Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Medicare Rural Hospital Flexibility Program Performance, OMB No. 0915-0363-Extension, 24527-24528 [2019-11050]
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Federal Register / Vol. 84, No. 102 / Tuesday, May 28, 2019 / Notices
electronic and written/paper comments
received, go to https://
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docket number, found in brackets in the
heading of this document, into the
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FOR FURTHER INFORMATION CONTACT:
Tiffany Kelley, Office of Regulatory
Affairs, Division of Operational Policy,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993–0002, 301–348–1970,
Tiffany.Kelley@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register on March 29,
2019, FDA published a notice of
availability with a 60-day comment
period to request comments on the draft
guidance for industry entitled ‘‘Review
and Update of Device Establishment
Inspection Processes and Standards.’’
The Agency has received a request for
a 30-day extension of the comment
period. The request conveyed concern
that the current 60-day comment period
does not allow sufficient time to
develop thoughtful and detailed input.
FDA has considered the request and
is extending the comment period for the
notice of availability for 30 days, until
June 27, 2019. The Agency believes that
a 30-day extension allows adequate time
for interested persons to submit
comments without significantly
delaying guidance on these important
issues.
II. Significance of Draft Guidance
FDA is issuing this draft guidance
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on this topic. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
jbell on DSK3GLQ082PROD with NOTICES
III. Paperwork Reduction Act of 1995
This draft guidance refers to currently
approved collections of information.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 803 have
been approved under OMB control
number 0910–0437. The collections of
information in 21 CFR part 820 have
VerDate Sep<11>2014
20:49 May 24, 2019
Jkt 247001
been approved under OMB control
number 0910–0073.
IV. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet at either https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm,
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/default.htm, or
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Review and Update of Device
Establishment Inspection Processes and
Standards; Draft Guidance for Industry’’
may send an email request to
ORAPolicyStaffs@fda.hhs.gov to receive
an electronic copy of the document.
Dated: May 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–11012 Filed 5–24–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Medicare Rural Hospital
Flexibility Program Performance, OMB
No. 0915–0363—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than June 27, 2019.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
SUMMARY:
PO 00000
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24527
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Medicare Rural Hospital Flexibility
Program Performance Measures, OMB
No. 0915–0363—Extension
Abstract: This information collection
comment request is for continued
approval of the Medicare Rural Hospital
Flexibility Program Performance
Measures. HRSA is proposing to
continue this data collection with no
changes. The current performance
measures are collected electronically in
the Performance Improvement and
Measurement System, which awardees
access securely through the HRSA
Electronic Handbooks.
The Medicare Rural Hospital
Flexibility Program (Flex Program) is
authorized by Section 1820 of the Social
Security Act (42 U.S.C. 1395i–4), as
amended. The purpose of the Flex
Program is to enable state designated
entities to support critical access
hospitals in quality improvement,
quality reporting, performance
improvement, and benchmarking; to
assist facilities seeking designation as
critical access hospitals; and to create a
program to establish or expand the
provision of rural emergency medical
services.
A 60-day Federal Register Notice was
published in the Federal Register on
February 5, 2019, vol. 84, No. 24; pp.
1751–1752. There were no public
comments.
Need and Proposed Use of the
Information: For this program,
performance measures were developed
to provide data useful to the Flex
program and to enable HRSA to provide
aggregate program data required by
Congress under the Government
Performance and Results Modernization
Act of 2010 (GPRA). These measures
cover principal topic areas of interest to
the Federal Office of Rural Health Policy
including: (a) Quality reporting, (b)
quality improvement interventions, (c)
financial and operational improvement
initiatives, (d) population health
management, and (e) innovative care
models. Several measures will be used
for this program and will inform the
Office’s progress toward meeting the
goals set in GPRA. Furthermore,
obtained information is important in
identifying and understanding
programmatic improvement across
program areas, as well as guiding future
iterations of the Flex Program and
prioritizing areas of need and support.
Likely Respondents: Respondents are
the Flex Program coordinator for the
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28MYN1
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Federal Register / Vol. 84, No. 102 / Tuesday, May 28, 2019 / Notices
states participating in the Flex Program.
There are currently 45 states
participating in the Flex 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
Number of
respondents
Form name
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
Medicare Rural Hospital Flexibility Program .......................
45
1
45
70
3,150
Total Estimated Annualized Burden—Hours ................
45
........................
45
........................
3,150
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2019–11050 Filed 5–24–19; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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 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.
jbell on DSK3GLQ082PROD with NOTICES
Number of
responses per
respondent
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.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Member
Conflict: Radiation Therapeutics and Biology.
Date: June 14, 2019.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: 6701 Rockledge Drive, Bethesda, MD
20892, (Telephone Conference Call).
Contact Person: Syed M. Quadri, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6210,
MSC 7804, Bethesda, MD 20892, 301–435–
1211, quadris@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Accelerating
the Pace of Drug Abuse Research Using
Existing Data.
Date: June 19, 2019.
Time: 11:00 a.m. to 3:00 p.m.
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20:49 May 24, 2019
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Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Karen Nieves Lugo, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, Bethesda, MD 20892,
karen.nieveslugo@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Biochemistry and Biophysics of Biological
Macromolecules Fellowship Applications.
Date: June 20–21, 2019.
Time: 10:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Sudha Veeraraghavan,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, 301–435–1504,
sudha.veeraraghavan@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Cancer Diagnostics and Treatments
(CDT).
Date: June 24–25, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Warwick Denver, 1776 Grant Street,
Denver, CO 80203.
Contact Person: Zhang-Zhi Hu, MD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6186,
MSC 7804, Bethesda, MD 20892, (301) 437–
8135, huzhuang@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Disease Prevention and
Management, Risk Reduction and Health
Behavior Change.
Date: June 24–25, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Westgate Hotel, 1055 Second
Avenue, San Diego, CA 92101.
Contact Person: Michael J. McQuestion,
Ph.D., Scientific Review Officer, Center for
PO 00000
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Fmt 4703
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Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3114,
Bethesda, MD 20892, 301–480–1276,
mike.mcquestion@nih.gov.
Name of Committee: Oncology 1-Basic
Translational Integrated Review Group;
Tumor Microenvironment Study Section.
Date: June 24–25, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Crowne Plaza Seattle, 1113 6th
Avenue, Seattle, WA 98101.
Contact Person: Angela Y. Ng, Ph.D., MBA,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6200,
MSC 7804, Bethesda, MD 20892, 301–435–
1715, ngan@mail.nih.gov.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
Group; Child Psychopathology and
Developmental Disabilities Study Section.
Date: June 24–25, 2019.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Wyndham Grand Chicago
Riverfront, 71, East Wacker Dr., Chicago, IL
60601.
Contact Person: Katherine Colona Morasch,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3170,
Bethesda, MD 20892, moraschkc@
csr.nih.gov.
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group;
Skeletal Muscle and Exercise Physiology
Study Section.
Date: June 24–25, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Virginian Suites, 1500 Arlington
Boulevard, Arlington, VA 22209.
Contact Person: Richard Ingraham, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4116,
MSC 7814, Bethesda, MD 20892, 301–496–
8551, ingrahamrh@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel PAR Panel;
Academic-Industrial Partnerships for
Translation of Medical Technologies.
E:\FR\FM\28MYN1.SGM
28MYN1
]]>Agencies
[Federal Register Volume 84, Number 102 (Tuesday, May 28, 2019)]
[Notices]
[Pages 24527-24528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11050]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Medicare Rural Hospital
Flexibility Program Performance, OMB No. 0915-0363--Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA
has submitted an Information Collection Request (ICR) to the Office of
Management and Budget (OMB) for review and approval. Comments submitted
during the first public review of this ICR will be provided to OMB. OMB
will accept further comments from the public during the review and
approval period.
DATES: Comments on this ICR should be received no later than June 27,
2019.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to [email protected] or by
fax to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Lisa Wright-Solomon, the
HRSA Information Collection Clearance Officer, at [email protected] or
call (301) 443-1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Medicare Rural Hospital
Flexibility Program Performance Measures, OMB No. 0915-0363--Extension
Abstract: This information collection comment request is for
continued approval of the Medicare Rural Hospital Flexibility Program
Performance Measures. HRSA is proposing to continue this data
collection with no changes. The current performance measures are
collected electronically in the Performance Improvement and Measurement
System, which awardees access securely through the HRSA Electronic
Handbooks.
The Medicare Rural Hospital Flexibility Program (Flex Program) is
authorized by Section 1820 of the Social Security Act (42 U.S.C. 1395i-
4), as amended. The purpose of the Flex Program is to enable state
designated entities to support critical access hospitals in quality
improvement, quality reporting, performance improvement, and
benchmarking; to assist facilities seeking designation as critical
access hospitals; and to create a program to establish or expand the
provision of rural emergency medical services.
A 60-day Federal Register Notice was published in the Federal
Register on February 5, 2019, vol. 84, No. 24; pp. 1751-1752. There
were no public comments.
Need and Proposed Use of the Information: For this program,
performance measures were developed to provide data useful to the Flex
program and to enable HRSA to provide aggregate program data required
by Congress under the Government Performance and Results Modernization
Act of 2010 (GPRA). These measures cover principal topic areas of
interest to the Federal Office of Rural Health Policy including: (a)
Quality reporting, (b) quality improvement interventions, (c) financial
and operational improvement initiatives, (d) population health
management, and (e) innovative care models. Several measures will be
used for this program and will inform the Office's progress toward
meeting the goals set in GPRA. Furthermore, obtained information is
important in identifying and understanding programmatic improvement
across program areas, as well as guiding future iterations of the Flex
Program and prioritizing areas of need and support.
Likely Respondents: Respondents are the Flex Program coordinator
for the
[[Page 24528]]
states participating in the Flex Program. There are currently 45 states
participating in the Flex 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.
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Medicare Rural Hospital 45 1 45 70 3,150
Flexibility Program............
-------------------------------------------------------------------------------
Total Estimated Annualized 45 .............. 45 .............. 3,150
Burden--Hours..............
----------------------------------------------------------------------------------------------------------------
Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2019-11050 Filed 5-24-19; 8:45 am]
BILLING CODE 4165-15-P
