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2018-03-01
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Sunscreen Innovation Act: Nonprescription Sunscreen Drug Products-Content and Format of Data Submissions; Draft Guidance for Industry; Availability
Notices
D09002ee1bdc23dc9
D09002ee1bdc23e39
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Nonprescription Sunscreen Drug Products--Content and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act''. This draft guidance addresses FDA's current thinking on how we will determine whether a sponsor's submission of safety and efficacy data is sufficiently complete to support a substantive review and determination under the Sunscreen Innovation Act (SIA) that an active ingredient is or is not generally recognized as safe and effective (GRASE) for use in nonprescription sunscreen products. This guidance is being issued in accordance with the SIA.
80 FR 72973
https://www.govinfo.gov/app/details/FR-2015-11-23/2015-29637
2015-29637
fr23no15-53
4164-01-P
Docket No. FDA-2015-D-4033
https://www.govinfo.gov/app/details/FR-2015-11-23/2015-29637
https://www.govinfo.gov/content/pkg/FR-2015-11-23/html/2015-29637.htm
https://www.govinfo.gov/content/pkg/FR-2015-11-23/pdf/2015-29637.pdf
3 p.
72973
72975
80 FR 72973
Sunscreen Innovation Act: Nonprescription Sunscreen Drug Products-Content and Format of Data Submissions; Draft Guidance for Industry; Availability; Federal Register Vol. 80, Issue
NOTICE
2015-29637
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2015-D-4033
4164-01-P
2015-29637
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Nonprescription Sunscreen Drug Products--Content and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act''. This draft guidance addresses FDA's current thinking on how we will determine whether a sponsor's submission of safety and efficacy data is sufficiently complete to support a substantive review and determination under the Sunscreen Innovation Act (SIA) that an active ingredient is or is not generally recognized as safe and effective (GRASE) for use in nonprescription sunscreen products. This guidance is being issued in accordance with the SIA.
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, 240-402- 4246.
Guidance:
Sunscreen Innovation Act; Nonprescription Sunscreen Drug ProductsContent and Format of Data Submissions
,
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:
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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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