[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13351-13352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04547]
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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,
[[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 (http://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.
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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
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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
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Total............................... .......................... 280 .............. .................................. 378
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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, [email protected] 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: [email protected]
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