Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Revision of ``Pediatric Use'' Subsection in the Labeling; Extension of Compliance Date
other · US Department of Health and Human Services · Rule · Published 1996-12-30 · 61 FR 68623
Document
Document number
96-33098
Federal Register citation
61 FR 68623
CFR reference
21 CFR 201
Type
Rule
Action
Final rule; extension of compliance date.
Category
other
Sub-agency
US Department of Health and Human Services
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.