Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: National Health Service Corps Scholar/Students to Service Travel Worksheet, OMB No. 0915-0278-Extension, 48317-48318 [2018-20708]
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FOR FURTHER INFORMATION CONTACT:
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Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5441, Silver Spring,
MD 20993–0002, letise.williams@
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default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
SUPPLEMENTARY INFORMATION: Agenda:
On November 15, 2018, the Committee
will discuss and make
recommendations on the topic
‘‘Connected and Empowered Patients: EPlatforms Potentially Expanding the
Definition of Scientific Evidence.’’ The
recommendations will address how
FDA can leverage patient-driven
platforms, such as social media and
registries, to better engage patients and
consumers as empowered partners in
the work of protecting public health and
promoting responsible innovation.
Social media and other web platform
enablers are facilitating the growth of
virtual patient communities.
Increasingly, patients and health care
consumers are using these platforms to
share their health experiences and seek
information from other patients and
consumers, rather than their health care
providers alone. Novel approaches and
methodologies are being used to tap into
some of these platforms as potentially
rich sources of patient-generated health
data, which could be used as relevant
and reliable real-world evidence
(https://www.fda.gov/ucm/groups/
fdagov-public/@fdagov-meddev-gen/
documents/document/ucm513027.pdf).
This meeting will help advance FDA’s
objective to assure the needs,
experiences, and perspectives of
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patients are included as part of FDA’s
deliberations involving the regulation of
medical devices and their use by
patients. For this meeting, FDA is
seeking input from the Committee and
the public on whether and how FDA
can harness the emerging potential of
these patient platforms to better engage
patients and consumers as empowered
partners in the work of protecting public
health and promoting responsible
innovation. In addition, FDA is seeking
recommendations from the Committee
on ways to leverage these platforms to
disseminate as well as potentially
collect and evaluate health information
to and from patients and consumers.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee-meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the Committee. Oral
presentations from the public will be
scheduled between approximately 11:15
a.m. to 12:15 p.m. on November 15,
2018. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before October 15, 2018. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
October 17, 2018. Individuals who do
not wish to speak at the open public
hearing session but would like their
comments to be heard by the Committee
may send written submissions to the
contact person on or before October 23,
2018.
FDA welcomes the attendance of the
public at its advisory committee
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meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact AnnMarie
Williams at Annmarie.Williams@
fda.hhs.gov, or 301–796–5966 at least 7
days in advance of the meeting.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings. Please be advised
that, for the round table portion of the
meeting, FDA will prepare a summary
of the discussion in lieu of detailed
transcripts.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20640 Filed 9–21–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: National
Health Service Corps Scholar/Students
to Service Travel Worksheet, OMB No.
0915–0278—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than November 23,
2018.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
SUMMARY:
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Federal Register / Vol. 83, No. 185 / Monday, September 24, 2018 / Notices
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
National Health Service Corps Scholar/
Students to Service Travel Worksheet
OMB No. 0915–0278—Extension
Abstract: Clinicians participating in
the HRSA National Health Service
Corps (NHSC) Scholarship Program and
the Students to Service (S2S) Loan
Repayment Program use the online
Travel Request Worksheet to receive
travel funds from the Federal
Government to visit eligible NHSC sites
to which they may be assigned in
accordance with the Public Health
Service Act (PHSA), section 331(c)(1).
The travel approval process is
initiated when a NHSC scholar or S2S
participant notifies the NHSC of an
impending interview at one or more
NHSC-approved practice sites. The
Travel Request Worksheet is also used
to initiate the relocation process after a
NHSC scholar or S2S participant has
successfully been matched to an
approved practice site in accordance
with the PHSA, section 331(c)(3). Upon
receipt of the Travel Request Worksheet,
the NHSC will review and approve or
disapprove the request and promptly
notify the scholar or S2S participant,
and the NHSC logistics contractor
regarding travel arrangements and
authorization of the funding for the site
visit or relocation.
Need and Proposed Use of the
Information: This information will
facilitate NHSC scholar and S2S
clinicians’ receipt of federal travel funds
that are used to visit high-need NHSC
sites. The Travel Request Worksheet is
also used to initiate the relocation
process after a NHSC scholar or S2S
participant has successfully been
matched to an approved practice site.
Likely Respondents: Clinicians
participating in the NHSC Scholarship
Program and S2S Loan Repayment
Program.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel to be able to respond to a
collection of information; to search data
sources; to complete and review the
collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Travel Request Worksheet ..................................................
250
2
500
.0667
33.35
Total ..............................................................................
250
........................
500
........................
33.35
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–20708 Filed 9–21–18; 8:45 am]
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Number of
responses per
respondent
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Office of the Assistant
Secretary for Health, Office of the
AGENCY:
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Secretary, Department of Health and
Human Services.
ACTION: Notice.
Pursuant to Section 10(a) of
the Federal Advisory Committee Act,
U.S.C. Appendix 2, notice is hereby
given that the Secretary’s Advisory
Committee on Human Research
Protections (SACHRP) will hold a
meeting that will be open to the public.
Information about SACHRP and the full
meeting agenda will be posted on the
SACHRP website at: https://
www.dhhs.gov/ohrp/sachrp-committee/
meetings/.
DATES: The meeting will be held on
Tuesday, October 16, 2018, from 8:30
a.m. until 5 p.m., and Wednesday,
October 17, 2018, from 8:30 a.m. until
4 p.m.
ADDRESSES: 6700B Rockledge Drive,
Bethesda, MD 20817.
FOR FURTHER INFORMATION CONTACT: Julia
Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
SUMMARY:
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Maryland 20852; telephone: 240–453–
8141; fax: 240–453–6909; email address:
SACHRP@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services (HHS),
through the Assistant Secretary for
Health, on issues and topics pertaining
to or associated with the protection of
human research subjects.
The Subpart A Subcommittee (SAS)
was established by SACHRP in October
2006 and is charged with developing
recommendations for consideration by
SACHRP regarding the application of
subpart A of 45 CFR part 46 in the
current research environment.
The Subcommittee on Harmonization
(SOH) was established by SACHRP at its
July 2009 meeting and charged with
identifying and prioritizing areas in
which regulations and/or guidelines for
human subjects research adopted by
various agencies or offices within HHS
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[Federal Register Volume 83, Number 185 (Monday, September 24, 2018)]
[Notices]
[Pages 48317-48318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20708]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: National
Health Service Corps Scholar/Students to Service Travel Worksheet, OMB
No. 0915-0278--Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act of 1995, HRSA announces plans to submit an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the
public regarding the burden estimate, below, or any other aspect of the
ICR.
DATES: Comments on this ICR should be received no later than November
23, 2018.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
[[Page 48318]]
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301)
443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: National Health Service Corps
Scholar/Students to Service Travel Worksheet OMB No. 0915-0278--
Extension
Abstract: Clinicians participating in the HRSA National Health
Service Corps (NHSC) Scholarship Program and the Students to Service
(S2S) Loan Repayment Program use the online Travel Request Worksheet to
receive travel funds from the Federal Government to visit eligible NHSC
sites to which they may be assigned in accordance with the Public
Health Service Act (PHSA), section 331(c)(1).
The travel approval process is initiated when a NHSC scholar or S2S
participant notifies the NHSC of an impending interview at one or more
NHSC-approved practice sites. The Travel Request Worksheet is also used
to initiate the relocation process after a NHSC scholar or S2S
participant has successfully been matched to an approved practice site
in accordance with the PHSA, section 331(c)(3). Upon receipt of the
Travel Request Worksheet, the NHSC will review and approve or
disapprove the request and promptly notify the scholar or S2S
participant, and the NHSC logistics contractor regarding travel
arrangements and authorization of the funding for the site visit or
relocation.
Need and Proposed Use of the Information: This information will
facilitate NHSC scholar and S2S clinicians' receipt of federal travel
funds that are used to visit high-need NHSC sites. The Travel Request
Worksheet is also used to initiate the relocation process after a NHSC
scholar or S2S participant has successfully been matched to an approved
practice site.
Likely Respondents: Clinicians participating in the NHSC
Scholarship Program and S2S Loan Repayment Program.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel to be able to respond to a
collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Travel Request Worksheet........ 250 2 500 .0667 33.35
-------------------------------------------------------------------------------
Total....................... 250 .............. 500 .............. 33.35
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-20708 Filed 9-21-18; 8:45 am]
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