Notices. Notification of withdrawal
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/register/2014/04/10/2014-08010A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4160-01-P 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. 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). 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. Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 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]
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