[Federal Register: May 19, 2003 (Volume 68, Number 96)]
[Proposed Rules]
[Page 27008]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my03-15]
 
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
21 CFR Parts 111 and 112
 
[Docket No. 96N-0417]
RIN 0910-AB88
 
 
Current Good Manufacturing Practice in Manufacturing, Packing, or
Holding Dietary Ingredients and Dietary Supplements
 
AGENCY: Food and Drug Administration, HHS.
 
ACTION: Proposed rule; extension of comment period.
 
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SUMMARY: The Food and Drug Administration (FDA) is extending to August
11, 2003, the comment period for a proposed rule published in the
Federal Register of March 13, 2003. The proposed rule would establish
the minimum current good manufacturing practices (CGMPs) necessary to
ensure that, if you engage in activities related to manufacturing,
packaging, or holding dietary ingredients or dietary supplements, you
do so in a manner that will not adulterate and misbrand such dietary
ingredients or dietary supplements. This action is being taken in
response to requests for more time to submit comments to FDA.
 
DATES: Submit written or electronic comments on the proposed rule by
August 11, 2003.
 
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to
http://www.fda.gov/dockets/ecomments.
 
FOR FURTHER INFORMATION CONTACT: Karen Strauss, Center for Food Safety
and Applied Nutrition (HFS-821), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 02740-3835, 301-436-2375.
 
SUPPLEMENTARY INFORMATION:
 
I. Background
 
    In the Federal Register of March 13, 2003 (68 FR 12158), FDA
published a proposed rule that, if finalized, would establish the
minimum CGMPs necessary to ensure that, if you engage in activities
related to manufacturing, packaging, or holding dietary ingredients or
dietary supplements, you do so in a manner that will not adulterate and
misbrand such dietary ingredients or dietary supplements. The proposed
provisions would require manufacturers to evaluate the identity,
purity, quality, strength, and composition of the dietary ingredients
and dietary supplements.
    In the March 13, 2003, proposed rule, FDA announced that the time
period for public comment would be 90 days from the date of the
publication in the Federal Register. On April 21, 2003, FDA received a
request to allow an additional 60 days for interested persons to
comment. In addition, on April 25, 2003, FDA received a request to
allow an additional 90 days for interested persons to comment. The
requesters assert that the time period of 90 days is insufficient to
respond fully to FDA's multiple requests for comments and analyses and
to enable all potential respondents adequate time to conduct the
research necessary to provide complete scientific responses to
questions posed in the proposed rule.
    FDA believes that an extension of the comment period is
appropriate, given the variety of issues raised by the proposed rule.
However, because the agency wants to move forward on finalizing the
rule as quickly as possible, FDA is extending the comment period only
for an additional 60 days, until August 11, 2003. This extension will
provide the public with a total of 150 days to submit comments. FDA
does not intend to grant any additional time for extensions of the
comment period.
 
II. Comments
 
    Interested persons may submit to the Dockets Management Branch (see
ADDRESSES) written or electronic comments regarding the proposal.
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 numbers found in brackets
in the heading of this document. Received comments may be seen in the
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
 
    Dated: May 10, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-12366 Filed 5-16-03; 8:45 am]
 
BILLING CODE 4160-01-S