[Federal Register: December 27, 2004 (Volume 69, Number 247)]
[Notices]
[Page 77258-77259]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de04-79]

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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: Kelly.Williams@cfsan.fda.gov.

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