Submission for OMB Review; 30-Day Comment Request: Community Evaluation of the National Diabetes Education Program's Diabetes HealthSense Web Site, 2458-2459 [2014-00460]

Download as PDF 2458 Federal Register / Vol. 79, No. 9 / Tuesday, January 14, 2014 / Notices CDRH home page at https://www.fda.gov/ MedicalDevices. You may access ‘‘Guidance on the Recognition and Use of Consensus Standards,’’ and the searchable database for ‘‘FDA Recognized Consensus Standards’’ at https://www.fda.gov/ MedicalDevices/ DeviceRegulationandGuidance/ Standards. This Federal Register document on modifications in FDA’s recognition of consensus standards is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ Standards/ucm123792.htm. VII. Submission of Comments and Effective Date Interested persons may submit either electronic comments concerning this document, or recommendations for additional standards for recognition, by email to standards@cdrh.fda.gov or written comments to the contact person (see FOR FURTHER INFORMATION CONTACT). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 033. These modifications to the list of recognized standards are effective upon publication of this notice in the Federal Register. Dated: January 8, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–00477 Filed 1–13–14; 8:45 am] BILLING CODE 4160–01–P Need and Use of Information Collection: This study will be a multicomponent 3-year evaluation of Diabetes HealthSense, an online compendium of psychosocial and behavioral resources to support lifestyle changes. The required forms will support the following evaluation tasks: (1) Assessing community educators’ experience and satisfaction with NDEP resources such as the Diabetes HealthSense Web site; (2) Assess the extent to which, through participation in Diabetes HealthSense educational sessions, community educators can increase their knowledge and ability to promote and use NDEP resources; and (3) Assess the extent to which the Web site, with guided exploration, can facilitate changes in lifestyle to help prevent or manage diabetes. The data collected from this evaluation will provide NDEP with information about how community educators use NDEPcreated resources in their communities and whether the Diabetes HealthSense resource has its intended effect on participants. Such data will help inform NDEP’s future decisions about the Diabetes HealthSense Web site, including whether to make changes to Diabetes HealthSense, and whether to invest additional resources to support, promote, or expand this resource. Frequency of Response: One time study. Affected Public: Adults with diabetes or at risk of diabetes and educators. Type of Respondents: Adult intervention participants and community educators. The annual reporting burden is outlined in the table below, and the annualized cost to respondents is estimated at: $6,597.15. There are no maintenance or capital costs to respondents to report. OMB approval is requested for three years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 310. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request: Community Evaluation of the National Diabetes Education Program’s Diabetes HealthSense Web Site Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 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 August 5, 2013, pages 47326 and 47327 and allowed 60days for public comment. There was one public comment. The comment conveyed broad discontent with the government’s use of money and the department’s involvement in diabetes prevention. An acknowledgement of receipt and a statement of appreciation was sent in response to this comment. The purpose of this notice is to allow an additional 30 days for public comment. The 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. Proposed Collection: Community Evaluation of the National Diabetes Education Program’s Diabetes HealthSense Web Site. 0925–NEW, National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), National Institutes of Health (NIH). SUMMARY: ESTIMATED ANNUALIZED BURDEN HOURS Estimated number of respondents Estimated number of responses per respondent Average time per response (in hours) Estimated total annual burden hours emcdonald on DSK67QTVN1PROD with NOTICES Form name Type of respondent Participant Pretest ............................. Participant Posttest ........................... Participant Exit Satisfaction Survey .. Participant Follow-up Interview ......... Participant Pretest ............................. Participant Posttest ........................... Community Educator Pre Interview .. Community Educator Post Interview Intervention Participant Recruitment Guide. Comparison Participant Recruitment Guide. Adult intervention participants .......... Adult intervention participants .......... Adult intervention participants .......... Adult intervention participants .......... Adult comparison group participants Adult comparison group participants Community educators ...................... Community educators ...................... Community educators ...................... 200 150 200 10 250 150 5 5 5 1 1 1 1 1 1 1 1 2 20/60 20/60 10/60 1 20/60 20/60 1 1 15/60 67 50 33 10 83 50 5 5 4 Community educators ...................... 10 1 15/60 3 VerDate Mar<15>2010 16:32 Jan 13, 2014 Jkt 232001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\14JAN1.SGM 14JAN1 Federal Register / Vol. 79, No. 9 / Tuesday, January 14, 2014 / Notices Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited to address 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. 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, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Joanne Gallivan, M.S., R.D., Director, National Diabetes Education Program, NIDDK, NIH, Building 31, Room 9A06, 31 Center Drive, Bethesda, MD 20892, or call non-toll-free number (301) 494– 6110 or email your request, including your address to: Joanne_Gallivan@ nih.gov. Comments 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. Name of Committee: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel; Center for Gamma Ray Imaging (2014/05). Date: March 14, 2014. Time: 10:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Virtual Meeting). Contact Person: John K. Hayes, Ph.D., Scientific Review Officer, National Institute of Biomedical Imaging and Bioengineering, 6707 Democracy Boulevard, Suite 959, Bethesda, MD 20892, 301–451–3398, hayesj@ mail.nih.gov. Dated: January 8, 2014. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–00471 Filed 1–13–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings National Institute of Biomedical Imaging and Bioengineering; 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 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/ contract proposals 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. Pursuant to section 10(d) of the Federal Advisory Committee Act, as Name of Committee: National Cancer Institute Special Emphasis Panel; SPORE in Dated: December 17, 2013. Ruby N. Akomeah, Project Clearance Liaison, NIDDK, National Institutes of Health. [FR Doc. 2014–00460 Filed 1–13–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES emcdonald on DSK67QTVN1PROD with NOTICES 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. National Institutes of Health VerDate Mar<15>2010 16:32 Jan 13, 2014 Jkt 232001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 2459 Breast, Cervical, Lung, Mesothelioma and Ovarian Cancers. Date: February 6–7, 2014. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, Montgomery County Conference Center Facility, 5701 Marinelli Road, North Bethesda, MD 20852. Contact Person: Caterina Bianco, MD, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W610, Bethesda, MD 20892, 240– 276–6459, biancoc@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Advanced Development & Validation of Emerging Molecular Analysis for Technical Research. Date: February 12, 2014. Time: 10:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 6W030, Rockville, MD 20892, (Telephone Conference Call). Contact Person: Jeffrey E. DeClue, Ph.D., Scientific Review Officer, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W238, Bethesda, MD 20892, 240–276–6371, decluej@mail.nih.gov. Name of Committee: National Cancer Institute Initial Review Group; Subcommittee J—Career Development. Date: February 26, 2014. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W640, Rockville, MD 20850, (Telephone Conference Call). Contact Person: Ilda F.S. Melo, Ph.D., Scientific Review Officer, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W122, Bethesda, MD 20892, 240– 276–6468, ilda.melo@nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Software for Measuring Environmental Effects on Cancer. Date: April 1, 2014. Time: 8:30 a.m. to 6:00 p.m. Agenda: To review and evaluate contract proposals. Place: Embassy Suites Alexandria, 1900 Diagonal Road, Alexandria, VA 22314. Contact Person: Marvin L. Salin, Ph.D., Scientific Review Officer, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W236, Bethesda, MD 20892, 240–276–6369, msalin@mail.nih.gov. Information is also available on the Institute’s/Center’s home page: https:// deainfo.nci.nih.gov/advisory/sep/sep.htm, where an agenda and any additional E:\FR\FM\14JAN1.SGM 14JAN1

Agencies

[Federal Register Volume 79, Number 9 (Tuesday, January 14, 2014)]
[Notices]
[Pages 2458-2459]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00460]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Submission for OMB Review; 30-Day Comment Request: Community
Evaluation of the National Diabetes Education Program's Diabetes
HealthSense Web Site

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK), 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 August 5, 2013, pages 47326 and 47327 and allowed
60-days for public comment. There was one public comment. The comment
conveyed broad discontent with the government's use of money and the
department's involvement in diabetes prevention. An acknowledgement of
receipt and a statement of appreciation was sent in response to this
comment. The purpose of this notice is to allow an additional 30 days
for public comment. The 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.
Proposed Collection: Community Evaluation of the National Diabetes
Education Program's Diabetes HealthSense Web Site. 0925-NEW, National
Institute of Diabetes and Digestive and Kidney Disease (NIDDK),
National Institutes of Health (NIH).
Need and Use of Information Collection: This study will be a multi-
component 3-year evaluation of Diabetes HealthSense, an online
compendium of psychosocial and behavioral resources to support
lifestyle changes. The required forms will support the following
evaluation tasks: (1) Assessing community educators' experience and
satisfaction with NDEP resources such as the Diabetes HealthSense Web
site; (2) Assess the extent to which, through participation in Diabetes
HealthSense educational sessions, community educators can increase
their knowledge and ability to promote and use NDEP resources; and (3)
Assess the extent to which the Web site, with guided exploration, can
facilitate changes in lifestyle to help prevent or manage diabetes. The
data collected from this evaluation will provide NDEP with information
about how community educators use NDEP-created resources in their
communities and whether the Diabetes HealthSense resource has its
intended effect on participants. Such data will help inform NDEP's
future decisions about the Diabetes HealthSense Web site, including
whether to make changes to Diabetes HealthSense, and whether to invest
additional resources to support, promote, or expand this resource.
Frequency of Response: One time study. Affected Public: Adults with
diabetes or at risk of diabetes and educators. Type of Respondents:
Adult intervention participants and community educators. The annual
reporting burden is outlined in the table below, and the annualized
cost to respondents is estimated at: $6,597.15. There are no
maintenance or capital costs to respondents to report.
OMB approval is requested for three years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 310.

Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Estimated
Type of Estimated number of Average time Estimated
Form name respondent number of responses per per response total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Participant Pretest........... Adult 200 1 20/60 67
intervention
participants.
Participant Posttest.......... Adult 150 1 20/60 50
intervention
participants.
Participant Exit Satisfaction Adult 200 1 10/60 33
Survey. intervention
participants.
Participant Follow-up Adult 10 1 1 10
Interview. intervention
participants.
Participant Pretest........... Adult comparison 250 1 20/60 83
group
participants.
Participant Posttest.......... Adult comparison 150 1 20/60 50
group
participants.
Community Educator Pre Community 5 1 1 5
Interview. educators.
Community Educator Post Community 5 1 1 5
Interview. educators.
Intervention Participant Community 5 2 15/60 4
Recruitment Guide. educators.
Comparison Participant Community 10 1 15/60 3
Recruitment Guide. educators.
----------------------------------------------------------------------------------------------------------------

[[Page 2459]]

Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited to address 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.
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, New Executive Office Building, Room 10235, Washington, DC
20503, Attention: Desk Officer for NIH. To request more information on
the proposed project or to obtain a copy of the data collection plans
and instruments, contact: Joanne Gallivan, M.S., R.D., Director,
National Diabetes Education Program, NIDDK, NIH, Building 31, Room
9A06, 31 Center Drive, Bethesda, MD 20892, or call non-toll-free number
(301) 494-6110 or email your request, including your address to:
Joanne_Gallivan@nih.gov.
Comments 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.

Dated: December 17, 2013.
Ruby N. Akomeah,
Project Clearance Liaison, NIDDK, National Institutes of Health.
[FR Doc. 2014-00460 Filed 1-13-14; 8:45 am]
BILLING CODE 4140-01-P

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