[Federal Register Volume 66, Number 25 (Tuesday, February 6, 2001)]
[Notices]
[Pages 9087-9088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3094]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1672]


Ashford Blood Bank, Inc.; Opportunity for Hearing on a Proposal 
to Revoke U.S. License No. 0740-001

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. 0740-001) and product licenses issued to 
Ashford Blood Bank, Inc., for the manufacture of Whole Blood and Red 
Blood Cells. The proposed revocation is based on the fact that 
authorized FDA employees have been unable to gain access to either of 
the establishment's locations for the purpose of carrying out a 
required inspection of the facility and that the manufacturing of 
products has been discontinued to an extent that a meaningful 
inspection or evaluation cannot be made.

DATES: The firm may submit written requests for a hearing by March 8, 
2001, and any data and information justifying a hearing by April 9, 
2001. Other interested persons may submit written comments on the 
proposed revocation by April 9, 2001.

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, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852.

FOR FURTHER INFORMATION CONTACT: Joseph L. Okrasinski, 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 No. 0740-001) and product licenses 
issued to Ashford Blood Bank, Inc., Ashford Medical Center, suite 401-
402, Santurce, PR 00907, for the manufacture of Whole Blood and Red 
Blood Cells. Proceedings to revoke the licenses are being initiated 
because: (1) Authorized FDA employees have been unable to gain access 
to either of the establishment's locations for the purpose of carrying 
out a required inspection of the facility, and (2) manufacturing of 
products has been discontinued to an extent that a meaningful 
inspection or evaluation cannot be made.
    In a certified return-receipt letter dated October 28, 1997, FDA 
notified an authorized official of the firm that FDA had suspended the 
firm's establishment and product licenses for the manufacture of Whole 
Blood and Red Blood Cells at its facilities at Santurce, PR, and 
Bayamon, PR. This action was based on the fact that significant 
deviations from the regulations were noted by FDA's San Juan district 
office during inspections of the facilities conducted August 19, 1997, 
through September 17, 1997, and September 9, 1997, through September 
17, 1997, respectively. FDA's San Juan district office attempted to 
conduct additional inspections of the two Ashford facilities. On May 1, 
1998, FDA investigators attempted to inspect the satellite collection 
facility at Bayamon, PR, but found that the facility was no longer in 
operation, and the manufacturing of Whole Blood and Red Blood Cells had 
been discontinued. On November 23, 1999, FDA investigators attempted to 
inspect the main facility in Santurce, PR, but found that the facility 
was no longer in operation and the manufacturing of Whole Blood and Red 
Blood Cells had been discontinued.
    In certified, return-receipt letters dated April 13, 2000, sent to 
the firm's facility at Santurce, PR, and also to the Ashford Blood 
Bank, Inc., P.O. Box 195034, San Juan, PR, 00919, FDA notified an 
authorized official of the firm that FDA's attempts to conduct 
inspections of the two facilities at Santurce, PR and Bayamon, PR were 
unsuccessful because the facilities were no longer in operation and the 
manufacture of Whole Blood and Red Blood Cells had been discontinued. 
The letter also advised the authorized official that, under 21 CFR 
601.5(b)(1) and (b)(2) (now codified as 21 CFR 601.5(b)(1)(i) and 
(b)(1)(ii)), when FDA finds that authorized employees have been unable 
to gain access to an establishment for the purpose of carrying out an 
inspection under 21 CFR 600.21, or the manufacturing of products or of 
a product has been discontinued to an extent that a meaningful 
inspection cannot be made, the Commissioner of Food and Drugs (the 
Commissioner) shall institute proceedings for license revocation. In 
the same letter, FDA stated that a meaningful inspection could not be 
made at the establishment and notified the firm of FDA's intent to 
revoke U.S. License No. 0740-001 and its intent to offer an opportunity 
for a hearing.
    Because FDA has made reasonable efforts to notify the firm of the 
proposed revocation and has not received any response from the firm to 
the revocation letter, 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 previously mentioned firm.
    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: (1) Summary of Findings, May 1, 1998; 
(2) memorandum regarding FDA visit to Santurce location, November 23, 
1999; and (3) FDA letters to the authorized official dated October 28, 
1997, and April 13, 2000. These documents are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.
    Ashford Blood Bank, Inc., may submit a written request for a 
hearing to the Dockets Management Branch by March

[[Page 9088]]

8, 2001, and any data and information justifying a hearing must be 
submitted by April 9, 2001. Other interested persons may submit written 
comments on the proposed license revocation to the Dockets Management 
Branch by April 9, 2001. 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. If 
the Commissioner determines upon review of any objections or requests 
for a hearing that a hearing is not justified, in whole or in part, or 
if a request for a hearing is not made within the required time with 
the required format or required analyses, the Commissioner will deny 
the hearing request, with an explanation for 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 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, 505, and 701 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 355, 
and 371), and under the authority delegated to the 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: January 24, 2001.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 01-3094 Filed 2-5-01; 8:45 am]
BILLING CODE 4160-01-F