Oral Dosage Form New Animal Drugs; Phenylbutazone Tablets and Boluses, 1146 [E9-265]
Download as PDF
<![CDATA[
1146
Federal Register / Vol. 74, No. 7 / Monday, January 12, 2009 / Rules and Regulations
middle, 1 square foot; and inboard, 2.5
square feet).
3. Seats do not have to meet the test
requirements of Title 14 CFR part 25,
Appendix F, parts IV and V, when
installed in compartments that are not
otherwise required to meet these
requirements. Examples include:
a. Airplanes with passenger capacities
of 19 or less,
b. Airplanes that do not have § 25.853,
Amendment 25–61 or later, in their
certification basis and do not need to
comply with the requirements of 14 CFR
121.312, and
c. Airplanes exempted from § 25.853,
Amendment 25–61 or later.
Issued in Renton, Washington, on
December 24, 2008.
Linda Navarro,
Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. E9–328 Filed 1–9–09; 8:45 am]
BILLING CODE 4910–13–P
List of Subjects in 21 CFR Part 520
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Part 520
[Docket No. FDA–2008–N–0039]
Oral Dosage Form New Animal Drugs;
Phenylbutazone Tablets and Boluses
Food and Drug Administration,
HHS.
dwashington3 on PROD1PC60 with RULES
ACTION:
1. The authority citation for 21 CFR
part 520 continues to read as follows:
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 First
Priority, Inc. The supplemental
application provides for revising the
description of a 1-gram oral dosage form
of phenylbutazone from tablet to bolus.
DATES: This rule is effective January 12,
2009.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: First
Priority, Inc., 1585 Todd Farm Dr.,
Elgin, IL 60123, filed a supplement to
NADA 48–647 for the veterinary
prescription use of PRIBUTAZONE
(phenylbutazone) Tablets in horses for
the relief of inflammatory conditions
associated with the musculoskeletal
system. The supplemental application
provides for revising the description of
15:14 Jan 09, 2009
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
■
Final rule.
VerDate Nov<24>2008
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 520 is amended as follows:
■
Food and Drug Administration
AGENCY:
this 1-gram oral dosage form of
phenylbutazone from tablet to bolus.
The supplemental NADA is approved as
of December 10, 2008, and 21 CFR
520.1720a is amended to reflect the
approval.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
The agency has determined under 21
CFR 25.33(d)(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.
Jkt 217001
Authority: 21 U.S.C. 360b.
2. In § 520.1720a, revise paragraphs
(a) and (b)(3); and add paragraph (b)(6)
to read as follows:
■
§ 520.1720a
boluses.
Phenylbutazone tablets and
(a) Specifications. Each tablet
contains 100, 200, or 400 milligrams
(mg), or 1 gram (g) of phenylbutazone.
Each bolus contains 1, 2, or 4 gram g of
phenylbutazone.
(b) * * *
(3) Nos. 000856 and 061623 for use of
100-mg or 1-g tablets in dogs and horses.
*
*
*
*
*
(6) No. 058829 for use of 100-mg or
1-g tablets in dogs and horses, or 1-g
boluses in horses.
*
*
*
*
*
Dated: January 5, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E9–265 Filed 1–9–09; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00004
Fmt 4700
Sfmt 4700
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R03–OAR–2008–0736; FRL–8759–7]
Approval and Promulgation of Air
Quality Implementation Plans; the
Metropolitan Washington
Nonattainment Area; Determination of
Attainment of the Fine Particle
Standard
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: EPA is determining that the
Metropolitan Washington, DC–MD–VA
nonattainment area for the 1997 fine
particle (PM2.5) National Ambient Air
Quality Standard (NAAQS) has attained
the 1997 PM2.5 NAAQS.
DATES: Effective Date: This final rule is
effective on January 12, 2009.
ADDRESSES: EPA has established a
docket for this action under Docket ID
Number EPA–R03–OAR–2008–0736. All
documents in the docket are listed in
the www.regulations.gov Web site.
Although listed in the electronic docket,
some information is not publicly
available, i.e., confidential business
information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically through
www.regulations.gov or in hard copy for
public inspection during normal
business hours at the Air Protection
Division, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
FOR FURTHER INFORMATION CONTACT:
Melissa Linden, (215) 814–2096, or by
e-mail at linden.melissa@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document whenever
‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean
EPA.
Organization of this document. The
following outline is provided to aid in
locating information in this preamble.
I. What Action Is EPA Taking?
II. What Is the Effect of This Action?
III. When Is This Action Effective?
IV. Final Action
V. Statutory and Executive Order Reviews
I. What Action Is EPA Taking?
EPA is determining that the
Metropolitan Washington, DC–MD–VA
nonattainment area for the 1997 PM2.5
NAAQS has attained the 1997 PM2.5
E:\FR\FM\12JAR1.SGM
12JAR1
]]>Agencies
[Federal Register Volume 74, Number 7 (Monday, January 12, 2009)]
[Rules and Regulations]
[Page 1146]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-265]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2008-N-0039]
Oral Dosage Form New Animal Drugs; Phenylbutazone Tablets and
Boluses
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 First Priority, Inc. The supplemental
application provides for revising the description of a 1-gram oral
dosage form of phenylbutazone from tablet to bolus.
DATES: This rule is effective January 12, 2009.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: First Priority, Inc., 1585 Todd Farm Dr.,
Elgin, IL 60123, filed a supplement to NADA 48-647 for the veterinary
prescription use of PRIBUTAZONE (phenylbutazone) Tablets in horses for
the relief of inflammatory conditions associated with the
musculoskeletal system. The supplemental application provides for
revising the description of this 1-gram oral dosage form of
phenylbutazone from tablet to bolus. The supplemental NADA is approved
as of December 10, 2008, and 21 CFR 520.1720a is amended to reflect the
approval.
Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
The agency has determined under 21 CFR 25.33(d)(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 520
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 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 520.1720a, revise paragraphs (a) and (b)(3); and add
paragraph (b)(6) to read as follows:
Sec. 520.1720a Phenylbutazone tablets and boluses.
(a) Specifications. Each tablet contains 100, 200, or 400
milligrams (mg), or 1 gram (g) of phenylbutazone. Each bolus contains
1, 2, or 4 gram g of phenylbutazone.
(b) * * *
(3) Nos. 000856 and 061623 for use of 100-mg or 1-g tablets in dogs
and horses.
* * * * *
(6) No. 058829 for use of 100-mg or 1-g tablets in dogs and horses,
or 1-g boluses in horses.
* * * * *
Dated: January 5, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E9-265 Filed 1-9-09; 8:45 am]
BILLING CODE 4160-01-S
