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 Technology Transfer, Inc. The NADA provides for use of zinc gluconate solution for chemical sterilization of dogs by intratesticular injection.
This rule is effective May 19, 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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
Technology Transfer, Inc., 33 East Broadway, suite 190, Columbia, MO 65203, filed NADA 141-217 that provides for use of NEUTERSOL (zinc gluconate neutralized by arginine) Injectable Solution for chemical sterilization of 3- to 10-month-old male dogs by intratesticular injection. The NADA is approved as of March 17, 2003, and the regulations are amended in 21 CFR part 522 by adding new § 522.2690 to reflect the approval. The basis of approval is discussed in the freedom of information summary.
In addition, Technology Transfer, 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 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, 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)(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning March 17, 2003.
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
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 “Technology Transfer, Inc.” and in the table in paragraph (c)(2) by numerically adding an entry for “067647” to read as follows:End Amendment Part
(c) * * *
(1) * * *
|Firm name and address||Drug labeler code|
|* * * * *|
|Technology Transfer, Inc., 33 East Broadway, suite 190, Columbia, MO 65203||067647|
|* * * * *|
(2) * * *
|Drug labeler code||Firm name and address|
|* * * * *|
|067647||Technology Transfer, Inc., 33 East Broadway, suite 190, Columbia, MO 65203.|
|* * * * *|
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
3. The authority citation forEnd Amendment Part Start Amendment Part
4. Section 522.2690 is added to read as follows:End Amendment Part
(a) Specifications. Each milliliter of solution contains 13.1 milligrams zinc as zinc gluconate neutralized to pH 7.0 with L-arginine.
(b) Sponsor. See No. 067647 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1) Amount. The volume injected into each testicle is based on testicular width as determined by measuring each testicle at its widest point using a metric scale (millimeter) caliper.
(2) Indications for use. Intratesticular injection for chemical sterilization of 3- to 10-month-old male dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.Start Signature
Dated: May 12, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-12368 Filed 5-16-03; 8:45 am]
BILLING CODE 4160-01-S