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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 558

NOTICE: RULES

ACTION: Animal drugs, feeds, and related products:

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: New Animal Drugs for Use in Animal Feeds; Laidlomycin and Chlortetracycline

DATES: This rule is effective March 21, 2003.

DOCUMENT 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 the use of approved, singleingredient Type A medicated articles containing laidlomycin and chlortetracycline to formulate twoway combination drug Type C medicated feeds for cattle fed in confinement for slaughter.

SUMMARY: Laidlomycin and chlortetracycline,

SUPPLEMENTAL INFORMATION

Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed NADA 141201 for use of CATTLYST (laidlomycin propionate potassium) and AUREOMYCIN (chlortetracycline) Type A medicated articles to formulate twoway combination drug Type C medicated feeds for cattle fed in confinement for slaughter. The NADA is approved as of December 18, 2002, and the regulations are amended in 21 CFR 558.128 and 558.305 to reflect the approval and a current format. 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)(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.

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. 801808.
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 558NEW 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 558.128 Chlortetracycline is amended in paragraph (e)(6) by redesignating paragraphs (e)(6)(vii) through (e)(6)(xii) as paragraphs (e)(6)(viii) through (e)(6)(xiii); and by adding new paragraph (e)(6)(vii) to read as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(6) * * *
(vii) Laidlomycin in accordance with Sec. 558.305.
* * * * *

3. Section 558.305 is amended by:

a. Revising the section heading;

b. Redesignating paragraph (b) as paragraph (c);

c. Adding new paragraphs (b) and (c)(3); and

d. Revising paragraphs (a) and (d) to read as follows: Sec. 558.305 Laidlomycin.
(a) Specifications. Type A medicated articles containing 50 grams laidlomycin propionate potassium per pound.
(b) Approvals. See No. 046573 in Sec. 510.600(c) of this chapter. (c) Special considerations.
* * * * *
(3) Labeling for all Type B feeds (liquid and dry) and Type C feeds containing laidlomycin shall bear the following statements: (i) Do not allow horses or other equines access to feeds containing laidlomycin propionate potassium.
(ii) The safety of laidlomycin propionate potassium in unapproved species has not been established.
(iii) Not for use in animals intended for breeding.
(d) Conditions of use. It is used in cattle being fed in confinement for slaughter as follows:
Laidlomycin in Combination in Indications
grams per ton grams per ton for use Limitations Sponsor (1) 5 .............. For improved Feed 046573 feed continuously efficiency in a Type C and increased feed at a
rate of rate of 30 weight gain. to 75 mg/
head/day.
[[Page 13840]]
(2) 5 Chlortetracycl For improved Feed 046573 ine10 mg/lb feed continuously body weight efficiency at a rate of and increased 30 to 75 mg rate of laidlomycin weight gain; propionate and for potassium
treatment of per head per bacterial day for not enteritis more than 5 caused by days. A
Echerichia withdrawal coli and period has bacterial not been
pneumonia established caused by for this
Pasteurella product in multocida pre
organisms ruminating susceptible calves. Do to not use in chlortetracyc calves to be line. processed
for veal.
(3) 5 Chlortetracycl For improved Feed 046573 ine 350 mg/ feed continuously head/day efficiency at a rate of and increased 30 to 75 mg rate of laidlomycin weight gain; propionate and for potassium
control of per head per bacterial day. A
pneumonia withdrawal associated period has with shipping not been
fever complex established caused by for this
Pasteurella product in spp. pre
susceptible ruminating to calves. Do chlortetracyc not use in line. calves to be processed
for veal.
(4) 5 to 10 .............. For improved Feed 046573 feed continuously efficiency. in a Type C feed at a
rate of 30 to 150
milligrams/ head/day.
(5) 5 to 10 Chlortetracycl For improved Feed 046573 ine 10 mg/ feed continuously pound body efficiency; at a rate of weight and for 30 to 150 mg treatment of laidlomycin bacterial propionate enteritis potassium
caused by E. per head per coli and day for not bacterial more than 5 pneumonia days. A
caused by P. withdrawal multocida period has organisms not been
susceptible established to for this
chlortetracyc product in line. pre
ruminating calves. Do not use in calves to be processed
for veal.
(6) 5 to 10 Chlortetracycl For improved Feed 046573 ine 350 mg/ feed continuously head/day efficiency; at a rate of and for 30 to 150 mg control of laidlomycin bacterial propionate pneumonia potassium
associated per head per with shipping day. A
fever complex withdrawal caused by period has Pasteurella not been
spp. established susceptible for this
to product in chlortetracyc pre
line. ruminating calves. Do not use in calves to be processed
for veal.

Dated: February 25, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 036508 Filed 32003; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Eric S. Dubbin, Center for Veterinary Medicine (HFV128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018270232, email: edubbin@cvm.fda.gov.