[Federal Register Volume 68, Number 96 (Monday, May 19, 2003)]
[Rules and Regulations]
[Pages 26995-26996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12368]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522


Injectable or Implantable Dosage Form New Animal Drugs; Zinc 
Gluconate

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 Technology Transfer, Inc. The NADA provides for use of 
zinc gluconate solution for chemical sterilization of dogs by 
intratesticular injection.

DATES: This rule is effective May 19, 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: 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 Sec.  
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.

List of Subjects

21 CFR Part 510

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

21 CFR Part 522

    Animal drugs.

0
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 
522 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
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.
0
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:


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

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

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
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                                * * * * *
Technology Transfer, Inc., 33 East Broadway,  067647
 suite 190, Columbia, MO 65203.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
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                                * * * * *
067647                       Technology Transfer, Inc., 33 East
                              Broadway, suite 190, Columbia, MO 65203.
                                * * * * *
------------------------------------------------------------------------

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority:  21 U.S.C. 360b.

0
4. Section 522.2690 is added to read as follows:

[[Page 26996]]

Sec.  522.2690   Zinc gluconate.

    (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 Sec.  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.

    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