[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