[Federal Register Volume 64, Number 72 (Thursday, April 15, 1999)]
[Notices]
[Pages 18623-18624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9457]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0671]


Bestblood, Ltd.; Opportunity for Hearing on a Proposal to Revoke 
U.S. License No. 1116

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an

[[Page 18624]]

opportunity for a hearing on a proposal to revoke the establishment 
license (U.S. License No. 1116) and product licenses issued to 
Bestblood, Ltd., doing business as Optimum Healthcare, Inc., for the 
manufacture of Whole Blood, Red Blood Cells, Red Blood Cells Frozen, 
Whole Blood CPD, Red Blood Cells Deglycerolized, and Whole Blood CPDA-
1. 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 by May 17, 
1999, and any data and information justifying a hearing by June 14, 
1999. Other interested persons may submit written comments on the 
proposed revocation by June 14, 1999.
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: 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 No. 1116) and product licenses 
issued to Bestblood, Ltd., doing business as Optimum Healthcare, Inc., 
239 Randall St., San Francisco, CA 94131, for the manufacture of Whole 
Blood, Red Blood Cells, Red Blood Cells Frozen, Whole Blood CPD, Red 
Blood Cells Deglycerolized, and Whole Blood CPDA-1. Proceedings to 
revoke the licenses are being initiated because an attempted inspection 
of the facility by FDA, as required under Sec. 600.21 (21 CFR 600.21), 
revealed that the firm was no longer in operation.
     In a certified, return-receipt letter dated June 16, 1997, FDA 
notified the Responsible Head of the firm that its attempt to conduct 
an inspection at Bestblood, Ltd., 239 Randall St., San Francisco, CA 
94131, 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 sent to 239 Randall St., San Francisco, 
CA 94131, and to P.O. Box 843, Cupertino, CA 95054-0843, and each was 
returned to the agency as undeliverable.
     In a certified, return-receipt letter sent to Bestblood, Ltd., 
dated March 4, 1998, at both addresses mentioned previously and 
returned as undeliverable, FDA indicated that an attempt to conduct an 
inspection at the facility was unsuccessful. The letter 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 required 
under Sec. 600.21, 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. 1116 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 
previously mentioned 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: (1) Summary of Findings, May 28, 1997 
(Endorsement Form FDA 481), and (2) FDA letters to the Responsible Head 
dated June 16, 1997, and March 4, 1998. These documents are available 
for public examination in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.
     Bestblood, Ltd., may submit a written request for a hearing to the 
Dockets Management Branch by May 17, 1999, and any data and information 
justifying a hearing must be submitted by June 14, 1999. Other 
interested persons may submit written comments on the proposed license 
revocation to the Dockets Management Branch by June 14, 1999. 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, 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 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: April 5, 1999.
Mark Elengold,
Deputy Director, Operations, Center for Biologics Evaluation and 
Research.
[FR Doc. 99-9457 Filed 4-14-99; 8:45 am]
BILLING CODE 4160-01-F