Ophthalmic and Topical Dosage Form New Animal Drugs; Triamcinolone Cream, 79318 [E8-30694]
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Federal Register / Vol. 73, No. 249 / Monday, December 29, 2008 / Rules and Regulations
Shippers did not provide sufficient
justification for the Commission to
further modify the requirements of
FERC Form Nos. 6 and 6–Q.
9. The Commission recognizes that
FERC Form No. 6 contains only enough
information for a threshold
determination of whether the existing
rates are just and reasonable. However,
the Commission concludes that FERC
Form Nos. 6 and 6–Q continue to
provide sufficient information to allow
shippers to file a complaint requesting
a determination of the justness and
reasonableness of a pipeline’s rates.
Accordingly, the Commission concludes
that no changes to FERC Form Nos. 6
and 6–Q are warranted at this time, and
the Commission terminates Docket No.
RM07–9–000.
The Commission Orders
Docket No. RM07–9–000 is hereby
terminated, as discussed in the body of
this order.
By the Commission.
Kimberly D. Bose,
Secretary.
[FR Doc. E8–30621 Filed 12–24–08; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0039]
21 CFR Part 524
Ophthalmic and Topical Dosage Form
New Animal Drugs; Triamcinolone
Cream
AGENCY:
Food and Drug Administration,
HHS.
dwashington3 on PROD1PC60 with RULES
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an abbreviated new animal
drug application (ANADA) filed by
Modern Veterinary Therapeutics, LLC.
The ANADA provides for veterinary
prescription use of triamcinolone cream
on dogs for topical treatment of allergic
dermatitis and summer eczema.
DATES: This rule is effective December
29, 2008.
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, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Modern
Veterinary Therapeutics, LLC, 1550
VerDate Aug<31>2005
13:28 Dec 24, 2008
Jkt 217001
Madruga Ave., suite 329, Coral Gables,
FL 33146, filed ANADA 200–459 that
provides for veterinary prescription use
of VETAZINE (triamcinolone acetonide)
Cream on dogs for topical treatment of
allergic dermatitis and summer eczema.
Modern Veterinary Therapeutics, LLC’s
VETAZINE Cream is approved as a
generic copy of VETALOG Cream,
sponsored by Fort Dodge Animal
Health, A Division of Wyeth Holdings
Corp., under NADA 46–146. The
ANADA is approved as of November 13,
2008, and the regulations are amended
in § 524.2481 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)(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.
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 524 is amended as follows:
■
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 524 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
2. In § 524.2481, revise paragraphs (b),
(c)(2), and (c)(3) to read as follows:
■
§ 524.2481
Triamcinolone cream.
*
*
*
*
*
(b) Sponsor. See Nos. 015914, 053501,
and 054925 in § 510.600(c) of this
chapter.
(c) * * *
PO 00000
Frm 00052
Fmt 4700
Sfmt 4700
(2) Indications for use. For topical
treatment of allergic dermatitis and
summer eczema.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: December 18, 2008.
William T. Flynn,
Acting Director, Center for Veterinary
Medicine.
[FR Doc. E8–30694 Filed 12–24–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1314
[Docket No. DEA–298F]
RIN 1117–AB13
Combat Methamphetamine Epidemic
Act of 2005: Fee for Self-Certification
for Regulated Sellers of Scheduled
Listed Chemical Products
AGENCY: Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Final rule.
SUMMARY: To comply with the
requirement of the Controlled
Substances Act that fees be set at a level
to ensure the recovery of the full costs
of operating the various aspects of the
Diversion Control Program, this Final
Rule establishes an annual selfcertification fee for certain ‘‘regulated
sellers,’’ that is, persons and entities
selling scheduled listed chemical
products at retail locations who are
required to self-certify with DEA
relative to compliance with certain
requirements of the Combat
Methamphetamine Epidemic Act of
2005 (CMEA). This Final Rule
establishes the annual self-certification
fee for regulated sellers who are not
DEA pharmacy registrants.
DATES: Effective Date: February 1, 2009.
The new fee will be in effect for all new
applications electronically sent on or
after the effective date and for all
renewal applications electronically sent
on or after the effective date.
FOR FURTHER INFORMATION CONTACT:
Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion
Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152; Telephone (202)
307–7297.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\29DER1.SGM
29DER1
]]>Agencies
[Federal Register Volume 73, Number 249 (Monday, December 29, 2008)]
[Rules and Regulations]
[Page 79318]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-30694]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0039]
21 CFR Part 524
Ophthalmic and Topical Dosage Form New Animal Drugs;
Triamcinolone Cream
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 abbreviated new animal drug
application (ANADA) filed by Modern Veterinary Therapeutics, LLC. The
ANADA provides for veterinary prescription use of triamcinolone cream
on dogs for topical treatment of allergic dermatitis and summer eczema.
DATES: This rule is effective December 29, 2008.
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: Modern Veterinary Therapeutics, LLC, 1550
Madruga Ave., suite 329, Coral Gables, FL 33146, filed ANADA 200-459
that provides for veterinary prescription use of VETAZINE
(triamcinolone acetonide) Cream on dogs for topical treatment of
allergic dermatitis and summer eczema. Modern Veterinary Therapeutics,
LLC's VETAZINE Cream is approved as a generic copy of VETALOG Cream,
sponsored by Fort Dodge Animal Health, A Division of Wyeth Holdings
Corp., under NADA 46-146. The ANADA is approved as of November 13,
2008, and the regulations are amended in Sec. 524.2481 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)(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 524 is
amended as follows:
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 524.2481, revise paragraphs (b), (c)(2), and (c)(3) to read
as follows:
Sec. 524.2481 Triamcinolone cream.
* * * * *
(b) Sponsor. See Nos. 015914, 053501, and 054925 in Sec.
510.600(c) of this chapter.
(c) * * *
(2) Indications for use. For topical treatment of allergic
dermatitis and summer eczema.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: December 18, 2008.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. E8-30694 Filed 12-24-08; 8:45 am]
BILLING CODE 4160-01-S
