[Federal Register Volume 67, Number 90 (Thursday, May 9, 2002)]
[Notices]
[Pages 31348-31349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11509]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0144]


Bavarian Red Cross; Opportunity for Hearing on a Proposal to 
Revoke U.S. License No. 1002

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 biologics license 
(U.S. License No. 1002), issued to the Bavarian Red Cross (BRC), for 
the manufacture of Whole Blood and Red Blood Cells. The proposed 
revocation is based on the failure of the establishment and the product 
for which the license has been issued, to conform to the applicable 
standards established in the license and in the regulations.

DATES: The firm may submit written or electronic requests for a hearing 
by June 10, 2002, and any data and information justifying a hearing by 
July 8, 2002. Other interested persons may submit written or electronic 
comments on the proposed revocation by July 8, 2002.

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. Submit electronic comments to: http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Michael D. Anderson, 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 
biologics license (U.S. License No. 1002) issued to BRC, Herzog-
Heinrich-Strasse 4, D-80336, Munich, Germany, for the manufacture of 
Whole Blood and Red Blood Cells. Additional locations affected by the 
proposed revocation include: Prof.-Ernst-Nathan-Str. 1, D-90419, 
Nurnburg, Germany; Klinikstrasse 5, D-97070, Wurzburg, Germany; Dr. 
Franz-Strasse 3, D-95445, Bayreuth, Germany; Westheimer Strasse 80, D-
86156, Augsburg, Germany; Nikolaus-Fey-Strasse 32, D-97353, 
Wiesentheid, Germany; and Hoher Kreuz Weg 7, D-93055, Regensburg, 
Germany. The proposed revocation is based on the failure of BRC to 
conform to the applicable standards established in its license and the 
requirements of parts 211 and 600 to 680 (21 CFR parts 211 and 600 to 
680).
    FDA inspected four of the six licensed locations of the BRC from 
October 27 through November 13, 1997. The inspections were conducted at 
the Munich, Wiesentheid, Nurnberg, and Bayreuth facilities. During the 
inspections, FDA observed significant deviations from the standards 
established in the license as well as the applicable Federal 
regulations. The standards and regulations are designed to ensure the 
continued safety, purity, and potency of the manufactured product. FDA 
also determined that the firm had discontinued the manufacture of Whole 
Blood and Red Blood Cells intended for distribution in the United 
States. FDA concluded that a meaningful inspection of BRC's ability to 
appropriately manufacture products under the license could not be made. 
The deviations noted during the inspections included, but were not 
limited to, the following: (1) In violation of Sec. 640.3(b), donor 
suitability was not adequately determined, in that questions were not 
asked, concurrently with the direct questions on high risk behavior, 
for exclusion of donors who are at increased risk for human 
immunodeficiency virus-1 (HIV-1) group O infection; (2) in violation of 
Secs. 606.140, 610.40, and 610.45, inspections of the Nurnburg and 
Munich facilities disclosed that the Abbott Prism system, a device not 
approved by FDA, was utilized to test for antibody to HIV types 1 and 2 
plus O (anti-HIV 1/2), the hepatitis B surface antigen (HBsAg), the 
antibody to hepatitis B core antigen (anti-HBc), and antibody to 
hepatitis C virus encoded antigen (anti-HCV). Additionally, blood and 
blood products were not tested for HIV-1 antigen and antibody to human 
lymphotropic virus type I (anti-HTLV-I); (3) in violation of 
Sec. 606.140, the New LAV-Bolt I by Sanofi Diagnostics Pasteur, an HIV-
1 western blot assay that was not approved by FDA, was used as an assay 
for reentry of donors; (4) in violation of Sec. 606.140, the New LAV-
Bolt II by Sanofi Diagnostics Pasteur, an HIV-2 western blot assay that 
was not approved by FDA, was used as an assay for reentry of donors; 
and (5) in violation of Sec. 606.121(c)(5)(i), blood and blood products 
that were intended for transfusion and collected from paid donors were 
not labeled as to distinguish them from blood products collected from 
volunteer donors.
    In a letter dated July 8, 1998, and issued under Sec. 601.5(b), FDA 
outlined the deviations noted at the inspection. FDA notified BRC of 
FDA's intent to revoke U.S. License No. 1002 and announced its intent 
to offer an opportunity for a hearing unless the deviations were 
adequately addressed. In a letter to FDA dated July 30, 1998, BRC 
responded to FDA's concerns about the inability to inspect products 
prepared under the U.S. License No. 1002.
    In a certified, return-receipt letter to BRC, dated January 21, 
1999, FDA stated that the firm's July 30, 1998, response was inadequate 
to address all the violations that FDA documented at the inspections. 
FDA advised BRC that its response was unsatisfactory in that BRC had 
not provided a comprehensive corrective action plan, adequate to bring 
the firm into compliance with the applicable Federal standards and 
regulations. In the same letter, FDA suggested that the firm 
voluntarily request that U.S. License No. 1002 be revoked, and a new 
application be submitted at a later date.
    In a letter dated November 3, 2000, FDA notified BRC that since the 
receipt of the July 30, 1998, letter to FDA, FDA had not received any 
additional response from the firm. The letter stated that under 
Sec. 601.5(b)(2), FDA had provided a reasonable period for the firm to 
demonstrate or achieve compliance with the applicable standards 
established in the license and regulations before proceeding to 
initiate revocation of U.S. License No. 1002. Since BRC did not submit 
a response addressing the methods intended to demonstrate or achieve 
compliance and did not waive an opportunity for a hearing, FDA notified 
the firm in the same letter of FDA's intent to revoke the license and 
to issue a notice of opportunity for a hearing under Sec. 12.21(b) (21 
CFR 12.21(b)).
    Under Sec. 12.21(b), FDA is issuing a notice of opportunity for a 
hearing on a proposal to revoke the biologics license (U.S. License No. 
1002) issued to BRC.
    FDA has placed copies of the documents relevant to the proposed 
revocation on file with Dockets Management Branch (see ADDRESSES) under 
the docket number found in brackets in the heading of this document. 
These documents include:

[[Page 31349]]

(1) FDA's letters to BRC dated July 8, 1998, January 21, 1999, and 
November 3, 2000; and (2) BRC's response to FDA dated July 30, 1998. 
These documents are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
    BRC may submit to the Dockets Management Branch (see ADDRESSES) a 
written request for a hearing by June 10, 2002, and any data and 
information justifying a hearing must be submitted by July 8, 2002. 
Other interested persons may submit written comments on the proposed 
license revocation to the Dockets Management Branch by July 8, 2002. 
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 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 the Commissioner of the Food and Drugs (the 
Commissioner) determines upon review of any objections or request for a 
hearing that a hearing is not justified, in whole or in part, or if a 
request for a hearing is not made within the required time with the 
required format or required analyses, the Commissioner will deny the 
hearing request, with an explanation for 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 (see 
ADDRESSES) 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: May 2, 2002.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 02-11509 Filed 5-8-02; 8:45 am]
BILLING CODE 4160-01-S