[Federal Register Volume 70, Number 38 (Monday, February 28, 2005)]
[Rules and Regulations]
[Pages 9515-9516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-3834]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 526


Intramammary Dosage Forms; Ceftiofur

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 new animal drug application 
(NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The 
NADA provides for the veterinary prescription use of ceftiofur 
hydrochloride suspension, by intramammary infusion, for the treatment 
of clinical mastitis in lactating dairy cattle.

DATES: This rule is effective February 28, 2005.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Division of 
Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed NADA 141-238 
for SPECTRAMAST LC (ceftiofur hydrochloride) Sterile Suspension. The 
NADA provides for the veterinary prescription use of ceftiofur 
hydrochloride suspension, by intramammary infusion, for the treatment 
of clinical mastitis in lactating dairy cattle associated with 
coagulase-negative staphylococci, Streptococcus dysgalactiae, and 
Escherichia coli. The application is approved as of February 9, 2005, 
and the regulations are amended in 21 CFR part 526 by adding new Sec.  
526.314 to reflect the approval. The basis of approval is discussed in 
the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    FDA has determined under 21 CFR 25.33(d)(5) 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.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning February 9, 2005.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because

[[Page 9516]]

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. Section 526.314 is added to read as follows:


Sec.  526.314  Ceftiofur.

    (a) Specifications--(1) Each 10-milliliter (mL) syringe contains 
ceftiofur hydrochloride suspension equivalent to 125 milligrams (mg) 
ceftiofur.
    (2) [Reserved]
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.113 of this chapter.
    (d) Conditions of use in cattle--(1) Lactating cows--(i) Amount. 
125 mg per affected quarter using product described in paragraph (a)(1) 
of this section. Repeat treatment in 24 hours. Once daily treatment may 
be repeated for up to 8 consecutive days.
    (ii) Indications for use. For the treatment of clinical mastitis in 
lactating dairy cattle associated with coagulase-negative 
staphylococci, Streptococcus dysgalactiae, and Escherichia coli.
    (iii) Limitations. Milk taken from cows during treatment (a maximum 
of eight daily infusions) and for 72 hours after the last treatment 
must not be used for human consumption. Following label use for up to 8 
consecutive days, no preslaughter withdrawal period is required. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) [Reserved]

    Dated: February 17, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-3834 Filed 2-25-05; 8:45 am]
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