[Federal Register Volume 72, Number 4 (Monday, January 8, 2007)]
[Proposed Rules]
[Page 694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-47]



[[Page 694]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 101 and 170

[Docket No. 2002P-0122] (formerly 02P-0122)


Conventional Foods Being Marketed as ``Functional Foods''; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to March 
5, 2007, the comment period for the notice of public hearing that 
appeared in the Federal Register of October 25, 2006 (71 FR 62400). In 
the notice of public hearing, FDA requested comments on how the agency 
should regulate conventional foods marketed as ``functional foods'' 
under its existing legal authority. The agency is taking this action in 
response to requests for an extension to allow interested persons 
additional time to submit comments.

DATES: Submit written and electronic comments by March 5, 2007.

ADDRESSES: You may submit comments, identified by Docket No. 2002P-
0122, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and docket number for this rulemaking. All comments received may be 
posted without change to http://www.fda.gov/ohrms/dockets/default.htm, 
including any personal information provided. For additional information 
on submitting comments, see the ``Comments'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Juanita Yates, Center for Food Safety 
and Applied Nutrition (HFS-555), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-1731.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 25, 2006, FDA published a notice 
of public hearing with a 72-day comment period to request comments on 
the regulation of conventional foods marketed as ``functional foods,'' 
specifically the issues and questions presented in section III of the 
notice (see 71 FR 62400 at 62403). Comments will inform FDA's 
approaches to the regulation of conventional foods marketed as 
``functional foods.''
    The agency has received requests for a 60-day extension of the 
comment period for the notice of public hearing. Each request conveyed 
concern that the current 72-day comment period, which closes 30 days 
subsequent to the public hearing held December 5, 2006, does not allow 
sufficient time to develop a meaningful or thoughtful response to the 
request for comments on the issues and questions presented in section 
III of the notice.
    FDA has considered the requests and is extending the comment period 
for the notice of public hearing for 60 days, until March 5, 2007. The 
agency believes that a 60-day extension allows adequate time for 
interested persons to submit comments on the issues and questions 
presented in section III of the notice without significantly delaying 
the agency's consideration of how FDA should regulate conventional 
foods marketed as ``functional foods'' under its existing legal 
authority.

II. Request for 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. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: December 29, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-47 Filed 1-5-07; 8:45 am]
BILLING CODE 4160-01-S