[Federal Register Volume 64, Number 237 (Friday, December 10, 1999)]
[Rules and Regulations]
[Pages 69191-69192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32002]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of Sponsor Address
AGENCY: Food and Drug Administration
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 address for Hoechst
Roussel Vet.
Dates: This regulation is effective December 10, 1999.
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: Hoechst Roussel Vet, 30 Independence Blvd.,
P.O. Box 4915, Warren, NJ 07059, has informed FDA of a change of
sponsor address to Perryville Corporate Park III, P.O. Box 4010,
Clinton, NJ 08809-4010. Accordingly, the agency is amending the
regulations in 21 CFR 510.600(c)(1) and (c)(2) to reflect the change of
sponsor address.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A), because it is a rule of ``particular applicability.''
Therefore, it is not subject to congressional review requirements in 5
U.S.C 801-808.
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: 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
revising the entry for ``Hoechst Roussel Vet'' and in the table in
paragraph (c)(2) by revising the entry for ``012799'' 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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* * * *
* * *
Hoechst Roussel Vet, Perryville 012799
Corporate Park III, P.O. Box 4010,
Clinton, NJ 08809-4010.
* * * *
* * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * *
* * *
012799 Hoechst Roussel Vet, Perryville
Corporate Park III, P.O. Box 4010,
Clinton, NJ 08809-4010.
* * * *
* * *
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[[Page 69192]]
Dated: December 2, 1999.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 99-32002 Filed 12-9-99; 8:45 am]
BILLING CODE 4160-01-F