[Federal Register Volume 63, Number 118 (Friday, June 19, 1998)]
[Notices]
[Page 33680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16294]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0384]


Knickerbocker Biologicals, Inc.; Revocation of U.S. License No. 
458-001

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the establishment license (U.S. License No. 458-001) and 
the product licenses issued to Knickerbocker Biologicals, Inc., for the 
manufacture of Whole Blood, Red Blood Cells, Plasma, and Source 
Leukocytes. Knickerbocker Biologicals, Inc., did not respond to a 
notice of opportunity for a hearing on a proposal to revoke its 
licenses.

DATES: The revocation of the establishment license (U.S. License No. 
458-001) and the product licenses is effective June 19, 1998.

FOR FURTHER INFORMATION CONTACT: Astrid L. Szeto, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: FDA is revoking the establishment license 
(U.S. License No. 458-001) and the product licenses issued to 
Knickerbocker Biologicals, Inc., doing business as Knickerbocker Blood 
Bank, 272 Willis Ave., Bronx, NY 10454, for the manufacture of Whole 
Blood, Red Blood Cells, Plasma, and Source Leukocytes.
    An attempted inspection of the facility by FDA revealed that the 
facility was no longer in operation at the location listed on the 
license. A certified, returned-receipt letter from FDA dated November 
14, 1996, notifying the Responsible Head of the unsuccessful inspection 
and requesting the status of the firm was returned to the agency as 
``undeliverable; address unknown''. A later attempt by FDA to visit 
three other known addresses of Knickerbocker Biologicals, Inc., New 
York, NY, verified that the company was no longer in business at these 
locations. The respective post office for each location was also 
visited and each verified that no information regarding either a 
forwarding address or address change was available. Based on the 
inability of authorized FDA employees to conduct a meaningful 
inspection of the facility, FDA initiated proceedings for the 
revocation of the licenses under 21 CFR 601.5(b)(1) and (b)(2). A 
certified, returned-receipt letter, dated January 24, 1997, to the 
firm's Responsible Head providing notice of FDA's intent to revoke the 
licenses and its intent to offer an opportunity for a hearing on the 
proposed revocation was returned as undeliverable.
    Under 21 CFR 12.21(b), FDA published in the Federal Register of 
October 6, 1997 (62 FR 52135), a notice of opportunity for a hearing on 
a proposal to revoke the licenses of Knickerbocker Biologicals, Inc. In 
the notice, FDA explained that the proposed license revocation was 
based on the inability of authorized FDA employees to conduct a 
meaningful inspection of the facility because it was no longer in 
operation and noted that documentation in support of the license 
revocation had been placed on file for public examination with the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. The notice provided 
the firm 30 days to submit a written request for a hearing and 60 days 
to submit any data and information justifying a hearing. The notice 
provided other interested persons with 60 days to submit written 
comments on the proposed revocation. The firm did not respond within 
the 30-day time period with a written request for a hearing. The 30-day 
time period, prescribed in the notice of opportunity for a hearing and 
in the regulation, may not be extended. No comments were received from 
any other parties within the 60-day time period.
    Accordingly, under 21 CFR 12.38, section 351 of the Public Health 
Service Act (42 U.S.C. 262), and under authority delegated to the 
Commissioner of Food and Drugs (21 CFR 5.10) and redelegated to the 
Director, Center for Biologics Evaluation and Research (21 CFR 5.68), 
the establishment license (U.S. License No. 458-001), and the product 
licenses issued to Knickerbocker Biologicals, Inc., are revoked, 
effective June 19, 1998.

    Dated: May 28, 1998.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 98-16294 Filed 6-18-98; 8:45 am]
BILLING CODE 4160-01-F