Reclassification of Category IIIA Biological Products, Bacterial Vaccines and Related Biological Products; Implementation of Efficacy Review; Final Order; and Delmont Laboratories, Inc.: Denial of Request for a Hearing, and Revocation of License

The Food and Drug Administration (FDA) is issuing a final order pursuant to the reclassification procedures under the biologics regulations; denying the request by Delmont Laboratories, Inc. (Delmont), for a hearing on FDA's proposal to revoke Delmont's license based on the proposed reclassification of its product, Polyvalent Bacterial Antigens with "No U.S. Standard of Potency," Staphage Lysate[supreg] (SPL) (hereinafter referred to as SPL) into Category II (unsafe, ineffective, or misbranded); and revoking Delmont's U.S. License No. 299. The final order finalizes the proposed order published in the Federal Register of May 15, 2000 (65 FR 31003) (May 2000 proposal), to reclassify Category IIIA bacterial vaccines and bacterial antigens into Category I or Category II.