[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]                         

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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.

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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.
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                                                                              21 CFR Section Affected (Sponsor
              Sponsor                     NADA Number, Product (Drug)                Drug Labeler Code)
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Bioproducts, Inc., 320 Springside    NADA 119-063, Pyrantel Tartrate Ton    558.485 (051359)
 Dr., Suite 300, Fairlawn, OH 44333-  Pack (pyrantel tartrate)
 2435
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Farmland Industries, Inc., Kansas    NADA 138-656, BN Wormer--19.2          558.485 (021676)
 City, MO 64116                       BANMINTH Premix (pyrantel tartrate)
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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)
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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
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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)
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M & M Livestock Products Co., Eagle  NADA 96-837, M & M Tylosin Premix      558.625 (026282)
 Grove, IA 50533                      (tylosin)
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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)
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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
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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)
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Triple ``F'', Inc., 10104 Douglas    NADA 131-146, FLAVOMYCIN 0.4           558.95 (011490)
 Ave., Des Moines, IA 50322           (bambermycins)
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    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