[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

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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