[Federal Register Volume 63, Number 138 (Monday, July 20, 1998)]
[Rules and Regulations]
[Pages 38749-38750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19176]


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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; Flunixin 
Meglumine

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 supplemental new animal drug 
application (NADA) filed by Schering-Plough Animal Health Corp. The 
supplemental NADA provides for veterinary prescription use of flunixin 
meglumine solution, intravenously, for control of pyrexia associated 
with bovine respiratory disease and endotoxemia, and control of 
inflammation in endotoxemia, in beef and nonlactating dairy cattle.

EFFECTIVE DATE: July 20, 1998.

FOR FURTHER INFORMATION CONTACT: Estella Z. Jones, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095 
Morris Ave., P.O. Box 3182, Union, NJ 07083-1982, is sponsor of NADA 
101-479 Banamine<Register> (flunixin meglumine) Injectable Solution 
that provides for veterinary prescription use of flunixin meglumine, 
intravenously or intramuscularly, for alleviation of inflammation and 
pain associated with musculoskeletal disorders, and alleviation of 
visceral pain associated with colic in the horse. The sponsor filed a 
supplemental NADA that provides for veterinary prescription use of 
flunixin meglumine solution, intravenously, for control of pyrexia 
associated with bovine respiratory disease and endotoxemia, and control 
of inflammation in endotoxemia, in beef cattle and nonlactating dairy 
cattle. The supplemental NADA is approved as of May 6, 1998, and the 
regulations are amended in 21 CFR 522.970 by revising paragraph (b), by 
redesignating existing paragraph (c) as (d), by revising newly 
redesignated paragraph (d), and by adding paragraph (c) to reflect the 
approval. The basis for approval is discussed in the freedom of 
information summary.
    In addition, a tolerance for residues of flunixin meglumine in 
edible tissues of cattle has not been previously established. Section 
556.286 is added to provide tolerances for flunixin meglumine residues 
in cattle liver (target tissue) and in cattle muscle.
    Also, in addition to codifying a tolerance for flunixin residues in 
cattle tissues, FDA is amending the regulation to codify the acceptable 
daily intake (ADI) for total residues of flunixin. The ADI is the 
amount of total drug residue that can be consumed by humans every day. 
Previously, FDA had codified safe concentrations which represent the 
ADI corrected for consumption. The safe concentrations were confusing 
because few individuals understood the relationship between safe 
concentrations, a value representing total residues, and tolerance, the 
part of the drug residue in a given tissue that is detected by an 
analytical method. To eliminate this confusion, FDA is codifying the 
ADI.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval 
for beef cattle and nonlactating dairy cattle qualifies for 3 years of 
marketing exclusivity beginning May 6, 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 approval and conducted or sponsored by 
the applicant. Three years marketing exclusivity is limited to use of 
the drug for the control of pyrexia associated with bovine respiratory 
disease and endotoxemia, and control of inflammation in endotoxemia, in 
beef cattle and nonlactating dairy cattle.
    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.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

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 522.970 is amended by revising paragraph (b), by 
redesignating paragraph (c) as (d), by revising newly redesignated 
paragraph (d), and by adding paragraph (c) to read as follows:


Sec. 522.970  Flunixin meglumine solution.

* * * * *
    (b) Sponsors. See 000061 in Sec. 510.600(c) of this chapter for use 
as in paragraph (d) of this section. See 000856 and 059130 for use as 
in paragraph (d)(1) of this section only.
    (c) Related tolerances. See Sec. 556.286 of this chapter.
    (d) Conditions of use--(1) Horses--(i) Amount. 0.5 milligram of 
flunixin per pound of body weight (1 milliliter per 100 pounds) per 
day.
    (ii) Indications for use. For alleviation of inflammation and pain 
associated with musculoskeletal disorders, and alleviation of visceral 
pain associated with colic.
    (iii) Limitations. For musculoskeletal disorders, administer 
intravenously or intramuscularly for up to 5 days. For colic, 
administer a single dose intravenously--treatment may be repeated when 
signs of colic recur. Caution: The effect of this drug on pregnancy has 
not been determined. Not for use in horses intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[[Page 38750]]

    (2) Beef cattle and nonlactating dairy cattle--(i) Amount. 1.1 to 
2.2 milligrams per kilogram of body weight (0.5 to 1 milligram per 
pound, 1 to 2 milliliters per 100 pounds), once a day as a single dose 
or divided into 2 doses administered at 12-hour intervals for up to 3 
days.
    (ii) Indications for use. For control of pyrexia associated with 
bovine respiratory disease and endotoxemia. Also indicated for control 
of inflammation in endotoxemia.
    (iii) Limitations. Do not slaughter for food use within 4 days of 
last treatment. Not for use in lactating or dry dairy cows. A 
withdrawal period has not been established for use in preruminating 
calves. Do not use in calves to be processed for veal. Do not use in 
bulls intended for breeding as reproductive effects in this class of 
cattle have not been studied. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.

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 556.286 is added to subpart B to read as follows:


Sec. 556.286  Flunixin meglumine.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
flunixin is 0.72 micrograms per kilogram of body weight per day.
    (b) Tolerances. For residues of parent flunixin free acid of 0.125 
part per million (ppm) in cattle liver (target tissue) and 0.025 ppm in 
cattle muscle are established.

    Dated: July 9, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-19176 Filed 7-17-98; 8:45 am]
BILLING CODE 4160-01-F