Submission for OMB Review; 30-Day Comment Request; Interactive Informed Consent for Pediatric Clinical Trials, 59943-59944 [2013-23755]

Download as PDF Federal Register / Vol. 78, No. 189 / Monday, September 30, 2013 / Notices information. The total annual burden hours estimated for this Information 59943 Collection Request are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN HOURS Form Nnme Number of respondents Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours Baseline Pre-TED (Transplant Essential Data) ................... Product Form (includes Infusion, HLA, and Infectious Disease Marker inserts) ........................................................ 100-Day Post-TED ............................................................... 6-Month Post-TED ............................................................... 12-Month Post-TED ............................................................. Annual Post-TED ................................................................. 200 38 7,600 1 7,600 200 200 200 200 200 29 38 31 27 104 5,800 7,600 6,200 5,400 20,800 1 0.85 1 1 1 5,800 6,460 6,200 5,400 20,800 Total .............................................................................. 200 ........................ 53,400 ........................ 52,260 HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Dated: September 20, 2013. Bahar Niakan, Director, Division of Policy and Information Coordination. [FR Doc. 2013–23774 Filed 9–27–13; 8:45 am] BILLING CODE 4165–15–P 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 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. tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:45 Sep 27, 2013 Jkt 229001 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, OIRA_submission@omb.eop.gov 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. 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 nontoll-free number (301) 435–0510 or Email your request, including your address to: pembertonv@nhlbi.nih.gov. Formal requests for additional plans and FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 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. E:\FR\FM\30SEN1.SGM 30SEN1 59944 Federal Register / Vol. 78, No. 189 / Monday, September 30, 2013 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondents Parents ............................................................................................................. Children ............................................................................................................ 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Closed Meetings tkelley on DSK3SPTVN1PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health Special Emphasis Panel; P30 Centers Program for Research on HIV/AIDS & Mental Health. Date: October 25, 2013. Time: 11:00 a.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: David W. Miller, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6140, MSC 9608, Bethesda, MD 20892–9608, 301–443–9734, millerda@mail.nih.gov. Name of Committee: National Institute of Mental Health Special Emphasis Panel; Dimensional Approaches to Research Classification in Psychiatric Disorders (RDoC). Date: October 29, 2013. Time: 8:00 a.m. to 5:00 p.m. VerDate Mar<15>2010 18:06 Sep 27, 2013 Jkt 229001 148 136 Agenda: To review and evaluate grant applications. Place: Washington Marriott, 1221 22nd Street NW, Washington, DC 20037. Contact Person: Rebecca C Steiner, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6149, MSC 9608, Bethesda, MD 20892–9608, 301–443–4525, steinerr@mail.nih.gov. Name of Committee: National Institute of Mental Health Special Emphasis Panel; BSNIP–2. Date: October 29, 2013. Time: 11:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: David I. Sommers, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, National Institutes of Health, 6001 Executive Blvd., Room 6154, MSC 9606, Bethesda, MD 20892–9606, 301–443–7861, dsommers@mail.nih.gov. Name of Committee: National Institute of Mental Health Special Emphasis Panel; Intervention Conflicts Panel Review. Date: October 29, 2013. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Karen Gavin-Evans, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Boulevard, Room 6153, MSC 9606, Bethesda, MD 20892, 301–451–2356, gavinevanskm@mail.nih.gov. Name of Committee: National Institute of Mental Health Special Emphasis Panel; NIH Pathway to Independence Award (K99). Date: November 1, 2013. Time: 11:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Megan Kinnane, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6148, MSC 9609, Rockville, MD 20852–9609, 301–402–6807, libbeym@mail.nih.gov. PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 Number of responses per response Average burden per response (in hour) 1 1 Total annual burden hours 43/60 37/60 106 84 (Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS) Dated: September 24, 2013. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–23638 Filed 9–27–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Programs in Superfund and Related Sites. Date: October 23–25, 2013. Time: 8:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: Sheraton Chapel Hill Hotel, One Europa Drive, Chapel Hill, NC 27517. Contact Person: Linda K Bass, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, National Institute of Environmental Health Sciences, P.O. Box 12233, MD EC–30, Research Triangle Park, NC 27709, (919) 541– 1307, bass@niehs.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and E:\FR\FM\30SEN1.SGM 30SEN1

Agencies

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

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

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, OIRA_submission@omb.eop.gov 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: pembertonv@nhlbi.nih.gov. 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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Number of responses per per response Total annual
respondents response (in hour) burden hours
----------------------------------------------------------------------------------------------------------------
Parents......................................... 148 1 43/60 106
Children........................................ 136 1 37/60 84
----------------------------------------------------------------------------------------------------------------

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

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