[Federal Register Volume 68, Number 55 (Friday, March 21, 2003)]
[Rules and Regulations]
[Pages 13839-13840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6508]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Laidlomycin and 
Chlortetracycline

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 the use of 
approved, single-ingredient Type A medicated articles containing 
laidlomycin and chlortetracycline to formulate two-way combination drug 
Type C medicated feeds for cattle fed in confinement for slaughter.

DATES: This rule is effective March 21, 2003.

FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed NADA 141-201 for use of CATTLYST 
(laidlomycin propionate potassium) and AUREOMYCIN (chlortetracycline) 
Type A medicated articles to formulate two-way 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. 801-808.

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 558.128 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. 03-6508 Filed 3-20-03; 8:45 am]
BILLING CODE 4160-01-S