# Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Revision of ``Pediatric Use'' Subsection in the Labeling; Extension of Compliance Date
> **US Department of Health and Human Services** · Final rule; extension of compliance date. · Published 1996-12-30 · 61 FR 68623
## Document
- **Document number:** 96-33098
- **Category:** other
- **Sub-agency:** US Department of Health and Human Services
- **Federal Register citation:** 61 FR 68623
- **CFR reference:** 21 CFR 201
- **Publication date:** 1996-12-30
- **HHS docket:** Docket No. 92N-0165
## Abstract

The Food and Drug Administration (FDA) is extending the compliance date of a final rule, that published in the Federal Register of December 13, 1994. The document revised the ``Pediatric use'' subsection of the professional labeling requirements for prescription drugs. This final rule extends to April 7, 1997, the date for submission of supplemental applications to comply with the new regulation for those manufacturers who notify FDA in writing by January 29, 1997 of their intent to submit a supplement. The agency is taking this action in response to a request for an extension of the compliance date.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1996/12/30/96-33098/specific-requirements-on-content-and-format-of-labeling-for-human-prescription-drugs-revision-of)
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