Agency Forms Undergoing Paperwork Reduction Act Review, 29457-29458 [2020-10408]
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jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Notices
significant reliance on informatics to
achieve a meaningful and reportable
result. As a consequence, clinical
laboratories require personnel
knowledgeable in bioinformatics or
pathology/laboratory informatics to
design and manage the bioinformatics
analysis.
While CLIA regulations apply to
clinical NGS testing, there is a lack of
clarity regarding how the general CLIA
quality system and personnel
requirements should be specifically
implemented for the NGS
bioinformatics components. In April
2019, CLIAC made eight
recommendations regarding CLIA’s
application to NGS-based technologies.
This request for information is soliciting
comments from the public for more
information on topic areas mentioned in
two of the recommendations,
specifically, the qualifications of
personnel performing bioinformatics
activities; storage and retention of NGS
data files; and maintenance of sequence
analysis software. The April 2019
CLIAC summary is available in the
docket under the Supporting Materials
tab and at https://www.cdc.gov/cliac/
past-meetings.html.
The qualifications and responsibilities
of personnel performing the informatics
component of the testing process are not
addressed in the CLIA regulations. For
the purpose of this request for
information, the informatics component
of NGS includes the analysis of NGS
machine-generated data and subsequent
computational processes. Therefore,
CDC is asking the public to describe
different responsibilities of personnel
providing bioinformatics or pathology/
laboratory informatics expertise such as
validating and assuring that the
informatics pipeline meets documented
performance specifications.
CDC is also interested in learning the
skills, training, and education of
personnel who will fill bioinformatics
or pathology/laboratory informatics
positions, and how clinical and public
health laboratories can recruit and
retain personnel with these identified
skills.
Lastly, the NGS testing process
generates large amounts of data and
requires multiple file types. CLIA
regulations specify at 42 CFR
493.1105(a)(3) that all analytic systems
records must be kept for at least two
years, but the regulations do not specify
the types of data to be captured or the
retention time for a given data type. The
regulations do not address the capability
to access and reanalyze the data after
the test is performed. This capability
may require retention of the version of
software used in the original analysis.
VerDate Sep<11>2014
17:09 May 14, 2020
Jkt 250001
CDC requests comment from the public
on this topic.
Dated: May 12, 2020.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2020–10461 Filed 5–14–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–20–19BHC]
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 National
Evaluation of the DP18–1815
Cooperative Agreement Program:
Category A, Diabetes Management and
Type 2 Diabetes Prevention 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 July 5,
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
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
PO 00000
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Fmt 4703
Sfmt 4703
29457
(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
National Evaluation of the DP18–1815
Cooperative Agreement Program:
Category A, Diabetes Management and
Type 2 Diabetes Prevention—New—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC) Division of Diabetes
Translation (DDT) and Division for
Heart Disease and Stroke Prevention
(DHDSP) are submitting this new
information collection request (ICR) for
an evaluation of the recently launched
five-year Cooperative Agreement
program CDC–RFA–DP18–1815PPHF18:
Improving the Health of Americans
Through Prevention and Management of
Diabetes and Heart Disease and Stroke,
hereafter referred to as ‘‘1815’’. This
cooperative agreement funds all 50 State
Health Departments and the
Washington, DC health department
(hereafter referred to as ‘‘HD
recipients’’) to support investments in
implementing evidence-based strategies
to prevent and manage cardiovascular
disease (CVD) and diabetes in highburden populations/communities
within each state and the District of
Columbia. High burden populations/
communities are those affected
disproportionately by high blood
pressure, high blood cholesterol,
diabetes, or prediabetes due to
socioeconomic or other characteristics,
including access to care, poor quality of
care, or low income. The 1815 program
is a collaboration between DDT and
DHDSP and is structured into two
program categories aligning with each
E:\FR\FM\15MYN1.SGM
15MYN1
29458
Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Notices
Division: Category A focuses on diabetes
management and type 2 diabetes
prevention; Category B focuses on CVD
prevention and management. This
information request package focuses on
data collection activities for the
Category A diabetes assessment.
This cooperative agreement is a
substantial investment of federal funds.
DDT and DHDSP are responsible for the
stewardship of these funds, and they
must be able to demonstrate the types of
interventions being implemented and
what is being accomplished through the
use of these funds. Thus, throughout the
five-year cooperative agreement period,
CDC will work with HD recipients to
track the implementation of the
cooperative agreement strategies and
evaluate program processes and
outcomes. In order to collect this
information for Category A, CDC has
designed two overarching components:
(1) Category A rapid evaluation of
DSMES and National DPP partner sites
and (2) Category A recipient-led
evaluations. Each component consists of
data collection mechanisms and tools
that are designed to capture the most
relevant information needed to inform
the evaluation effort while placing
minimum burden on respondents.
Respondents will include HD recipients,
as well as select HD recipient partner
sites, which are organizations that HD
recipients are partnering with in the
implementation of the 1815 strategies.
The evaluation of cooperative
agreement strategies and activities
conducted by DDT will determine the
efficiency, effectiveness, impact and
sustainability of 1815-funded strategies
in the promotion, prevention, and
management of diabetes and heart
disease and help identify promising
practices that can be replicated and
scaled to better improve health
outcomes. In addition, evaluation plays
a critical role in organizational learning,
program planning, decision-making, and
measurement of the 1815 strategies. As
an action-oriented process, the
evaluation will serve to identify
programs that have positive outcomes,
identify those that may need additional
technical assistance support, and
highlight the specific activities that
make the biggest contribution to
improving diabetes and cardiovascular
disease prevention and management
efforts. Without collection of new
evaluative data, CDC will not be able to
capture critical information needed to
continuously improve programmatic
efforts and clearly demonstrate the use
of federal funds.
OMB approval is requested for three
years. Participation is required for
cooperative agreement awardees and
voluntary for partner sites. The total
estimated annualized burden hours are
1,084.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average
burden per
response
(in hours)
Form name
Health Department (1815 Recipient).
Evaluation and Performance Measurement Plan (EPMP) ....
17
1
8
Recipient-Led Evaluation Reporting Template ......................
DSMES Partner Site-Level Rapid Evaluation Rapid Evaluation Form.
National DPP Partner Site-Level Rapid Evaluation Nomination Form.
DSMES Partner Site-Level Rapid Evaluation Survey Questionnaire.
Program Coordinator Interview Guide ...................................
Professional Team Member Interview Guide .........................
Paraprofessional Team Member Interview Guide .................
National DPP Partner Site-Level Rapid Evaluation Survey
Questionnaire.
Program Coordinator Interview Guide ...................................
Lifestyle Coach Interview Guide ............................................
51
17
1
1
8
0.5
17
1
0.5
340
1
0.5
14
28
28
340
1
1
1
1
2
2
2
0.5
14
28
1
1
1
1
DSMES Partner Site ...............
National DPP Partner Site ......
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–10408 Filed 5–14–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
jbell on DSKJLSW7X2PROD with NOTICES
Number of
respondents
Type of respondent
Tribal Consultation Meetings
Office of Head Start (OHS),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS).
ACTION: Notice of meetings.
AGENCY:
VerDate Sep<11>2014
17:09 May 14, 2020
Jkt 250001
Pursuant to the Head Start
Act, notice is hereby given of three 1day tribal consultation sessions to be
held between HHS/ACF OHS leadership
and the leadership of tribal governments
operating Head Start and Early Head
Start programs. The purpose of these
consultation sessions is to discuss ways
to better meet the needs of American
Indian and Alaska Native (AIAN)
children and their families, taking into
consideration funding allocations,
distribution formulas, and other issues
affecting the delivery of Head Start
services in their geographic locations.
Three tribal consultations will be held
as part of HHS/ACF or ACF Tribal
Consultation Sessions. Please note the
planned tribal consultation dates may
be impacted by COVID–19 travel
SUMMARY:
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
restrictions. OHS will consider virtual
means of facilitating tribal consultations
and/or the postponing of tribal
consultations should travel restrictions
and group meeting limitations remain in
effect.
DATES: July 9–10, 2020, 1 to 3 p.m.
July 14–16, 2020, 1 to 3 p.m.
Aug. 3, 2020, 1 to 5 p.m.
ADDRESSES:
• July 9–10, 2020—Glendale, AZ
(Location TBD)
• July 14–16, 2020—Denver, CO
(Location TBD)
• Aug. 3, 2020—Spokane, WA
(Northern Quest Resort)
FOR FURTHER INFORMATION CONTACT:
Todd Lertjuntharangool, regional
program manager, Region XI/AIAN,
Office of Head Start, email
E:\FR\FM\15MYN1.SGM
15MYN1
]]>Agencies
[Federal Register Volume 85, Number 95 (Friday, May 15, 2020)]
[Notices]
[Pages 29457-29458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10408]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-20-19BHC]
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 National Evaluation of the DP18-1815
Cooperative Agreement Program: Category A, Diabetes Management and Type
2 Diabetes Prevention 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
July 5, 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 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
National Evaluation of the DP18-1815 Cooperative Agreement Program:
Category A, Diabetes Management and Type 2 Diabetes Prevention--New--
National Center for Chronic Disease Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention (CDC) Division of
Diabetes Translation (DDT) and Division for Heart Disease and Stroke
Prevention (DHDSP) are submitting this new information collection
request (ICR) for an evaluation of the recently launched five-year
Cooperative Agreement program CDC-RFA-DP18-1815PPHF18: Improving the
Health of Americans Through Prevention and Management of Diabetes and
Heart Disease and Stroke, hereafter referred to as ``1815''. This
cooperative agreement funds all 50 State Health Departments and the
Washington, DC health department (hereafter referred to as ``HD
recipients'') to support investments in implementing evidence-based
strategies to prevent and manage cardiovascular disease (CVD) and
diabetes in high-burden populations/communities within each state and
the District of Columbia. High burden populations/communities are those
affected disproportionately by high blood pressure, high blood
cholesterol, diabetes, or prediabetes due to socioeconomic or other
characteristics, including access to care, poor quality of care, or low
income. The 1815 program is a collaboration between DDT and DHDSP and
is structured into two program categories aligning with each
[[Page 29458]]
Division: Category A focuses on diabetes management and type 2 diabetes
prevention; Category B focuses on CVD prevention and management. This
information request package focuses on data collection activities for
the Category A diabetes assessment.
This cooperative agreement is a substantial investment of federal
funds. DDT and DHDSP are responsible for the stewardship of these
funds, and they must be able to demonstrate the types of interventions
being implemented and what is being accomplished through the use of
these funds. Thus, throughout the five-year cooperative agreement
period, CDC will work with HD recipients to track the implementation of
the cooperative agreement strategies and evaluate program processes and
outcomes. In order to collect this information for Category A, CDC has
designed two overarching components: (1) Category A rapid evaluation of
DSMES and National DPP partner sites and (2) Category A recipient-led
evaluations. Each component consists of data collection mechanisms and
tools that are designed to capture the most relevant information needed
to inform the evaluation effort while placing minimum burden on
respondents. Respondents will include HD recipients, as well as select
HD recipient partner sites, which are organizations that HD recipients
are partnering with in the implementation of the 1815 strategies.
The evaluation of cooperative agreement strategies and activities
conducted by DDT will determine the efficiency, effectiveness, impact
and sustainability of 1815-funded strategies in the promotion,
prevention, and management of diabetes and heart disease and help
identify promising practices that can be replicated and scaled to
better improve health outcomes. In addition, evaluation plays a
critical role in organizational learning, program planning, decision-
making, and measurement of the 1815 strategies. As an action-oriented
process, the evaluation will serve to identify programs that have
positive outcomes, identify those that may need additional technical
assistance support, and highlight the specific activities that make the
biggest contribution to improving diabetes and cardiovascular disease
prevention and management efforts. Without collection of new evaluative
data, CDC will not be able to capture critical information needed to
continuously improve programmatic efforts and clearly demonstrate the
use of federal funds.
OMB approval is requested for three years. Participation is
required for cooperative agreement awardees and voluntary for partner
sites. The total estimated annualized burden hours are 1,084.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondent Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Health Department (1815 Recipient). Evaluation and Performance 17 1 8
Measurement Plan (EPMP).
Recipient-Led Evaluation 51 1 8
Reporting Template.
DSMES Partner Site-Level 17 1 0.5
Rapid Evaluation Rapid
Evaluation Form.
National DPP Partner Site- 17 1 0.5
Level Rapid Evaluation
Nomination Form.
DSMES Partner Site................. DSMES Partner Site-Level 340 1 0.5
Rapid Evaluation Survey
Questionnaire.
Program Coordinator 14 1 2
Interview Guide.
Professional Team Member 28 1 2
Interview Guide.
Paraprofessional Team 28 1 2
Member Interview Guide.
National DPP Partner Site.......... National DPP Partner Site- 340 1 0.5
Level Rapid Evaluation
Survey Questionnaire.
Program Coordinator 14 1 1
Interview Guide.
Lifestyle Coach Interview 28 1 1
Guide.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2020-10408 Filed 5-14-20; 8:45 am]
BILLING CODE 4163-18-P
