[Federal Register Volume 65, Number 130 (Thursday, July 6, 2000)]
[Rules and Regulations]
[Pages 41589-41590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17020]



[[Page 41589]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene 
Disalicylate and Fenbendazole

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 use of approved 
bacitracin methylene disalicylate and fenbendazole Type A medicated 
articles to make combination Type B and C medicated feeds for growing 
and finishing swine and pregnant sows for the removal of various 
internal parasites, for increased rate of weight gain and improved feed 
efficiency, for control of swine dysentery associated with Treponema 
hyodysenteriae, and for control of clostridial enteritis in suckling 
pigs caused by Clostridium perfringens. Technical corrections are also 
being made.

DATES: This rule is effective July 6, 2000.

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.

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed NADA 141-144 that provides for use of 
BMD (10, 25, 30, 40, 50, 60, or 75 grams per pound (g/lb) 
bacitracin methylene disalicylate) and SafeGuard (18.1, 36.2, 
or 90.7 g/lb fenbendazole) Type A medicated articles to make 
combination Type B and C medicated feeds for growing and finishing 
swine and pregnant sows.
    For growing and finishing swine, the Type A medicated articles are 
used to make combination Type B medicated feeds that contain 300 to 
1,780 grams per ton (g/ton) of bacitracin methylene disalicylate and 
300 to 17,740 g/ton of fenbendazole and combination Type C medicated 
feeds that contain 10 to 30 g/ton of bacitracin methylene disalicylate 
and 10 to 300 g/ton of fenbendazole. The combination Type C medicated 
feeds are used for increased rate of weight gain and improved feed 
efficiency; and for the removal of adult-stage lungworms 
(Metastrongylus apri andM. pudendotectus); adult and larvae (L3, 4 
stages--liver, lung, and intestinal forms) large roundworms (Ascaris 
suum); adult-stage nodular worms (Oesophagostomum dentatum, O. 
quadrispinulatum); small stomach worms (Hyostrongylus rubidus); adult 
and larvae (L2, 3, 4 stages--intestinal mucosal forms) whipworms 
(Trichuris suis); and adult and larvae kidneyworms (Stephanurus 
dentatus).
    For growing and finishing swine and for pregnant sows, the Type A 
medicated articles are used to make Type B medicated feeds that contain 
7,460 to 14,837 g/ton of bacitracin methylene disalicylate and 300 to 
17,740 g/ton of fenbendazole and Type C medicated feeds that contain 
250 g/ton of bacitracin methylene disalicylate and 10 to 300 g/ton of 
fenbendazole.
    The combination Type C medicated growing and finishing swine feeds 
are used for the control of swine dysentery associated with T. 
hyodysenteriae in growing and finishing swine on premises with a 
history of swine dysentery but where signs of disease have not yet 
occurred, or following an approved treatment of the disease; and for 
the removal of adult-stage lungworms (M. apri andM. pudendotectus); 
adult and larvae (L3, 4 stages--liver, lung, and intestinal forms) 
large roundworms (A. suum); adult-stage nodular worms (O. dentatum,O. 
quadrispinulatum); small stomach worms (H. rubidus); adult and larvae 
(L2, 3, 4 stages--intestinal mucosal forms) whipworms (T. suis); and 
adult and larvae kidneyworms (S. dentatus).
    The combination Type C medicated sow feeds are used for the control 
of clostridial enteritis in suckling pigs caused by C. perfringens; and 
for the removal of adult stage lungworms (M. apri and M. 
pudendotectus); adult and larvae (L3, 4 stages--liver, lung, and 
intestinal forms) large roundworms (A. suum); adult-stage nodular worms 
(O. dentatum, O. quadrispinulatum); small stomach worms (H. rubidus); 
adult and larvae (L2, 3, 4 stages--intestinal mucosal forms) whipworms 
(T. suis); and adult and larvae kidneyworms (S. dentatus).
    The NADA is approved as of April 7, 2000, and 21 CFR 558.76 and 
Sec. 558.258 (21 CFR 558.258) are amended to add new entries to reflect 
the approval. The basis for approval is discussed in the freedom of 
information summary.
    Also, Sec. 558.258 is amended to redesignate paragraph (c) as 
paragraph (d) and add paragraph (c) to reflect a newer 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 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 558.76 is amended by adding paragraph (d)(3)(xxii) to 
read as follows:


Sec. 558.76  Bacitracin methylene disalicylate.

* * * * *
    (d) * * *
    (3) * * *
    (xxii) Fenbendazole as in Sec. 558.258.

    3. Section 558.258 is amended by redesignating paragraph (c) as 
paragraph (d) and reserving paragraph (c), and by adding paragraphs 
(d)(1)(vi) and (d)(1)(vii) to read as follows:


Sec. 558.258  Fenbendazole.

* * * * *
    (c) [Reserved]
    (d) * * *
    (1) * * *
    (vi) Amount. Fenbendazole, 10 to 300 grams per ton (to provide 9 
milligrams per kilogram body weight), and bacitracin methylene 
disalicylate, 10 to 30 grams per ton.
    (A) Indications for use. As an anthelmintic (as provided in 
paragraph

[[Page 41590]]

(d)(1)(i)(A) of this section) and for increased rate of weight gain and 
improved feed efficiency in growing/finishing swine.
    (B) Limitations. Feed as sole ration. Under conditions of continued 
exposure to parasites, retreatment may be needed after 4 to 6 weeks. 
Consult your veterinarian for assistance in the diagnosis, treatment, 
and control of parasitism. Bacitracin methylene disalicylate as 
provided by 046573 in Sec. 510.600(c) of this chapter.
    (vii) Amount. Fenbendazole, 10 to 300 grams per ton, and bacitracin 
methylene disalicylate, 250 grams per ton.
    (A) Indications for use--(1) Growing/finishing swine. As an 
anthelmintic (as provided in paragraph (d)(1)(i)(A) of this section) 
and for control of swine dysentery associated withTreponema 
hyodysenteriae on premises with a history of swine dysentery, but where 
signs of disease have not yet occurred; or following an approved 
treatment of the disease condition.
    (2) Pregnant sows. As an anthelmintic (as provided in paragraph 
(d)(1)(i)(A) of this section) and for control of clostridial enteritis 
in suckling pigs caused by Clostridium perfringens.
    (B) Limitations--(1)Growing/finishing swine. Feed as sole ration. 
Not for use in growing and finishing swine that weigh more than 250 
pounds. Diagnosis of swine dysentery should be confirmed by a 
veterinarian when results are not satisfactory. Under conditions of 
continued exposure to parasites, retreatment may be needed after 4 to 6 
weeks. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism. Bacitracin methylene disalicylate 
as provided by 046573 in Sec. 510.600(c) of this chapter.
    (2) Pregnant sows. Feed as sole ration. Diagnosis of clostridial 
enteritis should be confirmed by a veterinarian when results are not 
satisfactory. Under conditions of continued exposure to parasites, 
retreatment may be needed after 4 to 6 weeks. Consult your veterinarian 
for assistance in the diagnosis, treatment, and control of parasitism. 
Bacitracin methylene disalicylate as provided by 046573 in 
Sec. 510.600(c) of this chapter.
* * * * *

    Dated: June 19, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-17020 Filed 7-5-00; 8:45 am]
BILLING CODE 4160-01-F