[Federal Register Volume 63, Number 193 (Tuesday, October 6, 1998)]
[Rules and Regulations]
[Pages 53578-53579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26650]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522 and 556
Implantation or Injectable Dosage Form New Animal Drugs;
Ceftiofur Hydrochloride Sterile Suspension
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 two supplemental new animal
drug applications (NADA's) filed by Pharmacia & Upjohn Co. One
supplemental NADA provides for veterinary prescription use of ceftiofur
hydrochloride sterile suspension for intramuscular or subcutaneous
injection in cattle for treatment of bovine respiratory disease and
acute bovine interdigital necrobacillosis. The second supplemental NADA
provides for a revised label warning against use in veal calves.
EFFECTIVE DATE: October 6, 1998.
FOR FURTHER INFORMATION CONTACT: Naba K. Das, Center for Veterinary
Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1659.
SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., 7000 Portage Rd.,
Kalamazoo, MI 49001-0199, filed two supplements to NADA 140-890. One
supplement provides for veterinary prescription use of
Excenel (ceftiofur hydrochloride) Sterile Suspension for
intramuscular or subcutaneous injection in cattle for treatment of
bovine respiratory disease (BRD, shipping fever, pneumonia) associated
with Pasteurella haemolytica, P. multocida, and Haemophilus somnus and
acute bovine interdigital necrobacillosis (foot rot, pododermatitis)
associated with Fusobacterium necrophorum and Bacteroides
melaninogenicus. This supplemental NADA is approved as of July 26,
1998. The second supplemental NADA provides for a revised label warning
against use in veal calves and is approved as of August 18, 1998. The
regulation is amended in 21 CFR part 522.314 to reflect the approvals.
The basis for approval is discussed in the freedom of information
summary.
In addition, due to injection site residues following subcutaneous
use of this product in cattle, 21 CFR 556.113 is amended to establish
tolerances for residues of ceftiofur in edible tissues of treated
cattle. Also, the regulation is amended to establish an acceptable
daily intake (ADI) for total ceftiofur residues. The ADI represents the
total amount of drug residue that can safely be consumed by humans
every day.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 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 Dockets Management Branch (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.
Under 21 U.S.C. 360b(c)(2)(F)(iii), this approval for food
producing animals qualifies for 3 years of marketing exclusivity
beginning July 26, 1998, because the supplemental application contains
substantial evidence of the effectiveness of the drug involved, any
studies of animal safety, or, in the case of food producing animals,
human food safety studies (other than bioequivalence or residue
studies) required for the approval of the supplement and conducted or
sponsored by the applicant. The 3 years of marketing exclusivity
applies only to the new species (cattle) for which the supplemental
application is approved.
The agency 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.
List of Subjects
21 CFR Part 522
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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
556 are amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 522.314 is amended by adding paragraph (d)(2) to read as
follows:
Sec. 522.314 Ceftiofur hydrochloride sterile suspension.
* * * * *
(d) * * *
(2) Cattle-- (i) Dosage. 1.1 to 2.2 milligrams per kilogram (0.5 to
1.0 milligrams per pound) of body weight, at 24-hour intervals for 3 to
5 consecutive days. In addition, for bovine respiratory disease,
administer 2.2 milligrams per kilogram (1.0 milligram per pound) of
body weight every other day on days 1 and 3 (48-hour interval).
(ii) Indications for use. For treatment of bovine respiratory
disease (BRD, shipping fever, pneumonia) associated with Pasteurella
haemolytica, P. multocida, and Haemophilus somnus and acute bovine
interdigital necrobacillosis (foot rot, pododermatitis) associated with
Fusobacterium necrophorum and Bacteroides melaninogenicus.
(iii) Limitations. For intramuscular or subcutaneous use only. Do
not inject more than 15 milliliters at each intramuscular injection
site. Do not slaughter treated cattle for 48 hours (2 days) after last
treatment. A withdrawal period has not been established in
preruminating calves. Do not use in calves to be processed for veal.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
[[Page 53579]]
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
3. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
4. Section 556.113 is revised to read as follows:
Sec. 556.113 Ceftiofur.
(a) Acceptable daily intake (ADI). The ADI for total residues of
ceftiofur is 30 micrograms per kilogram of body weight per day.
(b) Tolerances--(1) Swine, poultry, and sheep. A tolerance for
residues of ceftiofur in edible tissue is not required.
(2) Cattle. Tolerances are established for residues of
desfuroylceftiofur (marker residue) in edible cattle tissues at 8 parts
per million in kidney (target tissue), 2 parts per million in the
liver, 1 part per million in muscle, and 100 parts per billion in milk.
Dated: September 23, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-26650 Filed 10-5-98; 8:45 am]
BILLING CODE 4160-01-F
