[Federal Register Volume 59, Number 123 (Tuesday, June 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15672]


[Federal Register: June 28, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N--0097]


Miles, Inc., et al.; Withdrawal of Approval of NADA's

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of two new animal drug applications (NADA's). One NADA is held by 
Miles, Inc., and provides for use of febantel-trichlorfon paste as an 
equine anthelmintic and boticide. The other NADA is held by Nutra-Blend 
Corp. and provides for use of a tylosin concentrate to manufacture a 
Type A medicated article and Type B medicated feeds. In a final rule 
published elsewhere in this issue of the Federal Register, FDA is 
amending the regulations by removing the entries which reflect approval 
of the NADA's.

EFFECTIVE DATE: July 8, 1994.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0749.

SUPPLEMENTARY INFORMATION: Miles, Inc., Agriculture Division, Animal 
Health Products, P.O. Box 390, Shawnee Mission, KS 66201, is the 
sponsor of NADA 131-412 that provides for use of Combotel/Negabot-Plus 
(febantel-trichlorfon) Paste in horses as an anthelmintic and boticide. 
In a letter dated December 20, 1993, Miles, Inc., requested that FDA 
withdraw approval of NADA 131-412 because it no longer manufactures or 
distributes the product.
    Nutra-Blend Corp., P.O. Box 485, Neosho, MO 64850, is the sponsor 
of NADA 122-158 that provides for the manufacture of Type B medicated 
feeds containing 4, 5, 10, and 20 grams per pound (g/lb) of tylosin and 
a Type A medicated article containing 40 g/lb of tylosin. Currently, 
Nutra-Blend Corp. is purchasing the 40-gram-per-pound article to 
manufacture the 10-gram-per-pound feed. Because this arrangement no 
longer requires that Nutra-Blend Corp. hold an approved NADA, the firm 
requested in its letter of December 15, 1993, that FDA withdraw 
approval of NADA 122-158.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs (21 CFR 5.10) and redelegated to the Center for Veterinary 
Medicine (21 CFR 5.84), and in accordance with Sec. 514.115 Withdrawal 
of approval of applications (21 CFR 514.115), notice is given that 
approval of NADA's 122-158 and 131-412, and all supplements and 
amendments thereto is hereby withdrawn, effective July 8, 1994.
    In a final rule published elsewhere in this issue of the Federal 
Register, FDA is removing 21 CFR 520.903c and amending 21 CFR 558.625 
to reflect the withdrawal of approval of these NADA's.

    Dated: June 15, 1994.
 Richard H. Teske,
 Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-15672 Filed 6-27-94; 8:45 am]
BILLING CODE 4160-01-F