Proposed Collection; 60-day Comment Request Cancer Trials Support Unit (CTSU) (NCI), 53763-53764 [2013-21225]
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Federal Register / Vol. 78, No. 169 / Friday, August 30, 2013 / Notices
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (MVCB), 1800 F
Street NW., 2nd Floor, Washington, DC
20405–0001, telephone (202) 501–4755.
Please cite OMB Control No. 9000–0136
regarding Commercial Item Acquisitions
in all correspondence.
Dated: August 22, 2013.
Karlos Morgan,
Acting Director, Federal Acquisition Policy
Division, Office of Governmentwide
Acquisition Policy, Office of Acquisition
Policy, Office of Governmentwide Policy.
[FR Doc. 2013–21183 Filed 8–29–13; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-day Comment
Request Cancer Trials Support Unit
(CTSU) (NCI)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI),
National Institutes of Health (NIH), will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
SUMMARY:
Expiration Date 12/31/2013, REVISION,
National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The Cancer Therapy
Evaluation Program (CTEP) establishes
and supports programs to facilitate the
participation of qualified investigators
on CTEP-supported studies, and to
institute programs that minimize
redundancy among grant and contract
holders, thereby reducing overall cost of
maintaining a robust treatment trials
program. Currently guided by the efforts
of the Clinical Trials Working Group
(CTWG) and the Institute of Medicine
(IOM) recommendations to revitalize the
Cooperative Group program, CTEP has
funded the Cancer Trials Support Unit
(CTSU). The CTSU collects
standardized forms to process site
regulatory information, changes to
membership, patient enrollment data,
and routing information for case report
forms. In addition, CTSU collects
annual surveys of customer satisfaction
for clinical site staff using the CTSU
Help Desk, the CTSU Web site, and the
Protocol and Information Office (PIO).
An ongoing user satisfaction survey is in
place for the Oncology Patient
Enrollment Network (OPEN). User
satisfaction surveys are compiled as part
of the project quality assurance
activities and are used to direct
improvements to processes and
technology.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
24,996.
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments and For Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Michael Montello,
Cancer Therapy Evaluation Program,
Division of Cancer Treatment and
Diagnosis, 9609 Medical Center Drive
Rockville, MD 20850 or call non-tollfree number 240–276–6080 or Email
your request, including your address to:
montellom@mail.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: Cancer Trials
Support Unit (CTSU) (NCI), 0925–0624,
ESTIMATED ANNUALIZED BURDEN HOURS
tkelley on DSK3SPTVN1PROD with NOTICES
Form name
CTSU IRB/Regulatory Approval Transmittal Form
CTSU IRB Certification Form ...............................
CTSU Acknowledgement ......................................
Withdrawal from Protocol Participation Form .......
Site Addition ..........................................................
CTSU Roster Update Form ..................................
CTSU Radiation Therapy Facilities Inventory
Form.
CTSU IBCSG Drug Accountability Form ..............
CTSU IBCSG Transfer of Investigational Agent
Form.
Site Initiated Data Update Form ...........................
Data Clarification Form .........................................
RTOG 0834 CTSU Data Transmittal Form ..........
MC0845(8233) CTSU Data Transmittal ...............
CTSU Generic Data Transmittal Form .................
CTSU Patient Enrollment Transmittal Form .........
CTSU P2C Enrollment Transmittal Form .............
CTSU Transfer Form ............................................
CTSU System Account Request Form .................
CTSU Request for Clinical Brochure ....................
VerDate Mar<15>2010
18:00 Aug 29, 2013
Number of
respondents
Type of respondent
Jkt 229001
Health
Health
Health
Health
Health
Health
Health
Average
burden per
response
(in hours)
Total
annual
burden hour
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
9,000
8,500
500
50
25
50
20
12
12
12
12
12
12
12
2/60
10/60
5/60
5/60
5/60
4/60
30/60
3,600
17,000
500
50
25
40
120
Health Care Practitioner
Health Care Practitioner
11
3
12
12
10/60
20/60
22
12
10
341
60
50
500
200
15
20
20
75
12
12
12
12
12
12
12
12
12
12
10/60
20/60
10/60
10/60
10/60
10/60
10/60
10/60
20/60
10/60
20
1,364
120
100
1,000
400
30
40
80
150
Health
Health
Health
Health
Health
Health
Health
Health
Health
Health
PO 00000
Care
Care
Care
Care
Care
Care
Care
Number of
responses per
respondent
Care
Care
Care
Care
Care
Care
Care
Care
Care
Care
Frm 00038
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
Fmt 4703
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E:\FR\FM\30AUN1.SGM
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53764
Federal Register / Vol. 78, No. 169 / Friday, August 30, 2013 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name
CTSU Supply Request Form ................................
CTSU Web Site Customer Satisfaction Survey ...
CTSU Helpdesk Customer Satisfaction Survey ...
CTSU OPEN Survey ............................................
PIO Customer Satisfaction Survey .......................
Dated: August 26, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–13–13AGH]
tkelley on DSK3SPTVN1PROD with NOTICES
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
comments to Kimberly S. Lane, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (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
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Examining Traumatic Brain Injury in
Youth—NEW—National Center for
Jkt 229001
Care
Care
Care
Care
Care
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
Traumatic brain injury (TBI) is one of
the highest priorities in public health
because of its magnitude, economic and
human impact, and preventability. The
Centers for Disease Control and
Prevention (CDC) estimates that
approximately 1.7 million TBIs are
sustained in the United States annually,
either alone or in conjunction with
another injury or condition. These
figures may be an underestimation as
they do not include people who are
treated in physicians’ offices or
outpatient facilities, those who did not
seek medical care, military personnel, or
Americans living abroad. Moreover, the
number of sports and recreation-related
TBIs treated in U.S. emergency
departments is increasing and has
increased steadily since the early 2000s.
Children, ages 0 to 4 years and
adolescents, ages 15–19, are at the
greatest risk of sustaining a TBI. A TBI
is caused by a bump, blow or jolt to the
head or a penetrating head injury that
disrupts the normal function of the
brain. The severity of a TBI may range
from ‘‘mild’’ (a brief change in mental
status or consciousness) to ‘‘severe’’ (an
extended period of unconsciousness or
amnesia after the injury).
In 1996, Congress passed Public Law
104–166, the Traumatic Brain Injury
Act, which charged CDC with
implementing projects to reduce the
incidence of traumatic brain injury. The
CDC definition of TBI uses selected
codes of the International Classification
of Diseases, 9th Clinical Modification
(ICD–9 CM) to identify cases of TBI from
hospital and non-hospital databases
containing billing records for services
rendered to patients. It is thought,
however, that the ICD–9 CM codes
currently used in CDC’s surveillance
system to capture cases of TBI are not
sufficiently sensitive to capture
diagnosed TBI. CDC, therefore, would
like to collect de-identified medical
information of a representative sample
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
75
275
325
60
100
Background and Brief Description
BILLING CODE 4140–01–P
18:00 Aug 29, 2013
Health
Health
Health
Health
Health
Injury Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
[FR Doc. 2013–21225 Filed 8–29–13; 8:45 am]
VerDate Mar<15>2010
Number of
respondents
Type of respondent
12
1
1
1
1
Average
burden per
response
(in hours)
10/60
15/60
15/60
15/60
5/60
Total
annual
burden hour
150
69
81
15
8
of pediatric patients, from two clinical
settings, who received a confirmed
diagnosis of mild to severe TBI and link
these patients to their administrative
medical claims forms. Collectively, the
data will allow CDC to estimate the
sensitivity of currently utilized ICD–9
CM codes to capture cases of diagnosed
TBI, as well as ICD–9 CM codes not
currently being utilized that may
improve the sensitivity to capture cases
of TBI. We propose to conduct a
retrospective cross-sectional study of a
random sample of patients with a
suspected TBI within two clinical
settings (Emergency Departments and
Concussion Clinics).
Information for this study is being
collected to better understand the
coding practices related to TBI among
children within multiple clinical
settings. The data will benefit public
health by providing a more accurate
case definition of TBI for the Central
Nervous System (CNS) Injury
Surveillance. Results from this study
will be shared with CDC stakeholders,
such as state and local health
departments, clinicians and TBI-related
medical researchers through CDC
reports and peer-reviewed publications.
CDC requests OMB approval for three
years to abstract data from medical and
billing records dated April 1st to
September 30, 2013. Data will be
collected electronically, analyzed with
findings compiled in a final report. The
following information is needed from
the medical record: Age at injury,
encrypted or randomly generated
identification number (that can be
linked to billing system), head injury
assessment value (indicator variable,
Yes/No), Traumatic injury mechanism,
Glasgow Coma Scale (GCS) score, ICD–
9 CM codes and External cause of injury
(E) codes if available, Head injury
assessment value (indicator), Confirmed
Diagnosis of TBI (Yes/No), based on the
TBI case definition and if yes, Injury
Type. The necessary data fields from the
hospital billing system are: Encrypted or
randomly generated identification
number (that can be linked to medical
chart), diagnosis codes (all available
E:\FR\FM\30AUN1.SGM
30AUN1
]]>Agencies
[Federal Register Volume 78, Number 169 (Friday, August 30, 2013)]
[Notices]
[Pages 53763-53764]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21225]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-day Comment Request Cancer Trials Support
Unit (CTSU) (NCI)
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Cancer Institute
(NCI), National Institutes of Health (NIH), will publish periodic
summaries of proposed projects to be submitted to the Office of
Management and Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected
agencies are invited on one or more of the following points: (1)
Whether the proposed collection of information is necessary for the
proper performance of the function of the agency, including whether the
information will have practical utility; (2) The accuracy of the
agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) Ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) Ways to minimize the burden of the
collection of information on those who are to respond, including the
use of appropriate automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology.
To Submit Comments and For Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Michael
Montello, Cancer Therapy Evaluation Program, Division of Cancer
Treatment and Diagnosis, 9609 Medical Center Drive Rockville, MD 20850
or call non-toll-free number 240-276-6080 or Email your request,
including your address to: montellom@mail.nih.gov. Formal requests for
additional plans and instruments must be requested in writing.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Proposed Collection: Cancer Trials Support Unit (CTSU) (NCI), 0925-
0624, Expiration Date 12/31/2013, REVISION, National Cancer Institute
(NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The Cancer Therapy
Evaluation Program (CTEP) establishes and supports programs to
facilitate the participation of qualified investigators on CTEP-
supported studies, and to institute programs that minimize redundancy
among grant and contract holders, thereby reducing overall cost of
maintaining a robust treatment trials program. Currently guided by the
efforts of the Clinical Trials Working Group (CTWG) and the Institute
of Medicine (IOM) recommendations to revitalize the Cooperative Group
program, CTEP has funded the Cancer Trials Support Unit (CTSU). The
CTSU collects standardized forms to process site regulatory
information, changes to membership, patient enrollment data, and
routing information for case report forms. In addition, CTSU collects
annual surveys of customer satisfaction for clinical site staff using
the CTSU Help Desk, the CTSU Web site, and the Protocol and Information
Office (PIO). An ongoing user satisfaction survey is in place for the
Oncology Patient Enrollment Network (OPEN). User satisfaction surveys
are compiled as part of the project quality assurance activities and
are used to direct improvements to processes and technology.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 24,996.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Type of Number of responses per per response Total annual
respondent respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
CTSU IRB/Regulatory Approval Health Care 9,000 12 2/60 3,600
Transmittal Form. Practitioner.
CTSU IRB Certification Form... Health Care 8,500 12 10/60 17,000
Practitioner.
CTSU Acknowledgement.......... Health Care 500 12 5/60 500
Practitioner.
Withdrawal from Protocol Health Care 50 12 5/60 50
Participation Form. Practitioner.
Site Addition................. Health Care 25 12 5/60 25
Practitioner.
CTSU Roster Update Form....... Health Care 50 12 4/60 40
Practitioner.
CTSU Radiation Therapy Health Care 20 12 30/60 120
Facilities Inventory Form. Practitioner.
CTSU IBCSG Drug Accountability Health Care 11 12 10/60 22
Form. Practitioner.
CTSU IBCSG Transfer of Health Care 3 12 20/60 12
Investigational Agent Form. Practitioner.
Site Initiated Data Update Health Care 10 12 10/60 20
Form. Practitioner.
Data Clarification Form....... Health Care 341 12 20/60 1,364
Practitioner.
RTOG 0834 CTSU Data Health Care 60 12 10/60 120
Transmittal Form. Practitioner.
MC0845(8233) CTSU Data Health Care 50 12 10/60 100
Transmittal. Practitioner.
CTSU Generic Data Transmittal Health Care 500 12 10/60 1,000
Form. Practitioner.
CTSU Patient Enrollment Health Care 200 12 10/60 400
Transmittal Form. Practitioner.
CTSU P2C Enrollment Health Care 15 12 10/60 30
Transmittal Form. Practitioner.
CTSU Transfer Form............ Health Care 20 12 10/60 40
Practitioner.
CTSU System Account Request Health Care 20 12 20/60 80
Form. Practitioner.
CTSU Request for Clinical Health Care 75 12 10/60 150
Brochure. Practitioner.
[[Page 53764]]
CTSU Supply Request Form...... Health Care 75 12 10/60 150
Practitioner.
CTSU Web Site Customer Health Care 275 1 15/60 69
Satisfaction Survey. Practitioner.
CTSU Helpdesk Customer Health Care 325 1 15/60 81
Satisfaction Survey. Practitioner.
CTSU OPEN Survey.............. Health Care 60 1 15/60 15
Practitioner.
PIO Customer Satisfaction Health Care 100 1 5/60 8
Survey. Practitioner.
----------------------------------------------------------------------------------------------------------------
Dated: August 26, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2013-21225 Filed 8-29-13; 8:45 am]
BILLING CODE 4140-01-P
