[Federal Register Volume 67, Number 124 (Thursday, June 27, 2002)]
[Rules and Regulations]
[Pages 43248-43252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-16161]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; 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 supplemental new animal drug 
application (NADA) filed by Alpharma, Inc. The supplemental NADA 
provides for the administration of Type C medicated feeds containing 
chlortetracycline to cattle as a top dress on feed for the treatment of 
enteritis and pneumonia.

DATES: This rule is effective June 27, 2002.

FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed a supplement to NADA 48-761 for 
AUREOMYCIN 50, 90, or 100 (chlortetracycline) Type A medicated 
articles. The supplemental NADA provides for the administration of Type 
C medicated feeds containing chlortetracycline to calves, beef and 
nonlactating dairy cattle as a top dress on feed to deliver 10 
milligrams (mg) chlortetracycline per pound of body weight daily. These 
medicated feeds are used for the treatment of bacterial enteritis 
caused by Escherichia coli and

[[Page 43249]]

bacterial pneumonia caused by Pasteurella multocida susceptible to 
chlortetracycline. The supplemental NADA is approved as of January 24, 
2002, and the regulations are amended in 21 CFR 558.128 to reflect the 
approval. The basis of approval is discussed in the freedom of 
information summary.
    Section 558.128 is also being amended to relocate a recently 
assigned withdrawal time (64 FR 23539, May 3, 1999) to the 
``Limitations'' column of the table describing conditions of use. This 
is being done to improve the readability of the regulations.
    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 supplemental 
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.
    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 approval for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning January 24, 2002, because the 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 the approval and conducted or sponsored by the 
applicant.
    The agency has determined under 21 CFR 25.33(a)(1) 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 is amended by redesignating paragraphs (a), (b), 
and (d) as paragraphs (b), (c), and (e), respectively; by adding new 
paragraphs (a) and (d); and by revising newly redesignated paragraphs 
(b) and (e) to read as follows:


Sec. 558.128  Chlortetracycline.

    (a) Specifications. Type A medicated articles containing either 
chlortetracycline calcium complex equivalent to chlortetracycline 
hydrochloride or, for products intended for use in milk replacer, 
chlortetracycline hydrochloride.
    (b) Approvals. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (e) of this section.
    (1) Nos. 046573, 053389, and 066104: 50 to 100 grams per pound (g/
lb) of Type A medicated article.
    (2) No. 017519: 50 g/lb of Type A medicated article.
* * * * *
    (d) Special considerations. (1) In milk replacers or starter feed; 
include on labeling the warning: ``A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal.''
    (2) Manufacture for use in free-choice feeds as in paragraph 
(e)(4)(iii) of this section must conform to Sec. 510.455 of this 
chapter.
    (3) When manufactured for use as in paragraph (e)(5)(iv) of this 
section, include on labeling the warning: ``Psittacosis, avian 
chlamydiosis, or ornithosis is a reportable communicable disease, 
transmissible between wild and domestic birds, other animals, and man. 
Contact appropriate public health and regulatory officials.''
    (e) Conditions of use--(1) Chickens. It is used as follows:

----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount           Indications for use                      Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 to 50 g/ton        Chickens: For increased rate of        . . . . . . . . . . . . . . . .   046573.
                           weight gain and improved feed          . . . . . . . . . . . . . . . .
                           efficiency.                            .                                017519,
                                                                                                   046573,
                                                                 Do not feed to chickens           053389,
                                                                  producing eggs for human         066104.
                                                                  consumption.
----------------------------------------------------------------------------------------------------------------
(ii) 100 to 200 g/ton     Chickens: For control of infectious    1. Feed continuously for 7 to 14  046573.
                           synovitis caused by Mycoplasma         d.
                           synoviae susceptible to                                                 017519,
                           chlortetracycline.                    2. Feed continuously for 7 to 14  046573,
                                                                  d; do not feed to chickens       053389,
                                                                  producing eggs for human         066104.
                                                                  consumption.
----------------------------------------------------------------------------------------------------------------
(iii) 200 to 400 g/ton    Chickens: For the control of chronic   1. Feed continuously for 7 to 14  046573.
                           respiratory disease (CRD) and air      d.
                           sac infection caused by M.                                              017519,
                           gallisepticum and Escherichia coli    2. Feed continuously for 7 to 14  046573,
                           susceptible to chlortetracycline.      d; do not feed to chickens       053389,
                                                                  producing eggs for human         066104.
                                                                  consumption.
----------------------------------------------------------------------------------------------------------------
(iv) 500 g/ton            Chickens: For the reduction of         1. Feed for 5 d.                  046573.
                           mortality due to E. coli infections
                           susceptible to chlortetracycline.     2. Feed for 5 d; do not feed to   017519,
                                                                  chickens producing eggs for      046573,
                                                                  human consumption.               053389,
                                                                                                   066104.
----------------------------------------------------------------------------------------------------------------


[[Page 43250]]

    (2) Turkeys. It is used as follows:

----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount           Indications for use                      Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 to 50 g/ton        Growing turkeys: For increased rate    Do not feed to turkeys producing  017519,
                           of weight gain and improved feed       eggs for human consumption.      046573,
                           efficiency.                                                             053389,
                                                                                                   066104.
----------------------------------------------------------------------------------------------------------------
(ii) 200 g/ton            Turkeys: For control of infectious     Feed continuously for 7 to 14 d;  017519,
                           synovitis caused by M. synoviae        do not feed to turkeys           046573,
                           susceptible to chlortetracycline.      producing eggs for human         053389,
                                                                  consumption.                     066104.
----------------------------------------------------------------------------------------------------------------
(iii) 400 g/ton           1. Turkeys: For control of             Feed continuously for 7 to 14 d;  017519,
                           hexamitiasis caused by Hexamita        do not feed to turkeys           046573,
                           meleagrides susceptible to             producing eggs for human         053389,
                           chlortetracycline.                     consumption.                     066104.
 
                          2. Turkey poults not over 4 weeks of                                     017519,
                           age: For reduction of mortality due                                     046573,
                           to paratyphoid caused by Salmonella                                     053389,
                           typhimurium susceptible to                                              066104.
                           chlortetracycline.
----------------------------------------------------------------------------------------------------------------
(iv) 25 mg/lb of body     Turkeys: For control of complicating   Feed continuously for 7 to 14 d;  017519,
 weight                    bacterial organisms associated with    do not feed to turkeys           046573,
                           bluecomb (transmissible enteritis;     producing eggs for human         053389,
                           coronaviral enteritis) susceptible     consumption.                     066104.
                           to chlortetracycline.
----------------------------------------------------------------------------------------------------------------

    (3) Swine. It is used as follows:

----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount           Indications for use                      Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 to 50 g/ton        Growing swine: For increased rate of                                     017519,
                           weight gain and improved feed                                           046573,
                           efficiency.                                                             053389,
                                                                                                   066104.
----------------------------------------------------------------------------------------------------------------
(ii) 50 to 100 g/ton      Swine: For reducing the incidence of                                     017519,
                           cervical lymphadenitis (jowl                                            046573,
                           abscesses) caused by Group E.                                           053389,
                           Streptococci susceptible to                                             066104.
                           chlortetracycline.
----------------------------------------------------------------------------------------------------------------
(iii) 400 g/ton           Breeding swine: For the control of     Feed continuously for not more    017519,
                           leptospirosis (reducing the            than 14 d.                       046573,
                           incidence of abortion and shedding                                      053389,
                           of leptospirae) caused by Leptospira                                    066104.
                           pomona susceptible to
                           chlortetracycline.
----------------------------------------------------------------------------------------------------------------
(iv) 10 mg/lb of body     1. Swine: For the treatment of         Feed approximately 400 g/t,       017519,
 weight                    bacterial enteritis caused by E.       varying with body weight and     046573,
                           coli and S. choleraesuis and           feed consumption to provide 10   053389,
                           bacterial pneumonia caused by          mg/lb per day. Feed for not      066104.
                           Pasteurella multocida susceptible to   more than 14 d; withdraw 5 d
                           chlortetracycline.                     prior to slaughter for sponsor
                                                                  017519.
 
                          2. Swine: For the control of porcine   Feed for not more than 14 d.      046573.
                           proliferative enteropathies
                           (ileitis) caused by Lawsonia
                           intracellularis susceptible to
                           chlortetracycline.
----------------------------------------------------------------------------------------------------------------

    (4) Cattle. It is used as follows:

----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount           Indications for use                      Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.1 mg/lb of body     Calves (up to 250 lb): For increased   See paragraph (d)(1) of this      017519,
 weight daily.             rate of weight gain and improved       section.                         046573,
                           feed efficiency.                                                        053389,
                                                                                                   066104.
----------------------------------------------------------------------------------------------------------------
(ii) 0.5 mg/lb of body    Beef cattle (over 700 lb); control of  Withdraw 48 h prior to            017519,
 weight daily.             active infection of anaplasmosis       slaughter. To sponsor No.        046573,
                           caused by Anaplasma marginale          046573: zero withdrawal time.    053389,
                           susceptible to chlortetracycline.      To sponsor No. 053389: 1 d       066104.
                                                                  withdrawal time.
----------------------------------------------------------------------------------------------------------------

[[Page 43251]]

 
(iii) 0.5 to 2.0 mg/lb    Beef cattle and nonlactating dairy     In free-choice cattle feeds such  046573.
 of body weight daily.     cattle: As an aid in the control of    as feed blocks or salt-mineral
                           active infection of anaplsmosis        mixes manufactured from
                           caused by A. marginale susceptible     approved Type A articles. See
                           to chlortetracycline.                  paragraph (d)(2) of this
                                                                  section.
----------------------------------------------------------------------------------------------------------------
(iv) 10 mg/lb of body     1. Calves, beef and nonlactating       Feed approximately 400 g/ton,     017519,
 weight daily.             dairy cattle; treatment of bacterial   varying with body weight and     046573,
                           enteritis caused by E. coli and        feed consumption to provide 10   053389,
                           bacterial pneumonia caused by P.       mg/lb per day. Treat for not     066104.
                           multocida organisms susceptible to     more than 5 d; in feed
                           chlortetracycline.                     including milk replacers;
                                                                  withdraw 10 d prior to
                                                                  slaughter. To sponsor No.
                                                                  053389: 1 d withdrawal time. To
                                                                  sponsor No. 046573: zero
                                                                  withdrawal time. See paragraph
                                                                  (d)(1) of this section.
 
                          2. Calves (up to 250 lb): For the      See paragraph (d)(1) of this      017519,
                           treatment of bacterial enteritis       section.                         046573,
                           caused by E. coli susceptible to                                        053389,
                           chlortetracycline.                                                      066104.
----------------------------------------------------------------------------------------------------------------
(v) 4,000 to 20,000 g/    Calves, beef and nonlactating dairy    As a top dress, varying with      046573.
 ton                       cattle; treatment of bacterial         body weight and feed
                           enteritis caused by E. coli and        consumption, to provide 10 mg/
                           bacterial pneumonia caused by P.       lb per day. Treat for not more
                           multocida organisms susceptible to     than 5 days. See paragraph
                           chlortetracycline.                     (d)(1) of this section.
----------------------------------------------------------------------------------------------------------------
(vi) 25 to 70 mg/head/    Calves (250 to 400 lb): For increased  See paragraph (d)(1) of this      017519,
 day                       rate of weight gain and improved       section.                         046573,
                           feed efficiency.                                                        053389,
                                                                                                   066104.
----------------------------------------------------------------------------------------------------------------
(vii) 70 mg/head/day      Growing cattle (over 400 lb): For      See paragraph (d)(1) of this      017519,
                           increased rate of weight gain,         section.                         046573,
                           improved feed efficiency, and                                           053389,
                           reduction of liver condemnation due                                     066104.
                           to liver abscesses.
----------------------------------------------------------------------------------------------------------------
(viii) 350 mg/head/day    1. Beef cattle: For control of         Withdraw 48 h prior to            017519,
                           bacterial pneumonia associated with    slaughter. For sponsor 046573:    046573,
                           shipping fever complex caused by       zero withdrawal time. For         053389,
                           Pasteurellaspp. susceptible to         sponsor 053389: 1 d withdrawal    066104.
                           chlortetracycline.                     time.
 
                          2. Beef cattle (under 700 lb): For     Withdraw 48 h prior to            017519,
                           control of active infection of         slaughter. For sponsor 046573:   046573,
                           anaplasmosis caused by A. marginale    zero withdrawal time. For        053389,
                           susceptible to chlortetracycline.      sponsor 053389: 1 d withdrawal   066104.
                                                                  time.
----------------------------------------------------------------------------------------------------------------

    (5) Minor species. It is used as follows:

----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount           Indications for use                      Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 20 to 50 g/ton        Growing sheep; increased rate of                                         046573,
                           weight gain and improved feed                                           053389,
                           efficiency.                                                             066104.
----------------------------------------------------------------------------------------------------------------
(ii) 80 mg/head/day       Breeding sheep; reducing the                                             046573,
                           incidence of (vibrionic) abortion                                       053389,
                           caused by Campylobacter fetus                                           066104.
                           infection susceptible to
                           chlortetracycline.
----------------------------------------------------------------------------------------------------------------
(iii) 200 to 400 g/ton    Ducks: For the control and treatment   Feed in complete ration to        046573.
                           of fowl cholera caused by P.           provide from 8 to 28 mg/lb of
                           multocida susceptible to               body weight per day depending
                           chlortetracycline.                     upon age and severity of
                                                                  disease, for not more than 21
                                                                  d. Do not feed to ducks
                                                                  producing eggs for human
                                                                  consumption.
----------------------------------------------------------------------------------------------------------------

[[Page 43252]]

 
(iv) 10 mg/g of finished  Psittacine birds (cockatoos, macaws,   Feed continuously for 45 d; each  046573.
 feed daily.               and parrots) suspected or known to     bird should consume daily an
                           be infected with psittacosis caused    amount of medicated feed equal
                           by Chlamydia psittaci sensitive to     to one fifth of its body
                           chlortetracycline.                     weight.
 
                                                                 See paragraph (d)(3) of this
                                                                  section.
----------------------------------------------------------------------------------------------------------------

    (6) Chlortetracycline. It may be used in accordance with this 
section in combinations as follows:
    (i) Amprolium in accordance with Sec. 558.55.
    (ii) Amprolium plus ethopabate in accordance with Sec. 558.58.
    (iii) Bacitracin methylene disalicylate in accordance with 
Sec. 558.76.
    (iv) Clopidol in accordance with Sec. 558.175.
    (v) Decoquinate in accordance with Sec. 558.195.
    (vi) Hygromycin B in accordance with Sec. 558.274.
    (vii) Monensin in accordance with Sec. 558.355.
    (viii) Robenidine hydrochloride in accordance with Sec. 558.515.
    (ix) Roxarsone in accordance with Sec. 558.530.
    (x) Salinomycin alone or with roxarsone in accordance with 
Sec. 558.550.
    (xi) Tiamulin in accordance with Sec. 558.600.
    (xii) Zoalene in accordance with Sec. 558.680.

    Dated: May 29, 2002.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 02-16161 Filed 6-26-02; 8:45 am]
BILLING CODE 4160-01-S