View Rule
View EO 12866 Meetings | Printer-Friendly Version Download RIN Data in XML |
HHS/FDA | RIN: 0910-AH97 | Publication ID: Spring 2018 |
Title: ●Topical Antimicrobial Drug Products for Over-the-Counter Human Use: Final Monograph for Consumer Antiseptic Rub Products | |
Abstract:
This final rule amends the 1994 tentative final monograph (TFM) for over-the-counter (OTC) antiseptic drug products that published in the Federal Register of June 17, 1994,(the 1994 TFM). The final rule is part of the ongoing review of OTC drug products conducted by FDA. In this final rule, we address whether certain active ingredients used in OTC consumer antiseptic products intended for use without water (referred to as consumer antiseptic rubs) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded. |
|
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
EO 13771 Designation: Regulatory | |
CFR Citation: 21 CFR 310 | |
Legal Authority: 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 360 and 361 21 U.S.C. 371 21 U.S.C. 374 and 375 21 U.S.C. 379 42 U.S.C. 216 42 U.S.C. 241 and 242 42 U.S.C. 262 |
Legal Deadline:
|
||||||||
Overall Description of Deadline: NRDC and FDA, under a judicial Consent Decree, agreed that FDA would publish the final monograph for Consumer Antiseptic Rub Products in the Federal Register by April 15, 2019 (10 Civ. 5690) |
||||||||
Timetable:
|
Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
Federalism: Undetermined | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Anita Kumar Biologist Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 22, Room 5445, Silver Spring, MD 20993 Phone:301 796-1032 Email: anita.kumar@fda.hhs.gov |