Document ID: FDA-2008-N-0039-0009
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsor; Ketamine
Posted Date: 2008-02-13T05:00Z

[Federal Register: February 13, 2008 (Volume 73, Number 30)]
[Rules and Regulations]               
[Page 8191-8192]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13fe08-4]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522

 
New Animal Drugs; Change of Sponsor; Ketamine

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 an abbreviated new 
animal drug application (ANADA) for ketamine hydrochloride injectable 
solution from Veterinary Research Associates, Inc., to Putney, Inc.

DATES:  This rule is effective February 13, 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:  Veterinary Research Associates, Inc., 2817 
West Country Rd., 54G, Fort Collins, CO 80524, has informed FDA that it 
has transferred ownership of, and all rights and interest in, ANADA 
200-073 for Ketamine Hydrochloride Injection, USP, to Putney, Inc., 400 
Congress St., suite 200, Portland, ME 04101. Accordingly, the 
regulations are amended in 21 CFR 522.1222a to reflect this change of 
sponsorship.
    Following these changes of sponsorship, Veterinary Research 
Associates, Inc., is no longer the sponsor of an approved application. 
In addition, Putney, Inc., is not currently listed in the animal drug 
regulations as a sponsor of an approved application. Accordingly, 21 
CFR 510.600(c) is being amended to remove the entries for Veterinary 
Research Associates, Inc., and to add entries for Putney, Inc.
    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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 522

    Animal drugs.

[[Page 8192]]

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 parts 510 and 
522 are 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) remove the entry 
for ``Veterinary Research Associates, Inc.'' and alphabetically add a 
new entry for ``Putney, Inc.''; and in the table in paragraph (c)(2) 
remove the entry for ``064408'' and numerically add an entry for 
``026637'' 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
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                                * * * * *
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Putney, Inc., 400 Congress St., suite 200,          026637
 Portland, ME 04101
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                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
 Drug  labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
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026637                Putney, Inc., 400 Congress St., suite 200,
                       Portland, ME 04101
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                                * * * * *
------------------------------------------------------------------------

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority:  21 U.S.C. 360b.

Sec.  522.1222a   [Amended]

0
4. In Sec.  522.1222a, revise paragraph (b) by removing ``064408'' and 
numerically adding ``026637''.

    Dated: January 31, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-2607 Filed 2-12-08; 8:45 am]

BILLING CODE 4160-01-S