[Federal Register Volume 78, Number 189 (Monday, September 30, 2013)]
[Notices]
[Pages 59943-59944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23755]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; Interactive 
Informed Consent for Pediatric Clinical Trials

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 Institute Heart, 
Lung, and Blood Institute (NHBLI), the 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. The 60-day FRN was published 05/9/2013 (Vol. 78, No. 90, page 
27243). No public comments were received. The purpose of this notice is 
to allow an additional 30 days for public comment. The National 
Institute of Dental and Craniofacial Research (NIDCR), 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 or request more information on the 
proposed project contact: Victoria Pemberton, Clinical Trials 
Specialist, NHLBI, 6701 Rockledge Drive, Room 8102, MSC 7940, Bethesda, 
MD 20892 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: Interactive Informed Consent for Pediatric 
Clinical Trials, 0925-New, National Heart, Lung, and Blood Institute 
(NHLBI), National Institutes of Health (NIH).
    Need and Use of Information Collection: This study will compare 
parents' and children's understanding of information about a 
hypothetical clinical trial presented using either a standard paper 
consent document or an interactive computer-based consent program. 
Parents' and children's understanding, regardless of whether they 
received the standard consent or the interactive computer-based 
program, will be assessed by face-to-face interview. In addition, 
parents' and children's perceptions of, and satisfaction with, the 
information presented will be evaluated by completion of a short 
questionnaire. The primary hypothesis to be tested is that interactive 
computer-based research consent information is better understood and 
accepted by parents and children compared with the standard paper 
consent document. Given that many individuals have difficulty reading 
and interpreting standard written consent documents, this technology 
holds promise as a means to optimize the consent and assent process 
particularly among individuals with low literacy and numeracy skills.
    OMB approval is requested for 18 months. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 190.

[[Page 59944]]



                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
               Type of respondents                   Number of     responses per   per response    Total annual
                                                    respondents      response        (in hour)     burden hours
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Parents.........................................             148               1           43/60             106
Children........................................             136               1           37/60              84
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    Dated: September 23, 2013.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
Michael S. Lauer,
Director, DCVS, National Institutes of Health.
[FR Doc. 2013-23755 Filed 9-27-13; 8:45 am]
BILLING CODE 4140-01-P