[Federal Register Volume 72, Number 239 (Thursday, December 13, 2007)]
[Rules and Regulations]
[Pages 70774-70776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24146]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Oxytetracycline

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 approval of a supplemental new animal drug 
application (NADA) filed by Pennfield Oil Co. that provides for a zero-
day preslaughter withdrawal time following use of oxytetracycline in 
turkey and swine feed.

DATES: This rule is effective December 13, 2007.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Pennfield Oil Co., 14040 Industrial Rd., 
Omaha, NE 68144, filed a supplement to NADA 138-938 for PENNOX 
(oxytetracycline) Type A medicated articles used for making medicated 
feeds for the treatment of various bacterial diseases of livestock and 
fish. The supplemental NADA provides for a zero-day withdrawal time 
prior to slaughter when Type C medicated feeds containing 
oxytetracycline are fed to turkeys or swine and for minor label 
revisions. The supplemental application is approved as of November 26, 
2007, and the regulations are amended in 21 CFR 558.450 to reflect the 
approval, an editorial change, and a current format.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), summaries of safety and 
effectiveness data and information submitted to support approval of 
these applications 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.
    The agency has determined under 21 CFR 25.33(a)(1) 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 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.  558.450, revise paragraphs (a)(1), (a)(2), (b)(3), and (d) 
to read as follows:


Sec.  558.450  Oxytetracycline.

    (a) * * *
    (1) 10, 20, 30, 50, 100, and 200 grams per pound to No. 066104 in 
Sec.  510.600(c) of this chapter.
    (2) 50, 100, and 200 grams per pound to No. 048164 in Sec.  
510.600(c) of this chapter.
    (b) * * *
    (3) 50-, 100-, and 200-gram per pound articles in paragraph (a)(2) 
of this section contain oxytetracycline dihydrate expressed in terms of 
an equivalent amount of oxytetracycline hydrochloride. Another 100-gram 
per pound article in paragraph (a)(2) of this section contains 
oxytetracycline hydrochloride.
* * * * *
    (d) Conditions of use--(1) Chickens--

------------------------------------------------------------------------
 Oxytetracycline
      amount        Indications for use       Limitations       Sponsor
------------------------------------------------------------------------
(i) 10 to 50       Chickens: For         Feed continuously;    066104,
 grams per ton (g/  increased rate of     do not feed to       048164
 ton)               weight gain and       chickens producing
                    improved feed         eggs for human
                    efficiency.           consumption.
------------------------------------------------------------------------
(ii) 100 to 200 g/ Chickens: For         Feed continuously     066104,
 ton                control of            for 7 to 14 days     048164
                    infectious            (d); do not feed to
                    synovitis caused by   chickens producing
                    Mycoplasma synoviae   eggs for human
                    and control of fowl   consumption; in low
                    cholera caused by     calcium feeds,
                    Pasteurella           withdraw 3 d before
                    multocida             slaughter.
                    susceptible to
                    oxytetracycline.
------------------------------------------------------------------------
(iii) 400 g/ton    Chickens: For         Feed continuously     066104,
                    control of chronic    for 7 to 14 d; do    048164
                    respiratory disease   not feed to
                    (CRD) and air sac     chickens producing
                    infection caused by   eggs for human
                    Mycoplasma            consumption; in low
                    gallisepticum and     calcium feeds,
                    Escherichia coli      withdraw 3 d before
                    susceptible to        slaughter.
                    oxytetracycline.
------------------------------------------------------------------------
(iv) 500 g/ton     Chickens: For         Feed continuously     066104,
                    reduction of          for 5 d; do not      048164
                    mortality due to      feed to chickens
                    air sacculitis (air   producing eggs for
                    sac infection)        human consumption;
                    caused by E. coli     withdraw 24 hours
                    susceptible to        before slaughter;
                    oxytetracycline.      in low calcium
                                          feeds, withdraw 3 d
                                          before slaughter.
------------------------------------------------------------------------

    (2) Turkeys--

------------------------------------------------------------------------
 Oxytetracycline
      amount        Indications for use       Limitations       Sponsor
------------------------------------------------------------------------
(i) 10 to 50 g/    Growing turkeys: For  Feed continuously;    066104,
 ton                increased rate of     do not feed to       048164
                    weight gain and       turkeys producing
                    improved feed         eggs for human
                    efficiency.           consumption.
------------------------------------------------------------------------

[[Page 70775]]

 
(ii) 100 g/ton     Turkeys: For control  Feed continuously     066104,
                    of hexamitiasis       for 7 to 14 d; do    048164
                    caused by Hexamita    not feed to turkeys
                    meleagridis           producing eggs for
                    susceptible to        human consumption.
                    oxytetracycline.
------------------------------------------------------------------------
(iii) 200 g/ton    Turkeys: For control  Feed continuously     066104,
                    of infectious         for 7 to 14 d; for   048164
                    synovitis caused by   No. 066104 withdraw
                    M. synoviae           5 d before
                    susceptible to        slaughter; for No.
                    oxytetracycline.      048164 zero-day
                                          withdrawal time; do
                                          not feed to turkeys
                                          producing eggs for
                                          human consumption.
------------------------------------------------------------------------
(iv) 25            Turkeys: For control  Feed continuously     066104,
 milligrams/pound   of complicating       for 7 to 14 d; for   048164
 (mg/lb) of body    bacterial organisms   No. 066104 withdraw
 weight daily       associated with       5 d before
                    bluecomb              slaughter; for No.
                    (transmissible        048164 zero-day
                    enteritis;            withdrawal time; do
                    coronaviral           not feed to turkeys
                    enteritis)            producing eggs for
                    susceptible to        human consumption.
                    oxytetracycline.
------------------------------------------------------------------------

    (3) Swine--

------------------------------------------------------------------------
 Oxytetracycline
      amount        Indications for use       Limitations       Sponsor
------------------------------------------------------------------------
(i) 10 to 50 g/    Swine: For increased  Feed continuously.    066104,
 ton                rate of weight gain                        048164
                    and improved feed
                    efficiency.
------------------------------------------------------------------------
(ii) 10 mg/lb of   1. Swine: For         Feed continuously     066104,
 body weight        treatment of          for 7 to 14 d.       048164
 daily              bacterial enteritis
                    caused by E. coli
                    and Salmonella
                    choleraesuis
                    susceptible to
                    oxytetracycline and
                    treatment of
                    bacterial pneumonia
                    caused by P.
                    multocida
                    susceptible to
                    oxytetracycline.
                   2. Breeding swine:    Feed continuously     066104,
                    For control and       for 14 d.            048164
                    treatment of
                    leptospirosis
                    (reducing the
                    incidence of
                    abortion and
                    shedding of
                    leptospirae) caused
                    by Leptospira
                    pomona susceptible
                    to oxytetracycline.
------------------------------------------------------------------------

    (4) Cattle--

------------------------------------------------------------------------
 Oxytetracycline
      amount        Indications for use       Limitations       Sponsor
------------------------------------------------------------------------
(i) 0.05 to 0.1    Calves (up to 250     Feed continuously in  066104,
 mg/lb of body      lb): For increased    milk replacer or     048164
 weight daily       rate of weight gain   starter feed.
                    and improved feed
                    efficiency.
------------------------------------------------------------------------
(ii) 10 mg/lb of   1. Calves and beef    Feed continuously     066104,
 body weight        and nonlactating      for 7 to 14 d; for   048164
 daily              dairy cattle: For     No. 048164,
                    treatment of          withdraw 5 d before
                    bacterial enteritis   slaughter; for No.
                    caused by E. coli     066104, zero-day
                    and bacterial         withdrawal time.
                    pneumonia (shipping
                    fever complex)
                    caused by P.
                    multocida
                    susceptible to
                    oxytetracycline.
                   2. Calves: For        Feed continuously     066104,
                    treatment of          for 7 to 14 d in     048164
                    bacterial enteritis   milk replacer or
                    caused by E. coli     starter feed; for
                    susceptible to        No. 048164,
                    oxytetracycline.      withdraw 5 d before
                                          slaughter; for No.
                                          066104, zero-day
                                          withdrawal time.
------------------------------------------------------------------------
(iii) 25 mg/head/  Calves (250 to 400    Feed continuously.    066104,
 day                lb): For increased                         048164
                    rate of weight gain
                    and improved feed
                    efficiency.
------------------------------------------------------------------------
(iv) 75 mg/head/   Growing cattle (over  Feed continuously.    066104,
 day                400 lb): For                               048164
                    increased rate of
                    weight gain,
                    improved feed
                    efficiency, and
                    reduction of liver
                    condemnation due to
                    liver abscesses.
------------------------------------------------------------------------
(v) 0.5 to 2.0 g/  Cattle: For           Feed 3 to 5 d before  066104,
 head/day           prevention and        and after arrival    048164
                    treatment of the      in feedlots.
                    early stages of
                    shipping fever
                    complex.
------------------------------------------------------------------------

    (5) Minor species--

------------------------------------------------------------------------
 Oxytetracycline
      amount        Indications for use       Limitations       Sponsor
------------------------------------------------------------------------
(i) 10 to 20 g/    Sheep: For increased  Feed continuously.    066104,
 ton                rate of weight gain                        048164
                    and improved feed
                    efficiency.
------------------------------------------------------------------------

[[Page 70776]]

 
(ii) 10 mg/lb of   Sheep: For treatment  Feed continuously     066104,
 body weight        of bacterial          for 7 to 14 d;       048164
 daily              enteritis caused by   withdraw 5 d before
                    E. coli and           slaughter.
                    bacterial pneumonia
                    caused by P.
                    multocida
                    susceptible to
                    oxytetracycline.
------------------------------------------------------------------------
(iii) 200 mg/      Honey bees: For       Remove at least 6     066104,
 colony             control of American   weeks prior to main  048164
                    foulbrood caused by   honey flow.
                    Paenibacillus
                    larvae and European
                    foulbrood caused by
                    Streptococcus
                    pluton susceptible
                    to oxytetracycline.
------------------------------------------------------------------------
(iv) 250 mg/       Pacific salmon: For   For salmon not over   066104
 kilogram of fish/  marking of skeletal   30 g body weight;
 day (11.35 g/100   tissue.               administer as sole
 lb of fish/day)                          ration for 4
                                          consecutive days;
                                          fish not to be
                                          liberated for at
                                          least 7 d following
                                          the last
                                          administration of
                                          medicated feed.
------------------------------------------------------------------------
(v) 2.5 to 3.75 g/ 1. Salmonids: For     Administer in mixed   066104
 100 lb of fish/    control of ulcer      ration for 10 d; do
 day                disease caused by     not liberate fish
                    Hemophilus piscium,   or slaughter fish
                    furunculosis caused   for food for 21 d
                    by Aeromonas          following the last
                    salmonicida,          administration of
                    bacterial             medicated feed; do
                    hemorrhagic           not administer when
                    septicemia caused     water temperature
                    by A. liquefaciens,   is below 9 [deg]C
                    and pseudomonas       (48.2 [deg]F).
                    disease.
                   2. Catfish: For       Administer in mixed   066104
                    control of            ration for 10 d; do
                    bacterial             not liberate fish
                    hemorrhagic           or slaughter fish
                    septicemia caused     for food for 21 d
                    by A. liquefaciens    following the last
                    and pseudomonas       administration of
                    disease.              medicated feed; do
                                          not administer when
                                          water temperature
                                          is below 16.7
                                          [deg]C (62 [deg]F).
------------------------------------------------------------------------
(vi) 1 g/lb of     Lobsters: For         Administer as sole    066104
 medicated feed     control of            ration for 5
                    gaffkemia caused by   consecutive days;
                    Aerococcus            withdraw medicated
                    viridans.             feed 30 d before
                                          harvesting
                                          lobsters.
------------------------------------------------------------------------

    (6) Oxytetracycline may be used in accordance with the provisions 
of this section in the combinations as follows:
    (i) Carbadox as in Sec.  558.115.
    (ii) Lasalocid as in Sec.  558.311.
    (iii) Melengestrol acetate as in Sec.  558.342.
    (iv) Robenidine hydrochloride as in Sec.  558.515.
    (v) Salinomycin as in Sec.  558.550.

    Dated: December 5, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-24146 Filed 12-12-07; 8:45 am]
BILLING CODE 4160-01-S