<PRE>
[Federal Register: September 5, 2001 (Volume 66, Number 172)]
[Rules and Regulations]               
[Page 46371-46372]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05se01-8]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

 
New Animal Drugs for Use in Animal Feeds; Lasalocid 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 lasalocid and bacitracin methylene disalicylate Type 
A medicated articles to make two-way combination drug Type C medicated 
feeds. These combination medicated feeds are used for the prevention of 
coccidiosis, and for increased rate of weight gain and improved feed 
efficiency in growing turkeys.

DATES: This rule is effective September 5, 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 141-179 that provides for use of 
AVATEC<Register> (90.7 grams per pound (g/lb) of lasalocid sodium) and 
BMD<Register> (50 g/lb of bacitracin methylene disalicylate) Type A 
medicated articles to make combination drug Type C medicated turkey 
feeds. The combination Type C medicated feeds are used for prevention 
of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, E. 
adenoeides, and for increased rate of weight gain and improved feed 
efficiency in growing turkeys. The NADA is approved as of July 11, 
2001, and the regulations are amended in 21 CFR 558.311 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 558.311 is amended in the table in paragraph (e)(1) by 
alphabetically adding an item under entry (xv) following ``Bacitracin 4 
to 50'' to read as follows:


Sec. 558.311  Lasalocid.

* * * * *
    (e) * * * 
    (1) * * * 

------------------------------------------------------------------------
Lasalocid sodium   Combination
   activity in     in grams per   Indications    Limitations    Sponsor
  grams per ton        ton          for use
------------------------------------------------------------------------

*                  *                  *                  *
                  *                  *                  *
(xv) 68 (0.0075
 pct) to 113
 (0.0125 pct)
                  Bacitracin 4   * * *          * * *          * * *
                   to 50
                  Bacitracin     Growing        Feed           046573
                   methylene      turkeys; for   continuously
                   disalicylate   prevention     as sole
                   4 to 50        of             ration.
                                  coccidiosis    Bacitracin
                                  caused by E.   methylene
                                  meleagrimiti   disalicylate
                                  s, E.          as provided
                                  gallopavonis   by No.
                                  , and E.       046573 in
                                  adenoeides;    Sec.  510.60
                                  for            0(c) of this
                                  increased      chapter.
                                  rate of
                                  weight gain
                                  and improved
                                  feed
                                  efficiency.

*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------


[[Page 46372]]

* * * * *

    Dated: August 21, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-22163 Filed 9-4-01; 8:45 am]
BILLING CODE 4160-01-S

</PRE>