New Animal Drugs For Use in Animal Feed; Zilpaterol, 6018-6019 [E8-1903]
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Federal Register / Vol. 73, No. 22 / Friday, February 1, 2008 / Rules and Regulations
Injectable Solution. The supplemental
NADA provides for treatment of
infectious bovine keratoconjunctivitis
associated with Moraxella bovis and the
addition of a pathogen, Mycoplasma
hyopneumoniae, to the indication for
use for treatment of swine respiratory
disease. The application is approved as
of December 28, 2007, and the
regulations are amended in 21 CFR
522.2630 to reflect the approval.
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.
Under section 512(c)(2)(F)(iii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(iii)), this
supplemental approval qualifies for 3
years of marketing exclusivity beginning
on the date of approval.
The agency has determined under 21
CFR 25.33(a)(1) and (d)(5) 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.
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 522 is amended as follows:
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
pwalker on PROD1PC71 with PROPOSALS
Authority: 21 U.S.C. 360b.
2. In § 522.2630, revise paragraphs
(d)(1)(ii) and (d)(2)(ii) to read as follows:
I
§ 522.2630
*
Tulathromycin.
*
*
(d) * * *
(1) * * *
VerDate Aug<31>2005
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*
18:27 Jan 31, 2008
Jkt 214001
(ii) Indications for use. For the
treatment of bovine respiratory disease
(BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, and
Histophilus somni (Haemophilus
somnus), and Mycoplasma bovis; for the
control of respiratory disease in cattle at
high risk of developing BRD associated
with M. haemolytica, P. multocida, H.
somni, and M. bovis; and for the
treatment of infectious bovine
keratoconjunctivitis (IBK) associated
with Moraxella bovis.
*
*
*
*
*
(2) * * *
(ii) Indications for use. For the
treatment of swine respiratory disease
(SRD) associated with Actinobacillus
pleuropneumoniae, Pasteurella
multocida, Bordetella bronchiseptica,
Haemophilus parasuis, and
Mycoplasma hyopneumoniae.
*
*
*
*
*
Dated: January 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–1906 Filed 1–31–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal
Feed; Zilpaterol
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 a new animal drug
application (NADA) filed by Intervet,
Inc. The NADA provides for use of
zilpaterol, monensin, and tylosin in
three-way combination Type B and
Type C medicated feeds for cattle fed in
confinement for slaughter.
DATES: This rule is effective February 1,
2008.
FOR FURTHER INFORMATION CONTACT:
Gerald L. Rushin, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8103, email: gerald.rushin@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Intervet,
Inc., P.O. Box 318, 29160 Intervet Lane,
Millsboro, DE 19966, filed NADA 141–
276 that provides for use of ZILMAX
(zilpaterol hydrochloride), and
RUMENSIN (monensin), and TYLAN
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
(tylosin phosphate) Type A medicated
articles to make dry and liquid threeway combination Type B and Type C
medicated feeds used for increased rate
of weight gain, improved feed
efficiency, and increased carcass
leanness; for prevention and control of
coccidiosis due to Eimeria bovis and E.
zuernii; and for reduction of incidence
of liver abscesses caused by
Fusobacterium necrophorum and
Arcanobacterium (Actinomyces)
pyogenes in cattle fed in confinement
for slaughter during the last 20 to 40
days on feed. The NADA is approved as
of January 10, 2008, and the regulations
in 21 CFR 558.355, 558.625, and
558.665 are amended to reflect the
approval.
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)(2) that this action is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
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:
I
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 § 558.355, add paragraph
(f)(7)(iv) to read as follows:
I
§ 558.355
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Monensin.
*
*
(f) * * *
(7) * * *
E:\FR\FM\01FER1.SGM
01FER1
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*
Federal Register / Vol. 73, No. 22 / Friday, February 1, 2008 / Rules and Regulations
(iv) Zilpaterol alone or in combination
as in § 558.665.
I 3. In § 558.625, add paragraph
(f)(2)(ix) to read as follows:
(f) * * *
(2) * * *
(ix) Zilpaterol alone or in combination
as in § 558.665.
§ 558.625
Tylosin.
*
Zilpaterol.
I
*
§ 558.665
6019
*
*
*
*
*
*
(e) Conditions of use in cattle. It is
administered in feed as follows:
4. In § 558.665, revise paragraph (e) to
read as follows:
*
Zilpaterol in
grams/ton
*
Combination in
grams/ton
Limitations
Cattle fed in confinement for slaughter: For
increased rate of weight gain, improved
feed efficiency, and increased carcass
leanness in cattle fed in confinement for
slaughter during the last 20 to 40 days
on feed.
(1) 6.8 to provide
60 to 90 mg/
head/day
Indications for use
Sponsor
Feed continuously as the sole ration during
the last 20 to 40 days on feed. Withdrawal period: 3 days.
057926
Cattle fed in confinement for slaughter: As
in paragraph (e)(1) of this section; for
prevention and control of coccidiosis due
to Eimeria bovis and E. zuernii; and for
reduction of incidence of liver abscesses
caused by Fusobacterium necrophorum
and Arcanobacterium (Actinomyces)
pyogenes.
As in paragraph (e)(1) of this section; see
§§ 558.355(d) and 558.625(c) of this
chapter. Monensin and tylosin as provided by No. 000986 in § 510.600(c) of
this chapter.
057926
(2) [Reserved]
(3) [Reserved]
(4) 6.8 to provide
60 to 90 mg/
head/day
Monensin 10 to
40, plus tylosin
8 to 10
Dated: January 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–1903 Filed 1–31–08; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4160–01–S
SUPPLEMENTARY INFORMATION:
Penny J. Coleman, Acting General
Counsel, at 202–632–7003; fax 202–
632–7066 (not toll-free numbers).
I. Background
DEPARTMENT OF THE INTERIOR
National Indian Gaming Commission
25 CFR Parts 502, 522, 559 and 573
RIN 3141–AA23
Facility License Standards
National Indian Gaming
Commission (‘‘NIGC’’ or
‘‘Commission’’).
ACTION: Final rule.
pwalker on PROD1PC71 with PROPOSALS
AGENCY:
SUMMARY: The rule adds new sections
and a new part to the Commission’s
regulations that require tribes to adopt
and enforce standards for facility
licenses. These standards will help the
Commission ensure that each place,
facility or location where class II or
class III gaming will occur is located on
Indian lands eligible for gaming as
required by the Indian Gaming
Regulatory Act. The rules will ensure
that gaming facilities are constructed,
maintained and operated in a manner
that adequately protects the
environment and the public health and
safety.
DATES: Effective March 3, 2008.
VerDate Aug<31>2005
18:27 Jan 31, 2008
Jkt 214001
On October 17, 1988, Congress
enacted the Indian Gaming Regulatory
Act (‘‘IGRA’’ or ‘‘Act’’), 25 U.S.C. 2701–
21, creating the National Indian Gaming
Commission (‘‘NIGC’’ or ‘‘Commission’’)
and developing a comprehensive
framework for the regulation of gaming
on Indian lands. 25 U.S.C. 2702. The
NIGC was granted, among other things,
the authority to promulgate such
regulations and guidelines as it deems
appropriate to implement the provisions
of IGRA, 25 U.S.C. 2706(b)(10), as well
as oversight and enforcement authority,
including the authority to monitor tribal
compliance with the Act, Commission
regulations, and tribal gaming
ordinances.
First, the IGRA allows gaming on
Indian lands pursuant to 25 U.S.C.
2703(4), and it contains a general
prohibition against gaming on lands
acquired into trust by the United States
for the benefit of the tribe after the Act’s
effective date of October 17, 1988,
unless one of several exceptions are
met. 25 U.S.C. 2719. The Commission
has jurisdiction only over gaming
operations on Indian lands and
therefore must establish that it has
jurisdiction as a prerequisite to its
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
monitoring, enforcement, and oversight
duties. 25 U.S.C. 2702(3).
Second, the NIGC needs to obtain
information on a tribe’s environmental
and public health and safety laws to
oversee the implementation of approved
tribal gaming ordinances. Before
opening a gaming operation, a tribe
must adopt an ordinance governing
gaming activities on its Indian lands. 25
U.S.C. 2710. The Act specifies a number
of mandatory provisions to be contained
in each tribal gaming ordinance and
subjects such ordinances to the NIGC
Chairman’s approval. Id. Approval by
the Chairman is predicated on the
inclusion of each of the Act’s specified
mandatory provisions in the tribal
gaming ordinance. Id. Among these is a
requirement that the ordinance must
contain a provision ensuring that ‘‘the
construction and maintenance of the
gaming operation, and the operation of
that gaming is conducted in a manner
that adequately protects the
environment and the public health and
safety.’’ 25 U.S.C. 2710(b)(2)(E). Since
1993, when the Commission became
operational, the Chairman has required
each tribal gaming ordinance submitted
for approval to include the express
environmental and public health and
safety statement set out in 25 U.S.C.
2710(b)(2)(E).
The Commission believes that tribes
must have some form of basic laws in
the following environmental and public
health and safety areas: (1) Emergency
preparedness, including but not limited
E:\FR\FM\01FER1.SGM
01FER1
]]>Agencies
[Federal Register Volume 73, Number 22 (Friday, February 1, 2008)]
[Rules and Regulations]
[Pages 6018-6019]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-1903]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal Feed; Zilpaterol
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 a new animal drug application
(NADA) filed by Intervet, Inc. The NADA provides for use of zilpaterol,
monensin, and tylosin in three-way combination Type B and Type C
medicated feeds for cattle fed in confinement for slaughter.
DATES: This rule is effective February 1, 2008.
FOR FURTHER INFORMATION CONTACT: Gerald L. Rushin, Center for
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8103, e-mail:
gerald.rushin@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160
Intervet Lane, Millsboro, DE 19966, filed NADA 141-276 that provides
for use of ZILMAX (zilpaterol hydrochloride), and RUMENSIN (monensin),
and TYLAN (tylosin phosphate) Type A medicated articles to make dry and
liquid three-way combination Type B and Type C medicated feeds used for
increased rate of weight gain, improved feed efficiency, and increased
carcass leanness; for prevention and control of coccidiosis due to
Eimeria bovis and E. zuernii; and for reduction of incidence of liver
abscesses caused by Fusobacterium necrophorum and Arcanobacterium
(Actinomyces) pyogenes in cattle fed in confinement for slaughter
during the last 20 to 40 days on feed. The NADA is approved as of
January 10, 2008, and the regulations in 21 CFR 558.355, 558.625, and
558.665 are amended to reflect the approval.
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)(2) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
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. 558.355, add paragraph (f)(7)(iv) to read as follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(7) * * *
[[Page 6019]]
(iv) Zilpaterol alone or in combination as in Sec. 558.665.
0
3. In Sec. 558.625, add paragraph (f)(2)(ix) to read as follows:
Sec. 558.625 Tylosin.
* * * * *
(f) * * *
(2) * * *
(ix) Zilpaterol alone or in combination as in Sec. 558.665.
0
4. In Sec. 558.665, revise paragraph (e) to read as follows:
Sec. 558.665 Zilpaterol.
* * * * *
(e) Conditions of use in cattle. It is administered in feed as
follows:
----------------------------------------------------------------------------------------------------------------
Zilpaterol in Combination in
grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 6.8 to ................. Cattle fed in confinement for Feed continuously as the sole 057926
provide 60 to slaughter: For increased rate ration during the last 20 to
90 mg/head/day of weight gain, improved feed 40 days on feed. Withdrawal
efficiency, and increased period: 3 days.
carcass leanness in cattle
fed in confinement for
slaughter during the last 20
to 40 days on feed.
----------------------------------------------------------------------------------------------------------------
(2) [Reserved] ................. .............................. .............................. ...........
----------------------------------------------------------------------------------------------------------------
(3) [Reserved] ................. .............................. .............................. ...........
----------------------------------------------------------------------------------------------------------------
(4) 6.8 to Monensin 10 to Cattle fed in confinement for As in paragraph (e)(1) of this 057926
provide 60 to 40, plus tylosin slaughter: As in paragraph section; see Sec. Sec.
90 mg/head/day 8 to 10 (e)(1) of this section; for 558.355(d) and 558.625(c) of
prevention and control of this chapter. Monensin and
coccidiosis due to Eimeria tylosin as provided by No.
bovis and E. zuernii; and for 000986 in Sec. 510.600(c)
reduction of incidence of of this chapter.
liver abscesses caused by
Fusobacterium necrophorum and
Arcanobacterium (Actinomyces)
pyogenes.
----------------------------------------------------------------------------------------------------------------
Dated: January 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-1903 Filed 1-31-08; 8:45 am]
BILLING CODE 4160-01-S
