[Federal Register Volume 63, Number 212 (Tuesday, November 3, 1998)]
[Rules and Regulations]
[Page 59216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29334]


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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; Carbadox

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 Pfizer Animal Health, Inc. The supplemental 
NADA provides for the establishment of a 42-day slaughter withdrawal 
period for use of carbadox in swine feed.

EFFECTIVE DATE: November 3, 1998.

FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for 
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1652.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, is sponsor of NADA 41-061 that provides for the use of 
Mecadox 10 (carbadox) Type A medicated article used to make 
Type B and Type C medicated swine feeds. Mecadox is indicated 
for the control of bacterial swine enteritis, increased rate of weight 
gain, and improved feed efficiency. The sponsor filed a supplemental 
NADA that provides for the establishment of a withdrawal period of 42 
days in swine and a limitation against use in pregnant swine or swine 
intended for breeding purposes. The supplemental NADA is approved as of 
October 5, 1998, and the regulations are amended in 21 CFR 
558.115(d)(1)(ii) and (d)(2)(ii) to reflect the approval. The basis for 
approval is discussed in the freedom of information summary.
    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)(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.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the 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 558.115 is amended by revising paragraphs (d)(1)(ii) and 
(d)(2)(ii) to read as follows:


Sec. 558.115  Carbadox.

* * * * *
    (d) * * *
    (1) * * *
    (ii) Limitations. Not for use in pregnant swine or swine intended 
for breeding purposes. Do not feed to swine within 42 days of 
slaughter.
    (2) * * *
    (ii) Limitations. Not for use in pregnant swine or swine intended 
for breeding purposes. Do not feed to swine within 42 days of 
slaughter.
* * * * *
    Dated: October 25, 1998.
 Margaret Ann Miller,
 Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-29334 Filed 11-2-98; 8:45 am]
BILLING CODE 4160-01-F