Agency Information Collection Request. 30-Day Public Comment Request, 60752-60753 [2017-27559]
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60752
Federal Register / Vol. 82, No. 245 / Friday, December 22, 2017 / Notices
21 CFR part 211 have been approved
under OMB control number 0910–0139;
the collections of information in 21 CFR
601.12 have been approved under OMB
control numbers 0910–0338, and the
collections of information in 21 CFR
part 820 have been approved under
OMB control number 0910–0073.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: December 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27589 Filed 12–21–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–new]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before January 22, 2018.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
SUMMARY:
show that one-on-one mentoring
through healthy eating, physical
activity, and sport participation can
support the development of social skills,
improve positive self-esteem, and
increase self-confidence among children
and adults with a disability. I Can Do It,
You Can Do It! partners with K–12
schools and school districts, colleges
and universities, and other communitybased entities to provide access and
opportunities for children and adults
with a wide range of physical and
cognitive disabilities to lead healthy,
active lives. PCFSN plans to conduct a
rigorous evaluation of I Can Do It, You
Can Do It! The evaluation will assess the
impact of the program on mentee level
outcomes (impact evaluation) as well as
barriers and facilitators to program
implementation (process evaluation).
Evaluation activities will take place in
10 sites between summer 2018 and fall
2019. The I Can Do It, You Can Do It!
sites recruited to participate in the
evaluation will be identified from a list
of schools and community organizations
that have signed up to be program sites.
The aims of the process evaluation are
to determine what parts of the program
were successful, the usefulness of
program materials, and what changes
are necessary to improve the
administration of the program. The aims
of the impact evaluation are to examine
how ICDI impacts Mentee physical
activity and healthy eating behaviors.
The information collected for the I Can
Do It, You Can Do It! Program
Evaluation will allow the OPCFSN and
partners to assess the impact of the
program and gather critical information
for improvement. OMB approval is
requested for three years. Participation
in I Can Do It, You Can Do It! is
voluntary and there are no costs to
respondents other than their time.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990–New–30D and project title for
reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (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.
Title of the Collection: I Can Do It,
You Can Do It! Program Evaluation.
Type of Collection: New.
OMB No. 0990—NEW—Office within
OS—President’s Council on Fitness,
Sports & Nutrition (PCFSN), Office of
the Assistant Secretary for Health.
Abstract: Approximately 56 million
children and adults living in the United
States have some level of disability.
Despite physical activity and good
nutrition being the cornerstones of
evidence-based health promotion
interventions for reducing the risk of
comorbidities (e.g., diabetes, heart
disease, and stroke), many people with
a disability or caregivers who have a
child with a disability experience
substantial difficulty accessing these
programs. Benefits of physical activity
and good nutrition have been well
documented for individuals with and
without a disability, including: reducing
the risk of developing chronic diseases
and medical conditions. Studies also
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Number of
responses per
respondents
Average
burden per
response
Total burden
hours
sradovich on DSK3GMQ082PROD with NOTICES
Forms
Respondents
Site Application .................................
Partner Application ............................
Site Annual Follow-Up Survey ..........
End of Wave 1 Interview ..................
End of Wave 1 Feedback Survey .....
End of Wave 2 Interview ..................
End of Wave 2 Feedback Survey .....
Technical Assistance Assessment ...
Mentee Pre-Assessment ...................
Mentee Post-Assessment .................
Mentor Feedback Survey ..................
Weekly Goal-Setting Guide ..............
Site Coordinator ...............................
National Partner Organizations ........
Site Coordinator ...............................
Site Coordinator ...............................
Site Coordinator ...............................
Site Coordinator ...............................
Site Coordinator ...............................
Site Coordinator ...............................
Mentee/Program Participant ............
Mentee/Program Participant ............
Mentor ..............................................
Mentor ..............................................
10
50
10
10
10
10
10
10
700
700
700
700
1
1
1
1
1
1
1
1
1
1
1
8
7/60
15/60
5/60
30/60
11/60
30/60
6/60
10/60
20/60
25/60
8/60
10/60
1
12
1
5
2
5
1
2
233
292
94
936
Total ...........................................
...........................................................
........................
19
........................
1,584
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Federal Register / Vol. 82, No. 245 / Friday, December 22, 2017 / Notices
Dated: December 12, 2017.
Darius Taylor,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2017–27559 Filed 12–21–17; 8:45 am]
BILLING CODE 4150–35–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Establishment of the Health
Information Technology Advisory
Committee
Office of the National
Coordinator for Health Information
Technology (ONC), HHS.
ACTION: Notice of establishment meeting
dates of the Health Information
Technology Advisory Committee.
AGENCY:
The Health Information
Technology Advisory Committee
(HITAC) is established in accordance
with section 4003(e) of the 21st Century
Cures Act and the Federal Advisory
Committee Act. The Health information
Technology Advisory Committee,
among other things, shall identify
priorities for standards adoption and
make recommendations to the National
Coordinator of Health Information
Technology (National Coordinator) on a
policy framework to advance an
interoperable health information
technology infrastructure. The HITAC
will hold public meetings throughout
2018 with its first public meeting
scheduled for January 18, 2018, from
approximately 9:30 a.m. to 2:30 p.m./
Eastern Time at the Omni Shoreham
Hotel, 2500 Calvert Street NW,
Washington, DC 20008.
FOR FURTHER INFORMATION CONTACT:
Lauren Richie, Designated Federal
Officer, at Lauren.Richie@hhs.gov.
SUPPLEMENTARY INFORMATION: Section
4003(e) of the 21st Century Cures Act
(Pub. L. 114–255) establishes the Health
Information Technology Advisory
Committee (referred to as the ‘‘HITAC’’).
The HITAC will be governed by the
provisions of the Federal Advisory
Committee Act (FACA) (Pub. L. 92–
463), as amended (5 U.S.C. App .),
which sets forth standards for the
formation and use of federal advisory
committees.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
Composition
The HITAC is comprised of at least 25
members, of which:
• No fewer than 2 members are
advocates for patients or consumers of
health information technology;
• 3 members are appointed by the
HHS Secretary
VerDate Sep<11>2014
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60753
• March 21, 2018 from approximately
9:30 a.m. to 2:30 p.m./Eastern Time
(virtual meeting)
• April 18, 2018 from approximately
9:30 a.m. to 2:30 p.m./Eastern Time at
the Omni Shoreham Hotel, 2500
Calvert Street NW, Washington, DC
20008
• May 16, 2018 from approximately
9:30 a .m. to 2:30 p.m./Eastern Time
(virtual meeting)
• June 20, 2018 from approximately
9:30 a.m. to 2:30 p.m./Eastern Time
(virtual meeting)
• September 5, 2018 from
approximately 9:30 a.m. to 2:30 p.m./
Eastern Time at the Omni Shoreham
Hotel, 2500 Calvert Street NW,
Washington, DC 20008
• October 17, 2018 from approximately
9:30 a.m. to 2:30 p.m./Eastern Time
(virtual meeting)
• November 14, 2018 from
approximately 9:30 a.m. to 2:30 p.m./
Eastern Time (virtual meeting)
All meetings are open to the public.
For web conference instructions and the
most up-to-date information, please visit
the HITAC calendar on the ONC
Recommendations
website, https://www.healthit.gov/
The HITAC shall recommend to the
FACAS/calendar.
National Coordinator a policy
Contact Person for Meetings: Lauren
framework for adoption by the Secretary Richie, lauren.richie@hhs.gov. A notice
consistent with the strategic plan under in the Federal Register about last
section 3001(c)(3) for advancing
minute modifications that impact a
following target areas: (1) Achieving a
previously announced advisory
health information technology
committee meeting cannot always be
infrastructure that allows for the
published quickly enough to provide
electronic access, exchange, and use of
timely notice. Please email Lauren
health information; (2) the promotion
Richie for the most current information
and protection of privacy and security
about meetings.
of health information in health
Agenda: The committee will take care
information technology; (3) the
of administrative matters and hear
facilitation of secure access by an
reports from ONC. ONC intends to make
individual to such individual’s
background material available to the
protected health information; and (4)
public no later than 24 hours prior to
any other target area that the HITAC
the meeting start time. If ONC is unable
identifies as an appropriate target area
to post the background material on its
to be considered. Such policy
website prior to the meeting, it will be
framework shall seek to prioritize
made publicly available at the location
achieving advancements in these target
of the advisory committee meeting, and
areas and may incorporate policy
the background material will be posted
recommendations made by the HIT
on ONC’s website after the meeting, at
Policy Committee, as in existence before https://www.healthit.gov/hitac.
Procedure: Interested persons may
the date of the enactment of the 21st
present data, information, or views,
Century Cures Act.
orally or in writing, on issues pending
Public Meetings
before the Committee. Written
The first public meeting of the HITAC submissions may be made to the contact
will be held on January 18, 2018, from
person prior to the meeting date. An
approximately 9:30 a.m. to 2:30 p.m./
oral public comment period will be
Eastern Time at the Omni Shoreham
scheduled at each meeting. Time
Hotel, 2500 Calvert Street NW,
allotted for each presentation will be
Washington, DC 20008. Subsequently,
limited to three minutes. If the number
the remainder of the meetings to be held of speakers requesting to comment is
in 2018 is scheduled as follows:
greater than can be reasonably
• February 21, 2018 from approximately accommodated during the scheduled
public comment period, ONC will take
9:30 a.m.. to 2:30 p.m./Eastern Time
written comments after the meeting.
(virtual meeting)
Æ 1 of whom shall be appointed to
represent the Department of Health and
Human Services and
Æ 1 of whom shall be a public health
official;
• 2 members are appointed by the
majority leader of the Senate;
• 2 members are appointed by the
minority leader of the Senate;
• 2 members are appointed by the
Speaker of the House of Representatives;
• 2 members are appointed by the
minority leader of the House of
Representatives; and
• Other members are appointed by
the Comptroller General of the United
States.
Introductory members will serve for
one-, two-, or three-year terms. All
members may be reappointed for
subsequent three-year terms. Each
member is limited to two three-year
terms, not to exceed six years of service.
After establishment, members shall be
appointed for a three year term.
Members serve without pay, but will be
provided per-diem and travel costs for
committee services.
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]]>Agencies
[Federal Register Volume 82, Number 245 (Friday, December 22, 2017)]
[Notices]
[Pages 60752-60753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27559]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-new]
Agency Information Collection Request. 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before January 22,
2018.
ADDRESSES: Submit your comments to [email protected] or via
facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 795-7714. When submitting comments or requesting information,
please include the document identifier 0990-New-30D and project title
for reference.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (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.
Title of the Collection: I Can Do It, You Can Do It! Program
Evaluation.
Type of Collection: New.
OMB No. 0990--NEW--Office within OS--President's Council on
Fitness, Sports & Nutrition (PCFSN), Office of the Assistant Secretary
for Health.
Abstract: Approximately 56 million children and adults living in
the United States have some level of disability. Despite physical
activity and good nutrition being the cornerstones of evidence-based
health promotion interventions for reducing the risk of comorbidities
(e.g., diabetes, heart disease, and stroke), many people with a
disability or caregivers who have a child with a disability experience
substantial difficulty accessing these programs. Benefits of physical
activity and good nutrition have been well documented for individuals
with and without a disability, including: reducing the risk of
developing chronic diseases and medical conditions. Studies also show
that one-on-one mentoring through healthy eating, physical activity,
and sport participation can support the development of social skills,
improve positive self-esteem, and increase self-confidence among
children and adults with a disability. I Can Do It, You Can Do It!
partners with K-12 schools and school districts, colleges and
universities, and other community-based entities to provide access and
opportunities for children and adults with a wide range of physical and
cognitive disabilities to lead healthy, active lives. PCFSN plans to
conduct a rigorous evaluation of I Can Do It, You Can Do It! The
evaluation will assess the impact of the program on mentee level
outcomes (impact evaluation) as well as barriers and facilitators to
program implementation (process evaluation). Evaluation activities will
take place in 10 sites between summer 2018 and fall 2019. The I Can Do
It, You Can Do It! sites recruited to participate in the evaluation
will be identified from a list of schools and community organizations
that have signed up to be program sites. The aims of the process
evaluation are to determine what parts of the program were successful,
the usefulness of program materials, and what changes are necessary to
improve the administration of the program. The aims of the impact
evaluation are to examine how ICDI impacts Mentee physical activity and
healthy eating behaviors. The information collected for the I Can Do
It, You Can Do It! Program Evaluation will allow the OPCFSN and
partners to assess the impact of the program and gather critical
information for improvement. OMB approval is requested for three years.
Participation in I Can Do It, You Can Do It! is voluntary and there are
no costs to respondents other than their time.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of
Forms Respondents Number of responses per Average burden Total burden
respondents respondents per response hours
----------------------------------------------------------------------------------------------------------------
Site Application.............. Site Coordinator 10 1 7/60 1
Partner Application........... National Partner 50 1 15/60 12
Organizations.
Site Annual Follow-Up Survey.. Site Coordinator 10 1 5/60 1
End of Wave 1 Interview....... Site Coordinator 10 1 30/60 5
End of Wave 1 Feedback Survey. Site Coordinator 10 1 11/60 2
End of Wave 2 Interview....... Site Coordinator 10 1 30/60 5
End of Wave 2 Feedback Survey. Site Coordinator 10 1 6/60 1
Technical Assistance Site Coordinator 10 1 10/60 2
Assessment.
Mentee Pre-Assessment......... Mentee/Program 700 1 20/60 233
Participant.
Mentee Post-Assessment........ Mentee/Program 700 1 25/60 292
Participant.
Mentor Feedback Survey........ Mentor.......... 700 1 8/60 94
Weekly Goal-Setting Guide..... Mentor.......... 700 8 10/60 936
---------------------------------------------------------------------------------
Total..................... ................ .............. 19 .............. 1,584
----------------------------------------------------------------------------------------------------------------
[[Page 60753]]
Dated: December 12, 2017.
Darius Taylor,
Office of the Secretary, Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. 2017-27559 Filed 12-21-17; 8:45 am]
BILLING CODE 4150-35-P
