TRICARE, Formerly Known as the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); Coverage of Physician Assistant Services, 63987-63988 [07-5624]
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Federal Register / Vol. 72, No. 219 / Wednesday, November 14, 2007 / Rules and Regulations
Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Fort
Dodge Animal Health, Division of
Wyeth Holdings Corp., P.O. Box 1339,
Fort Dodge, IA 50501, filed a
supplement to NADA 65–440 for
AUREOMYCIN (chlortetracycline)
Soluble Powder Concentrate, approved
for oral use in medicated drinking water
of chickens, growing turkeys, swine,
calves, beef cattle, and nonlactating
dairy cattle for the control and/or
treatment of various bacterial diseases.
The supplemental NADA provides for
label revisions. The supplemental
application is approved as of October
18, 2007, and the regulations are
amended in 21 CFR 520.445b to reflect
the approval.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
The agency has determined under
§ 25.33(a)(1) 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 Parts 520
Animal drugs.
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 520 is amended as follows:
I
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. In § 520.445b, revise paragraph
(b)(2) and add paragraph (d)(5) to read
as follows:
I
§ 520.445b
Chlortetracycline powder.
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(b) * * *
(2) No. 053501 for use as in paragraph
(d)(5) of this section.
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(d) * * *
(5) Use in a drench or drinking water
as follows:
VerDate Aug<31>2005
14:53 Nov 13, 2007
Jkt 214001
(i) Chickens—(A) Amount. 200 to 400
mg/gal, for 7 to 14 days.
(1) Indications for use. Control of
infectious synovitis caused by M.
synoviae susceptible to
chlortetracycline.
(2) Limitations. Prepare fresh solution
daily; use as the sole source of
chlortetracycline; do not use for more
than 14 consecutive days; do not use in
laying chickens; do not administer to
chickens within 24 hours of slaughter.
(B) Amount. 400 to 800 mg/gal, for 7
to 14 days.
(1) Indications for use. Control of
chronic respiratory disease (CRD) and
air-sac infections caused by M.
gallisepticum and E. coli susceptible to
chlortetracycline.
(2) Limitations. As in paragraph
(d)(5)(i)(A)(2) of this section.
(C) Amount. One thousand mg/gal, for
7 to 14 days.
(1) Indications for use. Control of
mortality due to fowl cholera caused by
Pasteurella multocida susceptible to
chlortetracycline.
(2) Limitations. As in paragraph
(d)(5)(i)(A)(2) of this section.
(ii) Growing Turkeys—(A) Amount.
400 mg/gal, for 7 to 14 days.
(1) Indications for use. Control of
infectious synovitis caused by
Mycoplasma synoviae susceptible to
chlortetracycline.
(2) Limitations. Prepare fresh solution
daily; use as the sole source of
chlortetracycline; do not use for more
than 14 consecutive days; do not
administer to growing turkeys within 24
hours of slaughter.
(B) Amount. 25 mg/lb body weight
daily, for 7 to 14 days.
(1) Indications for use. Control of
complicating bacterial organisms
associated with bluecomb (transmissible
enteritis, coronaviral enteritis)
susceptible to chlortetracycline.
(2) Limitations. As in paragraph
(d)(5)(ii)(A)(2) of this section.
(iii) Swine—(A) Amount. 10 mg/lb
body weight daily, for 3 to 5 days.
(B) Indications for use. Control and
treatment of bacterial enteritis (scours)
caused by E. coli and Salmonella spp.,
and bacterial pneumonia associated
with Pasteurella spp., A.
pleuropneumoniae, and Klebsiella spp.
susceptible to chlortetracycline.
(C) Limitations. Prepare fresh solution
daily; use as the sole source of
chlortetracycline; do not use for more
than 5 days; do not administer to swine
within 24 hours of slaughter.
(iv) Calves, beef cattle, and
nonlactating dairy cattle—(A) Amount.
10 mg/lb body weight daily in divided
doses, for 3 to 5 days.
(B) Indications for use. Control and
treatment of bacterial enteritis (scours)
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63987
caused by Escherichia coli and
Salmonella spp., and bacterial
pneumonia associated with Pasteurella
spp., Histophilus spp., and Klebsiella
spp. susceptible to chlortetracycline.
(C) Limitations. Prepare fresh solution
daily; use as a drench; use as the sole
source of chlortetracycline; do not use
for more than 5 days; do not administer
to cattle within 24 hours of slaughter; do
not use in lactating dairy cattle; do not
administer this product with milk or
milk replacers; administer 1 hour before
or 2 hours after feeding milk or milk
replacers; a withdrawal period has not
been established in preruminating
calves; do not use in calves to be
processed for veal.
Dated: November 2, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–22261 Filed 11–13–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF DEFENSE
Office of the Secretary
[DOD–2007–HA–0118]
32 CFR Part 199
TRICARE, Formerly Known as the
Civilian Health and Medical Program of
the Uniformed Services (CHAMPUS);
Coverage of Physician Assistant
Services
Department of Defense.
Administrative correction.
AGENCY:
ACTION:
SUMMARY: This action corrects the
reference to a re-designated paragraph
within this part regarding the allowable
charge for physician assistant services.
This document is published to improve
the accuracy of 32 CFR part 199.
DATES: Effective Dates: November 14,
2007.
TRICARE Management
Activity, 16401 East Centretech
Parkway, Aurora, CO 80011.
FOR FURTHER INFORMATION CONTACT:
Michael Kottyan, Office of Medical
Benefits and Reimbursement Systems,
TRICARE Management Activity,
telephone (303) 676–3520.
SUPPLEMENTARY INFORMATION: The final
rule published in the Federal Register
on August 1, 1990 (55 FR 31179)
provided the authority for CHAMPUS
payment of services rendered by
physician assistants (PA) and included
a reference to a paragraph elsewhere in
this part. Subsequent actions redesignated that paragraph. This action
ADDRESSES:
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14NOR1
63988
Federal Register / Vol. 72, No. 219 / Wednesday, November 14, 2007 / Rules and Regulations
provides the correct designation of the
paragraph being referenced.
List of Subjects in 32 CFR Part 199
Claims, Handicapped, Health
insurance, Military personnel.
I Accordingly, 32 CFR part 199 is
amended as follows:
PART 199—[AMENDED]
1. The authority citation for part 199
continues to read as follows:
I
Authority: 5 U.S.C. 301; 10 U.S.C. chapter
55.
2. Section 199.6(c)(3)(iii)(H) is
amended by revising ‘‘199.14(g)(1)(iii)’’
to read ‘‘199.14(j)(1)(ix)’’.
I 3. Paragraph 199.14(j) is amended by
revising ‘‘provers’’ to read ‘‘providers’’.
I
Dated: November 5, 2007.
L.M. Bynum,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 07–5624 Filed 11–13–07; 8:45 am]
BILLING CODE 5001–06–M
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 49
[EPA–R01–OAR–2005–TR–0001; A–1–FRL–
8491–7]
Approval and Promulgation of Air
Quality Implementation Plans;
Mohegan Tribe of Indians of
Connecticut
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: EPA is approving a Tribal
Implementation Plan (TIP) submitted by
the Mohegan Tribe of Indians of
Connecticut. The TIP establishes an
enforceable cap on nitrogen oxide
emissions from stationary sources
owned by the Mohegan Tribal Gaming
Authority and located within the
external boundaries of the Mohegan
Reservation. This action is intended to
help attain the National Ambient Air
Quality Standards (NAAQS) for groundlevel ozone. This action is being taken
in accordance with the Clean Air Act.
DATES: Effective Date: This rule is
effective on December 14, 2007.
ADDRESSES: EPA has established a
docket for this action under Docket
Identification No. EPA–R01–OAR–
2005–TR–0001. All documents in the
docket are listed on the
www.regulations.gov Web site.
Although listed in the index, some
information is not publicly available,
VerDate Aug<31>2005
14:53 Nov 13, 2007
Jkt 214001
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 through
www.regulations.gov or in hard copy at
the Office of Ecosystem Protection, U.S.
Environmental Protection Agency, EPA
New England Regional Office, One
Congress Street, Suite 1100, Boston,
MA. EPA requests that if at all possible,
you contact the contact listed in the FOR
FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional
Office’s official hours of business are
Monday through Friday, 8:30 to 4:30,
excluding legal holidays.
Copies of the documents relevant to
this action are also available for public
inspection during normal business
hours, by appointment at the Mohegan
Tribe, Mohegan Environmental
Protection Department, 49 Sandy Desert
Road, Uncasville, CT 06382, telephone
number (860) 862–6112.
FOR FURTHER INFORMATION CONTACT: Ida
E. McDonnell, Air Permits, Toxics and
Indoor Air Unit, Office of Ecosystem
Protection, U.S. Environmental
Protection Agency, EPA New England
Regional Office, One Congress Street,
11th floor, (CAP), Boston, MA 02114–
2023, telephone number (617) 918–
1653, fax number (617) 918–0653, email mcdonnell.ida@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document whenever
‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean
EPA.
Organization of this document. The
following outline is provided to aid in
locating information in this preamble.
I. Background and Purpose
II. Final Action
III. Statutory and Executive Order Reviews
I. Background and Purpose
On September 6, 2007 (72 FR 51204)
EPA published a Notice of Proposed
Rulemaking (NPR) for the Mohegan
Tribe of Indians of Connecticut.
The NPR proposed approval of the
Mohegan Tribal Implementation Plan
(TIP) consisting of a tribal ordinance,
entitled ‘‘Area Wide NOX Emissions
Limitation Regulation,’’ that establishes
a limit on nitrogen oxide (NOX)
emissions from stationary sources
owned by the Mohegan Tribal Gaming
Authority and located within the
external boundaries of the Mohegan
Reservation. The formal TIP was
submitted by Mohegan Tribe of Indians
of Connecticut on May 4, 2005 and
amended on August 22, 2007.
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Other specific requirements of the
Tribal Implementation Plan and the
rationale for EPA’s proposed action are
explained in the NPR and will not be
restated here. No public comments were
received on the NPR.
II. Final Action
EPA is approving the Mohegan Tribal
Implementation Plan that was submitted
by the Mohegan Tribe of Indians of
Connecticut on May 4, 2005, and
amended on August 22, 2007 for
limiting NOX emissions from stationary
sources owned by the Mohegan Tribal
Gaming Authority to 49 TPY.
III. Statutory and Executive Order
Reviews
Under Executive Order 12866 (58 FR
51735, October 4, 1993), this action is
not a ‘‘significant regulatory action’’ and
therefore is not subject to review by the
Office of Management and Budget. For
this reason, this action is also not
subject to Executive Order 13211,
‘‘Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001). This action merely approves
tribal law as meeting Federal
requirements and imposes no additional
requirements beyond those imposed by
tribal law. Accordingly, the
Administrator certifies that this rule
will not have a significant economic
impact on a substantial number of small
entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.). Because this
rule approves pre-existing requirements
under tribal law and does not impose
any additional enforceable duty beyond
that required by tribal law, it does not
contain any unfunded mandate or
significantly or uniquely affect small
governments, as described in the
Unfunded Mandates Reform Act of 1995
(Pub. L. 104–4).
Since this rule simply approves preexisting tribal law, it does not result in
any direct costs or preemption of tribal
law as specified by Executive Order
13175 (65 FR 67249, November 9, 2000).
Nonetheless, EPA has consulted
extensively with the Mohegan Tribe
concerning this proposed TIP approval.
This action also does not have
Federalism implications because it does
not have substantial direct effects on the
States, on the relationship between the
national government and the States, or
on the distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132 (64 FR 43255,
August 10, 1999), because it merely
approves a tribal rule implementing a
federal standard within the exterior
boundaries of the Tribe’s reservation,
E:\FR\FM\14NOR1.SGM
14NOR1
Agencies
[Federal Register Volume 72, Number 219 (Wednesday, November 14, 2007)]
[Rules and Regulations]
[Pages 63987-63988]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-5624]
=======================================================================
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DEPARTMENT OF DEFENSE
Office of the Secretary
[DOD-2007-HA-0118]
32 CFR Part 199
TRICARE, Formerly Known as the Civilian Health and Medical
Program of the Uniformed Services (CHAMPUS); Coverage of Physician
Assistant Services
AGENCY: Department of Defense.
ACTION: Administrative correction.
-----------------------------------------------------------------------
SUMMARY: This action corrects the reference to a re-designated
paragraph within this part regarding the allowable charge for physician
assistant services. This document is published to improve the accuracy
of 32 CFR part 199.
DATES: Effective Dates: November 14, 2007.
ADDRESSES: TRICARE Management Activity, 16401 East Centretech Parkway,
Aurora, CO 80011.
FOR FURTHER INFORMATION CONTACT: Michael Kottyan, Office of Medical
Benefits and Reimbursement Systems, TRICARE Management Activity,
telephone (303) 676-3520.
SUPPLEMENTARY INFORMATION: The final rule published in the Federal
Register on August 1, 1990 (55 FR 31179) provided the authority for
CHAMPUS payment of services rendered by physician assistants (PA) and
included a reference to a paragraph elsewhere in this part. Subsequent
actions re-designated that paragraph. This action
[[Page 63988]]
provides the correct designation of the paragraph being referenced.
List of Subjects in 32 CFR Part 199
Claims, Handicapped, Health insurance, Military personnel.
0
Accordingly, 32 CFR part 199 is amended as follows:
PART 199--[AMENDED]
0
1. The authority citation for part 199 continues to read as follows:
Authority: 5 U.S.C. 301; 10 U.S.C. chapter 55.
0
2. Section 199.6(c)(3)(iii)(H) is amended by revising
``199.14(g)(1)(iii)'' to read ``199.14(j)(1)(ix)''.
0
3. Paragraph 199.14(j) is amended by revising ``provers'' to read
``providers''.
Dated: November 5, 2007.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 07-5624 Filed 11-13-07; 8:45 am]
BILLING CODE 5001-06-M