[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]


-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
          Form name                 Type of          Number of     responses per   per response    Total annual
                                  respondents       respondents     respondent      (in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------



[[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