70 FR 241 pgs. 74822-74823 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications
Type: NOTICEVolume: 70Number: 241Pages: 74822 - 74823
Docket number: [Docket No. 2005N-0150]
FR document: [FR Doc. 05-24103 Filed 12-15-05; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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:
| 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.
[FR Doc. 05-24103 Filed 12-15-05; 8:45 am]
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