[Federal Register Volume 69, Number 150 (Thursday, August 5, 2004)]
[Rules and Regulations]
[Pages 47362-47363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17876]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Romifidine

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 Boehringer Ingelheim Vetmedica, Inc. The NADA provides 
for the veterinary prescription use of romifidine hydrochloride 
injectable solution in horses as a sedative and analgesic, and as a 
preanesthetic agent.

DATES: This rule is effective August 5, 2004.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621 
North Belt Highway, St. Joseph, MO 64506-2002, filed NADA 141-229 that 
provides for the veterinary prescription use of SEDIVET (romifidine 
hydrochloride) 1% Injection as a sedative and analgesic to facilitate 
handling, clinical examinations, clinical procedures, and minor 
surgical procedures in adult horses. SEDIVET 1% Injection is also 
indicated as a preanesthetic to the induction of general anesthesia in 
adult horses. The NADA is approved as of June 3, 2004, and 21 CFR part 
522 is amended by adding Sec.  522.2076 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

[[Page 47363]]

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.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval 
qualifies for 5 years of marketing exclusivity beginning .
    The agency has determined under 21 CFR 25.33(d)(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.

0
2. Section 522.2076 is added to read as follows:


Sec.  522.2076  Romifidine.

    (a) Specifications. Each milliliter of solution contains 10 
milligrams (mg) romifidine hydrochloride.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 40 to 120 micrograms 
per kilogram of body weight (mcg/kg BW) intravenously for sedation and 
analgesia; 100 mcg/kg BW intravenously as a preanesthetic.
    (2) Indications for use. For use as a sedative and analgesic to 
facilitate handling, clinical examinations, clinical procedures, and 
minor surgical procedures in adult horses; and for use as a 
preanesthetic prior to the induction of general anesthesia in adult 
horses.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. Not for horses intended for human 
consumption

    Dated: June 23, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-17876 Filed 8-4-04; 8:45 am]
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