New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications, 76387-76388 [2015-31040]
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76387
Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Rules and Regulations
directive (VFD) drug to use by or on the
order of a licensed veterinarian. See
§ 558.6 for additional requirements.
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■ 14. In § 558.261, revise paragraphs
(c)(1) and (2) introductory text to read
as follows:
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
10. The authority citation for 21 CFR
part 524 continues to read as follows:
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Authority: 21 U.S.C. 360b.
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11. Add § 524.957 to read as follows:
§ 558.261
§ 524.957 Florfenicol, terbinafine, and
mometasone otic solution.
Florfenicol.
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(a) Specifications. Each single-dose,
prefilled dropperette contains 1
milliliter (mL) of a solution containing
15 milligrams (mg) florfenicol, 13.3 mg
terbinafine, and 2 mg mometasone
furoate.
(b) Sponsor. See No. 000859 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer one dropperette (1
mL) per affected ear(s).
(2) Indications for use. For the
treatment of otitis externa in dogs
associated with susceptible strains of
yeast (Malassezia pachydermatis) and
bacteria (Staphylococcus
pseudintermedius).
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
12. The authority citation for 21 CFR
part 558 continues to read as follows:
ACTION:
§ 558.618
Tilmicosin.
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(c) * * *
(1) Federal law restricts medicated
feed containing this veterinary feed
directive (VFD) drug to use by or on the
order of a licensed veterinarian. See
§ 558.6 for additional requirements.
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[Amended]
13. In § 558.68, revise paragraph (c)(1)
to read as follows:
16. Effective December 21, 2015, in
§ 558.625, remove paragraph (b)(5) and
redesignate paragraph (b)(6) as
paragraph (b)(5).
§ 558.68
§ 558.630
21 CFR Parts 520 and 558
[Docket No. FDA–2015–N–0002]
New Animal Drugs; Withdrawal of
Approval of New Animal Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of two new animal drug
applications (NADAs) and two
abbreviated new animal drug
applications (ANADAs). This action is
being taken at the sponsors’ requests
because these products are no longer
manufactured or marketed.
DATES: Withdrawal of approval is
effective December 21, 2015.
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
SUMMARY:
The
following three sponsors have requested
that FDA withdraw approval of the
NADAs and ANADAs listed in the
following table because the products are
no longer manufactured or marketed:
SUPPLEMENTARY INFORMATION:
[Amended]
17. Effective December 21, 2015, in
§ 558.630, in paragraph (b)(2), remove
‘‘Nos. 054771 and 069254’’ and in its
place add ‘‘No. 054771’’.
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(c) * * *
(1) Federal law restricts medicated
feed containing this veterinary feed
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
15. In § 558.618, revise paragraph
(c)(1) to read as follows:
■
Authority: (P≤21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
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BILLING CODE 4164–01–P
Food and Drug Administration
§ 558.625
Avilamycin.
[FR Doc. 2015–31042 Filed 12–8–15; 8:45 am]
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(c) * * *
(1) Federal law restricts medicated
feed containing this veterinary feed
directive (VFD) drug to use by or on the
order of a licensed veterinarian. See
§ 558.6 for additional requirements.
(2) The expiration date of VFDs for
florfenicol medicated feeds:
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Dated: December 4, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
21 CFR
section
File No.
Sponsor
Product name
140–680 1 .......................
Pharmgate LLC, 1015 Ashes Dr., suite 102, Wilmington, NC 28405.
Pharmgate LLC, 1015 Ashes Dr., suite 102, Wilmington, NC 28405.
Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514.
Bayer HealthCare LLC, Animal Health Division,
P.O. Box 390, Shawnee Mission, KS 66201.
TYLAN (tylosin phosphate) Premix ......................
558.625
TYLAN SULFA G (tylosin phosphate and
sulfamethazine) Premix.
EVICT 300 (pyrantel pamoate) Suspension ........
558.630
520.2043
CLINDAROBE (clindamycin) Capsules ................
520.446
140–681 1 .......................
200–028 .........................
200–383 .........................
wgreen on DSK2VPTVN1PROD with RULES
1 These NADAs were identified as being affected by guidance for industry #213, ‘‘New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily
Aligning Product Use Conditions with GFI #209,’’ December 2013.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with 21 CFR 514.116 Notice of
VerDate Sep<11>2014
15:17 Dec 08, 2015
Jkt 238001
withdrawal of approval of application,
notice is given that approval of NADA
140–680, NADA 140–681, ANADA 200–
028, and ANADA 200–383, and all
supplements and amendments thereto,
PO 00000
Frm 00033
Fmt 4700
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is hereby withdrawn, effective
December 21, 2015.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
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Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Rules and Regulations
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
withdrawal of approval of these
applications.
Dated: December 4, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
I. General Information
A. Does this action apply to me?
[FR Doc. 2015–31040 Filed 12–8–15; 8:45 am]
BILLING CODE 4164–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2014–0822; FRL–9939–52]
Azoxystrobin; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of azoxystrobin
in or on quinoa grain, ti leaves, ti roots,
and modifies the existing tolerances for
the stone fruit group 12 and tree nut
group 14 to read ‘‘stone fruit group 12–
12’’ and ‘‘tree nut group 14–12, except
pistachio’’ respectively. Interregional
Research Project Number 4 (IR–4)
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
SUMMARY:
This regulation is effective
December 9, 2015. Objections and
requests for hearings must be received
on or before February 8, 2016, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2014–0822, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
wgreen on DSK2VPTVN1PROD with RULES
DATES:
VerDate Sep<11>2014
15:17 Dec 08, 2015
Jkt 238001
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2014–0822 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before February 8, 2016. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
PO 00000
Frm 00034
Fmt 4700
Sfmt 4700
2014–0822, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of March 4,
2015 (80 FR 11611) (FRL–9922–68),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 4E8319) by IR–4,
500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition
requested that 40 CFR part 180 be
amended by establishing tolerances for
residues of azoxystrobin (methyl (E)-2{2-[6-(2-cyanophenoxy) pyrimidin-4yloxy]phenyl}-3-methoxyacrylate) and
the Z isomer of azoxystrobin (methyl
(Z)-2-{2-[6-(2-cyanophenoxy)pyrimidin4-yloxy]phenyl}-3-methoxyacrylate) in
or on the raw agricultural commodities
ti palm, leaves at 50 parts per million
(ppm); ti palm, roots at 0.5 ppm; fruit,
stone, group 12–12 at 2.0 ppm; and nut,
tree, group 14–12 at 0.02 ppm. Upon the
approval of the aforementioned
tolerances, the petitioner requested to
remove the established tolerances for
azoxystrobin in or on the raw
agricultural commodities fruit, stone,
group 12 at 1.5 ppm; and nut, tree,
group 14 at 0.02 ppm. That document
referenced a summary of the petition
prepared by Syngenta Crop Protection,
the registrant, which is available in the
docket, https://www.regulations.gov. EPA
received two comments in response to
the March 4, 2015 Notice of Filing that
simply said ‘‘Good.’’
In the Federal Register of October 21,
2015 (80 FR 63731) (FRL–9935–29),
EPA amended the initial notice of filing
for pesticide petition (PP 4E8319),
including the commodity quinoa grain
at 3.0 ppm in addition to the
commodities originally requested and
listed above. Comments were received
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]]>Agencies
[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Rules and Regulations]
[Pages 76387-76388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31040]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520 and 558
[Docket No. FDA-2015-N-0002]
New Animal Drugs; Withdrawal of Approval of New Animal Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of two new animal drug applications (NADAs) and two abbreviated new
animal drug applications (ANADAs). This action is being taken at the
sponsors' requests because these products are no longer manufactured or
marketed.
DATES: Withdrawal of approval is effective December 21, 2015.
FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The following three sponsors have requested
that FDA withdraw approval of the NADAs and ANADAs listed in the
following table because the products are no longer manufactured or
marketed:
----------------------------------------------------------------------------------------------------------------
21 CFR
File No. Sponsor Product name section
----------------------------------------------------------------------------------------------------------------
140-680 \1\......................... Pharmgate LLC, 1015 Ashes TYLAN (tylosin phosphate) 558.625
Dr., suite 102, Wilmington, Premix.
NC 28405.
140-681 \1\......................... Pharmgate LLC, 1015 Ashes TYLAN SULFA G (tylosin 558.630
Dr., suite 102, Wilmington, phosphate and
NC 28405. sulfamethazine) Premix.
200-028............................. Pegasus Laboratories, Inc., EVICT 300 (pyrantel pamoate) 520.2043
8809 Ely Rd., Pensacola, FL Suspension.
32514.
200-383............................. Bayer HealthCare LLC, Animal CLINDAROBE (clindamycin) 520.446
Health Division, P.O. Box Capsules.
390, Shawnee Mission, KS
66201.
----------------------------------------------------------------------------------------------------------------
\1\ These NADAs were identified as being affected by guidance for industry #213, ``New Animal Drugs and New
Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing
Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,''
December 2013.
Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with 21 CFR 514.116 Notice of withdrawal of approval of
application, notice is given that approval of NADA 140-680, NADA 140-
681, ANADA 200-028, and ANADA 200-383, and all supplements and
amendments thereto, is hereby withdrawn, effective December 21, 2015.
Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the voluntary
[[Page 76388]]
withdrawal of approval of these applications.
Dated: December 4, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-31040 Filed 12-8-15; 8:45 am]
BILLING CODE 4164-01-P
