[Federal Register Volume 67, Number 234 (Thursday, December 5, 2002)]
[Rules and Regulations]
[Pages 72370-72373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30863]


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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; Decoquinate

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 Alpharma, Inc. The supplemental NADA 
provides for the use of decoquinate Type A medicated articles to make 
Type C medicated feeds for cattle, sheep, and goats at a broader range 
of concentrations for the prevention of coccidiosis.

DATES: This rule is effective December 5, 2002.

FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed a supplement to NADA 39-417 that 
provides for use of DECCOX (decoquinate) Type A medicated articles to 
make Type C medicated feeds for cattle, sheep, and goats at a broader 
range of concentrations for the prevention of coccidiosis caused by 
various Eimeria species. The NADA is approved as of September 4, 2002, 
and the regulations are amended in 21 CFR 558.195 to reflect the 
approval. Section 558.195 is also revised to reflect a current format.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Dockets Management Branch (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.

    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

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

    Authority: 21 U.S.C. 360b, 371.
    2. Section 558.195 is revised to read as follows:


Sec.  558.195  Decoquinate.

    (a) Specifications. Type A medicated article containing 6 percent 
decoquinate.
    (b) Approvals. See No. 046573 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.170 of this chapter.
    (d) Special considerations. (1) Bentonite should not be used in 
decoquinate feeds.
    (2) Type A medicated articles may be used to manufacture dry or 
liquid Type B cattle (including veal calf), sheep, and goat feeds as in 
paragraphs (e)(2) and (e)(3) of this section.
    (3) Type C cattle feeds may be manufactured from decoquinate liquid 
Type B feeds having a pH between 5.0 to 6.5 and containing a suspending 
agent to maintain a viscosity of not less than 500 centipoises.
    (e) Conditions of use. It is used as follows:
    (1)Chickens.

------------------------------------------------------------------------
Decoquinate in  Combination in    Indications
   grams/ton       grams/ton        for use      Limitations    Sponsor
------------------------------------------------------------------------
(i) 27.2        ..............  Broiler         Do not feed    046573
                                 chickens: For   to laying
                                 prevention of   chickens.
                                 coccidiosis
                                 caused by
                                 Eimeria
                                 tenella, E.
                                 necatrix, E.
                                 mivati,E.
                                 acervulina,
                                 E. maxima,
                                 and E.
                                 brunetti.
(ii) 27.2       Bacitracin      Broiler          Feed          046573
                 methylene       chickens: As    continuously
                 disalicylate    in paragraph    as sole
                 4 to 50         (e)(1)(i) of    ration; do
                                 this section;   not feed to
                                 and for         laying
                                 increased       chickens.
                                 rate of         Bacitracin
                                 weight gain     methylene
                                 and improved    disalicylate
                                 feed            as provided
                                 efficiency.     by No.
                                                 046573 in
                                                 Sec.
                                                 510.600(c)
                                                 of this
                                                 chapter.
(iii) 27.2      Bacitracin      Broiler          Feed           046573
                 zinc 10 to 50   chickens: As    continuously
                                 in paragraph    as sole
                                 (e)(1)(ii) of   ration; do
                                 this section.   not feed to
                                                 laying
                                                 chickens.
                                                 Bacitracin
                                                 zinc as
                                                 provided by
                                                 No. 046573
                                                 in Sec.
                                                 510.600(c)
                                                 of this
                                                 chapter.
(iv) 27.2       Bacitracin      Broiler          Do not feed   046573
                 zinc 12 to 50   chickens: As    to laying
                 plus            in paragraph    chickens;
                 roxarsone 11    (e)(1)(ii) of   withdraw 5
                 to 45           this section.   days before
                                                 slaughter;
                                                 as sole
                                                 source of
                                                 organic
                                                 arsenic.
                ..............  ..............  Bacitracin     .........
                                                 zinc and
                                                 roxarsone as
                                                 provided by
                                                 No. 046573
                                                 in Sec.
                                                 510.600(c)
                                                 of this
                                                 chapter.

[[Page 72371]]

 
(v) 27.2        Bacitracin      Broiler         Feed           046573
                 methylene       chickens: As    continuously
                 disalicylate    in paragraph    as sole
                 50 and          (e)(1)(ii) of   ration; do
                 roxarsone       this section;   not feed to
                 22.7 to 45.4    as an aid in    laying
                                 the             chickens;
                                 prevention of   withdraw 5
                                 necrotic        days before
                                 enteritis       slaughter.
                                 caused or       Not for use
                                 complicated     in breeder
                                 by              chickens.
                                 Clostridium     Use as sole
                                 spp. or other   source of
                                 organisms       organic
                                 susceptible     arsenic.
                                 to              Poultry
                                 bacitracin;     should have
                                 and for         access to
                                 improved        drinking
                                 pigmentation.   water at all
                                                 times. Drug
                                                 overdosage
                                                 or lack of
                                                 drinking
                                                 water may
                                                 result in
                                                 leg weakness
                                                 or
                                                 paralysis.
                                                 Bacitracin
                                                 methylene
                                                 disalicylate
                                                 and
                                                 roxarsone as
                                                 provided by
                                                 No. 046573
                                                 in Sec.
                                                 510.600(c)
                                                 of this
                                                 chapter.
(vi) 27.2       Chlortetracycl  Chickens: As    Feed           046573
                 ine 100 to      in paragraph    continuously
                 200             (e)(1)(i) of    for 7 to 14
                                 this section;   days; do not
                                 control of      feed to
                                 infectious      chickens
                                 synovitis       producing
                                 caused by       eggs for
                                 Mycoplasma      human
                                 synoviae        consumption.
                                 susceptible
                                 to
                                 chlortetracyc
                                 line.
(vii) 27.2      Chlortetracycl  Chickens: As     As in         046573
                 ine 200 to      in paragraph    paragraph
                 400             (e)(1)(i) of    (e)(1)(vi)
                                 this section;   of this
                                 and for         section.
                                 control of
                                 chronic
                                 respiratory
                                 disease (CRD)
                                 and air sac
                                 infection
                                 caused by M.
                                 gallisepticum
                                 and
                                 Escherichia
                                 coli
                                 susceptible
                                 to
                                 chlortetracyc
                                 line.
(viii) 27.2     Lincomycin 2    Broiler          Feed as sole   000009
                                 chickens: As    ration; do    046573
                                 in paragraph    not feed to
                                 (e)(1)(ii) of   laying
                                 this section.   chickens;
                                                 lincomycin
                                                 provided by
                                                 No. 000009
                                                 in Sec.
                                                 510.600(c)
                                                 of this
                                                 chapter.
(ix) 27.2       Roxarsone 45.4  Broiler          Do not feed    046573
                                 chickens: As    to laying
                                 in paragraph    chickens;
                                 (e)(1)(ii) of   withdraw 5
                                 this section;   days before
                                 and for         slaughter;
                                 improving       as sole
                                 pigmentation.   source of
                                                 organic
                                                 arsenic.
------------------------------------------------------------------------

    (2) Cattle.

------------------------------------------------------------------------
Decoquinate in  Combination in    Indications
   grams/ton       grams/ton        for use      Limitations    Sponsor
------------------------------------------------------------------------
(i) 12.9 to     ..............   Cattle         Feed Type C    046573
 90.8                            (including      feed or milk
                                 ruminating      replacer at
                                 and             a rate to
                                 nonruminating   provide 22.7
                                 calves and      milligrams
                                 veal calves):   (mg) per 100
                                 For             pounds (lb)
                                 prevention of   of body
                                 coccidiosis     weight (0.5
                                 caused by       mg/kilogram
                                 Eimeria bovis   (kg)) per
                                 and E.          day. Feed at
                                 zuernii.        least 28
                                                 days during
                                                 periods of
                                                 exposure to
                                                 coccidiosis
                                                 or when it
                                                 is likely to
                                                 be a hazard.
                                                 Do not feed
                                                 to cows
                                                 producing
                                                 milk for
                                                 food. May be
                                                 prepared
                                                 from dry or
                                                 liquid Type
                                                 B feed
                                                 containing
                                                 0.0125 to
                                                 0.5 percent
                                                 decoquinate.
                                                 See
                                                 paragraph
                                                 (d)(3) of
                                                 this
                                                 section.
(ii) 90.9 to    ..............   Cattle         Feed as a top  046573
 535.7                           (including      dress at a
                                 ruminating      rate to
                                 and             provide 22.7
                                 nonruminating   mg per 100
                                 calves and      lb of body
                                 veal calves):   weight (0.5
                                 As in           mg/kg) per
                                 paragraph       day. Feed at
                                 (e)(2)(i) of    least 28
                                 this section.   days during
                                                 periods of
                                                 exposure to
                                                 coccidiosis
                                                 or when it
                                                 is likely to
                                                 be a hazard.
                                                 Do not feed
                                                 to cows
                                                 producing
                                                 milk for
                                                 food. May be
                                                 prepared
                                                 from dry or
                                                 liquid Type
                                                 B feed
                                                 containing
                                                 0.0125 to
                                                 0.5 percent
                                                 decoquinate.
                                                 See
                                                 paragraph
                                                 (d)(3) of
                                                 this
                                                 section.

[[Page 72372]]

 
(iii) 13.6      Chlortetracycl  Calves, beef    Feed Type C    046573
                 ine             and             feed to
                 approximately   nonlactating    provide 22.7
                 400 (varying    dairy cattle:   mg
                 with body       As in           decoquinate
                 weight and      paragraph       and 1 gram
                 feed            (e)(2)(i) of    (g)
                 consumption     this section;   chlortetracy
                 to provide 10   for treatment   cline per
                 mg/lb of body   of bacterial    100 lb body
                 weight per      enteritis       weight (0.5
                 day)            caused by E.    mg/kg) per
                                 coli; and for   day for not
                                 treatment of    more than 5
                                 bacterial       days. Type C
                                 pneumonia       feed may be
                                 caused by       prepared
                                 Pasteurella     from Type B
                                 multocida       feed
                                 organisms       containing
                                 susceptible     535.8 to
                                 to              5,440 g/ton
                                 chlortetracyc   decoquinate
                                 line.           and 6,700 to
                                                 80,000 g/ton
                                                 chlortetracy
                                                 cline. When
                                                 consumed,
                                                 feed 22.7 mg
                                                 decoquinate
                                                 per 100 lb
                                                 body weight/
                                                 day for a
                                                 total of 28
                                                 days to
                                                 prevent
                                                 coccidiosis.
                                                 Withdraw 24
                                                 hours prior
                                                 to slaughter
                                                 when
                                                 manufactured
                                                 from CTC
                                                 (chlortetrac
                                                 ycline) Type
                                                 A medicated
                                                 articles
                                                 under NADA
                                                 141-147.
                                                 Zero
                                                 withdrawal
                                                 time when
                                                 manufactured
                                                 from
                                                 AUREOMYCIN
                                                 (chlortetrac
                                                 ycline) Type
                                                 A medicated
                                                 articles
                                                 under NADA
                                                 141-185. Do
                                                 not feed to
                                                 calves to be
                                                 processed
                                                 for veal. Do
                                                 not feed to
                                                 animals
                                                 producing
                                                 milk for
                                                 food.
(iv) 13.6       Monensin 5 to   Cattle fed in   Feed only to   046573
                 30              confinement     cattle fed
                                 for             in
                                 slaughter: As   confinement
                                 in paragraph    for
                                 (e)(2)(i) of    slaughter.
                                 this section;   Feed
                                 and for         continuously
                                 improved feed   as the sole
                                 efficiency.     ration to
                                                 provide 22.7
                                                 mg of
                                                 decoquinate
                                                 per 100 lb
                                                 body weight
                                                 per day and
                                                 50 to 360 mg
                                                 of monensin
                                                 per head per
                                                 day. Feed at
                                                 least 28
                                                 days during
                                                 period of
                                                 exposure to
                                                 coccidiosis
                                                 or when it
                                                 is likely to
                                                 be a hazard.
                                                 Do not feed
                                                 to animals
                                                 producing
                                                 milk for
                                                 food. Also
                                                 see
                                                 paragraph
                                                 (d)(1) of
                                                 this section
                                                 and Sec.
                                                 558.355(d)(8
                                                 ). Monensin
                                                 as provided
                                                 by No.
                                                 000986 in
                                                 Sec.
                                                 510.600(c)
                                                 of this
                                                 chapter.
(v) 13.6        Monensin 5 to   Cattle fed in    Feed only to  046573
                 30 plus         confinement     cattle fed
                 tylosin 8 to    for             in
                 10              slaughter: As   confinement
                                 in paragraph    for
                                 (e)(2)(i) of    slaughter.
                                 this section;   Feed
                                 for improved    continuously
                                 feed            as the sole
                                 efficiency;     ration to
                                 and for         provide 22.7
                                 reduction of    mg of
                                 incidence of    decoquinate
                                 liver           per 100 lb
                                 abscesses       body weight
                                 caused by       per day, 50
                                 Fusobacterium   to 360 mg of
                                 necrophorum     monensin per
                                 and             head per
                                 Actinomyces     day, and 60
                                 (Corynebacter   to 90 mg of
                                 ium)            tylosin per
                                 pyogenes.       head per
                                                 day. Feed at
                                                 least 28
                                                 days during
                                                 period of
                                                 exposure to
                                                 coccidiosis
                                                 or when it
                                                 is likely to
                                                 be a hazard.
                                                 Do not feed
                                                 to animals
                                                 producing
                                                 milk for
                                                 food. Also
                                                 see
                                                 paragraph
                                                 (d)(1) of
                                                 this section
                                                 and Sec.
                                                 558.355(d)(8
                                                 ). Monensin
                                                 and tylosin
                                                 as provided
                                                 by No.
                                                 000986 in
                                                 Sec.
                                                 510.600(c)
                                                 of this
                                                 chapter.
------------------------------------------------------------------------

    (3) Minor species.

------------------------------------------------------------------------
Decoquinate in  Combination in    Indications
   grams/ton       grams/ton        for use      Limitations    Sponsor
------------------------------------------------------------------------
(i) 12.9 to     ..............   1. Young        Feed Type C    046573
 90.8                            sheep: For      feed or milk
                                 the             replacer at
                                 prevention of   a rate to
                                 coccidiosis     provide 22.7
                                 caused by       mg per 100
                                 Eimeria         lb of body
                                 ovinoidalis,    weight (0.5
                                 E.              mg per kg)
                                 crandallis,     per day;
                                 E. parva, and   feed for at
                                 E. bakuensis.   least 28
                                                 days during
                                                 periods of
                                                 exposure to
                                                 coccidiosis
                                                 or when it
                                                 is likely to
                                                 be a hazard.
                                                 Do not feed
                                                 to sheep
                                                 producing
                                                 milk for
                                                 food.

[[Page 72373]]

 
                ..............  2. Young        Feed Type C    .........
                                 goats: For      feed or milk
                                 the             replacer at
                                 prevention of   a rate to
                                 coccidiosis     provide 22.7
                                 caused by E.    mg per 100
                                 christenseni    lb of body
                                 and E.          weight (0.5
                                 ninakohlyakim   mg per kg)
                                 ovae.           per day;
                                                 feed for at
                                                 least 28
                                                 days during
                                                 periods of
                                                 exposure to
                                                 coccidiosis
                                                 or when it
                                                 is likely to
                                                 be a hazard.
                                                 Do not feed
                                                 to goats
                                                 producing
                                                 milk for
                                                 food.
(ii) 90.9 to    ..............  1. Young        Feed as a top  046573
 535.7                           sheep: As in    dress at a
                                 item 1 of       rate to
                                 paragraph       provide 22.7
                                 (e)(3)(i) of    mg per 100
                                 this section.   lb of body
                                                 weight (0.5
                                                 mg per kg)
                                                 per day;
                                                 feed for at
                                                 least 28
                                                 days during
                                                 periods of
                                                 exposure to
                                                 coccidiosis
                                                 or when it
                                                 is likely to
                                                 be a hazard.
                                                 Do not feed
                                                 to sheep
                                                 producing
                                                 milk for
                                                 food.
                ..............  2. Young        Feed as a top  .........
                                 goats: As in    dress at a
                                 item 2 of       rate to
                                 paragraph       provide 22.7
                                 (e)(3)(i) of    mg per 100
                                 this section.   lb of body
                                                 weight (0.5
                                                 mg per kg)
                                                 per day;
                                                 feed for at
                                                 least 28
                                                 days during
                                                 periods of
                                                 exposure to
                                                 coccidiosis
                                                 or when it
                                                 is likely to
                                                 be a hazard.
                                                 Do not feed
                                                 to goats
                                                 producing
                                                 milk for
                                                 food.
------------------------------------------------------------------------


    Dated: November 25, 2002.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 02-30863 Filed 12-4-02; 8:45 am]
BILLING CODE 4160-01-S