{"database": "openregs", "table": "federal_register", "rows": [["2011-5145", "Benzocaine; Weight Control Drug Products for Over-the-Counter Human Use", "Proposed Rule", "The Food and Drug Administration (FDA) is issuing a proposed rule to reclassify benzocaine from its previously proposed monograph status (category I) for over-the-counter (OTC) weight control use to nonmonograph status. Although, in the Federal Register of February 26, 1982, an advanced notice of proposed rulemaking (ANPR) included the recommendation of an Advisory Panel, consisting of health care providers from outside FDA, recommended that benzocaine should be generally recognized as safe and effective (GRASE) for weight control, this document includes our first evaluation of benzocaine for this use. Based on our evaluation of the available data and information, we have tentatively concluded that the data are not sufficient to support the safety and effectiveness of benzocaine for this use. This proposed rule, if finalized, would require an approved new drug application (NDA) or abbreviated new drug application (ANDA) for the marketing of OTC weight control products containing benzocaine.", "2011-03-09", 2011, 3, "https://www.federalregister.gov/documents/2011/03/09/2011-5145/benzocaine-weight-control-drug-products-for-over-the-counter-human-use", "https://www.govinfo.gov/content/pkg/FR-2011-03-09/pdf/2011-5145.pdf", "Health and Human Services Department; Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA) is issuing a proposed rule to reclassify benzocaine from its previously proposed monograph status (category I) for over-the-counter (OTC) weight control use to nonmonograph status. Although, in the Federal...", 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": ["2011-5145"], "units": {}, "query_ms": 0.6916231941431761, "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"}