Ag-Mark, Inc., et al.; Withdrawal of Approval of New Animal Drug Applications, 14803-14804 [2013-04998]

Download as PDF Federal Register / Vol. 78, No. 45 / Thursday, March 7, 2013 / Notices applications have repeatedly failed to file required annual reports for the applications. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Withdrawal of approval is effective March 18, 2013. DATES: [Docket No. FDA–2012–N–1167] FOR FURTHER INFORMATION CONTACT: Ag-Mark, Inc., et al.; Withdrawal of Approval of New Animal Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. David Alterman, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–453–6843, david.alterman@fda.hhs.gov. 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). In the Federal Register of December, 17, 2012 (77 FR 74672), FDA published SUPPLEMENTARY INFORMATION: The Food and Drug Administration (FDA) is withdrawing approval of 19 new animal drug applications (NADAs) and 1 abbreviated new animal drug application (ANADA) from multiple holders of these applications. The basis for the withdrawals is that the holders of these SUMMARY: 14803 a notice offering an opportunity for a hearing (NOOH) on a proposal to withdraw approval of 19 NADAs and 1 ANADA because the sponsors had failed to submit the required annual reports for these applications. The holders of these applications did not respond to the NOOH. Failure to file a written notice of participation and request for a hearing as required by § 514.200(b) (21 CFR 514.200(b)) constitutes an election by the applicant not to make use of the opportunity for a hearing concerning the proposal to withdraw approval of the applications and a waiver of any contentions concerning the legal status of the drug products. Therefore, the Director, Center for Veterinary Medicine, is withdrawing approval of the 20 applications listed in Table 1 of this document. TABLE 1—NADAS AND ANADA FOR WHICH APPROVAL IS WITHDRAWN Trade Name (drug) Applicant NADA 009–252 .......... FUMIDIL B (bicyclohexylammonium fumagillin) .................. NADA 034–601 .......... SYNCHRO–MATE (flurogestone acetate) ........................... NADA 039–284 .......... NADA 040–920 .......... Swisher Super Broiler 300–108 (amprolium, ethopabate, bacitracin zinc, and roxarsone). Chick Grower-Developer Fortified (amprolium) ................... NADA 094–223 .......... Canine Worm Caps (n-butyl chloride) ................................. NADA 098–429 .......... Medic-Meal-T Premix (tylosin phosphate) ........................... NADA 098–639 .......... TYLAN Sulfa-G (tylosin phosphate and sulfamethazine) .... NADA 106–507 .......... TYLAN 10 (tylosin phosphate) ............................................. NADA 110–044 .......... PRO–TONE Plus Pak GF T–1 (tylosin phosphate) ............. NADA 117–688 .......... Dichlorophene and Toluene Capsules ................................. NADA 120–614 .......... NADA 120–671 .......... TYLAN Sulfa-G (tylosin phosphate and sulfamethazine) .... Pet-Worm-Caps (dichlorophene and toluene) ..................... NADA 121–147 .......... NADA 122–522 .......... Nutra-Mix TYLAN (tylosin phosphate) ................................. TYLAN Sulfa-G (tylosin phosphate and sulfamethazine) .... NADA 124–391 .......... Nutra-Mix TYLAN-Sulfa Premixes (tylosin phosphate and sulfamethazine). TYLAN 10 (tylosin phosphate) ............................................. Custom Ban Wormer 9.6 BANMINTH (pyrantel tartrate) .... Mid-Continent Agrimarketing, Inc., 8833 Quivira Rd., Overland Park, KS 66214. G. D. Searle LLC, Pharmacia Corp., 4901 Searle Pkwy., Skokie, IL 60077. Swisher Feed Division, William Davies Co., Inc., P.O. Box 578, Danville, IL 61832. Honeggers and Co., Inc., 201 W. Locust St., Fairbury, IL 61739. K. C. Pharmacal, Inc., 8345 Melrose Dr., Lenexa, KS 66214. J. C. Feed Mills, 1050 Sheffield, P.O. Box 224, Waterloo, IA 50704. Bioproducts, Inc., 320 Springside Dr., suite 300, Fairlawn, OH 44333–2435. Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort Dodge, IA 50501. Peavey Co., 730 Second Ave. South, Minneapolis, MN 55402. Texas Vitamin Co., P.O. Box 18417, 10695 Aledo St., Dallas, TX 57218. Webel Feeds, Inc., R.R. 3, Pittsfield, IL 62363. K. C. Pharmacal, Inc., 8345 Melrose Dr., Lenexa, KS 66214. Ag-Mark, Inc., P.O. Box 127, Teachey, NC 28464. Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort Dodge, IA 50501. Ag-Mark, Inc., P.O. Box 127, Teachey, NC 28464. NADA 127–195 .......... NADA 129–415 .......... NADA 130–092 .......... NADA 141–101 .......... ALFAVET (alfaprostol) ......................................................... PREEMPT (competitive exclusion culture) .......................... ANADA 200–187 ........ emcdonald on DSK67QTVN1PROD with NOTICES Application No. Isoflurane, USP .................................................................... The Director, Center for Veterinary Medicine, under section 512(e)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(e)(2)(A)), and under authority delegated by the Commissioner, finds that the holders of VerDate Mar<15>2010 14:43 Mar 06, 2013 Jkt 229001 I.M.S. Inc., 13619 Industrial Rd., Omaha, NE 68137. Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort Dodge, IA 50501. Vetem, S.p.A., Viale E. Bezzi 24, 20146 Milano, Italy. Bioscience Division, of Milk Specialties Co., 1902 Tennyson Lane, Madison, WI 53704. Marsam Pharmaceuticals, LLC, Bldg. 31, 24 Olney Ave., Cherry Hill, NJ 08034. the applications listed in this document have repeatedly failed to submit reports required by § 514.80. In addition, under § 514.200(b), we find that the holders of the applications have waived any contentions concerning the legal status PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 of the drug products. Therefore, under these findings, approval of the applications listed in this document, and all amendments and supplements thereto, is hereby withdrawn, effective March 18, 2013. E:\FR\FM\07MRN1.SGM 07MRN1 14804 Federal Register / Vol. 78, No. 45 / Thursday, March 7, 2013 / Notices 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 applications. Dated: February 27, 2013. Bernadette Dunham, Director, Center for Veterinary Medicine. Information Collection Request Title: Rural Health Information Technology Network Development Performance Improvement and Measurement System Database (OMB No. 0915–0354)— [Revision] [FR Doc. 2013–04998 Filed 3–6–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities; Proposed Collection; Comment Request ACTION: estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Notice. SUMMARY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443– 1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the The purpose of the Rural Health Information Technology Network Development (RHITND) Program, authorized under the Public Health Service Act, Section 330A(f) (42 U.S.C. 254c(f)) as amended by Section 201, Public Law 107–251 of the Health Care Safety Net Amendments of 2002, is to improve health care and support the adoption of Health Information Technology (HIT) in rural America by providing targeted HIT support to rural health networks. HIT plays a significant role in the advancement of Health and Human Services’ (HHS) priority policies to improve health care delivery. Some of these priorities include: improving health care quality, safety, and efficiency; reducing disparities; engaging patients and families in managing their health; enhancing care coordination; improving population and public health; and ensuring adequate privacy and security of health information. The intent of RHITND is to support the adoption and use of electronic health records (EHR) in coordination with the ongoing HHS activities related to the Health Information Technology for Economic and Clinical Health (HITECH) Act (Pub. L. 111–5). This legislation provides HHS with the authority to establish programs to Number of respondents Form name Number of responses per respondent improve health care quality, safety, and efficiency through the promotion of health information technology, including EHR. For this program, performance measures were drafted to provide data useful to the program and to enable HRSA to provide aggregate program data required by Congress under the Government Performance and Results Act (GPRA) of 1993 (Pub. L. 103–62). These measures cover the principal topic areas of interest to the Office of Rural Health Policy, including: (a) Access to care; (b) the underinsured and uninsured; (c) workforce recruitment and retention; (d) sustainability; (e) health information technology; (f) network development; and (g) health related clinical measures. Several measures will be used for this program. These measures will speak to the Office of Rural Health Policy’s progress toward meeting the goals set. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. The annual estimate of burden is as follows: Total responses Average burden per response (in hours) Total burden hours 41 1 41 6.33 259.53 Total .............................................................................. emcdonald on DSK67QTVN1PROD with NOTICES Performance Improvement and Measurement System (PIMS) Database .............................................................. 41 1 41 6.33 259.53 Submit your comments to paperwork@hrsa.gov or mail the HRSA ADDRESSES: VerDate Mar<15>2010 18:42 Mar 06, 2013 Jkt 229001 Reports Clearance Officer, Room 10–29, PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. E:\FR\FM\07MRN1.SGM 07MRN1

Agencies

[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Notices]
[Pages 14803-14804]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04998]



[[Page 14803]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Ag-Mark, Inc., et al.; 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 19 new animal drug applications (NADAs) and 1 abbreviated new animal 
drug application (ANADA) from multiple holders of these applications. 
The basis for the withdrawals is that the holders of these applications 
have repeatedly failed to file required annual reports for the 
applications.

DATES: Withdrawal of approval is effective March 18, 2013.

FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-453-6843, david.alterman@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).
    In the Federal Register of December, 17, 2012 (77 FR 74672), FDA 
published a notice offering an opportunity for a hearing (NOOH) on a 
proposal to withdraw approval of 19 NADAs and 1 ANADA because the 
sponsors had failed to submit the required annual reports for these 
applications. The holders of these applications did not respond to the 
NOOH. Failure to file a written notice of participation and request for 
a hearing as required by Sec.  514.200(b) (21 CFR 514.200(b)) 
constitutes an election by the applicant not to make use of the 
opportunity for a hearing concerning the proposal to withdraw approval 
of the applications and a waiver of any contentions concerning the 
legal status of the drug products. Therefore, the Director, Center for 
Veterinary Medicine, is withdrawing approval of the 20 applications 
listed in Table 1 of this document.

        Table 1--NADAs and ANADA for Which Approval Is Withdrawn
------------------------------------------------------------------------
        Application No.          Trade Name  (drug)       Applicant
------------------------------------------------------------------------
NADA 009-252..................  FUMIDIL B            Mid-Continent
                                 (bicyclohexylammon   Agrimarketing,
                                 ium fumagillin).     Inc., 8833 Quivira
                                                      Rd., Overland
                                                      Park, KS 66214.
NADA 034-601..................  SYNCHRO-MATE         G. D. Searle LLC,
                                 (flurogestone        Pharmacia Corp.,
                                 acetate).            4901 Searle Pkwy.,
                                                      Skokie, IL 60077.
NADA 039-284..................  Swisher Super        Swisher Feed
                                 Broiler 300-108      Division, William
                                 (amprolium,          Davies Co., Inc.,
                                 ethopabate,          P.O. Box 578,
                                 bacitracin zinc,     Danville, IL
                                 and roxarsone).      61832.
NADA 040-920..................  Chick Grower-        Honeggers and Co.,
                                 Developer            Inc., 201 W.
                                 Fortified            Locust St.,
                                 (amprolium).         Fairbury, IL
                                                      61739.
NADA 094-223..................  Canine Worm Caps (n- K. C. Pharmacal,
                                 butyl chloride).     Inc., 8345 Melrose
                                                      Dr., Lenexa, KS
                                                      66214.
NADA 098-429..................  Medic-Meal-T Premix  J. C. Feed Mills,
                                 (tylosin             1050 Sheffield,
                                 phosphate).          P.O. Box 224,
                                                      Waterloo, IA
                                                      50704.
NADA 098-639..................  TYLAN Sulfa-G        Bioproducts, Inc.,
                                 (tylosin phosphate   320 Springside
                                 and                  Dr., suite 300,
                                 sulfamethazine).     Fairlawn, OH 44333-
                                                      2435.
NADA 106-507..................  TYLAN 10 (tylosin    Custom Feed
                                 phosphate).          Blenders Corp.,
                                                      540 Hawkeye Ave.,
                                                      Fort Dodge, IA
                                                      50501.
NADA 110-044..................  PRO-TONE Plus Pak    Peavey Co., 730
                                 GF T-1 (tylosin      Second Ave. South,
                                 phosphate).          Minneapolis, MN
                                                      55402.
NADA 117-688..................  Dichlorophene and    Texas Vitamin Co.,
                                 Toluene Capsules.    P.O. Box 18417,
                                                      10695 Aledo St.,
                                                      Dallas, TX 57218.
NADA 120-614..................  TYLAN Sulfa-G        Webel Feeds, Inc.,
                                 (tylosin phosphate   R.R. 3,
                                 and                  Pittsfield, IL
                                 sulfamethazine).     62363.
NADA 120-671..................  Pet-Worm-Caps        K. C. Pharmacal,
                                 (dichlorophene and   Inc., 8345 Melrose
                                 toluene).            Dr., Lenexa, KS
                                                      66214.
NADA 121-147..................  Nutra-Mix TYLAN      Ag-Mark, Inc., P.O.
                                 (tylosin             Box 127, Teachey,
                                 phosphate).          NC 28464.
NADA 122-522..................  TYLAN Sulfa-G        Custom Feed
                                 (tylosin phosphate   Blenders Corp.,
                                 and                  540 Hawkeye Ave.,
                                 sulfamethazine).     Fort Dodge, IA
                                                      50501.
NADA 124-391..................  Nutra-Mix TYLAN-     Ag-Mark, Inc., P.O.
                                 Sulfa Premixes       Box 127, Teachey,
                                 (tylosin phosphate   NC 28464.
                                 and
                                 sulfamethazine).
NADA 127-195..................  TYLAN 10 (tylosin    I.M.S. Inc., 13619
                                 phosphate).          Industrial Rd.,
                                                      Omaha, NE 68137.
NADA 129-415..................  Custom Ban Wormer    Custom Feed
                                 9.6 BANMINTH         Blenders Corp.,
                                 (pyrantel            540 Hawkeye Ave.,
                                 tartrate).           Fort Dodge, IA
                                                      50501.
NADA 130-092..................  ALFAVET              Vetem, S.p.A.,
                                 (alfaprostol).       Viale E. Bezzi 24,
                                                      20146 Milano,
                                                      Italy.
NADA 141-101..................  PREEMPT              Bioscience
                                 (competitive         Division, of Milk
                                 exclusion culture).  Specialties Co.,
                                                      1902 Tennyson
                                                      Lane, Madison, WI
                                                      53704.
ANADA 200-187.................  Isoflurane, USP....  Marsam
                                                      Pharmaceuticals,
                                                      LLC, Bldg. 31, 24
                                                      Olney Ave., Cherry
                                                      Hill, NJ 08034.
------------------------------------------------------------------------

    The Director, Center for Veterinary Medicine, under section 
512(e)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360b(e)(2)(A)), and under authority delegated by the Commissioner, 
finds that the holders of the applications listed in this document have 
repeatedly failed to submit reports required by Sec.  514.80. In 
addition, under Sec.  514.200(b), we find that the holders of the 
applications have waived any contentions concerning the legal status of 
the drug products. Therefore, under these findings, approval of the 
applications listed in this document, and all amendments and 
supplements thereto, is hereby withdrawn, effective March 18, 2013.

[[Page 14804]]

    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 applications.

    Dated: February 27, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-04998 Filed 3-6-13; 8:45 am]
BILLING CODE 4160-01-P