0910-AC44 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 Presubmission Conferences This rule will implement section 512(b)(3) of the Federal Food, Drug, and Cosmetic Act (the Act). This section of the Act states that any person intending to file a new animal drug application or supplemental new animal drug application, or to investigate a new animal drug is entitled to one or more conferences with the agency prior to submission to reach an agreement establishing a submission or investigational requirement. This rule would describe how to request a presubmission conference and describe the procedures for the conduct of presubmission conferences. Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 514 21 USC 360b No NPRM 08/25/2000 65 FR 51782 Final Action 06/00/2004 No None NA Not Collected 0910-AB68 Previously reported as Gail Schmerfeld L. 0910 Food and Drug Administration FDA 877 287-1373 240 276-3904 gail.schmerfeld@fda.hhs.gov HFV-100, 9200 Corporate Boulevard, Rockville MD 20850-3229