Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by RMS Laboratories, Inc. The NADA provides for use of triamcinolone topical spray in dogs for the control of pruritus associated with allergic dermatitis.
This rule is effective January 31, 2003.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: email@example.com.End Further Info End Preamble Start Supplemental Information
RMS Laboratories, Inc., 1903 East First St., Vidalia, GA 30474, filed NADA 141-210 that provides for use of GENESIS (triamcinolone acetonide) Topical Spray in dogs for the control of pruritus associated with allergic dermatitis. The NADA is approved as of November 4, 2002, and the regulations are amended in part 524 (21 CFR part 524) by adding new § 524.2482 to reflect the approval. The basis of approval is discussed in the freedom of information summary.
In addition, RMS Laboratories, Inc., has not been previously listed in the animal drug regulations as a sponsor of an approved application. At this time, 21 CFR 510.600(c) is being amended to add entries for the firm.
In accordance with the freedom of information provisions of 21 CFR part 20 and 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 Dockets Management Branch (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.
Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning November 4, 2002.
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.Start List of Subjects
List of Subjects
- Administrative practice and procedure
- Animal drugs
- Reporting and recordkeeping requirements
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine,End Amendment Part Start Part Start Printed Page 4916
PART 510—NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part Start Amendment Part
2. Section 510.600 is amended in the table in paragraph (c)(1) by alphabetically adding an entry for “RMS Laboratories, Inc.” and in the table in paragraph (c)(2) by numerically adding an entry for “067292” to read as follows:End Amendment Part
(c) * * *
(1) * * *
|Firm name and address||Drug labeler code|
|* * * * *|
|RMS Laboratories, Inc., 1903 East First St., Vidalia, GA 30474||067292|
|* * * * *|
(2) * * *
|Drug labeler code||Firm name and address|
|* * * * *|
|067292||RMS Laboratories, Inc., 1903 East First St., Vidalia, GA 30474|
|* * * * *|
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
3. The authority citation forEnd Amendment Part Start Amendment Part
4. Section 524.2482 is added to read as follows:End Amendment Part
(a) Specifications. Each milliliter of solution contains 0.15 milligrams triamcinolone acetonide.
(b) Sponsor. See No. 067292 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1) Amount. Apply sufficient pump sprays to uniformly and thoroughly wet the affected areas while avoiding run off of excess product. Administer twice daily for 7 days, then once daily for 7 days, then every other day for an additional 14 days (28 days total).
(2) Indications for use. For the control of pruritus associated with allergic dermatitis.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.Start Signature
Dated: January 10, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-2211 Filed 1-30-03; 8:45 am]
BILLING CODE 4160-01-S