Document ID: FDA-2013-N-0002-0050
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Amprolium; Bambermycins; Ceftiofur; Deslorelin;
Florfenicol; Florfenicol and Flunixin; Paclitaxel; Phenylbutazone;
Pimobendan; Salinomycin; Tilmicosin; Tiludronate; Change of Sponsor
Posted Date: 2014-04-01T04:00Z

[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]

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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, 
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: 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
----------------------------------------------------------------------------------------------------------------
                                     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