[Federal Register Volume 68, Number 82 (Tuesday, April 29, 2003)]
[Rules and Regulations]
[Pages 22593-22594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10474]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Butorphanol Tartrate Injection

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an abbreviated new animal drug 
application (ANADA) filed by Phoenix Scientific, Inc. The ANADA 
provides for the use of a butorphanol

[[Page 22594]]

tartrate injectable solution for the relief of pain in horses.

DATES: This rule is effective April 29, 2003.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed ANADA 200-322 that provides 
for the use of Butorphanol Tartrate Injection for the relief of pain 
associated with colic and postpartum pain in adult and yearling horses. 
Phoenix Scientific's Butorphanol Tartrate Injection is approved as a 
generic copy of Fort Dodge Animal Health's TORBUGESIC approved under 
NADA 135-780. The ANADA is approved as of January 22, 2003, and the 
regulations are amended in 21 CFR 522.246 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 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(a)(1) 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.

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 522 is 
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.


Sec.  522.246  [Amended]

0
2. Section 522.246 Butorphanol tartrate injection is amended in 
paragraph (b)(1) by removing ``No. 057926'' and by adding in its place 
``Nos. 057926 and 059130''.

    Dated: April 1, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-10474 Filed 4-28-03; 8:45 am]
BILLING CODE 4160-01-S