0910-AF43 201804 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; Tentative Final Monograph

The proposed rule will address the general recognition of safety and effectiveness (GRASE) status of the 16 sunscreen monograph ingredients and describe data gaps that FDA believes need to be filled in order for FDA to permit the continued marketing of these ingredients without submitting new drug applications for premarket review. Consistent with the Sunscreen Innovation Act, we also expect to address sunscreen dosage forms and maximum SPF values.

]]> Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes No Deregulatory 21 CFR 201 21 CFR 310 21 CFR 330 to 358 21 U.S.C. 321p 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. 371 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 12/00/2018 Yes Businesses Local State Yes Yes No 0910-AA01 Split from Kristen Hardin 0910 Food and Drug Administration FDA 240 402-4246 301 796-9841 kristen.hardin@fda.hhs.gov Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, WO 22, Room 5491, Silver Spring MD 20993