Document ID: FDA-2014-N-0002-0020
Agency: fda
Document Type: Rule
Title: Withdrawal of Approval of New Animal Drug Applications; Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and Sulfamethazine; Virginiamycin
Posted Date: 2014-04-10T04:00Z

[Federal Register Volume 79, Number 69 (Thursday, April 10, 2014)]
[Rules and Regulations]
[Page 19816]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08010]

[[Page 19816]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558

[Docket No. FDA-2014-N-0002]

Withdrawal of Approval of New Animal Drug Applications; 
Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and 
Sulfamethazine; Virginiamycin

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 19 new animal drug applications (NADAs) for certain Type A medicated 
articles and Type B medicated feeds. This action is being taken at the 
sponsors' request because these products are no longer manufactured or 
marketed.

DATES: Withdrawal of approval is effective April 21, 2014.

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, john.bartkowiak@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The following 5 sponsors have requested that 
FDA withdraw approval of the 19 NADAs listed in the following tables 
because the products are no longer manufactured or marketed:
     ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, 
IL 62305-3115:

------------------------------------------------------------------------
               NADA                             Product name
------------------------------------------------------------------------
091-582 \1\.......................  Gilt Edge TYLAN (tylosin phosphate)
                                     Mix.
108-484 \1\.......................  HFA Tylosin-10 Plus Sulfa (tylosin
                                     phosphate and sulfamethazine).
110-045 \1\.......................  Good Life TYLAN 10 (tylosin
                                     phosphate) Premix.
110-439 \1\.......................  HFA HYGROMIX 0.48 (hygromycin B)
                                     Medicated Premix.
128-411 \1\.......................  TYLAN 5 Sulfa (tylosin phosphate and
                                     sulfamethazine) Premix.
------------------------------------------------------------------------

     Micro Beef Technologies LTD, P.O. Box 9262, Amarillo, TX 
79105:

------------------------------------------------------------------------
               NADA                             Product name
------------------------------------------------------------------------
138-187 \1\.......................  TYLAN 40 or 100 (tylosin phosphate).
------------------------------------------------------------------------

     Ridley USA, Inc. d/b/a Ridley Feed Ingredients, 1609 1st 
Ave., P.O. Box 110, Mendota, IL 61342:

------------------------------------------------------------------------
               NADA                             Product name
------------------------------------------------------------------------
099-468 \1\.......................  Waynextra for Swine (tylosin
                                     phosphate).
131-958 \1\.......................  TYLAN Sulfa-G (tylosin phosphate and
                                     sulfamethazine).
132-136...........................  Ban-A-Worm II (pyrantel tartrate).
------------------------------------------------------------------------

     Provimi North America, Inc., 6531 State Rte. 503, 
Lewisburg, OH 45338:

------------------------------------------------------------------------
               NADA                           Proprietary name
------------------------------------------------------------------------
103-089 \1\.......................  TYLAN 5, 10, 20, or 40 (tylosin
                                     phosphate).
118-814...........................  WORM-BAN 5 or 10 (pyrantel
                                     tartrate).
127-508 \1\.......................  HYGROMIX 0.6 (hygromycin B).
131-413...........................  FLAVOMYCIN 0.4 or 2 (bambermycins).
133-333 \1\.......................  STAFAC 10 (virginiamycin).
------------------------------------------------------------------------

     Virbac AH, Inc., 3200 Meacham Blvd., Fort Worth, TX 76137:

------------------------------------------------------------------------
               NADA                           Proprietary name
------------------------------------------------------------------------
013-214 \1\.......................  PURINA HYGROMIX (hygromycin B) for
                                     Swine.
042-660 \1\.......................  PURINA Pork-Plus (tylosin phosphate
                                     and sulfamethazine).
043-387 \1\.......................  PURINA Hog Plus II (tylosin
                                     phosphate).
099-767 \1\.......................  PURINA TYLAN 40 (tylosin) Plus
                                     Sulfamethazine.
132-574 \1\.......................  PURINA Check-R-Ton Ll (lincomycin
                                     hydrochloride).
------------------------------------------------------------------------

     
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    \1\ The NADAs listed were identified as being affected by 
guidance for industry (GFI) 213, ``New Animal Drugs and New 
Animal Drug Combination Products Administered in or on Medicated 
Feed or Drinking Water of Food-Producing Animals: Recommendations 
for Drug Sponsors for Voluntarily Aligning Product Use Conditions 
With GFI 209'', December 2013.
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    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and redelegated to the Center for Veterinary Medicine, and in 
accordance with Sec.  514.116 Notice of withdrawal of approval of 
application (21 CFR 514.116), notice is given that approval of the 
NADAs listed in this document, and all supplements and amendments 
thereto, is hereby withdrawn.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect the voluntary withdrawal of 
approval of these applications.

    Dated: April 4, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-08010 Filed 4-9-14; 8:45 am]
BILLING CODE 4160-01-P