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Guidance for Industry on Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007; Availability

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled “Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007.” The document provides guidance to the industry in complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA), and more specifically, this guidance provides information to the industry on submitting a single reportable food report to FDA covering reportable food located at more than one of a company's facilities.

DATES:

Submit written or electronic comments on agency guidances at any time.

ADDRESSES:

Submit written comments on the guidance to the Division of Dockets Management (HFA—305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written requests for single copies of the guidance to the Office of Food Defense, Communication and Emergency Response (HFS-005), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance.

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FOR FURTHER INFORMATION CONTACT:

Faye Feldstein, Center for Food Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2428.

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SUPPLEMENTARY INFORMATION:Start Printed Page 14446

I. Background

On September 27, 2007, the President signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85). This law amends the Federal Food, Drug, and Cosmetic Act (the act) by creating a new section 417 (21 U.S.C. 350f), Reportable Food Registry. Section 417 of the act requires the Secretary of Health and Human Services (the Secretary) to establish within FDA a Reportable Food Registry. The congressionally-identified purpose of the Reportable Food Registry is to provide a “reliable mechanism to track patterns of adulteration in food [which] would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public health” (Section 1005(a)(4) of FDAAA). The Secretary has delegated to the Commissioner of the Food and Drug Administration the responsibility for administering the act, including section 417. To further the development of the Reportable Food Registry, section 417 of the act requires FDA to establish an electronic portal by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials. After receipt of reports through the electronic portal, FDA is required to review and assess the information submitted for purposes of identifying reportable food, submitting entries to the Reportable Food Registry, issuing an alert or notification as FDA deems necessary, and exercising other existing food safety authorities under FDAAA to protect the public health. The requirements under the Reportable Food Registry became effective on September 8, 2009.

In the Federal Register of June 11, 2009 (74 FR 27803), FDA announced the availability of a draft guidance entitled “Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007” and gave interested parties an opportunity to submit comments by July 27, 2009. The agency reviewed and evaluated these comments and issued a final guidance on September 8, 2009. This document is a related final guidance entitled “Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007” and contains a question and answer addressing the circumstance where reportable food is located at more than one of a company's facilities.

FDA is issuing this guidance as level 1 guidance. Consistent with FDA's good guidance practices regulation (§ 10.115 (21 CFR 10.115)), the agency will accept comments, but it is implementing the guidance document immediately, in accordance with § 10.115(g)(2), because the agency has determined that prior public participation is not feasible or appropriate. As noted, the requirements under the Reportable Food Registry became effective on September 8, 2009. Clarifying the Reportable Food Registry requirements will facilitate compliance and implementation, and will lessen the burden on industry and FDA caused by unnecessary submission of multiple reports when one reportable food situation affects more than one of a company's facilities. The guidance represents the agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in the act. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information related to submitting reportable food reports to FDA in section 417 of the act have been approved under OMB Control No. 0910-0645.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/​FoodGuidances or http://www.regulations.gov.

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Dated: March 19, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2010-6578 Filed 3-24-10; 8:45 am]

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