E9-21713. Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled “Questions and Answers Regarding the Reportable Food Registry 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).

DATES:

Submit written or electronic comments on the guidance at any time.

ADDRESSES:

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.

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.

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, 1-888-SAFEFOOD.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of June 11, 2009 (74 FR 27803), FDA announced the availability of a draft guidance entitled “Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007” and gave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 has modified the guidance where appropriate.

The guidance contains questions and answers intended to assist those parties responsible for complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (Public Law 110-085), including: (1) How, when, and where to submit reports to FDA; (2) who is required to submit reports to FDA; (3) what is required to be submitted to FDA; and (4) what may be required when providing notifications to other persons in the supply chain of an article of food.

FDA is issuing this guidance as level 1 guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). 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 contains information collection provisions that 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 in this guidance were approved under OMB Control Nos. 0910-0643 and 0910-0645. This guidance also refers to previously approved collections of information found in FDA regulations. The collection of information in 21 CFR 7.46 has been approved under OMB Control No. 0910-0249.

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 http://www.fda.gov/​Food/​GuidanceComplianceRegulatoryInformation/​GuidanceDocuments/​default.htm or http://www.regulations.gov.

Dated: September 3, 2009.

David Horowitz,

Assistant Commissioner for Policy.