[Federal Register Volume 65, Number 147 (Monday, July 31, 2000)]
[Notices]
[Pages 46721-46722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19286]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1200]


Dietary Supplements Containing Ephedrine Alkaloids; Availability; 
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 from 
August 10 to September 30, 2000, the comment period for a notice that 
published in the Federal Register of April 3, 2000 (65 FR 17510), 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 conjunction with a separate 
Federal Register notice by the U.S. Department of Health and Human 
Services' Office of Women's Health (OWH), which is part of the U.S. 
Public Health Service (PHS), announcing that it will hold a public 
meeting on August 8 and 9, 2000, to discuss available information about 
the safety of dietary supplements containing ephedrine alkaloids. FDA 
is also giving notice of the availability of a report on 
phenylpropanolomine and risk of hemorrhagic stroke.

DATES: Submit written comments on the notice of availability by 
September 30, 2000.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, e-mail: [email protected], or http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. 
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:

[[Page 46722]]

I. Reopening the Comment Period

    In the Federal Register of April 3, 2000 (65 FR 17510), FDA 
published a notice announcing a new public docket that makes available 
new AER's and related information concerning dietary supplements 
containing ephedrine alkaloids. The Federal Register notice (65 FR 
17510) also announced FDA's intent to participate in a public forum to 
address safety information on such products. Interested persons were 
given until May 18, 2000, to submit written comments on the April 3, 
2000, Federal Register notice to FDA's public docket (Docket No. 00N-
1200). FDA later extended this comment period until July 3, 2000 (65 FR 
32113, May 22, 2000).
    In a separate Federal Register notice (65 FR 43021, July 12, 2000), 
OWH announced that it will convene a public meeting to discuss 
available information about the safety of dietary supplements 
containing ephedrine alkaloids. These products are promoted for uses 
such as weight loss, body building, and increased energy. This meeting 
will afford all interested persons an opportunity to provide focused 
comment in a manner that will assist PHS in understanding the benefits 
and risks associated with dietary supplements containing ephedrine 
alkaloids. The PHS public meeting is scheduled for August 8 and 9, 
2000. For more information, refer to the July 12, 2000, Federal 
Register notice, or visit the OWH Internet site (The National Women's 
Health Information Center) at http://www.4woman.gov/owh/public.
    In light of this public meeting, FDA is reopening the comment 
period for the April 3, 2000, notice from August 10 to September 30, 
2000. The information and comments generated from the PHS public 
meeting, along with the information in the public docket (Docket No. 
00N-1200), will be considered by FDA in assessing the safety of dietary 
supplements containing ephedrine alkaloids that are promoted for uses 
such as weight loss, body building, and increased energy.
    The agency has added a report entitled ``Phenylpropanolomine and 
Risk of Stroke: Final Report of the Hemorrhagic Stroke Project'' to the 
public docket (Docket No. 00N-1200). The agency seeks written comment 
on this report and its relevancy to an assessment of the safety of 
dietary supplements containing ephedrine alkaloids.

II. How to Submit Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments from August 10 to September 30, 2000. 
You may also send comments to the Dockets Management Branch via the 
Internet at http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm, or e-mail: [email protected]. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. You may review received comments in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
    You may request a transcript of the PHS meeting in writing from the 
Freedom of Information Office (HFI-35), Food and Drug Administration, 
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 
working days after the meeting, at a cost of 10 cents per page. You may 
also examine the transcript of the meeting after August 25, 2000, at 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday, as well as on the Internet at http://www.fda.gov.

    Dated: July 25, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-19286 Filed 7-26-00; 4:06 pm]
BILLING CODE 4160-01-F