[Federal Register Volume 79, Number 62 (Tuesday, April 1, 2014)]
[Rules and Regulations]
[Pages 18156-18159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07220]
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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.
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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,
[email protected].
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: http://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: http://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
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New animal drug 21 CFR
NADA/ANADA Sponsor product name Action section FOIA summary NEPA review
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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.
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\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]]
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Firm name and address Drug labeler code
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* * * * * * *
Hikma Pharmaceuticals LLC, P.O. Box 182400, 059115
Bayader Wadi Seer, Amman, Jordan 11118........
* * * * * * *
Oasmia Pharmaceutical AB, Vallongatan 1, 75228 052818
Uppsala, Sweden...............................
* * * * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * * * *
052818................................ Oasmia Pharmaceutical AB,
Vallongatan 1, 75228 Uppsala,
Sweden.
* * * * * * *
059115................................ Hikma Pharmaceuticals LLC, P.O.
Box 182400, Bayader Wadi Seer,
Amman, Jordan 11118.
* * * * * * *
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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