Document ID: FDA-2010-N-0002-0079
Agency: fda
Document Type: Rule
Title: Intramammary Dosage Form New Animal Drugs: Cloxacillin Benzathine
Posted Date: 2010-11-22T05:00Z

[Federal Register Volume 75, Number 224 (Monday, November 22, 2010)]
[Rules and Regulations]
[Pages 71016-71017]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29326]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 526

[Docket No. FDA-2010-N-0002]

Intramammary Dosage Form New Animal Drugs; Cloxacillin Benzathine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplementary new animal drug 
application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The 
supplement provides for minor revisions to labeling.

DATES: This rule is effective November 22, 2010.

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: Boehringer Ingelheim Vetmedica, Inc., 2621 
North Belt Highway, St. Joseph, MO 64506-2002 has filed a supplement to 
NADA 55-058 for DRY-CLOX (cloxacillin benzathine) Intramammary Infusion 
for dry dairy cattle. The supplemental NADA provides for various minor 
revisions to labeling. The supplemental application is approved as of 
October 21, 2010, and the regulations in Sec.  526.464a (21 CFR 
526.464a) are amended to reflect the approval.
    In addition, FDA has noticed that certain portions of Sec.  
526.464a were inadvertently removed when the regulations were amended 
to reflect a change of sponsorship (75 FR 10165, March 5, 2010). At 
this time, the regulations are being amended to reflect fully the 
approved conditions of use of this new animal drug product. This change 
is being made to improve the accuracy of the animal drug regulations.
    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 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

[[Page 71017]]

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 526

    Animal drugs.

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 526 is 
amended as follows:

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 526 continues to read as 
follows:

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

0
2. Revise the heading for part 526 to read as set forth above.

0
3. In Sec.  526.464a, revise paragraph (c) to read as follows:

Sec.  526.464a  Cloxacillin benzathine.

* * * * *
    (c) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter for 
use in dairy cows.
    (1) Amount. Administer aseptically into each quarter immediately 
after last milking.
    (2) Indications for use. For the treatment of mastitis caused by 
Staphylococcus aureus and Streptococcus agalactiae including penicillin 
resistant strains in dairy cows during the dry period.
    (3) Limitations. For use in dry cows only. Not to be used within 30 
days of calving. Animals infused with this product must not be 
slaughtered for food use for 30 days after the latest infusion. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

    Dated: November 16, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2010-29326 Filed 11-19-10; 8:45 am]
BILLING CODE 4160-01-P