[Federal Register Volume 60, Number 226 (Friday, November 24, 1995)]
[Rules and Regulations]
[Pages 57927-57928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28598]



-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES
 21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Semduramicin; Technical 
Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

-----------------------------------------------------------------------

[[Page 57928]]


SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations that reflect approval of a new animal drug application 
(NADA) filed by Pfizer, Inc. The previous amendment, which appeared in 
the Federal Register of April 13, 1994 (59 FR 17476), provided for 
making a semduramicin Type A medicated article used to make a Type C 
medicated broiler chicken feed for the prevention of coccidiosis. The 
agency has since realized it needs to more accurately reflect both the 
assay limits for semduramicin Type A articles and the limitation for 
its use. This action is being taken to ensure the accuracy and 
consistency of the regulations.

EFFECTIVE DATE: November 24, 1995.

FOR FURTHER INFORMATION CONTACT: Thomas Letonja, Center for Veterinary 
Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1656.
SUPPLEMENTARY INFORMATION: In the Federal Register of April 13, 1994 
(59 FR 17476), FDA published a final rule to announce the approval of 
Pfizer's new animal drug application (NADA) 140-940. The NADA provides 
for use of AviaxTM (semduramicin sodium) Type A medicated article 
to make a semduramicin Type C medicated broiler chicken feed used for 
the prevention of coccidiosis. That document inadvertently failed to 
reflect the correct assay limits for Type A medicated articles in 21 
CFR 558.4 and the correct limitation for use in 21 CFR 
558.555(b)(1)(iii). This document corrects those errors. Due to these 
amendments, FDA is also providing an amended freedom of information 
(FOI) summary for public display. The FOI summary has been amended to 
reflect the correct assay limits and efficacy evaluation. The amended 
copy of the FOI summary is available at the Dockets Management Branch 
(HFA-305), 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 
a.m. and 4 p.m., Monday through Friday.

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: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).

Sec. 558.4   [Amended]

    -2. Section 558.4 Medicated feed applications is amended in 
paragraph (d) in the ``Category I'' table in the entry for 
``Semduramicin'' under the second column by removing ``94-102'' and 
adding in its place ``90-110''.


Sec. 558.555   [Amended]

    -3. Section 558.555 Semduramicin is amended in paragraph 
(b)(1)(iii) by removing the last sentence.

    Dated: November 13, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-28598 Filed 11-22-95; 8:45 am]
BILLING CODE 4160-01-F