[Federal Register Volume 68, Number 21 (Friday, January 31, 2003)]
[Rules and Regulations]
[Pages 4915-4916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2211]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 524


Ophthalmic and Topical Dosage Form New Animal Drugs; 
Triamcinolone Spray

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 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.

DATES: This rule is effective January 31, 2003.

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 protected].

SUPPLEMENTARY 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 Sec.  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.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 524

    Animal drugs.

    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, 21 CFR parts 510 and 
524 are amended as follows:

[[Page 4916]]

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
    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:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
RMS Laboratories, Inc., 1903 East First St.,  067292
 Vidalia, GA 30474.
                                * * * * *
------------------------------------------------------------------------

    (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 DRUGS

    3. The authority citation for 21 CFR part 524 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.
    4. Section 524.2482 is added to read as follows:


Sec.  524.2482  Triamcinolone spray.

    (a) Specifications. Each milliliter of solution contains 0.15 
milligrams triamcinolone acetonide.
    (b) Sponsor. See No. 067292 in Sec.  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.

    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