Document ID: FDA-2008-N-0039-0040
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsors Name
Posted Date: 2008-04-29T04:00Z

[Federal Register: April 29, 2008 (Volume 73, Number 83)]
[Rules and Regulations]               
[Page 23066-23067]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ap08-2]                         

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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 Name

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's name from Halocarbon 
Laboratories, Division of Halocarbon Products Corp., to Halocarbon 
Products Corp.

DATES: This rule is effective April 29, 2008.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Halocarbon Laboratories, Division of 
Halocarbon Products Corp., 887 Kinderkamack Rd., P.O. Box 661, River 
Ridge, NJ 07661, has informed FDA that it has changed its name to 
Halocarbon Products Corp. Accordingly, the agency is amending the 
regulations in 21 CFR 510.600(c) to reflect these changes. FDA is also 
correcting the sponsor's address in the regulation.
    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

[[Page 23067]]

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 ``Halocarbon Laboratories''; and in the table in paragraph (c)(2), 
revise the entry for ``012164'' 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
------------------------------------------------------------------------
                                * * * * *
Halocarbon Products Corp., 887 Kinderkamack   012164
 Rd., River Edge, NJ 07661.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
012164                       Halocarbon Products Corp., 887 Kinderkamack
                              Rd., River Edge, NJ 07661.
                                * * * * *
------------------------------------------------------------------------

    Dated: April 16, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-9328 Filed 4-28-08; 8:45 am]

BILLING CODE 4160-01-S