[Federal Register Volume 62, Number 68 (Wednesday, April 9, 1997)]
[Notices]
[Pages 17193-17195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8987]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0115]
SEF, P.A.; Opportunity for Hearing on a Proposal to Revoke U.S.
License No. 1166
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. 1166) and the product licenses issued to SEF,
P.A., doing business as National Health Guard, Inc., for the
manufacture of Whole Blood and Red Blood Cells. The proposed revocation
is based on the establishment's discontinuance of product manufacturing
to the extent that a meaningful inspection cannot be made.
DATES: The firm may submit a written request for a hearing to the
Dockets Management Branch by May 9, 1997
[[Page 17194]]
and any data and information justifying a hearing by June 9, 1997.
Other interested persons may submit written comments on the proposed
revocation by June 9, 1997.
ADDRESSES: Submit written requests for a hearing, and any data and
information that would justify a hearing, including 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: Dano B. Murphy, 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. 1166) and product licenses
issued to SEF, P.A., doing business as National Health Guard, Inc.,
1885 West Commercial Blvd., suite 140, Fort Lauderdale, FL 33309, for
the manufacture of Whole Blood (CPDA-1) and Red Blood Cells (RBC)
including frozen, deglycerolized, frozen rejuvenated, and rejuvenated
deglycerolized RBC's. 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 February 13, 1996, FDA attempted to inspect the SEF, P.A.,
facility located at 1820 North University Dr., Plantation, FL. The
facility was found to be vacant. A visit that same day to the firm's
previous business address, 1885 West Commercial Blvd., suite 140, Fort
Lauderdale, FL, found that location to be vacant as well. Later that
same day, February 13, 1996, FDA contacted by telephone the person on
file with the agency as being the responsible head of SEF, P.A. The
individual informed FDA that he had resigned from the firm on July 12,
1995, because he lacked sufficient authority to bring the firm into
compliance with FDA regulations. The individual also informed FDA that
the person succeeding him as the responsible head had resigned in
December 1995, and that the firm had ceased operations in January or
February of 1996.
In a telephone conversation between FDA and the owner of SEF, P.A.,
on February 28, 1996, the owner stated that all the firm's equipment
was stored in a Miami, FL, warehouse. During this conversation the
owner indicated that he would voluntarily surrender the firm's license
since SEF, P.A., was no longer in operation and there were no plans to
resume operations. After this telephone conversation, FDA made several
attempts to obtain the voluntary revocation of the firm's license. This
effort included telephone calls on March 21 and 27, 1996, and April 9,
1996. On each occasion, a secretary or receptionist took a message from
FDA requesting the owner to return FDA's calls. On April 15, 1996, FDA
was contacted by the owner who verified that the firm was out of
business and that a letter from him requesting the voluntary revocation
of U.S. License No. 1166 would be forthcoming. On June 17, 1996, FDA
successfully contacted the owner who indicated that he no longer
desired to relinquish the license. Further attempts to contact the
owner on July 2 and 29, 1996, were unsuccessful. On both occasions,
messages were left with the answering party that were never replied to
by the owner. On August 1, 1996, the last two known locations of the
SEF, P.A., were visited again by FDA investigators who determined that
both locations were vacant and displayed no evidence of recent business
activity. On October 10, 1996, FDA contacted the State of Florida,
Agency for Health Care Administration, which reported that Florida
License No. 800001631 held by SEF, P.A., had been terminated on July 2,
1996.
FDA sent a certified, return-receipt letter dated November 1, 1996,
to the firm's owner. The letter stated that under 21 CFR 601.5(b) a
license may be revoked when the Commissioner of Food and Drugs (the
Commissioner) finds that: (1) Authorized FDA employees after reasonable
efforts have been unable to gain access to an establishment or a
location for the purposes of carrying out an inspection, or (2)
manufacturing of products or of a product has been discontinued to an
extent that a meaningful inspection or evaluation cannot be made. The
letter provided the firm's owner notice of FDA's intent to revoke U.S.
License No. 1166 and announced FDA's intent to offer an opportunity for
a hearing.
Because SEF, P.A., is no longer in operation and is not
manufacturing any products, a meaningful inspection required under 21
CFR 600.21 cannot be conducted. Furthermore, FDA made reasonable
efforts to obtain the voluntary revocation of the firm's licenses.
Therefore, FDA is proceeding under to 21 CFR 12.21(b) and publishing
this notice of 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
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) Intention to revoke
license letter dated November 1, 1996; (2) memorandum of investigation
inspection March 5, 1996. These documents are available for public
examination in the Dockets Management Branch (address above) between 9
a.m. and 4 p.m., Monday through Friday.
SEF, P.A., may submit a written request for a hearing to the
Dockets Management Branch by May 9, 1997 and any data and information
justifying a hearing must be submitted by June 9, 1997. Other
interested persons may submit written comments on the proposed
revocation by June 9, 1997. 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, 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 is not
accompanied by the required analyses, the Commissioner 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 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
[[Page 17195]]
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: March 27, 1997.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 97-8987 Filed 4-8-97; 8:45 am]
BILLING CODE 4160-01-F
