[Federal Register Volume 80, Number 48 (Thursday, March 12, 2015)]
[Notices]
[Pages 13013-13014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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)
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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