Submission for OMB Review; Comment Request: Clinical Mythteries: A Video Game About Clinical Trials, 13351-13352 [2013-04547]
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13351
Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices
0925–0649. Need and Use of
Information Collection: The HCS will
address the need for a cross-cutting
national study of community programs
and policies and their relationship to
childhood obesity. The HCS is an
observational study of communities that
aims to (1) determine the associations
between community programs/policies
and body mass index (BMI), diet, and
physical activity for children; (2)
identify the community, family, and
child factors that modify or mediate the
associations between community
programs/policies and BMI, diet, and
physical activity in children; and (3)
assess the associations between
programs/policies and BMI, diet and
physical activity in children in
communities that have a high
proportion of African American, Latino,
and/or low-income residents. A total of
264 communities and over 21,000
elementary and middle school children
and their parents will be part of this
study. A HCS community is defined as
a high school catchment area. The study
examines quantitative and qualitative
information obtained from communitybased initiatives; community
characteristics (e.g., school
environment); measurements of
children’s physical activity levels and
dietary practices; and children’s and
parents’ BMIs. Results from the Healthy
Communities Study may influence the
future development and funding of
policies and programs to reduce
childhood obesity. Furthermore, HCS
results will be published in scientific
journals and will be used for the
development of future research
Estimated
number of
respondents
Type of respondents
initiatives targeting childhood obesity.
Frequency of Response: One time.
Affected Public: Families or households;
businesses, other for-profit, and nonprofit. Type of Respondents: Parents,
children, community key informants
(who have knowledge about community
programs/policies related to nutrition,
physical activity, and weight of
children), food service personnel,
physical education instructors, school
liaisons, and physicians or medical
secretaries. The annual reporting burden
is as follows: Estimated number of
respondents: 69,010; Estimated Number
of Responses per Respondent: 1; and
Estimated Total Burden Hours
Requested: 29,657. The annualized cost
to respondents is estimated at $381,841.
There are no capital, operating, or
maintenance costs to report.
Estimated
number of
responses per
respondent
Average
burden per
response
(in hours)
Estimated total
annual burden
hours
requested
39,600
7,128
3,564
880
7,128
3,520
1,056
352
88
352
352
4,990
1
1
1
1
1
1
1
1
1
1
1
1
10/60
1.56
7/60
10/60
1.04
5/60
2.25
5/60
30/60
15/60
25/60
10/60
6,732
11,120
428
150
7,413
282
2,376
28
44
88
148
848
Total ..........................................................................................................
erowe on DSK2VPTVN1PROD with NOTICES
Parents (screening) .........................................................................................
Parents/Caregivers ..........................................................................................
Second Parents ...............................................................................................
Parents who refuse to participate ....................................................................
Children ............................................................................................................
Key Informants (screening) .............................................................................
Key Informants .................................................................................................
Food Service Personnel ..................................................................................
District Food Service Administrator/Manager ..................................................
Physical Education Instructors ........................................................................
School Liaisons ................................................................................................
Physicians/medical secretaries ........................................................................
69,010
........................
........................
29,657
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) 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.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
VerDate Mar<15>2010
15:18 Feb 26, 2013
Jkt 229001
instruments contact: Dr. Sonia Arteaga,
NIH, NHLBI, 6701 Rockledge Drive,
MSC 7936, Bethesda, MD 20892–7936,
or call non-toll free number (301) 435–
0377 or Email your request, including
your address to: hcs@nhlbi.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
Dated: February 19, 2013.
Lynn Susulske,
NHLBI Project Clearance Liaison, National
Institutes of Health.
Michael S. Lauer,
Director, DCVS, National Institutes of Health.
[FR Doc. 2013–04528 Filed 2–26–13; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request: Clinical Mythteries:
A Video Game About Clinical Trials
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on June 13, 2012,
page 35407 and allowed 60-days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institutes of Health may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
E:\FR\FM\27FEN1.SGM
27FEN1
13352
Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
Proposed Collection: Title: Clinical
Mythteries: A Video Game About
Clinical Trials. Type of Information
Collection Request: NEW. Need and Use
of Information Collection: New England
Research Institutes as a contractor for
the National Heart Lung and Blood
Institute is planning to create an
engaging, informational ‘‘serious video
game’’ for adolescents about clinical
studies which: (1) Incorporates core
learning objectives; and (2) dispels
misconceptions. Two types of
information collection are planned:
• Usability testing to understand gameplay/usability. This information will be
collected by focus group and will be
digitally recorded 90 minute groups.
• A pre/post randomized trial to
measure change in knowledge. This
information will be collected
electronically through on-line
questionnaire.
The game will be incorporated with a
larger initiative to provide information
about clinical research (https://
www.nhlbi.nih.gov/
childrenandclinicalstudies/index.php).
Frequency of Response: Once. Affected
Public: Individuals. Type of
Respondents: Adolescents—aged 8–14.
Estimated
number of
respondents
The annual reporting burden is as
follows: Estimated Number of
Respondents: 280; Estimated Number of
Responses per Respondent: 1; Average
Burden Hours per Response: Wave 1—
90/60 (1.5 hours), Wave 2—80/60 (1.33
hours); and Estimated Total Annual
Burden Hours Requested: 378. The
annualized cost to respondents is
estimated at: $3,783. There are no
Capital Costs to report. The Operating
Costs to collect this information is
estimated at $42,425.00.
Note: The following table is acceptable for
the Respondent and Burden Estimate
information, if appropriate, instead of the
text as shown above.
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
requested
Form name
Type of respondents
Qualtative Focus Group Discussion Guide
and screener.
Screen pre post eval ...................................
Adolescents—Wave one
30
1
90/60 (1.5 hours) ..
45
Adolescents—Wave two
250
1
80/60 (1.33 hours)
333
.........................................
280
........................
...............................
378
erowe on DSK2VPTVN1PROD with NOTICES
Total .....................................................
Request For Comments: 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.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Victoria
Pemberton, RNC, MS, CCRC, National
Heart, Lung and Blood Institute, 6701
VerDate Mar<15>2010
15:18 Feb 26, 2013
Jkt 229001
Rockledge Drive, Rm. 8109, Bethesda,
MD 20892, or call non-toll-free number
(301) 435–0510 or Email your request,
including your address to:
pembertonv@mail.nih.gov
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
Dated: February 8, 2013.
Michael Lauer,
Director, Division of Cardiovascular Diseases,
National Heart, Lung, and Blood Institute,
NIH.
Dated: February 12, 2013.
Lynn Susulske,
NHLBI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2013–04547 Filed 2–26–13; 8:45 am]
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.
FOR FURTHER INFORMATION CONTACT:
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.
BILLING CODE 4140–01–P
Java Software for Investigational Drug
Clinical Research
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Description of Technology: A Java
based software application available for
academic use and on a royalty-bearing
basis for commercial licensing. The
Investigational Drug Management
System (IDMS) supports the operational
needs of the investigation drug section
of a pharmacy providing inventory
management functions which fulfill the
recordkeeping requirements defined in
the Code of Federal Regulations related
to the storage, labeling, handling, and
dispensing of investigational drugs. The
internet/browser based application
interfaces with the Computerized
Provider Order Entry (CPOE) system for
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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
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]]>Agencies
[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13351-13352]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04547]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request: Clinical Mythteries:
A Video Game About Clinical Trials
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH) has
submitted to the Office of Management and Budget (OMB) a request for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on June 13, 2012, page 35407 and allowed 60-days for public
comment. No public comments were received. The purpose of this notice
is to allow an additional 30 days for public comment. The National
Institutes of Health may not conduct or sponsor, and the respondent is
not required to respond to, an information collection that has been
extended,
[[Page 13352]]
revised, or implemented on or after October 1, 1995, unless it displays
a currently valid OMB control number.
Proposed Collection: Title: Clinical Mythteries: A Video Game About
Clinical Trials. Type of Information Collection Request: NEW. Need and
Use of Information Collection: New England Research Institutes as a
contractor for the National Heart Lung and Blood Institute is planning
to create an engaging, informational ``serious video game'' for
adolescents about clinical studies which: (1) Incorporates core
learning objectives; and (2) dispels misconceptions. Two types of
information collection are planned: Usability testing to
understand game-play/usability. This information will be collected by
focus group and will be digitally recorded 90 minute groups. A
pre/post randomized trial to measure change in knowledge. This
information will be collected electronically through on-line
questionnaire.
The game will be incorporated with a larger initiative to provide
information about clinical research (https://www.nhlbi.nih.gov/childrenandclinicalstudies/index.php). Frequency of Response: Once.
Affected Public: Individuals. Type of Respondents: Adolescents--aged 8-
14. The annual reporting burden is as follows: Estimated Number of
Respondents: 280; Estimated Number of Responses per Respondent: 1;
Average Burden Hours per Response: Wave 1--90/60 (1.5 hours), Wave 2--
80/60 (1.33 hours); and Estimated Total Annual Burden Hours Requested:
378. The annualized cost to respondents is estimated at: $3,783. There
are no Capital Costs to report. The Operating Costs to collect this
information is estimated at $42,425.00.
Note: The following table is acceptable for the Respondent and
Burden Estimate information, if appropriate, instead of the text as
shown above.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of total annual
Form name Type of respondents number of responses per Average burden hours per response burden hours
respondents respondent requested
--------------------------------------------------------------------------------------------------------------------------------------------------------
Qualtative Focus Group Discussion Guide Adolescents--Wave one..... 30 1 90/60 (1.5 hours)................. 45
and screener.
Screen pre post eval.................... Adolescents--Wave two..... 250 1 80/60 (1.33 hours)................ 333
---------------------------------------------------------------------------------------------------------------
Total............................... .......................... 280 .............. .................................. 378
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request For Comments: 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.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: Desk Officer for NIH. To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Victoria Pemberton, RNC, MS, CCRC, National Heart,
Lung and Blood Institute, 6701 Rockledge Drive, Rm. 8109, Bethesda, MD
20892, or call non-toll-free number (301) 435-0510 or Email your
request, including your address to: pembertonv@mail.nih.gov
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
Dated: February 8, 2013.
Michael Lauer,
Director, Division of Cardiovascular Diseases, National Heart, Lung,
and Blood Institute, NIH.
Dated: February 12, 2013.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2013-04547 Filed 2-26-13; 8:45 am]
BILLING CODE 4140-01-P
