Implantation or Injectable Dosage Form New Animal Drugs; Flunixin, 76260 [2010-30769]
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Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Rules and Regulations
Dated: December 2, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
and for 36 hours after the last treatment
must not be used for food. Do not use
in dry dairy cows. A withdrawal period
has not been established for use in
preruminating calves. Do not use in
calves to be processed for veal.
*
*
*
*
*
Food and Drug Administration
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.
21 CFR Part 522
List of Subjects in 21 CFR Part 522
[FR Doc. 2010–30769 Filed 12–7–10; 8:45 am]
[FR Doc. 2010–30814 Filed 12–7–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Animal drugs.
[Docket No. FDA–2010–N–0002]
Dated: December 1, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
BILLING CODE 4160–01–P
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:
■
Implantation or Injectable Dosage
Form New Animal Drugs; Flunixin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
jlentini on DSKJ8SOYB1PROD with RULES
17:00 Dec 07, 2010
24 CFR Parts 5, 84, and 85
[Docket No. FR–5350–F–02]
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental abbreviated
new animal drug application (ANADA)
filed by Agri Laboratories, Ltd. The
supplemental ANADA provides for use
of flunixin meglumine solution by
intravenous injection in lactating dairy
cows for control of pyrexia associated
with acute bovine mastitis.
DATES: This rule is effective December 8,
2010.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197,
e-mail: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Agri
Laboratories, Ltd., P.O. Box 3103, St.
Joseph, MO 64503, filed a supplement
to ANADA 200–061 that provides for
veterinary prescription use of FLU–NIX
(flunixin meglumine) Injectable
Solution. The supplemental ANADA
provides for use of flunixin meglumine
solution by intravenous injection in
lactating dairy cows for control of
pyrexia associated with acute bovine
mastitis. The supplemental application
is approved as of September 27, 2010,
and the regulations are amended in 21
CFR 522.970 to reflect the approval.
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 that this action is of a type
that does not individually or
SUMMARY:
VerDate Mar<15>2010
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
Jkt 223001
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.
2. In § 522.970, revise paragraphs (b),
(e)(1)(iii), and (e)(2) to read as follows:
■
§ 522.970
Conforming Changes to Applicant
Submission Requirements;
Implementing Federal Financial Report
and Central Contractor Registration
Requirements
*
*
*
*
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (e) of this section.
(1) See Nos. 000061, 055529, and
061623 for use as in paragraph (e) of this
section.
(2) See No. 000856 for use as in
paragraph (e)(1) of this section.
(3) See Nos. 057561 and 059130 for
use as in paragraphs (e)(1) and (2) of this
section.
*
*
*
*
*
(e) * * *
(1) * * *
(iii) Limitations. Do not use in horses
intended for human consumption.
(2) Cattle—(i) Amounts and
indications for use—(A) Administer 1.1
to 2.2 mg/kilogram (kg) (0.5 to 1.0 mg/
lb) of body weight per day
intravenously, as a single dose or
divided into two doses administered at
12-hour intervals, for up to 3 days for
control of pyrexia associated with
bovine respiratory disease and
endotoxemia or for control of
inflammation in endotoxemia.
(B) Administer 2.2 mg/kg (1.0 mg/lb)
of body weight once intravenously for
control of pyrexia associated with acute
bovine mastitis.
(ii) Limitations. Cattle must not be
slaughtered for human consumption
within 4 days of last treatment. Milk
that has been taken during treatment
Frm 00008
Fmt 4700
Sfmt 4700
Office of the Secretary, HUD.
Final rule.
AGENCY:
ACTION:
Flunixin.
*
PO 00000
RIN 2501–AD50
This final rule follows
publication of a July 15, 2010, interim
rule that revised HUD regulations to
reference the new governmentwide
Federal Financial Report (FFR)
approved by the Office of Management
and Budget (OMB). The FFR
consolidates requirements from the
OMB-issued Standard Forms SF–269,
SF–269A, SF–272, and SF–272A into a
single governmentwide form. In
incorporating reference to the new FFR
in its regulations, HUD amended its
regulations to remove references to old
and outdated forms that are no longer in
use. The July 15, 2010, interim rule also
codified the requirement that applicants
for HUD assistance possess an active
Central Contractor Registration (CCR).
HUD is adopting the interim rule
without change.
DATES: Effective Date: January 7, 2011.
FOR FURTHER INFORMATION CONTACT:
Barbara Dorf, Director, Office of
Departmental Grants Management and
Oversight, Office of Administration,
Chief Human Capital Officer,
Department of Housing and Urban
Development, 451 7th Street, SW.,
Room 3156, Washington, DC 20410–
0500, telephone number 202–708–0667.
Persons with hearing or speech
impairments may access this number
through TTY by calling the toll-free
Federal Information Relay Service at
800–877–8339.
SUMMARY:
E:\FR\FM\08DER1.SGM
08DER1
]]>Agencies
[Federal Register Volume 75, Number 235 (Wednesday, December 8, 2010)]
[Rules and Regulations]
[Page 76260]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30769]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2010-N-0002]
Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
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 abbreviated new
animal drug application (ANADA) filed by Agri Laboratories, Ltd. The
supplemental ANADA provides for use of flunixin meglumine solution by
intravenous injection in lactating dairy cows for control of pyrexia
associated with acute bovine mastitis.
DATES: This rule is effective December 8, 2010.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Agri Laboratories, Ltd., P.O. Box 3103, St.
Joseph, MO 64503, filed a supplement to ANADA 200-061 that provides for
veterinary prescription use of FLU-NIX (flunixin meglumine) Injectable
Solution. The supplemental ANADA provides for use of flunixin meglumine
solution by intravenous injection in lactating dairy cows for control
of pyrexia associated with acute bovine mastitis. The supplemental
application is approved as of September 27, 2010, and the regulations
are amended in 21 CFR 522.970 to reflect the approval.
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 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. 522.970, revise paragraphs (b), (e)(1)(iii), and (e)(2) to
read as follows:
Sec. 522.970 Flunixin.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (e) of this section.
(1) See Nos. 000061, 055529, and 061623 for use as in paragraph (e)
of this section.
(2) See No. 000856 for use as in paragraph (e)(1) of this section.
(3) See Nos. 057561 and 059130 for use as in paragraphs (e)(1) and
(2) of this section.
* * * * *
(e) * * *
(1) * * *
(iii) Limitations. Do not use in horses intended for human
consumption.
(2) Cattle--(i) Amounts and indications for use--(A) Administer 1.1
to 2.2 mg/kilogram (kg) (0.5 to 1.0 mg/lb) of body weight per day
intravenously, as a single dose or divided into two doses administered
at 12-hour intervals, for up to 3 days for control of pyrexia
associated with bovine respiratory disease and endotoxemia or for
control of inflammation in endotoxemia.
(B) Administer 2.2 mg/kg (1.0 mg/lb) of body weight once
intravenously for control of pyrexia associated with acute bovine
mastitis.
(ii) Limitations. Cattle must not be slaughtered for human
consumption within 4 days of last treatment. Milk that has been taken
during treatment and for 36 hours after the last treatment must not be
used for food. Do not use in dry dairy cows. A withdrawal period has
not been established for use in preruminating calves. Do not use in
calves to be processed for veal.
* * * * *
Dated: December 1, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-30769 Filed 12-7-10; 8:45 am]
BILLING CODE 4160-01-P
