New Animal Drugs for Use in Animal Feeds; Bacitracin; Nicarbazin; Oxytetracycline and Neomycin; Penicillin, 16223-16227 [06-3120]
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Federal Register / Vol. 71, No. 62 / Friday, March 31, 2006 / Rules and Regulations
these three combination drug medicated
feeds.
The NADAs are approved as of
February 15, 2006, and the regulations
are amended in 21 CFR 558.76, 558.78,
558.369, and 558.680 to reflect the
approval. Approval of these
supplemental NADAs did not require
review of any new safety or
effectiveness data. Therefore, a freedom
of information summary was not
prepared.
The agency has determined under 21
CFR 25.33(a)(2) that these actions are of
a type that do 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.
Zoalene in grams/ton
§ 558.78
Bacitracin zinc.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
I 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:
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(d) * * *
(3) * * *
(x) Nitarsone as in § 558.369.
*
*
*
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PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
I
1. The authority citation for 21 CFR
part 558 continues to read as follows:
I
[Amended]
2. In § 558.76, amend paragraph
(d)(3)(xviii) by adding ‘‘or roxarsone’’
after ‘‘arsanilic acid’’.
I 3. In § 558.78, amend paragraph (d)(3)
by redesignating paragraphs (d)(3)(x)
through (d)(3)(xii) as paragraphs
(d)(3)(xi) through (d)(3)(xiii); and add
new paragraph (d)(3)(x) to read as
follows:
I
Combination in grams/ton
§ 558.369
[Amended]
4. In § 558.369, amend paragraph
(d)(2)(i) by adding ‘‘or bacitracin zinc’’
after ‘‘disalicylate’’.
5. In § 558.680, amend the table in
paragraph (d)(1)(i), after the entry for
‘‘Arsanilic acid 90 (0.01%) plus
penicillin 2.4 to 50’’ by adding entries
for ‘‘Bacitracin 4 to 50’’ and ‘‘Bacitracin
methylene disalicylate 4 to 50 plus
roxarsone 22.7 to 45.4’’ to read as
follows:
I
Authority: 21 U.S.C. 360b, 371.
§ 558.76
*
§ 558.680
*
Zoalene.
*
*
(d) * * *
(1) * * *
*
*
Indications for use
Limitations
Bacitracin 4 to 50
Replacement chickens: For development
of active immunity to coccidiosis; for increased rate of weight gain, improved
feed efficiency
Bacitracin methylene disalicylate 4 to 50 plus
roxarsone 22.7 to 45.4
Replacement chickens: For development
of active immunity to coccidiosis; for increased rate of weight gain, improved
feed efficiency, and improved pigmentation
Feed as in subtable in § 558.680(d)(1)(i);
grower ration not to be fed to birds over
14 weeks of age. As bacitracin methylene disalicylate provided by No.
046573 in § 510.600(c) of this chapter
Feed as in subtable in § 558.680(d)(1)(i);
grower ration not to be fed to birds over
14 weeks of age. Discontinue use 5
days before slaughter; as sole source
of organic arsenic; drug overdose or
lack of water may result in leg weakness. As bacitracin methylene disalicylate and roxarsone provided by No.
046573 in § 510.600(c) of this chapter
(i) * * *
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Dated: March 22, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06–3122 Filed 3–30–06; 8:45 am]
BILLING CODE 4160–01–S
*
*
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. 2003N–0324]
New Animal Drugs for Use in Animal
Feeds; Bacitracin; Nicarbazin;
Oxytetracycline and Neomycin;
Penicillin
AGENCY:
Food and Drug Administration,
hsrobinson on PROD1PC61 with RULES
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of four supplemental new
animal drug applications (NADAs) filed
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*
by Phibro Animal Health. One
supplemental NADA provides for the
use of fixed-combination Type A
medicated articles containing
oxytetracycline and neomycin sulfate to
formulate two-way fixed-combination
drug Type B and Type C medicated
feeds for chickens, turkeys, swine,
cattle, and sheep. Two of the
supplemental NADAs provide for the
use of approved, single-ingredient Type
A medicated articles containing
nicarbazin and penicillin, with or
without roxarsone, to formulate twoway or three-way combination drug
Type C medicated feeds for broiler
chickens. The fourth supplemental
NADA provides for the use of approved,
single-ingredient Type A medicated
articles nicarbazin, bacitracin methylene
disalicylate, and roxarsone to formulate
three-way combination drug Type C
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Federal Register / Vol. 71, No. 62 / Friday, March 31, 2006 / Rules and Regulations
medicated feeds for broiler chickens.
These approvals reflect FDA’s
effectiveness conclusions which relied
on the National Academy of Sciences/
National Research Council (NAS/NRC)
Drug Efficacy Study Group’s evaluation
of the effectiveness of these drugs when
used in animal feed as single
ingredients.
DATES: This rule is effective March 31,
2006.
FOR FURTHER INFORMATION CONTACT:
Andrew J. Beaulieu, Center for
Veterinary Medicine (HFV–50), 7519
Standish Pl., Rockville, MD 20855, 240–
276–9090, e-mail:
andrew.beaulieu@fda.hhs.gov.
In the
Federal Register of August 8, 2003 (68
FR 47332), as corrected October 7, 2003
(68 FR 57919), as part of the Drug
Efficacy Study Implementation (DESI)
program, CVM announced the effective
conditions of use for several drug
products and use combinations listed in
21 CFR 558.15. CVM proposed to
withdraw the new animal drug
applications (NADAs) for those
products or use combinations lacking
substantial evidence of effectiveness
following a 90-day opportunity to
supplement the NADAs with labeling
conforming to the relevant findings of
effectiveness. Phibro Animal Health, 65
Challenger Rd., 3d Floor, Ridgefield
Park, NJ 07660, filed supplements to
four of its approved NADAs to revise
the labeling of its products to comply
with these findings of effectiveness.
Phibro Animal Health filed a
supplement to approved NADA 94–975
for NEO–TM 50/50D and NEO–TM 100/
100D (oxytetracycline and neomycin
sulfate) Type A medicated articles. The
supplemental NADA provides for use of
these fixed-combination Type A
medicated articles to formulate two-way
fixed-combination drug Type B and
Type C medicated feeds containing
oxytetracycline and neomycin sulfate,
in a 1:1 ratio, for several production and
therapeutic indications in chickens,
turkeys, swine, cattle, and sheep.
Phibro Animal Health also filed a
supplement to approved NADA 98–371
for use of nicarbazin, procaine
penicillin, and roxarsone singleingredient Type A medicated articles to
make three-way combination drug Type
C medicated feeds. This supplemental
NADA provides for the use of
combination feeds containing
NICARBAZIN (nicarbazin) at 90.8 to
181.6 grams per ton (g/ton), PENICILLIN
hsrobinson on PROD1PC61 with RULES
SUPPLEMENTARY INFORMATION:
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G PROCAINE (procaine penicillin) at
2.4 to 50 g/ton, and 3–NITRO
(roxarsone) at 22.7 to 45.4 g/ton of feed
in broiler chickens as an aid in
preventing outbreaks of cecal (Eimeria
tenella) and intestinal (E. acervulina, E.
maxima, E. necatrix, and E. brunetti)
coccidiosis; for increased rate of weight
gain and improved feed efficiency; and
for improved pigmentation.
Phibro Animal Health also filed a
supplement to approved NADA 98–374
for use of nicarbazin and procaine
penicillin G Type A medicated articles
to formulate two-way combination drug
Type C medicated feeds. This
supplemental NADA provides for the
use of combination feeds containing
NICARBAZIN (nicarbazin) at 90.8 to
181.6 g/ton and PENICILLIN G
PROCAINE (procaine penicillin) at 2.4
to 50 g/ton of feed in broiler chickens
as an aid in preventing outbreaks of
cecal (Eimeria tenella) and intestinal (E.
acervulina, E. maxima, E. necatrix, and
E. brunetti) coccidiosis; and for
increased rate of weight gain and
improved feed efficiency.
Phibro Animal Health also filed a
supplement to approved NADA 100–
853 for use of nicarbazin, bacitracin
methylene disalicylate, and roxarsone
single-ingredient Type A medicated
articles to make three-way combination
drug Type C medicated feeds. This
supplemental NADA provides for the
use of combination feeds containing
NICARBAZIN (nicarbazin) at 90.8 to
181.6 g/ton, BMD (bacitracin methylene
disalicylate) at 4 to 50 g/ton, and 3–
NITRO (roxarsone) at 22.7 to 45.4 g/ton
of feed in broiler chickens as an aid in
preventing outbreaks of cecal (Eimeria
tenella) and intestinal (E. acervulina, E.
maxima, E. necatrix, and E. brunetti)
coccidiosis, and for increased rate of
weight gain, improved feed efficiency,
and improved pigmentation.
The DESI evaluation is concerned
only with the effectiveness of the drug
products and use combinations. Nothing
in this document constitutes a bar to
further proceedings with respect to
questions of safety of the subject drugs
in treated animals or of the drugs or
their metabolites in food products
derived from treated animals.
Products that comply with FDA’s
findings of effectiveness are eligible for
copying, as described in the Generic
Animal Drug and Patent Term
Restoration Act Policy Letter Eight,
August 21, 1991 (56 FR 41561).
Accordingly, sponsors may now obtain
approval of abbreviated NADAs for this
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fixed combination Type A medicated
article and three combination drug
medicated feeds.
The supplemental NADAs are
approved as of February 15, 2006, and
the regulations are amended in 21 CFR
558.76, 558.460, and 558.366, and also
in 21 CFR part 558 by adding new
§ 558.455 to reflect these approvals.
Approval of these supplemental NADAs
did not require review of any new safety
or effectiveness data. Therefore, a
freedom of information summary was
not prepared.
The agency has determined under 21
CFR 25.33(a)(2) that these actions are of
a type that do 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.
I 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:
I
Authority: 21 U.S.C. 360b, 371.
2. In § 558.76, revise paragraph
(d)(3)(xiii) to read as follows:
I
§ 558.76
Bacitracin methylene disalicylate.
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*
*
*
*
(d) * * *
(3) * * *
(xiii) Nicarbazin alone or with narasin
or roxarsone or with narasin and
roxarsone as in § 558.366.
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*
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*
I 3. In § 558.366, amend the table in
paragraph (d) after the entry for
‘‘Narasin 27 to 45 and roxarsone 22.7 to
45.4’’ by adding three entries to read as
follows:
§ 558.366
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Nicarbazin.
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(d) * * *
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Federal Register / Vol. 71, No. 62 / Friday, March 31, 2006 / Rules and Regulations
Nicarbazin in grams
per ton
*
Combination in
grams per ton
Indications for use
*
90.8 to 181.6 (0.01
to 0.02 pct)
*
Limitations
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Sponsor
*
Feed continuously as sole ration from
time chicks are placed on litter until
past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for outbreaks of coccidiosis.
Feed as the sole source of organic arsenic; drug overdose or lack of water
may result in leg weakness; do not
use in flushing mashes. Discontinue
medication 5 days before marketing
the birds for human consumption to
allow for elimination of the drug from
edible tissue. Do not feed to laying
hens in production. Nicarbazin as provided by No. 066104; bacitracin methylene disalicylate and roxarsone by
No. 046573 in § 510.600(c) of this
chapter
066104
Broiler chickens: As an aid in preventing
outbreaks of cecal (Eimeria tenella)
and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis, and for increased rate of
weight gain and improved feed efficiency
Feed continuously as sole ration from
time chicks are placed on litter until
past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for outbreaks of coccidiosis. Do
not use in flushing mashes. Do not
feed to chickens producing eggs for
human consumption. Discontinue
medication 5 days before marketing
the birds for human consumption to
allow for elimination of the drug from
edible tissue. Penicillin as procaine
penicillin G. Nicarbazin and penicillin
as provided by No. 066104 in
§ 510.600(c) of this chapter
066104
Penicillin 2.4 to 50
and roxarsone
22.7 to 45.4
I
Broiler chickens: As an aid in preventing
outbreaks of cecal (Eimeria tenella)
and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis, and for increased rate of
weight gain and improved feed efficiency, and improved pigmentation
Penicillin 2.4 to 50
*
Bacitracin methylene disalicylate 4 to 50 and
roxarsone 22.7
to 45.4
Broiler chickens: As an aid in preventing
outbreaks of cecal (Eimeria tenella)
and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis, and for increased rate of
weight gain and improved feed efficiency, and improved pigmentation
Feed continuously as sole ration from
time chicks are placed on litter until
past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for outbreaks of coccidiosis.
Feed as the sole source of organic arsenic; drug overdose or lack of water
may result in leg weakness; do not
use in flushing mashes. Discontinue
medication 5 days before marketing
the birds for human consumption to
allow for elimination of the drug from
edible tissue. Do not feed to laying
hens in production. Penicillin as procaine penicillin G. Nicarbazin and penicillin as provided by No. 066104;
roxarsone by No. 046573 in
§ 510.600(c) of this chapter
066104
*
*
4. Add § 558.455 to read as follows:
§ 558.455
Oxytetracycline and neomycin.
hsrobinson on PROD1PC61 with RULES
(a) Specifications. Type A medicated
articles containing oxytetracycline
equivalent to 50 grams per pound (g/lb)
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oxytetracycline hydrochloride and 50 g/
lb neomycin sulfate or oxytetracycline
equivalent to 100 g/lb oxytetracycline
hydrochloride and 100 g/lb neomycin
sulfate.
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(b) Sponsors. See No. 066104 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See §§ 556.430
and 556.500 of this chapter.
(d) Indications for use—(1) Chickens.
It is used in feed as follows:
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Oxytetracycline and
neomycin sulfate
amount in grams
per ton of feed
Indications for use
Limitations
Sponsors
(i) 10 to 50
Chickens: For increased rate of weight gain and
improved feed efficiency
Feed continuously; do not feed to chickens producing eggs for human consumption
066104
(ii) 100 to 200
Chickens: For control of infectious synovitis
caused by Mycoplasma synoviae; control of
fowl cholera caused by Pasteurella multocida
susceptible to oxytetracycline
Feed continuously for 7 to 14 days (d); do not
feed to chickens producing eggs for human
consumption; in low calcium feed, withdraw 3
d before slaughter
066104
(iii) 400
Chickens: For control of chronic respiratory disease (CRD) and air sac infection caused by
M. gallisepticum and Escherichia coli susceptible to oxytetracycline
Feed continuously for 7 to 14 d; do not feed to
chickens producing eggs for human consumption; in low calcium feeds, withdraw 3 d before slaughter
066104
(iv) 500
Chickens: For reduction of mortality due to air
sacculitis (air-sac-infection) caused by E. coli
susceptible to oxytetracycline
Feed continuously for 5 d; do not feed to chickens producing eggs for human consumption;
withdraw 24 hours before slaughter; in low
calcium feeds withdraw 3 d before slaughter
066104
(2) Turkeys. It is used in feed as
follows:
Oxytetracycline and
neomycin sulfate
amount
Indications for use
Limitations
Sponsors
(i) 10 to 50 g/ton of
feed
Growing turkeys: For increased rate of weight
gain and improved feed efficiency
Feed continuously; do not feed to turkeys producing eggs for human consumption
066104
(ii) 100 g/ton of
feed
Turkeys: For control of hexamitiasis caused by
Hexamita meleagridis susceptible to oxytetracycline
Feed continuously for 7 to 14 d; do not feed to
turkeys producing eggs for human consumption
066104
(iii) 200 g/ton of
feed
Turkeys: For control of infectious synovitis
caused by M. synoviae susceptible to oxytetracycline
Feed continuously for 7 to 14 d; withdraw 5 d
before slaughter; do not feed to turkeys producing eggs for human consumption
066104
(iv) To provide 25
mg/lb of body
weight daily
Turkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to oxytetracycline
Feed continuously for 7 to 14 d; withdraw 5 d
before slaughter; do not feed to turkeys producing eggs for human consumption
066104
(3) Swine. It is used in feed as follows:
Oxytetracycline and
neomycin sulfate
amount
Indications for use
Limitations
Swine: For increased rate of weight gain and improved feed efficiency
(ii) To provide 10 mg/
lb of body weight
daily
hsrobinson on PROD1PC61 with RULES
(i) 10 to 50 g/ton of
feed
1. Swine: For treatment of bacterial enteritis caused by E. coli and
Salmonella choleraesuis and treatment of bacterial pneumonia
caused by P. multocida susceptible to oxytetracycline; treatment
and control of colibacillosis (bacterial enteritis) caused by E. coli
susceptible to neomycin
2. Breeding swine: For control and treatment of leptospirosis (reducing the incidence of abortion and shedding of leptospirae)
caused by Leptospira pomona susceptible to oxytetracycline
066104
Feed continuously for 7 to
14 d; withdraw 5 d before slaughter
066104
Feed continuously for not
more than 14 d; withdraw 5 d before slaughter
066104
(4) Cattle and sheep. It is used in feed
as follows:
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Sponsor
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Federal Register / Vol. 71, No. 62 / Friday, March 31, 2006 / Rules and Regulations
Oxytetracycline and
neomycin sulfate
amount
Indications for use
Limitations
Sponsor
(i) 10 to 20 grams
per ton of feed
Sheep: For increased rate of weight
gain and improved feed efficiency
(ii) To provide 0.05
to 0.1 mg/lb of
body weight
daily.
Calves (up to 250 lb): For increased
rate of weight gain and improved
feed efficiency
Feed continuously; in milk replacers or starter feed
066104
(iii) To provide 10
mg/lb of body
weight daily
1. Calves and beef and nonlactating
dairy cattle: For treatment of bacterial
enteritis caused by E. coli and bacterial pneumonia (shipping fever
complex) caused by P. multocida
susceptible to oxytetracycline; treatment and control of colibacillosis
(bacterial enteritis) caused by E. coli
susceptible to neomycin
Feed continuously for 7 to 14 d; in feed or milk replacers. If symptoms persist after using for 2 or 3 d, consult a veterinarian. Treatment should continue 24 to 48
hours beyond remission of disease symptoms. A withdrawal period has not been established for use in
preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in
female dairy cattle 20 months of age or older. Withdraw 5 d before slaughter
Feed continuously for 7 to 14 d; in milk replacers or
starter feed. If symptoms persist after using for 2 or 3
d, consult a veterinarian. Treatment should continue
24 to 48 hours beyond remission of disease symptoms. A withdrawal period has not been established for
use in preruminating calves. Do not use in calves to
be processed for veal. A milk discard time has not
been established for use in lactating dairy cattle. Do
not use in female dairy cattle 20 months of age or
older. Withdraw 5 d before slaughter
Feed continuously for 7 to 14 d. If symptoms persist after
using for 2 or 3 d, consult a veterinarian. Treatment
should continue 24 to 48 hours beyond remission of
disease symptoms. Withdraw 5 d before slaughter
066104
2. Calves (up to 250 lb): For treatment
of bacterial enteritis caused by E. coli
susceptible to oxytetracycline; treatment and control of colibacillosis
(bacterial enteritis) caused by E. coli
susceptible to neomycin
3. Sheep: For treatment of bacterial enteritis caused by E. coli and bacterial
pneumonia caused by P. multocida
susceptible to oxytetracycline; treatment and control of colibacillosis
(bacterial enteritis) caused by E. coli
susceptible to neomycin
066104
066104
066104
(iv) To provide 25
mg/head/day
Calves (250 to 400 lb): For increased
rate of weight gain and improved
feed efficiency
066104
(v) To provide 75
mg/head/day
Growing cattle (over 400 lb): For increased rate of weight gain; improved feed efficiency, and reduction
of liver condemnation due to liver abscesses
066104
(vi) To provide 0.5
to 2.0 g/head/day
Cattle: For prevention and treatment of
the early stages of shipping fever
complex
5. In § 558.460, redesignate
paragraphs (d)(2)(vi), (d)(2)(vii), and
(d)(2)(viii) as paragraphs (d)(2)(iii),
(d)(2)(v), and (d)(2)(vi); and add new
paragraph (d)(2)(iv) to read as follows:
I
§ 558.460
Feed 3 to 5 d before and after arrival in feedlots. A withdrawal period has not been established for use in
preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in
female dairy cattle 20 months of age or older
Dated: March 22, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06–3120 Filed 3–30–06; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–01–S
21 CFR Parts 814 and 820
Food and Drug Administration
Penicillin.
*
hsrobinson on PROD1PC61 with RULES
066104
*
*
*
*
(d) * * *
(2) * * *
(iv) Nicarbazin alone or with
roxarsone as in § 558.366.
*
*
*
*
*
[Docket No. 2006N–0127]
Medical Device Reporting; Premarket
Approval of Medical Devices; Quality
System Regulation; Technical
Amendment
AGENCY:
Food and Drug Administration,
HHS.
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]]>Agencies
[Federal Register Volume 71, Number 62 (Friday, March 31, 2006)]
[Rules and Regulations]
[Pages 16223-16227]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3120]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. 2003N-0324]
New Animal Drugs for Use in Animal Feeds; Bacitracin; Nicarbazin;
Oxytetracycline and Neomycin; Penicillin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of four supplemental new animal
drug applications (NADAs) filed by Phibro Animal Health. One
supplemental NADA provides for the use of fixed-combination Type A
medicated articles containing oxytetracycline and neomycin sulfate to
formulate two-way fixed-combination drug Type B and Type C medicated
feeds for chickens, turkeys, swine, cattle, and sheep. Two of the
supplemental NADAs provide for the use of approved, single-ingredient
Type A medicated articles containing nicarbazin and penicillin, with or
without roxarsone, to formulate two-way or three-way combination drug
Type C medicated feeds for broiler chickens. The fourth supplemental
NADA provides for the use of approved, single-ingredient Type A
medicated articles nicarbazin, bacitracin methylene disalicylate, and
roxarsone to formulate three-way combination drug Type C
[[Page 16224]]
medicated feeds for broiler chickens. These approvals reflect FDA's
effectiveness conclusions which relied on the National Academy of
Sciences/National Research Council (NAS/NRC) Drug Efficacy Study
Group's evaluation of the effectiveness of these drugs when used in
animal feed as single ingredients.
DATES: This rule is effective March 31, 2006.
FOR FURTHER INFORMATION CONTACT: Andrew J. Beaulieu, Center for
Veterinary Medicine (HFV-50), 7519 Standish Pl., Rockville, MD 20855,
240-276-9090, e-mail: andrew.beaulieu@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 8, 2003
(68 FR 47332), as corrected October 7, 2003 (68 FR 57919), as part of
the Drug Efficacy Study Implementation (DESI) program, CVM announced
the effective conditions of use for several drug products and use
combinations listed in 21 CFR 558.15. CVM proposed to withdraw the new
animal drug applications (NADAs) for those products or use combinations
lacking substantial evidence of effectiveness following a 90-day
opportunity to supplement the NADAs with labeling conforming to the
relevant findings of effectiveness. Phibro Animal Health, 65 Challenger
Rd., 3d Floor, Ridgefield Park, NJ 07660, filed supplements to four of
its approved NADAs to revise the labeling of its products to comply
with these findings of effectiveness.
Phibro Animal Health filed a supplement to approved NADA 94-975 for
NEO-TM 50/50D and NEO-TM 100/100D (oxytetracycline and neomycin
sulfate) Type A medicated articles. The supplemental NADA provides for
use of these fixed-combination Type A medicated articles to formulate
two-way fixed-combination drug Type B and Type C medicated feeds
containing oxytetracycline and neomycin sulfate, in a 1:1 ratio, for
several production and therapeutic indications in chickens, turkeys,
swine, cattle, and sheep.
Phibro Animal Health also filed a supplement to approved NADA 98-
371 for use of nicarbazin, procaine penicillin, and roxarsone single-
ingredient Type A medicated articles to make three-way combination drug
Type C medicated feeds. This supplemental NADA provides for the use of
combination feeds containing NICARBAZIN (nicarbazin) at 90.8 to 181.6
grams per ton (g/ton), PENICILLIN G PROCAINE (procaine penicillin) at
2.4 to 50 g/ton, and 3-NITRO (roxarsone) at 22.7 to 45.4 g/ton of feed
in broiler chickens as an aid in preventing outbreaks of cecal (Eimeria
tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E.
brunetti) coccidiosis; for increased rate of weight gain and improved
feed efficiency; and for improved pigmentation.
Phibro Animal Health also filed a supplement to approved NADA 98-
374 for use of nicarbazin and procaine penicillin G Type A medicated
articles to formulate two-way combination drug Type C medicated feeds.
This supplemental NADA provides for the use of combination feeds
containing NICARBAZIN (nicarbazin) at 90.8 to 181.6 g/ton and
PENICILLIN G PROCAINE (procaine penicillin) at 2.4 to 50 g/ton of feed
in broiler chickens as an aid in preventing outbreaks of cecal (Eimeria
tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E.
brunetti) coccidiosis; and for increased rate of weight gain and
improved feed efficiency.
Phibro Animal Health also filed a supplement to approved NADA 100-
853 for use of nicarbazin, bacitracin methylene disalicylate, and
roxarsone single-ingredient Type A medicated articles to make three-way
combination drug Type C medicated feeds. This supplemental NADA
provides for the use of combination feeds containing NICARBAZIN
(nicarbazin) at 90.8 to 181.6 g/ton, BMD (bacitracin methylene
disalicylate) at 4 to 50 g/ton, and 3-NITRO (roxarsone) at 22.7 to 45.4
g/ton of feed in broiler chickens as an aid in preventing outbreaks of
cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E.
necatrix, and E. brunetti) coccidiosis, and for increased rate of
weight gain, improved feed efficiency, and improved pigmentation.
The DESI evaluation is concerned only with the effectiveness of the
drug products and use combinations. Nothing in this document
constitutes a bar to further proceedings with respect to questions of
safety of the subject drugs in treated animals or of the drugs or their
metabolites in food products derived from treated animals.
Products that comply with FDA's findings of effectiveness are
eligible for copying, as described in the Generic Animal Drug and
Patent Term Restoration Act Policy Letter Eight, August 21, 1991 (56 FR
41561). Accordingly, sponsors may now obtain approval of abbreviated
NADAs for this fixed combination Type A medicated article and three
combination drug medicated feeds.
The supplemental NADAs are approved as of February 15, 2006, and
the regulations are amended in 21 CFR 558.76, 558.460, and 558.366, and
also in 21 CFR part 558 by adding new Sec. 558.455 to reflect these
approvals. Approval of these supplemental NADAs did not require review
of any new safety or effectiveness data. Therefore, a freedom of
information summary was not prepared.
The agency has determined under 21 CFR 25.33(a)(2) that these
actions are of a type that do 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. 558.76, revise paragraph (d)(3)(xiii) to read as follows:
Sec. 558.76 Bacitracin methylene disalicylate.
* * * * *
(d) * * *
(3) * * *
(xiii) Nicarbazin alone or with narasin or roxarsone or with
narasin and roxarsone as in Sec. 558.366.
* * * * *
0
3. In Sec. 558.366, amend the table in paragraph (d) after the entry
for ``Narasin 27 to 45 and roxarsone 22.7 to 45.4'' by adding three
entries to read as follows:
Sec. 558.366 Nicarbazin.
* * * * *
(d) * * *
[[Page 16225]]
----------------------------------------------------------------------------------------------------------------
Nicarbazin in grams Combination in grams
per ton per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
90.8 to 181.6 (0.01 Bacitracin methylene Broiler chickens: As an aid Feed continuously as sole 066104
to 0.02 pct) disalicylate 4 to in preventing outbreaks of ration from time chicks
50 and roxarsone cecal (Eimeria tenella) are placed on litter until
22.7 to 45.4 and intestinal (E. past the time when
acervulina, E. maxima, E. coccidiosis is ordinarily
necatrix, and E. brunetti) a hazard; do not use as a
coccidiosis, and for treatment for outbreaks of
increased rate of weight coccidiosis. Feed as the
gain and improved feed sole source of organic
efficiency, and improved arsenic; drug overdose or
pigmentation lack of water may result
in leg weakness; do not
use in flushing mashes.
Discontinue medication 5
days before marketing the
birds for human
consumption to allow for
elimination of the drug
from edible tissue. Do not
feed to laying hens in
production. Nicarbazin as
provided by No. 066104;
bacitracin methylene
disalicylate and roxarsone
by No. 046573 in Sec.
510.600(c) of this chapter
----------------------------------------------------------------------------------------------------------------
Penicillin 2.4 to 50 Broiler chickens: As an aid Feed continuously as sole 066104
in preventing outbreaks of ration from time chicks
cecal (Eimeria tenella) are placed on litter until
and intestinal (E. past the time when
acervulina, E. maxima, E. coccidiosis is ordinarily
necatrix, and E. brunetti) a hazard; do not use as a
coccidiosis, and for treatment for outbreaks of
increased rate of weight coccidiosis. Do not use in
gain and improved feed flushing mashes. Do not
efficiency feed to chickens producing
eggs for human
consumption. Discontinue
medication 5 days before
marketing the birds for
human consumption to allow
for elimination of the
drug from edible tissue.
Penicillin as procaine
penicillin G. Nicarbazin
and penicillin as provided
by No. 066104 in Sec.
510.600(c) of this chapter
----------------------------------------------------------------------------------------------------------------
Penicillin 2.4 to 50 Broiler chickens: As an aid Feed continuously as sole 066104
and roxarsone 22.7 in preventing outbreaks of ration from time chicks
to 45.4 cecal (Eimeria tenella) are placed on litter until
and intestinal (E. past the time when
acervulina, E. maxima, E. coccidiosis is ordinarily
necatrix, and E. brunetti) a hazard; do not use as a
coccidiosis, and for treatment for outbreaks of
increased rate of weight coccidiosis. Feed as the
gain and improved feed sole source of organic
efficiency, and improved arsenic; drug overdose or
pigmentation lack of water may result
in leg weakness; do not
use in flushing mashes.
Discontinue medication 5
days before marketing the
birds for human
consumption to allow for
elimination of the drug
from edible tissue. Do not
feed to laying hens in
production. Penicillin as
procaine penicillin G.
Nicarbazin and penicillin
as provided by No. 066104;
roxarsone by No. 046573 in
Sec. 510.600(c) of this
chapter
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
0
4. Add Sec. 558.455 to read as follows:
Sec. 558.455 Oxytetracycline and neomycin.
(a) Specifications. Type A medicated articles containing
oxytetracycline equivalent to 50 grams per pound (g/lb) oxytetracycline
hydrochloride and 50 g/lb neomycin sulfate or oxytetracycline
equivalent to 100 g/lb oxytetracycline hydrochloride and 100 g/lb
neomycin sulfate.
(b) Sponsors. See No. 066104 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. Sec. 556.430 and 556.500 of this
chapter.
(d) Indications for use--(1) Chickens. It is used in feed as
follows:
[[Page 16226]]
----------------------------------------------------------------------------------------------------------------
Oxytetracycline and neomycin
sulfate amount in grams per Indications for use Limitations Sponsors
ton of feed
----------------------------------------------------------------------------------------------------------------
(i) 10 to 50 Chickens: For increased rate of Feed continuously; do not feed 066104
weight gain and improved feed to chickens producing eggs
efficiency for human consumption
----------------------------------------------------------------------------------------------------------------
(ii) 100 to 200 Chickens: For control of Feed continuously for 7 to 14 066104
infectious synovitis caused by days (d); do not feed to
Mycoplasma synoviae; control chickens producing eggs for
of fowl cholera caused by human consumption; in low
Pasteurella multocida calcium feed, withdraw 3 d
susceptible to oxytetracycline before slaughter
----------------------------------------------------------------------------------------------------------------
(iii) 400 Chickens: For control of Feed continuously for 7 to 14 066104
chronic respiratory disease d; do not feed to chickens
(CRD) and air sac infection producing eggs for human
caused by M. gallisepticum and consumption; in low calcium
Escherichia coli susceptible feeds, withdraw 3 d before
to oxytetracycline slaughter
----------------------------------------------------------------------------------------------------------------
(iv) 500 Chickens: For reduction of Feed continuously for 5 d; do 066104
mortality due to air not feed to chickens
sacculitis (air-sac-infection) producing eggs for human
caused by E. coli susceptible consumption; withdraw 24
to oxytetracycline hours before slaughter; in
low calcium feeds withdraw 3
d before slaughter
----------------------------------------------------------------------------------------------------------------
(2) Turkeys. It is used in feed as follows:
----------------------------------------------------------------------------------------------------------------
Oxytetracycline and neomycin
sulfate amount Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 10 to 50 g/ton of feed Growing turkeys: For increased Feed continuously; do not feed 066104
rate of weight gain and to turkeys producing eggs for
improved feed efficiency human consumption
----------------------------------------------------------------------------------------------------------------
(ii) 100 g/ton of feed Turkeys: For control of Feed continuously for 7 to 14 066104
hexamitiasis caused by d; do not feed to turkeys
Hexamita meleagridis producing eggs for human
susceptible to oxytetracycline consumption
----------------------------------------------------------------------------------------------------------------
(iii) 200 g/ton of feed Turkeys: For control of Feed continuously for 7 to 14 066104
infectious synovitis caused by d; withdraw 5 d before
M. synoviae susceptible to slaughter; do not feed to
oxytetracycline turkeys producing eggs for
human consumption
----------------------------------------------------------------------------------------------------------------
(iv) To provide 25 mg/lb of Turkeys: For control of Feed continuously for 7 to 14 066104
body weight daily complicating bacterial d; withdraw 5 d before
organisms associated with slaughter; do not feed to
bluecomb (transmissible turkeys producing eggs for
enteritis; coronaviral human consumption
enteritis) susceptible to
oxytetracycline
----------------------------------------------------------------------------------------------------------------
(3) Swine. It is used in feed as follows:
------------------------------------------------------------------------
Oxytetracycline
and neomycin Indications for use Limitations Sponsor
sulfate amount
------------------------------------------------------------------------
(i) 10 to 50 g/ Swine: For increased ........... 066104
ton of feed rate of weight gain
and improved feed
efficiency
------------------------------------------------------------------------
(ii) To provide 1. Swine: For Feed 066104
10 mg/lb of treatment of continuous
body weight bacterial enteritis ly for 7
daily caused by E. coli and to 14 d;
Salmonella withdraw 5
choleraesuis and d before
treatment of slaughter
bacterial pneumonia
caused by P.
multocida susceptible
to oxytetracycline;
treatment and control
of colibacillosis
(bacterial enteritis)
caused by E. coli
susceptible to
neomycin
2. Breeding swine: For Feed 066104
control and treatment continuous
of leptospirosis ly for not
(reducing the more than
incidence of abortion 14 d;
and shedding of withdraw 5
leptospirae) caused d before
by Leptospira pomona slaughter
susceptible to
oxytetracycline
------------------------------------------------------------------------
(4) Cattle and sheep. It is used in feed as follows:
[[Page 16227]]
----------------------------------------------------------------------------------------------------------------
Oxytetracycline and neomycin
sulfate amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 to 20 grams per ton Sheep: For increased rate of ................................. 066104
of feed weight gain and improved
feed efficiency
----------------------------------------------------------------------------------------------------------------
(ii) To provide 0.05 to 0.1 Calves (up to 250 lb): For Feed continuously; in milk 066104
mg/lb of body weight daily. increased rate of weight replacers or starter feed
gain and improved feed
efficiency
----------------------------------------------------------------------------------------------------------------
(iii) To provide 10 mg/lb of 1. Calves and beef and Feed continuously for 7 to 14 d; 066104
body weight daily nonlactating dairy cattle: in feed or milk replacers. If
For treatment of bacterial symptoms persist after using for
enteritis caused by E. coli 2 or 3 d, consult a
and bacterial pneumonia veterinarian. Treatment should
(shipping fever complex) continue 24 to 48 hours beyond
caused by P. multocida remission of disease symptoms. A
susceptible to withdrawal period has not been
oxytetracycline; treatment established for use in
and control of preruminating calves. Do not use
colibacillosis (bacterial in calves to be processed for
enteritis) caused by E. veal. A milk discard time has
coli susceptible to not been established for use in
neomycin lactating dairy cattle. Do not
use in female dairy cattle 20
months of age or older. Withdraw
5 d before slaughter
2. Calves (up to 250 lb): Feed continuously for 7 to 14 d; 066104
For treatment of bacterial in milk replacers or starter
enteritis caused by E. coli feed. If symptoms persist after
susceptible to using for 2 or 3 d, consult a
oxytetracycline; treatment veterinarian. Treatment should
and control of continue 24 to 48 hours beyond
colibacillosis (bacterial remission of disease symptoms. A
enteritis) caused by E. withdrawal period has not been
coli susceptible to established for use in
neomycin preruminating calves. Do not use
in calves to be processed for
veal. A milk discard time has
not been established for use in
lactating dairy cattle. Do not
use in female dairy cattle 20
months of age or older. Withdraw
5 d before slaughter
3. Sheep: For treatment of Feed continuously for 7 to 14 d. 066104
bacterial enteritis caused If symptoms persist after using
by E. coli and bacterial for 2 or 3 d, consult a
pneumonia caused by P. veterinarian. Treatment should
multocida susceptible to continue 24 to 48 hours beyond
oxytetracycline; treatment remission of disease symptoms.
and control of Withdraw 5 d before slaughter
colibacillosis (bacterial
enteritis) caused by E.
coli susceptible to
neomycin
----------------------------------------------------------------------------------------------------------------
(iv) To provide 25 mg/head/ Calves (250 to 400 lb): For ................................. 066104
day increased rate of weight
gain and improved feed
efficiency
----------------------------------------------------------------------------------------------------------------
(v) To provide 75 mg/head/ Growing cattle (over 400 ................................. 066104
day lb): For increased rate of
weight gain; improved feed
efficiency, and reduction
of liver condemnation due
to liver abscesses
----------------------------------------------------------------------------------------------------------------
(vi) To provide 0.5 to 2.0 g/ Cattle: For prevention and Feed 3 to 5 d before and after 066104
head/day treatment of the early arrival in feedlots. A
stages of shipping fever withdrawal period has not been
complex established for use in
preruminating calves. Do not use
in calves to be processed for
veal. A milk discard time has
not been established for use in
lactating dairy cattle. Do not
use in female dairy cattle 20
months of age or older
----------------------------------------------------------------------------------------------------------------
0
5. In Sec. 558.460, redesignate paragraphs (d)(2)(vi), (d)(2)(vii),
and (d)(2)(viii) as paragraphs (d)(2)(iii), (d)(2)(v), and (d)(2)(vi);
and add new paragraph (d)(2)(iv) to read as follows:
Sec. 558.460 Penicillin.
* * * * *
(d) * * *
(2) * * *
(iv) Nicarbazin alone or with roxarsone as in Sec. 558.366.
* * * * *
Dated: March 22, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06-3120 Filed 3-30-06; 8:45 am]
BILLING CODE 4160-01-S
