[Federal Register Volume 67, Number 6 (Wednesday, January 9, 2002)]
[Notices]
[Page 1223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-483]



[[Page 1223]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0563]


Beauregard Plasma, Inc., Jackson Plasma, Inc., Baton Rouge 
Plasma, Inc., and Claiborne Plasma, Inc.; Opportunity for Hearing on a 
Proposal to Revoke U.S. License Nos. 1030, 1031, 1032, and 1033

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 
licenses (U.S. License Nos. 1030, 1031, 1032, and 1033) issued to 
Beauregard Plasma, Inc.; Jackson Plasma, Inc.; Baton Rouge Plasma, 
Inc.; and Claiborne Plasma, Inc., respectively, for the manufacture of 
Source Plasma. The proposed revocations are based on the fact that 
authorized FDA employees have been unable to gain access to these 
establishments' locations for the purpose of carrying out required 
inspections of the facilities, which are no longer in operation, and 
manufacturing of products has been discontinued to an extent that 
meaningful inspections cannot be made.

DATES: The establishments may submit written or electronic requests for 
a hearing by February 8, 2002, and any data and information justifying 
a hearing by March 11, 2002. Other interested persons may submit 
written or electronic comments on the proposed revocations by March 11, 
2002.

ADDRESSES: Submit written requests for a hearing, any data and 
information justifying a hearing, and any written comments on the 
proposed revocations 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: Stephen Ripley, 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. 1030) issued to Beauregard Plasma, 
Inc., P.O. Box 96, Hwy. 27, DeQuincy, LA 70633; the biologics license 
(U.S. License No. 1031) issued to Jackson Plasma, Inc., P.O. Box 788, 
Hwy. 68, Jackson, LA 70748; the biologics license (U.S. License No. 
1032) issued to Baton Rouge Plasma, Inc., P.O. Box 174, Hwy. 74, St. 
Gabriel, LA 70776; and the biologics license (U.S. License No. 1033) 
issued to Claiborne Plasma, Inc., Route 2, Box 75, Homer, LA 71040, for 
the manufacture of Source Plasma. FDA is initiating proceedings to 
revoke the licenses because authorized FDA employees have been unable 
to gain access to any of the establishments for the purpose of carrying 
out required inspections of the facilities, and manufacturing of 
products has been discontinued to an extent that meaningful inspections 
cannot be made.
    In a certified return-receipt letter dated May 11, 2001, FDA 
notified the authorized official of the establishments that attempts to 
conduct inspections of the establishments were unsuccessful because the 
establishments were apparently no longer in operation, and the 
manufacture of Source Plasma had been discontinued. The letter advised 
the authorized official that, under 21 CFR 601.5(b)(1)(i) and 
(b)(1)(ii) (formerly codified as 21 CFR 601.5(b)(1) and (b)(2)), when 
FDA finds that authorized employees have been unable to gain access to 
an establishment for the purpose of carrying out an inspection under 21 
CFR 600.21 or that manufacturing of a product has been discontinued to 
an extent that a meaningful inspection cannot be made, the Commissioner 
of Food and Drugs (the Commissioner) shall institute proceedings for 
license revocation. In the same letter, FDA notified the establishments 
of FDA's intent to revoke U.S. License Nos. 1030, 1031, 1032, and 1033 
and its intent to offer an opportunity for a hearing.
    Because FDA has notified the establishments of the proposed license 
revocations and has received no response from the establishments, FDA 
is proceeding under 21 CFR 12.21(b) and publishing an opportunity for a 
hearing on a proposal to revoke the licenses.
    FDA has placed a copy of the May 11, 2001, letter to the 
establishments on file with the Dockets Management Branch (address 
above) under the docket number found in brackets in the heading of this 
notice. The document is available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
    Beauregard Plasma, Inc.; Jackson Plasma, Inc.; Baton Rouge Plasma, 
Inc.; and Claiborne Plasma, Inc., may submit a written or electronic 
request for a hearing to the Dockets Management Branch by February 8, 
2002, and any data and information justifying a hearing must be 
submitted by March 11, 2002. Other interested persons may submit 
written or electronic comments on the proposed license revocations to 
the Dockets Management Branch by March 11, 2002. The failure of the 
licensees to file timely written requests for hearings constitutes an 
election by the licensees not to avail themselves of the opportunity 
for a hearing concerning the proposed license revocations.
    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 a 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 be set forth a genuine and substantial issue of fact. 
If the Commissioner determines upon review of any objections or 
requests 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 between 
9 a.m. or 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 the 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: December 27, 2001.
Mark Elengold,
Deputy Director for Operations, Center for Biologics Evaluation and 
Research.
[FR Doc. 02-483 Filed 1-8-02; 8:45 am]
BILLING CODE 4160-02-S