Agency Forms Undergoing Paperwork Reduction Act Review, 21444-21445 [2020-08164]
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21444
Federal Register / Vol. 85, No. 75 / Friday, April 17, 2020 / Notices
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
5. Assess information collection costs.
Proposed Project
National Healthcare Safety Network
(NHSN) Patient Impact Module for
Coronavirus (COVID–19) Surveillance
in Healthcare Facilities—New—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Division of Healthcare Quality
Promotion (DHQP), National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC) collects
data from healthcare facilities in the
National Healthcare Safety Network
(NHSN) under OMB Control Number
0920–0666. NHSN is a public health
surveillance system that collects,
analyzes, reports, and makes available
data for monitoring, measuring, and
responding to healthcare associated
infections (HAIs), antimicrobial use and
resistance, blood transfusion safety
events, and the extent to which
healthcare facilities adhere to infection
prevention practices and antimicrobial
stewardship.
of cases that are community-acquired
versus healthcare-associated. CDC and
health departments alike will use this
surveillance data to prioritize the
allocation of resources and response
efforts. Metrics collected in NHSN will
include:
• Number of and proportion of
hospitalized patients with suspected
or confirmed COVID–19
• Number of and proportion of
hospitalized patients with suspected
or confirmed COVID–19 that are on
mechanical ventilators
• Number of patients with suspected or
confirmed COVID–19 who are in the
emergency department (ED) or any
overflow locations awaiting an
inpatient bed
• Number of and proportion of
inpatient COVID–19 patients with
suspected or confirmed COVID–19
with onset 14 or more days after
hospitalization (most likely
healthcare-associated)
• Proportion of inpatient beds occupied
by those who are suspected or
confirmed with COVID–19 (or
proportion of inpatients who are
suspected or confirmed with COVID–
19)
There will be no cost to respondents
other than their time to complete the
COVID–19 Patient Impact Module Form
on a daily basis, for 180 days. The
estimated annualized time burden is
292,500 hours.
On March 11, 2020, the World Health
Organization declared COVID–19 a
pandemic, and the President of the
United States (U.S.) proclaimed the
outbreak a national emergency on
March 13, 2020. As rates of infection
continue to rise across the U.S.,
healthcare facilities and public health
departments are facing significant strain
on patient care and infection prevention
efforts. NHSN plans to introduce a new
COVID–19 module in the Patient Safety
Component that will enable hospitals to
report daily COVID–19 patient counts to
NHSN, and NHSN in turn will enable
state and local health departments to
gain immediate access to the COVID–19
data for hospitals in their jurisdiction.
NHSN’s role as a shared platform for
HAI surveillance provides a valuable
foundation for COVID–19 surveillance.
A very large number of the nation’s
hospitals participate in NHSN, and
infection preventionists (IPs) in those
hospitals already use NHSN for
surveillance and reporting. Hospitals’
IPs will voluntarily report COVID–19
patient surveillance data to NHSN by
manual entry or by uploading a comma
separated values (CSV) file. State and
local health departments will be able to
gain immediate access to this data
reported by facilities in their
jurisdictions via existing NHSN groups.
This information will be used to
inform the overall real-time COVID–19
response efforts and possible resource
allocation, including an understanding
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
Microbiologist ....................................
COVID–19 Patient Impact Module
Form.
3,900
180
25/60
292,500
Total ...........................................
...........................................................
........................
........................
........................
292,500
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2020–08170 Filed 4–16–20; 8:45 am]
Centers for Disease Control and
Prevention
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Agency Forms Undergoing Paperwork
Reduction Act Review
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Number of
responses per
respondent
Type of respondents
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled [Management
Information System for Comprehensive
Cancer Control Programs] to the Office
of Management and Budget (OMB) for
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review and approval. CDC previously
published a ‘‘Proposed Data Collection
Submitted for Public Comment and
Recommendations’’ notice on November
4, 2019 to obtain comments from the
public and affected agencies. CDC did
not receive comments related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
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21445
Federal Register / Vol. 85, No. 75 / Friday, April 17, 2020 / Notices
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
Management Information Systems for
Comprehensive Cancer Control
Programs (OMB Control No. 0920–0841,
Exp. 6/30/2019)—Reinstatement with
Change—National Center for Chronic
Disease and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
In 2017, 66 awardees, representing all
50 states, the District of Columbia, seven
United States Association Pacific
Islands and territories, and eight tribes
and tribal organizations, were selected
for funding under NOFO (DP17–1701,
‘‘Cancer Prevention and Control
Programs for State, Territorial, and
Tribal Organizations’’). Under this
cooperative agreement, awardees
implement cancer prevention and
control programs to reduce cancer
morbidity, mortality, and disparities. To
facilitate program monitoring,
performance assessment, and
evaluation, a web-based management
information system (MIS) is needed for
collection and abstraction of
information about program resources,
partnerships, work plan activities, and
evaluation efforts. Information
collection is organized into eight areas
(MIS tabs): (1) FOA & Recipients; (2)
Program Information; (3) Resources; (4)
Leadership Team; (5) Financial; (6)
Planning; (7) Action Plan; and (8)
Reports. The Leadership Team tab is
new. CDC conducted user acceptability
testing of the leadership team tab data
elements which allowed for an accurate
estimate of burden per response. All
information collected by CDC will be
analyzed and used in aggregate to
describe program efforts.
OMB approval is requested for three
years, which coincides with the last
three years of the program. All awardees
will submit information to CDC
annually. Participation is required as a
condition of funding under the
cooperative agreement. The estimated
burden per response is one hour and the
total estimated annualized burden is 66
hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Program Director for State- Tribal-, or
Territorial- based Cancer Prevention and
Control Program.
Data Elements for All CPC Programs: Annual Reporting.
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–08164 Filed 4–16–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0907]
jbell on DSKJLSW7X2PROD with NOTICES
Number of
respondents
Type of respondents
Medical Device User Fee Amendments
for Fiscal Years 2023 Through 2027;
Public Meeting; Request for
Comments; Postponement
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
postponed.
ACTION:
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The Food and Drug
Administration (FDA) is announcing
that the public meeting entitled
‘‘Medical Device User Fee Amendments
for Fiscal Years 2023 Through 2027;
Public Meeting; Request for Comments’’
that was scheduled in the Federal
Register on April 3, 2020, to take place
on May 5, 2020, is postponed until
further notice.
DATES: The public meeting will be
rescheduled for a future date.
Information about the rescheduled
meeting will be provided when
available. Submit either electronic or
written comments on the medical
device user fee program and suggestions
regarding the commitments FDA should
propose for the next reauthorized
program.
FOR FURTHER INFORMATION CONTACT:
Ellen Olson, Center for Devices and
Radiological Health, Food and Drug
SUMMARY:
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66
Number of
responses per
respondent
1
Average
burden per
response
(in hours)
1
Administration, Bldg. 66, Rm. 1664,
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–4322,
ellen.olson@fda.hhs.gov or CDRHOPEQ-StrategicInitiatives@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
public meeting entitled ‘‘Medical Device
User Fee Amendments for Fiscal Years
2023 Through 2027; Public Meeting;
Request for Comments’’ was originally
announced in the Federal Register of
March 6, 2020 (85 FR 13165), and was
initially scheduled for April 7, 2020. On
April 3, 2020, the meeting was
postponed to May 5, 2020, and was
planned to take place by webcast only
due to extenuating circumstances (85 FR
18992). FDA continues to evaluate
whether and how to proceed with
upcoming scheduled meetings while
our day-to-day operations are impacted
by the COVID–19 public health
emergency, and we have decided to
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]]>Agencies
[Federal Register Volume 85, Number 75 (Friday, April 17, 2020)]
[Notices]
[Pages 21444-21445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08164]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-20-0841]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled [Management Information System for
Comprehensive Cancer Control Programs] to the Office of Management and
Budget (OMB) for review and approval. CDC previously published a
``Proposed Data Collection Submitted for Public Comment and
Recommendations'' notice on November 4, 2019 to obtain comments from
the public and affected agencies. CDC did not receive comments related
to the previous notice. This notice serves to allow an additional 30
days for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the proposed collection of information is
necessary for the proper performance of the
[[Page 21445]]
functions of the agency, including whether the information will have
practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) Minimize the burden of the collection of information on those
who are to respond, including, through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
Management Information Systems for Comprehensive Cancer Control
Programs (OMB Control No. 0920-0841, Exp. 6/30/2019)--Reinstatement
with Change--National Center for Chronic Disease and Health Promotion
(NCCDPHP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
In 2017, 66 awardees, representing all 50 states, the District of
Columbia, seven United States Association Pacific Islands and
territories, and eight tribes and tribal organizations, were selected
for funding under NOFO (DP17-1701, ``Cancer Prevention and Control
Programs for State, Territorial, and Tribal Organizations''). Under
this cooperative agreement, awardees implement cancer prevention and
control programs to reduce cancer morbidity, mortality, and
disparities. To facilitate program monitoring, performance assessment,
and evaluation, a web-based management information system (MIS) is
needed for collection and abstraction of information about program
resources, partnerships, work plan activities, and evaluation efforts.
Information collection is organized into eight areas (MIS tabs): (1)
FOA & Recipients; (2) Program Information; (3) Resources; (4)
Leadership Team; (5) Financial; (6) Planning; (7) Action Plan; and (8)
Reports. The Leadership Team tab is new. CDC conducted user
acceptability testing of the leadership team tab data elements which
allowed for an accurate estimate of burden per response. All
information collected by CDC will be analyzed and used in aggregate to
describe program efforts.
OMB approval is requested for three years, which coincides with the
last three years of the program. All awardees will submit information
to CDC annually. Participation is required as a condition of funding
under the cooperative agreement. The estimated burden per response is
one hour and the total estimated annualized burden is 66 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Program Director for State- Tribal-, Data Elements for All 66 1 1
or Territorial- based Cancer CPC Programs: Annual
Prevention and Control Program. Reporting.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2020-08164 Filed 4-16-20; 8:45 am]
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