[Federal Register Volume 62, Number 193 (Monday, October 6, 1997)]
[Notices]
[Pages 52135-52136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26454]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0384]
Knickerbocker Biologicals, Inc.; Opportunity for Hearing on a
Proposal to Revoke 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 an
opportunity for a hearing on a proposal to revoke the establishment
license (U.S. License No. 458-001) and product licenses issued to
Knickerbocker Biologicals, Inc., for the manufacture of Whole Blood,
Red Blood Cells, Plasma, and Source Leukocytes. The proposed revocation
is based on the inability of authorized FDA employees to conduct an
inspection of this facility, which is no longer in operation.
DATES: The firm may submit written requests for a hearing to the
Dockets Management Branch by November 5, 1997, and any data and
information justifying a hearing by December 5, 1997. Other interested
persons may submit written comments on the proposed revocation by
December 5, 1997.
ADDRESSES: Submit written requests for a hearing, any data and
information justifying a hearing, and any written comments on the
proposed revocation to the Dockets Management Branch (HFA-305), Food
and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD
20857.
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 initiating proceedings to revoke the
establishment license (U.S. License 458-001) and 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. Proceedings to revoke the licenses are being initiated
because an attempted inspection of the facility by FDA revealed that
the firm was no longer in operation.
In a certified, return-receipt letter dated November 14, 1996, FDA
notified the Responsible Head of the firm that its attempt to conduct
an inspection at Knickerbocker Biologicals, Inc., at 272 Willis Ave.,
Bronx, NY 10454, was unsuccessful because the facility was apparently
no longer in operation, and requested that the firm notify FDA in
writing of the firm's status. This letter was returned to the agency
marked ``undeliverable; address unknown.''
On December 3, 1996, FDA visited three other known addresses of
Knickerbocker Biologicals, Inc., New York, NY, and attempted to conduct
an inspection. These attempts were also unsuccessful. Upon
consultation, the U.S. Postal Service reported no information regarding
a forwarding address or change of address for any of the last known
locations.
In a certified, return-receipt letter sent to Knickerbocker
Biologicals, Inc., dated January 24, 1997, and returned as
undeliverable, FDA indicated that the attempts to conduct an inspection
at the facility were unsuccessful. The letter also advised the
Responsible Head that, under 21 CFR 601.5(b)(1) and (b)(2), when FDA
finds that authorized employees have been unable to gain access to an
establishment for the purpose of carrying out an inspection or the
manufacturing of products or of a product has been discontinued to an
extent that a meaningful inspection cannot be made, proceedings for
license revocation may be instituted. In the same letter, FDA indicated
that a meaningful inspection could not be made at the establishment and
issued the firm notice of FDA's intent to revoke U.S. License No. 458-
001 and announced its intent to offer an opportunity for a hearing.
Because FDA has made reasonable efforts to notify the firm of the
proposed revocation and no response was received from the firm, FDA is
proceeding under 21 CFR 12.21(b) and publishing this notice of
opportunity for a hearing on a proposal to revoke the licenses of the
above establishment.
FDA has placed copies of the documents relevant to the proposed
revocation on file with the Dockets Management Branch (address above)
under the docket number found in brackets in the heading of this
notice. These documents include the following: (1) FDA letters to the
Responsible Head dated November 14, 1996, and January 24, 1997; and (2)
memorandum regarding the investigation and inspection dated December 9,
1996. These documents are available for public examination in the
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
Knickerbocker Biologicals, Inc., may submit a written request for a
hearing to the Dockets Management Branch by November 5, 1997, and any
data and information justifying a hearing must be submitted by December
5, 1997. Other interested persons may submit comments on the proposed
license revocation to the Dockets Management Branch by December 5,
1997. The failure of the licensee to file a timely written request for
a hearing constitutes an election by the licensee not to avail itself
of the opportunity for a hearing concerning the proposed license
revocation.
FDA's procedures and requirements governing a notice of opportunity
for a hearing, notice of appearance and request for a hearing, grant or
denial of a hearing, and submission of data to justify a hearing on
proposed revocation of a license are contained in 21 CFR parts 12 and
601. A request for a hearing may not rest upon mere allegations or
denials but must set forth a genuine and substantial issue of fact that
requires a hearing. If it conclusively appears from the face of the
data, information, and factual analyses submitted in support of the
request for a hearing that there is no genuine and substantial issue of
fact for resolution at a hearing, or if a request for a hearing is not
made within the required time with the required format or required
analyses, the Commissioner of Food and Drugs will deny the hearing
request, making findings and conclusions that justify the denial.
Two copies of any submissions are to be provided to FDA, except
that individuals may submit one copy. Submissions are to be identified
with the docket number found in brackets in the heading of this
document. Such submissions, except for data and information prohibited
from public disclosure under 21 CFR 10.20(j)(2)(i), 21 U.S.C. 331(j),
or 18 U.S.C. 1905, may be seen in the Dockets Management Branch
(address above) between 9 a.m. and 4 p.m., Monday through Friday.
This notice is issued under section 351 of the Public Health
Service Act (42 U.S.C. 262) and sections 201, 501, 502,
[[Page 52136]]
505, and 701 of the Federal Food, Drug, and Cosmetic Acts (21 U.S.C.
321, 351, 352, 355, and 371), and under the authority delegated to
Commissioner of Food and Drugs (21 CFR 5.10) and redelegated to the
Director of the Center for Biologics Evaluation and Research (21 CFR
5.67).
Dated: September 17, 1997.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 97-26454 Filed 10-3-97; 8:45 am]
BILLING CODE 4160-01-F
