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HHS/FDA RIN: 0910-AC44 Publication ID: Spring 2004 
Title: Presubmission Conferences 
Abstract: 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. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 514   
Legal Authority: 21 USC 360b   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/25/2000  65 FR 51782   
Final Action  08/00/2004    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
Related RINs: Previously reported as 0910-AB68 
Agency Contact:
Gail L. Schmerfeld
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
HFV-100, Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:877 287-1373
Fax:301 595-1426
Email: ctpregulations@fda.hhs.gov