Ag-Mark, Inc., et al.; Withdrawal of Approval of New Animal Drug Applications, 14803-14804 [2013-04998]
Download as PDF
<![CDATA[
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TABLE 1—NADAS AND ANADA FOR WHICH APPROVAL IS WITHDRAWN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]]
-----------------------------------------------------------------------
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
