Ag-Mark, Incorporated, et al.; Proposal To Withdraw Approval of New Animal Drug Applications; Opportunity for a Hearing, 74672-74673 [2012-30089]
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Federal Register / Vol. 77, No. 242 / Monday, December 17, 2012 / Notices
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III. Comments
Ag-Mark, Incorporated, et al.; Proposal
To Withdraw Approval of New Animal
Drug Applications; Opportunity for a
Hearing
Interested persons may submit either
written comments regarding this
document to the Division of Dockets
Management (see ADDRESSES) or
electronic comments to https://
www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
[FR Doc. 2012–30328 Filed 12–14–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1167]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
SUMMARY:
(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
Trade name
(drug)
Sponsor
009–252 ..........
FUMIDIL B (bicyclohexylammonium fumagillin) ..........
034–601 ..........
SYNCHRO–MATE (flurogestone acetate) ..................
039–284 ..........
040–920 ..........
Swisher Super Broiler 300–108 (amprolium,
ethopabate, bacitracin zinc, and roxarsone).
Chick Grower-Developer Fortified (amprolium) ...........
094–223 ..........
Canine Worm Caps (n-butyl chloride) .........................
098–429 ..........
Medic-Meal-T Premix (tylosin phosphate) ...................
098–639 ..........
106–507 ..........
TYLAN
Sulfa-G
(tylosin
phosphate
and
sulfamethazine).
TYLAN 10 (tylosin phosphate) ....................................
110–044 ..........
PRO–TONE Plus Pak GF T–1 (tylosin phosphate) ....
117–688 ..........
srobinson on DSK4SPTVN1PROD with
NADA/ANADA
No.
Dichlorophene & Toluene Capsules ............................
120–614 ..........
TYLAN
Sulfa-G
(tylosin
phosphate
and
sulfamethazine).
Pet-Worm-Caps (dichlorophene and toluene) .............
Mid-Continent Agrimarketing, Inc., 8833 Quivira Rd.,
Overland Park, KS 66214.
G. D. Searle LLC, 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 ...........
120–671 ..........
121–147 ..........
122–522 ..........
VerDate Mar<15>2010
Nutra-Mix TYLAN (tylosin phosphate) .........................
TYLAN
Sulfa-G
(tylosin
phosphate
and
sulfamethazine).
16:21 Dec 14, 2012
Jkt 229001
PO 00000
Frm 00040
Fmt 4703
Citation in
21 CFR
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.
Sfmt 4703
E:\FR\FM\17DEN1.SGM
17DEN1
520.182
529.1003
558.58
Not codified
520.260
558.625
558.630
558.625
558.625
520.580
558.630
520.580
558.625
558.630
74673
Federal Register / Vol. 77, No. 242 / Monday, December 17, 2012 / Notices
TABLE 1—APPROVED NADAS AND ANADAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN MADE—Continued
NADA/ANADA
No.
Trade name
(drug)
Sponsor
124–391 ..........
Ag-Mark, Inc., P.O. Box 127, Teachey, NC 28464 .....
558.630
200–187 ..........
Isoflurane, USP ...........................................................
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, Inc., Bldg. 31, 24 Olney
Ave., Cherry Hill, NJ 08034.
558.625
558.485
130–092 ..........
141–101 ..........
Nutra-Mix TYLAN-Sulfa Premixes (tylosin phosphate
and sulfamethazine).
TYLAN 10 (tylosin phosphate) ....................................
Custom Ban Wormer 9.6 BANMINTH (pyrantel tartrate).
ALFAVET (alfaprostol) .................................................
PREEMPT (competitive exclusion culture) .................
srobinson on DSK4SPTVN1PROD with
127–195 ..........
129–415 ..........
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
VerDate Mar<15>2010
16:21 Dec 14, 2012
Jkt 229001
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 https://
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
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Citation in
21 CFR
522.46
529.469
529.1186
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HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
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Federal Advisory Committee Act, as
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is hereby given of the meeting of the
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reasonable accommodations, should
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A portion of the meeting will be
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the provisions set forth in sections
552b(c)(4), and 552b(c)(6), Title 5
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applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
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E:\FR\FM\17DEN1.SGM
17DEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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 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.
----------------------------------------------------------------------------------------------------------------
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 https://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
