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HHS/FDA | RIN: 0910-AF43 | Publication ID: Spring 2020 |
Title: Sunscreen Drug Products For Over-The-Counter-Human Use; Final Monograph | |
Abstract:
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. |
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Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Completed Actions |
Major: Yes | Unfunded Mandates: Private Sector |
EO 13771 Designation: Regulatory | |
CFR Citation: 21 CFR 201 21 CFR 310 21 CFR 347 21 CFR 352 | |
Legal Authority: 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 |
Legal Deadline:
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Timetable:
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Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: Local, State |
Small Entities Affected: Businesses | Federalism: Yes |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: Yes | |
Related RINs: Split from 0910-AA01 | |
Agency Contact: Trang Tran Regulatory Project Manager Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, WO 22, Room 4139, Silver Spring , MD 20993 Phone:240 402-7945 Email: trang.tran@fda.hhs.gov |