[Federal Register Volume 65, Number 99 (Monday, May 22, 2000)]
[Notices]
[Pages 32113-32114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12749]


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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 ``[email protected]''. 
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 
``[email protected]''. 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