Document ID: FDA-2008-N-0039-0017
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Procaine Aqueous Suspension
Posted Date: 2008-03-17T04:00Z

[Federal Register: March 17, 2008 (Volume 73, Number 52)]
[Rules and Regulations]               
[Page 14177]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17mr08-5]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

 
Implantation or Injectable Dosage Form New Animal Drugs; 
Penicillin G Procaine Aqueous Suspension

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 approval of a supplemental new animal drug 
application (NADA) filed by IVX Animal Health, Inc. The supplemental 
NADA provides for changing scientific nomenclature for a swine pathogen 
on labeling for penicillin G procaine aqueous suspension.

DATES: This rule is effective March 17, 2008.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: 
cindy.burnsteel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed a supplement to NADA 65-110 
for PEN-G MAX (penicillin G procaine) Aqueous Suspension used for the 
treatment of animal diseases associated with several bacterial 
pathogens. The supplemental NADA provides for changing a pathogen name 
from Erysipelothrix insidiosato Erysipelothrix rhusiopathiae on product 
labeling. The supplemental NADA is approved as of February 12, 2008, 
and the regulations are amended in 21 CFR 522.1696b to reflect the 
approval.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    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 522

    Animal drugs.

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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 522 is 
amended as follows:

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

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

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

Sec.  522.1696b  [Amended]

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2. In Sec.  522.1696b, in paragraph (d)(2)(ii), remove ``Erysipelothrix 
insidiosa'' and add in its place ``Erysipelothrix rhusiopathiae''.

    Dated: March 6, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-5217 Filed 3-14-08; 8:45 am]

BILLING CODE 4160-01-S