Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin, 17890 [E8-6706]
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17890
Federal Register / Vol. 73, No. 64 / Wednesday, April 2, 2008 / Rules and Regulations
Issued in Fort Worth, TX, on March 20,
2008.
Ronnie L. Uhlenhaker,
Acting Manager, System Support Group, ATO
Central Service Center.
[FR Doc. E8–6580 Filed 4–1–08; 8:45 am]
BILLING CODE 4910–13–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Enrofloxacin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by Bayer
HealthCare, LLC. The supplemental
NADA provides for the use of
enrofloxacin injectable solution in
female dairy cattle less than 20 months
of age.
DATES: This rule is effective April 2,
2008.
FOR FURTHER INFORMATION CONTACT: Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8342, email: joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Bayer
HealthCare, LLC, Animal Health
Division, P.O. Box 390, Shawnee
Mission, KS 66201, filed a supplement
to NADA 141–068 for BAYTRIL 100
(enrofloxacin) injectable solution used
for the treatment of bovine respiratory
disease associated with several bacterial
pathogens. The supplemental NADA
provides for the use of enrofloxacin
injectable solution in female dairy cattle
less than 20 months of age. The
supplemental NADA is approved as of
February 13, 2008, and the regulations
in 21 CFR 522.812 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.
mstockstill on PROD1PC66 with RULES
SUMMARY:
VerDate Aug<31>2005
18:23 Apr 01, 2008
Jkt 214001
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) 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
Authority: 21 U.S.C. 360b.
2. In § 522.812, revise paragraphs
(e)(2)(i) through (e)(2)(iii) to read as
follows:
I
§ 522.812
*
Enrofloxacin.
*
*
*
(e) * * *
(2) * * *
(i) Amount. Single-dose therapy: 7.5
to 12.5 mg/kg of body weight by
subcutaneous injection. Multiple-day
therapy: 2.5 to 5.0 mg/kg of body weight
by subcutaneous injection. Treatment
should be repeated at 24-hour intervals
for 3 days. Additional treatments may
be given on days 4 and 5 to animals that
have shown clinical improvement but
not total recovery.
(ii) Indications for use. For the
treatment of bovine respiratory disease
(BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, and
Histophilus somni (previously
Haemophilus somnus) in beef and nonlactating dairy cattle.
(iii) Limitations. Animals intended for
human consumption must not be
slaughtered within 28 days from the last
treatment. Do not use in female dairy
cattle 20 months of age or older. Use of
enrofloxacin in this class of cattle may
cause milk residues. A withdrawal
PO 00000
*
Frm 00010
Fmt 4700
Sfmt 4700
period has not been established for this
product in pre-ruminating calves. Do
not use in calves to be processed for
veal.
Dated: March 21, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–6706 Filed 4–1–08; 8:45 am]
BILLING CODE 4160–01–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R07–OAR–2008–0100; FRL–8549–6]
Approval and Promulgation of
Implementation Plans; State of
Missouri
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
SUMMARY: EPA is taking direct final
action to approve Missouri’s request to
revise the State Implementation Plan
(SIP) to include the State’s recently
revised ozone season NOX cap and trade
rules for electric generating units (EGUs)
and non-electric generating units (Non–
EGUs) submitted on May 18, 2007. Two
existing rules were revised by the State
to allow for the transition into the
State’s recently adopted ozone season
trading rule to meet the requirements of
the Clean Air Interstate Rule (CAIR).
The ozone season rules, an interstate
cap and trade rule for EGUs and Non–
EGUs in the eastern one-third of the
State and a statewide intrastate trading
rule for EGUs, were revised to include
language that will rescind their
requirements in the year 2009, the year
CAIR compliance begins. The CAIR
ozone season trading rule is more
restrictive than the aforementioned
rules, and this action is needed to avoid
imposing duplicative requirements for
the affected sources in the year 2009
and thereafter.
DATES: This direct final rule will be
effective June 2, 2008, without further
notice, unless EPA receives adverse
comment by May 2, 2008. If adverse
comment is received, EPA will publish
a timely withdrawal of the direct final
rule in the Federal Register informing
the public that the rule will not take
effect.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R07–
OAR–2008–0100, by one of the
following methods:
1. https://www.regulations.gov. Follow
the on-line instructions for submitting
comments.
E:\FR\FM\02APR1.SGM
02APR1
]]>Agencies
[Federal Register Volume 73, Number 64 (Wednesday, April 2, 2008)]
[Rules and Regulations]
[Page 17890]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6706]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Enrofloxacin
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 supplemental new animal drug
application (NADA) filed by Bayer HealthCare, LLC. The supplemental
NADA provides for the use of enrofloxacin injectable solution in female
dairy cattle less than 20 months of age.
DATES: This rule is effective April 2, 2008.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8342, e-mail:
joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Bayer HealthCare, LLC, Animal Health
Division, P.O. Box 390, Shawnee Mission, KS 66201, filed a supplement
to NADA 141-068 for BAYTRIL 100 (enrofloxacin) injectable solution used
for the treatment of bovine respiratory disease associated with several
bacterial pathogens. The supplemental NADA provides for the use of
enrofloxacin injectable solution in female dairy cattle less than 20
months of age. The supplemental NADA is approved as of February 13,
2008, and the regulations in 21 CFR 522.812 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.
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) 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.
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 522.812, revise paragraphs (e)(2)(i) through (e)(2)(iii) to
read as follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(e) * * *
(2) * * *
(i) Amount. Single-dose therapy: 7.5 to 12.5 mg/kg of body weight
by subcutaneous injection. Multiple-day therapy: 2.5 to 5.0 mg/kg of
body weight by subcutaneous injection. Treatment should be repeated at
24-hour intervals for 3 days. Additional treatments may be given on
days 4 and 5 to animals that have shown clinical improvement but not
total recovery.
(ii) Indications for use. For the treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, and Histophilus somni (previously Haemophilus somnus) in
beef and non-lactating dairy cattle.
(iii) Limitations. Animals intended for human consumption must not
be slaughtered within 28 days from the last treatment. Do not use in
female dairy cattle 20 months of age or older. Use of enrofloxacin in
this class of cattle may cause milk residues. A withdrawal period has
not been established for this product in pre-ruminating calves. Do not
use in calves to be processed for veal.
Dated: March 21, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-6706 Filed 4-1-08; 8:45 am]
BILLING CODE 4160-01-S
