New Animal Drug Approvals; Change of Sponsor; Change of Sponsor's Drug Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel; Propofol; Sevoflurane; Triamcinolone Acetonide, 17866-17868 [2013-06748]

Download as PDF 17866 Federal Register / Vol. 78, No. 57 / Monday, March 25, 2013 / Rules and Regulations (78 FR 11572, February 19, 2013). Allowing the airworthiness limitation section (ALS) required by AD 2008–07– 11 to remain valid could cause confusion as to what is required and this could introduce an unsafe condition if certain areas were not inspected. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days. srobinson on DSK4SPTVN1PROD with NOTICES Comments Invited This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include ‘‘Docket No. FAA–2008–0070; Directorate Identifier 2007–CE–098– AD’’ at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments. We will post all comments we receive, without change, to http:// www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA’s authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. ‘‘Subtitle VII: Aviation Programs,’’ describes in more detail the scope of the Agency’s authority. We are issuing this rulemaking under the authority described in ‘‘Subtitle VII, Part A, Subpart III, Section 44701: General requirements.’’ Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We determined that this AD will not have federalism implications under VerDate Mar<15>2010 16:01 Mar 22, 2013 Jkt 229001 Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD: (1) Is not a ‘‘significant regulatory action’’ under Executive Order 12866, (2) Is not a ‘‘significant rule’’ under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979), (3) Will not affect intrastate aviation in Alaska, and (4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. Issued in Kansas City, Missouri on March 11, 2013. Earl Lawrence, Manager, Small Airplane Directorate, Aircraft Certification Service. List of Subjects in 14 CFR Part 39 HHS. Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: ■ Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by removing AD 2008–07–11, Amendment 39–15452 (73 FR 18433, April 4, 2008), and adding the following new AD: ■ 2008–07–11 R1 PILATUS AIRCRAFT LTD.: Amendment 39–17398; Docket No. FAA–2008–0070; Directorate Identifier 2007–CE–098–AD. (a) Effective Date This airworthiness directive (AD) becomes effective April 15, 2013. (b) Affected ADs This AD rescinds AD 2008–07–11, Amendment 39–15452 (73 FR 18433, April 4, 2008). (c) Applicability This AD applies to PILATUS AIRCRAFT LTD. Models PC–12, PC–12/45, and PC–12/ 47 airplanes, all serial numbers, certificated in any category. (d) Subject Air Transport Association of America (ATA) Code 27: Flight Controls. PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 [FR Doc. 2013–06169 Filed 3–22–13; 8:45 am] BILLING CODE 4910–13–P 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: ACTION: Food and Drug Administration, 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 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 SUMMARY: E:\FR\FM\25MRR1.SGM 25MRR1 17867 Federal Register / Vol. 78, No. 57 / Monday, March 25, 2013 / Rules and Regulations 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 NADA/ ANADA Sponsor 200–541 ....... Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia. New animal drug product name GONABREED (gonadorelin acetate) Injectable Solution. 21 CFR Section Action 1. Original approval as a generic copy of NADA 098–379; and. 2. Supplemental 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 FOIA Summary 522.1073 yes NEPA Review 1. CE 2 2. EA/FONSI 3 1 Supplemental approval under section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act. 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. 2 The 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: srobinson on DSK4SPTVN1PROD with NOTICES PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: Laboratories’’ and remove the entry for ‘‘RMS Laboratories, Inc.’’; and ■ 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: * * (c) * * * (1) * * * * 2. Amend § 510.600 as follows: a. In the table in paragraph (c)(1), revise the entry for ‘‘Abbott 16:01 Mar 22, 2013 Jkt 229001 * * * Abbott Laboratories, North Chicago, IL 60064. * * * Abbott Laboratories, North Chicago, IL 60064 ........... Drug labeler code * * * Frm 00003 Fmt 4700 * 000044 * (2) * * * PO 00000 * * * 3. The authority citation for 21 CFR part 522 continues to read as follows: Authority: 21 U.S.C. 360b. ■ * * ■ Firm name and address ■ ■ VerDate Mar<15>2010 * * 000044 ............. PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS * ■ Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. Firm name and address * § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * Drug labeler code Sfmt 4700 * 4. Add § 522.1073 to read as follows: § 522.1073 Gonadorelin acetate. (a) Specifications. Each milliliter of solution contains 100 micrograms (mg) of gonadorelin as gonadorelin acetate. (b) Sponsor. See No. 068504 in § 510.600(c) of this chapter. E:\FR\FM\25MRR1.SGM 25MRR1 17868 Federal Register / Vol. 78, No. 57 / Monday, March 25, 2013 / Rules and Regulations (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 mg 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 mg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 mg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 mg gonadorelin by intramuscular injection. (2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. ■ 5. In § 522.1077, revise the section heading to read as set forth below; and in paragraph (c)(3), remove the first sentence. § 522.1077 Gonadorelin hydrochloride. * * * § 522.1078 * * Authority: 21 U.S.C. 360b. 12. In paragraph (b) of § 529.1186, remove ‘‘000074’’ and in its place add ‘‘000044’’. also modify the regulations under section 704(b) regarding the maintenance of the partners’ capital accounts and the determination of the partners’ distributive shares of partnership items. The final regulations also contain a characterization rule providing that the holder of a noncompensatory option is treated as a partner under certain circumstances. DATES: This correction is effective on March 25, 2013 and is applicable on or after February 5, 2013. FOR FURTHER INFORMATION CONTACT: Benjamin Weaver, at (202) 622–3050 (not a toll-free number). SUPPLEMENTARY INFORMATION: § 529.2150 Background § 524.2482 [Amended] 10. In paragraph (b) of § 524.2482, remove ‘‘067292’’ and in its place add ‘‘051311’’. ■ PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 11. The authority citation for 21 CFR part 529 continues to read as follows: ■ Authority: 21 U.S.C. 360b. § 529.1186 [Amended] ■ [Amended] 13. In paragraph (b) of § 529.2150, remove ‘‘000074’’ and in its place add ‘‘000044’’. ■ The final regulations that are the subject of this document are under sections 171, 704, 721, 761, 1272, 1273, and 1275 of the Internal Revenue Code. Dated: March 20, 2013. Bernadette Dunham, Director, Center for Veterinary Medicine. Need for Correction BILLING CODE 4160–01–P List of Subjects in 26 CFR Part 1 Internal Revenue Service 6. Redesignate § 522.1078 as § 522.1075. ■ 7. In § 522.1870, revise the section heading and paragraphs (b), (c)(1)(iii), and (c)(2)(iii) to read as follows: As published, the final regulations (TD 9612) contain errors that may prove to be misleading and are in need of clarification. DEPARTMENT OF THE TREASURY [Redesignated as § 522.1075] Income taxes, Reporting and recordkeeping requirements. 26 CFR Part 1 Correction of Publication [TD 9612] RIN 1545–BA53 Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments: Noncompensatory Partnership Options; Correction PART 1—INCOME TAXES [FR Doc. 2013–06748 Filed 3–22–13; 8:45 am] ■ § 522.1870 Praziquantel. * * * * * (b) Sponsors. See Nos. 000859 and 061623 in § 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. § 522.2005 [Amended] 8. In paragraph (b)(2) of § 522.2005, remove ‘‘000074’’ and in its place add ‘‘000044’’. ■ PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 9. The authority citation for 21 CFR part 524 continues to read as follows: ■ Internal Revenue Service (IRS), Treasury. ACTION: Correcting amendment. AGENCY: This document contains corrections to final regulations (TD 9612) that were published in the Federal Register on Tuesday, February 5, 2013 (78 FR 7997) relating to the tax treatment of noncompensatory options and convertible instruments issued by a partnership. The final regulations generally provide that the exercise of a noncompensatory option does not cause the recognition of immediate income or loss by either the issuing partnership or the option holder. The final regulations Authority: 26 U.S.C. 7805 * * * SUMMARY: K srobinson on DSK4SPTVN1PROD with NOTICES Paragraph 1. The authority citation for part 1 continues to read in part as follows: ■ Tax Par. 2. Section 1.704–1 is amended by revising the table in paragraph (b)(5) Example 35 (ii), and the first sentence of paragraph (b)(5) Example 35 (iii) to read as follows: ■ § 1.704–1 * Partner’s distributive share. * * * * (b) * * * (5) * * * Example 35. * * * (ii) * * * L Book Tax M Book Tax Book Initial capital account ............................... Year 1 net income ................................... Year 2 net income ................................... Year 3 net income ................................... $10,000 1,000 1,000 1,000 $10,000 1,000 1,000 1,000 $10,000 1,000 1,000 1,000 $10,000 1,000 1,000 1,000 0 0 0 0 0 0 0 0 Year 4 initial capital account .................... 13,000 13,000 13,000 13,000 0 0 VerDate Mar<15>2010 16:01 Mar 22, 2013 Jkt 229001 PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 E:\FR\FM\25MRR1.SGM 25MRR1

Agencies

[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]


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

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.

-----------------------------------------------------------------------

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       New animal drug                                21 CFR        FOIA
       NADA/ANADA                 Sponsor               product name               Action            Section      Summary            NEPA Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
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\.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
------------------------------------------------------------------------
 
                                * * * * *
Abbott Laboratories, North Chicago, IL 60064...........           000044
 
                                * * * * *
------------------------------------------------------------------------

     (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