[Federal Register Volume 62, Number 161 (Wednesday, August 20, 1997)]
[Proposed Rules]
[Page 44247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22127]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 111

[Docket No. 95N-0304]
RIN 0901-AA59


Dietary Supplements Containing Ephedrine Alkaloids; Notification 
of Intent to Reopen Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
will reopen the comment period for the proposed rule on dietary 
supplements containing ephedrine alkaloids that appeared in the Federal 
Register of June 4, 1997 (62 FR 30678). The agency intends to take this 
action because FDA has identified a number of inadvertent omissions in 
the administrative record. After the agency rectifies these omissions, 
it will announce in the Federal Register the reopening of the comment 
period for 75 days.

FOR FURTHER INFORMATION CONTACT: Margaret C. Binzer, Center for Food 
Safety and Applied Nutrition (HFS-456), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-401-9859, FAX 202-260-8957, or 
E-mail [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of June 4, 1997, FDA 
published a proposed rule regarding the formulation and labeling of 
dietary supplements containing ephedrine alkaloids. FDA proposed this 
rule in response to reports of serious illnesses and injuries, 
including multiple deaths, associated with the use of dietary 
supplement products that contain ephedrine alkaloids and the agency's 
investigations and analyses of these reports of illnesses and injuries. 
Interested persons were given until August 18, 1997, to comment on the 
proposal.
    It has come to FDA's attention that there are omissions in the 
administrative record. The agency has identified a number of missing 
pages in some documents that were placed in the administrative record 
and other minor problems. FDA will rectify these omissions and problems 
and make the corrected administrative record available with ample time 
for interested persons to review the record and prepare comments. Thus, 
the agency will correct the administrative record and will provide a 
new 75-day period for comment.

    Dated: August 15, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination, FDA.
[FR Doc. 97-22127 Filed 8-15-97; 8:45 am]
BILLING CODE 4160-01-P