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2015-02-25
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Over-the-Counter Sunscreen Drug Products-Regulatory Status of Enzacamene
Proposed Rules
D09002ee1c17457df
D09002ee1c174586b
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or the Agency) is issuing a proposed sunscreen order (proposed order) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA). The proposed order announces FDA's tentative determination that enzacamene is not generally recognized as safe and effective (GRASE) and is misbranded when used in over-the- counter (OTC) sunscreen products because the currently available data are insufficient to classify it as GRASE and not misbranded, and additional information is needed to allow us to determine otherwise.
80 FR 10026
https://www.govinfo.gov/app/details/FR-2015-02-25/2015-03884
2015-03884
fr25fe15-11
4164-01-P
Docket Nos. FDA-2003-N-0196 (Formerly 2003N-0233), FDA-1978-N-0018 (Formerly 1978N-0038 and 78N-0038), and FDA-1996-N-0006 (Formerly 96N-0277)
https://www.govinfo.gov/app/details/FR-2015-02-25/2015-03884
https://www.govinfo.gov/content/pkg/FR-2015-02-25/html/2015-03884.htm
https://www.govinfo.gov/content/pkg/FR-2015-02-25/pdf/2015-03884.pdf
10 p.
10026
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80 FR 10026
Code of Federal Regulations
Title 21 Part 310
21 CFR Part 310
Over-the-Counter Sunscreen Drug Products-Regulatory Status of Enzacamene; Federal Register Vol. 80, Issue
PRORULE
2015-03884
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2015-04-13
2015-03-27
Docket Nos. FDA-2003-N-0196 (Formerly 2003N-0233), FDA-1978-N-0018 (Formerly 1978N-0038 and 78N-0038), and FDA-1996-N-0006 (Formerly 96N-0277)
4164-01-P
2015-03884
Proposed order; request for comments.
The Food and Drug Administration (FDA or the Agency) is issuing a proposed sunscreen order (proposed order) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA). The proposed order announces FDA's tentative determination that enzacamene is not generally recognized as safe and effective (GRASE) and is misbranded when used in over-the- counter (OTC) sunscreen products because the currently available data are insufficient to classify it as GRASE and not misbranded, and additional information is needed to allow us to determine otherwise.
Submit either electronic or written comments on this proposed order by April 13, 2015. Sponsors may submit written requests for a meeting with FDA to discuss this proposed order by March 27, 2015. See section VI for the proposed effective date of a final order based on this proposed order.
Kristen Hardin, Division of Nonprescription Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5491, Silver Spring, MD 20993-0002, 240-402-4246.
Over-the-Counter Sunscreen Drug Products:
Status of Enzacamene
,
http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_141.pdf
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidance/UCM074911.pdf
http://www.fda.gov/downloads/drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072112.pdf
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM074916.pdf
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM074919.pdf
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM074937.pdf
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079252.pdf
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S5_R2/Step4/S5_R2__Guideline.pdf
http://www.regulations.gov
Federal Register
Vol. 80, no. 37
Office of the Federal Register, National Archives and Records Administration
2015-02-25
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347 p.
Table of Contents:
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GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2015-02-25
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https://www.govinfo.gov/content/pkg/FR-2015-02-25/pdf/FR-2015-02-25.pdf
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