New Animal Drugs; Ceftiofur, 39544-39545 [E6-10973]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 134 (Thursday, July 13, 2006)]
[Rules and Regulations]
[Pages 39544-39545]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10973]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 526


New Animal Drugs; 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 four supplemental new animal 
drug applications (NADAs) filed by Pharmacia & Upjohn Co. The 
supplemental NADAs establish or revise preslaughter withdrawal periods 
in cattle injected with a solution made from ceftiofur sodium powder or 
with a suspension of ceftiofur hydrochloride, or receiving an 
intramammary infusion of ceftiofur hydrochloride.

DATES: This rule is effective July 13, 2006.

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: 
joan.gotthardt@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Division of 
Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed supplements 
to NADA 140-338 for NAXCEL (ceftiofur sodium) Sterile Powder for 
Injection and to NADA 140-890 for EXCENEL RTU (ceftiofur hydrochloride) 
Sterile Suspension. These products are approved for veterinary 
prescription use in livestock by injection for the treatment or control 
of various bacterial diseases. Pharmacia & Upjohn Co. also filed 
supplements to NADA 141-238 for SPECTRAMAST LC (ceftiofur 
hydrochloride) Sterile Suspension and to NADA 141-239 for SPECTRAMAST 
DC (ceftiofur hydrochloride) Sterile Suspension. These products are 
approved for veterinary prescription use by intramammary infusion in 
dairy cows for the treatment of bacterial mastitis. The supplemental 
NADAs establish or revise preslaughter withdrawal periods in cattle 
consistent with the tolerance for residues of ceftiofur in bovine 
kidney which was revised elsewhere in this issue of the Federal 
Register. The applications are approved as of June 2, 2006, and the 
regulations are amended in 21 CFR 522.313 and 526.314 to reflect the 
approval. The basis of approval is discussed in the freedom of 
information summaries.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), summaries of the safety and 
effectiveness data and information submitted to support approval of 
these applications 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.
    The agency has determined under 21 CFR 25.33(a) that these actions 
are of a type that do 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 Parts 522 and 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 parts 522 and 
526 are amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. Redesignate Sec.  522.314 as Sec.  522.313b and amend as follows:
0
a. Revise paragraph (a);
0
b. Redesignate paragraph (d) as paragraph (e);
0
c. Add new paragraph (d); and
0
d. Revise newly redesignated paragraphs (e)(1)(ii), (e)(1)(iii), 
(e)(2)(ii), and (e)(2)(iii).
    The redesignation, revisions, and addition read as follows:


Sec.  522.313b  Ceftiofur hydrochloride.

    (a) Specifications. Each milliliter of ceftiofur hydrochloride 
suspension contains 50 milligrams (mg) ceftiofur equivalents.
* * * * *
    (d) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (e) * * *
    (1) * * *
    (ii) Indications for use. For treatment and control of swine 
bacterial respiratory disease (swine bacterial pneumonia) associated 
with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella 
choleraesuis, and Streptococcus suis.
    (iii) Limitations. Treated swine must not be slaughtered for 4 days 
following the last treatment.
    (2) * * *
    (ii) Indications for use. For treatment of bovine respiratory 
disease (BRD, shipping fever, pneumonia) associated with Mannheimia 
haemolytica, P. multocida, and Histophilus somni; acute bovine 
interdigital necrobacillosis (foot rot, pododermatitis) associated with 
Fusobacterium necrophorum and Bacteroides melaninogenicus; and acute 
metritis (0 to 14 days post-partum) associated with bacteria 
susceptible to ceftiofur.
    (iii) Limitations. Treated cattle must not be slaughtered for 3 
days following the last treatment. A withdrawal period has not been 
established in preruminating calves. Do not use in calves to be 
processed for veal.

0
3. Redesignate Sec.  522.313 as Sec.  522.313c and amend as follows:
0
a. Revise the section heading and paragraphs (a) and (b);
0
b. Redesignate paragraph (d) as paragraph (e);
0
c. Add new paragraph (d); and
0
d. Revise newly redesignated paragraph (e).

[[Page 39545]]

    The redesignation, revisions, and addition read as follows:


Sec.  522.313c  Ceftiofur sodium.

    (a) Specifications. Each milliliter of aqueous solution constituted 
from ceftiofur sodium powder contains 50 milligrams (mg) ceftiofur 
equivalents.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (e) Conditions of use--(1) Swine--(i) Amount. 3 to 5 mg per 
kilogram (/kg) body weight by intramuscular injection for 3 consecutive 
days.
    (ii) Indications for use. For treatment and control of swine 
bacterial respiratory disease (swine bacterial pneumonia) associated 
with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella 
choleraesuis, and Streptococcus suis.
    (iii) Limitations. Treated pigs must not be slaughtered for 4 days 
following the last treatment.
    (2) Cattle--(i) Amount. 0.5 to 1.0 mg/lb body weight by 
intramuscular or subcutaneous injection for 3 days. Additional 
treatments may be given on days 4 and 5 for animals which do not show 
satisfactory response.
    (ii) Indications for use. For treatment of bovine respiratory 
disease (shipping fever, pneumonia) associated with Mannheimia 
haemolytica, P. multocida, and Histophilus somni in beef and dairy 
cattle; and for treatment of acute bovine interdigital necrobacillosis 
(foot rot, pododermatitis) associated with Fusobacterium necrophorum 
and Bacteroides melaninogenicus.
    (iii) Limitations. Treated cattle must not be slaughtered for 4 
days following the last treatment.
    (3) Sheep--(i) Amount. 0.5 to 1.0 mg/lb body weight by 
intramuscular injection for 3 days. Additional treatments may be given 
on days 4 and 5 for animals which do not show satisfactory response.
    (ii) Indications for use. For treatment of sheep respiratory 
disease (pneumonia) associated with M. haemolytica and P. multocida.
    (4) Goats--(i) Amount. 0.5 to 1.0 mg/lb body weight by 
intramuscular injection for 3 days. Additional treatments may be given 
on days 4 and 5 for animals which do not show satisfactory response.
    (ii) Indications for use. For treatment of caprine respiratory 
disease (goat pneumonia) associated with M. haemolytica and P. 
multocida.
    (5) Chickens--(i) Amount. 0.08 to 0.20 mg as a single subcutaneous 
injection in the neck.
    (ii) Indications for use. For control of early mortality associated 
with Escherichia coli organisms susceptible to ceftiofur in day-old 
chicks.
    (6) Turkeys--(i) Amount. 0.17 to 0.5 mg as a single subcutaneous 
injection in the neck.
    (ii) Indications for use. For control of early mortality associated 
with E. coli organisms susceptible to ceftiofur in day-old poults.
    (7) Horses--(i) Amount. 2.2 to 4.4 mg/kg (1.0 to 2.0 mg/lb) body 
weight by intramuscular injection. Treatment should be repeated every 
24 hours, continued for 48 hours after clinical signs have disappeared, 
and should not exceed 10 days. A maximum of 10 mL should be 
administered per injection site.
    (ii) Indications for use. For treatment of respiratory infections 
in horses associated with Streptococcus zooepidemicus.
    (iii) Limitations. Do not use in horses intended for human 
consumption.
    (8) Dogs--(i) Amount. 1.0 mg/lb (2.2 mg/kg) body weight by 
subcutaneous injection. Treatment should be repeated at 24-hour 
intervals, continued for 48 hours after clinical signs have 
disappeared, for 5 to 14 days.
    (ii) Indications for use. For treatment of canine urinary tract 
infections associated with E. coli and Proteus mirabilis.

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4. Add new Sec.  522.313 as a heading only to read as follows:


Sec.  522.313  Ceftiofur injectable dosage forms.

PART 526--INTRAMAMMARY DOSAGE FORMS

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

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


0
6. Redesignate Sec.  526.314 as Sec.  526.313 and amend as follows:
0
a. Revise paragraph (a);
0
b. Redesignate paragraph (d) as paragraph (e) and add new paragraph 
(d);
0
c. Revise newly redesignated paragraphs (e)(1)(i) and (e)(2)(i);
0
d. In the second sentence of newly redesignated paragraph (e)(1)(iii), 
remove ``no preslaughter withdrawal period'' and add in its place ``a 
2-day pre-slaughter withdrawal period'';
0
e. In the second sentence of newly redesignated paragraph (e)(2)(iii), 
remove ``a 3-day preslaughter withdrawal period'' and add in its place 
``a 16-day pre-slaughter withdrawal period''; and
0
f. In newly redesignated paragraphs (e)(1)(iii) and (e)(2)(iii), remove 
``Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.''
    The revisions and additions read as follows:


Sec.  526.313  Ceftiofur.

    (a) Specifications. Each single-use, 10-milliliter syringe of 
ceftiofur hydrochloride suspension contains 125 milligrams (mg) or 500 
mg ceftiofur equivalents.
* * * * *
    (d) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (e) * * *
    (1) * * *
    (i) Amount. Infuse 125 mg per affected quarter. Repeat treatment in 
24 hours. Once daily treatment may be repeated for up to 8 consecutive 
days.
* * * * *
    (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 
eight consecutive days, a 2-day pre-slaughter withdrawal period is 
required.
    (2) * * *
    (i) Amount. Infuse 500 mg per affected quarter at the time of dry 
off.
* * * * *
    (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 16-day pre-slaughter 
withdrawal period is required for treated cows. Following label use, no 
pre-slaughter withdrawal period is required for neonatal calves from 
treated cows regardless of colostrum consumption.

    Dated: June 27, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-10973 Filed 7-12-06; 8:45 am]
BILLING CODE 4160-01-S