Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007; Availability; Announcement of Further Delay in Implementation of the Food and Drug Administration Amendments Act of 2007

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled “Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007.” The draft guidance, when finalized, will assist the industry in complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDA is also announcing a further delay in the implementation of the Reportable Food Registry (the Registry) of FDAAA until September 8, 2009, to consider any comments received on the draft guidance and through the agency's planned outreach initiatives, and to allow for further testing of the electronic portal for reportable foods.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on the draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by July 27, 2009.

ADDRESSES:

Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments on the draft guidance to http://www.regulations.gov . Submit written requests for single copies of the draft guidance to the Office of Food Defense, Communication and Emergency Response, Center for Food Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 5100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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.

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.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance entitled “Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007.” The draft guidance is intended to assist those parties responsible for complying with the Reportable Food Registry requirements prescribed by FDAAA.

FDA is issuing this draft guidance as a level 1 draft guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent 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. Notice of Further Delay in Implementation

On September 27, 2007, the President signed FDAAA into law (Public Law 110-85). Section 1005 of FDAAA amends the Federal Food, Drug, and Cosmetic Act (the act) by creating a new section 417 (21 U.S.C. 350f), among other things. Section 417 of the act requires the Secretary of Health and Human Services to establish within FDA a Reportable Food Registry (the Registry); the Registry is to be established not later than 1 year after the date of enactment (i.e., by September 27, 2008).

To further the development of the Registry, section 417 of the act requires FDA to establish, also within 1 year after the date of enactment (i.e., by September 27, 2008), an electronic portal (the Reportable Food electronic portal) by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials.

FDA made the decision that the most efficient and cost effective means to implement the requirements of section 417 of the act relating to the Registry was to utilize the business enterprise system currently under development within the agency: the MedWatch^Plus Portal. This would permit the agency to establish an electronic portal through which instances of reportable food may be submitted to the agency. However, FDA recognized that the MedWatch^Plus Portal would not be implemented in time to meet the September 27, 2008, deadline for establishing the Reportable Food electronic portal and therefore announced that it was delaying its implementation until spring 2009 (73 FR 30405; May 27, 2008).

The agency now expects the system to be operational on September 8, 2009, and is therefore announcing that the implementation of the requirements of section 417 of the act will be further delayed until September 8, 2009.

In the interim, FDA strongly encourages persons to continue to report instances of adulterated food through existing mechanisms, such as notifying the relevant FDA District office, until such time as the Registry and its associated electronic portal are fully implemented.

III. Paperwork Reduction Act of 1995

This draft guidance document contains a collection of information that requires clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FDA intends to submit the collection of information to OMB in the near future for emergency processing. At that time, the agency will publish a notice in the Federal Register soliciting comments on the collection of information.

The draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in question 28 of the guidance have been approved under OMB control no. 0910-0249.

IV. 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.

V. Electronic Access

Persons with access to the Internet may obtain the draft guidance at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm or http://www.regulations.gov .