Document ID: FDA-2012-N-0902-0001
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Chorionic Gonadotropin; Naloxone; Oxymorphone; Oxytocin
Posted Date: 2012-09-10T04:00Z

[Federal Register Volume 77, Number 175 (Monday, September 10, 2012)]
[Rules and Regulations]
[Pages 55413-55414]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22196]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522

[Docket No. FDA-2012-N-0902]

New Animal Drugs; Chorionic Gonadotropin; Naloxone; Oxymorphone; 
Oxytocin

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 the withdrawal of approval of four new 
animal drug applications (NADAs) at the sponsor's request because the 
products are no longer manufactured or marketed.

DATES: This rule is effective September 20, 2012.

FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855; 240-453-6843; email: david.alterman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The sponsors of the four approved NADAs 
listed in table 1 of this document have requested that FDA withdraw 
approval because the products are no longer manufactured or marketed:

                                    Table 1--Withdrawal of Approval Requests
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                                                                                                 Citation in 21
            NADA No.                   Trade name (drug)                 Applicant                    CFR
----------------------------------------------------------------------------------------------------------------
030-525.........................  NUMORPHAN (oxymorphone      Endo Pharmaceuticals Inc., 100            522.1642
                                   hydrochloride) Injection.   Painters Dr., Chadds Ford, PA
                                                               19317.
035-825.........................  NARCAN (naloxone            Endo Pharmaceuticals Inc., 100            522.1462
                                   hydrochloride) Injection.   Painters Dr., Chadds Ford, PA
                                                               19317.
046-822.........................  VETOCIN (oxytocin)          United Vaccines, A Harlan                 522.1680
                                   Injection.                  Sprague Dawley, Inc., Co.,
                                                               P.O. Box 4220, Madison, WI
                                                               53711.
103-090.........................  CHORTROPIN (chorionic       United Vaccines, A Harlan                 522.1081
                                   gonadotropin) Injection.    Sprague Dawley, Inc., Co.,
                                                               P.O. Box 4220, Madison, WI
                                                               53711.
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    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADAs 030-525, 035-825, 046-822, and 103-090, and all 
supplements and amendments thereto, is withdrawn, effective September 
20, 2012. As provided in the regulatory text of this document, the 
animal drug regulations are amended to reflect these voluntary 
withdrawals of approval.
    Following these withdrawals of approval, Endo Pharmaceuticals Inc. 
and United Vaccines, A Harlan Sprague Dawley, Inc., Co., will no longer 
be the sponsor of an approved application. Accordingly, 21 CFR 
510.600(c) is being amended to remove the entries for these firms.

[[Page 55414]]

    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.

    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.

Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the 
entries for ``Endo Pharmaceuticals Inc.'' and ``United Vaccines, A 
Harlan Sprague Dawley, Inc., Co.''; and in the table in paragraph 
(c)(2), remove the entries for ``058639'' and ``060951''.

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.

Sec.  522.1081  [Amended]

0
4. In Sec.  522.1081, remove and reserve paragraph (b)(2).

Sec.  522.1462  [Removed]

0
5. Remove Sec.  522.1462.

Sec.  522.1642  [Removed]

0
6. Remove Sec.  522.1642.

Sec.  522.1680  [Amended]

0
7. In Sec.  522.1680, in paragraph (b), remove ``058639,''.

    Dated: September 5, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-22196 Filed 9-7-12; 8:45 am]
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