Document ID: FDA-2013-N-0002-0039
Agency: fda
Document Type: Rule
Title: Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone
Posted Date: 2013-11-22T05:00Z

[Federal Register Volume 78, Number 226 (Friday, November 22, 2013)]
[Rules and Regulations]
[Pages 69992-69995]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27917]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

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

Withdrawal of Approval of New Animal Drug Applications; 
Carbarsone; Roxarsone

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 the withdrawal approval of three new animal 
drug applications (NADAs) for roxarsone or carbarsone Type A medicated 
articles at the sponsor's request because the products are no longer 
manufactured or marketed.

DATES: This rule is effective December 2, 2013.

FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9079, john.bartkowiak@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Zoetis Inc., 333 Portage St., Kalamazoo, MI 
49007, has requested that FDA withdraw approval of the following three 
NADAs because the products, used to manufacture Type B and Type C 
medicated feeds, are no longer manufactured or marketed: NADA 007-891 
for 3-NITRO (roxarsone) Type A

[[Page 69993]]

medicated articles, NADA 092-953 for Roxarsone Type A Medicated 
Articles, and NADA 010-285 for CARB-O-SEP (carbarsone) Type A medicated 
article.
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADAs 007-891, 010-285, and 092-953, and all 
supplements and amendments thereto, is withdrawn, effective December 2, 
2013. As provided in the regulatory text of this document, the animal 
drug regulations are amended to reflect these voluntary withdrawals of 
approval.
    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.

List of Subjects in 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 part 558 is 
amended as follows:

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

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

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

Sec.  558.120  [Amended]

0
2. In Sec.  558.120, remove and reserve paragraphs (a)(1) and 
(d)(1)(i).

0
3. In Sec.  558.530, remove and reserve paragraphs (a) and (b); and 
revise the tables in paragraphs (d)(1) through (3) to read as follows:

Sec.  558.530  Roxarsone.

* * * * *
    (d) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                 Combinations in
  Roxarsone in grams per ton      grams per ton      Indications for use          Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
(i) [Reserved]...............
(ii) 22.7 to 45.4............  Chlortetracycline   Growing chickens: For    Feed continuously             054771
                                10 to 50.           increased rate of        throughout growing
                                                    weight gain, improved    period; withdraw 5
                                                    feed efficiency, and     days before slaughter;
                                                    improved pigmentation.   as sole source of
                                                                             organic arsenic; drug
                                                                             overdose or lack of
                                                                             water may result in
                                                                             weakness or paralysis
                                                                             of the legs.
                                                                            Chlortetracycline as
                                                                             provided by No. 054771
                                                                             in Sec.   510.600(c)
                                                                             of this chapter.
(iii) 22.7 to 45.4...........  Chlortetracycline   Growing chickens: For    Feed continuously for 7       054771
                                100 to 200.         increased rate of        to 14 days; withdraw 5
                                                    weight gain, improved    days before slaughter;
                                                    feed efficiency, and     as sole source of
                                                    improved pigmentation;   organic arsenic; drug
                                                    and for control of       overdose or lack of
                                                    infectious synovitis     water may result in
                                                    caused by Mycoplasma     weakness or paralysis
                                                    synoviae susceptible     of the legs.
                                                    to chlortetracycline.   Chlortetracycline as
                                                                             provided by No. 054771
                                                                             in Sec.   510.600(c)
                                                                             of this chapter.
(iv) 22.7 to 45.4............  Chlortetracycline   Growing chickens: For    Feed continuously for 7       054771
                                200 to 400.         increased rate of        to 14 days; withdraw 5
                                                    weight gain, improved    days before slaughter;
                                                    feed efficiency, and     as sole source of
                                                    improved pigmentation;   organic arsenic; drug
                                                    and for control of       overdose or lack of
                                                    chronic respiratory      water may result in
                                                    disease (CRD) and air    weakness or paralysis
                                                    sac infection caused     of the legs.
                                                    by M. gallisepticum     Chlortetracycline as
                                                    and Escherichia coli     provided by No. 054771
                                                    susceptible to           in Sec.   510.600(c)
                                                    chlortetracycline.       of this chapter.
(v) 22.7 to 45.4.............  Chlortetracycline   Growing chickens: For    Feed continuously for 5       054771
                                500.                increased rate of        days; withdraw 5 days
                                                    weight gain, improved    before slaughter; as
                                                    feed efficiency, and     sole source of organic
                                                    improved pigmentation;   arsenic; drug overdose
                                                    and for reduction of     or lack of water may
                                                    mortality due to E.      result in weakness or
                                                    coli infections          paralysis of the legs.
                                                    susceptible to          Chlortetracycline as
                                                    chlortetracycline.       provided by No. 054771
                                                                             in Sec.   510.600(c)
                                                                             of this chapter.
----------------------------------------------------------------------------------------------------------------

    (2) * * *

----------------------------------------------------------------------------------------------------------------
                                 Combinations in
  Roxarsone in grams per ton      grams per ton      Indications for use          Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
(i) [Reserved]...............
(ii) 22.7 to 45.4............  Chlortetracycline   Growing turkeys: For     Feed continuously             054771
                                10 to 50.           increased rate of        throughout growing
                                                    weight gain, improved    period; withdraw 5
                                                    feed efficiency, and     days before slaughter;
                                                    improved pigmentation.   as sole source of
                                                                             organic arsenic; drug
                                                                             overdose or lack of
                                                                             water may result in
                                                                             weakness or paralysis
                                                                             of the legs.
                                                                            Chlortetracycline as
                                                                             provided by No. 054771
                                                                             in Sec.   510.600(c)
                                                                             of this chapter.

[[Page 69994]]

 
(iii) 22.7 to 45.4...........  Chlortetracycline   Growing turkeys: For     Feed continuously for 7       054771
                                200.                increased rate of        to 14 days; withdraw 5
                                                    weight gain, improved    days before slaughter;
                                                    feed efficiency, and     as sole source of
                                                    improved pigmentation;   organic arsenic; drug
                                                    and for control of       overdose or lack of
                                                    infectious synovitis     water may result in
                                                    caused by Mycoplasma     weakness or paralysis
                                                    synoviae susceptible     of the legs.
                                                    to chlortetracycline.   Chlortetracycline as
                                                                             provided by No. 054771
                                                                             in Sec.   510.600(c)
                                                                             of this chapter.
(iv) 22.7 to 45.4............  Chlortetracycline   1. Growing turkeys: For  Feed continuously for 7       054771
                                400.                increased rate of        to 14 days; withdraw 5
                                                    weight gain, improved    days before slaughter;
                                                    feed efficiency, and     as sole source of
                                                    improved pigmentation;   organic arsenic; drug
                                                    and for control of       overdose or lack of
                                                    hexamitiasis caused by   water may result in
                                                    Hexamita meleagrides     weakness or paralysis
                                                    susceptible to           of the legs.
                                                    chlortetracycline.      Chlortetracycline as
                                                   2. Turkey poults not      provided by No. 054771
                                                    over 4 weeks of age:     in Sec.   510.600(c)
                                                    Reduction of mortality   of this chapter.
                                                    due to paratyphoid
                                                    caused by Salmonella
                                                    typhimurium
                                                    susceptible to
                                                    chlortetracycline.
(v) 22.7 to 45.4.............  Chlortetracycline,  Growing turkeys: For     Feed continuously for 7       054771
                                25 mg/lb body       increased rate of        to 14 days; withdraw 5
                                weight daily.       weight gain, improved    days before slaughter;
                                                    feed efficiency, and     as sole source of
                                                    improved pigmentation;   organic arsenic; drug
                                                    and for control of       overdose or lack of
                                                    complicating bacterial   water may result in
                                                    organisms associated     weakness or paralysis
                                                    with bluecomb            of the legs.
                                                    (transmissible          Chlortetracycline as
                                                    enteritis, coronaviral   provided by No. 054771
                                                    enteritis) susceptible   in Sec.   510.600(c)
                                                    to chlortetracycline.    of this chapter.
----------------------------------------------------------------------------------------------------------------

    (3) * * *

----------------------------------------------------------------------------------------------------------------
                                 Combinations in
  Roxarsone in grams per ton      grams per ton      Indications for use          Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
(i) [Reserved]...............
(ii) 22.7 to 34.1............  Chlortetracycline   Growing and finishing    Feed for not more than        054771
                                400 (to             swine: For increased     14 days; withdraw 5
                                administer 10 mg/   rate of weight gain      days before slaughter;
                                lb body weight).    and improved feed        as sole source of
                                                    efficiency; and for      organic arsenic.
                                                    treatment of bacterial
                                                    enteritis caused by E.
                                                    coli and S.
                                                    choleraesuis and
                                                    bacterial pneumonia
                                                    caused by Pasteurella
                                                    multocida susceptible
                                                    to chlortetracycline.
(iii) [Reserved].............
(iv) 181.5...................  Chlortetracycline   Growing and finishing    Feed for not more than        054771
                                10 to 50.           swine: For increased     6 consecutive days; if
                                                    rate of weight gain      improvement is not
                                                    and improved feed        observed, consult a
                                                    efficiency; and for      veterinarian; withdraw
                                                    treatment of swine       5 days before
                                                    dysentery.               slaughter; as a sole
                                                                             source of organic
                                                                             arsenic; animals must
                                                                             consume enough
                                                                             medicated feed to
                                                                             provide a therapeutic
                                                                             dose.
(v) 181.5....................  Chlortetracycline   Growing and finishing    Feed for not more than        054771
                                400 (to             swine: For the           6 consecutive days; if
                                administer 10 mg/   treatment of swine       improvement is not
                                lb body weight).    dysentery; and for       observed, consult a
                                                    treatment of bacterial   veterinarian; withdraw
                                                    enteritis caused by E.   5 days before
                                                    coli and S.              slaughter; as a sole
                                                    choleraesuis and         source of organic
                                                    bacterial pneumonia      arsenic; animals must
                                                    caused by P. multocida   consume enough
                                                    susceptible to           medicated feed to
                                                    chlortetracycline.       provide a therapeutic
                                                                             dose.
----------------------------------------------------------------------------------------------------------------

[[Page 69995]]

* * * * *

    Dated: November 18, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-27917 Filed 11-21-13; 8:45 am]
BILLING CODE 4160-01-P