Document ID: FDA-2013-N-0002-0009
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin
Posted Date: 2013-04-30T04:00Z

[Federal Register Volume 78, Number 83 (Tuesday, April 30, 2013)]
[Rules and Regulations]
[Pages 25182-25184]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10152]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 558

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

New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; 
Monensin; and Tylosin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule, Technical Amendment.

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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 and abbreviated new animal drug applications during March 
2013. 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 April 30, 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 new animal drug applications (NADAs) 
and abbreviated new animal drug applications (ANADAs) during March 
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 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, the animal drug regulations are being amended at 21 
CFR 522.558 to add a new strength of dexmedetomidine hydrochloride 
injectable solution for use in dogs and cats. This change is being made 
to improve the accuracy of the regulations.
    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 March 2013
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                                                              New animal drug product                           21 CFR
            NADA/ANADA                      Sponsor                    name                   Action            section      FOIA summary    NEPA review
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200-532..........................  Huvepharma AD, 5th        TYLOVET 100 (tylosin      Original approval           558.342  yes...........  CE \1\
                                    Floor, 3A Nikolay         phosphate) and MGA        as a generic copy
                                    Haytov Str., 1113         (melegestrone acetate)    of NADA 139-192.
                                    Sophia, Bulgaria.         Type A medicated
                                                              articles.
200-533..........................  Huvepharma AD, 5th        TYLOVET 100 (tylosin      Original approval           558.195  yes...........  CE \1\
                                    Floor, 3A Nikolay         phosphate) and RUMENSIN   as a generic copy
                                    Haytov Str., 1113         (monensin) and DECCOX     of NADA 141-149.
                                    Sophia, Bulgaria.         (decoquinate) Type A
                                                              medicated articles.

[[Page 25183]]

 
200-535..........................  Huvepharma AD, 5th        TYLOVET 100 (tylosin      Original approval           558.342  yes...........  CE \1\
                                    Floor, 3A Nikolay         phosphate) and BOVATEC    as a generic copy
                                    Haytov Str., 1113         (lasalocid) and MGA       of NADA 138-992.
                                    Sophia, Bulgaria.         (melegestrone acetate)
                                                              Type A medicated
                                                              articles.
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\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 (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.

List of Subjects

21 CFR Part 522

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feed.

    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 522 and 
558 are amended as follows:

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

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

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

0
2. In Sec.  522.558, revise paragraph (a) to read as follows:

Sec.  522.558  Dexmedetomidine.

    (a) Specifications. Each milliliter of solution contains 0.5 or 1.0 
milligrams dexmedetomidine hydrochloride.
* * * * *

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

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

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

0
4. In Sec.  558.195, in the table, in paragraph (e)(2)(v), revise the 
last sentence in the ``Limitations'' column and revise the ``Sponsor'' 
column to read as follows:

Sec.  558.195  Decoquinate.

* * * * *
    (e) * * *
    (2) * * *

----------------------------------------------------------------------------------------------------------------
                               Combination in    Indications for
Decoquinate in grams per ton    grams per ton          use             Limitations               Sponsor
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                                                  * * * * * * *
(v) * * *...................  ................  ................  * * * Monensin as               016592, 046573
                                                                   provided by No.
                                                                   000986, and tylosin
                                                                   as provided by Nos.
                                                                   000986 and 016592
                                                                   in Sec.
                                                                   510.600(c) of this
                                                                   chapter.
 
                                                  * * * * * * *
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* * * * *

0
5. In Sec.  558.342, in the table, in paragraphs (e)(1)(iv) and 
(e)(1)(ix), revise the last sentence in the ``Limitations'' column and 
revise the ``Sponsor'' column to read as follows:

Sec.  558.342  Melengestrol.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
 Melengestrol acetate   Combination in mg/    Indications for
    in mg/head/day           head/day               use               Limitations                Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iv) * * *............  ..................  ..................  * * * Lasalocid           000009, 000986, 016592
                                                                 provided by No.
                                                                 046573, and tylosin
                                                                 provided by Nos.
                                                                 000986 and 016592 in
                                                                 Sec.   510.600(c) of
                                                                 this chapter.
 
                                                  * * * * * * *
(ix) * * *............  ..................  ..................  Tylosin provided by       000009, 000986, 016592
                                                                 Nos. 000986 and
                                                                 016592 in Sec.
                                                                 510.600(c) of this
                                                                 chapter.
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* * * * *

    Dated: April 25, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-10152 Filed 4-29-13; 8:45 am]
BILLING CODE 4160-01-P