Animal drugs, feeds, and related products: Pyrantel tartrate, etc.; withdrawn,

[Federal Register: December 16, 2005 (Volume 70, Number 241)]

[Notices]

[Page 74822-74823]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr16de05-75]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0150]

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: pesposit@cvm.fda.gov.

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.

21 CFR Section Affected (Sponsor Sponsor

NADA Number, Product (Drug)

Drug Labeler Code)

Bioproducts, Inc., 320 Springside NADA 119-063, Pyrantel Tartrate Ton 558.485 (051359) Dr., Suite 300, Fairlawn, OH 44333- Pack (pyrantel tartrate) 2435

Farmland Industries, Inc., Kansas NADA 138-656, BN Wormer--19.2

558.485 (021676) City, MO 64116

BANMINTH Premix (pyrantel tartrate)

I.M.S. Inc., 13619 Industrial Rd., NADA 129-395, HYGROMIX 0.6 Premix 558.274 (050639) Omaha, NE 68137

(hygromycin B) NADA 129-646, TYLAN 10 Sulfa-G

558.630 (050639) (tylosin, sulfamethazine) NADA 136-601, Swine Guard-BN

558.485 (050639) (pyrantel tartrate)

J. & R. Specialty Supply Co., 310 NADA 96-780, TYLAN 10; TYLAN 40

n/a (049768) Second Ave., SW,, P.O. Box 506, (tylosin) Waseca, MN 56093

Kerber Milling Co., Box 152, 1817 NADA 98-687, Hy-Test Hy-Boost TY 5 558.625 (029341) E. Main St., Emmetsburg, IA 50536 Medicated (tylosin)

M & M Livestock Products Co., Eagle NADA 96-837, M & M Tylosin Premix 558.625 (026282) Grove, IA 50533

(tylosin)

Nutra-Blend Corp., P.O. Box 485, NADA 129-161, Nutra-Blend TYLAN 10 558.630 (050568) Neosho, MO 64850

Sulfa Premix (tylosin, sulfamethazine) NADA 136-384, Swine Wormer-BN

558.485 (050568) BANMINTH (pyrantel tartrate)

South St. Paul Feeds, Inc., 500 NADA 136-369, Custom Ban Wormer 9.6 558.485 (001800) Farwell Ave., South St. Paul, MN (pyrantel tartrate) 55075

Stockton Hay & Grain Co.

NADA 49-462, Rainbrook Broiler Premix n/a (036541) No. 1 (ampolium, arsanilic acid, ethopabate, penicillin G procaine, streptomycin) NADA 91-646, Rainbow Broiler Base n/a (036541) Concentrate (ampolium, bacitracin zinc, ethopabate) NADA 91-647, Broiler Base Concentrate n/a (036541) (ampolium, chlortetracyline, ethopabate)

Triple ``F'', Inc., 10104 Douglas NADA 131-146, FLAVOMYCIN 0.4

558.95 (011490) Ave., Des Moines, IA 50322

(bambermycins)

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 Sec. 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

[[Page 74823]]

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.

[FR Doc. 05-24103 Filed 12-15-05; 8:45 am]

BILLING CODE 4160-01-S

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