[Federal Register: January 31, 2003 (Volume 68, Number 21)]
[Rules and Regulations]
[Page 4915-4916]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31ja03-11]
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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:
mberson@cvm.fda.gov.
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) * * *
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Firm name and address Drug labeler code
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* * * * *
RMS Laboratories, Inc., 1903 East First St., 067292
Vidalia, GA 30474.
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
067292 RMS Laboratories, Inc., 1903 East First
St., Vidalia, GA 30474
* * * * *
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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