[Federal Register Volume 63, Number 33 (Thursday, February 19, 1998)]
[Rules and Regulations]
[Pages 8347-8348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4076]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
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 a new animal drug
application (NADA) from PM Resources, Inc., to Akzo Nobel Surface
Chemistry AB.
EFFECTIVE DATE: February 19, 1998
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: PM Resources, Inc., 13001 St. Charles Rock
Rd., Bridgeton, MO 63044, has informed FDA that it has transferred
ownership of, and all rights and interests in approved NADA 10-886
(Piperazine Monohydrochloride liquid) to Akzo Nobel Surface Chemistry
AB, Box 851, S-44485 Stenungsund, Sweden. Accordingly, the agency is
amending the regulations in 21 CFR 520.1806 to reflect the change of
sponsor. The agency is also amending the regulations in 21 CFR
510.600(c)(1) and (c)(2) by alphabetically adding a new listing for
Akzo Nobel Surface Chemistry AB.
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: 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 ``Akzo Nobel Surface Chemistry
AB'' and in the table in paragraph (c)(2) by numerically adding a new
entry for ``063765'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
[[Page 8348]]
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Firm name and address Drug labeler code
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* * * *
* * *
Akzo Nobel Surface Chemistry AB, Box 851, 063765
S-44485 Stenungsund, Sweden
* * * *
* * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * *
* * *
063765................................. Akzo Nobel Surface Chemistry
AB, Box 851, S-44485
Stenungsund, Sweden.
* * * *
* * *
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PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.1806 [Amended]
4. Section 520.1806 Piperazine monohydrochloride liquid is amended
in paragraph (b) by removing ``See 017135 and 060594'' and adding in
its place ``See Nos. 017135 and 063765''.
Dated: January 21, 1998.
Andrew J. Beaulieau,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 98-4076 Filed 2-18-98; 8:45 am]
BILLING CODE 4160-01-F
