{"database": "openregs", "table": "federal_register", "rows": [["E7-17709", "\"Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms\"; Availability", "Notice", "The Food and Drug Administration (FDA) is announcing the availability of a document entitled \"Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms\" dated September 2007. The guidance document is intended to provide guidance to manufacturers using spore- forming microorganisms in the production of certain biological products. The guidance document provides recommendations to industry in response to changes made to the requirements for spore-forming microorganisms to allow greater flexibility in manufacturing. The guidance announced in this notice finalizes the draft guidance entitled \"Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms\" dated February 2005.", "2007-09-07", 2007, 9, "https://www.federalregister.gov/documents/2007/09/07/E7-17709/guidance-for-industry-manufacturing-biological-intermediates-and-biological-drug-substances-using", "https://www.govinfo.gov/content/pkg/FR-2007-09-07/pdf/E7-17709.pdf", "Health and Human Services Department; Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA) is announcing the availability of a document entitled \"Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms\" dated September 2007. The...", 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": ["E7-17709"], "units": {}, "query_ms": 0.37645804695785046, "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"}