[Federal Register Volume 69, Number 247 (Monday, December 27, 2004)]
[Notices]
[Pages 77258-77259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28135]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0454]


Dietary Supplements; Premarket Notification for New Dietary 
Ingredient Notifications; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening to 
February 1, 2005, the comment period for a notice that appeared in the 
Federal Register of October 20, 2004 (69 FR 61680). In the notice, FDA 
solicited comments on FDA's premarket notification program for new 
dietary ingredients (NDIs) and announced a public meeting on that 
topic. The comment period closed on December 3, 2004. FDA is reopening 
the comment period in response to a request from trade associations 
representing firms in the dietary supplement industry for additional 
time to submit comments.

DATES: Submit written or electronic comments by February 1, 2005.

[[Page 77259]]


ADDRESSES: Submit written comments to the Division of Dockets 
Management (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: Kelly Williams-Randolph, Center for 
Food Safety and Applied Nutrition (HFS-810), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-2506, FAX: 301-436-2639, or e-mail: <a href="/cdn-cgi/l/email-protection#5318363f3f2a7d043a3f3f3a323e2013303520323d7d3537327d343c25"><span class="__cf_email__" data-cfemail="216a444d4d580f76484d4d48404c5261424752404f0f4745400f464e57">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 20, 2004, FDA published a notice 
announcing a public meeting on November 15, 2004, and soliciting 
comments on FDA's premarket notification program for NDIs with an 
opportunity for public comment for 45 days. FDA requested comments from 
industry, consumers, and other interested members of the public 
concerning the content and format requirements for NDI notifications 
made under section 413(a)(2) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 350b(a)(2)). FDA held this meeting to give the public an 
opportunity to provide information and views on topics outlined in the 
notice. The agency intends to consider all comments received in the 
meeting and sent to the docket in determining whether any future action 
is necessary or appropriate.
    The agency has received a request from a number of trade 
associations for an extension of the comment period to and including 
February 1, 2005. The request set forth several reasons in support of 
allowing additional time to submit comments. First, according to the 
request, the 45-day comment period did not allow sufficient time for 
interested parties to adequately address the large number of detailed 
and specific questions put forth by FDA and the significant impact on 
industry, especially small businesses, of the issues raised in the 
notice. The request noted that the questions (many of which contained 
subparts) will require extended industry discussion to ensure broad 
input from member firms and to organize the information obtained from 
their member companies. Second, the request noted that the original 
December 3, 2004, deadline for submitting comments did not provide 
interested parties enough time to consider the transcript of the 
November 15, 2004, meeting in developing their comments. The request 
explained that an extension until February 1, 2005, would allow 
industry to submit more focused and detailed comments without 
significantly delaying the agency's consideration of the issues set 
forth in the meeting notice.
    FDA has considered the request and is reopening the comment period 
for the October 20, 2004, notice until February 1, 2005. The agency 
agrees that reopening the comment period will allow adequate time for 
interested persons to submit comments without significantly delaying 
the agency's consideration of the issues set forth in the October 20, 
2004, notice.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the issues 
raised in the October 20, 2004, notice. 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 17, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-28135 Filed 12-23-04; 8:45 am]
BILLING CODE 4160-01-S


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