[Federal Register Volume 72, Number 185 (Tuesday, September 25, 2007)]
[Notices]
[Pages 54446-54447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-18816]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0202]


Draft Guidance for Industry: Microbiological Considerations for 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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availability of the draft guidance document entitled ``Guidance for 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 The draft guidance explains, using a question 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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES: Submit written requests for single copies of the draft 
guidance document to the Office of Food Additive Safety (HFS-200), 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

[[Page 54447]]

Drug 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 Submit written comments on the draft guidance 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draft guidance document.

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.

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.

    Dated: September 18, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-18816 Filed 9-24-07; 8:45 am]
BILLING CODE 4160-01-S