federal_register: 2011-29485

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
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International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Draft Guidance on Implementation; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility; Availability; Correction Notice The Food and Drug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 The document announced the availability of a draft guidance entitled "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs): Implementation Guide--Data Elements and Message Specification" (the draft E2B(R3) implementation guidance) and an appendix to the draft guidance entitled "ICSRs: Appendix to the Implementation Guide--Backwards and Forwards Compatibility" (the draft BFC appendix).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 The document announced the availability of a draft guidance entitled "E2B(R3) Electronic Transmission of...

Links from other tables