Document ID: FDA-2012-N-0002-0027
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Butorphanol; Doxapram; Triamcinolone; Tylosin
Posted Date: 2012-10-03T04:00Z

[Federal Register Volume 77, Number 192 (Wednesday, October 3, 2012)]
[Rules and Regulations]
[Pages 60301-60302]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24331]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 522, 524, and 558

[Docket No. FDA-2012-N-0002]

New Animal Drugs; Butorphanol; Doxapram; Triamcinolone; Tylosin

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 approval of a new animal 
drug application (NADA) and three abbreviated new animal drug 
applications (ANADAs) at the sponsors' request because the products are 
no longer manufactured or marketed.

DATES: This rule is effective October 15, 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 NADA and ANADAs listed 
in table 1 have requested that FDA withdraw approval because the 
products are no longer manufactured or marketed:

   Table 1--NADA and ANADAs for Which Withdrawal of Approval Has Been
                                Requested
------------------------------------------------------------------------
                      Trade name                          Citation in 21
  NADA/ANADA No.        (drug)            Applicant             CFR
------------------------------------------------------------------------
100-556..........  Vigorena Feeds   Springfield Milling          558.625
                    Hy-Ty Premix     Corp., Vigorena
                    (tylosin         Feeds, Springfield,
                    phosphate).      MN 56087.
200-435..........  RESPIRAM         Modern Veterinary            522.775
                    (doxapram        Therapeutics, LLC,
                    hydrochloride)   18001 Old Cutler
                    Injection.       Rd., suite 317,
                                     Miami, FL 33157.
200-446..........  BUTORPHINE       Modern Veterinary            522.246
                    (butorphanol     Therapeutics, LLC,
                    tartrate)        18001 Old Cutler
                    Injection.       Rd., suite 317,
                                     Miami, FL 33157.
200-459..........  VETAZINE         Modern Veterinary           524.2483
                    (triamcinolone   Therapeutics, LLC,
                    ) Cream.         18001 Old Cutler
                                     Rd., suite 317,
                                     Miami, FL 33157.
------------------------------------------------------------------------

[[Page 60302]]

    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADA 100-556 and ANADAs 200-435, 200-446, and 200-459, 
and all supplements and amendments thereto, is withdrawn, effective 
October 15, 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, Modern Veterinary 
Therapeutics, LLC, and Springfield Milling Corp. 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.
    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 Parts 522 and 524

    Animal drugs.

21 CFR Parts 558

    Animal drugs, Animal feeds.

    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, 
522, 524, and 558 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 ``Modern Veterinary Therapeutics, LLC'' and ``Springfield 
Milling Corp.''; and in the table in paragraph (c)(2), remove the 
entries for ``015914'' and ``035955''.

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.  522.246  [Amended]

0
4. In Sec.  522.246, in paragraph (b)(2), remove ``Nos. 015914 and 
059130'' and in its place add ``No. 059130''.

Sec.  522.775  [Amended]

0
5. In Sec.  522.775, in paragraph (b), remove ``Nos. 000010 and 
015914'' and in its place add ``No. 000010''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
6. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

Sec.  524.2483  [Amended]

0
7. In Sec.  524.2483, in paragraph (b), remove ``015914,''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
8. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority:  21 U.S.C. 360b, 371.

Sec.  558.625  [Amended]

0
9. In Sec.  558.625, remove and reserve paragraph (b)(40).

    Dated: September 27, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-24331 Filed 10-2-12; 8:45 am]
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