[Federal Register Volume 63, Number 8 (Tuesday, January 13, 1998)]
[Notices]
[Pages 1973-1974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-886]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97P-0441]


Administrative Proceeding; Re: Pharmanex, Inc.

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of opportunity to comment.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
comments related to the regulatory status of CholestinTM may 
be submitted until January 30, 1998. This action is being taken as a 
part of the agency's deliberation on the regulatory status of 
CholestinTM. All comments postmarked on or before January 
30, 1998, will be accepted as part of the official record for this 
matter.

DATES: Submit written comments by January 30, 1998.

ADDRESSES: Submit written comments regarding this issue to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857, ATTN: Docket 97P-0441.

FOR FURTHER INFORMATION CONTACT: Ilisa B.G. Bernstein, Office of Policy 
(HF-23), Office of the Commissioner, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3380, or 
IB[email protected].

SUPPLEMENTARY INFORMATION: On October 29, 1997, FDA received a document 
entitled ``Petition to the Food and Drug Administration for a Stay of 
Action With Respect to CholestinTM Dietary Supplement,'' 
(petition) from Pharmanex, Inc. (Pharmanex). The petition requested FDA 
to stay the effect of a September 30, 1997, FDA letter to Pharmanex 
discussing the regulatory status of CholestinTM, and to also 
stay any form of enforcement action adverse to Pharmanex or 
CholestinTM. In response to the petition, in a letter dated 
November 14, 1997, from William Schultz, FDA's Deputy Commissioner for 
Policy, to Stuart Pape, Counsel to Pharmanex, Inc., the agency informed 
the petitioner that it was not acting on the petition because there was 
no administrative action taken by the Commissioner of Food and Drugs 
capable of being stayed, and because FDA decisions to take enforcement 
actions are not subject to petitions or other action by interested 
persons outside the agency. In the November 14, 1997 letter, the agency 
also informed the petitioner that it was initiating an administrative 
proceeding under 21 CFR 10.25(b) to decide the regulatory status of 
CholestinTM. The agency stated that it would use its ``best 
efforts'' to conclude the proceeding by the end of 1997.
    Since the November 14, 1997, letter was issued, FDA has received a 
number of comments regarding the regulatory status of 
CholestinTM, including three additional submissions from 
Pharmanex (one received by the agency on December 29, 1997). Several 
requests for extensions of time to submit comments have also been 
received. Under the circumstances, it is apparent that additional time 
is required to afford all interested parties adequate opportunity to 
submit comments in this matter.
    With this notice the agency announces that comments related to this 
matter may be submitted until January 30, 1998. All comments postmarked 
on or before January 30, 1998, will be accepted as part of the official 
record for this matter. Comments should be sent to the Dockets 
Management Branch (address above) and should be identified

[[Page 1974]]

with the docket number found in brackets in the heading of this 
document. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Received comments may be seen in the 
office above between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-886 Filed 1-9-98; 2:09 pm]
BILLING CODE 4160-01-F