This script search US Code. View Rule
Menu Item - Home
Menu Item - Agenda Main page
Menu Item - Historical Agenda
Menu Item - Historical Agenda
Menu Item - Agenda Search
Menu Item - EO Dashboard
Menu Item - Reg Review
Menu Item - EO Agency lists
Menu Item - EO Search
Menu Item - EO Historical Reports
Menu Item - Review Counts
Menu Item - OIRA Letters
Menu Item - EOM 12866 Search
Menu Item - EO XML Reports
Menu Item - ICR Dashboard page
Menu Item - ICR Main page
Menu Item - ICR Search
Menu Item - ICR XML Reports
Menu Item - FAQ
Menu Item - Additional Resources
Menu Item - Contact Us
Search: Agenda Reg Review ICR
       Search

View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AF43 Publication ID: Spring 2013 
Title: Over-the-Counter (OTC) Drug Review--Sunscreen Products 
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. The first of the future actions will address the safety of sunscreen active ingredients. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
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 360; 21 USC 371 
Legal Deadline:  None
Timetable:
Action Date FR Cite
ANPRM (Sunscreen and Insect Repellent)  02/22/2007  72 FR 7941 
ANPRM Comment Period End  05/23/2007   
NPRM (UVA/UVB)  08/27/2007  72 FR 49070 
NPRM Comment Period End  12/26/2007   
Final Action (UVA/UVB)  06/17/2011  76 FR 35620 
NPRM (Effectiveness)  06/17/2011  76 FR 35672 
NPRM (Effectiveness) Comment Period End   09/15/2011   
ANPRM (Dosage Forms)  06/17/2011  76 FR 35669 
ANPRM (Dosage Forms) Comment Period End  09/15/2011   
ANPRM (Safety)  11/00/2013   
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:
David Eng
Regulatory Project Manager
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-2773
Fax:301 796-9899
Email: david.eng@fda.hhs.gov

 
About Us   Vertical Spacer Spacer Related Resources   Vertical Spacer Spacer Disclosure   Vertical Spacer Spacer Accessibility   Vertical Spacer Spacer Privacy Policy   Vertical Spacer Spacer Contact Us