[Federal Register Volume 67, Number 144 (Friday, July 26, 2002)]
[Notices]
[Page 48918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19017]


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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.; Revocation of 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 the 
revocation of 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., for the 
manufacture of Source Plasma. These establishments did not respond to a 
notice of opportunity for a hearing on a proposal to revoke their 
licenses.

DATES:  The revocation of the biologics licenses (U.S. License Nos. 
1030, 1031, 1032, and 1033) is effective July 26, 2002.

FOR FURTHER INFORMATION CONTACT: Earline Robinson, 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 revoking 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 initiated proceedings to revoke the licenses because 
authorized FDA employees were unable to gain access to any of the 
establishments to carry out required inspections of the facilities, and 
manufacturing of products had been discontinued to an extent that 
meaningful inspections could not 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 had 
apparently discontinued the manufacture of Source Plasma. 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 could not be made, the 
Commissioner of Food and Drugs 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.
    Under 21 CFR 12.21(b), FDA published in the Federal Register of 
January 9, 2002 (67 FR 1223), a notice of opportunity for a hearing on 
a proposal to revoke the license of Beauregard Plasma, Inc., Jackson 
Plasma, Inc., Baton Rouge Plasma, Inc., and Claiborne Plasma, Inc. In 
the notice, FDA explained that the proposed license revocations were 
based on the inability of authorized FDA employees to conduct a 
meaningful inspection of the facilities because they were no longer in 
operation, and noted that documentation in support of license 
revocation had been placed on file with the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. The notice provided the establishments 30 days to 
submit a written or electronic request for a hearing and 60 days to 
submit any data and information justifying a hearing. The notice 
provided other interested persons 60 days to submit written or 
electronic comments on the proposed revocation. The notice also stated 
that a licensee's failure to file timely written requests for a hearing 
constitutes an election by the licensee not to avail itself of the 
opportunity for a hearing concerning the proposed license revocation. 
The establishments did not respond within the 30-day time period with a 
written or electronic request for a hearing, and under 21 CFR 12.21(b), 
the 30-day time period prescribed in the notice of opportunity for a 
hearing may not be extended. No other comments were received.
    Accordingly, under 21 CFR 12.38, section 351 of the Public Health 
Service Act (42 U.S.C. 262), and under the authority delegated to the 
Commissioner of Food and Drugs (21 CFR 5.10), 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, are revoked, effective July 26, 
2002.

    Dated: July 17, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-19017 Filed 7-25-02; 8:45 am]
BILLING CODE 4160-01-S