[Federal Register Volume 71, Number 93 (Monday, May 15, 2006)]
[Rules and Regulations]
[Pages 27954-27959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-4505]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 558
New Animal Drugs; Change of Sponsor
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 a change of sponsor for 25 approved new
animal drug applications (NADAs) and 16 approved abbreviated new animal
drug applications (ANADAs) for Type A medicated articles and feed use
combinations from Intervet, Inc., to Huvepharma AD.
DATES: This rule is effective May 15, 2006.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet
Lane, Millsboro, DE 19966, has informed FDA that it has transferred
ownership of, and all rights and interest in, the following 25 approved
NADAs and 16 approved ANADAs for Type A medicated articles and feed use
combinations to Huvepharma AD, 33 James Boucher Blvd., Sophia 1407,
Bulgaria:
------------------------------------------------------------------------
Application No. Trade Name(s)
------------------------------------------------------------------------
NADA 044-759 FLAVOMYCIN (bambermycins) Type A
medicated article
------------------------------------------------------------------------
NADA 095-543 AMPROL HI-E / FLAVOMYCIN
------------------------------------------------------------------------
NADA 095-547 AMPROL HI-E / FLAVOMYCIN / 3-NITRO
------------------------------------------------------------------------
NADA 095-548 AMPROL / 3-NITRO / FLAVOMYCIN
------------------------------------------------------------------------
NADA 095-549 AMPROL PLUS / 3-NITRO / FLAVOMYCIN
------------------------------------------------------------------------
NADA 098-340 FLAVOMYCIN / MONENSIN
------------------------------------------------------------------------
NADA 098-341 FLAVOMYCIN / 3-NITRO / COBAN
------------------------------------------------------------------------
NADA 101-628 FLAVOMYCIN / 3-NITRO / ZOALENE
------------------------------------------------------------------------
NADA 101-629 FLAVOMYCIN / ZOALENE
------------------------------------------------------------------------
NADA 130-185 FLAVOMYCIN / AMPROLIUM
------------------------------------------------------------------------
NADA 130-661 FLAVOMYCIN / CARB-O-SEP
------------------------------------------------------------------------
NADA 130-951 STENOROL (halofuginone hydrobromide)
------------------------------------------------------------------------
[[Page 27955]]
NADA 137-483 FLAVOMYCIN / STENOROL
------------------------------------------------------------------------
NADA 139-473 STENOROL / STAFAC
------------------------------------------------------------------------
NADA 140-339 FLAVOMYCIN / NICARB
------------------------------------------------------------------------
NADA 140-340 STENOROL / LINCOMIX
------------------------------------------------------------------------
NADA 140-533 STENOROL / 3-NITRO / BMD
------------------------------------------------------------------------
NADA 140-584 STENOROL / BMD
------------------------------------------------------------------------
NADA 140-824 STENOROL Type A medicated article
------------------------------------------------------------------------
NADA 140-843 MONTEBAN / FLAVOMYCIN / 3-NITRO
------------------------------------------------------------------------
NADA 140-845 FLAVOMYCIN / MONTEBAN
------------------------------------------------------------------------
NADA 140-918 STENOROL / FLAVOMYCIN
------------------------------------------------------------------------
NADA 140-919 STENOROL / BMD
------------------------------------------------------------------------
NADA 141-034 GAINPRO (bambermycins) Type A medicated
article
------------------------------------------------------------------------
NADA 141-129 AVATEC / FLAVOMYCIN
------------------------------------------------------------------------
ANADA 200-075 SACOX (salinomycin sodium) Type A
medicated article
------------------------------------------------------------------------
ANADA 200-080 SACOX / 3-NITRO / FLAVOMYCIN
------------------------------------------------------------------------
ANADA 200-081 SACOX / 3-NITRO / BMD
------------------------------------------------------------------------
ANADA 200-082 SACOX / BMD
------------------------------------------------------------------------
ANADA 200-083 SACOX / FLAVOMYCIN
------------------------------------------------------------------------
ANADA 200-086 SACOX / ALBAC / 3-NITRO
------------------------------------------------------------------------
ANADA 200-089 SACOX / BACIFERM
------------------------------------------------------------------------
ANADA 200-090 SACOX / LINCOMIX / 3-NITRO
------------------------------------------------------------------------
ANADA 200-091 SACOX / 3-NITRO / AUREOMYCIN
------------------------------------------------------------------------
ANADA 200-092 SACOX / STAFAC
------------------------------------------------------------------------
ANADA 200-093 SACOX / LINCOMIX
------------------------------------------------------------------------
ANADA 200-094 SACOX / STAFAC / 3-NITRO
------------------------------------------------------------------------
ANADA 200-095 SACOX / AUREOMYCIN
------------------------------------------------------------------------
ANADA 200-096 SACOX / TERRAMYCIN
------------------------------------------------------------------------
ANADA 200-097 SACOX / 3-NITRO
------------------------------------------------------------------------
ANADA 200-143 SACOX / 3-NITRO / BACIFERM
------------------------------------------------------------------------
------------------------------------------------------------------------
Accordingly, the agency is amending the regulations in 21 CFR
558.55, 558.58, 558.95, 558.120, 558.265, 558.311, 558.355, 558.363,
558.366, 558.450, 558.550, and 558.680 to reflect the transfer of
ownership and a current format.
In addition, Huvepharma AD has not been previously listed in the
animal drug regulations as a sponsor of an approved application. At
this time, 21 CFR 510.600(c) is being amended to add entries for the
firm.
Also, FDA has found that the April 1, 2005, edition of Title 21,
parts 500 to 599 of the Code of Federal Regulations (CFR) does not
accurately reflect the use limitations for amprolium in single-
ingredient, medicated broiler chicken feeds. The existing entry
erroneously includes limitations normally associated with the use of
arsenicals in feed. At this time, the regulations are being amended in
Sec. 558.55 to correct this error. FDA is also taking this opportunity
to consolidate entries for similar combination medicated feeds in the
same section of part 558, and to eliminate duplicate entries. These
actions are being taken to improve the accuracy and readability 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.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 parts 510 and
558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1) alphabetically
add an entry for ``Huvepharma AD''; and in the table in paragraph
(c)(2) numerically add an entry for ``016592'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Huvepharma AD, 33 James Boucher Blvd., 016592
Sophia 1407, Bulgaria
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
016592 Huvepharma AD, 33 James Boucher Blvd.,
Sophia 1407, Bulgaria
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
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.
Sec. 558.55 [Amended]
0
4. Amend Sec. 558.55 as follows:
0
a. In the table in paragraph (d)(2)(ii), in the ``Limitations'' column
in the entry for ``Amprolium 72.6 to 113.5 grams per ton'', remove the
first sentence;
0
b. In the table in paragraph (d)(2)(iii), in the ``Limitations'' column
in the entry for ``Bambermycins 1 to 3 plus roxarsone 22.8 to 34.1
(0.0025% to 0.00375%)'', remove ``057926'' and add in its place
``016592''; and in the ``Sponsor'' column add ``016592'' and
0
c. In the table in paragraph (d)(2)(iii), in the ``Limitations'' column
and ``Sponsor'' column in the entry for
[[Page 27956]]
``Bambermycins 1 to 4'', remove ``057926'' and add in its place
``016592''.
0
5. Amend Sec. 558.58 as follows:
0
a. Revise paragraph (a);
0
b. Redesignate paragraphs (b), (c), and (d) as paragraphs (c), (d), and
(e);
0
c. Add new paragraph (b);
0
d. In the table in newly redesignated paragraph (e)(1)(i), add an entry
for ``Bambermycins 1 to 3 plus roxarsone 22.8 to 34.1'';
0
e. In the table in newly redesignated paragraph (e)(1)(ii), in the
``Limitations'' column in the entries for ``Bambermycins 2 to 3 plus
roxarsone 22.8 to 34.1'', remove ``057926'' and add in its place
``016592''; and in the ``Sponsor'' column add ``016592''; and
0
f. In the table in newly redesignated paragraph (e)(1)(iii), in the
``Limitations'' column in the entries for ``Bambermycins 1 to 3'' and
``Bambermycins 1 to 3 plus roxarsone 22.8 to 34.1'', remove ``057926''
and add in its place ``016592''; and in the ``Sponsor'' column add
``016592''.
The revisions and additions read as follows:
Sec. 558.58 Amprolium and ethopabate.
(a) Specifications. Type A medicated articles containing:
(1) 25 percent amprolium and 8 percent ethopabate or 5 percent
amprolium and 1.6 percent ethopabate;
(2) 25 percent amprolium and 0.8 percent ethopabate or 5 percent
amprolium and 0.16 percent ethopabate.
(b) Approvals. See No. 050604 in Sec. 510.600(c) of this chapter.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Amprolium and
ethopabate in grams Combination in grams Indications for use Limitations Sponsor
per ton per ton
----------------------------------------------------------------------------------------------------------------
(i) Amprolium 113.5 * * * * * *
(0.0125%) and
ethopabate 3.6
(0.0004%).
----------------------------------------------------------------------------------------------------------------
Bambermycins, 1 to Broiler chickens: As an Feed continuously as the 016592
3; plus roxarsone, aid in the prevention sole ration; as sole
22.8 to 34.1 of coccidiosis; and for source of amprolium and
increased rate of organic arsenic; withdraw
weight gain, improved 5 d before slaughter;
feed efficiency, and roxarsone provided by No.
improved pigmentation. 046573, bambermycins by
No. 016592 in Sec.
510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
6. Amend Sec. 558.95 as follows:
0
a. In paragraphs (a)(1), (a)(2), and (a)(5), remove ``057926'' and add
in its place ``016592'';
0
b. Remove and reserve paragraph (d)(1)(ii);
0
c. Remove paragraphs (d)(1)(iii) through (d)(1)(xiv) and paragraphs
(d)(3)(iii) and (d)(3)(iv); and
0
d. Revise paragraph (d)(5).
The revision reads as follows:
Sec. 558.95 Bambermycins.
* * * * *
(d) * * *
(5) Bambermycins may also be used in combination with:
(i) Amprolium alone or with roxarsone as in Sec. 558.55.
(ii) Amprolium and ethopabate alone or with roxarsone as in Sec.
558.58.
(iii) Diclazuril as in Sec. 558.198.
(iv) Halofuginone as in Sec. 558.265.
(v) Lasalocid alone or with roxarsone as in Sec. 558.311.
(vi) Monensin alone or with roxarsone as in Sec. 558.355.
(vii) Narasin alone or with nicarbazin or roxarsone as in Sec.
558.363.
(viii) Nicarbazin as in Sec. 558.366.
(ix) Salinomycin alone or with roxarsone as in Sec. 558.550.
(x) Zoalene alone or with roxarsone as in Sec. 558.680.
0
7. In Sec. 558.120, add paragraph (d)(1)(iv) and remove paragraph
(d)(2)(iii) to read as follows:
Sec. 558.120 Carbarsone (not U.S.P.).
* * * * *
(d) * * *
(1) * * *
(iv) Grams per ton. 227 carbarsone, plus 1 or 4 grams per ton
bambermycins.
(a) Indications for use. As an aid in the prevention of blackhead;
and for increased rate of weight gain (4 grams per ton bambermycins) or
improved feed efficiency (1 gram per ton bambermycins).
(b) Limitations. Feed continuously 2 weeks before blackhead is
expected and continue as long as prevention is needed. Withdraw 5 days
before slaughter. As sole source of organic arsenic. Bambermycins
provided by No. 046573 in Sec. 510.600(c) of this chapter.
* * * * *
0
8. In Sec. 558.265, revise paragraph (a); redesignate paragraphs (b)
and (c) as paragraphs (c) and (d); and add new paragraph (b) to read as
follows:
Sec. 558.265 Halofuginone hydrobromide.
(a) Specifications. Type A medicated articles containing 6 grams of
halofuginone hydrobromide per kilogram.
(b) Approvals. See No. 016592 in Sec. 510.600(c) of this chapter.
* * * * *
0
9. Amend Sec. 558.311 as follows:
0
a. In the table in paragraph (e)(1)(ii) in the entry in the
``Combination in grams per ton'' column for ``Roxarsone 45.4 plus
bambermycins 1'', in the ``Limitations'' column remove ``012799'' and
add in its place ``016592'';
0
b. In the table in paragraph (e)(1)(ii) following the entry in the
``Combination in grams per ton'' column for ``Roxarsone 45.4 plus
bambermycins 1'', add an entry for ``Bambermycins 1 to 2''; and
0
c. Remove and reserve paragraph (e)(5)(ii).
The addition reads as follows:
Sec. 558.311 Lasalocid.
* * * * *
(e) * * *
(1) * * *
[[Page 27957]]
----------------------------------------------------------------------------------------------------------------
Lasalocid in Combination in grams
grams per ton per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(ii) 68 (0.0075 * * * * * ...........
pct) to 113
(0.0125 pct).
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
Bambermycins 1 to 2 Broiler chickens: For prevention Feed continuously as 016592
of coccidiosis caused by sole ration.
Eimeria tenella, E. necatrix, Bambermycins provided
E. acervulina, E. brunetti, E. by No. 016592 in Sec.
mivati, and E. maxima; and for 510.600(c) of this
increased rate of weight gain chapter.
and improved feed efficiency.
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
10. In Sec. 558.355, in paragraphs (b)(10), (f)(2)(v)(b), and
(f)(2)(vi)(b), remove ``057926'' and add in its place ``016592''; and
revise paragraphs (f)(1)(vi), (f)(1)(vii), and (f)(1)(xvii) to read as
follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(1) * * *
(vi) Amount per ton. Monensin, 90 to 110 grams; plus bambermycins,
1 to 2 grams.
(a) Indications for use. For increased rate of weight gain and
improved feed efficiency; and as an aid in the prevention of
coccidiosis caused by E. necatrix, E. tenella,E. acervulina, E.
brunetti, E. mivati, and E. maxima.
(b) Limitations. Feed continuously as sole ration; do not feed to
laying chickens. Bambermycins provided by No. 016592 in Sec.
510.600(c) of this chapter.
(vii) Amount per ton. Monensin, 90 to 110 grams; plus bambermycins,
1 gram; plus roxarsone, 22.7 to 45.4 grams
(a) Indications for use. For increased rate of weight gain and
improved feed efficiency; and as an aid in the prevention of
coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E.
brunetti, E. mivati, and E. maxima.
(b) Limitations. Feed continuously as sole ration; use as sole
source of organic arsenic; withdraw 5 d before slaughter; do not feed
to laying chickens. Bambermycins provided by No. 016592 in Sec.
510.600(c) of this chapter; roxarsone provided by No. 046573.
* * * * *
(xvii) Amount per ton. Bambermycins, 1 to 2 grams plus monensin, 90
to 110 grams plus roxarsone, 22.7 to 45.4 grams.
(a) Indications for use. For increased rate of weight gain; and as
an aid in prevention of coccidiosis caused by E. necatrix, E. tenella,
E. acervulina, E. brunetti, E. mivati, and E. maxima.
(b) Limitations. Feed continuously as sole ration; use as sole
source of organic arsenic; withdraw 5 d before slaughter; do not feed
to laying chickens. Bambermycins provided by No. 016592 in Sec.
510.600(c) of this chapter; roxarsone provided by No. 046573.
* * * * *
0
11. Amend Sec. 558.363 as follows:
0
a. In paragraphs (a)(4), (a)(5), and (d)(1)(vii)(B), remove ``057926''
and add in its place ``016592'';
0
b. In paragraph (d)(1)(iv)(B) add a new sentence at the end of the
paragraph; and
0
c. Remove paragraph (d)(1)(xii).
The addition reads as follows:
Sec. 558.363 Narasin.
* * * * *
(d) * * *
(1) * * *
(iv) * * *
(B) * * * Narasin as provided by No. 000986; bambermycins by No.
016592 in Sec. 510.600(c) of this chapter.
* * * * *
0
12. In the table in paragraph (d) of Sec. 558.366, alphabetically add
new entries for ``Narasin 27 to 45, and bambermycins 1 to 2'' and
``Bambermycins 1 to 2'' to read as follows:
Sec. 558.366 Nicarbazin.
* * * * *
(d) * * *
----------------------------------------------------------------------------------------------------------------
Nicarbazin in Combination in grams
grams per ton per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
Narasin 27 to 45, and * * * * *
bacitracin methylene
disalicylate 50, and
roxarsone 22.7 to
45.4
----------------------------------------------------------------------------------------------------------------
[[Page 27958]]
Narasin 27 to 45, and Broiler chickens: As an Feed continuously as sole 000986
bambermycins 1 to 2 aid in preventing ration from time chicks are
outbreaks of cecal placed on litter until past
(Eimeria tenella) and the time when coccidiosis is
intestinal (E. ordinarily a hazard; do not
acervulina, E. maxima, use as a treatment for
E. necatrix, and E. coccidiosis; do not use in
brunetti) coccidiosis; flushing mashes; do not feed
and for increased rate to laying hens; withdraw 4
of weight gain and days before slaughter.
improved feed Bambermycins provided by No.
efficiency. 016592; nicarbazin and narasin
by No. 066104 in Sec.
510.600(c) of this chapter..
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
113.5 (0.0125 * * * * * * *
pct)
----------------------------------------------------------------------------------------------------------------
Bacitracin zinc 4 to * * * * *
50
----------------------------------------------------------------------------------------------------------------
Bambermycins 1 to 2 Broiler chickens: For Feed continuously as sole 016592
prevention of ration. Bambermycins provided
coccidiosis caused by by No. 016592 in Sec.
Eimeria tenella, E. 510.600(c) of this chapter.
necatrix, E.
acervulina, E.
brunetti, E. mivati,
and E. maxima; and for
increased rate of
weight gain and
improved feed
efficiency.
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
0
13. In the table in paragraph (d)(1)(vii) of Sec. 558.450, remove the
entry for ``Salinomycin 40 to 60 g/ton''; and add paragraph (d)(3)(v)
to read as follows:
Sec. 558.450 Oxytetracycline.
* * * * *
(d) * * *
(3) * * *
(v) Salinomycin as in Sec. 558.550.
0
14. In Sec. 558.550, in paragraphs (d)(1)(xv)(c) and (d)(1)(xvi)(c),
remove ``057926'' and add in its place ``016592''; add paragraphs
(d)(1)(xxiii) and (d)(1)(xxiv); and revise paragraphs (b)(2) and (d)(4)
to read as follows:
Sec. 558.550 Salinomycin.
* * * * *
(b) * * *
(2) No. 016592 for use as in paragraphs (d)(1)(i), (d)(1)(iii)
through (d)(1)(xvi), (d)(1)(xxiii) and (d)(1)(xxiv), (d)(2)(i),
(d)(3)(i), and (d)(4) of this section.
* * * * *
(d) * * *
(1) * * *
(xxiii) Amount per ton. Salinomycin, 40 to 60 grams; plus
bambermycins, 1 to 3 grams.
(a) Indications for use. Broiler chickens: For prevention of
coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E.
maxima, E. brunetti, and E. mivati; and for improved feed efficiency.
(b) Limitations. Feed continuously as sole ration. Do not feed to
laying chickens; not approved for use with pellet binders; may be fatal
if accidentally fed to adult turkeys or horses. Salinomycin as provided
by Nos. 046573 and 016592; bambermycins by No. 016592 in Sec.
510.600(c) of this chapter.
(xxiv) Amount per ton. Salinomycin, 40 to 60 grams; plus
bambermycins, 1 to 2 grams; plus roxarsone, 45.4 grams.
(a) Indications for use. Broiler chickens: For prevention of
coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E.
maxima, E. brunetti, and E. mivati, including some field strains of E.
tenella that are more susceptible to roxarsone combined with
salinomycin than salinomycin alone; and for improved feed efficiency.
(b) Limitations. Feed continuously as sole ration. Do not feed to
laying chickens; as sole source or organic arsenic; withdraw 5 days
before slaughter; not approved for use with pellet binders; may be
fatal if accidentally fed to adult turkeys or horses; Salinomycin as
provided by Nos. 046573and 016592; bambermycins by No. 016592;
roxarsone by No. 046573 in Sec. 510.600(c) of this chapter.
* * * * *
(4) Chickens: It is used in chicken feed as follows:
(i) Amount per ton. Salinomycin, 40 to 60 grams; plus
oxytetracycline, 500 grams.
(a) Indications for use. For prevention of coccidiosis caused by
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti,
and E. mivati; and for reduction of mortality due to air sacculitis
(air-sac-infection) caused by Escherichia coli susceptible to
oxytetracycline.
(b) Limitations. Feed continuously for 5 days; do not feed to
chickens producing eggs for human consumption; withdraw 24 hours before
slaughter; in low calcium feeds withdraw 3 d before slaughter.
Salinomycin as provided by Nos. 046573 and 016592; oxytetracycline as
provided by No. 066104 in Sec. 510.600(c) of this chapter.
(ii) [Reserved]
0
15. In Sec. 558.680, alphabetically add two entries to the table in
paragraph (d)(1)(ii); and revise paragraph (d)(2) to read as follows:
Sec. 558.680 Zoalene.
* * * * *
(d) * * *
(1) * * *
[[Page 27959]]
------------------------------------------------------------------------
Combination
Zoalene in grams in grams per Indications for Limitations
per ton ton use
------------------------------------------------------------------------
(ii) 113.5 * * * * * * *
(0.0125%).
------------------------------------------------------------------------
Bacitracin * * * * *
100 to 500
------------------------------------------------------------------------
Bambermycins Broiler chickens: Feed continuously
1 As an aid in the as sole ration.
prevention and Do not feed to
control of chickens over 14
coccidiosis; and weeks of age.
for increased Bambermycins as
rate of weight provided by No.
gain and improved 016592 in Sec.
feed efficiency. 510.600(c) of
this chapter.
------------------------------------------------------------------------
Bambermycins Broiler chickens: Feed continuously
1 plus As an aid in the as sole ration.
roxarsone prevention and Do not feed to
22.7 control of chickens over 14
coccidiosis; and weeks of age;
for increased feed as sole
rate of weight source of
gain and improved organic arsenic;
feed efficiency. withdraw 5 days
before
slaughter.
Bambermycins as
provided by No.
016592,
roxarsone by No.
046573 in Sec.
510.600(c) of
this chapter.
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
(2) Zoalene may also be used in combination with roxarsone as in
Sec. 558.530.
Dated: May 3, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 06-4505 Filed 5-12-06; 8:45 am]
BILLING CODE 4160-01-S