80_FR_13061 80 FR 13013 - Proposed Collection; 60-Day Comment Request Web-Based Resource for Youth About Clinical Research (NHLBI) [email protected] Formal requests for additional plans and instruments must be requested in writing."> [email protected] Formal requests for additional plans and instruments must be requested in writing." /> [email protected] Formal requests for additional plans and instruments must be requested in writing." />

80 FR 13013 - Proposed Collection; 60-Day Comment Request Web-Based Resource for Youth About Clinical Research (NHLBI)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 48 (March 12, 2015)

Page Range13013-13014
FR Document2015-05592

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 Heart, Lung and Blood Institute (NHLBI), 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. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: 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.

Federal Register, Volume 80 Issue 48 (Thursday, March 12, 2015)
[Federal Register Volume 80, Number 48 (Thursday, March 12, 2015)]
[Notices]
[Pages 13013-13014]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-05592]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request Web-Based Resource 
for Youth About Clinical Research (NHLBI)

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 Heart, Lung and 
Blood Institute (NHLBI), 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.
    Written comments and/or suggestions from the public and affected 
agencies are invited on one or more of the following points: (1) 
Whether the proposed collection of information is necessary for the 
proper performance of the function of the agency, including whether the 
information will have practical utility; (2) The accuracy of the 
agency's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) Ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) Ways to minimize the burden of the 
collection of information on those who are to respond, including the 
use of appropriate automated, electronic, mechanical, or other 
technological collection techniques or other forms of information 
technology.
    To Submit Comments and For Further Information: 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 pembertonv@nhlbi.nih.gov. 
Formal requests for additional plans and instruments must be requested 
in writing.

DATES: Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.
    Proposed Collection: Web-based Resource for Youth about Clinical 
Research (NHLBI), 0925-New, National Heart, Lung, and Blood Institute 
(NHLBI), 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 164.

                                            Estimates of Hour Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Type of         Number of       Number of      burden per     Total annual
           Form name               respondent       respondents    responses per   response (in     burden hour
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Individual Interview            Individual                     9               1               2              18
 Questionnaire.                  Interviews
                                 Study.
One-to-One Evaluation           One-to-One                     5               1               2              10
 Questionnaire.                  Evaluation
                                 Study.
Pre-Post Study Questionnaire..  Pre-Post                      34               1               4             136
                                 Feedback Study.
----------------------------------------------------------------------------------------------------------------


    Dated: February 23, 2015.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2015-05592 Filed 3-11-15; 8:45 am]
 BILLING CODE 4140-01-P



                                                                                 Federal Register / Vol. 80, No. 48 / Thursday, March 12, 2015 / Notices                                                   13013

                                                    Prevention and the Agency for Toxic                     on those who are to respond, including                 motivation to participate in that
                                                    Substances and Disease Registry.                        the use of appropriate automated,                      research. In addition, the knowledge
                                                                                                            electronic, mechanical, or other                       gained will be invaluable to the field of
                                                    Elaine L. Baker,                                        technological collection techniques or                 clinical research given the need for
                                                    Director, Management Analysis and Services              other forms of information technology.                 more clinical trials with youth.
                                                    Office, Centers for Disease Control and                   To Submit Comments and For Further                   Specifically, the proposed web-based
                                                    Prevention.                                             Information: To obtain a copy of the                   resource will be an interactive,
                                                    [FR Doc. 2015–05576 Filed 3–11–15; 8:45 am]             data collection plans and instruments,                 multimedia, developmentally
                                                    BILLING CODE 4163–18–P                                  submit comments in writing, or request                 appropriate resource for youth to be
                                                                                                            more information on the proposed                       educated about pediatric clinical trials.
                                                                                                            project, contact: Ms. Victoria                         The resource will be developed for
                                                    DEPARTMENT OF HEALTH AND                                Pemberton, National Heart, Lung, and
                                                    HUMAN SERVICES                                                                                                 youth aged 8 to 14 years. The theme of
                                                                                                            Blood Institute, National Institutes of                ‘‘investigative cyber-reporting’’ will be
                                                                                                            Health, 6701 Rockledge Dr., Room 8102,                 used throughout and will include youth
                                                    National Institutes of Health                           MSC 7940, Bethesda, MD 20892–7940,                     making a series of decisions about
                                                    Proposed Collection; 60-Day Comment                     or call non-toll-free number 301–435–
                                                                                                                                                                   different aspects of participating in
                                                    Request Web-Based Resource for                          0510, or Email your request, including
                                                                                                                                                                   clinical research studies. Youth will be
                                                    Youth About Clinical Research (NHLBI)                   your address to
                                                                                                                                                                   tasked with the responsibility of
                                                                                                            pembertonv@nhlbi.nih.gov. Formal
                                                                                                                                                                   learning all they can about clinical
                                                    SUMMARY:    In compliance with the                      requests for additional plans and
                                                                                                            instruments must be requested in                       research trials in order to facilitate their
                                                    requirement of Section 3506(c)(2)(A) of
                                                                                                            writing.                                               knowledge and decision-making
                                                    the Paperwork Reduction Act of 1995,
                                                                                                                                                                   processes. Language typically used in
                                                    for opportunity for public comment on                   DATES:  Comment Due Date: Comments                     journalism and design elements
                                                    proposed data collection projects, the                  regarding this information collection are              reminiscent of journalism will be
                                                    National Heart, Lung and Blood                          best assured of having their full effect if            incorporated into the content, design,
                                                    Institute (NHLBI), National Institutes of               received within 60 days of the date of                 and layout of the resource. There are
                                                    Health (NIH), will publish periodic                     this publication.                                      three main components that will
                                                    summaries of proposed projects to be                       Proposed Collection: Web-based                      comprise the web-based resource. These
                                                    submitted to the Office of Management                   Resource for Youth about Clinical                      include an interactive leaning module,
                                                    and Budget (OMB) for review and                         Research (NHLBI), 0925-New, National                   full length video testimonials, and an
                                                    approval.                                               Heart, Lung, and Blood Institute                       electronic comic book. The benefits and
                                                       Written comments and/or suggestions                  (NHLBI), National Institutes of Health                 necessities for this particular research
                                                    from the public and affected agencies                   (NIH).                                                 on pediatric clinical trials are congruent
                                                    are invited on one or more of the                          Need and Use of Information
                                                                                                                                                                   with NHLBI’s research goals and
                                                    following points: (1) Whether the                       Collection: The purpose and use of the
                                                                                                                                                                   mission statement: Attempting to assist
                                                    proposed collection of information is                   information collection for this project is
                                                                                                                                                                   in the enhancement of the health of
                                                    necessary for the proper performance of                 to develop a comprehensive web-based
                                                                                                                                                                   individuals so that they can live longer
                                                    the function of the agency, including                   resource for youth with chronic
                                                    whether the information will have                                                                              and more fulfilling lives. The current
                                                                                                            illnesses or diseases that will attempt to
                                                    practical utility; (2) The accuracy of the              increase knowledge, self-efficacy, and                 lack of knowledge surrounding pediatric
                                                    agency’s estimate of the burden of the                  positive attitudes towards participation               clinical trials can be dangerous and
                                                    proposed collection of information,                     in various clinical trials and research.               unhealthy towards the lives of youth,
                                                    including the validity of the                           As a result of the proposed web-based                  becoming a large public health need.
                                                    methodology and assumptions used; (3)                   resource, the knowledge gained from                      OMB approval is requested for 3
                                                    Ways to enhance the quality, utility, and               developing and testing this web-based                  years. There are no costs to respondents
                                                    clarity of the information to be                        resource will ultimately help equip                    other than their time. The total
                                                    collected; and (4) Ways to minimize the                 youth to make informed decisions about                 estimated annualized burden hours are
                                                    burden of the collection of information                 clinical research and increase                         164.
                                                                                                                  ESTIMATES OF HOUR BURDEN
                                                                                                                                                                                      Average
                                                                                                                                                                   Number of
                                                                                                                                                Number of                           burden per        Total annual
                                                                 Form name                                 Type of respondent                                    responses per
                                                                                                                                               respondents                           response         burden hour
                                                                                                                                                                   respondent        (in hours)

                                                    Individual Interview Questionnaire ....      Individual Interviews Study ..............                  9               1                    2             18
                                                    One-to-One Evaluation Question-              One-to-One Evaluation Study ..........                      5               1                    2             10
                                                      naire.
                                                    Pre-Post Study Questionnaire ..........      Pre-Post Feedback Study ................                  34                1                    4            136
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                      Dated: February 23, 2015.
                                                    Lynn Susulske,
                                                    NHLBI Project Clearance Liaison, National
                                                    Institutes of Health.
                                                    [FR Doc. 2015–05592 Filed 3–11–15; 8:45 am]
                                                    BILLING CODE 4140–01–P




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                                                    13014                        Federal Register / Vol. 80, No. 48 / Thursday, March 12, 2015 / Notices

                                                    DEPARTMENT OF THE INTERIOR                              U.S.C. 1300j et seq., and the                         your name and address in writing or by
                                                                                                            Department’s land-into-trust regulations              voicemail to Scott Doig. His contact
                                                    Bureau of Indian Affairs                                at 25 CFR part 151. Under the Council                 information is listed in the ADDRESSES
                                                                                                            on Environmental Quality National                     section of this notice. Individual paper
                                                    [AAK6006201 156A2100DD
                                                    AOR3B3030.999900]
                                                                                                            Environmental Policy Act (NEPA)                       copies of the DEIS will be provided only
                                                                                                            regulations (40 CFR 1506.10), the                     upon payment of applicable printing
                                                    Draft Environmental Impact Statement                    publication of the Notice of Availability             expenses by the requestor for the
                                                    for the Proposed Pokagon Band of                        by the EPA in the Federal Register                    number of copies requested.
                                                    Potawatomi Indians Fee-to-Trust                         initiates the 45-day public comment                     Public Comment Availability:
                                                    Transfer for Tribal Village and Casino,                 period.                                               Comments, including names and
                                                    City of South Bend, St. Joseph County,                     The Tribe has requested that the                   addresses of respondents, will be
                                                    Indiana                                                 Secretary of the Interior accept in trust             available for public review at the BIA
                                                                                                            status for the benefit of the Tribe certain           address shown in the ADDRESSES
                                                    AGENCY:   Bureau of Indian Affairs,                     real property consisting of 18 parcels of             section, during regular business hours,
                                                    Interior.                                               land totaling 165.81 acres, more or less,             8:00 a.m. to 4:30 p.m., Monday through
                                                    ACTION: Notice of Availability.                         that are located in within the municipal              Friday, except holidays. Before
                                                                                                            limits of the City of South Bend in St.               including your address, phone number,
                                                    SUMMARY:    This notice advises the public              Joseph County, Indiana. The purpose of                email address, or other personal
                                                    that the Bureau of Indian Affairs (BIA),                the proposed action is to improve access              identifying information in your
                                                    in cooperation with the Pokagon Band                    to essential tribal government services,              comment, you should be aware that
                                                    of Potawatomi Indians (Tribe), intends                  and provide housing, employment                       your entire comment—including your
                                                    to file a draft environmental impact                    opportunities, and economic                           personal identifying information—may
                                                    statement (DEIS) with the U.S.                          development for the tribal community                  be made publicly available at any time.
                                                    Environmental Protection Agency (EPA)                   residing in northern Indiana. The Tribe               While you can ask in your comment that
                                                    for the Tribe’s application requesting a                proposes to develop 44 housing units, a               your personal identifying information
                                                    fee-to-trust transfer of land located                   multi-purpose facility, health service                be withheld from public review, BIA
                                                    within the municipal limits of the City                 and other tribal government facilities.               cannot guarantee that this will occur.
                                                    of South Bend, Indiana, for the                         The Tribe also proposes to develop a
                                                    construction of a tribal housing,                       Class III gaming facility with a hotel,                 Authority: This notice is published in
                                                    government facilities, and a Class III                  restaurants, meeting space, and a                     accordance with section 1503.1 of the
                                                    gaming facility. This notice also                       parking garage.                                       Council of Environmental Quality regulations
                                                    announces that the DEIS is available for                   The BIA held a public scoping                      (40 CFR 1500 et seq.) and the Department of
                                                    public review and that a public hearing                 meeting on September 27, 2012.                        the Interior Regulations (43 CFR part 46)
                                                    will be held to receive comments.                       Alternatives considered in the DEIS                   implementing the procedural requirements of
                                                                                                            include: (1) Preferred alternative—South              the NEPA (42 U.S.C. 4321 et seq.), and in
                                                    DATES: The date of the public meeting
                                                                                                                                                                  accordance with the exercise of authority
                                                    will be announced at least 15 days in                   Bend tribal housing government
                                                                                                                                                                  delegated to the Assistant Secretary—Indian
                                                    advance through a notice in the South                   facilities and casino, (2) Elkhart site
                                                                                                                                                                  Affairs by part 209 of the Department
                                                    Bend Tribune and on the following Web                   with same uses as the preferred
                                                                                                                                                                  Manual.
                                                    site: www.pokagonsouthbendeis.com.                      alternative, (3) South Bend site with
                                                    Written comments on the DEIS must                       government facilities and commercial                    Dated: March 3, 2015.
                                                    arrive within 45 days after EPA                         development, and (4) no action.                       Kevin K. Washburn,
                                                    publishes its Notice of Availability in                 Environmental issues addressed in the                 Assistant Secretary—Indian Affairs.
                                                    the Federal Register.                                   DEIS include land resources, water                    [FR Doc. 2015–05573 Filed 3–11–15; 8:45 am]
                                                                                                            resources, air quality, biological
                                                    ADDRESSES: The public hearing will be                                                                         BILLING CODE 4337–2A–P
                                                                                                            resources, cultural resources,
                                                    held at the South Bend Century Center,
                                                                                                            socioeconomic conditions, resource use,
                                                    120 S. St. Joseph Street, South Bend, IN
                                                                                                            public services, noise, hazardous                     DEPARTMENT OF THE INTERIOR
                                                    46601. You may send comments to Mr.
                                                                                                            materials, visual resources,
                                                    Scott Doig, Environmental Protection
                                                                                                            environmental justice, cumulative                     Bureau of Land Management
                                                    Specialist, Midwest Regional Office,
                                                                                                            effects, indirect effects, unavoidable
                                                    Bureau of Indian Affairs, 5600 West
                                                                                                            adverse effects, and mitigation.
                                                    American Blvd. Suite 500, Bloomington,                                                                        [15X.LLAZ956000.L14400000.BJ0000.
                                                                                                               Directions for Submitting Comments:
                                                    MN 55437 or via email to Scott.Doig@                                                                          LXSSA225000.241A]
                                                                                                            Please include your name, return
                                                    bia.gov. See the SUPPLEMENTARY
                                                                                                            address and the title ‘‘DEIS Comments,                Notice of filing of plats of survey;
                                                    INFORMATION section of this notice for
                                                                                                            Pokagon Tribal project’’ on the first page            Arizona
                                                    addresses where the DEIS is available
                                                                                                            of your written comments.
                                                    for review.
                                                                                                               Locations where the DEIS is Available              AGENCY:     Bureau of Land Management,
                                                    FOR FURTHER INFORMATION CONTACT: Mr.                    for Review: The DEIS will be available                Interior.
                                                    Scott Doig, Environmental Protection                    at the South Bend Public Library, main
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    Specialist, at (612) 725–4514.                          branch-304 S. Main St., South Bend, IN                ACTION: Notice of filing of plats of
                                                    SUPPLEMENTARY INFORMATION:                              46601, and the Elkhart Public Library                 survey; Arizona.
                                                    Compliance with the National                            main branch-300 S 2nd St, Elkhart, IN
                                                    Environmental Policy Act (NEPA) and                     46516. An electronic version of the DEIS              SUMMARY:  The plats of survey of the
                                                    public review of the DEIS are part of the               can be viewed at the following Web site:              described lands were officially filed in
                                                    administrative process for the                          www.pokagonsouthbendeis.com.                          the Arizona State Office, Bureau of Land
                                                    evaluation of the Tribe’s application                      If you would like to obtain a compact              Management, Phoenix, Arizona, on
                                                    under the Pokagon Restoration Act, 25                   disc copy of the DEIS, please provide                 dates indicated.


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Document Created: 2018-02-21 09:35:46
Document Modified: 2018-02-21 09:35:46
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
DatesComment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
FR Citation80 FR 13013 

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