions No No 21 CFR 314.96(a)(1) 21 CFR 314.94(a)(7) 21 CFR 320.21(b)(1) 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 to 355a 21 USC 356 21 USC 356a to 356c 21 USC 371 21 USC 374 21 USC 379 No NPRM 10/29/2003 68 FR 61640 Final Action 01/16/2009 74 FR 2849 Yes Businesses None No Yes No Michael Bernstein 0910 Food and Drug Administration FDA 301 796-3478 michael.bernstein@fda.hhs.gov Center for Drug Evaluation and Research, WO Bldg. 51, Rm. 6240, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002