New Animal Drugs; Change of Sponsor's Address, 63986 [E7-22210]

Download as PDF 63986 Federal Register / Vol. 72, No. 219 / Wednesday, November 14, 2007 / Rules and Regulations LIST OF COMMENTERS Abbreviation Name Allegheny ........................................ AGA ................................................ APPA and TAPS ............................ Butte County ................................... California Resources ...................... California State Agencies ............... Allegheny Power and Allegheny Energy Supply Company, L.L.C. American Gas Association. American Public Power Association and Transmission Access Policy Study Group. Butte County, California. California Resources Agency. California Coastal Commission, California Energy Commission, California Electricity Oversight Board, and California State Lands Commission. Dominion Transmission Inc., Dominion Cove Point, LNG, LP, and Dominion South Pipeline Company, LP. Edison Electric Institute. Interstate Natural Gas Association of America. MidAmerican Energy Company. National Association of Regulatory Utility Commissioners. National Hydropower Association. Southern California Edison Company. Western Interstate Energy Board and Committee on Regional Electric Power Cooperation. Williston Basin Interstate Pipeline Company. United States Department of the Interior. Dominion ......................................... EEI .................................................. INGAA ............................................. MidAmerican ................................... NARUC ........................................... NHA ................................................ SCE ................................................ Western Energy Board ................... Williston Basin ................................ Department of the Interior .............. [FR Doc. E7–22141 Filed 11–13–07; 8:45 am] List of Subjects in 21 CFR Part 510 BILLING CODE 6717–01–P Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. DEPARTMENT OF HEALTH AND HUMAN SERVICES 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: 21 CFR Part 510 New Animal Drugs; Change of Sponsor’s Address PART 510—NEW ANIMAL DRUGS 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 address for IDEXX Pharmaceuticals, Inc. This rule is effective November 14, 2007. DATES: FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov. IDEXX Pharmaceuticals, Inc., 4249–105 Piedmont Pkwy., Greensboro, NC 27410, has informed FDA of a change of address to 7009 Albert Pick Rd., Greensboro, NC 27409. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect the change. 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. rmajette on PROD1PC64 with RULES 14:53 Nov 13, 2007 Jkt 214001 * * Firm name and address IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., Greensboro, NC 27409 * * * Dated: November 6, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–22210 Filed 11–13–07; 8:45 am] BILLING CODE 4160–01–S 1. The authority citation for 21 CFR part 510 continues to read as follows: I Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. DEPARTMENT OF HEALTH AND HUMAN SERVICES 2. In § 510.600, in the table in paragraph (c)(1) revise the entry for ‘‘IDEXX Pharmaceuticals, Inc.’’; and in the table in paragraph (c)(2) revise the entry for ‘‘065274’’ to read as follows: Food and Drug Administration I § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * (c) * * * (1) * * * * * * * IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., Greensboro, NC 27409. * * * Drug labeler code * 065274 * * * (2) * * * Drug labeler code PO 00000 * 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Chlortetracycline Powder AGENCY: Firm name and address * * * Frm 00020 Fmt 4700 Sfmt 4700 Food and Drug Administration, HHS. ACTION: * Firm name and address SUPPLEMENTARY INFORMATION: VerDate Aug<31>2005 065274 I Food and Drug Administration AGENCY: Drug labeler code Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Fort Dodge Animal Health, Division of Wyeth Holdings Corp. The supplemental NADA provides for label revisions for chlortetracycline soluble powder. DATES: This rule is effective November 14, 2007. FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for Veterinary Medicine (HFV–130), Food and Drug Administration, 7500 Standish Pl., * E:\FR\FM\14NOR1.SGM 14NOR1

Agencies

[Federal Register Volume 72, Number 219 (Wednesday, November 14, 2007)]
[Rules and Regulations]
[Page 63986]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22210]


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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 address for IDEXX 
Pharmaceuticals, Inc.

DATES: This rule is effective November 14, 2007.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: IDEXX Pharmaceuticals, Inc., 4249-105 
Piedmont Pkwy., Greensboro, NC 27410, has informed FDA of a change of 
address to 7009 Albert Pick Rd., Greensboro, NC 27409. Accordingly, the 
agency is amending the regulations in 21 CFR 510.600(c) to reflect the 
change.
    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.

0
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

0
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.

0
2. In Sec.  510.600, in the table in paragraph (c)(1) revise the entry 
for ``IDEXX Pharmaceuticals, Inc.''; and in the table in paragraph 
(c)(2) revise the entry for ``065274'' 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
------------------------------------------------------------------------
                                * * * * *
IDEXX Pharmaceuticals, Inc., 7009 Albert      065274
 Pick Rd., Greensboro, NC 27409.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
065274                        IDEXX Pharmaceuticals, Inc., 7009 Albert
                              Pick Rd., Greensboro, NC 27409
                                * * * * *
------------------------------------------------------------------------


    Dated: November 6, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-22210 Filed 11-13-07; 8:45 am]
BILLING CODE 4160-01-S
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