Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 /Rules and Regulations 38749

Dated: June 24, 1998.

L. Robert Lake,

Director, Office of Policy, Planning and

Strategic Initiatives, Center for Food Safety

and Applied Nutrition.

[FR Doc. 98–19174 Filed 7–17–98; 8:45 am]

BILLING CODE 4160–01–F

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.

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: ScheringPlough Animal Health Corp., 1095

Morris Ave., P.O. Box 3182, Union, NJ

07083–1982, is sponsor of NADA 101–

479 Banamine (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 foodproducing 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:

§ 522.970 Flunixin meglumine solution.

* * * * *

(b) Sponsors. See 000061 in

§ 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 § 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.
38750 Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 /Rules and Regulations

(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:

§ 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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs For Use In Animal

Feeds; Bacitracin Methylene

Disalicylate and Zoalene

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 a new animal drug

application (NADA) filed by Alpharma

Inc. The NADA provides for using

approved bacitracin methylene

disalicylate and zoalene Type A

medicated articles to make Type C

medicated turkey feeds.

EFFECTIVE DATE: July 20, 1998.

FOR FURTHER INFORMATION CONTACT:

Charles J. Andres, Center for Veterinary

Medicine (HFV–128), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1600.

SUPPLEMENTARY INFORMATION: Alpharma

Inc., One Executive Dr., P.O. Box 1399,

Fort Lee, NJ 07024, is sponsor of NADA

141–085 which provides for combining

approved BMD (10, 25, 30, 40, 50, 60,

or 75 gram per pound (g/lb) bacitracin

methylene disalicylate), and Zoamix

(113.5 g/lb zoalene) Type A medicated

articles to make Type C medicated feeds

for growing turkeys containing 4 to 50

g per ton (g/t) bacitracin methylene

disalicylate and 113.5 to 170.3 g/t

zoalene. The Type C medicated turkey

feed is used for prevention and control

of coccidiosis, and for increased rate of

weight gain and improved feed

efficiency. The NADA is approved as of

June 3, 1998, and the regulations are

amended in 21 CFR 558.76(d)(3) by

adding paragraph (d)(3)(xv), and in 21

CFR 558.680(c), in the table, in item (iii)

by adding an entry to reflect the

approval. The basis for 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 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.

FDA has determined under 21 CFR

25.33(a)(2) 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.

List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.

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 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

2. Section 558.76 is amended by

adding paragraph (d)(3)(xv) to read as

follows:

§ 558.76 Bacitracin methylene disalicylate.

* * * * *

(d) * * *

(3) * * *

(xv) Zoalene alone or in combination

as in § 558.680.

3. Section 558.680 is amended in the

table in paragraph (c)(1) in item (iii) by

alphabetically adding an entry for

‘‘Bacitracin methylene disalicylate 4–

50’’ to read as follows:

§ 558.680 Zoalene.

* * * * *

(c) * * *

(1) * * *

Zoalene in grams/ton Combination in grams/ton Indications for use Limitations

* * * * * * *

(iii) 113.5–170.3 (0.0125–

0.01875%)