Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act | Guideline Explorer

Description

This guidance document provides updated information pertaining to the Food and Drug Administration’s (FDA) authority to access and copy records under sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance is a revision of FDA’s November 2005 guidance entitled “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; Final Guidance.” FDA’s staff manuals, the Regulatory Procedures Manual (RPM) and Investigations Operations Manual (IOM), contain operational and procedural steps for FDA staff to follow for accessing records under sections 414 and 704 of the FD&C Act; therefore, that information has been removed from this guidance. Both the RPM and IOM are located on FDA’s website,www.fda.gov.

Scope & Applicability

Product Classes

1

Infant Formula

The primary product category covered by the guidance; Essential food product that is the sole source of nutrition for many infants.

Stakeholders

4

Manufacturer

Entity responsible for submitting NDINs

Importer

Must comply with registration if meeting facility/responsible person definitions

Farm

An operation devoted to the growing of crops, harvesting of crops, or raising of animals; An operation devoted to the growing of crops, the raising of animals, or both.; Considered a business, not a consumer, for registration purposes.; Classification of activities for Farms and Facilities

Restaurant

Includes pet shelters, kennels, and veterinary facilities providing food to animals.; Establishment that prepares and sells food for immediate consumption

Regulatory Context

Attributes

1

Trade secret

Information in an NDIN protected from public disclosure

Identified Hazards

Hazards

5

Serious adverse health consequences or death

Threshold for requiring an onsite audit of a supplier

Salmonella

biological hazard in dried milk powder; Microbiological hazard in pet treats; hazard in animal-derived protein ingredients; biological hazard requiring control in turmeric

Clostridium botulinum toxin

Risk associated with improper storage temperature of mushrooms.

Listeria monocytogenes

biological hazard in frozen ice cream novelty; Biological hazard in cheese

Choking hazard

Risk if a restricted delivery system is easily removed or pushed into the bottle.

Related CFR Sections (1)

21CFR1.328§ 1.328 What definitions apply to this subpart?
The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) ( 21 U.S.C. 321 ) apply to such terms when used in this subpart. In addition, for the purposes of this subpart:Read full regulation →

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