Implantation or Injectable Dosage Form New Animal Drugs; Flunixin, 13225 [2010-6038]
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Federal Register / Vol. 75, No. 53 / Friday, March 19, 2010 / Rules and Regulations
21 CFR Part 522
approved as a generic copy of
BANAMINE–S, sponsored by ScheringPlough Animal Health Corp. under
NADA 101–479. The ANADA is
approved as of March 1, 2010, and the
regulations are amended in 21 CFR
522.970 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 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.
[Docket No. FDA–2010–N–0002]
List of Subjects in 21 CFR Part 522
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2009–0452; Directorate
Identifier 2007–NM–326–AD; Amendment
39–16223; AD 2010–05–13]
RIN 2120–AA64
Airworthiness Directives; The Boeing
Company Model 737–100, –200, –200C,
–300, –400, and –500 Series Airplanes
Correction
In rule document 2010–4511
beginning on page 10658 in the issue of
Tuesday, March 9, 2010, make the
following correction:
On page 10660, in the table, under the
heading ‘‘Number of U.S.–registered
airplanes’’, the second entry ‘‘87’’ should
read ‘‘787’’.
[FR Doc. C1–2010–4511 Filed 3–18–10; 8:45 am]
BILLING CODE 1505–01–D
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Implantation or Injectable Dosage
Form New Animal Drugs; Flunixin
AGENCY:
Animal drugs.
Food and Drug Administration,
HHS.
erowe on DSK5CLS3C1PROD with RULES
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an original abbreviated new
animal drug application (ANADA) filed
by Cross Vetpharm Group Ltd. The
ANADA provides for the use of flunixin
meglumine injectable solution in swine.
DATES: This rule is effective March 19,
2010.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–170), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Cross
Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed
ANADA 200–489 that provides for use
of FLUNAZINE–S (flunixin meglumine)
Injectable Solution in swine for control
of pyrexia associated with swine
respiratory disease. Cross Vetpharm
Group Ltd.’s FLUNAZINE–S is
VerDate Nov<24>2008
14:13 Mar 18, 2010
Jkt 220001
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:
■
Authority: 21 U.S.C. 360b.
2. In § 522.970, revise paragraphs
(b)(1) and (b)(4) to read as follows:
■
§ 522.970
Flunixin.
*
*
*
*
*
(b) * * *
(1) See Nos. 000061, 055529, and
061623 for use as in paragraph (e) of this
section.
*
*
*
*
*
(4) See No. 059130 for use as in
paragraphs (e)(1) and (e)(2) of this
section.
*
*
*
*
*
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
13225
Dated: March 12, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010–6038 Filed 3–18–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1140
[Docket No. FDA–1995–N–0259] (formerly
Docket No. 1995N–0253)
RIN 0910–AG33
Regulations Restricting the Sale and
Distribution of Cigarettes and
Smokeless Tobacco To Protect
Children and Adolescents
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is reissuing a
final rule restricting the sale,
distribution, and use of cigarettes and
smokeless tobacco. As required by the
Family Smoking Prevention and
Tobacco Control Act (Tobacco Control
Act), FDA is issuing a final rule that is
identical to the provisions of the final
rule on cigarettes and smokeless tobacco
published by FDA in 1996, with certain
required exceptions. The rule prohibits
the sale of cigarettes and smokeless
tobacco to individuals under the age of
18 and imposes specific marketing,
labeling, and advertising requirements.
Elsewhere in this issue of the Federal
Register, FDA is issuing an advance
notice of proposed rulemaking to obtain
information related to the regulation of
outdoor advertising of cigarettes and
smokeless tobacco.
DATES: This rule is effective June 22,
2010.
FOR FURTHER INFORMATION CONTACT:
Annette Marthaler, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229, 877–287–
1373, annette.marthaler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
II. Overview of the Final Rule
III. Scientific Information That Has Become
Available Since the Publication of the 1996
Final Rule
A. Access
B. Marketing
IV. Legal Authority
V. Executive Order 12866
E:\FR\FM\19MRR1.SGM
19MRR1
]]>Agencies
[Federal Register Volume 75, Number 53 (Friday, March 19, 2010)]
[Rules and Regulations]
[Page 13225]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6038]
=======================================================================
-----------------------------------------------------------------------
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 an original abbreviated new
animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The
ANADA provides for the use of flunixin meglumine injectable solution in
swine.
DATES: This rule is effective March 19, 2010.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed ANADA 200-489 that provides for use
of FLUNAZINE-S (flunixin meglumine) Injectable Solution in swine for
control of pyrexia associated with swine respiratory disease. Cross
Vetpharm Group Ltd.'s FLUNAZINE-S is approved as a generic copy of
BANAMINE-S, sponsored by Schering-Plough Animal Health Corp. under NADA
101-479. The ANADA is approved as of March 1, 2010, and the regulations
are amended in 21 CFR 522.970 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 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)(1) and (b)(4) to read as
follows:
Sec. 522.970 Flunixin.
* * * * *
(b) * * *
(1) See Nos. 000061, 055529, and 061623 for use as in paragraph (e)
of this section.
* * * * *
(4) See No. 059130 for use as in paragraphs (e)(1) and (e)(2) of
this section.
* * * * *
Dated: March 12, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-6038 Filed 3-18-10; 8:45 am]
BILLING CODE 4160-01-S
