[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]


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

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.

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

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