Document ID: FDA-2008-N-0039-0001
Agency: fda
Document Type: Rule
Title: Intramammary Dosage Forms; Cephapirin Sodium
Posted Date: 2008-01-17T05:00Z

[Federal Register: January 17, 2008 (Volume 73, Number 12)]
[Rules and Regulations]               
[Page 3181]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17ja08-1]                         

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[[Page 3181]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 526

 
Intramammary Dosage Forms; Cephapirin Sodium

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 supplemental new animal drug 
applications (NADAs) filed by Fort Dodge Animal Health, Division of 
Wyeth. The supplemental NADAs provide for revisions to the labeling of 
two cephapirin sodium products administered by intramammary infusion to 
lactating cows for the treatment of mastitis.

DATES: This rule is effective January 17, 2008.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8342, e-mail: 
joan.gotthardt@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth, 
800 Fifth St. NW., Fort Dodge, IA 50501, filed supplements to NADA 97-
222 that revise labeling of CEFA-LAK (cephapirin sodium) and TODAY 
(cephapirin sodium) Intramammary Infusion administered to lactating 
cows for the treatment of mastitis. The application is approved as of 
December 20, 2007, and the regulations are amended in 21 CFR 526.365 to 
reflect the approval and a current format.
    Approval of these supplemental NADAs did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    FDA 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 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 FORMS

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

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

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2. In Sec.  526.365, revise the section heading and paragraph (d) to 
read as follows:

Sec.  526.365  Cephapirin sodium.

* * * * *
    (d) Conditions of use in lactating cows--(1) Amount. Infuse one 
dose into each infected quarter immediately after the quarter has been 
completely milked out. Do not milk out for 12 hours. Repeat once only 
in 12 hours.
    (2) Indications for use. For the treatment of mastitis in lactating 
cows caused by susceptible strains of Streptococcus agalactiae and 
Staphylococcus aureus including strains resistant to penicillin.
    (3) Limitations. If improvement is not noted within 48 hours after 
treatment, consult your veterinarian. Milk that has been taken from 
animals during treatment and for 96 hours after the last treatment must 
not be used for food. Treated animals must not be slaughtered for food 
until 4 days after the last treatment.

    Dated: January 4, 2008.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E8-816 Filed 1-16-08; 8:45 am]

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