[Federal Register Volume 61, Number 123 (Tuesday, June 25, 1996)]
[Rules and Regulations]
[Pages 32651-32653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16103]



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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; Ivermectin and 
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 new animal drug application 
(NADA) filed by Merck Research Laboratories, Division of Merck & Co., 
Inc. The NADA provides for use of single ingredient ivermectin and 
lincomycin Type A medicated articles to make combination drug Type B 
and C medicated swine feeds used for treatment and control of certain 
helminth, lice, and mite infections, increased rate of weight gain, 
treatment and control of swine dysentery, and reduction of severity of 
swine mycoplasma pneumonia in growing-finishing swine.

EFFECTIVE DATE: June 25, 1996.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Merck Research Laboratories, Division of 
Merck & Co., Inc., P.O. Box 2000, Rahway, NJ 07065, is sponsor of NADA 
141-054, which provides for the use of Ivomec (ivermectin 0.6 
percent) Type A medicated article and Lincomix (lincomycin 20 
and 50 grams (g)/pound) Type A medicated articles to make ivermectin/ 
lincomycin Type B and C medicated swine feeds. The Type C medicated 
swine feeds containing 1.8 g ivermectin/ton with 20, 40, 100, or 200 g 
lincomycin/ton are fed to growing-finishing swine for treatment and 
control of gastrointestinal roundworms, kidney worms, lungworms, lice, 
mites, swine dysentery; reduction of severity of mycoplasmal pneumonia; 
and to increase rate of weight gain. The NADA is approved as of June 
25, 1996, and the regulations are amended in 21 CFR 558.300 and 558.325 
to reflect the

[[Page 32652]]

approval. The basis of approval is discussed in the freedom of 
information summary.
    NADA 141-054 provides for use of ivermectin and lincomycin Type A 
medicated articles to make combination drug Type B and C medicated 
swine feeds. Ivermectin is a Category II drug which, as provided in 21 
CFR 558.4(b), requires an approved Form FDA 1900 for making Type C 
medicated feeds. Therefore, use of ivermectin and lincomycin Type A 
medicated articles in making combination drug Type B and C medicated 
feeds, as in this NADA, requires an approved Form FDA 1900.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
a 3-year marketing exclusivity beginning June 25, 1996, because the 
application contains reports of new clinical or field investigations 
(other than bioequivalence or residue studies) essential to the 
approval and conducted or sponsored by the applicant.
    The agency has determined under 21 CFR 25.24(d)(1)(ii) 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: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).

    2. Section 558.300 is amended by revising paragraph (a) and by 
adding new paragraphs (c)(2) through (c)(5) to read as follows:


Sec. 558.300  Ivermectin.

    (a) Approvals. (1) Type A medicated articles: 0.6 percent (2.72 
grams per pound; 6 grams per kilogram) to 000006 in Sec. 510.600(c) of 
this chapter, and
    (2) Type B medicated feeds for ivermectin alone or with lincomycin. 
See Sec. 558.4 of this chapter for maximum drug levels to 000006 in 
Sec. 510.600(c) of this chapter.
* * * * *
    (c) *   *   *
    (2) Amount per ton. 1.8 grams of ivermectin (to provide 0.1 
milligram per kilogram of body weight per day) with 20 grams of 
lincomycin.
    (i) Indications for use. For treatment and control of 
gastrointestinal roundworms (Ascaris suum, adults and fourth-stage 
larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and 
fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage 
larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage 
larvae), lungworms (Metastrongylus spp., adults), lice (Haematopinus 
suis), and mange mites (Sarcoptes scabiei var. suis). For increased 
rate of weight gain.
    (ii) Limitations. For weaned, growing-finishing swine. Feed as sole 
ration for 7 consecutive days. Withdraw 5 days before slaughter. A 
separate feed containing 20 grams per ton lincomycin may be continued. 
Not to be fed to swine that weigh more than 250 pounds. Do not allow 
rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds 
containing lincomycin. Ingestion by these species may result in severe 
gastrointestinal effects. Consult your veterinarian for assistance in 
the diagnosis, treatment, and control of parasitism.
    (3) Amount per ton. 1.8 grams of ivermectin (to provide 0.1 
milligram per kilogram of body weight per day) with 40 grams of 
lincomycin.
    (i) Indications for use. For treatment and control of 
gastrointestinal roundworms (Ascaris suum, adults and fourth-stage 
larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and 
fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage 
larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage 
larvae), lungworms (Metastrongylus spp., adults), lice (Haematopinus 
suis), and mange mites (Sarcoptes scabiei var. suis). For control of 
swine dysentery. For use in swine on premises with a history of swine 
dysentery, but where symptoms have not yet occurred.
    (ii) Limitations. For weaned, growing-finishing swine. Feed as sole 
ration for 7 consecutive days. Withdraw 5 days before slaughter. A 
separate feed containing 40 grams per ton lincomycin may be continued. 
Not to be fed to swine that weigh more than 250 pounds. Do not allow 
rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds 
containing lincomycin. Ingestion by these species may result in severe 
gastrointestinal effects. Consult your veterinarian for assistance in 
the diagnosis, treatment and control of parasitism.
    (4) Amount per ton. 1.8 grams of ivermectin (to provide 0.1 
milligram per kilogram of body weight per day) with 100 grams of 
lincomycin.
    (i) Indications for use. For treatment and control of 
gastrointestinal roundworms (Ascaris suum, adults and fourth-stage 
larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and 
fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage 
larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage 
larvae), lungworms (Metastrongylus spp., adults), lice (Haematopinus 
suis), and mange mites (Sarcoptes scabiei var. suis). Treatment of 
swine dysentery.
    (ii) Limitations. For weaned, growing-finishing swine. Feed as sole 
ration for 7 consecutive days followed by a separate feed containing 
100 grams per ton lincomycin for an additional 14 days to complete the 
lincomycin treatment. Withdraw 6 days before slaughter. Not to be fed 
to swine that weigh more than 250 pounds. Do not allow rabbits, 
hamsters, guinea pigs, horses, or ruminants access to feeds containing 
lincomycin. Ingestion by these species may result in severe 
gastrointestinal effects. Consult your veterinarian for assistance in 
the diagnosis, treatment, and control of parasitism.
    (5) Amount per ton. 1.8 grams of ivermectin (to provide 0.1 
milligram per kilogram of body weight per day) with 200 grams of 
lincomycin.
    (i) Indications for use. For treatment and control of 
gastrointestinal roundworms (Ascaris suum, adults and fourth-stage 
larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and 
fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage 
larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage 
larvae), lungworms (Metastrongylus spp., adults), lice (Haematopinus 
suis), and mange mites (Sarcoptes scabiei var. suis). For reduction in 
severity of swine

[[Page 32653]]

mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae.
    (ii) Limitations. For weaned, growing-finishing swine. Feed as sole 
ration for 7 consecutive days followed by a separate feed containing 
200 grams per ton lincomycin for an additional 14 days to complete the 
lincomycin treatment. Withdraw 6 days before slaughter. Not to be fed 
to swine that weigh more than 250 pounds. Do not allow rabbits, 
hamsters, guinea pigs, horses, or ruminants access to feeds containing 
lincomycin. Ingestion by these species may result in severe 
gastrointestinal effects. Consult your veterinarian for assistance in 
the diagnosis, treatment, and control of parasitism.
    3. Section 558.325 is amended by adding new paragraph (c)(4)(iii) 
to read as follows:


Sec. 558.325  Lincomycin.

* * * * *
    (c) * * *
    (4) * * *-
    (iii) Ivermectin as in Sec. 558.300.

    Dated: June 14,1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-16103 Filed 6-24-96; 8:45 am]
BILLING CODE 4160-01-F