[Federal Register Volume 64, Number 52 (Thursday, March 18, 1999)]
[Rules and Regulations]
[Pages 13342-13343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6527]


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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 
Bacitracin Methylene Disalicylate

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 Merial Ltd. The NADA provides for use of ivermectin and 
bacitracin methylene disalicylate (BMD) Type A medicated articles to 
make Type B and Type C medicated swine feeds for use as antiparasitics, 
antibacterials, and growth promotants.

EFFECTIVE DATE:  March 18, 1999.

FOR FURTHER INFORMATION CONTACT:  Estella Z. Jones, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7575.

SUPPLEMENTARY INFORMATION:  Merial Ltd., 2100 Ronson Rd., Iselin, NJ 
08830-3077, filed NADA 141-097 that provides for use of 
Ivomec (ivermectin 0.6 percent) and BMD (BMD 30, 50, 60, and 
75 grams(g) per pound) Type A medicated articles to make ivermectin and 
BMD Type B and Type C medicated swine feeds. The Type C medicated feeds 
contain 1.8 g of ivermectin and 10, 30, or 250 g of BMD per ton for 
feeding to growing and finishing swine, and pregnant sows. It is used 
for the treatment and control of gastrointestinal roundworms, 
kidneyworms, lungworms, and threadworm infections; lice and mange mite 
infestations; increased rate of weight gain and improved feed 
efficiency; and for the control of clostridial enteritis and swine 
dysentery. The NADA is approved as of February 3, 1999, and the 
regulations are amended in 21 CFR 558.76 and Sec. 558.300 (21 CFR 
558.300) to reflect the approval. The basis of approval is discussed in 
the freedom of information summary.
    Also, the regulation concerning the limitations for use of 
ivermectin feeds in Sec. 558.300(d) are editorially amended by removing 
``sole ration'' and adding in its place ``only feed''.
    This NADA is for use of approved ivermectin and BMD Type A 
medicated articles to make Type B and Type C medicated swine feeds. 
Ivermectin is a category II drug as defined in 21 CFR 558.3(b)(1)(ii). 
As provided in 21 CFR 558.4(b), an approved medicated feed application 
is required for making Type B or Type C medicated feeds as in this 
application. Under section 512(m) of the Federal Food, Drug, and 
Cosmetic Act, as amended by the Animal Drug Availability Act of 1996 
(Pub. L. 104-250), medicated feed applications have been replaced by 
the requirement for feed mill licenses. Therefore, use of ivermectin 
and BMD Type A medicated articles to make Type B and Type C medicated 
feeds as in this NADA is limited to manufacture in a licensed feed 
mill.
    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 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.

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 558.76 is amended by adding paragraph (d)(3)(xx) to read 
as follows:


Sec. 558.76   Bacitracin methylene disalicylate.

* * * * *
    (d) * * *
    (3) * * *
    (xx) Ivermectin as in Sec. 558.300.
    3. Section 558.300 is amended in paragraphs (d)(1)(ii), (d)(2)(ii), 
(d)(3)(ii), (d)(4)(ii), and (d)(5)(ii) by removing the phrase ``sole 
ration'' and adding in its place the phrase ``only feed'', and by 
adding new paragraph (d)(6) to read as follows:


Sec. 558.300   Ivermectin.

* * * * *
    (d) * * *
    (6) Amount per ton. For weaned, growing-finishing pigs, feed 1.8 
grams of ivermectin (to provide 0.1 milligram per kilogram of body 
weight per day), and 10 to 30 or 250 grams of bacitracin methylene 
disalicylate. For adult and breeding swine, feed 1.8 grams of 
ivermectin (to provide 0.1 milligram per kilogram of body weight per 
day), and 10 to 30 or 250 grams of bacitracin methylene disalicylate.
    (i) Indications for use. For treatment and control of 
gastrointestinal

[[Page 13343]]

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); threadworms (Strongyloides 
ransomi, adults and somatic larvae, and prevention of transmission of 
infective larvae to piglets, via the colostrum or milk, when fed during 
gestation); lice (Haematopinus suis); and mange mites (Sarcoptes 
scabiei var. suis). For increased rate of weight gain and improved feed 
efficiency in growing and finishing swine. For control of clostridial 
enteritis caused by Clostridium perfringens in suckling piglets. For 
control of swine dysentery associated with Treponema hypdysenteriae on 
premises with a history of swine dysentery but where signs of disease 
have not yet occurred, or following an approved treatment of disease 
condition.
    (ii) Limitations. For use in swine feed only. Feed as the only feed 
for 7 consecutive days. For weaned growing and finishing swine, feed 
bacitracin methylene disalicylate Type C medicated feed from weaning to 
market weight for increased rate of weight gain and improved feed 
efficiency. For pregnant sows, feed bacitracin methylene disalicylate 
to sows from 14 days before through 21 days after farrowing on premises 
with a history of clostridial scours. Withdraw ivermectin-containing 
feeds 5 days before slaughter.

    Dated: February 26, 1999.
 Stephen F. Sundlof,
 Director, Center for Veterinary Medicine.
[FR Doc. 99-6527 Filed 3-17-99; 8:45 am]
BILLING CODE 4160-01-F