[Federal Register Volume 61, Number 80 (Wednesday, April 24, 1996)]
[Notices]
[Pages 18149-18150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10025]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0015]
Personal Blood Storage of Memphis, Inc.; Opportunity for Hearing
on a Proposal to Revoke U.S. License No. 1131
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. 1131) and the product licenses issued to
Personal Blood Storage of Memphis, Inc., for the manufacture of Whole
Blood, Red Blood Cells, Plasma, and Platelets. The proposed revocation
is based on the establishment's discontinuing of manufacturing of
products to the extent that a meaningful inspection or evaluation
cannot be made.
DATES: The firm may submit a written request for a hearing to the
Dockets Management Branch by May 24, 1996, and any data and information
justifying a hearing by June 24, 1996. Other interested persons may
submit written comments on the proposed revocation by June 24, 1996.
ADDRESSES: Submit written requests for a hearing, any data and
information justifying a hearing, and any 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: Gloria J. Hicks, Center for Biologics
Evaluation and Research (HFM-630), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, 301-594-3074.
SUPPLEMENTARY INFORMATION: FDA is initiating proceedings to revoke the
establishment license (U.S. License No. 1131) and product licenses
issued to Personal Blood Storage of Memphis, Inc., formerly located at
5182 East Raines Rd., Memphis, TN 38118, for the manufacture of Whole
Blood, Red Blood Cells, Plasma, and Platelets. Proceedings to revoke
the licenses are being initiated because an inspection of the facility
by FDA revealed that the firm was no longer in operation.
On May 23, 1995, an FDA investigator attempted to conduct an
inspection of Personal Blood Storage of Memphis, Inc., and found that
the facility was vacant. Communication with the person listed as the
responsible head indicated that all of the firm's employees were
[[Page 18150]]
dismissed on March 3, 1995. During a June 1, 1995, telephone
conversation with FDA staff at the Center for Biologics Evaluation and
Research (CBER), one of the owners of the firm stated that the firm
ceased operations in December 1994. FDA explained that it could move to
revoke the license if the firm remained inoperative. FDA requested a
written response within 30 days regarding whether the owners intended
to reopen the establishment. As of July 24, 1995, none of the owners
had contacted FDA regarding the firm's intentions. In addition,
messages left by FDA staff on one owner's telephone answering machine
were not answered. An FDA investigator, from the Nashville District
Office, was permitted to visit the unoccupied facility by the property
owner on August 3, 1995. The investigator documented that the office
space and two walk-in freezers were empty and that there was no
electrical or water service at the facility. The U.S. Postal Service
supplied FDA with the firm's forwarding address, and FDA sent a
certified letter, dated September 8, 1995, to the firm's responsible
head. The certified letter stated that, under 21 CFR 601.5(b), a
license may be revoked if the Commissioner finds that after reasonable
efforts authorized FDA employees have been unable to gain access to an
establishment for the purposes of conducting an inspection, or that the
manufacturing of a product has been discontinued to an extent that a
meaningful inspection cannot be made. The letter also stated that
following repeated attempts to conduct an inspection, FDA had
determined that a meaningful inspection could not be made. The letter
provided the firm's responsible head notice of FDA's intent to revoke
U.S. License No. 1131 and announced FDA's intent to offer an
opportunity for a hearing. The responsible head responded by telephone
on September 12, 1995, and said that she was no longer employed by
Personal Blood Storage of Memphis, Inc. She also sent a copy of a March
3, 1995, letter to CBER in which she had stated that she was no longer
the Technical Director or responsible head for Personal Blood Storage
of Memphis, Inc. A copy of FDA's letter of intent to revoke U.S.
License No. 1131 was also sent to one owner's address in Texas and was
returned by the U.S. Postal Service as unclaimed.
Because FDA made reasonable efforts to notify the firm of the
proposed revocation and no response was received from the firm, FDA is
proceeding pursuant to 21 CFR 12.21(b) and publishing this notice of an
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
license 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) Record of
teleconference dated June 1, 1995; (2) letter to FDA from responsible
head dated March 3, 1995; (3) Summary of Findings dated August 3, 1995,
(Endorsement-Form FDA 481); (4) FDA certified letter to responsible
head dated September 8, 1995; (5) copy of information returned from the
U.S. Postal Service showing that the copy of FDA certified letter of
September 8, 1995, sent to one owner's Texas address, was unclaimed;
and (6) record of teleconference dated September 12, 1995. These
documents are available for public examination in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Personal Blood Storage of Memphis, Inc., may submit a written
request for a hearing to the Dockets Management Branch by May 24, 1996,
and any data and information justifying a hearing must be submitted by
June 24, 1996. Other interested persons may submit comments on the
proposed revocation by June 24, 1996. 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 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 and information to justify
a hearing on a 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 requested time, or in the required
format or with the required analyses, the Commissioner of Food and
Drugs will deny the hearing request, making available the 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. The public availability of information in submissions is
governed by 21 CFR 10.20(j)(2)(i). Publicly available submissions 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 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 authority delegated to the Commissioner of Food and
Drugs (21 CFR 5.10) and redelegated to the Director of CBER (21 CFR
5.67).
Dated: April 12, 1996.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 96-10025 Filed 4-23-96; 8:45 am]
BILLING CODE 4160-01-F