[Federal Register Volume 74, Number 134 (Wednesday, July 15, 2009)]
[Rules and Regulations]
[Pages 34236-34237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16733]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2009-N-0665]


New Animal Drugs for Use in Animal Feeds; Lasalocid; Roxarsone

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an original new animal drug 
application (NADA) filed by Alpharma Inc. The NADA provides for use of 
single-ingredient Type A medicated articles containing lasalocid and 
roxarsone to formulate two-way combination drug Type C medicated feeds 
for use in growing turkeys.

DATES: This rule is effective July 15, 2009.

FOR FURTHER INFORMATION CONTACT:  Timothy Schell, Center for Veterinary 
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8116, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Alpharma Inc., 440 Rte. 22, Bridgewater, NJ 
08807, filed NADA 141-293 that provides for use of AVATEC (lasalocid 
sodium) and 3-NITRO (roxarsone) single-ingredient Type A medicated 
articles to formulate two-way combination drug Type C medicated feeds 
for use in growing turkeys. The NADA is approved as of May 22, 2009, 
and the regulations are amended in 21 CFR 558.311 and Sec.  558.530 (21 
CFR 558.530) to reflect the approval.

[[Page 34237]]

    In addition, FDA is amending Sec.  558.530 to remove an incorrect 
human food safety warning and to revise an animal safety limitation for 
use of roxarsone in chicken and turkey feeds. The food safety warning 
restricting use of roxarsone in poultry producing eggs for human 
consumption was codified in error during a change from text to table 
format in 2005 (70 FR 41958; July 21, 2005). The animal safety warning 
is revised to reflect recommendations of the National Academy of 
Sciences-National Research Council (NAS-NRC) Drug Efficacy Study in 
1970 (35 FR 14273; September 10, 1970), following their evaluation of 
the product. NAS-NRC's recommended warning was restated, but not 
codified, at the time of Drug Efficacy Study Implementation's 
finalization of NADA 7-891 for a roxarsone Type A medicated article in 
1981 (46 FR 52330; October 27, 1981). The revised warning for medicated 
feed use agrees with the warning that is codified for roxarsone oral 
dosage forms in 21 CFR part 520.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 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 Division of Dockets Management 
(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 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.

0
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

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

0
2. In Sec.  558.311, in the table in paragraph (e)(1)(xv), 
alphabetically add a new entry for ``Roxarsone 22.7 to 45.4'' to read 
as follows:


Sec.  558.311  Lasalocid.

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

------------------------------------------------------------------------
 Lasalocid
   sodium     Combination
activity in   in grams per  Indications for    Limitations     Sponsor
 grams per        ton             use
    ton
------------------------------------------------------------------------
(xv) 68       *              * *              * *                      *
 (0.0075
 pct) to
 113
 (0.0125
 pct).
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------
             Roxarsone      Growing          Feed                 046573
              22.7 to 45.4   turkeys: For     continuously
                             prevention of    as the sole
                             coccidiosis      ration.
                             caused by E.     Roxarsone
                             meleagrimitis,   provided by
                             E.               No. 046573 in
                             gallopavonis,    Sec.
                             and E.           510.600(c) in
                             adenoeides,      this chapter.
                             increased rate
                             of weight
                             gain, improved
                             feed
                             efficiency,
                             and improved
                             pigmentation.
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------

Sec.  558.530  [Amended]

0
3. Amend Sec.  558.530 as follows:
    a. In the table in paragraph (d)(1)(i), in the ``Limitations'' 
column, remove the phrase ``do not feed to chickens producing eggs for 
human consumption;'' and remove the phrase ``may result in leg 
weakness'' and in its place add the phrase ``may result in weakness or 
paralysis of the legs'' and
    b. In the table in paragraph (d)(2)(i), in the ``Limitations'' 
column, remove the phrase ``do not feed to turkeys producing eggs for 
human consumption;'' and remove the phrase ``may result in leg 
weakness'' and in its place add the phrase ``may result in weakness or 
paralysis of the legs''.

    Dated: July 9, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-16733 Filed 7-14-09; 8:45 am]
BILLING CODE 4160-01-S