[Federal Register Volume 80, Number 162 (Friday, August 21, 2015)]
[Notices]
[Pages 50857-50858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20708]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Web-Based
Resource for Youth About Clinical Research
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 3/12/2015 pages 13013-13014, and allowed 60-days for public
comment. One public comment was received. The purpose of this notice is
to allow an additional 30 days for public comment. The National Heart,
Lung and Blood Institute (NHLBI), 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, revised, or
implemented on or after October 1, 1995, unless it displays a currently
valid OMB control number.
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: NIH Desk Officer.
Comment 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.
FOR FURTHER INFORMATION CONTACT: 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.
Proposed Collection: Web-based Resource for Youth about Clinical
Research (NHLBI), 0925-New, National Heart, Lung, and Blood Institute
(NHLBI), the 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 172.
Estimates of Hour Burden
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Number of Average burden
Form name Type of Number of responses per per response Total annual
respondents respondents respondent (in hours) burden hour
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Individual Interview Parent parents.......... 9 1 5/60 1
Permission Form.
One-to-One Evaluation Study parents.......... 5 1 5/60 0.42
Parent Permission Form.
Pre-Post Feedback Study parents.......... 34 1 5/60 3
Parent Permission.
Individual Interview Child youth............ 9 1 5/60 1
Assent Form.
One-to-One Evaluation Study youth............ 5 1 5/60 0.42
Child Assent Form.
Pre-Post Feedback Study Child youth............ 34 1 5/60 3
Assent Form.
Individual Interview youth............ 3 1 2 6
Questions (Feature Stories).
Individual Interview youth............ 3 1 2 6
Questions (Family
Spotlights).
Individual Interview youth............ 3 1 2 6
Questions (Comic Book).
One-to-One Evaluation Study youth............ 5 1 2 10
Questionnaire.
Pre-Post Feedback Study youth............ 34 1 4 136
Questionnaire.
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[[Page 50858]]
Dated: July 30, 2015.
Valery Gheen,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2015-20708 Filed 8-20-15; 8:45 am]
BILLING CODE 4140-01-P