New Animal Drugs for Use in Animal Feeds; Bacitracin; Nitarsone; Zoalene, 16222-16223 [06-3122]
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Federal Register / Vol. 71, No. 62 / Friday, March 31, 2006 / Rules and Regulations
prescription for the control of
inflammation in horses and cattle. Cross
Vetpharm Group’s Flunixin Injectable
Solution is approved as a generic copy
of Schering-Plough Animal Health’s
BANAMINE (flunixin) Solution,
approved under NADA 101–479. The
ANADA is approved as of March 2,
2006, and the regulations in 21 CFR
522.970 are amended to reflect the
approval. The basis of approval is
discussed in the freedom of information
summary.
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 Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
The agency has determined under 21
CFR 25.33(a)(1) that this action is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects in 21 CFR Part 522
Animal drugs.
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 522 is amended as follows:
I
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
[Amended]
2. Section 522.970 is amended in
paragraphs (b)(2) and (e)(2)(iii) by
removing ‘‘and 059130’’ and by adding
in its place ‘‘059130, and 061623’’.
hsrobinson on PROD1PC61 with RULES
I
Dated: March 13, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06–3118 Filed 3–30–06; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
14:51 Mar 30, 2006
Jkt 208001
Food and Drug Administration
21 CFR Part 558
[Docket No. 2003N–0324]
New Animal Drugs for Use in Animal
Feeds; Bacitracin; Nitarsone; Zoalene
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 three supplemental new
animal drug applications (NADAs) filed
by Alpharma, Inc. Two of the
supplemental NADAs provide for the
use of approved, single-ingredient Type
A medicated articles containing
bacitracin methylene disalicylate and
zoalene, with or without roxarsone, to
formulate two-way or three-way
combination drug Type C medicated
feeds for replacement chickens. The
third NADA provides for the use of
bacitracin zinc and nitarsone singleingredient Type A medicated articles for
two-way combination Type C medicated
feeds for growing turkeys. 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 57911), 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 NADAs for those products
or use combinations lacking substantial
evidence of effectiveness following a 90day opportunity to supplement the
NADAs with labeling conforming to the
relevant findings of effectiveness.
Alpharma, Inc., One Executive Dr., Fort
Lee, NJ 07024, filed supplements to
three of its approved NADAs to revise
SUPPLEMENTARY INFORMATION:
I
§ 522.970
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
Frm 00030
Fmt 4700
Sfmt 4700
the labeling of its products to comply
with these findings of effectiveness.
Alpharma, Inc., filed a supplement to
approved NADA 141–130 for use of
bacitracin methylene disalicylate and
zoalene 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
BMD (bacitracin methylene disalicylate)
at 4 to 50 grams per ton (g/ton) and
ZOAMIX (zoalene) at 36.3 to 113.5 g/ton
of feed in replacement chickens for
increased rate of weight gain and
improved feed efficiency; and for
development of active immunity to
coccidiosis.
Alpharma, Inc., also filed a
supplement to approved NADA 141–
131 for use of bacitracin methylene
disalicylate, zoalene, 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
BMD (bacitracin methylene disalicylate)
at 4 to 50 g/ton, ZOAMIX (zoalene) at
36.3 to 113.5 g/ton, and 3–NITRO
(roxarsone) at 22.7 to 45.4 g/ton of feed
in replacement chickens for increased
rate of weight gain and improved feed
efficiency; for development of active
immunity to coccidiosis; and for
improved pigmentation.
Alpharma, Inc., also filed a
supplement to approved NADA 141–
132 for use of bacitracin zinc and
nitarsone single-ingredient Type A
medicated articles to make two-way
combination drug Type C medicated
feeds. This supplemental NADA
provides for the use of combination
feeds containing ALBAC (bacitracin
zinc) at 4 to 50 g/ton and HISTOSTAT
(nitarsone) at 170 g/ton (0.01875
percent) of feed in growing turkeys for
increased rate of weight gain and
improved feed efficiency; and as an aid
in the prevention of blackhead.
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
E:\FR\FM\31MRR1.SGM
31MRR1
16223
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:
*
*
*
*
(d) * * *
(3) * * *
(x) Nitarsone as in § 558.369.
*
*
*
*
*
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) * * *
*
*
*
*
*
*
*
*
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
VerDate Aug<31>2005
14:51 Mar 30, 2006
Jkt 208001
PO 00000
Frm 00031
Fmt 4700
Sfmt 4700
*
*
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
E:\FR\FM\31MRR1.SGM
31MRR1
]]>Agencies
[Federal Register Volume 71, Number 62 (Friday, March 31, 2006)]
[Rules and Regulations]
[Pages 16222-16223]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3122]
-----------------------------------------------------------------------
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; Nitarsone;
Zoalene
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 three supplemental new animal
drug applications (NADAs) filed by Alpharma, Inc. Two of the
supplemental NADAs provide for the use of approved, single-ingredient
Type A medicated articles containing bacitracin methylene disalicylate
and zoalene, with or without roxarsone, to formulate two-way or three-
way combination drug Type C medicated feeds for replacement chickens.
The third NADA provides for the use of bacitracin zinc and nitarsone
single-ingredient Type A medicated articles for two-way combination
Type C medicated feeds for growing turkeys. 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 57911), 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
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. Alpharma, Inc., One Executive Dr., Fort Lee, NJ 07024,
filed supplements to three of its approved NADAs to revise the labeling
of its products to comply with these findings of effectiveness.
Alpharma, Inc., filed a supplement to approved NADA 141-130 for use
of bacitracin methylene disalicylate and zoalene 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 BMD (bacitracin methylene disalicylate) at 4 to 50 grams per
ton (g/ton) and ZOAMIX (zoalene) at 36.3 to 113.5 g/ton of feed in
replacement chickens for increased rate of weight gain and improved
feed efficiency; and for development of active immunity to coccidiosis.
Alpharma, Inc., also filed a supplement to approved NADA 141-131
for use of bacitracin methylene disalicylate, zoalene, 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 BMD (bacitracin
methylene disalicylate) at 4 to 50 g/ton, ZOAMIX (zoalene) at 36.3 to
113.5 g/ton, and 3-NITRO (roxarsone) at 22.7 to 45.4 g/ton of feed in
replacement chickens for increased rate of weight gain and improved
feed efficiency; for development of active immunity to coccidiosis; and
for improved pigmentation.
Alpharma, Inc., also filed a supplement to approved NADA 141-132
for use of bacitracin zinc and nitarsone single-ingredient Type A
medicated articles to make two-way combination drug Type C medicated
feeds. This supplemental NADA provides for the use of combination feeds
containing ALBAC (bacitracin zinc) at 4 to 50 g/ton and HISTOSTAT
(nitarsone) at 170 g/ton (0.01875 percent) of feed in growing turkeys
for increased rate of weight gain and improved feed efficiency; and as
an aid in the prevention of blackhead.
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
[[Page 16223]]
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.
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.
Sec. 558.76 [Amended]
0
2. In Sec. 558.76, amend paragraph (d)(3)(xviii) by adding ``or
roxarsone'' after ``arsanilic acid''.
0
3. In Sec. 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:
Sec. 558.78 Bacitracin zinc.
* * * * *
(d) * * *
(3) * * *
(x) Nitarsone as in Sec. 558.369.
* * * * *
Sec. 558.369 [Amended]
0
4. In Sec. 558.369, amend paragraph (d)(2)(i) by adding ``or
bacitracin zinc'' after ``disalicylate''.
0
5. In Sec. 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:
Sec. 558.680 Zoalene.
* * * * *
(d) * * *
(1) * * *
------------------------------------------------------------------------
Zoalene in Combination
grams/ton in grams/ton Indications for use Limitations
------------------------------------------------------------------------
(i) * * *
Bacitracin 4 Replacement Feed as in subtable
to 50 chickens: For in Sec.
development of 558.680(d)(1)(i);
active immunity to grower ration not
coccidiosis; for to be fed to birds
increased rate of over 14 weeks of
weight gain, age. As bacitracin
improved feed methylene
efficiency disalicylate
provided by No.
046573 in Sec.
510.600(c) of this
chapter
Bacitracin Replacement Feed as in subtable
methylene chickens: For in Sec.
disalicylate development of 558.680(d)(1)(i);
4 to 50 plus active immunity to grower ration not
roxarsone coccidiosis; for to be fed to birds
22.7 to 45.4 increased rate of over 14 weeks of
weight gain, age. Discontinue
improved feed use 5 days before
efficiency, and slaughter; as sole
improved source of organic
pigmentation arsenic; drug
overdose or lack of
water may result in
leg weakness. As
bacitracin
methylene
disalicylate and
roxarsone provided
by No. 046573 in
Sec. 510.600(c)
of this chapter
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
* * * * *
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
