# Administrative Practices and Procedures; Internal Review of Agency Decisions
> **Food and Drug Administration** · Direct final rule. · Published 1998-06-16 · Effective 1998-10-29 · 63 FR 32733
## Document
- **Document number:** 98-15815
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 32733
- **CFR reference:** 21 CFR 10
- **Publication date:** 1998-06-16
- **Effective date:** 1998-10-29
- **HHS docket:** Docket No. 98N-0361
## Abstract

The Food and Drug Administration (FDA) is amending its regulations governing the review of agency decisions by inserting a statement that sponsors, applicants, or manufacturers of drugs (including biologics) or devices may request review of a scientific controversy by an appropriate scientific advisory panel, or an advisory committee. This action is being taken to clarify the availability of review of scientific controversies by such advisory panels and committees. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule. If any significant adverse comment is received, FDA will withdraw the direct final rule and will follow its usual procedures for notice-and-comment rulemaking based on the companion proposed rule.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/06/16/98-15815/administrative-practices-and-procedures-internal-review-of-agency-decisions)
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