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

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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 The document finalizes the draft guidance entitled "Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002."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).