New Animal Drugs; Enrofloxacin; Melengestrol; Meloxicam; Pradofloxacin; Tylosin, 76862-76864 [2012-31397]

Download as PDF 76862 Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations On August 7, 1998, Congress passed WIA. Under WIA, which superseded the JTPA, Congress required the Secretary of Labor to develop and publish interim final regulations (IFR) to implement this transition no later than 180 days after WIA’s enactment date. See 20 U.S.C. 9276(c)(1). The Department published the WIA IFR on April 15, 1999. See 64 FR 18662. In that IFR, the Department explicitly provided for the phased transition of the JTPA programs to WIA, to be fully completed by July 1, 2000. See 64 FR 18662, 18663 (Apr. 15, 1999). The final rule implementing WIA was published on August 11, 2000. See 65 FR 49293 (Aug. 11, 2000). Initially, although the JTPA authorizing legislation was repealed, the Department retained the JTPA regulations in the Code of Federal Regulations for grant closeout and auditing purposes. However, now that the JTPA programs have been transitioned to WIA for over a decade, the Department finds no reason to retain the JTPA regulations. Furthermore, the Department has previously removed several other JTPA regulatory provisions. Parts 629 and 630 were removed at 57 FR 62004 (Dec. 29, 1992). Part 635 was re-designated as 20 CFR part 1005 at 54 FR 39352 (Sept. 26, 1989), and the Department later removed part 1005 at 59 FR 26601 (May 23, 1994). Finally, the Department notes that it re-designated part 684 as part 638 at 55 FR 12992 (Apr. 6, 1990). Those JTPA regulatory provisions that remain are subject to this removal notice. List of Subjects 20 CFR Parts 626, 627, 628, 631 and 637 Accounting, Administrative practice and procedure, Disaster assistance, Grant programs—Labor, Manpower training programs, Reporting and recordkeeping requirements, Youth. 20 CFR Part 632 Administrative practice and procedure, Fraud, Grant programs— Indians, Grant programs—labor, Hawaiian Natives, Manpower training programs, Reporting and recordkeeping requirements Youth. ebenthall on DSK5TPTVN1PROD with 20 CFR Part 633 Grant programs—labor, Manpower training programs, Migrant labor, Recording and record keeping requirements. 20 CFR Part 634 Grant Programs—labor, Manpower training programs, Statistics. VerDate Mar<15>2010 01:38 Dec 29, 2012 Jkt 229001 20 CFR Part 636 Administrative practice and procedure, Grant programs—labor, Manpower training programs. 20 CFR Part 638 Grant programs—labor, Job Corps, Lobbying, Manpower training programs, Recording and record keeping requirements, Youth. Accordingly, under the authority of the Workforce Investment Act of 1998 (WIA), 29 U.S.C. 9276(a), and for the reasons discussed in the preamble, the Department amends 20 CFR Chapter V by removing Parts 626, 627, 628, 631, 632, 633, 634, 636, 637, and 638 as follows: 1. Remove and reserve part 626, consisting of §§ 626.1 through 626.5. ■ 2. Remove and reserve part 627, consisting of §§ 627.100 through 627.906. PART 628—[REMOVED AND RESERVED] 3. Remove and reserve part 628, consisting of §§ 628.100 through 628.804. PART 631—[REMOVED AND RESERVED] 4. Remove and reserve part 631, consisting of §§ 631.1 through 631.87. ■ PART 632—[REMOVED AND RESERVED] 5. Remove and reserve part 632, consisting of §§ 632.1 through 632.263. ■ PART 633—[REMOVED AND RESERVED] 6. Remove and reserve part 633, consisting of §§ 633.102 through 633.322. ■ PART 634—[REMOVED AND RESERVED] 7. Remove and reserve part 634, consisting of §§ 634.1 through 634.5. ■ PART 636—[REMOVED AND RESERVED] 8. Remove and reserve part 636, consisting of §§ 636.1 through 636.11. Sfmt 4700 Signed at Washington, DC, this 18th day of December, 2012. Jane Oates Assistant Secretary, Employment and Training Administration. [FR Doc. 2012–31029 Filed 12–28–12; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2012–N–0002] New Animal Drugs; Enrofloxacin; Melengestrol; Meloxicam; Pradofloxacin; Tylosin AGENCY: ■ Fmt 4700 10. Remove and reserve part 638, consisting of §§ 638.100 through 638.815. ■ 21 CFR Parts 520, 522, 529, and 558 ■ Frm 00054 PART 638—[REMOVED AND RESERVED] Food and Drug Administration PART 627—[REMOVED AND RESERVED] PO 00000 9. Remove and reserve part 637, consisting of §§ 637.100 through 637.310. ■ BILLING CODE 4510–FN–P PART 626—[REMOVED AND RESERVED] ■ PART 637—[REMOVED AND RESERVED] Food and Drug Administration, HHS. ACTION: 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 November 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. DATES: This rule is effective December 31, 2012. 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 original and supplemental approval actions during November 2012, as listed in table 1 of this document. 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 SUMMARY: E:\FR\FM\31DER1.SGM 31DER1 76863 Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations 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. 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 NOVEMBER 2012 NADA/ ANADA Sponsor New animal drug product name Action 141–344 .................. Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201. Abbott Laboratories, Inc., North Chicago, IL 60064. Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201. Huvepharma AD, 5th Floor, 3A Nikolay Haitov St., 1113 Sophia, Bulgaria. VERAFLOX (pradofloxacin) Oral Suspension for Cats. Original approval for the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida, Streptococcus canis, S. aureus, S. felis, and S. pseudintermedius. Original approval for the control of pain and inflammation associated with osteoarthritis in dogs. 141–346 .................. 141–068 .................. 200–534 .................. OROCAM (meloxicam) Transmucosal Oral Spray. BAYTRIL 100 (enrofloxacin) Injectable Solution. TYLOVET 100 (tylosin phosphate) and RUMENSIN (monensin) and MGA (melengestrone acetate) liquid and dry, combination drug Type C medicated feeds. 21 CFR Section FOIA summary NEPA review 520.1860 Yes CE 1 529.1350 Yes CE 1 Supplemental approval adding treatment and control of swine respiratory disease associated with Bordetella bronchiseptica and Mycoplasma hyopneumoniae. 522.812 Yes CE 1 Original approval as a generic copy of NADA 138–870. 558.342 Yes CE 1 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 Parts 520, 522, and 529 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 520, 522, 529, and 558 are amended as follows: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: (c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals. (d) Conditions of use in cats—(1) Amount. Administer 3.4 mg/lb (7.5 mg/ kg) body weight once daily for 7 consecutive days. (2) Indications for use. For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida, Streptococcus canis, Staphylococcus aureus, Staphylococcus felis, and Staphylococcus pseudintermedius. ■ PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS Authority: 21 U.S.C. 360b. ebenthall on DSK5TPTVN1PROD with ■ 2. Add § 520.1860 to read as follows: § 520.1860 01:38 Dec 29, 2012 Enrofloxacin. * * * * * (e) * * * (3) * * * (ii) Indications for use. For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma hyopneumoniae. * * * * * PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 5. The authority citation for 21 CFR part 529 continues to read as follows: ■ Authority: 21 U.S.C. 360b. ■ 6. Add § 529.1350 to read as follows: ■ Pradofloxacin. (a) Specifications. Each milliliter of suspension contains 25 milligrams (mg) pradofloxacin. (b) Sponsor. See No. 000859 in § 510.600(c) of this chapter. VerDate Mar<15>2010 3. The authority citation for 21 CFR part 522 continues to read as follows: § 522.812 Jkt 229001 § 529.1350 4. In § 522.812, revise paragraph (e)(3)(ii) to read as follows: (a) Specifications. Each milliliter of solution contains 5 milligrams (mg) meloxicam. (b) Sponsor. See No. 000074 in § 510.600(c) of this chapter. Authority: 21 U.S.C. 360b. ■ PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 E:\FR\FM\31DER1.SGM Meloxicam. 31DER1 76864 Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations (c) Conditions of use in dogs—(1) Amount. Administer 0.1 mg per kilogram of body weight once daily using the metered dose pump. (2) Indications for use. For the control of pain and inflammation associated with osteoarthritis in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 7. The authority citation for 21 CFR part 558 continues to read as follows: ■ Authority: 21 U.S.C. 360b, 371. § 558.342 Regulatory Analysis and Notices [Amended] 8. In § 558.342, in the table, in paragraph (e)(1)(xi), in the ‘‘Limitations’’ column, revise the last sentence to read ‘‘Monensin provided by No. 000986 and tylosin provided by Nos. 000986 and 016592 in § 510.600(c) of this chapter.’’; and in the ‘‘Sponsor’’ column, add ‘‘016592’’. ■ Dated: December 26, 2012. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2012–31397 Filed 12–28–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF STATE 22 CFR Parts 120 and 126 [Public Notice 8135] RIN 1400–AD26 Amendment to the International Traffic in Arms Regulations: Afghanistan and Change to Policy on Prohibited Exports Department of State. ACTION: Final rule. AGENCY: The Department of State is amending the International Traffic in Arms Regulations (ITAR) to list Afghanistan as a major non-NATO ally, and to make available the use of two additional defense export license exemptions for proscribed destinations. DATES: Effective Date: This rule is effective December 31, 2012. FOR FURTHER INFORMATION CONTACT: Ms. Candace M. J. Goforth, Director, Office of Defense Trade Controls Policy, U.S. Department of State, telephone (202) 663–2792, or email DDTCResponseTeam@state.gov. ATTN: Regulatory Change, Afghanistan and 126.1. SUPPLEMENTARY INFORMATION: On July 6, 2012, President Obama exercised his ebenthall on DSK5TPTVN1PROD with SUMMARY: VerDate Mar<15>2010 01:38 Dec 29, 2012 authority under section 517 of the Foreign Assistance Act of 1961 (FAA) to designate the Islamic Republic of Afghanistan as a major non-NATO ally (MNNA) for purposes of the FAA and the Arms Export Control Act. This final rule amends ITAR § 120.32, which lists major non-NATO allies, to account for this designation. Section 126.1 is amended to except the exemptions at ITAR §§ 126.4 and 126.6 from the prohibitions therein and the text is further amended to clarify the requirements therein. Additionally, § 126.1(g) is amended to clarify references to United Nations Security Council resolutions. Jkt 229001 Administrative Procedure Act The Department of State is of the opinion that controlling the import and export of defense articles and services is a foreign affairs function of the United States Government and that rules implementing this function are exempt from sections 553 (rulemaking) and 554 (adjudications) of the Administrative Procedure Act. Since the Department is of the opinion that this rule is exempt from 5 U.S.C. 553, it is the view of the Department that the provisions of section 553(d) do not apply to this rulemaking. Therefore, this rule is effective upon publication. The Department also finds that, given the national security issues surrounding U.S. policy towards Afghanistan, notice and public procedure on this rule would be impracticable, unnecessary, or contrary to the public interest; for the same reason, the rule will be effective immediately. Regulatory Flexibility Act Since the Department is of the opinion that this rule is exempt from the rulemaking provisions of 5 U.S.C. 553, it does not require analysis under the Regulatory Flexibility Act. Unfunded Mandates Act of 1995 This rulemaking does not involve a mandate that will result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. Small Business Regulatory Enforcement Fairness Act of 1996 This rulemaking has been found not to be a major rule within the meaning PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 of the Small Business Regulatory Enforcement Fairness Act of 1996. Executive Orders 12372 and 13132 This rulemaking will not have substantial direct effects 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. Therefore, in accordance with Executive Order 13132, it is determined that this rulemaking does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this rulemaking. Executive Orders 12866 and 13563 Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributed impacts, and equity). These Executive Orders stress the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated ‘‘significant regulatory actions,’’ although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, this rule has been reviewed by the Office of Management and Budget (OMB). Executive Order 12988 The Department of State has reviewed this rulemaking in light of sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden. Executive Order 13175 The Department of State has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not pre-empt tribal law. Accordingly, the requirement of Executive Order 13175 does not apply to this rulemaking. Paperwork Reduction Act This rule does not impose any new reporting or recordkeeping requirements E:\FR\FM\31DER1.SGM 31DER1

Agencies

[Federal Register Volume 77, Number 250 (Monday, December 31, 2012)]
[Rules and Regulations]
[Pages 76862-76864]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31397]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 522, 529, and 558

[Docket No. FDA-2012-N-0002]


New Animal Drugs; Enrofloxacin; Melengestrol; Meloxicam; 
Pradofloxacin; Tylosin

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 November 2012. FDA is also informing the public of the 
availability of summaries the basis of approval and of environmental 
review documents, where applicable.

DATES: This rule is effective December 31, 2012.

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 original and supplemental approval actions during November 
2012, as listed in table 1 of this document. 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

[[Page 76863]]

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.
    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 November 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       New animal drug                                                              FOIA
          NADA/ ANADA                  Sponsor          product name              Action                 21 CFR Section           summary    NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-344........................  Bayer HealthCare    VERAFLOX            Original approval for                        520.1860          Yes  CE \1\
                                  LLC, Animal         (pradofloxacin)     the treatment of skin
                                  Health Division,    Oral Suspension     infections (wounds and
                                  P.O. Box 390,       for Cats.           abscesses) in cats
                                  Shawnee Mission,                        caused by susceptible
                                  KS 66201.                               strains of Pasteurella
                                                                          multocida,
                                                                          Streptococcus canis,
                                                                          S. aureus, S. felis,
                                                                          and S.
                                                                          pseudintermedius.
141-346........................  Abbott              OROCAM (meloxicam)  Original approval for                        529.1350          Yes  CE \1\
                                  Laboratories,       Transmucosal Oral   the control of pain
                                  Inc., North         Spray.              and inflammation
                                  Chicago, IL 60064.                      associated with
                                                                          osteoarthritis in dogs.
141-068........................  Bayer HealthCare    BAYTRIL 100         Supplemental approval                         522.812          Yes  CE \1\
                                  LLC, Animal         (enrofloxacin)      adding treatment and
                                  Health Division,    Injectable          control of swine
                                  P.O. Box 390,       Solution.           respiratory disease
                                  Shawnee Mission,                        associated with
                                  KS 66201.                               Bordetella
                                                                          bronchiseptica and
                                                                          Mycoplasma
                                                                          hyopneumoniae.
200-534........................  Huvepharma AD, 5th  TYLOVET 100         Original approval as a                        558.342          Yes  CE \1\
                                  Floor, 3A Nikolay   (tylosin            generic copy of NADA
                                  Haitov St., 1113    phosphate) and      138-870.
                                  Sophia, Bulgaria.   RUMENSIN
                                                      (monensin) and
                                                      MGA
                                                      (melengestrone
                                                      acetate) liquid
                                                      and dry,
                                                      combination drug
                                                      Type C medicated
                                                      feeds.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 Parts 520, 522, and 529

    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 520, 
522, 529, and 558 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS


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

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

0
2. Add Sec.  520.1860 to read as follows:


Sec.  520.1860  Pradofloxacin.

    (a) Specifications. Each milliliter of suspension contains 25 
milligrams (mg) pradofloxacin.
    (b) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian. Federal law prohibits 
the extralabel use of this drug in food-producing animals.
    (d) Conditions of use in cats--(1) Amount. Administer 3.4 mg/lb 
(7.5 mg/kg) body weight once daily for 7 consecutive days.
    (2) Indications for use. For the treatment of skin infections 
(wounds and abscesses) in cats caused by susceptible strains of 
Pasteurella multocida, Streptococcus canis, Staphylococcus aureus, 
Staphylococcus felis, and Staphylococcus pseudintermedius.

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. In Sec.  522.812, revise paragraph (e)(3)(ii) to read as follows:


Sec.  522.812  Enrofloxacin.

* * * * *
    (e) * * *
    (3) * * *
    (ii) Indications for use. For the treatment and control of swine 
respiratory disease (SRD) associated with Actinobacillus 
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, 
Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma 
hyopneumoniae.
* * * * *

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
6. Add Sec.  529.1350 to read as follows:

Sec.  529.1350  Meloxicam.

    (a) Specifications. Each milliliter of solution contains 5 
milligrams (mg) meloxicam.
    (b) Sponsor. See No. 000074 in Sec.  510.600(c) of this chapter.

[[Page 76864]]

    (c) Conditions of use in dogs--(1) Amount. Administer 0.1 mg per 
kilogram of body weight once daily using the metered dose pump.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

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

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

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

Sec.  558.342  [Amended]

0
8. In Sec.  558.342, in the table, in paragraph (e)(1)(xi), in the 
``Limitations'' column, revise the last sentence to read ``Monensin 
provided by No. 000986 and tylosin provided by Nos. 000986 and 016592 
in Sec.  510.600(c) of this chapter.''; and in the ``Sponsor'' column, 
add ``016592''.

    Dated: December 26, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-31397 Filed 12-28-12; 8:45 am]
BILLING CODE 4160-01-P