Ophthalmic and Topical Dosage Form New Animal Drugs; Triamcinolone Cream, 79318 [E8-30694]

Download as PDF 79318 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.

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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