[Federal Register: June 25, 2008 (Volume 73, Number 123)]
[Notices]
[Page 36090]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn08-88]
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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announced the availability of a draft guidance entitled ``Guidance for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submit comments on the draft guidance by November 26, 2007.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guidance announced in this notice finalizes the draft guidance dated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