82 FR 56037 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 82, Issue 226 (November 27, 2017)
Health Resources and Services Administration
Federal Register Volume 82, Issue 226 (November 27, 2017)
| Page Range | 56037-56038 | |
| FR Document | 2017-25508 |
[Federal Register Volume 82, Number 226 (Monday, November 27, 2017)] [Notices] [Pages 56037-56038] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25508] ----------------------------------------------------------------------- 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 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 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 [[Page 56038]] 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. 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: ---------------------------------------------------------------------------------------------------------------- Number of Average burden Form name Number of responses per Total per response Total burden respondents respondent responses (in hours) 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] BILLING CODE 4165-15-P
![Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices 56037
documenting which adverse events are attending this public workshop must DEPARTMENT OF HEALTH AND
anticipated in the population under register online by January 8, 2018, HUMAN SERVICES
study and would not likely be reported midnight Eastern Time. Early
as a single occurrence, but instead registration is recommended because Health Resources and Services
would be evaluated by assessing seating is limited; therefore, FDA may Administration
whether there are differences in the rate limit the number of participants from
of occurrence of such events between Agency Information Collection
each organization. Registrants will Activities: Proposed Collection: Public
those receiving the intervention and the receive confirmation when they have
concurrent or historical control. Comment Request; Information
been accepted. Duke-Margolis will post Collection Request Title: Rural Health
This public workshop is being held in
on its Web site if registration closes Care Services Outreach Program
response to public comments received
to Docket No. FDA–2015–D–4562 for before the day of the public workshop. Performance Improvement and
the draft guidance entitled ‘‘Safety If you need special accommodations Measurement Systems (PIMS)
Assessment for IND Safety Reporting’’ due to a disability, please contact Sarah Measures, OMB No. 0906–0009—
issued in December 2015 requesting a Supsiri at the Duke-Margolis Center for Revision
public meeting to discuss the draft Health Policy, 202–791–9561, AGENCY: Health Resources and Services
guidance recommendations and their sarah.supsiri@duke.edu, no later than Administration (HRSA), Department of
implications, including the new January 4, 2018. Health and Human Services.
recommendations regarding the
Streaming Webcast of the Public ACTION: Notice.
formation of a safety assessment
Workshop: This public workshop will
committee and the submission of a SUMMARY: In compliance with the
portion of the safety surveillance plan to also be webcast; archived video footage
requirement for opportunity for public
the IND before initiating phase 2 or 3 will be available at the Duke-Margolis
comment on proposed data collection
studies. The public workshop is Web site (https://healthpolicy.duke.edu/
projects of the Paperwork Reduction Act
intended to engage external events/fda-ind-safety-reporting-meeting) of 1995, HRSA announces plans to
stakeholders in discussions related to following the workshop. Organizations submit an Information Collection
finalizing the draft guidance entitled are requested to register all participants, Request (ICR), described below, to the
‘‘Safety Assessment for IND Safety but to view using one connection per Office of Management and Budget
Reporting.’’ location whenever possible. Webcast (OMB). Prior to submitting the ICR to
participants will be sent technical OMB, HRSA seeks comments from the
II. Topics for Discussion at the Public
system requirements in advance of the public regarding the burden estimate,
Workshop
event. Prior to joining the streaming below, or any other aspect of the ICR.
During the public workshop, speakers webcast of the public workshop, we DATES: Comments on this ICR must be
and participants will address a range of recommend that you review these received no later than January 26, 2018.
issues related to the draft guidance technical system requirements in
‘‘Safety Assessment for IND Safety ADDRESSES: Submit your comments to
advance. paperwork@hrsa.gov or mail the HRSA
Reporting’’, issued in December 2015.
Items for discussion will include topics Transcripts: Please be advised that Information Collection Clearance
raised in public comments submitted to transcripts will not be available. Officer, Room 14N39, 5600 Fishers
the draft guidance docket, including but FDA has verified the Web site Lane, Rockville, MD 20857.
not limited to: The entity that conducts addresses in this document, as of the FOR FURTHER INFORMATION CONTACT: To
aggregate analysis of safety data for IND date this document publishes in the request more information on the
safety reporting, concerns with Federal Register, but Web sites are proposed project or to obtain a copy of
unblinding of data and trial integrity, the data collection plans and draft
subject to change over time.
methods for determining the threshold instruments, email paperwork@hrsa.gov
for reporting, and developing and Meeting Materials: All event materials or call Lisa Wright-Solomon, the HRSA
documenting a plan for safety will be provided to registered attendees Information Collection Clearance Officer
surveillance. Furthermore, input will be via email prior to the workshop and at (301) 443–1984.
sought on other factors that drive over- publicly available at the Duke-Margolis SUPPLEMENTARY INFORMATION: When
reporting of safety events that do not Web site: https://healthpolicy.duke.edu/ submitting comments or requesting
meet the definition of a suspected events/fda-ind-safety-reporting-meeting. information, please include the
unexpected serious adverse reaction. Dated: November 20, 2017. information request collection title for
Leslie Kux,
reference.
III. Participating in the Public Information Collection Request Title:
Workshop Associate Commissioner for Policy. Rural Health Care Services Outreach
Registration: To register for the public [FR Doc. 2017–25454 Filed 11–24–17; 8:45 am] Program Performance Improvement and
workshop, please visit the following BILLING CODE 4164–01–P Measurement Systems (PIMS) Measures
Web site: https://healthpolicy.duke.edu/ OMB No. 0906–0009 Revision.
events/fda-ind-safety-reporting-meeting Abstract: The Rural Health Care
and register online by January 8, 2018, Services Outreach (Outreach) Program is
asabaliauskas on DSKBBXCHB2PROD with NOTICES
midnight Eastern Time. There will be no authorized by Section 330A(e) of the
onsite registration. Please provide Public Health Service (PHS) Act (42
complete contact information for each U.S.C. 254c(e)), as amended, to
attendee, including name, title, ‘‘promote rural health care services
affiliation, address, email, and outreach by expanding the delivery of
telephone. health care services to include new and
Registration is free and based on enhanced services in rural areas.’’ The
space availability, with priority given to goals for the Outreach Program are as
early registrants. Persons interested in follows: (1) Expand the delivery of
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![56038 Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices
health care services in rural (d) sustainability; and (f) project specific Likely Respondents: The respondents
communities; (2) deliver health care domains. are award recipients of the Rural Health
services through a strong consortium, in There are proposed revisions to the Care Services Outreach Program.
which every consortium member currently approved Outreach Program Burden Statement: Burden in this
organization is actively involved and PIMS measures. The proposed Outreach
context means the time expended by
engaged in the planning and delivery of PIMS measures reflect a reduced
persons to generate, maintain, retain,
services; (3) utilize and/or adapt an number of measures including the
disclose, or provide the information
evidence-based or promising practice following: 16 process measures
requested. This includes the time
model(s) in the delivery of health care applicable to all awardees (previously
needed to review instructions; to
services; and (4) improve population 22), consolidation of the project-specific
measures (currently 7, previously 8), develop, acquire, install, and utilize
health, demonstrate health outcomes technology and systems for the purpose
and sustainability. and 8 clinical measures (previously 9).
In addition, the proposed measures of collecting, validating, and verifying
Need and Proposed Use of the include the addition of two Centers for information, processing and
Information: The PIMS measures for the Disease Control and Prevention (CDC) maintaining information, and disclosing
Outreach Program enable HRSA and the calculators: The CDC Heart Age and providing information; to train
Federal Office of Rural Health Policy to calculator and the CDC BMI Percentile personnel and to be able to respond to
capture awardee-level and aggregate Calculator for Child and Teen. Data for a collection of information; to search
data that illustrate the impact and scope both calculators will be collected on an data sources; to complete and review
of federal funding. The collection of this aggregate level and only from awardees the collection of information; and to
information helps further inform and with applicable projects; the CDC Heart transmit or otherwise disclose the
substantiate the focus and objectives of Age calculator is specific to awardees information. The total annual burden
the grant program. The measures participating in the Health Improvement hours estimated for this ICR are
encompass the following topics: (a) Special Project while the CDC BMI summarized in the table below.
Access to care; (b) population calculator is for projects focusing on Total Estimated Annualized Burden
demographics; (c) consortium/network; childhood obesity. Hours:
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
Name of instrument ............................................................. 25 1 25 3.0 75.0
Total .............................................................................. 25 ........................ 25 ........................ 75.0
HRSA specifically requests comments AGENCY: Health Resources and Services Information Collection Clearance Officer
on: (1) The necessity and utility of the Administration (HRSA), Derpartment of at (301) 443–1984.
proposed information collection for the Health and Human Services.
proper performance of the agency’s SUPPLEMENTARY INFORMATION: When
ACTION: Notice submitting comments or requesting
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance information, please include the
SUMMARY: In compliance with the information request collection title for
the quality, utility, and clarity of the requirement for opportunity for public
information to be collected; and (4) the reference, in compliance with Section
comment on proposed data collection 3506(c)(2)(A) of the Paperwork
use of automated collection techniques projects of the Paperwork Reduction Act
or other forms of information Reduction Act of 1995.
of 1995, HRSA announces plans to
technology to minimize the information submit an Information Collection Information Collection Request Title:
collection burden. Request (ICR), described below, to the Rural Health Network Development
Amy McNulty, Office of Management and Budget Program OMB No. 0906–0010—
(OMB). Prior to submitting the ICR to Revision.
Acting Director, Division of the Executive
Secretariat. OMB, HRSA seeks comments from the Abstract: The purpose of the Rural
[FR Doc. 2017–25508 Filed 11–24–17; 8:45 am] public regarding the burden estimate, Health Network Development (RHND)
BILLING CODE 4165–15–P below, or any other aspect of the ICR. program is to support mature, integrated
DATES: Comments on this Information rural health care networks that have
Collection Request must be received no combined the functions of the entities
DEPARTMENT OF HEALTH AND later than January 26, 2018. participating in the network in order to
HUMAN SERVICES address the health care needs of the
ADDRESSES: Submit your comments to targeted rural community. Awarded
Health Resources and Services paperwork@hrsa.gov or mail the HRSA programs combine the functions of the
Administration Information Collection Clearance entities participating in the network to
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Officer, Room 14N39, 5600 Fishers create innovative solutions to local
Agency Information Collection Lane, Rockville, MD 20857. healthcare needs while addressing the
Activities: Proposed Collection: Public
FOR FURTHER INFORMATION CONTACT: To following statutory charges: (i) Achieve
Comment Request
request more information on the efficiencies; (ii) expand access,
Information Collection Request Title: proposed project or to obtain a copy of coordinate, and improve the quality of
Rural Health Network Development the data collection plans and draft essential health care services; and (iii)
Program, OMB No. 0906–0010— instruments, email paperwork@hrsa.gov strengthen the rural health care system
Revision or call Lisa Wright-Solomon, the HRSA as a whole.
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Document Created: 2017-11-25 01:08:47
Document Modified: 2017-11-25 01:08:47
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this ICR must be received no later than January 26, 2018. | |
| 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. | |
| FR Citation | 82 FR 56037 |
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