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Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices
documenting which adverse events are
anticipated in the population under
study and would not likely be reported
as a single occurrence, but instead
would be evaluated by assessing
whether there are differences in the rate
of occurrence of such events between
those receiving the intervention and the
concurrent or historical control.
This public workshop is being held in
response to public comments received
to Docket No. FDA–2015–D–4562 for
the draft guidance entitled ‘‘Safety
Assessment for IND Safety Reporting’’
issued in December 2015 requesting a
public meeting to discuss the draft
guidance recommendations and their
implications, including the new
recommendations regarding the
formation of a safety assessment
committee and the submission of a
portion of the safety surveillance plan to
the IND before initiating phase 2 or 3
studies. The public workshop is
intended to engage external
stakeholders in discussions related to
finalizing the draft guidance entitled
‘‘Safety Assessment for IND Safety
Reporting.’’

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II. Topics for Discussion at the Public
Workshop
During the public workshop, speakers
and participants will address a range of
issues related to the draft guidance
‘‘Safety Assessment for IND Safety
Reporting’’, issued in December 2015.
Items for discussion will include topics
raised in public comments submitted to
the draft guidance docket, including but
not limited to: The entity that conducts
aggregate analysis of safety data for IND
safety reporting, concerns with
unblinding of data and trial integrity,
methods for determining the threshold
for reporting, and developing and
documenting a plan for safety
surveillance. Furthermore, input will be
sought on other factors that drive overreporting of safety events that do not
meet the definition of a suspected
unexpected serious adverse reaction.
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
Web site: https://healthpolicy.duke.edu/
events/fda-ind-safety-reporting-meeting
and register online by January 8, 2018,
midnight Eastern Time. There will be no
onsite registration. Please provide
complete contact information for each
attendee, including name, title,
affiliation, address, email, and
telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in

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attending this public workshop must
register online by January 8, 2018,
midnight Eastern Time. Early
registration is recommended because
seating is limited; therefore, FDA may
limit the number of participants from
each organization. Registrants will
receive confirmation when they have
been accepted. Duke-Margolis will post
on its Web site if registration closes
before the day of the public workshop.
If you need special accommodations
due to a disability, please contact Sarah
Supsiri at the Duke-Margolis Center for
Health Policy, 202–791–9561,
[email protected], no later than
January 4, 2018.
Streaming Webcast of the Public
Workshop: This public workshop will
also be webcast; archived video footage
will be available at the Duke-Margolis
Web site (https://healthpolicy.duke.edu/
events/fda-ind-safety-reporting-meeting)
following the workshop. Organizations
are requested to register all participants,
but to view using one connection per
location whenever possible. Webcast
participants will be sent technical
system requirements in advance of the
event. Prior to joining the streaming
webcast of the public workshop, we
recommend that you review these
technical system requirements in
advance.
Transcripts: Please be advised that
transcripts will not be available.
FDA has verified the Web site
addresses in this document, as of the
date this document publishes in the
Federal Register, but Web sites are
subject to change over time.
Meeting Materials: All event materials
will be provided to registered attendees
via email prior to the workshop and
publicly available at the Duke-Margolis
Web site: https://healthpolicy.duke.edu/
events/fda-ind-safety-reporting-meeting.
Dated: November 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–25454 Filed 11–24–17; 8:45 am]
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56037

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Rural Health
Care Services Outreach Program
Performance Improvement and
Measurement Systems (PIMS)
Measures, OMB No. 0906–0009—
Revision
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 must be
received no later than January 26, 2018.
ADDRESSES: Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 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:
Rural Health Care Services Outreach
Program Performance Improvement and
Measurement Systems (PIMS) Measures
OMB No. 0906–0009 Revision.
Abstract: The Rural Health Care
Services Outreach (Outreach) Program is
authorized by Section 330A(e) of the
Public Health Service (PHS) Act (42
U.S.C. 254c(e)), as amended, to
‘‘promote rural health care services
outreach by expanding the delivery of
health care services to include new and
enhanced services in rural areas.’’ The
goals for the Outreach Program are as
follows: (1) Expand the delivery of
SUMMARY:

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Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices

health care services in rural
communities; (2) deliver health care
services through a strong consortium, in
which every consortium member
organization is actively involved and
engaged in the planning and delivery of
services; (3) utilize and/or adapt an
evidence-based or promising practice
model(s) in the delivery of health care
services; and (4) improve population
health, demonstrate health outcomes
and sustainability.
Need and Proposed Use of the
Information: The PIMS measures for the
Outreach Program enable HRSA and the
Federal Office of Rural Health Policy to
capture awardee-level and aggregate
data that illustrate the impact and scope
of federal funding. The collection of this
information helps further inform and
substantiate the focus and objectives of
the grant program. The measures
encompass the following topics: (a)
Access to care; (b) population
demographics; (c) consortium/network;

(d) sustainability; and (f) project specific
domains.
There are proposed revisions to the
currently approved Outreach Program
PIMS measures. The proposed Outreach
PIMS measures reflect a reduced
number of measures including the
following: 16 process measures
applicable to all awardees (previously
22), consolidation of the project-specific
measures (currently 7, previously 8),
and 8 clinical measures (previously 9).
In addition, the proposed measures
include the addition of two Centers for
Disease Control and Prevention (CDC)
calculators: The CDC Heart Age
calculator and the CDC BMI Percentile
Calculator for Child and Teen. Data for
both calculators will be collected on an
aggregate level and only from awardees
with applicable projects; the CDC Heart
Age calculator is specific to awardees
participating in the Health Improvement
Special Project while the CDC BMI
calculator is for projects focusing on
childhood obesity.
Number of
respondents

Form name

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total
responses

Total burden
hours

Name of instrument .............................................................

25

1

25

3.0

75.0

Total ..............................................................................

25

........................

25

........................

75.0

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 McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2017–25508 Filed 11–24–17; 8:45 am]
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Health Resources and Services
Administration (HRSA), Derpartment of
Health and Human Services.

AGENCY:

ACTION:

Notice

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.

SUMMARY:

Comments on this Information
Collection Request must be received no
later than January 26, 2018.

DATES:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Likely Respondents: The respondents
are award recipients of the Rural Health
Care Services Outreach 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 and 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:

Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Information Collection Request Title:
Rural Health Network Development
Program, OMB No. 0906–0010—
Revision

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Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.

ADDRESSES:

Health Resources and Services
Administration

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

FOR FURTHER INFORMATION CONTACT:

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Information Collection Clearance Officer
at (301) 443–1984.
When
submitting comments or requesting
information, please include the
information request collection title for
reference, in compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995.
Information Collection Request Title:
Rural Health Network Development
Program OMB No. 0906–0010—
Revision.
Abstract: The purpose of the Rural
Health Network Development (RHND)
program is to support mature, integrated
rural health care networks that have
combined the functions of the entities
participating in the network in order to
address the health care needs of the
targeted rural community. Awarded
programs combine the functions of the
entities participating in the network to
create innovative solutions to local
healthcare needs while addressing the
following statutory charges: (i) Achieve
efficiencies; (ii) expand access,
coordinate, and improve the quality of
essential health care services; and (iii)
strengthen the rural health care system
as a whole.

SUPPLEMENTARY INFORMATION:

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