{"database": "openregs", "table": "federal_register", "rows": [["2011-29485", "International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Draft Guidance on Implementation; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility; Availability; Correction", "Notice", "The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Thursday, October 20, 2011 (76 FR 65199). The document announced the availability of a draft guidance entitled \"E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs): Implementation Guide--Data Elements and Message Specification\" (the draft E2B(R3) implementation guidance) and an appendix to the draft guidance entitled \"ICSRs: Appendix to the Implementation Guide--Backwards and Forwards Compatibility\" (the draft BFC appendix). The document was published with an incorrect date in the DATES section. This document corrects that error.", "2011-11-16", 2011, 11, "https://www.federalregister.gov/documents/2011/11/16/2011-29485/international-conference-on-harmonisation-e2br3-electronic-transmission-of-individual-case-safety", "https://www.govinfo.gov/content/pkg/FR-2011-11-16/pdf/2011-29485.pdf", "Health and Human Services Department; Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Thursday, October 20, 2011 (76 FR 65199). The document announced the availability of a draft guidance entitled \"E2B(R3) Electronic Transmission of...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year",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": ["2011-29485"], "units": {}, "query_ms": 0.9437617845833302, "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"}