[Federal Register Volume 64, Number 82 (Thursday, April 29, 1999)]
[Rules and Regulations]
[Pages 23017-23019]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 99-10696]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 556


Oral Dosage Form New Animal Drugs; Piperazine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the

[[Page 23018]]

animal drug regulations to reflect approval of a supplemental new 
animal drug application (NADA) filed by Fleming Laboratories, Inc. The 
supplemental NADA provides for the safe and effective use of piperazine 
in chickens, turkeys, and swine for the treatment of certain parasitic 
infections. The approval reflects compliance with the results of the 
National Academy of Sciences/National Research Council (NAS/NRC) Drug 
Efficacy Study Implementation (DESI) evaluation of the effectiveness of 
piperazine and FDA's conclusions concerning that evaluation. FDA also 
is amending the regulations to provide tolerances for piperazine 
residues.

EFFECTIVE DATE: April 29, 1999.
FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0212.

SUPPLEMENTARY INFORMATION: Fleming Laboratories, Inc., P.O. Box 34384, 
Charlotte, NC 28234, filed a supplement to its approved NADA 10-005 for 
use of piperazine soluble powder and liquid for oral treatment of 
chickens and turkeys for roundworm infections and swine for roundworm 
and nodular worm infections. NADA 10-005 was originally approved on 
June 9, 1955. The drug was the subject of a NAS/NRC evaluation of 
effectiveness under FDA's DESI program (DESI 10-005V). The findings of 
the evaluation were published in the Federal Register of February 14, 
1969 (34 FR 2213). The NAS/NRC DESI report concluded that the drug is 
effective as an anthelmintic for dogs, cats, chickens, turkeys, horses, 
swine, sheep, and cattle. FDA concurred with the conclusions of the 
report. Fleming Laboratories, Inc., filed a supplemental NADA providing 
revised labeling that brought its drug into compliance with the results 
of the NAS/NRC DESI evaluation and FDA's conclusions based on that 
evaluation.
     The supplemental NADA provides for treatment of animals for 
parasitic infections as follows: (1) Chickens and turkeys, for 
Ascaridia spp., chickens at 50 milligrams (mg)/bird under 6 weeks and 
100 mg/bird over 6 weeks; turkeys at 100 mg/bird up to 12 weeks and 200 
mg/bird over 12 weeks according to size, at 0.2 to 0.4 percent in feed 
or 0.1 to 0.2 percent in water for 1 to 2 days; and (2) swine, for 
Ascaris suum and Oesophagostomum spp., at 50 mg/pound (lb) body weight, 
at 0.2 to 0.4 percent in feed or 0.1 to 0.2 percent in water for 1 to 2 
days.
    The supplement is approved as of March 23, 1999, and the 
regulations are amended by adding 21 CFR 520.1807 to reflect the 
approval. The basis of approval is discussed in the freedom of 
information summary.
    In addition, tolerances for residues of piperazine in edible 
tissues of food-producing animals have been established. The 
regulations are amended by adding 21 CFR 556.513 to establish the 
residue tolerances.
    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.
    FDA 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.
    FDA has previously informed manufacturers of piperazine products 
for food-producing animals not covered by approved applications that 
such products may be subject to regulatory action. FDA advised sponsors 
of DESI-reviewed piperazine products to pursue finalization of their 
NADA's at the earliest possible time. FDA now is providing public 
notice that it is prepared to take regulatory action against unapproved 
piperazine products for food-producing animals. In order to provide for 
an orderly phaseout, the manufacture of piperazine powder and liquid 
that is not the subject of an approved NADA or abbreviated new animal 
drug application (ANADA) shall cease by August 27, 1999, and the 
distribution of said products not manufactured under an approved 
application shall also cease by that date.

List of Subjects

21 CFR Part 520

     Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.
    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 parts 520 and 
556 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

    2. Section 520.1807 is added to read as follows:


Sec. 520.1807  Piperazine.

    (a) Specifications. A soluble powder or liquid containing 
piperazine dihydrochloride or dipiperazine sulfate, equivalent to 17, 
34, or 230 grams of piperazine per pound or 100 milliliters.
    (b) Sponsor. See 015565 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.513 of this chapter.
    (d) Conditions of use--(1) Chickens--(i) Amount. 50 milligrams per 
bird under 6 weeks, 100 milligrams per bird over 6 weeks.
    (ii) Indications for use. For removal of large roundworm (Ascaridia 
spp.).
    (iii) Limitations. For use in drinking water or feed. Use as sole 
source of drinking water. Prepare fresh solution daily. Use as 1-day 
single treatment. Withdraw 14 days prior to slaughter. Do not use for 
chickens producing eggs for human consumption. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.
    (2) Turkeys--(i) Amount. 100 milligrams per bird up to 12 weeks and 
200 milligrams per bird over 12 weeks.
    (ii) Indications for use. For removal of large roundworm (Ascaridia 
spp.).
    (iii) Limitations. For use in drinking water or feed. Use as sole 
source of drinking water. Prepare fresh solution daily. Use as 1-day 
single treatment. Withdraw 14 days prior to slaughter. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.
    (3) Swine--(i) Amount. 50 milligrams per pound of body weight.
    (ii) Indications for use. For removal of large roundworm (Ascaris 
suum) and nodular worms (Oesophagostomum spp.).
    (iii) Limitations. For use in drinking water or feed. Use as sole 
source of drinking water. Prepare fresh solution daily. Use as 1-day 
single treatment. Withdraw 21 days prior to slaughter. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

    3. The authority citation for 21 CFR part 556 continues to read as 
follows:


[[Page 23019]]


    Authority: 21 U.S.C. 342, 360b, 371.

    4. Section 556.513 is added to subpart B to read as follows:


Sec. 556.513  Piperazine.

    A tolerance of 0.1 part per million piperazine base is established 
for edible tissues of poultry and swine.

    Dated: April 19, 1999.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-10696 Filed 4-28-99; 8:45 am]
BILLING CODE 4160-01-F