05-24103. Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of 15 new animal drug applications (NADAs) because the products are no longer manufactured or marketed. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of the NADAs.

DATES:

Withdrawal of approval is effective December 27, 2005.

FOR FURTHER INFORMATION CONTACT:

Pamela K. Esposito, Center for Veterinary Medicine (HFV-210), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9067, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The following sponsors have requested that FDA withdraw approval of the 15 NADAs listed in table 1 of this document because the products are no longer manufactured or marketed:

Table 1.

Sponsor	NADA Number, Product (Drug)	21 CFR Section Affected (Sponsor Drug Labeler Code)
Bioproducts, Inc., 320 Springside Dr., Suite 300, Fairlawn, OH 44333-2435	NADA 119-063, Pyrantel Tartrate Ton Pack (pyrantel tartrate)	558.485 (051359)
Farmland Industries, Inc., Kansas City, MO 64116	NADA 138-656, BN Wormer—19.2 BANMINTH Premix (pyrantel tartrate)	558.485 (021676)
I.M.S. Inc., 13619 Industrial Rd., Omaha, NE 68137	NADA 129-395, HYGROMIX 0.6 Premix (hygromycin B)	558.274 (050639)
	NADA 129-646, TYLAN 10 Sulfa-G (tylosin, sulfamethazine)	558.630 (050639)
	NADA 136-601, Swine Guard-BN (pyrantel tartrate)	558.485 (050639)
J. & R. Specialty Supply Co., 310 Second Ave., SW,, P.O. Box 506, Waseca, MN 56093	NADA 96-780, TYLAN 10; TYLAN 40 (tylosin)	n/a (049768)
Kerber Milling Co., Box 152, 1817 E. Main St., Emmetsburg, IA 50536	NADA 98-687, Hy-Test Hy-Boost TY 5 Medicated (tylosin)	558.625 (029341)
M & M Livestock Products Co., Eagle Grove, IA 50533	NADA 96-837, M & M Tylosin Premix (tylosin)	558.625 (026282)
Nutra-Blend Corp., P.O. Box 485, Neosho, MO 64850	NADA 129-161, Nutra-Blend TYLAN 10 Sulfa Premix (tylosin, sulfamethazine)	558.630 (050568)
	NADA 136-384, Swine Wormer-BN BANMINTH (pyrantel tartrate)	558.485 (050568)
South St. Paul Feeds, Inc., 500 Farwell Ave., South St. Paul, MN 55075	NADA 136-369, Custom Ban Wormer 9.6 (pyrantel tartrate)	558.485 (001800)
Stockton Hay & Grain Co.	NADA 49-462, Rainbrook Broiler Premix No. 1 (ampolium, arsanilic acid, ethopabate, penicillin G procaine, streptomycin)	n/a (036541)
	NADA 91-646, Rainbow Broiler Base Concentrate (ampolium, bacitracin zinc, ethopabate)	n/a (036541)
	NADA 91-647, Broiler Base Concentrate (ampolium, chlortetracyline, ethopabate)	n/a (036541)
Triple “F”, Inc., 10104 Douglas Ave., Des Moines, IA 50322	NADA 131-146, FLAVOMYCIN 0.4 (bambermycins)	558.95 (011490)

Therefore, under authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10), redelegated to the Center for Veterinary Medicine (21 CFR 5.84), and in accordance with § 514.115 Withdrawal of approval of applications (21 CFR 514.115), notice is given that approval of NADAs 49-462, 91-646, 91-647, 96-780, 96-837, 98-687, 119-063, 129-161, 129-395, 129-646, 131-146, 136-369, 136-384, 136-601, 138-656, and all supplements and amendments thereto, is hereby withdrawn, effective December 27, 2005.

In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the withdrawal of approval of these NADAs.

Dated: December 7, 2005.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.