Health and Human Services Department, Food and Drug Administration
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.
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 Part 352 [Docket No. FDA-1978-N-0018; formerly Docket No. 1978N-0038] RIN 0910-ZA40 AGENCY: Food and Drug Administration, HHS. ACTION: Advance notice of proposed rulemaking; request for data and information. SUMMARY: 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. DATES: Submit data and information either electronically or in writing by September 15, 2011. ADDRESSES: You may submit comments, identified by docket number FDA-1978-N-0018 (formerly Docket No. 1978N-0038) and/or RIN number 0910-ZA40, by any of the following methods: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting comments. Written Submissions Submit written…
Other Federal Register documents from the same docket.
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-The-Counter Human Use; Over-The-Counter Monograph Proposed Order (OTC 000008) Extension of Comment Period
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use; Over the Counter Monograph Proposed Order; Availability
Sunscreen Drug Products for Over-the-Counter Human Use; Correction
Sunscreen Drug Products for Over-the-Counter Human Use; Extension of Comment Period
Sunscreen Drug Products for Over-the-Counter Human Use
Citation: 76 FR 35669
