New Animal Drugs for Use in Animal Feeds; Roxarsone; Semduramycin, 41958-41963 [05-14329]
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41958
Federal Register / Vol. 70, No. 139 / Thursday, July 21, 2005 / Rules and Regulations
in any one year.’’ The current threshold
after adjustment for inflation is $115
million, using the most current (2003)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
VI. Paperwork Reduction Act of 1995
The final rule contains no collections
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
List of Subjects in 21 CFR Part 20
Confidential business information,
Courts, Freedom of information,
Government employees.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 20 is
amended as follows:
PART 20—PUBLIC INFORMATION
1. The authority citation for part 20
continues to read as follows:
I
Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19
U.S.C. 2531–2582; 21 U.S.C. 321–393, 1401–
1403; 42 U.S.C. 241, 242, 242a, 242l, 242n,
243, 262, 263, 263b–263n, 264, 265, 300u–
300u–5, 300aa–1.
2. Section 20.65 is added to read as
follows:
I
§ 20.65
policy.
§ 20.67 Records exempted by other
statutes.
Records or information may be
withheld from public disclosure if a
statute specifically allows the Food and
Drug Administration (FDA) to withhold
them. FDA may use another statute to
justify withholding records and
information only if it absolutely
prohibits disclosure, sets forth criteria to
guide our decision on releasing
material, or identifies particular types of
matters to be withheld.
I 5. Section 20.82 is amended by
revising paragraph (b)(3) to read as
follows:
§ 20.82 Discretionary disclosure by the
Commissioner.
*
*
*
*
*
(b) * * *
(3) Prohibited from public disclosure
under statute.
*
*
*
*
*
Dated: July 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–14320 Filed 7–20–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
National defense and foreign
(a) Records or information may be
withheld from public disclosure if they
are:
(1) Specifically authorized under
criteria established by an Executive
order to be kept secret in the interest of
national defense or foreign policy; and
(2) In fact properly classified under
such Executive order.
(b) [Reserved]
I 3. Section 20.66 is added to read as
follows:
§ 20.66 Internal personnel rules and
practices.
Records or information may be
withheld from public disclosure if they
are related solely to the internal
personnel rules and practices of the
Food and Drug Administration (FDA).
Under this exemption, FDA may
withhold records or information about
routine internal agency practices and
procedures. Under this exemption, the
agency may also withhold internal
records whose release would help some
persons circumvent the law.
I 4. Section 20.67 is added to read as
follows:
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Change of Address; Technical
Amendment
AGENCY:
Food and Drug Administration,
(5 U.S.C. 553). Notice and public
procedure are unnecessary because FDA
is merely correcting nonsubstantive
errors.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting
and recordkeeping requirements.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 101 is
amended as follows:
PART 101—FOOD LABELING
1. The authority citation for 21 CFR
part 101 continues to read as follows:
I
Authority: 15 U.S.C. 1453, 1454, 1455; 21
U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C.
243, 264, 271.
§ 101.83
[Amended]
2. Section 101.83 is amended in
paragraph (c)(2)(ii)(A)(2) by removing
‘‘200 C St. SW., rm. 2831, Washington,
DC 20204’’ and by adding in its place
‘‘5100 Paint Branch Pkwy., College Park,
MD 20740’’ and in paragraph
(c)(2)(ii)(B)(2)by removing ‘‘200 C St.,
SW., rm. 2831, Washington, DC 20204’’
and ‘‘200 C St., SW., Washington DC’’
and by adding in their place ‘‘5100 Paint
Branch Pkwy., College Park, MD 20740’’.
I
Dated: July 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–14328 Filed 7–20–05; 8:45 am]
BILLING CODE 4160–01–S
HHS.
Final rule; technical
amendment.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending its
regulations to correct an incorrect
address for the Center for Food Safety
and Applied Nutrition (CFSAN). This
action is editorial in nature and is
intended to improve the accuracy of the
agency’s regulations.
DATES: This rule is effective July 21,
2005.
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy and
Planning (HF–27), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–7010.
SUPPLEMENTARY INFORMATION: FDA is
amending its regulations in § 101.83 (21
CFR 101.83) to reflect the correct
address for CFSAN.
Publication of this document
constitutes final action on these changes
under the Administrative Procedure Act
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21 CFR Part 558
New Animal Drugs for Use in Animal
Feeds; Roxarsone; Semduramycin
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
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
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Federal Register / Vol. 70, No. 139 / Thursday, July 21, 2005 / Rules and Regulations
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, email: ghaibel@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: FDA has
found that the list of approved, singleingredient 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
Roxarsone in grams per ton
(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 § 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 § 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.
Combinations in
grams per ton
List of Subjects in 21 CFR 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:
I
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
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:
I
§ 558.530
Roxarsone.
(a) Specifications. Type A medicated
articles containing 10, 20, 50, or 80
percent roxarsone.
(b) Approvals. See sponsors in
§ 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 § 556.60 of
this chapter.
(d) Conditions of use—(1) Chickens. It
is used in chicken feed as follows:
Indications for use
Limitations
Growing chickens: For increased
rate of weight gain, improved
feed efficiency, and improved
pigmentation.
(i) 22.7 to 45.4
Feed continuously throughout growing
period; do not feed to chickens producing eggs for 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 45.4
Chlortetracycline
10 to 50
Growing chickens: As in paragraph (d)(1)(i) of this section.
As in paragraph (d)(1)(i) of this section. Chlortetracycline as provided
by No. 046573 in § 510.600(c) of
this chapter.
(iii) 22.7 to 45.4
Chlortetracycline
100 to 200
Growing chickens: As in paragraph (d)(1)(i) of this section;
and for control of infectious
synovitis caused by Mycoplasma synoviae susceptible to
chlortetracycline.
As in paragraph (d)(1)(i) of this section except feed continuously for 7
to 14 days. Chlortetracycline as provided by No. 046573 in § 510.600(c)
of this chapter.
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Sponsor
046573
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Federal Register / Vol. 70, No. 139 / Thursday, July 21, 2005 / Rules and Regulations
Combinations in
grams per ton
Indications for use
Limitations
(iv) 22.7 to 45.4
Chlortetracycline
200 to 400
Growing chickens: As in paragraph (d)(1)(i) of this section;
and for control of chronic respiratory disease (CRD) and air
sac infection caused by M.
gallisepticum and Escherichia
coli susceptible to chlortetracycline.
As in paragraph (d)(1)(i) of this section except feed continuously for 7
to 14 days. Chlortetracycline as provided by No. 046573 in § 510.600(c)
of this chapter.
(v) 22.7 to 45.4
Chlortetracycline
500
Growing chickens: As in paragraph (d)(1)(i) of this section;
and for reduction of mortality
due to E. coli infections susceptible to chlortetracycline.
As in paragraph (d)(1)(i) of this section except feed continuously for 5
days. Chlortetracycline as provided
by No. 046573 in § 510.600(c) of
this chapter.
Roxarsone in grams per ton
Sponsor
(2) Turkeys. It is used in turkey feed
as follows:
Roxarsone in grams per ton
Combinations in
grams per ton
(i) 22.7 to 45.4
Indications for use
Limitations
Growing turkeys: For increased
rate of weight gain, improved
feed efficiency, and improved
pigmentation.
Feed continuously throughout growing
period; do not feed to turkeys producing eggs for 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 45.4
Chlortetracycline
10 to 50
Growing turkeys: As in paragraph
(d)(2)(i) of this section.
As in paragraph (d)(2)(i) of this section. Chlortetracycline as provided
by No. 046573 in § 510.600(c) of
this chapter.
(iii) 22.7 to 45.4
Chlortetracycline
200
Growing turkeys: As in paragraph
(d)(2)(i) of this section; and for
control of infectious synovitis
caused by Mycoplasma
synoviae susceptible to chlortetracycline.
As in paragraph (d)(2)(i) of this section except feed continuously for 7
to 14 days. Chlortetracycline as provided by No. 046573 in § 510.600(c)
of this chapter.
(iv) 22.7 to 45.4
Chlortetracycline
400
1. Growing turkeys: As in paragraph (d)(2)(i) of this section;
and for control of hexamitiasis
caused by Hexamita
meleagrides susceptible to
chlortetracycline.
2. Turkey poults not over 4
weeks of age: Reduction of
mortality due to paratyphoid
caused by Salmonella
typhimurium susceptible to
chlortetracycline.
As in paragraph (d)(2)(i) of this section except feed continuously for 7
to 14 days. Chlortetracycline as provided by No. 046573 in § 510.600(c)
of this chapter.
(v) 22.7 to 45.4
Chlortetracycline
25 mg/lb body
weight daily
Growing turkeys: As in paragraph
(d)(2)(i) of this section; and for
control of complicating bacterial
organisms associated with
bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to chlortetracycline.
As in paragraph (d)(2)(i) of this section except feed continuously for 7
to 14 days. Chlortetracycline as provided by No. 046573 in § 510.600(c)
of this chapter.
(3) Swine. It is used in swine feed as
follows:
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046573
Federal Register / Vol. 70, No. 139 / Thursday, July 21, 2005 / Rules and Regulations
Roxarsone in grams per ton
Combinations in
grams per ton
Chlortetracycline
400 (to administer 10
mg/lb body
weight)
(iii) 181.5
Feed continuously throughout growing
period; withdraw 5 days before
slaughter; as sole source of organic
arsenic.
Growing and finishing swine: As
in paragraph (d)(3)(i) of this
section; and for treatment of
bacterial enteritis caused by E.
coli and S. choleraesuis and
bacterial pneumonia caused by
Pasteurella multocida susceptible to chlortetracycline.
Feed for not more than 14 days; withdraw 5 days before slaughter; as
sole source of organic arsenic.
Growing and finishing swine: For
the treatment of swine dysentery.
(ii) 22.7 to 34.1
Limitations
Growing and finishing swine: For
increased rate of weight gain
and improved feed efficiency.
(i) 22.7 to 34.1
Indications for use
Feed for not more than 6 consecutive
days; if improvement is not 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.
41961
(iv) 181.5
Chlortetracycline
10 to 50
Growing and finishing swine: As
in paragraph (d)(3)(i) of this
section; and for treatment of
swine dysentery.
Chlortetracycline
400 (to administer 10
mg/lb body
weight)
Growing and finishing swine: As
in paragraph (d)(3)(iii) of this
section; and for treatment of
bacterial enteritis caused by E.
coli and S. choleraesuis and
bacterial pneumonia caused by
P. multocida susceptible to
chlortetracycline.
046573
046573
Feed for not more than 6 consecutive
days; if improvement is not 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.
(v) 181.5
Sponsor
Feed for not more than 6 consecutive
days; if improvement is not 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.
§ 558.555 Semduramicin.
*
*
*
*
3. Section 558.555 is amended by
*
*
*
*
*
revising paragraph (d) to read as follows:
*
(d) Conditions of use in chickens. It is
used in chicken feed as follows:
I
Semduramicin in grams per ton
Combinations in
grams per ton
(1) 22.7 (25 ppm)
(2) 22.7
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Limitations
Sponsor
Broiler chickens: For the prevention of coccidiosis caused
by Eimeria acervulina, E.
brunetti, E. maxima, E. mivati/
E. mitis, E. necatrix, and E.
tenella.
Bacitracin methylene disalicylate 10 to 50
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Indications for use
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Do not feed to laying hens.
066104
Broiler chickens: As in paragraph (d)(1) of this section;
for improved feed efficiency.
Feed continuously as sole ration. Do
not feed to laying hens. Bacitracin
methylene disalicylate as provided
by No. 046573 in § 510.600(c) of
this chapter.
066104
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Federal Register / Vol. 70, No. 139 / Thursday, July 21, 2005 / Rules and Regulations
Semduramicin in grams per ton
Combinations in
grams per ton
Indications for use
Limitations
Sponsor
(3) 22.7
Bacitracin methylene disalicylate 10 to 50
plus roxarsone
45.4
Broiler chickens: As in paragraph (d)(4) of this section;
for improved feed efficiency.
Feed continuously as sole ration.
Use feed within 2 weeks of production. Do not feed to laying
hens. Use as 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 § 510.600(c) of this
chapter.
066104
(4) 22.7
Roxarsone 45.4
Broiler chickens: For the prevention of coccidiosis caused
by Eimeria acervulina, E.
brunetti, E. maxima, E. mivati/
E. mitis, E. necatrix, and E.
tenella, including some field
strains of E. tenella that are
more susceptible to
semduramicin combined with
roxarsone than semduramicin
alone.
Feed continuously as sole ration.
For broiler chickens only. Do not
feed to laying hens. Use as sole
source of organic arsenic. Withdraw 5 days before slaughter.
Roxarsone as provided by No.
046573 in § 510.600(c) of this
chapter.
066104
(5) 22.7
Virginiamycin 5
Broiler chickens: As in paragraph (d)(1) of this section;
for increased rate of weight
gain and improved feed efficiency.
Feed continuously as sole ration. Do
not feed to laying hens.
Virginiamycin as provided by No.
066104 in § 510.600(c) of this
chapter.
066104
(6) 22.7
Virginiamycin 5 to
15
Broiler chickens: As in paragraph (d)(1) of this section;
for increased rate of weight
gain.
Feed continuously as sole ration. Do
not feed to laying hens.
Virginiamycin as provided by No.
066104 in § 510.600(c) of this
chapter.
066104
(7) 22.7
Virginiamycin 20
Broiler chickens: As in paragraph (d)(1) of this section;
for prevention of necrotic enteritis caused by Clostridium
perfringens susceptible to
virginiamycin.
Feed continuously as sole ration. Do
not feed to laying hens.
Virginiamycin as provided by No.
066104 in § 510.600(c) of this
chapter.
066104
(8) 22.7
Virginiamycin 20
plus roxarsone
22.7 to 45.4
Broiler chickens: As in paragraph (d)(1) of this section;
for prevention of necrotic enteritis caused by Clostridium
perfringens susceptible to
virginiamycin; for increased
rate of weight gain and improved feed efficiency; and
for improved pigmentation.
Feed continuously as sole ration
throughout growing period. Do not
feed to laying hens. Use as sole
source of organic arsenic. Poultry
should have access to drinking
water at all times. Drug overdose
or lack of water may result in leg
weakness. Roxarsone as in
§ 558.530(b)(1) of this chapter
provided by No. 046573 in
§ 510.600(c) of this chapter;
semduramicin and virginiamycin
as provided by No. 066104.
066104
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Federal Register / Vol. 70, No. 139 / Thursday, July 21, 2005 / Rules and Regulations
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
subject of FR Doc. 05–13891, is
corrected as follows:
On page 40660, in the second column,
immediately following the name and
title of the document’s signer, in the
words of issuance, the word ‘‘amended’’
is corrected read ‘‘revised.’’
Dated: July 15, 2005.
James E. Cason,
Associate Deputy Secretary of the Interior.
[FR Doc. 05–14437 Filed 7–20–05; 8:45 am]
DEPARTMENT OF THE INTERIOR
Bureau of Indian Affairs
25 CFR Part 124
BILLING CODE 4310–2W–P
RIN 1076–AE74
Deposit of Proceeds From Lands
Withdrawn for Native Selection;
Correction
ENVIRONMENTAL PROTECTION
AGENCY
Bureau of Indian Affairs,
Interior.
ACTION: Final rule; correction.
40 CFR Part 52
This document contains a
correction to a final rule that was
published Thursday, July 14, 2005 (70
FR 40660). The regulation relates to
Deposit of Proceeds from Lands
Withdrawn for Native Selection.
EFFECTIVE DATE: July 14, 2005.
FOR FURTHER INFORMATION CONTACT:
Assistant Director, Office of Trust
Regulations, Policies and Procedures, by
telephone at (505) 816–1086, or by
facsimile transmission at (505) 816–
1377.
Approval and Promulgation of Air
Quality Implementation Plan; Idaho;
Correction
AGENCY:
[Docket # ID–03–003; FRL–7941–7]
SUMMARY:
This rule
is published by the authority of the
Secretary, granted under 43 U.S.C. 1601
et seq. and 25 U.S.C. 4001 et seq., and
delegated to the Assistant Secretary—
Indian Affairs 209 DM 8.1.
SUPPLEMENTARY INFORMATION:
Background
The final rule provides contact
information to be used by all
Departments and Agencies, the State of
Alaska, and any other interested parties
for deposit of proceeds from lands
withdrawn for native selection. This
rule was published by the Assistant
Secretary—Indian Affairs in
consultation with the Special Trustee
for American Indians under the
provisions of the American Indian Trust
Fund Management Reform Act of 1994.
Need for Correction
As published, the final rule was
introduced by words of issuance that do
not satisfy Office of the Federal Register
standards. The language must be
corrected to allow for correct
codification of the revised regulation.
Correction of Publication
Accordingly, the publication on July
14, 2005, of the final rule that was the
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Environmental Protection
Agency (EPA).
AGENCY:
ACTION:
Final rule; correction.
SUMMARY: This document corrects the
preamble to a final rule published in the
Federal Register of July 11, 2005 (70 FR
39658) regarding revisions to the open
burning regulations in Idaho’s State
Implementation Plan. This notice
clarifies that, under section 307(b)(1) of
the Clean Air Act, any petition for
judicial review of this action must be
filed in the United States Court of
Appeals for the appropriate circuit
within 60 days from the date notice of
approval appeared in the Federal
Register, and not 30 days, as
erroneously stated in July 11, 2005
action.
FOR FURTHER INFORMATION CONTACT:
Donna Deneen, (206) 553–6706.
SUPPLEMENTARY INFORMATION:
Correction
In the final rule, beginning on page
39658 in the issue of July 11, 2005,
make the following correction, in the
SUPPLEMENTARY INFORMATION section. On
page 39661 in the 3rd column, remove
‘‘August 10, 2005’’ in the first paragraph
and replace it with ’’September 9,
2005’’.
Dated: July 14, 2005.
Michelle Pirzadeh,
Acting Regional Administrator, Region 10.
[FR Doc. 05–14399 Filed 7–20–05; 8:45 am]
BILLING CODE 6560–50–M
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41963
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[R06–OAR–2005–NM–0001; FRL–7942–5]
Approval and Promulgation of Air
Quality Implementation Plans; New
Mexico; Albuquerque/Bernalillo
County
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This action finalizes our
approval of the State Implementation
Plan (SIP) revisions submitted by the
Governor of New Mexico on September
7, 2004. The submittal revises the
second ten-year carbon monoxide (CO)
maintenance plan for the Albuquerque/
Bernalillo County, New Mexico area.
The submittal also revises the relevant
parts of the New Mexico Administrative
Code (NMAC) including revisions to the
General Provisions, Inspection and
Maintenance (I&M) Program, and the
contingency measures. We are finalizing
approval of these revisions in
accordance with the requirements of the
Federal Clean Air Act (the Act).
DATES: This rule is effective on August
22, 2005.
ADDRESSES: The EPA has established a
docket for this action under Regional
Material in EDocket (RME) Docket ID
No. R06–OAR–2005–NM–0001. All
documents in the docket are listed in
the RME index at https://docket.epa.gov/
rmepub/, once in the system, select
‘‘quick search,’’ then key in the
appropriate RME Docket identification
number. Although listed in the index,
some information is not publicly
available, i.e., CBI or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically in RME or
in hard copy at the Air Planning Section
(6PD–L), Environmental Protection
Agency, 1445 Ross Avenue, Suite 700,
Dallas, Texas 75202–2733. The file will
be made available by appointment for
public inspection in the Region 6 FOIA
Review Room between the hours of 8:30
a.m. and 4:30 p.m. weekdays except for
legal holidays. Contact the person listed
in the FOR FURTHER INFORMATION
CONTACT paragraph below to make an
appointment. If possible, please make
the appointment at least two working
days in advance of your visit. There will
be a 15 cent per page fee for making
E:\FR\FM\21JYR1.SGM
21JYR1
]]>Agencies
[Federal Register Volume 70, Number 139 (Thursday, July 21, 2005)]
[Rules and Regulations]
[Pages 41958-41963]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14329]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
