80_FR_51019 80 FR 50857 - Submission for OMB Review; 30-Day Comment Request; Web-Based Resource for Youth About Clinical Research [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."> [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." /> [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." />

80 FR 50857 - Submission for OMB Review; 30-Day Comment Request; Web-Based Resource for Youth About Clinical Research

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 162 (August 21, 2015)

Page Range50857-50858
FR Document2015-20708

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.

Federal Register, Volume 80 Issue 162 (Friday, August 21, 2015) 
[Federal Register Volume 80, Number 162 (Friday, August 21, 2015)]
[Notices]
[Pages 50857-50858]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 80, No. 162 / Friday, August 21, 2015 / Notices 50857 Dated: August 17, 2015. of Management and Budget, Office of research. In addition, the knowledge Melanie J. Gray, Regulatory Affairs, OIRA_submission@ gained will be invaluable to the field of Program Analyst, Office of Federal Advisory omb.eop.gov or by fax to 202–395–6974, clinical research given the need for Committee Policy. Attention: NIH Desk Officer. more clinical trials with youth. [FR Doc. 2015–20643 Filed 8–20–15; 8:45 am] Comment Due Date: Comments Specifically, the proposed web-based BILLING CODE 4140–01–P regarding this information collection are resource will be an interactive, best assured of having their full effect if multimedia, developmentally received within 30-days of the date of appropriate resource for youth to be DEPARTMENT OF HEALTH AND this publication. educated about pediatric clinical trials. HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: To The resource will be developed for obtain a copy of the data collection youth aged 8 to 14 years. The theme of National Institutes of Health plans and instruments, submit ‘‘investigative cyber-reporting’’ will be comments in writing, or request more used throughout and will include youth Submission for OMB Review; 30-Day information on the proposed project, making a series of decisions about Comment Request; Web-Based contact: Ms. Victoria Pemberton, different aspects of participating in Resource for Youth About Clinical National Heart, Lung, and Blood clinical research studies. Youth will be Research Institute, National Institutes of Health, tasked with the responsibility of 6701 Rockledge Dr., Room 8102, MSC learning all they can about clinical SUMMARY: Under the provisions of 7940, Bethesda, MD 20892–7940, or call research trials in order to facilitate their Section 3507(a)(1)(D) of the Paperwork non-toll-free number 301–435–0510, or knowledge and decision-making Reduction Act of 1995, the National Email your request, including your processes. Language typically used in Institutes of Health (NIH) has submitted address to pembertonv@nhlbi.nih.gov. journalism and design elements to the Office of Management and Budget Formal requests for additional plans and reminiscent of journalism will be (OMB) a request for review and instruments must be requested in incorporated into the content, design, approval of the information collection writing. and layout of the resource. There are listed below. This proposed information Proposed Collection: Web-based collection was previously published in three main components that will Resource for Youth about Clinical comprise the web-based resource. These the Federal Register on 3/12/2015 pages Research (NHLBI), 0925–New, National 13013–13014, and allowed 60-days for include an interactive leaning module, Heart, Lung, and Blood Institute full length video testimonials, and an public comment. One public comment (NHLBI), the National Institutes of was received. The purpose of this notice electronic comic book. The benefits and Health (NIH). is to allow an additional 30 days for necessities for this particular research Need and Use of Information public comment. The National Heart, on pediatric clinical trials are congruent Collection: The purpose and use of the Lung and Blood Institute (NHLBI), information collection for this project is with NHLBI’s research goals and National Institutes of Health, may not to develop a comprehensive web-based mission statement: Attempting to assist conduct or sponsor, and the respondent resource for youth with chronic in the enhancement of the health of is not required to respond to, an illnesses or diseases that will attempt to individuals so that they can live longer information collection that has been increase knowledge, self-efficacy, and and more fulfilling lives. The current extended, revised, or implemented on or positive attitudes towards participation lack of knowledge surrounding pediatric after October 1, 1995, unless it displays in various clinical trials and research. clinical trials can be dangerous and a currently valid OMB control number. As a result of the proposed web-based unhealthy towards the lives of youth, Direct Comments to OMB: Written resource, the knowledge gained from becoming a large public health need. comments and/or suggestions regarding developing and testing this web-based OMB approval is requested for 3 the item(s) contained in this notice, resource will ultimately help equip years. There are no costs to respondents especially regarding the estimated youth to make informed decisions about other than their time. The total public burden and associated response clinical research and increase estimated annualized burden hours are time, should be directed to the: Office motivation to participate in that 172. ESTIMATES OF HOUR BURDEN Average Number of Type of Number of burden per Total annual Form name responses per respondents respondents response burden hour respondent (in hours) Individual Interview Parent Permission Form ........................ parents ........ 9 1 5/60 1 One-to-One Evaluation Study Parent Permission Form ........ parents ........ 5 1 5/60 0.42 Pre-Post Feedback Study Parent Permission ....................... parents ........ 34 1 5/60 3 Individual Interview Child Assent Form .................................. youth ........... 9 1 5/60 1 One-to-One Evaluation Study Child Assent Form ................. youth ........... 5 1 5/60 0.42 Pre-Post Feedback Study Child Assent Form ....................... youth ........... 34 1 5/60 3 Individual Interview Questions (Feature Stories) ................... youth ........... 3 1 2 6 Individual Interview Questions (Family Spotlights) ................ youth ........... 3 1 2 6 Individual Interview Questions (Comic Book) ........................ youth ........... 3 1 2 6 rmajette on DSK7SPTVN1PROD with NOTICES One-to-One Evaluation Study Questionnaire ......................... youth ........... 5 1 2 10 Pre-Post Feedback Study Questionnaire ............................... youth ........... 34 1 4 136 VerDate Sep<11>2014 15:07 Aug 20, 2015 Jkt 235001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\21AUN1.SGM 21AUN1

50858 Federal Register / Vol. 80, No. 162 / Friday, August 21, 2015 / Notices Dated: July 30, 2015. 93.393, Cancer Cause and Prevention significant role in neurotoxicity and Valery Gheen, Research; 93.394, Cancer Detection and human diseases, such as Parkinson’s Diagnosis Research; 93.395, Cancer disease, drug abuse (especially cocaine NHLBI Project Clearance Liaison, National Treatment Research; 93.396, Cancer Biology Institutes of Health. Research; 93.397, Cancer Centers Support; addiction), Attention Deficit Disorder/ [FR Doc. 2015–20708 Filed 8–20–15; 8:45 am] 93.398, Cancer Research Manpower; 93.399, Attention Deficit Hyperactivity Disorder BILLING CODE 4140–01–P Cancer Control, National Institutes of Health, (ADD/ADHD), and a number of other HHS) CNS disorders. Therefore, the dopamine Dated: August 17, 2015. transporter is a strong target for research DEPARTMENT OF HEALTH AND Melanie J. Gray, and the discovery of potential HUMAN SERVICES therapeutics for the treatment of these Program Analyst, Office of Federal Advisory Committee Policy. indications. National Institutes of Health This invention discloses novel [FR Doc. 2015–20644 Filed 8–20–15; 8:45 am] benztropine analogs and methods of National Cancer Institute; Notice of BILLING CODE 4140–01–P using these analogs for treatment of Closed Meeting mental and conduct disorders such as Pursuant to section 10(d) of the cocaine abuse, narcolepsy, ADHD, DEPARTMENT OF HEALTH AND Federal Advisory Committee Act, as HUMAN SERVICES obesity and nicotine abuse. The amended (5 U.S.C. Appendix 2); notice disclosed analogs are highly selective is hereby given of the following National Institutes of Health and potent inhibitors of DAT, but meeting. without an apparent cocaine-like The meeting will be closed to the Government-Owned Inventions; behavioral profile. In addition to their public in accordance with the Availability for Licensing use as a treatment for cocaine abuse, provisions set forth in sections these compounds have also shown AGENCY: National Institutes of Health, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., efficacy in animal models of ADHD and HHS. as amended. The purpose of this nicotine abuse, and have also been ACTION: Notice. shown to reduce food intake in animals. meeting is to evaluate requests for preclinical development resources for SUMMARY: The inventions listed below They may also be useful medications for potential new therapeutics for the are owned by an agency of the U.S. other indications where dopamine- treatment of cancer. The outcome of the Government and are available for related behavior is compromised, such evaluation will provide information to licensing in the U.S. in accordance with as alcohol addiction, tobacco addiction, internal NCI committees that will 35 U.S.C. 209 and 37 CFR part 404 to and Parkinson’s disease. decide whether NCI should support achieve expeditious commercialization Potential Commercial Applications: requests and make available contract of results of federally-funded research • Drug leads for treatment of cocaine resources for development of the and development. Foreign patent abuse, ADHD, nicotine abuse, obesity, potential therapeutic to improve the applications are filed on selected and other dopamine-related disorders treatment of various forms of cancer. inventions to extend market coverage • Imaging probes for dopamine The research proposals and the for companies and may also be available transporter binding sites discussions could disclose confidential Development Stage: Early-stage; In for licensing. trade secrets or commercial property vitro data available FOR FURTHER INFORMATION CONTACT: Inventors: Amy H. Newman, Mu-fa such as patentable material, and Licensing information and copies of the personal information concerning Zou, Jonathan L. Katz (all of NIDA) U.S. patent applications listed below Intellectual Property: HHS Reference individuals associated with the may be obtained by writing to the No. E–234–2005/1—US Patent No. proposed research projects, the indicated licensing contact at the Office 8,383,817 issued February 26, 2013 disclosure of which would constitute a of Technology Transfer, National Licensing Contact: Betty B. Tong, clearly unwarranted invasion of Institutes of Health, 6011 Executive Ph.D.; 301–594–6565; tongb@ personal privacy. Boulevard, Suite 325, Rockville, mail.nih.gov Name of Committee: National Cancer Maryland 20852–3804; telephone: 301– Collaborative Research Opportunity: Institute Special Emphasis Panel; Jun2015 496–7057; fax: 301–402–0220. A signed The National Institute on Drug Abuse, Cycle 20 NExT SEP Committee Meeting. Confidential Disclosure Agreement will Medicinal Chemistry and Psychobiology Date: September 22, 2015. be required to receive copies of the Sections, is seeking statements of Time: 8:30 a.m. to 4:30 p.m. patent applications. Agenda: To evaluate the NCI Experimental capability or interest from parties Therapeutics Program Portfolio. SUPPLEMENTARY INFORMATION: interested in collaborative research to Place: National Institutes of Health, 9000 Technology descriptions follow. further develop, evaluate, or Rockville Pike, Campus Building 31, commercialize medications to treat Novel Benztropine Analogs for Conference Room 6C6, Bethesda, MD 20892. cocaine abuse and addiction. For Treatment of Cocaine Abuse and Other Contact Person: Barbara Mroczkowski, collaboration opportunities please Ph.D., Executive Secretary, Discovery Mental Disorders contact John D. Hewes, Ph.D. at Experimental Therapeutics Program, Description of Technology: Dopamine john.hewes@nih.gov. National Cancer Institute, NIH, 31 Center is a neurotransmitter that exerts Drive, Room 3A44, Bethesda, MD 20817, important effects on locomotor activity, Novel Dopamine Receptor Ligands as (301) 496–4291, mroczkoskib@mail.nih.gov. motivation and reward, and cognition. Therapeutics for Central Nervous rmajette on DSK7SPTVN1PROD with NOTICES Toby Hecht, Ph.D., Executive Secretary, The dopamine transporter (DAT) is System Disorders Development Experimental Therapeutics expressed on the plasma membrane of Description of Technology: The Program, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 3W110, dopamine synthesizing neurons, and is dopamine D3 receptor subtype is a Rockville, MD 20850, (240) 276–5683, responsible for clearing dopamine member of the dopamine D2 subclass of toby.hecht2@nih.gov. released into the extra-cellular space, receptors. These receptors have been (Catalogue of Federal Domestic Assistance thereby regulating neurotransmission. implicated in a number of CNS Program Nos. 93.392, Cancer Construction; The dopamine transporter plays a disorders, including psychostimulant VerDate Sep<11>2014 15:07 Aug 20, 2015 Jkt 235001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\21AUN1.SGM 21AUN1


Document Created: 2018-02-23 11:00:50
Document Modified: 2018-02-23 11:00:50
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesComments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
ContactTo 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
FR Citation80 FR 50857 
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