Notice of Approval of Original Abbreviated New Animal Drug Application; Phenylbutazone Tablets, 66906-66907 [E8-26793]
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66906
Federal Register / Vol. 73, No. 219 / Wednesday, November 12, 2008 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
606.100(b)2
3535
1
353
24
8,472
606.100(c)
3535
10
3,530
1
3,530
606.110(a)3
356
1
35
0.5
18
606.151(e)
3535
12
4,236
0.083
352
606.1604
3535
793.20
280,000
0.75
210,000
2,000
10.50
21,000
.17
3,570
4,980
4.21
21,000
.17
3,570
2,000
23.40
46,800
.17
7,956
4,980
9.4
46,800
.17
7,956
HIV recipient notification
4,980
0.35
1,755
.17
298
HCV recipient notification
4,980
0.41
2,050
.17
349
606.160(b)(1)(ix)
2,081
840.94
1,750,000
0.05
87,500
606.160(b)(1)(xi)
2,000
3.375
6,750
0.05
338
606.165
3535
793.20
280,000
0.083
23,240
606.170(a)
3535
12
4,236
1.00
4,236
610.40(g)(1)
2,081
1
2,081
0.50
1,041
606.160(b)(1)(viii)
HIV consignee notification
HCV consignee notification
Total
362,426
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
recordkeeping requirements in §§ 640.3(a)(1), 640.4(a)(1), and 640.66, which address the maintenance of SOPs, are included in the estimate for § 606.100(b).
3The recordkeeping requirements in § 640.27(b), which address the maintenance of donor health records for the plateletpheresis, are included
in the estimate for § 606.110(a).
44 The recordkeeping requirements in §§ 640.3(a)(2) and (f); 640.4(a)(2); 640.25(b)(4) and (c)(1); 640.31(b); 640.33(b); 640.51(b); 640.53(b)
and (c); 640.56(b) and (d); 640.61; 640.63(b)(3), (e)(1), and (e)(3); 640.65(b)(2); 640.71(b)(1); 640.72; and 640.76(a) and (b), which address the
maintenance of various records are included in the estimate for § 606.160.
5Five percent of establishments that fall under the Clinical Laboratory Improvement Amendments of 1988 that transfuse blood and components
and FDA-registered blood establishments (0.05 x 4,980 + 2,081).
6Five percent of plateletpheresis and leukopheresis establishments (0.05 x 696).
2The
Dated: November 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–26863 Filed 11–10–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on PROD1PC66 with NOTICES
Notice of Approval of Original
Abbreviated New Animal Drug
Application; Phenylbutazone Tablets
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Aug<31>2005
18:30 Nov 10, 2008
Jkt 217001
John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: First
Priority, Inc., 1585 Todd Farm Dr.,
Elgin, IL 60123, filed ANADA 200–433
providing for veterinary prescription
FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2008–N–0039]
AGENCY:
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice that it has approved an original
abbreviated new animal drug
application (ANADA) filed by First
Priority, Inc. The ANADA provides for
veterinary prescription use of
phenylbutazone tablets in horses for the
relief of inflammatory conditions
associated with the musculoskeletal
system.
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
use of Phenylbutazone Tablets in horses
for the relief of inflammatory conditions
associated with the musculoskeletal
system. First Priority, Inc.’s, ANADA for
Phenylbutazone Tablets is approved as
a generic copy of First Priority, Inc.’s,
PRIBUTAZONE Tablets, approved
under NADA 48–647. In accordance
with section 512(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
360b(i)) and part 514 (21 CFR part 514),
in §§ 514.105(a) and 514.106(a), the
Center for Veterinary Medicine is
providing notice that this ANADA is
approved as of October 23, 2008.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
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66907
Federal Register / Vol. 73, No. 219 / Wednesday, November 12, 2008 / Notices
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
FDA has determined under 21 CFR
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.
Dated: November 5, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–26793 Filed 11–10–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995,
Public Law 104–13), the Health
Resources and Services Administration
(HRSA) publishes periodic summaries
of proposed projects being developed
for submission to the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
To request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer on (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
Number of
respondents
Form
Responses
per
respondent
or other forms of information
technology.
Proposed Project: Data Collection
Worksheet Form (DCW):
Reinstatement—(OMB No. 0915–0226)
The Data Collection Worksheet Form
for the National Health Service Corps
Scholarship Program enables the
Division of Applications and Awards/
Scholarship Branch (DAA/SB) within
the Health Resources and Services
Administration (HRSA) to obtain the
costs charged by each health professions
training program for tuition, fees, and
other reasonable educational expenses,
in order to determine the amount of
each scholarship award. The DAA/SB
enters this information into its
computerized data system, along with
the projected amount for the monthly
stipend, to determine the amount of
each scholarship award.
The estimated annual burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
Data Collection Worksheet ..................................................
650
1
650
0.5
325
Total ..............................................................................
650
........................
650
........................
325
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: November 4, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E8–26816 Filed 11–10–08; 8:45 am]
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
BILLING CODE 4165–15–P
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on PROD1PC66 with NOTICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
ACTION:
Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Notice.
VerDate Aug<31>2005
18:30 Nov 10, 2008
Jkt 217001
PO 00000
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Fmt 4703
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System for Correction of MRI Head
Motion
Description of Technology: Motion
artifacts continue to be a significant
problem in MRI of human brain.
Prospective motion correction based on
external tracking systems has been
proposed to ameliorate this issue.
However, the calibration of these
systems is very complicated and time
consuming, as it requires a camera
system calibration as well as a
calibration between camera and MRI
system using dedicated phantoms. An
alternative motion correction method
for MRI that does not require calibration
and can work with just a single video
camera has been developed and is
available for licensing. This technology
can be broadly applied in MRI to
account for motion artifacts in order to
improve acquisition time and provide
enhanced resolution. This technique
will provide a needed method to obtain
reliable MRI scans for uncooperative
patients (children, seizure patients, etc.)
E:\FR\FM\12NON1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 219 (Wednesday, November 12, 2008)]
[Notices]
[Pages 66906-66907]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26793]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0039]
Notice of Approval of Original Abbreviated New Animal Drug
Application; Phenylbutazone Tablets
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is providing notice
that it has approved an original abbreviated new animal drug
application (ANADA) filed by First Priority, Inc. The ANADA provides
for veterinary prescription use of phenylbutazone tablets in horses for
the relief of inflammatory conditions associated with the
musculoskeletal system.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: First Priority, Inc., 1585 Todd Farm Dr.,
Elgin, IL 60123, filed ANADA 200-433 providing for veterinary
prescription use of Phenylbutazone Tablets in horses for the relief of
inflammatory conditions associated with the musculoskeletal system.
First Priority, Inc.'s, ANADA for Phenylbutazone Tablets is approved as
a generic copy of First Priority, Inc.'s, PRIBUTAZONE Tablets, approved
under NADA 48-647. In accordance with section 512(i) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360b(i)) and part 514 (21 CFR
part 514), in Sec. Sec. 514.105(a) and 514.106(a), the Center for
Veterinary Medicine is providing notice that this ANADA is approved as
of October 23, 2008.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets
[[Page 66907]]
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday
through Friday.
FDA has determined under 21 CFR 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.
Dated: November 5, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-26793 Filed 11-10-08; 8:45 am]
BILLING CODE 4160-01-S
