[Federal Register: September 25, 2007 (Volume 72, Number 185)]
[Notices]
[Page 54446-54447]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25se07-48]
-----------------------------------------------------------------------
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Draft Guidance for Industry: Microbiological Considerations for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.
-----------------------------------------------------------------------
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availability of the draft guidance document entitled ``Guidance for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 The draft guidance explains, using a question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draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance document to the Office of Food Additive Safety (HFS-200),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 Submit written comments on the draft guidance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draft guidance document.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