[Federal Register Volume 66, Number 78 (Monday, April 23, 2001)]
[Rules and Regulations]
[Pages 20401-20402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9872]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


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

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, bacitracin methylene disalicylate, and 
roxarsone Type A medicated articles to make three-way combination drug 
Type C medicated feeds for replacement chickens.

DATES: This rule is effective April 23, 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,

[[Page 20402]]

Fort Lee, NJ 07024, filed NADA 141-142 that provides for use of 
Amprol (25 percent amprolium), BMD (10, 25, 30, 40, 
50, 60, or 75 grams per pound (g/lb) bacitracin methylene 
disalicylate), and 3-Nitro (45.4, 90, 227, or 360 g/lb 
roxarsone) Type A medicated articles to make combination Type C 
medicated feeds containing 36.3 to 113.5 g/ton amprolium, 50 g/ton 
bacitracin methylene disalicylate, and 22.7 to 45.4 g/ton roxarsone for 
use in replacement chickens. The Type C medicated feeds are used for 
the development of active immunity to coccidiosis; as an aid in the 
control of necrotic enteritis caused or complicated by Clostridium spp. 
or other organisms susceptible to bacitracin; and for increased rate of 
weight gain, improved feed efficiency, and improved pigmentation. The 
NADA is approved as of February 16, 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 entry (i);
               50 plus         of active       bacitracin
               roxarsone       immunity to     methylene
               22.7 to 45.4.   coccidiosis;    disalicylate
                               as an aid in    and roxarsone
                               the control     as provided
                               of necrotic     by 046573 in
                               enteritis       Sec.  510.600
                               caused or       (c) of this
                               complicated     chapter.
                               by
                               Clostridium
                               spp. or other
                               organisms
                               susceptible
                               to
                               bacitracin;
                               increased
                               rate of
                               weight gain,
                               improved feed
                               efficiency,
                               and improved
                               pigmentation.
 
*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------

* * * * *

    Dated: April 9, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-9872 Filed 4-20-01; 8:45 am]
BILLING CODE 4160-01-S