Document ID: FDA-2011-N-0003-0003
Agency: fda
Document Type: Notice
Title: Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications: Phenylbutazone; Pyrantel; Tylosin
Posted Date: 2011-03-02T05:00Z

[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Rules and Regulations]
[Pages 11330-11331]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4546]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 558

[Docket No. FDA-2011-N-0003]

Animal Drugs, Feeds, and Related Products; Withdrawal of Approval 
of a New Animal Drug Applications; Phenylbutazone; Pyrantel; 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 by removing those portions that reflect approval of 
eight new animal drug applications (NADAs). In a notice published 
elsewhere in this issue of the Federal Register, FDA is withdrawing 
approval of these NADAs.

DATES: This rule is effective March 14, 2011.

FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9079, e-mail: john.bartkowiak@fda.hhs.gov.

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

                      Table 1--Voluntary Requests for Withdrawal of Approval of Three NADAs
----------------------------------------------------------------------------------------------------------------
                                              NADA No. product          21 CFR section affected (sponsor drug
                Sponsor                  (established name of drug)                 labeler code)
----------------------------------------------------------------------------------------------------------------
First Priority, Inc., 1590 Todd Farm     NADA 48-647;                Sec.   520.1720a (058829).
 Dr., Elgin, IL 60123.                    Phenylbutazone Boluses
                                          (phenylbutazone).
Yoder Feed, Division of Yoder, Inc.,     NADA 96-161; Hy-Con TYLAN   Sec.   558.625 (035369).
 Kalona, IA 52247.                        Premix (tylosin
                                          phosphate).
Triple ``F'', Inc., 10104 Douglas Ave.,  NADA 119-062; Cadco-BN-10   Sec.   558.485 (011490).
 Des Moines, IA 50322.                    BANMINTH Premix (pyrantel
                                          tartrate).
----------------------------------------------------------------------------------------------------------------

    Truow Nutrition, Inc., 1590 Todd Farm Dr., Elgin, IL 60123 (Truow) 
has informed FDA that it is the owner of five feed premix NADAs 
previously owned by milling companies which it has purchased. NADA 100-
352 was owned by NutriBasics Co., last doing business at P.O. Box 1014, 
Wilmar, MN 56201. NADA 107-002 and NADA 123-000 were owned by Seeco, 
Inc., also last doing business at P.O. Box 1014, Wilmar, MN 56201. NADA 
133-833 and NADA 135-243 were owned by Southern Micro-Blenders, Inc., 
last doing business at 3801 N. Hawthorne St., Chattanooga, TN 37406. 
Truow has requested that FDA withdraw approval of the five NADAs in 
table 2 of this document because they are no longer manufactured or 
marketed:

[[Page 11331]]

          Table 2--Voluntary Requests for Withdrawal of Approval of Five NADAs by Truow Nutrition, Inc.
----------------------------------------------------------------------------------------------------------------
                                              NADA No. product          21 CFR section affected (sponsor drug
            Previous sponsor             (established name of drug)                 labeler code)
----------------------------------------------------------------------------------------------------------------
NutriBasics Co., P.O. Box 1014, Wilmar,  NADA 100-352; Seeco T-10    Sec.   558.625 (053740).
 MN 56201.                                Premix (tylosin
                                          phosphate).
Seeco, Inc., P.O. Box 1014, Wilmar, MN   NADA 107-002; Seeco TYLAN-  Not codified.
 56201.                                   Sulfa 10 Premix (tylosin
                                          phosphate and
                                          sulfamethazine).
Seeco, Inc., P.O. Box 1014, Wilmar, MN   NADA 123-000; Super Swine   Sec.   558.485 (011749).
 56201.                                   Wormer B-9
                                          BANMINTH(pyrantel
                                          tartrate).
Southern Micro-Blenders, Inc., 3801 N.   NADA 133-833; TYLAN 10      Sec.   558.625 (049685).
 Hawthorne St., Chattanooga, TN 37406.    Premix (tylosin
                                          phosphate).
Southern Micro-Blenders, Inc., 3801 N.   NADA 135-243; Swine Guard-  Sec.   558.485 (049685).
 Hawthorne St., Chattanooga, TN 37406.    BN BANMINTH Premix
                                          (pyrantel tartrate).
----------------------------------------------------------------------------------------------------------------

    In a notice published elsewhere in this issue of the Federal 
Register, FDA gave notice that approval of NADA 48-647, 96-161, 100-
352, 107-002, 119-062, 123-000, 133-833, and 135-243, and all 
supplements and amendments thereto, is withdrawn, effective March 14, 
2011. As provided in the regulatory text of this document, the animal 
drug regulations are amended to reflect these withdrawals of approval.
    Following these changes of sponsorship, Yoder Feed, Division of 
Yoder, Inc., Triple ``F'', Inc., NutriBasics Co., Seeco, Inc., and 
Southern Micro-Blenders, Inc., are no longer 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 Part 520

    Animal drugs.

21 CFR Part 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, 
520, 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 ``Triple ``F'', Inc.'' and ``Yoder Feed, Division of Yoder, 
Inc.''; and in the table in paragraph (c)(2), remove the entries for 
``011490'', ``011749'', ``035369'', ``049685'', and ``053740''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
4. In Sec.  520.1720a, revise paragraph (b)(6) to read as follows:

Sec.  520.1720a  Phenylbutazone tablets and boluses.

* * * * *
    (b) * * *
    (6) No. 058829 for use of 100-mg or 1-g tablets in dogs and horses.
* * * * *

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

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

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

0
6. In Sec.  558.485, revise the section heading and paragraph (b)(3) to 
read as follows:

Sec.  558.485  Pyrantel.

* * * * *
    (b) * * *
    (3) Nos. 010439, 012286, 016968, and 017790: 9.6 and 19.2 grams per 
pound for use as in paragraphs (e)(1)(i) through (e)(1)(iii) of this 
section.
* * * * *

Sec.  558.625  [Amended]

0
7. In Sec.  558.625, remove and reserve paragraphs (b)(8), (b)(38), and 
(b)(80).

    Dated: February 18, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-4546 Filed 3-1-11; 8:45 am]
BILLING CODE 4160-01-P