[Federal Register Volume 59, Number 140 (Friday, July 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17809]
[[Page Unknown]]
[Federal Register: July 22, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Melatonin Implant
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 Wildlife Laboratories, Inc. The NADA provides for the
subcutaneous use of melatonin implant in healthy male and female kit
and adult female mink to accelerate the fur priming cycle.
EFFECTIVE DATE: July 22, 1994.
FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center for
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-0614.
SUPPLEMENTARY INFORMATION: Wildlife Laboratories, Inc., 1401 Duff Dr.,
suite 600, Fort Collins, CO 80524, filed NADA 140-846 which provides
for the subcutaneous use of melatonin implant in healthy male and
female kit and adult female mink (Mustela vison) to accelerate the fur
priming cycle. The drug product is an implant consisting of a silicone
rubber elastomer that contains 2.7 milligrams of homogeneously
dispersed melatonin. The NADA is approved as of June 21, 1994, and the
regulations are amended in part 522 (21 CFR part 522) by adding new
Sec. 522.1350 to reflect the approval. The basis for approval is
discussed in the freedom of information summary.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for
5 years of marketing exclusivity beginning June 21, 1994, because no
active ingredient (including any ester or salt of the active
ingredient) has been approved in any other application.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
2. New Sec. 522.1350 is added to read as follows:
Sec. 522.1350 Melatonin implant.
(a) Specifications. The drug is a silicone rubber elastomer implant
containing 2.7 milligrams of melatonin.
(b) Sponsor. See No. 053923 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. One implant per mink.
(2) Indications for use. For use in healthy male and female kit and
adult female mink (Mustela vison) to accelerate the fur priming cycle.
(3) Limitations. For subcutaneous implantation in mink only. Do not
implant potential breeding stock. Do not use in food-producing animals.
Dated: July 15, 1994.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 94-17809 Filed 7-21-94; 8:45 am]
BILLING CODE 4160-01-F
