[Federal Register Volume 62, Number 150 (Tuesday, August 5, 1997)]
[Notices]
[Page 42134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20494]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96N-0015]


Personal Blood Storage of Memphis, Inc.; Revocation of U.S. 
License No. 1131

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of 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. 
Personal Blood Storage of Memphis, Inc., did not respond to a notice of 
opportunity for a hearing on a proposal to revoke its licenses.

DATES: The revocation of the establishment license (U.S. License No. 
1131) and the product licenses is effective August 5, 1997.
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 revoking the establishment license 
(U.S. License No. 1131) and the 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.
    An attempted onsite inspection by FDA on May 23, 1995, revealed 
that the facility was no longer in operation at the location listed on 
the license. An FDA investigator, from the Nashville District Office, 
was permitted to visit the unoccupied facility on August 3, 1995. The 
investigator documented that the office space and two walk-in freezers 
were empty and there was no electrical or water service at the 
facility. Based on the inability of authorized FDA employees to conduct 
a meaningful inspection of the facility, FDA initiated proceedings for 
the revocation of the licenses under 21 CFR 601.5(b)(1) and (b)(2). 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 providing notice of FDA's intent to revoke the 
licenses and its intent to offer an opportunity for a hearing on the 
proposed revocation. 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 the Center for Biologics Evaluation and Research 
(CBER), in which she 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 this letter was 
returned by the U.S. Postal Service as unclaimed.
    Under Sec. 12.21(b) (21 CFR 12.21(b)), FDA published in the Federal 
Register of April 24, 1996 (61 FR 18149), a notice of opportunity for a 
hearing on a proposal to revoke the licenses of Personal Blood Storage 
of Memphis, Inc. In the notice, FDA explained that the proposed license 
revocation was based on the inability of authorized FDA employees to 
conduct a meaningful inspection of the facility because it was no 
longer in operation and noted that documentation in support of the 
license revocation had been placed on file for public examination with 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. The notice provided 
the firm 30 days to submit a written request for a hearing and 60 days 
to submit any data and information justifying a hearing. The notice 
provided other interested persons with 60 days to submit written 
comments on the proposed revocation. The firm did not respond within 
the 30-day time period with a written request for a hearing. Under 
Sec. 12.21(b), the 30-day time period, prescribed in the notice of 
opportunity for a hearing and in the regulations, may not be extended. 
No other interested persons submitted written comments on the proposed 
revocation within the 60-day time period.
    Accordingly, under 21 CFR 12.38(a)(1), section 351 of the Public 
Health Service Act (42 U.S.C. 262), and under authority delegated to 
the Commissioner of Food and Drugs (21 CFR 5.10) and redelegated to the 
Director, CBER (21 CFR 5.67), the establishment license (U.S. License 
No. 1131), and the product licenses issued to Personal Blood Storage of 
Memphis, Inc., are revoked, effective August 5, 1997.
    This notice is issued and published under 21 CFR 601.8.

    Dated: July 28, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-20494 Filed 8-4-97; 8:45 am]
BILLING CODE 4160-01-F