Guidance for Industry and FDA 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 | Guideline Explorer

Description

This guidance document is being distributed for use by FDA staff and Industry. It is a revision of the previously issued guidance entitled "Draft Guidance for Records Access Authority provided in Title III, Subtitle A of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002" dated December 9, 2004.

Scope & Applicability

Product Classes

1

Food

articles used for food or drink for man or other animals

Stakeholders

3

Owner, operator, or agent in charge

Persons to whom the PCHF requirements apply; Responsible for determining hazards requiring preventive controls; Person responsible for determining hazards requiring preventive control

Importer

Must comply with registration if meeting facility/responsible person definitions

Manufacturer

Entity responsible for submitting NDINs

Identified Hazards

Hazards

1

Threat of serious adverse health consequences or death

Original criteria under the Bioterrorism Act.

Related CFR Sections (1)

21CFR1.361§ 1.361 What are the record availability requirements?
When FDA has a reasonable belief that an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, or when FDA believes that therRead full regulation →