# Records and Reports Concerning Experience With Approved New Animal Drugs
> **Food and Drug Administration** · Withdrawal of interim final rule and issuance of final rule. · Published 2003-03-31 · Effective 2003-06-30 · 68 FR 15355
## Document
- **Document number:** 03-7475
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 68 FR 15355
- **CFR reference:** 21 CFR 211
- **Publication date:** 2003-03-31
- **Effective date:** 2003-06-30
- **HHS docket:** Docket No. 88N-0038
## Abstract

The Food and Drug Administration (FDA) is withdrawing the interim final rule that it published on February 4, 2002. The interim final rule amended the regulations for records and reports concerning experiences with approved new animal drugs. FDA invited interested parties to comment on the interim final rule. As a result of those comments, this final rule more clearly defines the kinds of information to be maintained and submitted by new animal drug applicants for new animal drug applications (NADAs) or abbreviated new animal drug applications (ANADAs). In addition, the final rule revises the timing and content of certain reports to enhance their usefulness. This regulation will provide for protection of public and animal health and reduce unnecessary recordkeeping and reporting requirements.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2003/03/31/03-7475/records-and-reports-concerning-experience-with-approved-new-animal-drugs)
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