[Federal Register Volume 66, Number 103 (Tuesday, May 29, 2001)]
[Notices]
[Pages 29148-29149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13306]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1219]


Biological Products; Bacterial Vaccines and Related Biological 
Products; Revocation of Biologics Licenses

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of certain biologics licenses. This action was taken at the 
voluntary request of the licensees in response to a proposed order for 
the Implementation of Efficacy Review for Bacterial Vaccines and 
Related Biological Products.

DATES: The revocation of the biologics license for the manufacture of

[[Page 29149]]

Polyvalent Bacterial Vaccines with ``no U.S. Standard of Potency,'' 
manufactured by Hollister-Stier Laboratories, LLC, U.S. license 1272, 
became effective August 3, 2000. The revocation of the biologics 
license for the manufacture of Diphtheria and Tetanus Toxoids and 
Pertussis Vaccine Adsorbed, Diphtheria and Tetanus Toxoids Adsorbed, 
Diphtheria Toxoid Adsorbed, and Tetanus Toxoid Adsorbed, manufactured 
by BioPort Corp., U.S. license 1260, became effective November 20, 
2000. Other products under these licenses are not affected by this 
revocation.

FOR FURTHER INFORMATION CONTACT: Astrid L. Szeto, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of May 15, 2000 (65 FR 31003), FDA issued a proposed order to 
accept the conclusions and recommendations of the Vaccines and Related 
Biological Products Advisory Committee (VRBPAC) and the Panel on Review 
of Allergenic Extracts (the Allergenics Panel) concerning the safety, 
effectiveness, and labeling of certain bacterial vaccines and related 
biological products that were previously classified into Category IIIA 
(remaining on the market pending further studies in support of 
effectiveness). On the basis of the Allergenics Panel and the VRBPAC 
findings, FDA proposed to reclassify certain Category IIIA products 
into Category I (safe, effective, and not misbranded) or Category II 
(unsafe, ineffective, or misbranded). This action was taken under the 
reclassification review procedures specified in 21 CFR 601.26. The 
proposed order also announced the agency's intention to revoke the 
biologics licenses for those bacterial vaccines and related products 
classified as Category II (unsafe, ineffective, or misbranded).
    Certain Category IIIA bacterial vaccines and toxoids with standards 
of potency listed in the proposed order were classified into two 
categories based upon their use as a primary immunogen or as a booster. 
Diphtheria and Tetanus Toxoids Adsorbed, and Tetanus Toxoid Adsorbed 
manufactured by BioPort Corp. were recommended by the VRBPAC for 
classification into Category II (unsafe, ineffective, or misbranded) 
for primary immunization and Category I (safe, effective, and not 
misbranded) for booster immunization.
    Similarly, certain bacterial vaccines and related biological 
products listed in the proposed order were recommended for 
classification into Category II for both diagnosis and immunotherapy by 
the Allergenics Panel. Polyvalent Bacterial Vaccines with ``no U.S. 
Standard of Potency,'' manufactured by Hollister-Stier Laboratories, 
LLC, was recommended for classification into Category II for both 
diagnosis and immunotherapy by the Allergenics Panel.
    FDA agreed with the recommendations of the VRBPAC and the 
Allergenics Panel to reclassify the above cited products into Category 
II for their respective indications, and in the proposed order provided 
notice of the agency's intent to revoke the licenses to manufacture 
these products. On June 19, 2000, Hollister-Stier Laboratories, LLC, 
submitted a letter to FDA voluntarily requesting revocation of its 
license to manufacture Polyvalent Bacterial Vaccines with ``no U.S. 
Standard of Potency.'' On August 9, 2000, BioPort Corp. submitted a 
letter to FDA voluntarily requesting revocation of its license to 
manufacture Diphtheria and Tetanus Toxoids Adsorbed, and Tetanus Toxoid 
Adsorbed. In its August 9, 2000, letter, BioPort Corp. also voluntarily 
requested revocation of its license to manufacture Diphtheria and 
Tetanus Toxoids and Pertussis Vaccine Adsorbed, and Diphtheria Toxoid 
Adsorbed, although these products were not included in the proposed 
order.
    The proposed order announced that the agency would publish a notice 
of opportunity for a hearing on the revocation of the license of each 
product classified in Category II. BioPort Corp. and Hollister-Stier 
Laboratories waived their opportunity for a hearing when they 
voluntarily requested license revocation for their reclassified 
Category II products.
    Accordingly, under the provisions of 21 CFR 601.5(a), section 351 
of the Public Health Service Act, and under authority delegated to the 
Commissioner of Food and Drugs (21 CFR 5.10) and redelegated to the 
Director, Center for Biologics Evaluation and Research (21 CFR 5.68), 
FDA revoked the biologics license issued to Hollister-Stier, 
Laboratories, LLC, U.S. license 1272, for the manufacture of Polyvalent 
Bacterial Vaccines with ``no U.S. Standard of Potency,'' effective 
August 3, 2000; and FDA revoked the biologics license issued to BioPort 
Corp., U.S. license 1260, for the manufacture of Diphtheria and Tetanus 
Toxoids and Pertussis Vaccine Adsorbed, Diphtheria and Tetanus Toxoids 
Adsorbed, Diphtheria Toxoid Adsorbed, and Tetanus Toxoid Adsorbed 
effective November 20, 2000.

    Dated: May 9, 2001.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 01-13306 Filed 5-25-01; 8:45 am]
BILLING CODE 4160-01-S