federal_register: 07-4131
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 07-4131 | Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph | Proposed Rule | 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. | 2007-08-27 | 2007 | 8 | https://www.federalregister.gov/documents/2007/08/27/07-4131/sunscreen-drug-products-for-over-the-counter-human-use-proposed-amendment-of-final-monograph | https://www.govinfo.gov/content/pkg/FR-2007-08-27/pdf/07-4131.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | 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,... |