[Federal Register Volume 61, Number 244 (Wednesday, December 18, 1996)]
[Rules and Regulations]
[Pages 66580-66581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32067]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
Animal Drugs, Feeds, and Related Products; 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 a change of sponsor for a new animal drug
application (NADA) from Mallinckrodt Veterinary, Inc., to Veterinary
Specialties, Inc.
EFFECTIVE DATE: December 18, 1996.
FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0213.
SUPPLEMENTARY INFORMATION: Mallinckrodt Veterinary, Inc., Mundelein, IL
60060, has informed FDA that it has transferred ownership of, and all
rights and interests in, NADA 65-107 for entromycin powder to
Veterinary Specialties, Inc., 387 North Valley Ct., Barrington, IL
60010. Accordingly, the agency is amending the regulations in 21 CFR
510.600(c)(1) and (c)(2) by alphabetically adding a new listing for
Veterinary Specialties, Inc. The agency is also amending 21 CFR
520.154b to reflect the transfer of ownership.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 520
Animal drugs.
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
520 are 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
alphabetically adding a new entry for ``Veterinary Specialties, Inc.''
and in the table in paragraph (c)(2) by numerically adding a new entry
for ``062925'' 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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* * * * *
Veterinary Specialties, Inc., 387 062925
North Valley Ct., Barrington, IL
60010
* * * * *
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(2) * * *
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Drug labeler code Firm Name and address
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* * * * *
062925 Veterinary Specialties, Inc., 387
North Valley Ct., Barrington, IL
60010
* * * * *
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[[Page 66581]]
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 520.154b [Amended]
4. Section 520.154b Soluble bacitracin methylene disalicylate and
streptomycin sulfate oral powder is amended in paragraph (b) by
removing ``011716'' and adding in its place ``062925''.
Dated: December 5, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-32067 Filed 12-17-96; 8:45 am]
BILLING CODE 4160-01-F