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| HHS/FDA | RIN: 0910-AC44 | Publication ID: Spring 2003 |
| 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 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Federalism: Undetermined | |
| Included in the Regulatory Plan: No | |
| Related RINs: Previously reported as 0910-AB68 | |
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Agency Contact: Gail L. Schmerfeld Senior Regulatory Counsel Department of Health and Human Services Food and Drug Administration HFV-100, 9200 Corporate Boulevard, Rockville, MD 20850-3229 Phone:877 287-1373 Fax:240 276-3904 Email: gail.schmerfeld@fda.hhs.gov |
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