[Federal Register Volume 65, Number 225 (Tuesday, November 21, 2000)]
[Rules and Regulations]
[Page 69865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29764]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of Sponsor's Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor's address for Novartis
Animal Health US, Inc.
DATES: This rule is effective November 21, 2000.
FOR FURTHER INFORMATION CONTACT: Norman J. Turner, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0214.
SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., P.O. Box
18300, Greensboro, NC 27419-8300, has informed FDA of a change of
sponsor's address to 3200 Northline Ave., suite 300, Greensboro, NC
27408. Accordingly, the agency is amending the regulations in 21 CFR
510.600(c)(1) and (c)(2) to reflect the change of sponsor's 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 the 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 ``Novartis Animal Health US, Inc.'' and in the
table in paragraph (c)(2) by revising the entry for ``058198'' to read
as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * *
* * *
Novartis Animal Health US, Inc., 058198
3200 Northline Ave., suite 300,
Greensboro, NC 27408
* * * *
* * *
------------------------------------------------------------------------
(2) * * *
----------------------------------------------------------------------------------------------------------------
Drug labeler code Firm name and address
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
058198 Novartis Animal Health US, Inc., 3200 Northline Ave.,
suite 300, Greensboro, NC 27408
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
Dated: November 6, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 00-29764 Filed 11-20-00; 8:45 am]
BILLING CODE 4160-01-F