[Federal Register Volume 69, Number 159 (Friday, October 8, 2004)]
[Rules and Regulations]
[Pages 60308-60309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22606]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556


New Animal Drugs; Flunixin

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 the veterinary prescription use of 
flunixin meglumine solution by intravenous injection in lactating dairy 
cattle for control of pyrexia associated with bovine respiratory 
disease and endotoxemia, and for control of inflammation in 
endotoxemia. It also provides for the veterinary prescription use of 
flunixin meglumine solution by intravenous injection for control of 
pyrexia associated with acute bovine mastitis and for the establishment 
of a tolerance for residues of flunixin in milk.

DATES:  This rule is effective October 8, 2004.

FOR FURTHER INFORMATION CONTACT:  Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095 
Morris Ave., Union, NJ 07083, filed a supplement to NADA 101-479 that 
provides for the veterinary prescription use of BANAMINE (flunixin 
meglumine) Injectable Solution by intravenous injection in lactating 
dairy cattle for control of pyrexia associated with bovine respiratory 
disease and endotoxemia, and for control of inflammation in 
endotoxemia. It also provides for the veterinary prescription use of 
flunixin meglumine solution by intravenous injection for control of 
pyrexia associated with acute bovine mastitis and for the establishment 
of a tolerance for residues of flunixin in milk. The supplemental NADA 
is approved as of August 19, 2004, and the regulations are amended in 
21 CFR 522.970 and 556.286 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 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)(iii) of the Federal Food, Drug, and 
Cosmetic Act the act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental 
approval qualifies for 3 years of marketing exclusivity beginning 
August 19, 2004. The 3 years of marketing exclusivity applies only to 
the new indication of control of pyrexia associated with acute bovine 
mastitis.
    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.
    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

21 CFR Part 522

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

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 parts 522 and 
556 are 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 522.970 is amended by revising the section heading; by 
revising paragraph (b)(1); by redesignating paragraph (b)(2) as 
paragraph (b)(3); by adding new paragraph (b)(2); and by revising 
paragraphs (e)(2) introductory text, (e)(2)(i), (e)(2)(ii), and 
(e)(2)(iii) to read as follows:


Sec.  522.970  Flunixin.

* * * * *
    (b) * * *
    (1) See No. 000061 for use as in paragraph (e) of this section.
    (2) See Nos. 055529, 057561, and 059130 for use as in paragraphs 
(e)(1), (e)(2)(i)(A), (e)(2)(ii)(A), and (e)(2)(iii), of this section.
* * * * *
    (e) * * *
* * * * *
    (2) Cattle--(i) Amount. (A) 1.1 to 2.2 mg/kilogram (kg) (0.5 to 1.0 
mg/lb) of body weight per day, as a single dose or divided into two 
doses administered at 12-hour intervals, intravenously, for up to 3 
days.
    (B) 2.2 mg/kg (1.0 mg/lb) of body weight given once by intravenous 
administration.
    (ii) Indications for use. (A) For control of pyrexia associated 
with bovine respiratory disease and endotoxemia. Also indicated for 
control of inflammation in endotoxemia.
    (B) For control of pyrexia associated with acute bovine mastitis.
    (iii) Limitations. Do not slaughter for food use within 4 days of 
last treatment. A withdrawal period has not been established for use in 
preruminating calves. Do not use in calves to be processed for veal. 
For No. 000061: Do not use in dry dairy cows. Milk that has been taken 
during treatment and for 36 hours after the last treatment must not be 
used for food. For Nos. 055529, 057561, and 059130: Not for use in 
lactating or dry dairy cows.

[[Page 60309]]

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
3. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.
0
4. Section 556.286 is amended by revising the section heading; by 
revising paragraph (b); and by adding paragraph (c) to read as follows:


Sec.  556.286  Flunixin.

* * * * *
    (b) Tolerances--(1) Cattle. The tolerance for flunixin free acid 
(the marker residue) is:
    (i) Liver (the target tissue). 125 parts per billion (ppb).
    (ii) Muscle. 25 ppb.
    (iii) Milk. 2 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  522.970 of this chapter.

    Dated: September 27, 2004.
Stephen D. Vaughn,
Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 04-22606 Filed 10-7-04; 8:45 am]
BILLING CODE 4160-01-S