Oral Dosage Form New Animal Drugs; Chlortetracycline Powder, 63986-63987 [E7-22261]
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Federal Register / Vol. 72, No. 219 / Wednesday, November 14, 2007 / Rules and Regulations
LIST OF COMMENTERS
Abbreviation
Name
Allegheny ........................................
AGA ................................................
APPA and TAPS ............................
Butte County ...................................
California Resources ......................
California State Agencies ...............
Allegheny Power and Allegheny Energy Supply Company, L.L.C.
American Gas Association.
American Public Power Association and Transmission Access Policy Study Group.
Butte County, California.
California Resources Agency.
California Coastal Commission, California Energy Commission, California Electricity Oversight Board, and
California State Lands Commission.
Dominion Transmission Inc., Dominion Cove Point, LNG, LP, and Dominion South Pipeline Company, LP.
Edison Electric Institute.
Interstate Natural Gas Association of America.
MidAmerican Energy Company.
National Association of Regulatory Utility Commissioners.
National Hydropower Association.
Southern California Edison Company.
Western Interstate Energy Board and Committee on Regional Electric Power Cooperation.
Williston Basin Interstate Pipeline Company.
United States Department of the Interior.
Dominion .........................................
EEI ..................................................
INGAA .............................................
MidAmerican ...................................
NARUC ...........................................
NHA ................................................
SCE ................................................
Western Energy Board ...................
Williston Basin ................................
Department of the Interior ..............
[FR Doc. E7–22141 Filed 11–13–07; 8:45 am]
List of Subjects in 21 CFR Part 510
BILLING CODE 6717–01–P
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 510 is amended as follows:
21 CFR Part 510
New Animal Drugs; Change of
Sponsor’s Address
PART 510—NEW ANIMAL DRUGS
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor address for IDEXX
Pharmaceuticals, Inc.
This rule is effective November
14, 2007.
DATES:
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov.
IDEXX
Pharmaceuticals, Inc., 4249–105
Piedmont Pkwy., Greensboro, NC 27410,
has informed FDA of a change of
address to 7009 Albert Pick Rd.,
Greensboro, NC 27409. Accordingly, the
agency is amending the regulations in
21 CFR 510.600(c) to reflect the change.
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.
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14:53 Nov 13, 2007
Jkt 214001
*
*
Firm name and address
IDEXX Pharmaceuticals,
Inc., 7009 Albert Pick
Rd., Greensboro, NC
27409
*
*
*
Dated: November 6, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–22210 Filed 11–13–07; 8:45 am]
BILLING CODE 4160–01–S
1. The authority citation for 21 CFR
part 510 continues to read as follows:
I
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
2. In § 510.600, in the table in
paragraph (c)(1) revise the entry for
‘‘IDEXX Pharmaceuticals, Inc.’’; and in
the table in paragraph (c)(2) revise the
entry for ‘‘065274’’ to read as follows:
Food and Drug Administration
I
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
*
*
IDEXX Pharmaceuticals,
Inc., 7009 Albert Pick
Rd., Greensboro, NC
27409.
*
*
*
Drug labeler
code
*
065274
*
*
*
(2) * * *
Drug labeler
code
PO 00000
*
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Chlortetracycline Powder
AGENCY:
Firm name and address
*
*
*
Frm 00020
Fmt 4700
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Food and Drug Administration,
HHS.
ACTION:
*
Firm name and address
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
065274
I
Food and Drug Administration
AGENCY:
Drug labeler
code
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by Fort
Dodge Animal Health, Division of
Wyeth Holdings Corp. The
supplemental NADA provides for label
revisions for chlortetracycline soluble
powder.
DATES: This rule is effective November
14, 2007.
FOR FURTHER INFORMATION CONTACT: Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
*
E:\FR\FM\14NOR1.SGM
14NOR1
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.
*
*
*
*
*
(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)
PO 00000
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Fmt 4700
Sfmt 4700
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:
E:\FR\FM\14NOR1.SGM
14NOR1
]]>Agencies
[Federal Register Volume 72, Number 219 (Wednesday, November 14, 2007)]
[Rules and Regulations]
[Pages 63986-63987]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22261]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Chlortetracycline Powder
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Fort Dodge Animal Health, Division of Wyeth
Holdings Corp. The supplemental NADA provides for label revisions for
chlortetracycline soluble powder.
DATES: This rule is effective November 14, 2007.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl.,
[[Page 63987]]
Rockville, MD 20855, 301-827-7571, e-mail: 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 Sec. 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.
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 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 520.445b, revise paragraph (b)(2) and add paragraph (d)(5)
to read as follows:
Sec. 520.445b Chlortetracycline powder.
* * * * *
(b) * * *
(2) No. 053501 for use as in paragraph (d)(5) of this section.
* * * * *
(d) * * *
(5) Use in a drench or drinking water as follows:
(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) 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
