[Federal Register: July 21, 2005 (Volume 70, Number 139)]
[Rules and Regulations]
[Page 41958-41963]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jy05-13]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Roxarsone; Semduramycin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is correcting the
single-ingredient roxarsone Type A medicated article that may be used
to formulate three-way, combination drug Type C medicated broiler
chicken feeds containing semduramicin, virginiamycin, and roxarsone
under a new animal drug application (NADA) recently approved for Phibro
Animal Health. FDA is also amending the animal drug regulations to
reflect two roxarsone Type A medicated articles
[[Page 41959]]
approved under separate new animal drug applications (NADAs) for
different conditions of use. This action is being taken to improve the
accuracy of the agency's regulations.
DATES: This rule is effective July 21, 2005.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 301-827-4567, e-mail:
ghaibel@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: FDA has found that the list of approved,
single-ingredient Type A medicated articles used to formulate three-
way, combination drug Type C medicated broiler chicken feeds containing
semduramicin, virginiamycin, and roxarsone under NADA 141-226 is in
error. The Federal Register document that described approval of that
application for Phibro Animal Health on February 23, 2004 (69 FR 13221,
March 22, 2004), listed 3-NITRO (roxarsone) Type A Medicated article as
the source of roxarsone; however, the correct source for this
combination feed is ROXARSONE (roxarsone) Type A Medicated article,
approved under NADA 92-953. At this time, FDA is amending the
regulations in 21 CFR 558.555 to reflect the roxarsone Type A medicated
article approved for this combination and a current tabular format.
In addition, FDA has found that the April 1, 2004, edition of parts
500 to 599 (21 CFR parts 500 to 599) of Title 21 of the Code of Federal
Regulations (CFR) does not accurately reflect the approved conditions
of use for roxarsone Type A medicated articles. Roxarsone is approved
as single-ingredient Type A medicated articles under two separate
applications, NADA 7-891 for 3-NITRO and NADA 92-953 for ROXARSONE,
held by Alpharma, Inc. In error, portions of the regulation describing
approvals had been consolidated in July 2000 (65 FR 45711, July 25,
2000). At this time, FDA is amending the regulations in Sec. 558.530
to reflect two separate approvals for roxarsone Type A medicated
articles with different approved conditions of use and a current
tabular format.
Also, FDA has found that the approved conditions of use codified
for NADA 92-953 prior to the July 2000 change were in error. A specific
technical amendment to remove turkeys as an approved species (49 FR
30927, August 2, 1984) was reversed in a subsequent change that
implemented revised terminology for feed premixes (51 FR 7400, March 3,
1986). At this time, FDA is amending the regulations in Sec. 558.530
to reflect approval of NADA 92-953 for chickens only.
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 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. Section 558.530 is amended by revising paragraphs (a) through
(d)(3); removing paragraph (d)(4); and by redesignating paragraph
(d)(5) as paragraph (d)(4) to read as follows:
Sec. 558.530 Roxarsone.
(a) Specifications. Type A medicated articles containing 10, 20,
50, or 80 percent roxarsone.
(b) Approvals. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (d) of this section.
(1) No. 046573 for use of 10, 20, and 50 percent Type A medicated
articles as in paragraph (d)(1)(i) of this section.
(2) No. 046573 for use of 10, 20, 50, and 80 percent Type A
medicated articles as in paragraphs (d)(1) through (d)(3) of this
section.
(c) Related tolerances. See Sec. 556.60 of this chapter.
(d) Conditions of use--(1) Chickens. It is used in chicken feed as
follows:
------------------------------------------------------------------------
Roxarsone in Combinations
grams per in grams per Indications Limitations Sponsor
ton ton for use
------------------------------------------------------------------------
(i) 22.7 to .............. Growing Feed 046573
45.4 chickens: continuously
For throughout
increased growing
rate of period; do
weight gain, not feed to
improved chickens
feed producing
efficiency, eggs for
and improved human
pigmentation consumption;
. withdraw 5
days before
slaughter; as
sole source
of organic
arsenic; drug
overdose or
lack of water
may result in
leg weakness.
------------------------------------------------------------------------
(ii) 22.7 to Chlortetracycl Growing As in ...........
45.4 ine 10 to 50 chickens: As paragraph
in paragraph (d)(1)(i) of
(d)(1)(i) of this section.
this Chlortetracyc
section. line as
provided by
No. 046573 in
Sec.
510.600(c) of
this chapter.
------------------------------------------------------------------------
(iii) 22.7 Chlortetracycl Growing As in ...........
to 45.4 ine 100 to chickens: As paragraph
200 in paragraph (d)(1)(i) of
(d)(1)(i) of this section
this except feed
section; and continuously
for control for 7 to 14
of days.
infectious Chlortetracyc
synovitis line as
caused by provided by
Mycoplasma No. 046573 in
synoviae Sec.
susceptible 510.600(c) of
to this chapter.
chlortetracy
cline.
------------------------------------------------------------------------
[[Page 41960]]
(iv) 22.7 to Chlortetracycl Growing As in ...........
45.4 ine 200 to chickens: As paragraph
400 in paragraph (d)(1)(i) of
(d)(1)(i) of this section
this except feed
section; and continuously
for control for 7 to 14
of chronic days.
respiratory Chlortetracyc
disease line as
(CRD) and provided by
air sac No. 046573 in
infection Sec.
caused by M. 510.600(c) of
gallisepticu this chapter.
m and
Escherichia
coli
susceptible
to
chlortetracy
cline.
------------------------------------------------------------------------
(v) 22.7 to Chlortetracycl Growing As in ...........
45.4 ine 500 chickens: As paragraph
in paragraph (d)(1)(i) of
(d)(1)(i) of this section
this except feed
section; and continuously
for for 5 days.
reduction of Chlortetracyc
mortality line as
due to E. provided by
coli No. 046573 in
infections Sec.
susceptible 510.600(c) of
to this chapter.
chlortetracy
cline.
------------------------------------------------------------------------
(2) Turkeys. It is used in turkey feed as follows:
------------------------------------------------------------------------
Roxarsone in Combinations
grams per in grams per Indications Limitations Sponsor
ton ton for use
------------------------------------------------------------------------
(i) 22.7 to .............. Growing Feed 046573
45.4 turkeys: For continuously
increased throughout
rate of growing
weight gain, period; do
improved not feed to
feed turkeys
efficiency, producing
and improved eggs for
pigmentation human
. consumption;
withdraw 5
days before
slaughter; as
sole source
of organic
arsenic; drug
overdose or
lack of water
may result in
leg weakness.
------------------------------------------------------------------------
(ii) 22.7 to Chlortetracycl Growing As in ...........
45.4 ine 10 to 50 turkeys: As paragraph
in paragraph (d)(2)(i) of
(d)(2)(i) of this section.
this Chlortetracyc
section. line as
provided by
No. 046573 in
Sec.
510.600(c) of
this chapter.
------------------------------------------------------------------------
(iii) 22.7 Chlortetracycl Growing As in ...........
to 45.4 ine 200 turkeys: As paragraph
in paragraph (d)(2)(i) of
(d)(2)(i) of this section
this except feed
section; and continuously
for control for 7 to 14
of days.
infectious Chlortetracyc
synovitis line as
caused by provided by
Mycoplasma No. 046573 in
synoviae Sec.
susceptible 510.600(c) of
to this chapter.
chlortetracy
cline.
------------------------------------------------------------------------
(iv) 22.7 to Chlortetracycl 1. Growing As in ...........
45.4 ine 400 turkeys: As paragraph
in paragraph (d)(2)(i) of
(d)(2)(i) of this section
this except feed
section; and continuously
for control for 7 to 14
of days.
hexamitiasis Chlortetracyc
caused by line as
Hexamita provided by
meleagrides No. 046573 in
susceptible Sec.
to 510.600(c) of
chlortetracy this chapter.
cline.
2. Turkey
poults not
over 4 weeks
of age:
Reduction of
mortality
due to
paratyphoid
caused by
Salmonella
typhimurium
susceptible
to
chlortetracy
cline.
------------------------------------------------------------------------
(v) 22.7 to Chlortetracycl Growing As in ...........
45.4 ine 25 mg/lb turkeys: As paragraph
body weight in paragraph (d)(2)(i) of
daily (d)(2)(i) of this section
this except feed
section; and continuously
for control for 7 to 14
of days.
complicating Chlortetracyc
bacterial line as
organisms provided by
associated No. 046573 in
with Sec.
bluecomb 510.600(c) of
(transmissib this chapter.
le
enteritis,
coronaviral
enteritis)
susceptible
to
chlortetracy
cline.
------------------------------------------------------------------------
(3) Swine. It is used in swine feed as follows:
[[Page 41961]]
------------------------------------------------------------------------
Roxarsone in Combinations
grams per in grams per Indications Limitations Sponsor
ton ton for use
------------------------------------------------------------------------
(i) 22.7 to .............. Growing and Feed 046573
34.1 finishing continuously
swine: For throughout
increased growing
rate of period;
weight gain withdraw 5
and improved days before
feed slaughter; as
efficiency. sole source
of organic
arsenic.
------------------------------------------------------------------------
(ii) 22.7 to Chlortetracycl Growing and Feed for not ...........
34.1 ine 400 (to finishing more than 14
administer 10 swine: As in days;
mg/lb body paragraph withdraw 5
weight) (d)(3)(i) of days before
this slaughter; as
section; and sole source
for of organic
treatment of arsenic.
bacterial
enteritis
caused by E.
coli and S.
choleraesuis
and
bacterial
pneumonia
caused by
Pasteurella
multocida
susceptible
to
chlortetracy
cline.
------------------------------------------------------------------------
(iii) 181.5 .............. Growing and Feed for not 046573
finishing more than 6
swine: For consecutive
the days; if
treatment of improvement
swine is not
dysentery. observed,
consult a
veterinarian;
withdraw 5
days before
slaughter; as
a sole source
of organic
arsenic;
animals must
consume
enough
medicated
feed to
provide a
therapeutic
dose.
------------------------------------------------------------------------
(iv) 181.5 Chlortetracycl Growing and Feed for not ...........
ine 10 to 50 finishing more than 6
swine: As in consecutive
paragraph days; if
(d)(3)(i) of improvement
this is not
section; and observed,
for consult a
treatment of veterinarian;
swine withdraw 5
dysentery. days before
slaughter; as
a sole source
of organic
arsenic;
animals must
consume
enough
medicated
feed to
provide a
therapeutic
dose.
------------------------------------------------------------------------
(v) 181.5 Chlortetracycl Growing and Feed for not ...........
ine 400 (to finishing more than 6
administer 10 swine: As in consecutive
mg/lb body paragraph days; if
weight) (d)(3)(iii) improvement
of this is not
section; and observed,
for consult a
treatment of veterinarian;
bacterial withdraw 5
enteritis days before
caused by E. slaughter; as
coli and S. a sole source
choleraesuis of organic
and arsenic;
bacterial animals must
pneumonia consume
caused by P. enough
multocida medicated
susceptible feed to
to provide a
chlortetracy therapeutic
cline. dose.
------------------------------------------------------------------------
* * * * *
0
3. Section 558.555 is amended by revising paragraph (d) to read as
follows:
Sec. 558.555 Semduramicin.
* * * * *
(d) Conditions of use in chickens. It is used in chicken feed as
follows:
------------------------------------------------------------------------
Semduramicin Combinations
in grams per in grams per Indications Limitations Sponsor
ton ton for use
------------------------------------------------------------------------
(1) 22.7 (25 ............. Broiler Do not feed to 066104
ppm) chickens: laying hens.
For the
prevention
of
coccidiosis
caused by
Eimeria
acervulina,
E.
brunetti,
E. maxima,
E. mivati/
E. mitis,
E.
necatrix,
and E.
tenella.
------------------------------------------------------------------------
(2) 22.7 Bacitracin Broiler Feed 066104
methylene chickens: continuously
disalicylate As in as sole
10 to 50 paragraph ration. Do
(d)(1) of not feed to
this laying hens.
section; Bacitracin
for methylene
improved disalicylate
feed as provided
efficiency. by No. 046573
in Sec.
510.600(c) of
this chapter.
------------------------------------------------------------------------
[[Page 41962]]
(3) 22.7 Bacitracin Broiler Feed 066104
methylene chickens: continuously
disalicylate As in as sole
10 to 50 paragraph ration. Use
plus (d)(4) of feed within 2
roxarsone this weeks of
45.4 section; production.
for Do not feed
improved to laying
feed hens. Use as
efficiency. sole source
of organic
arsenic.
Poultry
should have
access to
drinking
water at all
times. Drug
overdosage or
lack of water
intake may
result in leg
weakness or
paralysis.
Withdraw 5
days before
slaughter.
Bacitracin
methylene
disalicylate
and roxarsone
as provided
by No. 046573
in Sec.
510.600(c) of
this chapter.
------------------------------------------------------------------------
(4) 22.7 Roxarsone Broiler Feed 066104
45.4 chickens: continuously
For the as sole
prevention ration. For
of broiler
coccidiosis chickens
caused by only. Do not
Eimeria feed to
acervulina, laying hens.
E. Use as sole
brunetti, source of
E. maxima, organic
E. mivati/ arsenic.
E. mitis, Withdraw 5
E. days before
necatrix, slaughter.
and E. Roxarsone as
tenella, provided by
including No. 046573 in
some field Sec.
strains of 510.600(c) of
E. tenella this chapter.
that are
more
susceptible
to
semduramici
n combined
with
roxarsone
than
semduramici
n alone.
------------------------------------------------------------------------
(5) 22.7 Virginiamycin Broiler Feed 066104
5 chickens: continuously
As in as sole
paragraph ration. Do
(d)(1) of not feed to
this laying hens.
section; Virginiamycin
for as provided
increased by No. 066104
rate of in Sec.
weight gain 510.600(c) of
and this chapter.
improved
feed
efficiency.
------------------------------------------------------------------------
(6) 22.7 Virginiamycin Broiler Feed 066104
5 to 15 chickens: continuously
As in as sole
paragraph ration. Do
(d)(1) of not feed to
this laying hens.
section; Virginiamycin
for as provided
increased by No. 066104
rate of in Sec.
weight 510.600(c) of
gain. this chapter.
------------------------------------------------------------------------
(7) 22.7 Virginiamycin Broiler Feed 066104
20 chickens: continuously
As in as sole
paragraph ration. Do
(d)(1) of not feed to
this laying hens.
section; Virginiamycin
for as provided
prevention by No. 066104
of necrotic in Sec.
enteritis 510.600(c) of
caused by this chapter.
Clostridium
perfringens
susceptible
to
virginiamyc
in.
------------------------------------------------------------------------
(8) 22.7 Virginiamycin Broiler Feed 066104
20 plus chickens: continuously
roxarsone As in as sole
22.7 to 45.4 paragraph ration
(d)(1) of throughout
this growing
section; period. Do
for not feed to
prevention laying hens.
of necrotic Use as sole
enteritis source of
caused by organic
Clostridium arsenic.
perfringens Poultry
susceptible should have
to access to
virginiamyc drinking
in; for water at all
increased times. Drug
rate of overdose or
weight gain lack of water
and may result in
improved leg weakness.
feed Roxarsone as
efficiency; in Sec.
and for 558.530(b)(1)
improved of this
pigmentatio chapter
n. provided by
No. 046573 in
Sec.
510.600(c) of
this chapter;
semduramicin
and
virginiamycin
as provided
by No.
066104.
------------------------------------------------------------------------
[[Page 41963]]
Dated: April 25, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation.
[FR Doc. 05-14329 Filed 7-20-05; 8:45 am]
BILLING CODE 4160-01-S