[Federal Register: March 31, 2006 (Volume 71, Number 62)]
[Rules and Regulations]
[Page 16222-16223]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr06-11]
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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: andrew.beaulieu@fda.hhs.gov.
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
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(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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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