federal_register: 2016-24459
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 | regulation_id_numbers |
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| 2016-24459 | Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request; Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request." This guidance provides recommendations for the process for withdrawing a 586A request submitted under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA), and withdrawing a pending request, as defined by the SIA. The recommendations in this guidance apply to 586A requests and pending requests that seek a determination from FDA of whether a nonprescription sunscreen active ingredient, or a combination of nonprescription sunscreen active ingredients, is generally recognized as safe and effective (GRASE) for use under specified conditions and should be included in the over-the-counter (OTC) sunscreen drug monograph. We are issuing this guidance under the SIA, which directs FDA to issue guidance on various topics, including guidance on the process by which a request under section 586A or a pending request is withdrawn. This guidance finalizes the draft guidance issued on November 23, 2015. | 2016-10-11 | 2016 | 10 | https://www.federalregister.gov/documents/2016/10/11/2016-24459/sunscreen-innovation-act-withdrawal-of-a-586a-request-or-pending-request-guidance-for-industry | https://www.govinfo.gov/content/pkg/FR-2016-10-11/pdf/2016-24459.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request." This guidance provides recommendations for the process for... |