[Federal Register: May 9, 2005 (Volume 70, Number 88)]
[Notices]               
[Page 24449]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09my05-72]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2000P-1439] (formerly Docket No. 00P-1439)

 
Iceberg Industries Corp.; Revocation of Temporary Permit for 
Market Testing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of a temporary permit issued to Iceberg Industries Corp. to 
market test products designated as ``Borealis Iceberg Water'' because 
there is no evidence that the company is operational, and the need for 
the permit no longer exists.

FOR FURTHER INFORMATION CONTACT: Loretta Carey, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-2371.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of September 7, 2000 (65 FR 54283), FDA issued a temporary 
permit to Iceberg Industries Corp., 16 Forest Rd., suite 300, St. 
John's, Newfoundland, Canada, A1C2B9, to market test products 
identified as ``iceberg water,'' a name that is not permitted under the 
U.S. standard of identity for bottled water in Sec.  165.110 (21 CFR 
165.110). The agency issued the permit to facilitate market testing of 
products whose labeling differs from the requirements of the standard 
of identity for bottled water issued under section 401 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 341). The permit covered 
limited interstate market testing of products that deviated from the 
standard for bottled water in Sec.  165.110 in that they were 
identified as ``iceberg water'' rather than as ``bottled water'' or one 
of the other names specified in Sec.  165.110(a)(2). The test product 
met all the requirements of the standard with the exception of this 
deviation.
    On September 28, 2001, Iceberg Industries Corp. requested that its 
temporary permit be extended to allow for additional time for the 
market testing of its products under the permit in order to gain 
additional information in support of its petition. In the Federal 
Register of June 27, 2002 (67 FR 43325), FDA announced that it was 
extending the temporary permit issued to Iceberg Industries Corp. to 
market test products designated as ``Borealis Iceberg Water.'' The 
extension allowed the permit holder to continue to collect data on 
consumer acceptance of products while the agency considered the 
petition to amend the standard of identity for bottled water, which was 
submitted by the permit holder. Under the extension, FDA invited 
interested persons to participate in the market test under the 
conditions that applied to Iceberg Industries Corp., except for the 
designated area of distribution. No one accepted the invitation to 
participate in the market test. In March 2004, FDA attempted to contact 
Iceberg Industries Corp. to discuss some issues regarding its petition 
at the telephone number listed in its petition. The telephone number 
was no longer in service. Attempts to reach the applicant by letter 
were unsuccessful. Therefore, under 21 CFR 130.17(g)(3), FDA is 
revoking the Iceberg Industries Corp.'s temporary permit because the 
need no longer exists.

    Dated: May 3, 2005.
Barbara Schneeman,
Director, Office of Nutritional Products, Labeling and Dietary 
Supplements, Center for Food Safety and Applied Nutrition.
[FR Doc. 05-9233 Filed 5-6-05; 8:45 am]

BILLING CODE 4160-01-S