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2018-03-01
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Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Availability
Notices
D09002ee1bdc23dca
D09002ee1bdc23e3a
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Over-the- Counter Sunscreens: Safety and Effectiveness Data.'' This draft guidance addresses FDA's current thinking about the safety and effectiveness data needed to determine whether a nonprescription sunscreen active ingredient or combination of active ingredients evaluated under the Sunscreen Innovation Act (SIA) is generally recognized as safe and effective (GRASE) and not misbranded when used under specified conditions. The guidance also addresses FDA's current thinking about an approach to safety-related final formulation testing that it anticipates adopting in the future.
80 FR 72975
https://www.govinfo.gov/app/details/FR-2015-11-23/2015-29636
2015-29636
fr23no15-54
4164-01-P
Docket No. FDA-2015-D-4021
https://www.govinfo.gov/app/details/FR-2015-11-23/2015-29636
https://www.govinfo.gov/content/pkg/FR-2015-11-23/html/2015-29636.htm
https://www.govinfo.gov/content/pkg/FR-2015-11-23/pdf/2015-29636.pdf
2 p.
72975
72976
80 FR 72975
Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Availability; Federal Register Vol. 80, Issue
NOTICE
2015-29636
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2015-D-4021
4164-01-P
2015-29636
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Over-the- Counter Sunscreens: Safety and Effectiveness Data.'' This draft guidance addresses FDA's current thinking about the safety and effectiveness data needed to determine whether a nonprescription sunscreen active ingredient or combination of active ingredients evaluated under the Sunscreen Innovation Act (SIA) is generally recognized as safe and effective (GRASE) and not misbranded when used under specified conditions. The guidance also addresses FDA's current thinking about an approach to safety-related final formulation testing that it anticipates adopting in the future.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 22, 2016.
Kristen Hardin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993-0002, 240- 402-4246.
Guidance:
Over-the-Counter SunscreensSafety and Effectiveness Data
,
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/ucm380890.htm
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.regulations.gov
Federal Register
Vol. 80, no. 225
Office of the Federal Register, National Archives and Records Administration
2015-11-23
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198 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2015-11-23
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https://www.govinfo.gov/app/details/FR-2015-11-23
https://www.govinfo.gov/content/pkg/FR-2015-11-23/pdf/FR-2015-11-23.pdf
https://www.govinfo.gov/content/pkg/FR-2015-11-23/xml/FR-2015-11-23.xml
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