View Rule
View EO 12866 Meetings | Printer-Friendly Version Download RIN Data in XML |
HHS/FDA | RIN: 0910-AF37 | Publication ID: Spring 2009 |
Title: Over-The-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use | |
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for convenience (small) size OTC drug packages. | |
Agency: Department of Health and Human Services(HHS) | Priority: Routine and Frequent |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Long-Term Actions |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 201 21 CFR 310 21 CFR 330 to 358 | |
Legal Authority: 21 USC 321p 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 358 21 USC 360 21 USC 371 21 UCS 374 21 USC 379e |
Legal Deadline:
None |
|||||||||
Timetable:
|
Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: Local, State |
Small Entities Affected: Businesses | Federalism: Yes |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: Yes | |
Related RINs: Split from 0910-AA01 | |
Agency Contact: Walter J. Ellenberg Regulatory Project Management Officer Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-2090 Fax:301 796-9899 Email: walter.ellenberg@fda.hhs.gov |