Petition to Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Extension of Comment Period, 52790 [E7-18293]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 179 (Monday, September 17, 2007)]
[Rules and Regulations]
[Page 52790]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18293]



[[Page 52790]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 111

[Docket No. 2007N-0186]
RIN 0910-AB88


Petition to Request an Exemption From 100 Percent Identity 
Testing of Dietary Ingredients: Current Good Manufacturing Practice in 
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary 
Supplements; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to October 
24, 2007, the comment period for the interim final rule (IFR) that 
appeared in the Federal Register of June 25, 2007 (72 FR 34959). In the 
IFR, FDA requested comments on a procedure for a petition to request an 
exemption from 100 percent identity testing of dietary ingredients. 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 October 24, 2007.

ADDRESSES: You may submit comments, identified by Docket No. 2007N-
0186, and/or Regulation Identifier Number (RIN) 0910-AB88, by any of 
the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: https://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 previously in 
the ADDRESSES portion of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and/or RIN for this rulemaking. All comments received 
may be posted without change to https://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 https://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number(s), 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: Vasilios Frankos, Center for Food 
Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1696.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 25, 2007 (72 FR 34959), FDA 
published an IFR with a 90-day comment period to request comments on a 
procedure for a petition to request an exemption from 100 percent 
identity testing of dietary ingredients. Comments on the exemption 
procedure will provide an opportunity for interested persons to comment 
on whether this exemption procedure should be modified, and if so, 
whether there is any additional information that may be helpful to 
articulate with respect to what a petition needs to show that may 
inform future guidance.
    The agency has received a request for a 60-day extension of the 
comment period for the IFR. The request conveyed concern that the 
current 90-day comment period does not allow sufficient time to develop 
a meaningful or thoughtful response to the IFR.
    FDA has considered the request and is extending the comment period 
for the IFR for 30 days, until October 24, 2007. The agency believes 
that a 30-day extension allows adequate time for interested persons to 
submit comments without significantly delaying rulemaking on these 
important issues.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on 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: September 11, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-18293 Filed 9-14-07; 8:45 am]
BILLING CODE 4160-01-S