Document ID: FDA-2013-N-0002-0002
Agency: fda
Document Type: Rule
Title: New Animal Drug Approvals: Change of Sponsor; Change of Sponsor's Drug Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel; Propofol; Sevoflurane; Triamcinolone Acetonide
Posted Date: 2013-03-25T04:00Z

[Federal Register Volume 78, Number 57 (Monday, March 25, 2013)]
[Rules and Regulations]
[Pages 17866-17868]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06748]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 522, 524, and 529

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

New Animal Drug Approvals; Change of Sponsor; Change of Sponsor's 
Drug Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel; 
Propofol; Sevoflurane; Triamcinolone Acetonide

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 2013. FDA is also informing the public of the 
availability of summaries the basis of approval and of environmental 
review documents, where applicable. The animal drug regulations are 
also being amended to reflect changes of sponsorship for an NADA and 
ANADA, and a change of a sponsor's drug labeler code.

DATES: This rule is effective March 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, email: 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
to reflect approval actions for NADAs and ANADAs during January 2013, 
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

[[Page 17867]]

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 through the Center for Veterinary Medicine's (CVM's) 
FOIA Electronic Reading Room at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
    In addition, FDA is amending the animal drug regulations to reflect 
changes of sponsorship for an NADA and ANADA, and a change of a 
sponsor's drug labeler code.
    RMS Laboratories, Inc., 1903 East First St., Vidalia, GA 30474, has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, NADA 141-210 for GENESIS (triamcinolone acetonide) Topical 
Spray to Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137. 
Following this change of sponsorship, RMS Laboratories, Inc., will no 
longer be the sponsor of an approved application.
    Teva Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, 
MO 64503, has informed FDA that it has transferred ownership of, and 
all rights and interest in, ANADA 200-176 for PRAZITECH (praziquantel) 
Injectable Solution to Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland.
    Abbott Laboratories, North Chicago, IL 60064, has informed FDA of a 
change in drug labeler code. Accordingly, the Agency is amending the 
regulations in 21 CFR 510.600 to reflect this change of drug labeler 
code and to remove entries for RMS Laboratories, Inc., and in 21 CFR 
parts 522 and 529 to make conforming changes to Abbott Laboratories' 
product listings.
    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 January 2013
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                                                       New animal drug                                21 CFR        FOIA
       NADA/ANADA                 Sponsor               product name               Action            Section      Summary            NEPA Review
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200-541.................  Parnell Technologies     GONABREED (gonadorelin  1. Original approval       522.1073          yes  1. CE \2\
                           Pty. Ltd., unit 4, 476   acetate) Injectable     as a generic copy of                             2. EA/FONSI \3\
                           Gardeners Rd.,           Solution.               NADA 098-379; and.
                           Alexandria, New South                           2. Supplemental
                           Wales 2015, Australia.                           approval for use with
                                                                            cloprostenol sodium
                                                                            to synchronize
                                                                            estrous cycles to
                                                                            allow for fixed time
                                                                            artificial
                                                                            insemination in
                                                                            lactating dairy cows
                                                                            and beef cows.\1\.
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\1\ Supplemental approval under section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act.
\2\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental
  assessment (EA) or an environmental impact statement (EIS) because it is of a type that does not individually or cumulatively have a significant
  effect on the human environment.
\3\ Based on its review of an EA submitted by the sponsor, the Agency has concluded that this action will not have a significant impact on the human
  environment and that an EIS is not required. A finding of no significant impact (FONSI) has been prepared.

List of Subjects

21 CFR Part 510

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

21 CFR Parts 522, 524, and 529

    Animal drugs.

    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, 
522, 524, and 529 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. Amend Sec.  510.600 as follows:
0
a. In the table in paragraph (c)(1), revise the entry for ``Abbott 
Laboratories'' and remove the entry for ``RMS Laboratories, Inc.''; and
0
b. In the table in paragraph (c)(2), remove the entries for ``000074'' 
and ``067292'' and add an entry for ``000044'' in numerical order.
    The addition and revision 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
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                                * * * * *
Abbott Laboratories, North Chicago, IL 60064...........           000044
 
                                * * * * *
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     (2) * * *

 
------------------------------------------------------------------------
           Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
000044................................  Abbott Laboratories, North
                                         Chicago, IL 60064.
 
                                * * * * *
------------------------------------------------------------------------

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
4. Add Sec.  522.1073 to read as follows:

Sec.  522.1073  Gonadorelin acetate.

    (a) Specifications. Each milliliter of solution contains 100 
micrograms ([micro]g) of gonadorelin as gonadorelin acetate.
    (b) Sponsor. See No. 068504 in Sec.  510.600(c) of this chapter.

[[Page 17868]]

    (c) Conditions of use in cattle--(1) Indications for use and 
amounts.
    (i) For the treatment of ovarian follicular cysts in dairy cattle. 
Administer 100 [micro]g gonadorelin by intramuscular or intravenous 
injection.
    (ii) For use with cloprostenol sodium to synchronize estrous cycles 
to allow for fixed-time artificial insemination in lactating dairy cows 
and beef cows. Administer to each cow 100 [micro]g gonadorelin by 
intramuscular injection, followed 6 to 8 days later by 500 [micro]g 
cloprostenol by intramuscular injection, followed 30 to 72 hours later 
by 100 [micro]g gonadorelin by intramuscular injection.
    (2) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
5. In Sec.  522.1077, revise the section heading to read as set forth 
below; and in paragraph (c)(3), remove the first sentence.

Sec.  522.1077  Gonadorelin hydrochloride.

* * * * *

Sec.  522.1078  [Redesignated as Sec.  522.1075]

0
6. Redesignate Sec.  522.1078 as Sec.  522.1075.
0
7. In Sec.  522.1870, revise the section heading and paragraphs (b), 
(c)(1)(iii), and (c)(2)(iii) to read as follows:

Sec.  522.1870  Praziquantel.

* * * * *
    (b) Sponsors. See Nos. 000859 and 061623 in Sec.  510.600(c) of 
this chapter.
    (c) * * *
    (1) * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  522.2005  [Amended]

0
8. In paragraph (b)(2) of Sec.  522.2005, remove ``000074'' and in its 
place add ``000044''.

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

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

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

Sec.  524.2482  [Amended]

0
10. In paragraph (b) of Sec.  524.2482, remove ``067292'' and in its 
place add ``051311''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
11. The authority citation for 21 CFR part 529 continues to read as 
follows:

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

Sec.  529.1186  [Amended]

0
12. In paragraph (b) of Sec.  529.1186, remove ``000074'' and in its 
place add ``000044''.

Sec.  529.2150  [Amended]

0
13. In paragraph (b) of Sec.  529.2150, remove ``000074'' and in its 
place add ``000044''.

    Dated: March 20, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-06748 Filed 3-22-13; 8:45 am]
BILLING CODE 4160-01-P