[Federal Register Volume 64, Number 4 (Thursday, January 7, 1999)]
[Rules and Regulations]
[Pages 991-992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-328]


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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; Oxytetracycline and 
Neomycin; Technical Amendment

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 concerning antibiotic, nitrofuran, and sulfonamide 
drugs in the feed of animals. The entry for type A medicated article 
oxytetracycline and neomycin is amended to reflect that the sponsor of 
the product is Pfizer, Inc., not Hoffman-La Roche, Inc. Also, the entry 
for use of type A medicated article oxytetracycline and neomycin base 
for type C turkey feeds, when used as an aid in reducing mortality in 
birds which have suffered an attack of air-sacculitis, is amended to 
change the neomycin use level from 35 to 100 grams (g) of neomycin base 
per ton of feed to 35 to 105 g/ton.

EFFECTIVE DATE: January 7, 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: FDA is amending the animal drug regulations 
in 21 CFR 558.15(g)(1) concerning antibiotic, nitrofuran, and 
sulfonamide drugs in the feed of animals. Previously, for use of type A 
medicated article oxytetracycline and neomycin, FDA had amended the 
regulations to remove several entries for Pfizer, Inc. (see 61 FR 51588 
at 51590, October 3, 1996). The amendment failed to change the ``do'' 
for the remaining entry to ``Pfizer, Inc.'' This document provides for 
that change.
     Also, in paragraph (g)(2), in the entry for drug sponsors 
``Pfizer, Pennfield, and VPO,'' for type A medicated article 
``Oxytetracycline and neomycin base,'' in species ``Turkeys (first 4 
weeks),'' the use level for use as an aid in reducing

[[Page 992]]

mortality in birds which have suffered an attack of air-sacculitis is 
changed. The level subject to interim approval has been recalculated 
and is changed from ``100 to 150 g/ton and 35 to 100 g/ton'' to ``100 
to 150 g/ton and 35 to 105 g/ton''.

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.


Sec. 558.15   [Amended]

    2. Section 558.15 Antibiotic, nitrofuran, and sulfonamide drugs in 
the feed of animals is amended in the table, in paragraph (g)(1), in 
the column ``Drug sponsor'' by removing the ``do'' following the entry 
``Hoffman La-Roche, Inc.'' and adding in its place ``Pfizer, Inc.''; 
and in the table in paragraph (g)(2) in the entry for ``Pfizer, Inc., 
Pennfield Oil Co., and VPO, Inc.'' for Type A medicated article 
``Oxytetracycline and neomycin base,'' for the species ``Turkeys (first 
4 weeks),'' by removing the use level ``100 to 150 g/ton and 35 to 100 
g/ton'' and adding in its place ``100 to 150 g/ton and 35 to 105 g/
ton.''

    Dated: December 18, 1998.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-328 Filed 1-6-99; 8:45 am]
BILLING CODE 4160-01-F