[Federal Register Volume 66, Number 76 (Thursday, April 19, 2001)]
[Rules and Regulations]
[Pages 20083-20084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9651]



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  Federal Register / Vol. 66, No. 76 / Thursday, April 19, 2001 / Rules 
and Regulations  

[[Page 20083]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Amprolium and 
Bacitracin Methylene Disalicylate

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) filed by Alpharma, Inc. The NADA provides for use of approved, 
single-ingredient amprolium and bacitracin methylene disalicylate Type 
A medicated articles to make two-way combination drug Type C medicated 
feeds used for the development of active immunity to coccidiosis, 
increased rate of weight gain, and improved feed efficiency in 
replacement chickens.

DATES: This rule is effective April 19, 2001.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-1600.

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed NADA 141-156 that provides for use of 
Amprol (25 percent amprolium) and BMD (10, 25, 30, 
40, 50, 60, or 75 grams per pound bacitracin methylene disalicylate) 
Type A medicated articles to make combination Type C medicated feeds 
containing 36.3 to 113.5 grams per ton (g/ton) amprolium and 4 to 50 g/
ton bacitracin methylene disalicylate for use in replacement chickens. 
The Type C medicated feeds are used for the development of active 
immunity to coccidiosis, increased rate of weight gain, and improved 
feed efficiency in replacement chickens. The NADA is approved as of 
February 12, 2001, and 21 CFR 558.55 is amended to reflect the 
approval. The basis of 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)(2) 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.

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.
    2. Section 558.55 is amended in the table in paragraph (d)(2) by 
alphabetically adding an item under entry (i) to read as follows:


Sec. 558.55  Amprolium.

* * * * *
    (d)    *    *    *
    (2)    *    *    *

------------------------------------------------------------------------
Amprolium in
  grams per   Combination in    Indications     Limitations     Sponsor
     ton       grams per ton      for use
------------------------------------------------------------------------
 
(i) 36.3 to
 113.5
 (0.004% to
 0.0125%).
 
*                  *                  *                  *
                  *                  *                  *
              Bacitracin      Replacement     Feed according  046573
               methylene       chickens;       to subtable
               disalicylate    development     in item (i);
               4 to 50.        of active       bacitracin
                               immunity to     methylene
                               coccidiosis,    disalicylate
                               increased       as provided
                               rate of         by 046573 in
                               weight gain,    Sec.  510.600
                               and improved    (c) of this
                               feed            chapter.
                               efficiency.
 
*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------


[[Page 20084]]

* * * * *

    Dated: April 9, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-9651 Filed 4-18-01; 8:45 am]
BILLING CODE 4160-01-S