[Federal Register Volume 59, Number 193 (Thursday, October 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24749]
[[Page Unknown]]
[Federal Register: October 6, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 510
New Animal Drugs; Change of Sponsor
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 change of sponsor for 13 new animal
drug applications (NADA's) from Central Soya Co., Inc., to Premiere
Agri Technologies, Inc.
EFFECTIVE DATE: October 6, 1994.
FOR FURTHER INFORMATION CONTACT: Benjamin A. Puyot, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1646.
SUPPLEMENTARY INFORMATION: Central Soya Co., Inc., P. O. Box 1400, Fort
Wayne, IN 46801-1400, has informed FDA that it has transferred
ownership of, and all rights and interests in, approved NADA 91-582
(Tylosin) to Premiere Agri Technologies, Inc., P.O. Box 2508, Fort
Wayne, IN 46801-2508.
Included in the sale were all of the assets of the following
wholly-owned subsidiaries or divisions of Central Soya Co., Inc.; these
subsidiaries will continue to operate under their current sponsor name
and drug labeler code:
------------------------------------------------------------------------
NADA Number Drug Sponsor
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48-480............ Chlortetracycline........ Feed Specialties Co.,
Inc., 1877 NE. 58th
Ave., Des Moines, IA
50313
65-256............ Chlortetracycline Feed Specialties Co.,
hydrochloride. Inc.
107-957........... Tylosin and Feed Specialties Co.,
sulfamethazine. Inc.
108-484........... Tylosin and Feed Specialties Co.,
sulfamethazine. Inc.
110-045........... Tylosin.................. Good-Life, Division of
Central Soya Co., Inc.,
Good-Life Dr., P.O. Box
687, Effingham, IL 62401
110-439........... Hygromycin B............. Feed Specialties Co.,
Inc.
118-877........... Pyrantel tartrate........ Feed Specialties Co.,
Inc.
128-411........... Tylosin and Good-Life, Division of
sulfamethazine. Central Soya Co., Inc.
131-956........... Tylosin and MAC-PAGE, Inc., 1600 S.
sulfamethazine. Wilson Ave., Dunn, NC
28334
132-448........... Bambermycins............. Feed Specialties Co.,
Inc.
133-490........... Pyrantel tartrate........ MAC-PAGE, Inc.
140-842........... Hygromycin B............. MAC-PAGE, Inc.
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Accordingly, the agency is amending the regulations in 21 CFR
510.600(c)(1) and (c)(2). The sponsor labeler code of Central Soya Co.,
Inc. is being retained as the labeler code for the new company.
List of Subjects in 21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 part 510 is
amended as follows:
PART 510-NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e).
2. Section 510.600 is amended in the table in paragraph (c)(1) by
removing the entry for ``Central Soya Co., Inc.,'' and by
alphabetically adding a new entry for ``Premiere Agri Technologies,
Inc.,'' and in the table in paragraph (c)(2) in the entry for
``012286'' by revising the sponsor name and address to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Firm name and address Drug labeler code
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*****
Premiere Agri Technologies, Inc., P.O. Box 2508, Fort
Wayne, IN 46801-2508................................ 012286
*****
------------------------------------------------------------------------
(2) * * *
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Drug
labeler Firm name and address
code
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*****
012286..... Premiere Agri Technologies, Inc., P.O. Box 2508, Fort
Wayne, IN 46801-2508.
*****
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Dated: September 28, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 94-24749 Filed 10-5-94; 8:45 am]
BILLING CODE 4160-01-F
