[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
