[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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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, [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