[Federal Register Volume 73, Number 123 (Wednesday, June 25, 2008)]
[Notices]
[Page 36090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14397]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0207] (formerly Docket No. 2007D-0202)


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 a guidance for industry entitled ``Guidance for 
Industry: Microbiological Considerations for Antimicrobial Food 
Additive Submissions.'' The guidance explains FDA's current thinking on 
a number of microbiological issues unique to the preparation of 
premarket submissions for antimicrobial food additives.

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

ADDRESSES:  Submit written requests for single copies of the guidance 
to the Office of Food Additive Safety (HFS-200), Center for Food Safety 
and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740. 
Send two self-addressed adhesive labels to assist that office in 
processing your request, or fax your request to 301-436-2972. Submit 
written comments 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.regulations.gov. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
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, 301-436-1071.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 25, 2007 (72 FR 54446), FDA 
announced the availability of a draft guidance entitled ``Guidance for 
Industry: Microbiological Considerations for Antimicrobial Food 
Additive Submissions.'' FDA gave interested parties an opportunity to 
submit comments on the draft guidance by November 26, 2007. The agency 
considered the one received comment as it finalized the guidance. The 
guidance announced in this notice finalizes the draft guidance dated 
September 2007.
    FDA is issuing this guidance document as level 1 guidance 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). The guidance document represents FDA's current thinking on a 
number of microbiological issues unique to the preparation of premarket 
submissions for antimicrobial food additives. 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.

II. Paperwork Reduction Act of 1995

    This 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 
collection 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 
0910-0298; and the collection of information in 21 CFR 170.101 and 
170.106 have been approved under OMB control number 0910-0495.

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. The guidance document and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA 
through FDMS only.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
http://www.cfsan.fda.gov/guidance.html.

    Dated: June 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14397 Filed 6-24-08; 8:45 am]
BILLING CODE 4160-01-S