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HHS/FDA RIN: 0910-AF43 Publication ID: Fall 2018 
Title: Sunscreen Drug Products For Over-The-Counter-Human Use; Tentative Final Monograph  
Abstract:

The proposed rule will address the general recognition of safety and effectiveness (GRASE) status of the 16 sunscreen monograph ingredients and describe data gaps that FDA believes need to be filled in order for FDA to permit the continued marketing of these ingredients without submitting new drug applications for premarket review. Consistent with the Sunscreen Innovation Act, we also expect to address sunscreen dosage forms and maximum SPF values.

 

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 201    21 CFR 310    21 CFR 330 to 358   
Legal Authority: 21 U.S.C. 321p    21 U.S.C. 331    21 U.S.C. 351 to 353    21 U.S.C. 355    21 U.S.C. 360    21 U.S.C. 371   
Legal Deadline:
Action Source Description Date
Final  Statutory  Sunscreen Innovation Act  11/26/2019 
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    
NPRM  11/00/2018 
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:
Kristen Hardin
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, WO 22, Room 5491,
Silver Spring, MD 20993
Phone:240 402-4246
Fax:301 796-9841
Email: kristen.hardin@fda.hhs.gov