federal_register: 2011-14768

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2011-14768 Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information Regarding Dosage Forms Proposed Rule 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. 2011-06-17 2011 6 https://www.federalregister.gov/documents/2011/06/17/2011-14768/sunscreen-drug-products-for-over-the-counter-human-use-request-for-data-and-information-regarding https://www.govinfo.gov/content/pkg/FR-2011-06-17/pdf/2011-14768.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...  

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