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Draft Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions; Availability

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled “Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions.” The draft guidance explains, using a question and answer format, FDA's current thinking on a number of microbiological issues unique to the preparation of premarket submissions for antimicrobial food additives.

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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by November 26, 2007.

ADDRESSES:

Submit written requests for single copies of the draft guidance document to the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Start Printed Page 54447Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 to http://www.fda.gov/​dockets/​ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

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FOR FURTHER INFORMATION CONTACT:

Judith Kidwell, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1071.

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SUPPLEMENTARY INFORMATION:

I. Background

The Food and Drug Administration (FDA) is responsible for prescribing the conditions of safe use of food additives under section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348). To evaluate the safety of food additives and determine their conditions of safe use, the agency uses various premarket approval processes (food additive petition process (21 CFR 171.1), premarket notification process for food contact substances (21 CFR 170.100), and threshold of regulation process for substances used in food contact articles that migrate or may be expected to migrate into food (21 CFR 170.39)). This guidance provides answers to common questions arising during the preparation of premarket submissions that seek FDA approval of new antimicrobial food additives. This guidance will assist petitioners and notifiers in designing studies to determine whether an antimicrobial food additive achieves its intended technical effect. In addition, this guidance discusses microbiological data that may demonstrate that an antimicrobial agent will be safe for the intended use. This guidance applies to all premarket approval submissions for food additives that are intended to control microbes in or on food, including sources of radiation for treating food.

The agency has adopted good guidance practices (GGPs) that set forth the agency's policies and procedures for the development, issuance, and use of guidance documents (21 CFR 10.115). This draft guidance is being issued as a Level 1 guidance document consistent with the GGPs. The draft guidance represents the agency's current thinking on microbiological considerations for antimicrobial food additive submissions. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance (see FOR FURTHER INFORMATION CONTACT).

II. Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of information found in FDA regulations. 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 in 21 CFR 70.25, 71.1, 170.35, and 171.1 have been approved under OMB control number 0910-0016; the collection of information in 21 CFR 170.39 has been approved under OMB control number 0190-0298; and the collections of information in 21 CFR 170.101 and 170.106 have been approved under OMB control number 0190-0495.

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. If you base your comments on scientific evidence or data, please submit copies of the specific information along with your comments. 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 draft guidance at http://www.cfsan.fda.gov/​guidance.html.

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Dated: September 18, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E7-18816 Filed 9-24-07; 8:45 am]

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