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 2011_register executive 2011-06-17 article Proposed Rules D09002ee1c7ffc443 D09002ee1c7ffc53f 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 We (Food and Drug Administration or FDA) are asking sunscreen manufacturers and other interested parties to submit data on over-the- counter (OTC) sunscreen drug products marketed without approved applications that are formulated in certain dosage forms. These data are necessary to address questions about these dosage forms. For spray dosage forms, we are requesting data to resolve specific questions about both effectiveness and safety. We are also inviting comment on possible labeling and testing requirements for spray dosage forms. This information will be used in establishing monograph conditions, including dosage forms, for sunscreens that are generally recognized as safe and effective (GRASE) and not misbranded. 76 FR 35669 https://www.govinfo.gov/app/details/FR-2011-06-17/2011-14768 2011-14768 fr17jn11-31 RIN 0910-ZA40 4160-01-P Docket No. FDA-1978-N-0018 formerly Docket No. 1978N-0038 https://www.govinfo.gov/app/details/FR-2011-06-17/2011-14768 https://www.govinfo.gov/content/pkg/FR-2011-06-17/html/2011-14768.htm https://www.govinfo.gov/content/pkg/FR-2011-06-17/pdf/2011-14768.pdf 4 p. 35669 35672 76 FR 35669 Title 21 Part 352 21 CFR Part 352 RIN 0910-ZA40 Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information Regarding Dosage Forms; Federal Register Vol. 76, Issue PRORULE 2011-14768 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2011-09-15 Docket No. FDA-1978-N-0018 formerly Docket No. 1978N-0038 4160-01-P 2011-14768 Advance notice of proposed rulemaking; request for data and information.

We (Food and Drug Administration or FDA) are asking sunscreen manufacturers and other interested parties to submit data on over-the- counter (OTC) sunscreen drug products marketed without approved applications that are formulated in certain dosage forms. These data are necessary to address questions about these dosage forms. For spray dosage forms, we are requesting data to resolve specific questions about both effectiveness and safety. We are also inviting comment on possible labeling and testing requirements for spray dosage forms. This information will be used in establishing monograph conditions, including dosage forms, for sunscreens that are generally recognized as safe and effective (GRASE) and not misbranded.

Submit data and information either electronically or in writing by September 15, 2011. Reynold Tan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Mail Stop 5411, Silver Spring, MD 20993, 301- 796-2090. Sunscreen Drug Products for Over-the-Counter Human Use; Dosage Forms , http://www.regulations.gov Vol. 76, no. 117 Office of the Federal Register, National Archives and Records Administration 2011-06-17 continuing daily deposited born digital 419 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2011-06-17 P0b002ee180d72c9b 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr17jn11 https://www.govinfo.gov/app/details/FR-2011-06-17 https://www.govinfo.gov/content/pkg/FR-2011-06-17/pdf/FR-2011-06-17.pdf https://www.govinfo.gov/content/pkg/FR-2011-06-17/xml/FR-2011-06-17.xml fdlp 35301 35711 DGPO 2011-06-17 2024-06-04 FR-2011-06-17 machine generated eng FR FR-2011-06-17 76 117