[Federal Register Volume 63, Number 160 (Wednesday, August 19, 1998)]
[Rules and Regulations]
[Pages 44382-44383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22224]


-----------------------------------------------------------------------
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Deslorelin Acetate

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

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 Peptech Animal Health Pty, Ltd. The NADA provides for 
veterinary prescription use of deslorelin acetate implants in horses 
and ponies for inducing ovulation in estrous mares with an ovarian 
follicle greater than 30 millimeters (mm) in diameter.

EFFECTIVE DATE: August 19, 1998.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1612.

SUPPLEMENTARY INFORMATION: Peptech Animal Health Pty, Ltd., 35-41 
Waterloo Rd., North Ryde, New South Wales 2113, Australia, filed NADA 
141-044 that provides for veterinary prescription use of 2.1 milligrams 
deslorelin acetate (OvuplantTM) implant to induce ovulation 
within 48 hours in estrous mares with an ovarian follicle greater than 
30 mm in diameter. Follicular size should be determined by rectal 
palpation and/or ultrasonography prior to treatment. NADA 144-044 is 
approved as of June 18, 1998, and the regulations are amended by adding 
Sec. 522.533 to reflect the approval. The basis for approval is 
discussed in the freedom of information summary.
    Peptech Animal Health Pty, Ltd., has not been previously listed in 
the animal drug regulations as the sponsor of an approved application. 
At this time, 21 CFR 510.600(c)(1) and (c)(2) are amended by adding a 
new listing to reflect the sponsor.
    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)(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 18, 1998, because no 
active ingredient (including any salt or ester of the active 
ingredient) has been approved in any other application.
    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.

 List of Subjects

21 CFR Part 510

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

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 parts 510 and 
522 are amended as follows:

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 ``Peptech Animal Health Pty, Ltd.'' 
and in the table in paragraph (c)(2) by numerically adding an entry for 
``064288'' to read as follows:


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

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

[[Page 44383]]



                                                                                                                
----------------------------------------------------------------------------------------------------------------
                 Firm name and address                                      Drug labeler code                   
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
Peptech Animal Health Pty, Ltd., 35-41 Waterloo Rd.,     064288                                                 
 North Ryde, New South Wales 2113, Australia                                                                    
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
----------------------------------------------------------------------------------------------------------------

    (2) * * *

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                   Drug labeler code                                      Firm name and address                 
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
 064288                                                   Peptech Animal Health Pty, Ltd., 35-41 Waterloo Rd.,  
                                                          North Ryde, New South Wales 2113, Australia           
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
----------------------------------------------------------------------------------------------------------------

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

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

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

    4. Section 522.533 is added to read as follows:

Sec. 522.533  Deslorelin acetate.

    (a) Specifications. Each implant contains 2.1 milligrams deslorelin 
acetate.
    (b) Sponsor. See 064288 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Horses and ponies--(i) Amount. One 
implant per mare.
    (ii)  Indications for use. For inducing ovulation within 48 hours 
in estrous mares with an ovarian follicle greater than 30 millimiters 
in diameter. Follicular size should be determined by rectal palpation 
and/or ultrasonography prior to treatment.
    (iii) Limitations. Administer subcutaneously in the neck. Not for 
use in horses or ponies intended for food. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (2) [Reserved]

    Dated: August 3, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-22224 Filed 8-18-98; 8:45 am]
BILLING CODE 4160-01-F