# Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records; Availability
> **Food and Drug Administration** · Notice of availability of guidance. · Published 2005-09-12 · 70 FR 53728
## Document
- **Document number:** 05-18039
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 70 FR 53728
- **CFR reference:** 21 CFR 1
- **Publication date:** 2005-09-12
- **HHS docket:** Docket No. 2005D-0356
## Abstract

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Questions and Answers Regarding Establishment and Maintenance of Records." The guidance responds to various questions raised about the recordkeeping provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulation, which requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and the immediate subsequent recipients of food.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2005/09/12/05-18039/guidance-for-industry-questions-and-answers-regarding-the-final-rule-on-establishment-and)
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