0910-AF43 202004 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Sunscreen Drug Products For Over-The-Counter-Human Use; Final Monograph

The final rule will describe the conditions of use under which OTC sunscreen products are generally recognized as safe and effective (GRASE) and not misbranded. Consistent with the Sunscreen Innovation Act, we expect that these conditions will include sunscreen dosage forms and the effectiveness of various SPF values.

]]> Economically Significant Previously Published in The Unified Agenda Completed Actions Yes Private Sector Regulatory 21 CFR 201 21 CFR 310 21 CFR 347 21 CFR 352 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 360ff-5 21 U.S.C. 371 to 374 21 U.S.C. 379e Statutory Final 11/26/2019 Sunscreen Innovation Act No ANPRM (Sunscreen and Insect Repellent) 02/22/2007 72 FR 7941 ANPRM Comment Period End 05/23/2007 NPRM (UVA/UVB) 08/27/2007 72 FR 49070 NPRM Comment Period End 12/26/2007 Final Action (UVA/UVB) 06/17/2011 76 FR 35620 NPRM (Effectiveness) 06/17/2011 76 FR 35672 NPRM (Effectiveness) Comment Period End 09/15/2011 ANPRM (Dosage Forms) 06/17/2011 76 FR 35669 ANPRM (Dosage Forms) Comment Period End 09/15/2011 NPRM 02/26/2019 84 FR 6204 NPRM Comment Period End 06/27/2019 NPRM Extension of Comment Period 04/18/2019 84 FR 16222 NPRM Extension of Comment Period End 06/27/2019 Withdrawn 05/04/2020 Yes Businesses Local State Yes Yes No 0910-AA01 Split from Trang Tran Regulatory Project Manager 0910 Food and Drug Administration FDA 240 402-7945 trang.tran@fda.hhs.gov Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, WO 22, Room 4139, Silver Spring MD 20993