Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions; Availability, 36090 [E8-14397]

Download as PDF 36090 Federal Register / Vol. 73, No. 123 / Wednesday, June 25, 2008 / Notices DC 20447, Attn: OPRE Reports Clearance Officer. E-mail address: OPREInfoCollection@acf.hhs.gov. All requests should be identified by the title of the information collection. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, FAX: 202–395–6974, Attn: Desk Officer for ACF. Dated: June 18, 2008. Brendan C. Kelly, OPRE Reports Clearance Officer. [FR Doc. E8–14222 Filed 6–24–08; 8:45 am] BILLING CODE 4184–01–M 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. 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, mstockstill on PROD1PC66 with NOTICES SUMMARY: VerDate Aug<31>2005 21:19 Jun 24, 2008 Jkt 214001 MD 20852. Submit electronic comments to https://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. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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 https:// 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Board of Scientific Counselors, NIEHS. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual other conducted by the National Institute of Environmental Health Sciences, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. E:\FR\FM\25JNN1.SGM 25JNN1

Agencies

[Federal Register Volume 73, Number 123 (Wednesday, June 25, 2008)]
[Notices]
[Page 36090]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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 https://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 
https://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

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