Document ID: FDA-2009-N-0665-0029
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feeds; Chlortetracycline
Posted Date: 2009-06-12T04:00Z

[Federal Register: June 12, 2009 (Volume 74, Number 112)]
[Rules and Regulations]               
[Page 27919-27920]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jn09-8]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2009-N-0665]

 
New Animal Drugs for Use in Animal Feeds; Chlortetracycline

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Alpharma Inc. The supplemental NADA 
provides for revised Blue Bird labeling for chlortetracycline Type A 
medicated articles used to formulate Type B and Type C medicated feeds 
in various classes of livestock and poultry.

DATES: This rule is effective June 12, 2009.

FOR FURTHER INFORMATION CONTACT:  Timothy Schell, Center for Veterinary 
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8116, e-mail: timothy.schell@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Alpharma Inc., 440 Rte. 22, Bridgewater, NJ 
08807, filed a supplement to NADA 46-699 that provides revised Blue 
Bird labeling for CHLORMAX (chlortetracycline) Type A medicated 
articles used to formulate Type B and Type C medicated feeds in various 
classes of livestock and poultry. The supplemental NADA is approved as 
of May 22, 2009, and the regulations are amended in Sec.  558.128 (21 
CFR 558.128) to reflect the approval.
    In addition, Sec.  558.128 is amended to differentiate certain 
withdrawal times in cattle for two chlortetracycline Type A medicated 
articles sponsored by Alpharma Inc. under separate NADAs and to correct 
the spelling of a turkey pathogen.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The agency has determined under 21 CFR 25.33 that this action is of 
a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
    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.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to

[[Page 27920]]

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.

0
2. In Sec.  558.128, in the table in paragraph (e)(2)(iii), in the 
``Indications for use'' column, remove ``meleagrides'' and in its place 
add ``meleagridis''; and revise paragraphs (e)(4)(iv), (e)(4)(v), and 
(e)(4)(ix) to read as follows:

Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
        Chlortetracycline amount               Indications for use              Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

(iv) 10 mg/lb of body weight daily......  1. Calves, beef and           Feed approximately 400 g/        012286,
                                           nonlactating dairy cattle;    ton, varying with body          048164,
                                           treatment of bacterial        weight and feed                 066104.
                                           enteritis caused by E. coli   consumption to provide 10
                                           and bacterial pneumonia       mg/lb per day. Treat for
                                           caused by P. multocida        not more than 5 d; in feed
                                           organisms susceptible to      including milk replacers;
                                           chlortetracycline.            withdraw 10 d prior to
                                                                         slaughter. To sponsor No.
                                                                         048164: zero withdrawal
                                                                         time. See paragraph (d)(1)
                                                                         of this section.

                                          2. Calves (up to 250 lb):     See paragraph (d)(1) of          012286,
                                           For the treatment of          this section.                   046573,
                                           bacterial enteritis caused                                    048164,
                                           by E. coli susceptible to                                     066104.
                                           chlortetracycline.
----------------------------------------------------------------------------------------------------------------
(v) 500 to 4,000 g/ton..................  Calves, beef and              Feed continuously for not        046573.
                                           nonlactating dairy cattle;    more than 5 days to
                                           treatment of bacterial        provide 10 mg/lb body
                                           enteritis caused by E. coli   weight per day. To sponsor
                                           and bacterial pneumonia       No. 046573 under NADA 046-
                                           caused by P. multocida        699: 24-h withdrawal time.
                                           organisms susceptible to      To sponsor No. 046573
                                           chlortetracycline.            under NADA 048-761: zero
                                                                         withdrawal time.
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
(ix) 350 mg/head/day....................  1. Beef cattle: For control   Withdraw 48 h prior to           012286,
                                           of bacterial pneumonia        slaughter. To sponsor No.       046573,
                                           associated with shipping      046573 under NADA 046-699:      048164,
                                           fever complex caused by       48-h withdrawal time. To        066104.
                                           Pasteurella spp.              sponsor No. 046573 under
                                           susceptible to                NADA 048-761 and No.
                                           chlortetracycline.            048164: zero withdrawal
                                                                         time.

                                          2. Beef cattle (under 700     Withdraw 48 h prior to           012286,
                                           lb): For control of active    slaughter. To sponsor No.       046573,
                                           infection of anaplasmosis     046573 under NADA 046-699:      048164,
                                           caused by A. marginale        48-h withdrawal time. To        066104.
                                           susceptible to                sponsor No. 046573 under
                                           chlortetracycline.            NADA 048-761 and No.
                                                                         048164: zero withdrawal
                                                                         time.
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: June 8, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-13849 Filed 6-11-09; 8:45 am]

BILLING CODE 4160-01-S