0910-AC23 200310 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 Requirements for Submission of In Vivo Bioequivalence Data The Food and Drug Administration (FDA) is proposing to amend its regulations on submission of bioequivalence (BE) data to require an abbreviated new drug application (ANDA) applicant to submit data from all BE studies the applicant conducts on a drug product formulation submitted for approval. In the past, ANDA applicants have submitted BE studies demonstrating that a generic product meets BE criteria for FDA to approve the ANDA but have not typically submitted additional BE studies conducted on the same drug product formulation. FDA is proposing to require ANDA applicants to submit information, in either a complete or summary report, from all additional passing and nonpassing BE studies conducted on the same drug product formulation submitted for approval. Substantive, Nonsignificant Previously Published in The Unified Agenda Long-Term 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 21 USC 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 Next Action Undetermined To Be Determined Yes Businesses None NA Not Collected Christine Rogers F. 0910 Food and Drug Administration FDA 301 796-3601 301 847-8440 HFD-7, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51, Room 6304, Silver Spring MD 20993-0002