Document ID: FDA-2013-N-0002-0031
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsor: Gonadorelin, Ivermectin, Ractopamine, Trimethoprim and Sulfadiazine Suspension, Tulathromycin
Posted Date: 2013-10-25T04:00Z

[Federal Register Volume 78, Number 207 (Friday, October 25, 2013)]
[Rules and Regulations]
[Pages 63870-63872]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25172]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, and 558

[Docket No. FDA-2013-N-0002]

New Animal Drugs; Change of Sponsor; Gonadorelin; Ivermectin; 
Ractopamine; Trimethoprim and Sulfadiazine Suspension; Tulathromycin

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 July 2013. 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 a change of sponsorship for an ANADA.

DATES: This rule is effective October 25, 2013.

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 July 2013, as 
listed in table 1. In addition, FDA is informing the public of the 
availability, where

[[Page 63871]]

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 CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
    In addition, ECO LLC, 344 Nassau St., Princeton, NJ 08540 has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, ANADA 200-348 for ECOMECTIN (ivermectin) Topical Solution 
to SmartVet USA, Inc., 22201 West Innovation Dr., Suite 170A, Olathe, 
KS 66061-1304. Accordingly, the Agency is amending the regulations to 
reflect this change of sponsorship.
    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.

                  Table 1--Original and Supplemental NADAs and ANADAs Approved During July 2013
----------------------------------------------------------------------------------------------------------------
                                    New Animal drug                          21 CFR
    NADA/ANADA         Sponsor        product name          Action          Section   FOIA Summary   NEPA Review
----------------------------------------------------------------------------------------------------------------
139-237..........  Zoetis Inc.,     FACTREL          Supplemental           522.1077  Yes.........  CE \1\
                    333 Portage      (gonadorelin     approval for use
                    St.,             injection)       with LUTALYSE
                    Kalamazoo, MI    Injection.       (dinoprost
                    49007.                            tromethamine)
                                                      Sterile Solution to
                                                      synchronize estrous
                                                      cycles to allow
                                                      fixed-time
                                                      artificial
                                                      insemination (FTAI)
                                                      in lactating dairy
                                                      cows.
141-349..........  Zoetis Inc.,     DRAXXIN 25       Original approval      522.2630  Yes.........  CE \1\
                    333 Portage      (tulathromycin   for the treatment
                    St.,             ) Injectable     and control of
                    Kalamazoo, MI    Solution.        swine respiratory
                    49007.                            disease (SRD).
141-360..........  Aurora           EQUISUL-SDT      Original approval      520.2612  Yes.........  CE \1\
                    Pharmaceutical   (sulfadiazine/   for the treatment
                    , LLC, 1196      trimethoprim)    of lower
                    Highway 3        Oral             respiratory tract
                    South,           Suspension.      infections in
                    Northfield, MN                    horses caused by
                    55057-3009.                       susceptible strains
                                                      of Streptococcus
                                                      equi subsp.
                                                      zooepidemicus.
200-542..........  Zoetis Inc.,     ENGAIN 9 and     Original approval as    558.500  Yes.........  CE \1\
                    333 Portage      ENGAIN 45        a generic copy of
                    St.,             (ractopamine     NADA 140-863.
                    Kalamazoo, MI    hydrochloride)
                    49007.           Type A
                                     medicated
                                     articles.
200-548..........  Zoetis Inc.,     ACTOGAIN 45      Original approval as    558.500  Yes.........  CE \1\
                    333 Portage      (ractopamine     a generic copy of
                    St.,             hydrochloride)   NADA 141-221.
                    Kalamazoo, MI    Type A
                    49007.           medicated
                                     articles.
----------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 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.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522 and 524

    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, 
520, 522, 524, 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 ``Aurora Pharmaceutical, LLC'' and ``SmartVet USA, 
Inc.''; and in the table in paragraph (c)(2), numerically add entries 
for ``051072'' and ``086001'' to read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                                * * * * *
Aurora Pharmaceutical, LLC, 1196 Highway 3 South,                 051072
 Northfield, MN 55057-3009..............................
 
                                * * * * *
SmartVet USA, Inc., 22201 West Innovation Dr., Suite              086001
 170A, Olathe, KS 66061-1304............................
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

[[Page 63872]]

------------------------------------------------------------------------
          Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
051072..............................  Aurora Pharmaceutical, LLC, 1196
                                       Highway 3 South, Northfield, MN
                                       55057-3009
 
                                * * * * *
086001..............................  SmartVet USA, Inc., 22201 West
                                       Innovation Dr., Suite 170A,
                                       Olathe, KS 66061-1304
 
                                * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
4. Revise Sec.  520.2612 to read as follows:

Sec.  520.2612  Trimethoprim and sulfadiazine suspension.

    (a) Specifications. Each milliliter (mL) of suspension contains:
    (1) 10 milligrams (mg) trimethoprim and 50 mg sulfadiazine; or
    (2) 400 mg combined active ingredients (67 mg trimethoprim and 333 
mg sulfadiazine).
    (b) Sponsors. See sponsor numbers in Sec.  510.600 of this chapter:
    (1) No. 000061 for use of product described in paragraph (a)(1) for 
use as in paragraph (c)(1) of this section.
    (2) No. 051072 for use of product described in paragraph (a)(2) for 
use as in paragraph (c)(2) of this section.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 1 mL (10 mg 
trimethoprim and 50 mg sulfadiazine) per 5 pounds (lb) of body weight 
once daily, or one-half the recommended daily dose every 12 hours, for 
up to 14 consecutive days.
    (ii) Indications for use. The drug is used in dogs where systemic 
antibacterial action against sensitive organisms is required, either 
alone or as an adjunct to surgery or debridement with associated 
infection. The drug is indicated where control of bacterial infection 
is required during the treatment of acute urinary tract infections, 
acute bacterial complications of distemper, acute respiratory tract 
infections, acute alimentary tract infections, wound infections, and 
abscesses.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Horses--(i) Amount. Administer 24 mg combined active 
ingredients per kilogram of body weight (2.7 mL/100 lb) twice daily for 
10 days.
    (ii) Indications for use. For the treatment of lower respiratory 
tract infections in horses caused by susceptible strains of 
Streptococcus equi subsp. zooepidemicus.
    (iii) 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 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
5. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority:  21 U.S.C. 360b.

0
6. Revise Sec.  522.1077 to read as follows:

Sec.  522.1077  Gonadorelin hydrochloride.

    (a) Specifications. Each milliliter of solution contains 50 
micrograms (mcg) of gonadorelin (as hydrochloride).
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in cattle--(1) Indications for use and 
amounts--(i) For the treatment of ovarian follicular cysts in cattle, 
administer 100 mcg gonadorelin by intramuscular injection.
    (ii) For use with dinoprost tromethamine to synchronize estrous 
cycles to allow fixed-time artificial insemination (FTAI) in lactating 
dairy cows, administer to each cow 100 to 200 mcg gonadorelin by 
intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost 
tromethamine by intramuscular injection, followed 30 to 72 hours later 
by 100 to 200 mcg gonadorelin by intramuscular injection.
    (2) Limitations. Dinoprost tromethamine as provided by sponsor No. 
054771 in Sec.  510.600(c) of this chapter. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

0
7. In Sec.  522.2630, revise paragraphs (a) and (b) to read as follows:

Sec.  522.2630  Tulathromycin.

    (a) Specifications. Each milliliter of solution contains:
    (1) 100 milligrams (mg) tulathromycin
    (2) 25 mg tulathromycin
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section:
    (1) Product described as in paragraph (a)(1) for use as in 
paragraph (d).
    (2) Product described as in paragraph (a)(2) for use as in 
paragraph (d)(2).
* * * * *

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
8. The authority citation for 21 CFR part 524 continues to read as 
follows:

    Authority:  21 U.S.C. 360b.

Sec.  524.1193  [Amended]

0
9. In paragraph (b)(2) of Sec.  524.1193, remove ``066916'' and in its 
place add ``086001''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
10. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec.  558.500  [Amended]

0
11. In Sec.  558.500, in paragraph (a), remove ``45'' and in its place 
add ``45.4''; in paragraph (b), remove ``No. 000986'' and in its place 
add ``Nos. 000986 and 054771''; in the table in paragraph (e)(1), in 
the ``Ractopamine in grams/ton'' column, remove ``4.5 to 9'' wherever 
it occurs and in its place add ``4.5 to 9.0''; and in the table in 
paragraphs (e)(1)(i), (e)(2)(i), (e)(2)(vi), and (e)(2)(xi), in the 
``Sponsor'' column, add ``054771''.

    Dated: October 22, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-25172 Filed 10-24-13; 8:45 am]
BILLING CODE 4160-01-P