[Federal Register Volume 66, Number 83 (Monday, April 30, 2001)]
[Rules and Regulations]
[Page 21283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10620]



[[Page 21283]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Ceftiofur Sterile Powder for Injection

<BD>AGENCY: <RM>Food and Drug Administration, HHS.

<BD>ACTION: <RM>Final rule.

-----------------------------------------------------------------------

<BD>SUMMARY: <RM>The Food and Drug Administration (FDA) is amending the 
animal drug regulations to reflect approval of a supplemental new 
animal drug application (NADA) filed by Pharmacia and Upjohn Co. The 
supplemental NADA provides for intramuscular injection of a solution of 
reconstituted ceftiofur sodium powder for treatment of caprine 
respiratory disease (goat pneumonia).

<BD>DATES:  <RM>This rule is effective April 30, 2001.

<BD>FOR FURTHER INFORMATION CONTACT: <RM>Naba K. Das, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7569.

<BD>SUPPLEMENTARY INFORMATION: <RM>Pharmacia and Upjohn Co., 7000 
Portage Rd., Kalamazoo, MI 49001-0199, filed supplemental NADA 140-338 
that provides for use of Naxcel<IT><Register> <RM>(ceftiofur sodium) 
sterile powder for injection for treatment by intramuscular injection 
of caprine respiratory disease (goat pneumonia) associated with 
<IT>Pasteurella haemolytica <RM>and <IT>P. multocida<RM>.
    The supplemental NADA is approved as of March 7, 2001, and the 
regulations are amended in 21 CFR 522.313 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 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this supplemental 
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.
    The agency has determined under 21 CFR 25.33(d)(4) 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 522

    Animal drugs.

    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 522 is 
amended as follows:

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

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

    <CS>Authority: <RM>21 U.S.C. 360b.
    2. Section 522.313 is amended by revising the section heading and 
by adding paragraph (d)(8) to read as follows:


Sec. 522.313  Ceftiofur sodium powder for injection.

* * * * *
    (d) * * *
    (8) <IT>Goats<RM>--(i) <IT>Amount<RM>. 0.5 to 1.0 milligram per 
pound of body weight by intramuscular injection at 24-hour intervals 
for a total of 3 consecutive days. Additional treatments may be given 
on days 4 and 5 for animals that do not show satisfactory response.
    (ii) <IT>Indications for use<RM>. For treatment of caprine 
respiratory disease (goat pneumonia) associated with <IT>Pasteurella 
haemolytica <RM>and <IT>P. multocida<RM>.
    (iii) <IT>Limitations<RM>. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

    Dated: April 16, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-10620 Filed 4-27-01; 8:45 am]
BILLING CODE 4160-01-S