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 2015_register executive 2015-01-09 article Notices D09002ee1c7f811a9 D09002ee1c7f811e8 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 letters containing FDA's initial determinations and feedback on safety and effectiveness data submitted to demonstrate that certain active ingredients are generally recognized as safe and effective (GRASE) and not misbranded for use in over-the-counter (OTC) sunscreen drug products (sunscreen feedback letters). We are taking this action under the Sunscreen Innovation Act (SIA). 80 FR 892 https://www.govinfo.gov/app/details/FR-2015-01-07/2015-00002 2015-00002 FR07JA15-38 4164-01-P Docket Nos. FDA-2005-N-0453, FDA-2003-N-0196, and FDA-2006-O-0314 https://www.govinfo.gov/app/details/FR-2015-01-07/2015-00002 https://www.govinfo.gov/content/pkg/FR-2015-01-07/html/2015-00002.htm https://www.govinfo.gov/content/pkg/FR-2015-01-07/pdf/2015-00002.pdf 2 p. 892 893 80 FR 892 Sunscreen Feedback Letters; Notice of Availability Under the Sunscreen Innovation Act; Federal Register Vol. 80, Issue NOTICE 2015-00002 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2015-02-23 2015-02-06 Docket Nos. FDA-2005-N-0453, FDA-2003-N-0196, and FDA-2006-O-0314 4164-01-P 2015-00002 Notice; request for comments.

The Food and Drug Administration (FDA or Agency) is announcing the availability of letters containing FDA's initial determinations and feedback on safety and effectiveness data submitted to demonstrate that certain active ingredients are generally recognized as safe and effective (GRASE) and not misbranded for use in over-the-counter (OTC) sunscreen drug products (sunscreen feedback letters). We are taking this action under the Sunscreen Innovation Act (SIA).

Submit either electronic or written comments by February 23, 2015. Sponsors may submit written requests for a meeting with FDA to discuss these proposed sunscreen orders by February 6, 2015. 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. Guidance for Industry and Staff: Sunscreen Feedback Letters , http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm239463.htm http://www.regulations.gov www.regulations.gov Vol. 80, no. 4 Office of the Federal Register, National Archives and Records Administration 2015-01-07 continuing daily deposited born digital 188 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-01-07 P0b002ee18a903cf2 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:FR07JA15 https://www.govinfo.gov/app/details/FR-2015-01-07 https://www.govinfo.gov/content/pkg/FR-2015-01-07/pdf/FR-2015-01-07.pdf https://www.govinfo.gov/content/pkg/FR-2015-01-07/xml/FR-2015-01-07.xml fdlp 823 1004 DGPO 2015-01-09 2024-06-02 FR-2015-01-07 machine generated eng FR FR-2015-01-07 80 4