Document ID: FDA-2008-N-0039-0025
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Benzathine and Penicillin G Procaine Suspension
Posted Date: 2008-03-31T04:00Z

[Federal Register: March 31, 2008 (Volume 73, Number 62)]
[Rules and Regulations]
[Page 16754]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr08-3]

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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 Benzathine and Penicillin G Procaine 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 bovine
pathogen on labeling for penicillin G benzathine and penicillin G
procaine injectable suspension.

DATES: This rule is effective March 31, 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 65-498
for PEN BP-48 (penicillin G benzathine and penicillin G procaine)
injectable suspension used for the treatment of animal diseases
associated with several bacterial pathogens. The supplemental NADA
provides for changing a bovine pathogen name from Corynebacterium
pyogenes to Actinomyces pyogenes on product labeling. The supplemental
NADA is approved as of February 22, 2008, and the regulations in 21 CFR
522.1696a are amended 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.  522.1696a  [Amended]

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2. In Sec.  522.1696a, in paragraph (d)(2)(ii)(A), remove
``Corynebacterium pyogenes'' and ``(C. pyogenes)'' and in their places
add ``Actinomyces pyogenes'' and ``(A. pyogenes)''.

    Dated: March 21, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-6603 Filed 3-28-08; 8:45 am]

BILLING CODE 4160-01-S