[Federal Register: September 17, 2007 (Volume 72, Number 179)]
[Rules and Regulations]
[Page 52790]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se07-6]
[[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: 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 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 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(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