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

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.

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 § 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 (bicyclohexylammonium fumagillin)

Mid-Continent Agrimarketing, Inc., 8833 Quivira Rd., Overland Park, KS 66214

520.182

034-601

SYNCHRO-MATE (flurogestone acetate)

G. D. Searle LLC, 4901 Searle Pkwy., Skokie, IL 60077

529.1003

039-284

Swisher Super Broiler 300-108 (amprolium, ethopabate, bacitracin zinc, and roxarsone)

Swisher Feed Division, William Davies Co., Inc., P.O. Box 578, Danville, IL 61832

558.58

040-920

Chick Grower-Developer Fortified (amprolium)

Honeggers and Co., Inc., 201 W. Locust St., Fairbury, IL 61739

Not codified

094-223

Canine Worm Caps (n-butyl chloride)

K. C. Pharmacal, Inc., 8345 Melrose Dr., Lenexa, KS 66214

520.260

098-429

Medic-Meal-T Premix (tylosin phosphate)

J. C. Feed Mills, 1050 Sheffield, P.O. Box 224, Waterloo, IA 50704

558.625

098-639

TYLAN Sulfa-G (tylosin phosphate and sulfamethazine)

Bioproducts, Inc., 320 Springside Dr., Suite 300, Fairlawn, OH 44333-2435

558.630

106-507

TYLAN 10 (tylosin phosphate)

Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort Dodge, IA 50501

558.625

110-044

PRO-TONE Plus Pak GF T-1 (tylosin phosphate)

Peavey Co., 730 Second Ave. South, Minneapolis, MN 55402

558.625

117-688

Dichlorophene & Toluene Capsules

Texas Vitamin Co., P.O. Box 18417, 10695 Aledo St., Dallas, TX 57218

520.580

120-614

TYLAN Sulfa-G (tylosin phosphate and sulfamethazine)

Webel Feeds, Inc., R.R. 3, Pittsfield, IL 62363

558.630

120-671

Pet-Worm-Caps (dichlorophene and toluene)

K. C. Pharmacal, Inc., 8345 Melrose Dr., Lenexa, KS 66214

520.580

121-147

Nutra-Mix TYLAN (tylosin phosphate)

Ag-Mark, Inc., P.O. Box 127, Teachey, NC 28464

558.625

122-522

TYLAN Sulfa-G (tylosin phosphate and sulfamethazine)

Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort Dodge, IA 50501

558.630

124-391

Nutra-Mix TYLAN-Sulfa Premixes (tylosin phosphate and sulfamethazine)

Ag-Mark, Inc., P.O. Box 127, Teachey, NC 28464

558.630

127-195

TYLAN 10 (tylosin phosphate)

I.M.S. Inc., 13619 Industrial Rd., Omaha, NE 68137

558.625

129-415

Custom Ban Wormer 9.6 BANMINTH (pyrantel tartrate)

Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort Dodge, IA 50501

558.485

130-092

ALFAVET (alfaprostol)

Vetem, S.p.A., Viale E. Bezzi 24, 20146 Milano, Italy

522.46

141-101

PREEMPT (competitive exclusion culture)

Bioscience Division of Milk Specialties Co., 1902 Tennyson Lane, Madison, WI 53704

529.469

200-187

Isoflurane, USP

Marsam Pharmaceuticals, Inc., Bldg. 31, 24 Olney Ave., Cherry Hill, NJ 08034

529.1186

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 § 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 § 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 § 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 § 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]

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