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.
Submit written requests for a hearing by January 16, 2013; submit data and information in support of the hearing request by February 15, 2013.
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: firstname.lastname@example.org.
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.
Director, Center for Veterinary Medicine.
[FR Doc. 2012-30089 Filed 12-14-12; 8:45 am]
BILLING CODE 4160-01-P