United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2016_register executive 2016-11-23 article Notices D09002ee1c7f32a6f D09002ee1c7f32b0d United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Nonprescription Sunscreen Drug Products--Safety and Effectiveness Data." This guidance addresses FDA's current thinking on 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 the Agency anticipates adopting in the future. 81 FR 84594 https://www.govinfo.gov/app/details/FR-2016-11-23/2016-28124 2016-28124 fr23no16-89 4164-01-P Docket No. FDA-2015-D-4021 https://www.govinfo.gov/app/details/FR-2016-11-23/2016-28124 https://www.govinfo.gov/content/pkg/FR-2016-11-23/html/2016-28124.htm https://www.govinfo.gov/content/pkg/FR-2016-11-23/pdf/2016-28124.pdf 2 p. 84594 84595 81 FR 84594 Nonprescription Sunscreen Drug Products-Safety and Effectiveness Data; Guidance for Industry; Availability; Federal Register Vol. 81, Issue NOTICE 2016-28124 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2015-D-4021 4164-01-P 2016-28124 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Nonprescription Sunscreen Drug Products--Safety and Effectiveness Data." This guidance addresses FDA's current thinking on 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 the Agency anticipates adopting in the future.

Submit either electronic or written comments on Agency guidances at any time. 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: Nonprescription Sunscreen Drug ProductsSafety 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/regulatory&information/dockets/default.htm http://www.regulations.gov Vol. 81, no. 226 Office of the Federal Register, National Archives and Records Administration 2016-11-23 continuing daily deposited born digital 726 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-11-23 P0b002ee19297b720 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr23no16 https://www.govinfo.gov/app/details/FR-2016-11-23 https://www.govinfo.gov/content/pkg/FR-2016-11-23/pdf/FR-2016-11-23.pdf https://www.govinfo.gov/content/pkg/FR-2016-11-23/xml/FR-2016-11-23.xml fdlp 84389 85104 DGPO 2016-11-23 2024-06-01 FR-2016-11-23 machine generated eng FR FR-2016-11-23 81 226