[Federal Register Volume 59, Number 116 (Friday, June 17, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14708]
[[Page Unknown]]
[Federal Register: June 17, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 510 and 522
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 Boehringer Ingelheim Animal Health, Inc., to
Phoenix Scientific, Inc.
EFFECTIVE DATE: June 17, 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: Boehringer Ingelheim Animal Health, Inc.,
2621 North Belth Hwy., St. Joseph, MO 64506-2002, has informed FDA that
it has transferred ownership of, and all rights and interests in NADA
99-169 for Oxytocin Injection to Phoenix Scientific, Inc., 3915 South
48th St. Terrace, P.O. Box 6457, St. Joseph, MO, 64506-0457.
Accordingly, the agency is amending the regulations in 21 CFR
510.600(c)(1) and (c)(2) and in 21 CFR 522.1680(b) to reflect the
change of sponsor.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 522
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
522 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 ``Phoenix Scientific, Inc.'' and
in the table in paragraph (c)(2) by numerically adding a new entry for
``059130'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Drug
Firm name and address labeler
code
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*****
Phoenix Scientific, Inc. 3915 South 48th St. Terrace, P.O.
Box 6457, St. Joseph, MO 64506-0457....................... 059130
*****
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(2) * * *
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Drug labeler code Firm name and address
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*****
059130............................ Phoenix Scientific, Inc. 3915 South
48th St. Terrace, P.O. Box 6457,
St. Joseph, MO 64506-0457
*****
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PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 522.1680 [Amended]
4. Section 522.1680 Oxytocin injection is amended in paragraph (b)
by removing ``000010'' and ``and 058639'' and by adding ``058639, and
059130'' before the word ``in''.
Dated: June 9, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 94-14708 Filed 6-16-94; 8:45 am]
BILLING CODE 4160-01-F
