Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is issuing a proposed rule that would amend the final monograph (FM) for over-the-counter (OTC) sunscreen drug products as part of FDA's ongoing review of OTC drug products. This amendment addresses formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection. FDA is issuing this proposed rule after considering public comments and new data and information that have come to FDA's attention. This rule proposes to lift the stays of 21 CFR 347.20(d) and 21 CFR Part 352 when FDA publishes a final rule based on this proposed rule.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Parts 347 and 352 [Docket No. 1978N-0038] (formerly Docket No. 78N-0038) RIN 0910-AF43 AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed rule that would amend the final monograph (FM) for over-the-counter (OTC) sunscreen drug products as part of FDA's ongoing review of OTC drug products. This amendment addresses formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection. FDA is issuing this proposed rule after considering public comments and new data and information that have come to FDA's attention. This rule proposes to lift the stays of 21 CFR 347.20(d) and 21 CFR Part 352 when FDA publishes a final rule based on this proposed rule. DATES: Submit written or electronic comments by November 26, 2007. Submit written or electronic comments on FDA's economic impact determination by November 26, 2007. Please see section X of this document for the effective and compliance dates of any final rule that may publish based on this proposal. ADDRESSES: You may submit comments, identified by Docket No. 1978N-0038 and RIN number 0910-AF43, by any of the following methods: Electronic Submissions Submit electronic comments in the following ways: Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting comments. Agency Web site: ht…
Other Federal Register documents from the same docket.
Revised Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use
Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information Regarding Dosage Forms
Sunscreen Drug Products for Over-The-Counter Human Use; Proposed Amendment of Final Monograph; Extension of Comment Period
Citation: 72 FR 49070
