Document ID: FDA-2012-N-1167-0001
Agency: fda
Document Type: Notice
Title: Proposals to Withdraw Approvals of New Animal Drug Applications: Ag-Mark, Inc., et al.; Opportunity for Hearing
Posted Date: 2012-12-17T05:00Z

[Federal Register Volume 77, Number 242 (Monday, December 17, 2012)]
[Notices]
[Pages 74672-74673]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30089]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1167]

Ag-Mark, Incorporated, et al.; Proposal To Withdraw Approval of 
New Animal Drug Applications; Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity to request a hearing on the Agency's proposal to withdraw 
approval of 19 new animal drug applications (NADAs) and 1 abbreviated 
new animal drug application (ANADA) from multiple sponsors. The basis 
for the proposal is that the sponsors have repeatedly failed to file 
required periodic reports for these applications.

DATES: Submit written requests for a hearing by January 16, 2013; 
submit data and information in support of the hearing request by 
February 15, 2013.

ADDRESSES: Requests for a hearing, supporting data, and other comments 
are to be identified with Docket No. FDA-2012-N-1167 and submitted to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Vernon Toelle, Center for Veterinary 
Medicine (HFV-234), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9238, email: vernon.toelle@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The holders of approved applications to 
market new animal drugs are required to submit annual reports to FDA 
concerning each of their approved applications in accordance with Sec.  
514.80 (21 CFR 514.80). The holders of the approved applications listed 
in table 1 of this document have failed to submit the required annual 
reports and have not responded to the Agency's repeated requests for 
submission of the reports including, in all cases, a request by 
certified mail.

                Table 1--Approved NADAs and ANADAs for Which Required Reports Have Not Been Made
----------------------------------------------------------------------------------------------------------------
      NADA/ANADA No.              Trade name (drug)                 Sponsor                Citation in 21 CFR
----------------------------------------------------------------------------------------------------------------
009-252...................  FUMIDIL B                     Mid-Continent                520.182
                             (bicyclohexylammonium         Agrimarketing, Inc., 8833
                             fumagillin).                  Quivira Rd., Overland
                                                           Park, KS 66214.
034-601...................  SYNCHRO-MATE (flurogestone    G. D. Searle LLC, 4901       529.1003
                             acetate).                     Searle Pkwy., Skokie, IL
                                                           60077.
039-284...................  Swisher Super Broiler 300-    Swisher Feed Division,       558.58
                             108 (amprolium, ethopabate,   William Davies Co., Inc.,
                             bacitracin zinc, and          P.O. Box 578, Danville, IL
                             roxarsone).                   61832.
040-920...................  Chick Grower-Developer        Honeggers and Co., Inc.,     Not codified
                             Fortified (amprolium).        201 W. Locust St.,
                                                           Fairbury, IL 61739.
094-223...................  Canine Worm Caps (n-butyl     K. C. Pharmacal, Inc., 8345  520.260
                             chloride).                    Melrose Dr., Lenexa, KS
                                                           66214.
098-429...................  Medic-Meal-T Premix (tylosin  J. C. Feed Mills, 1050       558.625
                             phosphate).                   Sheffield, P.O. Box 224,
                                                           Waterloo, IA 50704.
098-639...................  TYLAN Sulfa-G (tylosin        Bioproducts, Inc., 320       558.630
                             phosphate and                 Springside Dr., Suite 300,
                             sulfamethazine).              Fairlawn, OH 44333-2435.
106-507...................  TYLAN 10 (tylosin phosphate)  Custom Feed Blenders Corp.,  558.625
                                                           540 Hawkeye Ave., Fort
                                                           Dodge, IA 50501.
110-044...................  PRO-TONE Plus Pak GF T-1      Peavey Co., 730 Second Ave.  558.625
                             (tylosin phosphate).          South, Minneapolis, MN
                                                           55402.
117-688...................  Dichlorophene & Toluene       Texas Vitamin Co., P.O. Box  520.580
                             Capsules.                     18417, 10695 Aledo St.,
                                                           Dallas, TX 57218.
120-614...................  TYLAN Sulfa-G (tylosin        Webel Feeds, Inc., R.R. 3,   558.630
                             phosphate and                 Pittsfield, IL 62363.
                             sulfamethazine).
120-671...................  Pet-Worm-Caps (dichlorophene  K. C. Pharmacal, Inc., 8345  520.580
                             and toluene).                 Melrose Dr., Lenexa, KS
                                                           66214.
121-147...................  Nutra-Mix TYLAN (tylosin      Ag-Mark, Inc., P.O. Box      558.625
                             phosphate).                   127, Teachey, NC 28464.
122-522...................  TYLAN Sulfa-G (tylosin        Custom Feed Blenders Corp.,  558.630
                             phosphate and                 540 Hawkeye Ave., Fort
                             sulfamethazine).              Dodge, IA 50501.

[[Page 74673]]

 
124-391...................  Nutra-Mix TYLAN-Sulfa         Ag-Mark, Inc., P.O. Box      558.630
                             Premixes (tylosin phosphate   127, Teachey, NC 28464.
                             and sulfamethazine).
127-195...................  TYLAN 10 (tylosin phosphate)  I.M.S. Inc., 13619           558.625
                                                           Industrial Rd., Omaha, NE
                                                           68137.
129-415...................  Custom Ban Wormer 9.6         Custom Feed Blenders Corp.,  558.485
                             BANMINTH (pyrantel            540 Hawkeye Ave., Fort
                             tartrate).                    Dodge, IA 50501.
130-092...................  ALFAVET (alfaprostol).......  Vetem, S.p.A., Viale E.      522.46
                                                           Bezzi 24, 20146 Milano,
                                                           Italy.
141-101...................  PREEMPT (competitive          Bioscience Division of Milk  529.469
                             exclusion culture).           Specialties Co., 1902
                                                           Tennyson Lane, Madison, WI
                                                           53704.
200-187...................  Isoflurane, USP.............  Marsam Pharmaceuticals,      529.1186
                                                           Inc., Bldg. 31, 24 Olney
                                                           Ave., Cherry Hill, NJ
                                                           08034.
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    Therefore, notice is given to the holders of the approved 
applications listed in table 1 of this document and to all other 
interested persons that the Director of the Center for Veterinary 
Medicine proposes to issue an order under section 512(e) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(e)) 
withdrawing approval of the applications, and all amendments and 
supplements thereto, on the ground that the applicants have failed to 
submit the reports required under Sec.  514.80(b)(2).
    In accordance with section 512 of the FD&C Act and parts 12 and 514 
(21 CFR parts 12 and 514), the applicants are hereby provided an 
opportunity for a hearing to show why the applications listed in table 
1 of this document should not be withdrawn (and the corresponding 
regulations revoked) and an opportunity to raise, for administrative 
determination, all issues relating to the legal status of the new 
animal drug products covered by these applications.
    An applicant who decides to seek a hearing shall file the 
following: (1) A written notice of participation and request for a 
hearing (see DATES), and (2) the data, information, and analyses relied 
on to demonstrate that there is a genuine and substantial issue of fact 
that requires a hearing (see DATES). Any other interested person may 
also submit comments on this notice. The procedures and requirements 
governing this notice of opportunity for a hearing, notice of 
participation and request for a hearing, information and analyses to 
justify a hearing, other comments, and a grant or denial of a hearing 
are contained in Sec.  514.200 and in part 12.
    The failure of an applicant to file a timely written notice of 
participation and request for a hearing, as required by Sec.  514.200 
and part 12, constitutes an election by that applicant not to avail 
itself of the opportunity for a hearing concerning the proposal to 
withdraw approval of the applications and constitutes a waiver of any 
contentions concerning the legal status of the new animal drug 
products. FDA will then withdraw approval of the applications and the 
new animal drug products may not thereafter lawfully be marketed, and 
FDA may begin appropriate regulatory action to remove the products from 
the market. Any new animal drug product marketed without an approved 
NADA is subject to regulatory action at any time.
    A request for a hearing may not rest upon mere allegations or 
denials, but must present specific facts showing that there is a 
genuine and substantial issue of fact that requires a hearing. Reports 
submitted to remedy the deficiencies must be complete in all respects 
in accordance with Sec.  514.80. If the submission is not complete or 
if a request for a hearing is not made in the required format or with 
the required reports, the Commissioner of Food and Drugs (the 
Commissioner) will enter summary judgment against the person who 
requests the hearing, making findings and conclusions, and denying a 
hearing.
    All submissions under this notice of opportunity for a hearing must 
be filed in four copies. Except for data and information prohibited 
from public disclosure by law, the submissions may be seen in the 
Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 
p.m., Monday through Friday, or on the Internet at http://www.regulations.gov.
    This notice is issued under section 512 of the FD&C Act and under 
authority delegated to the Director, Center for Veterinary Medicine, by 
the Commissioner.

    Dated: December 10, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-30089 Filed 12-14-12; 8:45 am]
BILLING CODE 4160-01-P