federal_register: 2015-29634

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2015-29634 Sunscreen Innovation Act; Withdrawal of a 586A Request or Pending Request; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request." This draft guidance provides recommendations for the process for withdrawing a 586A request submitted under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by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 We are issuing this draft guidance under the SIA, which directs FDA to issue guidance on various topics, including guidance on the process by which a request under section 586A or a pending request is withdrawn. 2015-11-23 2015 11 https://www.federalregister.gov/documents/2015/11/23/2015-29634/sunscreen-innovation-act-withdrawal-of-a-586a-request-or-pending-request-draft-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2015-11-23/pdf/2015-29634.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and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request." This draft guidance provides recommendations for the...

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