[Federal Register Volume 62, Number 225 (Friday, November 21, 1997)]
[Rules and Regulations]
[Pages 62241-62242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30563]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
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 a change of sponsor for an approved new
animal drug application (NADA) from Schering-Plough Animal Health Corp.
to Sioux Biochemical, Inc.
EFFECTIVE DATE: November 21, 1997.
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: Schering-Plough Animal Health Corp., 1095
Morris Ave., Union, NJ 07083, has informed FDA that it has transferred
ownership of, and all rights and interests in NADA 9-505 (follicle
stimulating hormone) to Sioux Biochemical, Inc., 204 Third St. NW.,
Sioux Center, IA 51250. Accordingly, the agency is amending the
regulations in 21 CFR 522.1002 to reflect the transfer of ownership.
The agency is also amending the regulations in 21 CFR 510.600(c)(1) and
(c)(2) by alphabetically adding a new listing for Sioux Biochemical,
Inc.
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: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 376e.
2. Section 510.600 is amended in the table in paragraph (c)(1) by
alphabetically adding a new entry for ``Sioux Biochemical, Inc.'' and
in the table in paragraph (c)(2) by numerically adding a new entry for
``063112'' 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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* * * *
* * *
Sioux Biochemical, Inc., 204 Third St. 063112
NW., Sioux Center, IA 51250.
* * * *
* * *
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(2) * * *
[[Page 62242]]
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Drug labeler code Firm name and address
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* * * *
* * *
063112................................... Sioux Biochemical, Inc., 204
Third St. NW., Sioux Center,
IA 51250
* * * *
* * *
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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: 21 U.S.C. 360b.
Sec. 522.1002 [Amended]
4. Section 522.1002 Follicle stimulating hormone is amended in
paragraph (b)(2) by removing ``000061'' and adding in its place
``063112''.
Dated: November 6, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-30563 Filed 11-20-97; 8:45 am]
BILLING CODE 4160-01-F
