80 FR 13013 - Proposed Collection; 60-Day Comment Request Web-Based Resource for Youth About Clinical Research (NHLBI)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 48 (March 12, 2015)

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 Heart, Lung and Blood Institute (NHLBI), 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: Ms. Victoria Pemberton, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Dr., Room 8102, MSC 7940, Bethesda, MD 20892-7940, or call non-toll-free number 301-435-0510, or Email your request, including your address to [email protected] Formal requests for additional plans and instruments must be requested in writing.

[Federal Register Volume 80, Number 48 (Thursday, March 12, 2015)]
[Notices]
[Pages 13013-13014]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-05592]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request Web-Based Resource 
for Youth About Clinical Research (NHLBI)

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 Heart, Lung and 
Blood Institute (NHLBI), 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: Ms. 
Victoria Pemberton, National Heart, Lung, and Blood Institute, National 
Institutes of Health, 6701 Rockledge Dr., Room 8102, MSC 7940, 
Bethesda, MD 20892-7940, or call non-toll-free number 301-435-0510, or 
Email your request, including your address to [email protected]. 
Formal requests for additional plans and instruments must be requested 
in writing.

DATES: 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: Web-based Resource for Youth about Clinical 
Research (NHLBI), 0925-New, National Heart, Lung, and Blood Institute 
(NHLBI), National Institutes of Health (NIH).
    Need and Use of Information Collection: The purpose and use of the 
information collection for this project is to develop a comprehensive 
web-based resource for youth with chronic illnesses or diseases that 
will attempt to increase knowledge, self-efficacy, and positive 
attitudes towards participation in various clinical trials and 
research. As a result of the proposed web-based resource, the knowledge 
gained from developing and testing this web-based resource will 
ultimately help equip youth to make informed decisions about clinical 
research and increase motivation to participate in that research. In 
addition, the knowledge gained will be invaluable to the field of 
clinical research given the need for more clinical trials with youth. 
Specifically, the proposed web-based resource will be an interactive, 
multimedia, developmentally appropriate resource for youth to be 
educated about pediatric clinical trials. The resource will be 
developed for youth aged 8 to 14 years. The theme of ``investigative 
cyber-reporting'' will be used throughout and will include youth making 
a series of decisions about different aspects of participating in 
clinical research studies. Youth will be tasked with the responsibility 
of learning all they can about clinical research trials in order to 
facilitate their knowledge and decision-making processes. Language 
typically used in journalism and design elements reminiscent of 
journalism will be incorporated into the content, design, and layout of 
the resource. There are three main components that will comprise the 
web-based resource. These include an interactive leaning module, full 
length video testimonials, and an electronic comic book. The benefits 
and necessities for this particular research on pediatric clinical 
trials are congruent with NHLBI's research goals and mission statement: 
Attempting to assist in the enhancement of the health of individuals so 
that they can live longer and more fulfilling lives. The current lack 
of knowledge surrounding pediatric clinical trials can be dangerous and 
unhealthy towards the lives of youth, becoming a large public health 
need.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 164.

                                            Estimates of Hour Burden
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                                                                                      Average
                                     Type of         Number of       Number of      burden per     Total annual
           Form name               respondent       respondents    responses per   response (in     burden hour
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Individual Interview            Individual                     9               1               2              18
 Questionnaire.                  Interviews
                                 Study.
One-to-One Evaluation           One-to-One                     5               1               2              10
 Questionnaire.                  Evaluation
                                 Study.
Pre-Post Study Questionnaire..  Pre-Post                      34               1               4             136
                                 Feedback Study.
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    Dated: February 23, 2015.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2015-05592 Filed 3-11-15; 8:45 am]
 BILLING CODE 4140-01-P