[Federal Register Volume 64, Number 155 (Thursday, August 12, 1999)]
[Rules and Regulations]
[Pages 43909-43910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20844]


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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; Sulfadimethoxine, 
Ormetoprim

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the new 
animal drug regulations to reflect approval of a supplemental new 
animal drug application (NADA) filed by Roche Vitamins, Inc. The 
supplemental NADA provides for a change in the name of a duck pathogen. 
Infections of the pathogen are controlled by use of

[[Page 43910]]

sulfadimethoxine/ormetoprim Type C medicated feed.

EFFECTIVE DATE: August 12, 1999.

FOR FURTHER INFORMATION CONTACT: Naba K. Das, Center for Veterinary 
Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-7569.

SUPPLEMENTARY INFORMATION: Roche Vitamins, Inc., 45 Waterview Blvd., 
Parsippany, NJ 07054-1298, filed a supplement to NADA 40-209 that 
provides for use of Rofenaid 40 (113.5 grams per pound (g/lb) 
sulfadimethoxine with 68 g/lb ormetoprim) to make Type C medicated duck 
feeds containing 454 g per ton (/t) sulfadimethoxine with 272.4 g/t 
ormetoprim. The Type C medicated feeds are used as an aid in the 
control of bacterial infections in ducks. The supplement provides for a 
change of nomenclature of one pathogen from  Pasteurella anatipestifer 
to Riemerella anatipestifer based on the results of studies obtained 
from DNA-rRNA hybridization analyses and determinations of DNA ratios 
and from analyses of protein and fatty acids. According to the 
published report (Ref. 1), the causative agent of the disease known as 
``septicemia anserum exsudativa'' constitutes a separate taxon within 
the Flavobacterium-Cytophaga rRNA homology cluster and is named R. 
anatipestifer. This organism is distributed world wide and causes 
septicemia in ducks, geese, and turkeys. The supplemental NADA was 
approved as of June 15, 1999, and the regulations are amended in 21 CFR 
558.575 (d)(4)(ii)(a) to reflect the change in nomenclature.
     In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a copy of the 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.
     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.

Reference

     The following reference has been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. International Journal of Systematic Bacteriology, p. 768-776, 
October, 1993.

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.


Sec. 558.575   [Amended]

     2. Section 558.575 is amended in paragraph (d)(4)(ii)(a) by 
removing the first ``P.'' and adding in its place ``Riemerella''.

    Dated: August 2, 1999
Clair M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine
[FR Doc. 99-20844 Filed 8-11-99; 8:45 am]
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