federal_register: 05-23504

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
05-23504 Guidance for Industry and Food and Drug Administration Staff, Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of Guidance for Industry and FDA Staff entitled "Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002." The document finalizes the draft guidance entitled "Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002." The guidance clarifies the circumstances under which FDA may access and copy records under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. ("Bioterrorism Act"), and describes the procedure that FDA intends to follow to exercise its authority to inspect records under the Federal Food, Drug, and Cosmetic Act (the act). 2005-11-30 2005 11 https://www.federalregister.gov/documents/2005/11/30/05-23504/guidance-for-industry-and-food-and-drug-administration-staff-guidance-for-records-access-authority https://www.govinfo.gov/content/pkg/FR-2005-11-30/pdf/05-23504.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of Guidance for Industry and FDA Staff entitled "Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness...

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