Document ID: FDA-2010-N-0002-0088
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Deslorelin
Posted Date: 2010-12-28T05:00Z

[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Rules and Regulations]
[Pages 81455-81456]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32554]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522

[Docket No. FDA-2010-N-0002]

New Animal Drugs; Deslorelin

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 an original new animal drug 
application (NADA) filed by Thorn Bioscience LLC. The NADA provides for 
the use of deslorelin acetate injectable suspension in mares for 
inducing ovulation.

DATES: This rule is effective December 28, 2010.

FOR FURTHER INFORMATION CONTACT: 
    Amy L. Omer, Center for Veterinary Medicine (HFV-114), Food and 
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-
8336, e-mail: amy.omer@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Thorn Bioscience LLC, 1044 East Chestnut 
St., Louisville, KY 40204, filed NADA 141-319 that provides for use of 
SUCROMATE Equine (deslorelin acetate), an injectable suspension, in 
mares for inducing ovulation. The NADA is approved as of November 5, 
2010, and the regulations are amended in 21 CFR 522.533 to reflect the 
approval.
    In addition, Thorn Bioscience LLC has not been previously listed in 
the animal drug regulations as a sponsor of an approved application. 
Accordingly, 21 CFR 510.600(c) is being amended to add entries for this 
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 Division of Dockets Management 
(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.
    The Agency has determined under 21 CFR 25.33 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.
    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 on the date of approval.
    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.

[[Page 81456]]

21 CFR Part 522

    Animal drugs.

0
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

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. In Sec.  510.600, in the table in paragraph (c)(1) alphabetically 
add an entry for ``Thorn Bioscience LLC''; and in the table in 
paragraph (c)(2) numerically add an entry for ``051330'' to read as 
follows:
* * * * *

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

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

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                                * * * * *
Thorn Bioscience LLC, 1044 East Chestnut St.,                     051330
 Louisville, KY 40204...................................
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
                                                           Firm name and
                    Drug labeler code                         address
------------------------------------------------------------------------
 
                                * * * * *
051330..................................................           Thorn
                                                              Bioscience
                                                          LLC, 1044 East
                                                           Chestnut St.,
                                                          Louisville, KY
                                                                   40204
 
                                * * * * *
------------------------------------------------------------------------

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. Revise Sec.  522.533 to read as follows:

Sec.  522.533  Deslorelin.

    (a) Specifications--(1) Each implant contains 2.1 milligrams (mg) 
deslorelin acetate.
    (2) Each milliliter (mL) of suspension contains 1.8 mg deslorelin 
acetate.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter as follows:
    (1) No. 043246 for use of product described in paragraph (a)(1) as 
in paragraph (c)(1) of this section.
    (2) No. 051330 for use of product described in paragraph (a)(2) as 
in paragraph (c)(2) of this section.
    (c) Conditions of use--(1) Horses and ponies--(i) Amount. One 
implant per mare subcutaneously in the neck.
    (ii) Indications for use. For inducing ovulation within 48 hours in 
estrous mares with an ovarian follicle greater than 30 mL in diameter.
    (iii) Limitations. Do not use in horses or ponies intended for 
human consumption. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
    (2) Horses--(i) Amount. Administer 1.8 mg (1 mL) by intramuscular 
injection in the neck.
    (ii) Indications for use. For inducing ovulation within 48 hours in 
cyclic estrous mares with an ovarian follicle between 30 and 40 mL in 
diameter.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

    Dated: December 9, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-32554 Filed 12-27-10; 8:45 am]
BILLING CODE 4160-01-P