[Federal Register Volume 71, Number 62 (Friday, March 31, 2006)]
[Rules and Regulations]
[Pages 16222-16223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-3122]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. 2003N-0324]


New Animal Drugs for Use in Animal Feeds; Bacitracin; Nitarsone; 
Zoalene

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of three supplemental new animal 
drug applications (NADAs) filed by Alpharma, Inc. Two of the 
supplemental NADAs provide for the use of approved, single-ingredient 
Type A medicated articles containing bacitracin methylene disalicylate 
and zoalene, with or without roxarsone, to formulate two-way or three-
way combination drug Type C medicated feeds for replacement chickens. 
The third NADA provides for the use of bacitracin zinc and nitarsone 
single-ingredient Type A medicated articles for two-way combination 
Type C medicated feeds for growing turkeys. These approvals reflect 
FDA's effectiveness conclusions, which relied on the National Academy 
of Sciences/National Research Council (NAS/NRC) Drug Efficacy Study 
Group's evaluation of the effectiveness of these drugs when used in 
animal feed as single ingredients.

DATES: This rule is effective March 31, 2006.

FOR FURTHER INFORMATION CONTACT: Andrew J. Beaulieu, Center for 
Veterinary Medicine (HFV-50), 7519 Standish Pl., Rockville, MD 20855, 
240-276-9090, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of August 8, 2003 
(68 FR 47332), as corrected October 7, 2003 (68 FR 57911), as part of 
the Drug Efficacy Study Implementation (DESI) program CVM announced the 
effective conditions of use for several drug products and use 
combinations listed in 21 CFR 558.15. CVM proposed to withdraw the 
NADAs for those products or use combinations lacking substantial 
evidence of effectiveness following a 90-day opportunity to supplement 
the NADAs with labeling conforming to the relevant findings of 
effectiveness. Alpharma, Inc., One Executive Dr., Fort Lee, NJ 07024, 
filed supplements to three of its approved NADAs to revise the labeling 
of its products to comply with these findings of effectiveness.
    Alpharma, Inc., filed a supplement to approved NADA 141-130 for use 
of bacitracin methylene disalicylate and zoalene Type A medicated 
articles to formulate two-way combination drug Type C medicated feeds. 
This supplemental NADA provides for the use of combination feeds 
containing BMD (bacitracin methylene disalicylate) at 4 to 50 grams per 
ton (g/ton) and ZOAMIX (zoalene) at 36.3 to 113.5 g/ton of feed in 
replacement chickens for increased rate of weight gain and improved 
feed efficiency; and for development of active immunity to coccidiosis.
    Alpharma, Inc., also filed a supplement to approved NADA 141-131 
for use of bacitracin methylene disalicylate, zoalene, and roxarsone 
single-ingredient Type A medicated articles to make three-way 
combination drug Type C medicated feeds. This supplemental NADA 
provides for the use of combination feeds containing BMD (bacitracin 
methylene disalicylate) at 4 to 50 g/ton, ZOAMIX (zoalene) at 36.3 to 
113.5 g/ton, and 3-NITRO (roxarsone) at 22.7 to 45.4 g/ton of feed in 
replacement chickens for increased rate of weight gain and improved 
feed efficiency; for development of active immunity to coccidiosis; and 
for improved pigmentation.
    Alpharma, Inc., also filed a supplement to approved NADA 141-132 
for use of bacitracin zinc and nitarsone single-ingredient Type A 
medicated articles to make two-way combination drug Type C medicated 
feeds. This supplemental NADA provides for the use of combination feeds 
containing ALBAC (bacitracin zinc) at 4 to 50 g/ton and HISTOSTAT 
(nitarsone) at 170 g/ton (0.01875 percent) of feed in growing turkeys 
for increased rate of weight gain and improved feed efficiency; and as 
an aid in the prevention of blackhead.
    The DESI evaluation is concerned only with the effectiveness of the 
drug products and use combinations. Nothing in this document 
constitutes a bar to further proceedings with respect to questions of 
safety of the subject drugs in treated animals or of the drugs or their 
metabolites in food products derived from treated animals.
    Products that comply with FDA's findings of effectiveness are 
eligible for copying as described in the Generic Animal Drug and Patent 
Term Restoration Act Policy Letter Eight, August 21, 1991 (56 FR 
41561). Accordingly, sponsors may now obtain approval of abbreviated 
NADAs for

[[Page 16223]]

these three combination drug medicated feeds.
    The NADAs are approved as of February 15, 2006, and the regulations 
are amended in 21 CFR 558.76, 558.78, 558.369, and 558.680 to reflect 
the approval. Approval of these supplemental NADAs did not require 
review of any new safety or effectiveness data. Therefore, a freedom of 
information summary was not prepared.
    The agency has determined under 21 CFR 25.33(a)(2) that these 
actions are of a type that do 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.


Sec.  558.76  [Amended]

0
2. In Sec.  558.76, amend paragraph (d)(3)(xviii) by adding ``or 
roxarsone'' after ``arsanilic acid''.

0
3. In Sec.  558.78, amend paragraph (d)(3) by redesignating paragraphs 
(d)(3)(x) through (d)(3)(xii) as paragraphs (d)(3)(xi) through 
(d)(3)(xiii); and add new paragraph (d)(3)(x) to read as follows:


Sec.  558.78  Bacitracin zinc.

* * * * *
    (d) * * *
    (3) * * *
    (x) Nitarsone as in Sec.  558.369.
* * * * *


Sec.  558.369  [Amended]

0
4. In Sec.  558.369, amend paragraph (d)(2)(i) by adding ``or 
bacitracin zinc'' after ``disalicylate''.

0
5. In Sec.  558.680, amend the table in paragraph (d)(1)(i), after the 
entry for ``Arsanilic acid 90 (0.01%) plus penicillin 2.4 to 50'' by 
adding entries for ``Bacitracin 4 to 50'' and ``Bacitracin methylene 
disalicylate 4 to 50 plus roxarsone 22.7 to 45.4'' to read as follows:


Sec.  558.680  Zoalene.

* * * * *
    (d) * * *
    (1) * * *

------------------------------------------------------------------------
  Zoalene in    Combination
  grams/ton     in grams/ton   Indications for use       Limitations
------------------------------------------------------------------------
(i) * * *
               Bacitracin 4   Replacement           Feed as in subtable
                to 50          chickens: For         in Sec.
                               development of        558.680(d)(1)(i);
                               active immunity to    grower ration not
                               coccidiosis; for      to be fed to birds
                               increased rate of     over 14 weeks of
                               weight gain,          age. As bacitracin
                               improved feed         methylene
                               efficiency            disalicylate
                                                     provided by No.
                                                     046573 in Sec.
                                                     510.600(c) of this
                                                     chapter
               Bacitracin     Replacement           Feed as in subtable
                methylene      chickens: For         in Sec.
                disalicylate   development of        558.680(d)(1)(i);
                4 to 50 plus   active immunity to    grower ration not
                roxarsone      coccidiosis; for      to be fed to birds
                22.7 to 45.4   increased rate of     over 14 weeks of
                               weight gain,          age. Discontinue
                               improved feed         use 5 days before
                               efficiency, and       slaughter; as sole
                               improved              source of organic
                               pigmentation          arsenic; drug
                                                     overdose or lack of
                                                     water may result in
                                                     leg weakness. As
                                                     bacitracin
                                                     methylene
                                                     disalicylate and
                                                     roxarsone provided
                                                     by No. 046573 in
                                                     Sec.   510.600(c)
                                                     of this chapter
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                              * * * * * * *
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* * * * *

    Dated: March 22, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06-3122 Filed 3-30-06; 8:45 am]
BILLING CODE 4160-01-S