[Federal Register Volume 70, Number 73 (Monday, April 18, 2005)]
[Rules and Regulations]
[Pages 20048-20049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-7730]


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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 subclinical mastitis in dairy cattle at the time of dry off.

DATES: This rule is effective April 18, 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 141-239 
for SPECTRAMAST DC (ceftiofur hydrochloride) Sterile Suspension. The 
NADA provides for the veterinary prescription use of ceftiofur 
hydrochloride suspension, by intramammary infusion, for the treatment 
of subclinical mastitis in dairy cattle at the time of dry off 
associated with Staphylococcus aureus, Streptococcus dysgalactiae, and 
Streptococcus uberis. The application is approved as of March 15, 2005, 
and the regulations are amended in 21 CFR 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 March 15, 2005.
    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.

0
2. Section 526.314 is amended by adding paragraphs (a)(2) and (d)(2) to 
read as follows:


Sec.  526.314  Ceftiofur.

    (a) * * *
* * * * *
    (2) Each 10-mL syringe contains ceftiofur hydrochloride suspension 
equivalent to 500 mg ceftiofur.
* * * * *
    (d) * * *
    (2) Dry cows--(i) Amount. 500 mg per affected quarter at the time 
of dry off using product described in paragraph (a)(2) of this section.
    (ii) Indications for use. For the treatment of subclinical mastitis 
in dairy cattle at the time of dry off associated with Staphylococcus 
aureus, Streptococcus dysgalactiae, and Streptococcus uberis.
    (iii) Limitations. Milk taken from cows completing a 30-day dry off 
period may be used for food with no milk discard due to ceftiofur 
residues. Following intramammary infusion, a 3-day preslaughter 
withdrawal period is required for treated cows. Following label use, no 
preslaughter withdrawal period is required for neonatal calves from 
treated cows regardless of colostrum consumption. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.


[[Page 20049]]


    Dated: March 24, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-7730 Filed 4-15-05; 8:45 am]
BILLING CODE 4160-01-S