[Federal Register Volume 67, Number 101 (Friday, May 24, 2002)]
[Rules and Regulations]
[Pages 36512-36514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-13164]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Lincomycin

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 Pharmacia & Upjohn Co. The supplemental 
NADA provides for the use of lincomycin in swine feed for the control 
of porcine proliferative enteropathies (ileitis).

DATES: This rule is effective May 24, 2002.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7584, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., 7000 Portage Rd., 
Kalamazoo, MI 49001-0199, filed a supplement to NADA 97-505 that 
provides for use of LINCOMIX 20 (lincomycin hydrochloride) and LINCOMIX 
50 Feed Medications in medicated swine feeds for the control of porcine 
proliferative enteropathies (ileitis) caused by Lawsonia 
intracellularis. The supplemental application is approved as of 
February 28, 2002, and the regulations are amended in 21 CFR 558.325 to 
reflect the approval. Section 558.325 is also being revised to reflect 
a current format.
    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 qualifies 
for 3 years of marketing exclusivity beginning February 28, 2002, 
because the application contains substantial evidence of the 
effectiveness of the drug involved, any studies of animal safety

[[Page 36513]]

or, in the case of food-producing animals, human food safety studies 
(other than bioequivalence or residue studies) required for approval of 
the application 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 558.325 is amended in paragraph (a) by removing 
``paragraph (c)'' and in its place adding ``paragraph (d)''; by 
revising paragraphs (a)(1), (a)(5), and (a)(13); in paragraph (b) by 
removing ``in edible products''; and by revising paragraph (d) to read 
as follows:


[sect] 558.325  Lincomycin.

    (a) * * *
    (1) No. 000009 for 20 and 50 grams per pound.
* * * * *
    (5) No. 043733 for 8 and 20 grams per pound.
* * * * *
    (13) No. 017800 for 2.5 and 8 grams per pound.
* * * * *
    (d) Conditions of use--(1) Chickens. It is used in feed as follows:

------------------------------------------------------------------------
   Lincomycin      Indications for
   grams/ton             use              Limitations          Sponsor
------------------------------------------------------------------------
(i) 2            Broilers: For       As lincomycin               000009
                  control of          hydrochloride
                  necrotic            monohydrate.
                  enteritis caused
                  by Clostridium
                  spp. or other
                  susceptible
                  organisms.
------------------------------------------------------------------------
(ii) 2 to 4      Broilers: For       As lincomycin               000009
                  increased rate of   hydrochloride
                  weight gain and     monohydrate.
                  improved feed
                  efficiency.
------------------------------------------------------------------------

    (2) Swine. It is used in feed as follows:

------------------------------------------------------------------------
   Lincomycin      Indications for
   grams/ton             use              Limitations          Sponsor
------------------------------------------------------------------------
(i) 20           Growing-finishing   Feed as sole ration.        000009
                  swine: For          Not to be fed to
                  increased rate of   swine that weigh
                  weight gain.        more than 250 pounds
                                      (lb).
------------------------------------------------------------------------
(ii) 40          1. For control of   Feed as sole ration;        000009
                  swine dysentery.    for use in swine on        017800
                                      premises with a            043733
                                      history of swine
                                      dysentery but where
                                      symptoms have not
                                      yet occurred, or
                                      following use of
                                      lincomycin at 100
                                      grams (g)/ton for
                                      treatment of swine
                                      dysentery. Not to be
                                      fed to swine that
                                      weigh more than 250
                                      lb.
                 2. For control of   Feed as sole ration,        000009
                  porcine             or following use of
                  proliferative       lincomycin at 100 g/
                  enteropathies       ton for control of
                  (ileitis) caused    porcine
                  by Lawsonia         proliferative
                  intracellularis.    enteropathies
                                      (ileitis). Not to be
                                      fed to swine that
                                      weigh more than 250
                                      lb.
------------------------------------------------------------------------
(iii) 100        1. For treatment    Feed as sole ration         000009
                  of swine            for 3 weeks or until       017800
                  dysentery.          signs of disease           043733
                                      disappear. Not to be
                                      fed to swine that
                                      weigh more than 250
                                      lb.
                 2. For control of   Feed as sole ration         000009
                  porcine             for 3 weeks or until
                  proliferative       signs of disease
                  enteropathies       disappear. Not to be
                  (ileitis) caused    fed to swine that
                  by Lawsonia         weigh more than 250
                  intracellularis.    lb.
------------------------------------------------------------------------
(iv) 200         For reduction in    Feed as sole ration         000009
                  the severity of     for 3 weeks. Not to        017800
                  swine mycoplasmal   be fed to swine that
                  pneumonia caused    weigh more than 250
                  by Mycoplasma       lb.
                  hyopneumoniae.
------------------------------------------------------------------------

    (3) Lincomycin may also be used in combination with:
    (i) Amprolium and ethopabate or amprolium and ethopabate with 
roxarsone in accordance with [sect] 558.58.
    (ii) Clopidol in accordance with [sect] 558.175.
    (iii) Decoquinate in accordance with [sect] 558.195.
    (iv) Fenbendazole as provided in [sect] 558.258.
    (v) Halofuginone in accordance with [sect] 558.265.
    (vi) Ivermectin as in [sect] 558.300.
    (vii) Lasalocid alone or with roxarsone in accordance with [sect] 
558.311.
    (viii) Monensin alone or with roxarsone in accordance with [sect] 
558.355.
    (ix) Nicarbazin alone or with narasin or roxarsone as in [sect] 
558.366.
    (x) Pyrantel as in [sect] 558.485.
    (xi) Robenidine in accordance with [sect] 558.515.
    (xii) Roxarsone in accordance with [sect] 558.530.
    (xiii) Salinomycin with or without roxarsone as in [sect] 558.550.
    (xiv) Zoalene in accordance with [sect] 558.680.


[[Page 36514]]


    Dated: May 14, 2002.
Acting Director,
Office of New Animal Drug Evaluation,Center for Veterinary Medicine.
[FR Doc. 02-13164 Filed 5-23-02; 8:45 am]
BILLING CODE 4160-01-S