[Federal Register Volume 68, Number 96 (Monday, May 19, 2003)]
[Proposed Rules]
[Page 27008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12366]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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