{"database": "openregs", "table": "federal_register", "rows": [["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on various topics, including guidance on the process by which a request under section 586A or a pending request is withdrawn. This guidance finalizes the draft guidance issued on November 23, 2015.", "2016-10-11", 2016, 10,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...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month", "html_url", "pdf_url", "agency_names", "agency_ids", "excerpts", "regulation_id_numbers"], "primary_keys": ["document_number"], "primary_key_values": ["2016-24459"], "units": {}, "query_ms": 0.3208538983017206, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}