[Federal Register: May 22, 2000 (Volume 65, Number 99)]
[Notices]
[Page 32113-32114]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22my00-97]
 
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
[Docket No. 00N-1200]
 
 
Dietary Supplements Containing Ephedrine Alkaloids; Availability
 
AGENCY: Food and Drug Administration, HHS.
 
ACTION: Notice of availability; extension of comment period.
 
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SUMMARY: The Food and Drug Administration (FDA) is extending to July 3,
2000, the comment period for a notice published in the Federal Register
of April 3, 2000, that announced the availability of new adverse event
reports (AER's) and related information concerning dietary supplements
containing ephedrine alkaloids. This action is being taken in response
to requests for more time to submit comments to FDA.
 
DATES: Submit written comments on the notice of availability by July 3,
2000.
 
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, or via e-mail to ``FDADockets@oc.fda.gov''.
Comments are to be identified with the docket number found in brackets
in the heading of this document.
 
FOR FURTHER INFORMATION CONTACT: Marquita B. Steadman, Center for Food
Safety and Applied Nutrition (HF-26), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-827-6733.
 
SUPPLEMENTARY INFORMATION:
 
I. Extension of Comment Period
 
    In the Federal Register of April 3, 2000 (64 FR 17510), FDA
published a notice announcing a new public docket that makes available
new adverse event reports and related information concerning dietary
supplements containing ephedrine alkaloids. The Federal Register notice
also announced FDA's intent to participate in a public forum to address
safety information on such products.
    Since publication of the April 3, 2000, Federal Register notice,
FDA has received requests, both oral and written, to allow additional
time for interested persons to comment. FDA believes that an extension
of the comment period for an additional 45 days, until July 3, 2000,
would be appropriate, in light of the amount of data FDA made publicly
available on April 3, 2000. This extension will provide the public with
 
[[Page 32114]]
 
a total of 90 days to submit data, analyses, and other relevant
information.
    Although the agency has reviewed the requests asking for extensions
of the comment period, the longest of which is for an additional 1
year, FDA does not believe that such a lengthy delay is in the best
interest of the public health. FDA believes that delaying the receipt
of comments for more than an additional 45 days (for a total of 90
days) is too long given the public health concerns at issue.
 
II. How to Submit Comments
 
    Interested persons may, on or before July 3, 2000, submit written
comments to the Dockets Management Branch (address above). You may also
send comments to the Dockets Management Branch via e-mail to
``FDADockets@oc.fda.gov''. You should annotate and organize your
comments to identify the specific issues to which they refer. You must
submit two copies of comments, identified with the docket number found
in brackets in the heading of this document, except that you may submit
one copy if you are an individual. You may review received comments in
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
 
    Dated: May 16, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-12749 Filed 5-19-00; 8:45 am]
BILLING CODE 4160-01-F

Dietary Supplements Containing Ephedrine Alkaloids; Availability April 3, 2000 Federal Register Notice

"Dear Colleague" Letter About August 8, 2000 Public Meeting Concerning the Safety of Dietary Supplements Containing Ephedrine Alkaloids June 8, 2000