New Animal Drugs; Amprolium; Bambermycins; Ceftiofur; Deslorelin; Florfenicol; Florfenicol and Flunixin; Paclitaxel; Phenylbutazone; Pimobendan; Salinomycin; Tilmicosin; Tiludronate; Change of Sponsor, 18156-18159 [2014-07220]
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18156
Federal Register / Vol. 79, No. 62 / Tuesday, April 1, 2014 / Rules and Regulations
significant environmental impacts, and
no extraordinary circumstances exist
that warrant preparation of an
environmental assessment.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
List of Subjects in 14 CFR Part 71
21 CFR Parts 510, 516, 520, 522, 526,
and 558
Airspace, Incorporation by reference,
Navigation (air).
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR Part 71 as follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E. O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of the Federal Aviation
Administration Order 7400.9X, dated
August 7, 2013, and effective September
15, 2013 is amended as follows:
■
Paragraph 6005 Class E airspace areas
extending upward from 700 feet or more
above the surface of the earth.
*
*
*
AAL AK E5
*
*
Kwigillingok, AK [Removed]
Issued in Seattle, Washington, on March
21, 2014.
Christopher Ramirez,
Acting Manager, Operations Support Group,
Western Service Center.
[FR Doc. 2014–06800 Filed 3–31–14; 8:45 am]
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BILLING CODE 4910–13–P
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[Docket No. FDA–2013–N–0002]
New Animal Drugs; Amprolium;
Bambermycins; Ceftiofur; Deslorelin;
Florfenicol; Florfenicol and Flunixin;
Paclitaxel; Phenylbutazone;
Pimobendan; Salinomycin; Tilmicosin;
Tiludronate; Change of Sponsor
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval actions for new animal drug
applications (NADAs) and abbreviated
new animal drug applications
(ANADAs) during January and February
2014. FDA is also informing the public
of the availability of summaries of the
basis of approval and of environmental
review documents, where applicable.
The animal drug regulations are also
being amended to reflect previous
approval of revised food safety
warnings. This is being done to improve
the accuracy of the regulations. The
animal drug regulations are also being
amended to reflect a change of
sponsorship of an NADA and a change
to a sponsor’s address.
DATES: This rule is effective April 1,
2014.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9019,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
amending the animal drug regulations to
reflect approval actions for NADAs and
ANADAs during January and February
2014, as listed in table 1. In addition,
FDA is informing the public of the
availability, where applicable, of
documentation of environmental review
required under the National
Environmental Policy Act (NEPA) and,
SUMMARY:
1. The authority citation for 14 CFR
Part 71 continues to read as follows:
■
§ 71.1
Food and Drug Administration
PO 00000
Frm 00004
Fmt 4700
Sfmt 4700
for actions requiring review of safety or
effectiveness data, summaries of the
basis of approval (FOI Summaries)
under the Freedom of Information Act
(FOIA). These public documents may be
seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday. Persons with access to the
Internet may obtain these documents at
the Center for Veterinary Medicine
FOIA Electronic Reading Room: https://
www.fda.gov/AboutFDA/CentersOffices/
OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm. Marketing exclusivity and
patent information may be accessed in
FDA’s publication, Approved Animal
Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/
Products/
ApprovedAnimalDrugProducts/
default.htm.
In addition, the regulations are being
amended to reflect the previous
approval of revised food safety warnings
for florfenicol injectable solutions,
florfenicol and flunixin combination
drug injectable solution, ceftiofur
hydrochloride intramammary infusions,
and salinomycin medicated feeds. These
amendments are being done to improve
the accuracy of the regulations.
The regulations are also being
amended to reflect two changes of
sponsorship. Dechra, Ltd., Dechra
House, Jamage Industrial Estate, Talke
Pits, Stoke-on-Trent, Staffordshire, ST7
1XW, United Kingdom, has informed
FDA that it has transferred ownership
of, and all rights and interest in, NADA
141–044 for OVUPLANT (deslorelin
acetate implant) to Virbac AH, Inc.,
3200 Meacham Blvd., Fort Worth, TX
76137. Also, West-Ward Pharmaceutical
Corp., 465 Industrial Way West,
Eatontown, NJ 07724, has informed FDA
that it has transferred ownership of, and
all rights and interest in, ANADA 200–
323 for Phenylbutazone Tablets to
Hikma Pharmaceuticals LLC, P.O. Box
182400, Bayader Wadi Seer, Amman,
Jordan 11118. Accordingly, the Agency
is amending the regulations to reflect
these changes of sponsorship.
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18157
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY AND FEBRUARY 2014
NADA/
ANADA
Sponsor
141–361 .......
Elanco Animal Health,
A Division of Eli Lilly
& Co., Lilly Corporate Center, Indianapolis, IN 46285.
PULMOTIL AC
(tilmicosin phosphate) Concentrate
Solution.
141–420 .......
Ceva Sante Animale,
10 Avenue de la
`
Ballastiere, 33500
Libourne, France.
Oasmia Pharmaceutical AB,
Vallongatan 1, SE–
752 28, Uppsala,
75228 Sweden.
Huvepharma AD, 5th
Floor, 3A Nikolay
Haytov Str., 1113
Sophia, Bulgaria.
TILDREN (tiludronate
disodium).
Intervet, Inc., (d/b/a
Merck Animal
Health), 556 Morris
Ave., Summit, NJ
07901.
Boehringer Ingelheim,
Vetmedica, Inc.,
2621 North Belt
Hwy., St. Joseph,
MO 64506–2002.
AQUAFLOR
(florfenicol) Type A
medicated article.
141–422 .......
130–185 .......
141–246 .......
141–273 .......
New animal drug
product name
PACCAL VET–CA1
(paclitaxel for injection).
AMPROL 25%
(amprolium) plus
FLAVOMYCIN
(bambermycins)
Type A medicated
articles.
VETMEDIN
(pimobendan)
Chewable Tablets.
21 CFR
section
Action
FOIA
summary
NEPA
review
Original approval for the control of
swine respiratory disease associated with Pasteurella multocida
and Haemophilus parasuis in
groups of swine in buildings
where a respiratory disease outbreak is diagnosed.
Original approval for the control of
clinical signs associated with navicular syndrome.
520.2471
yes ...........
EA/
FONSI 1.
522.2473
yes ...........
CE 2 3.
Conditional approval for the treatment of certain carcinomas in
dogs that have not received previous chemotherapy or radiotherapy.
Supplemental approval for prevention of coccidiosis caused by
Eimeria tenella only or for prevention of coccidiosis where immunity to coccidiosis is not desired; and for increased rate of
weight gain and improved feed
efficiency in broiler chickens.
Supplemental approval for an increase in the maximum daily
dose
for
freshwater-reared
finfish other than freshwaterreared warmwater finfish.
Supplemental approval for the addition of a 10-milligram chewable
tablet.
516.1684
yes ...........
CE 2 3.
4 558.55
yes ...........
CE 2 5.
558.261
yes ...........
EA/
FONSI 1.
520.1780
no ............
CE 2 6.
1 The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a
finding of no significant impact (FONSI).
2 The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or
an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the human environment.
3 CE granted under 21 CFR 25.33(d)(1).
4 The regulation in 21 CFR 558.55 has been amended in a separate rule (79 FR 10980, February 27, 2014).
5 CE granted under 21 CFR 25.33(a)(2).
6 CE granted under 21 CFR 25.33(a)(1).
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects
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21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Part 516
Administrative practice and
procedure, Animal drugs, Confidential
business information, Reporting and
recordkeeping requirements.
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21 CFR Parts 520, 522, and 526
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 510, 516, 520, 522, 526, and
558 are amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
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2. In § 510.600, in the table in
paragraph (c)(1), alphabetically add
entries for ‘‘Hikma Pharmaceuticals
LLC’’ and ‘‘Oasmia Pharmaceutical AB’’,
and remove the entry for ‘‘West-Ward
Pharmaceutical Corp.’’; and in the table
in paragraph (c)(2), numerically add
entries for ‘‘052818’’ and ‘‘059115’’, and
remove the entry for ‘‘000143’’ to read
as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
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(c) * * *
(1) * * *
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Federal Register / Vol. 79, No. 62 / Tuesday, April 1, 2014 / Rules and Regulations
Firm name and address
Drug labeler code
*
*
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*
*
*
Hikma Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118 .........................................
*
*
*
*
*
*
*
Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala, Sweden ..............................................................................
*
*
*
*
*
*
059115
052818
*
*
*
*
(2) * * *
Drug labeler code
Firm name and address
*
052818 .......................
*
*
*
*
Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala, Sweden.
*
059115 .......................
*
*
*
*
*
Hikma Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118.
*
*
*
PART 516—NEW ANIMAL DRUGS FOR
MINOR USE AND MINOR SPECIES
*
§ 520.1780
*
[Amended].
3. The authority citation for 21 CFR
part 516 continues to read as follows:
Authority: 21 U.S.C. 360ccc, 360ccc–2,
371.
§ 520.2471
4. Add § 516.1684 to subpart E to read
as follows:
■
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§ 516.1684
Paclitaxel.
(a) Specifications. Each vial of powder
contains 60 milligrams (mg) paclitaxel.
Each milliliter of constituted solution
contains 1 mg paclitaxel.
(b) Sponsor. See No. 052818 in
510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer 150 mg per square
meter of body surface area intravenously
over 15 to 30 minutes, once every 3
weeks, for up to 4 doses.
(2) Indications for use. For the
treatment of nonresectable stage III, IV,
or V mammary carcinoma in dogs that
have not received previous
chemotherapy or radiotherapy. For the
treatment of resectable and
nonresectable squamous cell carcinoma
in dogs that have not received previous
chemotherapy or radiotherapy.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian. It is a violation
of Federal law to use this product other
than as directed in the labeling.
■
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
8. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 522.533
5. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
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Tilmicosin.
(a) Specifications. Each milliliter of
concentrate solution contains 250
milligrams (mg) tilmicosin as tilmicosin
phosphate.
(b) Sponsor. See No. 000986 in
§ 510.600(c) of this chapter.
(c) Tolerances. See § 556.735 of this
chapter.
(d) Conditions of use in swine—(1)
Amount. Administer in drinking water
at a concentration of 200 mg per liter for
5 consecutive days.
(2) Indication for use. For the control
of swine respiratory disease associated
with Pasteurella multocida and
Haemophilus parasuis in groups of
swine in buildings where a respiratory
disease outbreak is diagnosed.
(3) Limitations. Swine intended for
human consumption must not be
slaughtered within 7 days of the last
treatment with this product. Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
[Amended]
9. In paragraph (b)(1) of § 522.533,
remove ‘‘043246’’ and in its place add
‘‘051311’’.
■
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*
*
10. In § 522.955, revise paragraphs
(d)(1)(i)(C) and (d)(1)(ii)(C) to read as
follows:
■
6. In paragraph (a) of § 520.1780,
remove ‘‘or 5 milligrams’’ and in its
place add ‘‘5, or 10 milligrams’’.
■ 7. Add § 520.2471 to read as follows:
■
*
§ 522.955
Florfenicol.
*
*
*
*
*
(d) * * *
(1) * * *
(i) * * *
(C) Limitations. Do not slaughter
within 44 days of treatment. This drug
product is not approved for use in
female dairy cattle 20 months of age or
older, including dry dairy cows. Use in
these cattle may cause drug residues in
milk and/or in calves born to these
cows. A withdrawal period has not been
established in preruminating calves. Do
not use in calves to be processed for
veal. Federal law restricts this drug to
use by or on the order of a licensed
veterinarian.
(ii) * * *
(C) Limitations. Do not slaughter
within 28 days of last intramuscular
treatment or within 38 days of
subcutaneous treatment. This drug
product is not approved for use in
female dairy cattle 20 months of age or
older, including dry dairy cows. Use in
these cattle may cause drug residues in
milk and/or in calves born to these
cows. A withdrawal period has not been
established in preruminating calves. Do
not use in calves to be processed for
veal. Federal law restricts this drug to
use by or on the order of a licensed
veterinarian.
*
*
*
*
*
■ 11. In § 522.956, revise paragraph
(d)(3) to read as follows:
§ 522.956
Florfenicol and flunixin.
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(d) * * *
(3) Limitations. Animals intended for
human consumption must not be
slaughtered within 38 days of treatment.
This drug product is not approved for
use in female dairy cattle 20 months of
age or older, including dry dairy cows.
Use in these cattle may cause drug
residues in milk and/or in calves born
to these cows. A withdrawal period has
not been established in preruminating
calves. Do not use in calves to be
processed for veal. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 12. Add § 522.2473 to read as follows:
§ 522.2473
Tiludronate.
(a) Specifications. Each vial of powder
contains 500 milligrams (mg)
tiludronate disodium. Each milliliter of
constituted solution contains 20 mg
tiludronate disodium.
(b) Sponsor. See No. 013744 in
§ 510.600(c) of this chapter.
(c) Conditions of use in horses—(1)
Amount. Administer a single dose of 1
mg per kilogram (0.45 mg/pound) of
body weight by intravenous infusion.
(2) Indication for use. For the control
of clinical signs associated with
navicular syndrome.
(3) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
PART 526—INTRAMAMMARY DOSAGE
FORM NEW ANIMAL DRUGS
Authority: 21 U.S.C. 360b.
14. In § 526.313, remove paragraph
(d); redesignate paragraph (e) as
paragraph (d); and revise newly
redesignated paragraphs (d)(1)(iii) and
(d)(2)(iii) to read as follows:
Ceftiofur.
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(d) * * *
(1) * * *
(iii) Limitations. Milk taken from
cows during treatment (a maximum of
eight daily infusions) and for 72 hours
after the last treatment must not be used
for human consumption. Following
label use for up to 8 consecutive days,
a 2-day preslaughter withdrawal period
is required. Federal law restricts this
drug to use by or on the order of a
licensed veterinarian. Federal law
prohibits extra-label use of this drug in
lactating dairy cattle for disease
prevention purposes; at unapproved
doses; frequencies, durations, or routes
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15. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
§ 558.261
[Amended]
16. In § 558.261, in paragraph
(e)(2)(ii), in the ‘‘Limitations’’ column,
remove ‘‘10 mg florfenicol’’ and in its
place add ‘‘10 to 15 mg florfenicol’’; and
in paragraph (e)(2)(iii), in the
‘‘Limitations’’ column, remove ‘‘10 mg
florfenicol per kg of fish for’’.
■
ACTION:
Correcting amendment.
This document contains
corrections to final regulations (TD
9644) that were published in the
Federal Register on Monday, December
2, 2013 (78 FR 72394). The final
regulations provide guidance on the
general application of the Net
Investment Income Tax and the
computation of Net Investment Income.
DATES: This correction is effective April
1, 2014 and applicable December 2,
2013.
FOR FURTHER INFORMATION CONTACT:
Adrienne M. Mikolashek, at (202) 317–
6852 (not a toll free number).
SUPPLEMENTARY INFORMATION:
SUMMARY:
Background
The final regulations (TD 9644) that
are the subject of this correction is
under section 1411 of the Internal
Revenue Code.
Need for Correction
As published, the final regulations
(TD 9644) contain errors that may prove
to be misleading and are in need of
clarification.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
Correction of Publication
Accordingly, 26 CFR part 1 is
corrected by making the following
correcting amendments:
PART 1—INCOME TAXES
[Amended]
17. In § 558.550, in paragraph
(d)(1)(i)(c), remove ‘‘layers’’ and in its
place add ‘‘laying hens producing eggs
for human consumption’’; and add at
the end of paragraph (d)(2)(i)(c), ‘‘Do not
feed to laying hens producing eggs for
human consumption.’’
■
■
*
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
§ 558.550
13. The authority citation for 21 CFR
part 526 continues to read as follows:
■
§ 526.313
of administration; and in unapproved
major food producing species/
production classes.
(2) * * *
(iii) Limitations. Milk taken from
cows completing a 30-day dry-off period
may be used for food with no milk
discard due to ceftiofur residues.
Following intramammary infusion, a 16day preslaughter withdrawal period is
required for treated cows. Following
label use, no preslaughter withdrawal
period is required for neonatal calves
from treated cows regardless of
colostrum consumption. Federal law
restricts this drug to use by or on the
order of a licensed veterinarian. Federal
law prohibits extra-label use of this drug
in dry dairy cattle for disease prevention
purposes; at unapproved doses;
frequencies, durations, or routes of
administration; and in unapproved
major food producing species/
production classes.
Dated: March 27, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
Paragraph 1. The authority citation
for part 1 continues to read in part as
follows:
■
Authority: 26 U.S.C. 7805 ***
Par. 2. Section 1.469–11 is amended
by revising the first sentence of
paragraph (b)(3)(iv)(C)(1) and the last
sentence of paragraph (b)(3)(iv)(C)(3)
Example 4. to read as follows:
■
[FR Doc. 2014–07220 Filed 3–31–14; 8:45 am]
§ 1.469–11
rules.
BILLING CODE 4160–01–P
*
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9644]
RIN 1545–BK44
Net Investment Income Tax; Correction
Internal Revenue Service (IRS),
Treasury.
AGENCY:
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Effective date and transition
*
*
*
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(b) * * *
(3) * * *
(iv) * * *
(C) * * * (1) * * * An individual,
estate, or trust also may regroup
activities, in the manner described in
paragraph (b)(3)(iv)(A) of this section,
on an amended return only if the
changes reported on such amended
return cause the taxpayer to meet the
Eligibility Criteria for the first time
beginning in the taxable year for which
the amended return is applicable and
that the taxable year is not closed by the
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]]>Agencies
[Federal Register Volume 79, Number 62 (Tuesday, April 1, 2014)]
[Rules and Regulations]
[Pages 18156-18159]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07220]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 516, 520, 522, 526, and 558
[Docket No. FDA-2013-N-0002]
New Animal Drugs; Amprolium; Bambermycins; Ceftiofur; Deslorelin;
Florfenicol; Florfenicol and Flunixin; Paclitaxel; Phenylbutazone;
Pimobendan; Salinomycin; Tilmicosin; Tiludronate; Change of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval actions for new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during January and February 2014. FDA is also informing the
public of the availability of summaries of the basis of approval and of
environmental review documents, where applicable. The animal drug
regulations are also being amended to reflect previous approval of
revised food safety warnings. This is being done to improve the
accuracy of the regulations. The animal drug regulations are also being
amended to reflect a change of sponsorship of an NADA and a change to a
sponsor's address.
DATES: This rule is effective April 1, 2014.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9019,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions for NADAs and ANADAs during January and
February 2014, as listed in table 1. In addition, FDA is informing the
public of the availability, where applicable, of documentation of
environmental review required under the National Environmental Policy
Act (NEPA) and, for actions requiring review of safety or effectiveness
data, summaries of the basis of approval (FOI Summaries) under the
Freedom of Information Act (FOIA). These public documents may be seen
in the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday. Persons with access
to the Internet may obtain these documents at the Center for Veterinary
Medicine FOIA Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be
accessed in FDA's publication, Approved Animal Drug Products Online
(Green Book) at: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
In addition, the regulations are being amended to reflect the
previous approval of revised food safety warnings for florfenicol
injectable solutions, florfenicol and flunixin combination drug
injectable solution, ceftiofur hydrochloride intramammary infusions,
and salinomycin medicated feeds. These amendments are being done to
improve the accuracy of the regulations.
The regulations are also being amended to reflect two changes of
sponsorship. Dechra, Ltd., Dechra House, Jamage Industrial Estate,
Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW, United Kingdom, has
informed FDA that it has transferred ownership of, and all rights and
interest in, NADA 141-044 for OVUPLANT (deslorelin acetate implant) to
Virbac AH, Inc., 3200 Meacham Blvd., Fort Worth, TX 76137. Also, West-
Ward Pharmaceutical Corp., 465 Industrial Way West, Eatontown, NJ
07724, has informed FDA that it has transferred ownership of, and all
rights and interest in, ANADA 200-323 for Phenylbutazone Tablets to
Hikma Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman,
Jordan 11118. Accordingly, the Agency is amending the regulations to
reflect these changes of sponsorship.
[[Page 18157]]
Table 1--Original and Supplemental NADAs and ANADAs Approved During January and February 2014
----------------------------------------------------------------------------------------------------------------
New animal drug 21 CFR
NADA/ANADA Sponsor product name Action section FOIA summary NEPA review
----------------------------------------------------------------------------------------------------------------
141-361.......... Elanco Animal PULMOTIL AC Original 520.2471 yes.......... EA/
Health, A (tilmicosin approval for FONSI \1\.
Division of Eli phosphate) the control of
Lilly & Co., Concentrate swine
Lilly Corporate Solution. respiratory
Center, disease
Indianapolis, associated
IN 46285. with
Pasteurella
multocida and
Haemophilus
parasuis in
groups of
swine in
buildings
where a
respiratory
disease
outbreak is
diagnosed.
141-420.......... Ceva Sante TILDREN Original 522.2473 yes.......... CE 2 3.
Animale, 10 (tiludronate approval for
Avenue de la disodium). the control of
Ballasti[egrave clinical signs
]re, 33500 associated
Libourne, with navicular
France. syndrome.
141-422.......... Oasmia PACCAL VET-CA1 Conditional 516.1684 yes.......... CE 2 3.
Pharmaceutical (paclitaxel approval for
AB, Vallongatan for injection). the treatment
1, SE-752 28, of certain
Uppsala, 75228 carcinomas in
Sweden. dogs that have
not received
previous
chemotherapy
or
radiotherapy.
130-185.......... Huvepharma AD, AMPROL 25% Supplemental \4\ 558.55 yes.......... CE 2 5.
5th Floor, 3A (amprolium) approval for
Nikolay Haytov plus prevention of
Str., 1113 FLAVOMYCIN coccidiosis
Sophia, (bambermycins) caused by
Bulgaria. Type A Eimeria
medicated tenella only
articles. or for
prevention of
coccidiosis
where immunity
to coccidiosis
is not
desired; and
for increased
rate of weight
gain and
improved feed
efficiency in
broiler
chickens.
141-246.......... Intervet, Inc., AQUAFLOR Supplemental 558.261 yes.......... EA/FONSI \1\.
(d/b/a Merck (florfenicol) approval for
Animal Health), Type A an increase in
556 Morris medicated the maximum
Ave., Summit, article. daily dose for
NJ 07901. freshwater-
reared finfish
other than
freshwater-
reared
warmwater
finfish.
141-273.......... Boehringer VETMEDIN Supplemental 520.1780 no........... CE 2 6.
Ingelheim, (pimobendan) approval for
Vetmedica, Chewable the addition
Inc., 2621 Tablets. of a 10-
North Belt milligram
Hwy., St. chewable
Joseph, MO tablet.
64506-2002.
----------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact
of this action and has made a finding of no significant impact (FONSI).
\2\ The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an
environmental assessment or an environmental impact statement because it is of a type that does not
individually or cumulatively have a significant effect on the human environment.
\3\ CE granted under 21 CFR 25.33(d)(1).
\4\ The regulation in 21 CFR 558.55 has been amended in a separate rule (79 FR 10980, February 27, 2014).
\5\ CE granted under 21 CFR 25.33(a)(2).
\6\ CE granted under 21 CFR 25.33(a)(1).
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 516
Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 526
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
516, 520, 522, 526, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), alphabetically
add entries for ``Hikma Pharmaceuticals LLC'' and ``Oasmia
Pharmaceutical AB'', and remove the entry for ``West-Ward
Pharmaceutical Corp.''; and in the table in paragraph (c)(2),
numerically add entries for ``052818'' and ``059115'', and remove the
entry for ``000143'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
[[Page 18158]]
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * * * *
Hikma Pharmaceuticals LLC, P.O. Box 182400, 059115
Bayader Wadi Seer, Amman, Jordan 11118........
* * * * * * *
Oasmia Pharmaceutical AB, Vallongatan 1, 75228 052818
Uppsala, Sweden...............................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
052818................................ Oasmia Pharmaceutical AB,
Vallongatan 1, 75228 Uppsala,
Sweden.
* * * * * * *
059115................................ Hikma Pharmaceuticals LLC, P.O.
Box 182400, Bayader Wadi Seer,
Amman, Jordan 11118.
* * * * * * *
------------------------------------------------------------------------
PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
0
3. The authority citation for 21 CFR part 516 continues to read as
follows:
Authority: 21 U.S.C. 360ccc, 360ccc-2, 371.
0
4. Add Sec. 516.1684 to subpart E to read as follows:
Sec. 516.1684 Paclitaxel.
(a) Specifications. Each vial of powder contains 60 milligrams (mg)
paclitaxel. Each milliliter of constituted solution contains 1 mg
paclitaxel.
(b) Sponsor. See No. 052818 in 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer 150 mg per
square meter of body surface area intravenously over 15 to 30 minutes,
once every 3 weeks, for up to 4 doses.
(2) Indications for use. For the treatment of nonresectable stage
III, IV, or V mammary carcinoma in dogs that have not received previous
chemotherapy or radiotherapy. For the treatment of resectable and
nonresectable squamous cell carcinoma in dogs that have not received
previous chemotherapy or radiotherapy.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. It is a violation of Federal law
to use this product other than as directed in the labeling.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
5. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.1780 [Amended].
0
6. In paragraph (a) of Sec. 520.1780, remove ``or 5 milligrams'' and
in its place add ``5, or 10 milligrams''.
0
7. Add Sec. 520.2471 to read as follows:
Sec. 520.2471 Tilmicosin.
(a) Specifications. Each milliliter of concentrate solution
contains 250 milligrams (mg) tilmicosin as tilmicosin phosphate.
(b) Sponsor. See No. 000986 in Sec. 510.600(c) of this chapter.
(c) Tolerances. See Sec. 556.735 of this chapter.
(d) Conditions of use in swine--(1) Amount. Administer in drinking
water at a concentration of 200 mg per liter for 5 consecutive days.
(2) Indication for use. For the control of swine respiratory
disease associated with Pasteurella multocida and Haemophilus parasuis
in groups of swine in buildings where a respiratory disease outbreak is
diagnosed.
(3) Limitations. Swine intended for human consumption must not be
slaughtered within 7 days of the last treatment with this product.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
8. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.533 [Amended]
0
9. In paragraph (b)(1) of Sec. 522.533, remove ``043246'' and in its
place add ``051311''.
0
10. In Sec. 522.955, revise paragraphs (d)(1)(i)(C) and (d)(1)(ii)(C)
to read as follows:
Sec. 522.955 Florfenicol.
* * * * *
(d) * * *
(1) * * *
(i) * * *
(C) Limitations. Do not slaughter within 44 days of treatment. This
drug product is not approved for use in female dairy cattle 20 months
of age or older, including dry dairy cows. Use in these cattle may
cause drug residues in milk and/or in calves born to these cows. A
withdrawal period has not been established in preruminating calves. Do
not use in calves to be processed for veal. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
(ii) * * *
(C) Limitations. Do not slaughter within 28 days of last
intramuscular treatment or within 38 days of subcutaneous treatment.
This drug product is not approved for use in female dairy cattle 20
months of age or older, including dry dairy cows. Use in these cattle
may cause drug residues in milk and/or in calves born to these cows. A
withdrawal period has not been established in preruminating calves. Do
not use in calves to be processed for veal. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
* * * * *
0
11. In Sec. 522.956, revise paragraph (d)(3) to read as follows:
Sec. 522.956 Florfenicol and flunixin.
* * * * *
[[Page 18159]]
(d) * * *
(3) Limitations. Animals intended for human consumption must not be
slaughtered within 38 days of treatment. This drug product is not
approved for use in female dairy cattle 20 months of age or older,
including dry dairy cows. Use in these cattle may cause drug residues
in milk and/or in calves born to these cows. A withdrawal period has
not been established in preruminating calves. Do not use in calves to
be processed for veal. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
12. Add Sec. 522.2473 to read as follows:
Sec. 522.2473 Tiludronate.
(a) Specifications. Each vial of powder contains 500 milligrams
(mg) tiludronate disodium. Each milliliter of constituted solution
contains 20 mg tiludronate disodium.
(b) Sponsor. See No. 013744 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. Administer a single
dose of 1 mg per kilogram (0.45 mg/pound) of body weight by intravenous
infusion.
(2) Indication for use. For the control of clinical signs
associated with navicular syndrome.
(3) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
13. The authority citation for 21 CFR part 526 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
14. In Sec. 526.313, remove paragraph (d); redesignate paragraph (e)
as paragraph (d); and revise newly redesignated paragraphs (d)(1)(iii)
and (d)(2)(iii) to read as follows:
Sec. 526.313 Ceftiofur.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Milk taken from cows during treatment (a maximum
of eight daily infusions) and for 72 hours after the last treatment
must not be used for human consumption. Following label use for up to 8
consecutive days, a 2-day preslaughter withdrawal period is required.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian. Federal law prohibits extra-label use of this drug in
lactating dairy cattle for disease prevention purposes; at unapproved
doses; frequencies, durations, or routes of administration; and in
unapproved major food producing species/production classes.
(2) * * *
(iii) Limitations. Milk taken from cows completing a 30-day dry-off
period may be used for food with no milk discard due to ceftiofur
residues. Following intramammary infusion, a 16-day preslaughter
withdrawal period is required for treated cows. Following label use, no
preslaughter withdrawal period is required for neonatal calves from
treated cows regardless of colostrum consumption. Federal law restricts
this drug to use by or on the order of a licensed veterinarian. Federal
law prohibits extra-label use of this drug in dry dairy cattle for
disease prevention purposes; at unapproved doses; frequencies,
durations, or routes of administration; and in unapproved major food
producing species/production classes.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
15. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.261 [Amended]
0
16. In Sec. 558.261, in paragraph (e)(2)(ii), in the ``Limitations''
column, remove ``10 mg florfenicol'' and in its place add ``10 to 15 mg
florfenicol''; and in paragraph (e)(2)(iii), in the ``Limitations''
column, remove ``10 mg florfenicol per kg of fish for''.
Sec. 558.550 [Amended]
0
17. In Sec. 558.550, in paragraph (d)(1)(i)(c), remove ``layers'' and
in its place add ``laying hens producing eggs for human consumption'';
and add at the end of paragraph (d)(2)(i)(c), ``Do not feed to laying
hens producing eggs for human consumption.''
Dated: March 27, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-07220 Filed 3-31-14; 8:45 am]
BILLING CODE 4160-01-P
