Document ID: FDA-2013-N-0002-0023
Agency: fda
Document Type: Rule
Title: Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin
Posted Date: 2013-08-23T04:00Z

[Federal Register Volume 78, Number 164 (Friday, August 23, 2013)]
[Rules and Regulations]
[Pages 52430-52431]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20616]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558

[Docket No. FDA-2013-N-0002]

Withdrawal of Approval of New Animal Drug Applications; Quali-
Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin

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), held by Quali-Tech Products, Inc., at 
the sponsor's request because the products are no longer manufactured 
or marketed.

DATES: The rule is effective September 3, 2013.

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, david.alterman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Quali-Tech Products, Inc., has requested 
that FDA withdraw approval of the following four NADAs because the 
products, used to manufacture Type C medicated feeds, are no longer 
manufactured or marketed: NADA 097-980 for Quali-Tech TYLAN-10 (tylosin 
phosphate) Premix, NADA 118-815 for Q.T. BAN-TECH (pyrantel tartrate), 
NADA 132-705 for FLAVOMYCIN (bambermycins), and NADA 133-335 for STAFAC 
(virginiamycin) Swine Pak 10.
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADAs 097-980, 118-815, 132-705, and 133-335, and all 
supplements and amendments thereto, is withdrawn. 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, Quali-Tech Products, Inc., 
will no longer be the sponsor of an approved application. Accordingly, 
21 CFR 510.600(c) is being amended to remove the entries for this firm.
    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 558

    Animal drugs, Animal feeds.

    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 
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 entry 
for ``Quali-Tech Products, Inc.''; and in the table in paragraph 
(c)(2), remove the entry for ``016968''.

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

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

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

0
4. In Sec.  558.95, revise paragraphs (a), (d)(1), (d)(2), (d)(3), 
(d)(4)(i), and (d)(4)(ii) to read as follows:

Sec.  558.95  Bambermycins.

    (a) Approvals. See sponsors in Sec.  510.600(c) of this chapter for 
use of Type A medicated articles as in paragraph (d) of this section:
    (1) No. 016592: 2, 4, and 10 grams per pound for use as in 
paragraphs (d)(1), (d)(2), (d)(3), and (d)(4) of this section.
    (2) Nos. 012286 and 017790: 2 grams for use as in paragraph (d)(2) 
of this section and 0.4 and 2 grams per pound for use as in paragraph 
(d)(3).
* * * * *
    (d) * * *
    (1) Chickens. Use in medicated feed as follows:

----------------------------------------------------------------------------------------------------------------
    Bambermycins in grams/ton      Indications for use        Limitations                    Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 1 to 2......................  Broiler chickens: For  Feed continuously as   016592.
                                   increased rate of      the sole ration.
                                   weight gain and
                                   improved feed
                                   efficiency.
(ii) [Reserved].................
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys. Use in medicated feed as follows:

----------------------------------------------------------------------------------------------------------------
    Bambermycins in grams/ton      Indications for use        Limitations                    Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 1 to 2......................  Growing turkeys: For   Feed continuously as   012286, 016592, 017790.
                                   improved feed          the sole ration.
                                   efficiency.
(ii) 2..........................  Growing turkeys: For   Feed continuously as   012286, 016592, 017790.
                                   increased rate of      the sole ration.
                                   weight gain and
                                   improved feed
                                   efficiency.
----------------------------------------------------------------------------------------------------------------

[[Page 52431]]

    (3) Swine. Use in medicated feed as follows:

----------------------------------------------------------------------------------------------------------------
    Bambermycins in grams/ton      Indications for use        Limitations                    Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 2...........................  Growing-finishing      Feed continuously as   012286, 016592, 017790.
                                   swine: For increased   the sole ration.
                                   rate of weight gain
                                   and improved feed
                                   efficiency.
(ii) 2 to 4.....................  Growing-finishing      Feed continuously as   012286, 016592, 017790.
                                   swine: For increased   the sole ration.
                                   rate of weight.
----------------------------------------------------------------------------------------------------------------

    (4) Cattle. Use in medicated feed as follows:

----------------------------------------------------------------------------------------------------------------
    Bambermycins in grams/ton      Indications for use        Limitations                    Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 1 to 4......................  Cattle fed in          Feed continuously at   016592.
                                   confinement for        a rate of 10 to 20
                                   slaughter: For         milligrams per head
                                   increased rate of      per day.
                                   weight gain and
                                   improved feed
                                   efficiency.
(ii) 2 to 40....................  Pasture cattle         Feed continuously at   016592.
                                   (slaughter, stocker,   a rate of 10 to 40
                                   and feeder cattle,     milligrams per head
                                   and dairy and beef     per day in at least
                                   replacement            1 pound and not more
                                   heifers): For          than 10 pounds of
                                   increased rate of      feed. Daily
                                   weight gain.           bambermycins intakes
                                                          in excess of 20 mg/
                                                          head/day have not
                                                          been shown to be
                                                          more effective than
                                                          20 mg/head/day.
----------------------------------------------------------------------------------------------------------------

* * * * *

Sec.  558.485  [Amended]

0
5. In paragraph (b)(3) of Sec.  558.485, remove ``Nos. 016968, and 
017790'' and in its place add ``No. 017790''.

Sec.  558.625  [Amended]

0
6. In Sec.  558.625, remove and reserve paragraph (b)(14).

Sec.  558.635  [Amended]

0
7. In paragraph (a)(2) of Sec.  558.635, remove ``046573, 016968, and 
017790'' and in its place add ``046573 and 017790''.

    Dated: August 20, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-20616 Filed 8-22-13; 8:45 am]
BILLING CODE 4160-01-P