[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