Agency Forms Undergoing Paperwork Reduction Act Review, 10091-10093 [2019-05155]
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10091
Federal Register / Vol. 84, No. 53 / Tuesday, March 19, 2019 / Notices
personal information about all
individuals accessing the LRN website.
Since CDC must be able to contact all
laboratory personnel during an event,
each laboratory staff member who
obtains access to the restricted LRN
website must provide his or her contact
information to the LRN Program Office.
As a requirement of membership, LRN
laboratories must report all biological
and chemical testing results to the LRN
Program using a CDC developed
software tool called the LRN Results
Messenger, or through the laboratory
information management system (LIMS)
which CDC refers to as Data Integration.
CDC supplies this software to LRN
laboratories at no charge. This
information obtained from LRN
laboratories is essential for surveillance
of anomalies, to support response to an
event that may involve multiple
agencies, and to manage limited
resources.
LRN laboratories are also required to
participate in Proficiency Testing
Challenges or Validation Studies and
report their results to CDC. LRN
laboratories participate in multiple
Proficiency Testing Challenges,
Exercises and/or Validation Studies
every year. These activities consist of 5–
500 simulated samples provided by
CDC. These challenges are necessary to
verify the testing capability of the LRN
laboratories. Because biological or
chemical agents perceived to be of
bioterrorism concern can occur rarely,
some LRN laboratories may not be
maintaining proficiency in certain
testing methods as a result of day-to-day
testing. Thus, simulated samples are
distributed to ensure proficiency across
LRN member laboratories. LRN
laboratories also enter the results of
these simulated samples into the LRN
Results Messenger or through Data
Integration for evaluation by CDC.
During a surge event resulting from a
bioterrorism or chemical terrorism
attack, or during an emerging infectious
disease outbreak, LRN Laboratories
must submit all testing results using
LRN Results Messenger or through Data
Integration. CDC uses these results in
order to track the progression of a
bioterrorism event, responds in the most
efficient and effective way possible, and
shares this data with other Federal
partners involved in the response.
Data is collected via two primary
avenues, the program LRN Results
Messenger or through Data Integration
and the LRN website. Laboratories
belonging to the Laboratory Response
Network utilize the CDC developed
software tool LRN Results Messenger to
submit testing results to CDC. Data
Integration is an effort parallel to the
LRN Results Messenger which will
ultimately allow laboratories to submit
data to CDC using their own data
collection systems. Results include
details about the type and source of
samples as well as the tests performed
and the numerical and empirical results
of those tests. The LRN website is used
by laboratories to provide their
complete testing capabilities to CDC. All
individuals who use the LRN website
must provide their contact information
to the LRN Program Office during
registration.
An LRN laboratory must provide its
testing capabilities, physical and
shipping addresses, United States
Department of Agriculture (USDA) and
Select Agent Permits, and specified
responsible individuals’ names, phone
numbers and email addresses. After
registering with the LRN website, a user
must provide his/her first and last
name, work phone number, alternate
phone number, email address, and
month and day of birth.
During reporting of results, sample
details, tests performed, results
obtained, and conclusions of tests are
required. Accomplishments during the
last three years include the
requalification of labs. The
requalification occurred between
November 7, 2016 and December 12,
2016. We had 130 domestic LRN labs
tasked with completing the
requalification, and had a 96% response
rate. The LRN website has remained the
same, and has only undergone routine
maintenance since 2015 to keep it in
working order.
This data collection is authorized
under the Public Health Service Act, (42
U.S.C. 241) Section 301. CDC has
estimated the annualized burden for this
project to be 2,064,660 hours, a decrease
of 317,640 hours per year. There is no
cost to respondents other than the time
to participate.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Public health laboratories ...............................
Biennial Requalification ..................................
General Surveillance Testing Results ............
Proficiency Testing/Validation Testing Results.
Surge Event Testing Results .........................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–05152 Filed 3–18–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day-19–1090]
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 Formative and
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Number of
responses per
respondent
Average
burden per
response
(in hours)
130
130
130
1
25
5
2
24
56
130
625
24
Summative Evaluation of Scaling the
National Diabetes Prevention Program
(National DPP) in Underserved Areas 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 October 4, 2018 to obtain
comments from the public and affected
agencies. CDC received and responded
to five sets of unique public comments
related to the previous notice. This
notice serves to allow an additional 30
E:\FR\FM\19MRN1.SGM
19MRN1
10092
Federal Register / Vol. 84, No. 53 / Tuesday, March 19, 2019 / Notices
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
agency’s 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 or
send an email to omb@cdc.gov. 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
Formative and Summative Evaluation
of Scaling the National Diabetes
Prevention Program (National DPP) in
Underserved Areas (OMB No. 0920–
1090, exp. 12/31/2018)—Reinstatement
with Change—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The CDC-led National Diabetes
Prevention Program (DPP) is a
partnership of public and private
organizations working collectively to
build the infrastructure for nationwide
delivery of an evidence-based lifestyle
change program to prevent or delay type
2 diabetes among adults with
prediabetes. The National DPP lifestyle
change program is founded on the
science of the Diabetes Prevention
VerDate Sep<11>2014
17:54 Mar 18, 2019
Jkt 247001
Program research study and several
translation studies that followed, which
showed that making modest behavior
changes helped people with prediabetes
lose 5% to 7% of their body weight and
reduce their risk of developing type 2
diabetes by 58% (71% for people over
60 years old). From 2012 to 2017, CDC
funded six national organizations
through a cooperative agreement to
establish and expand multistate
networks of over 200 program delivery
organizations that were able to meet
national standards and achieve the
outcomes proven to prevent or delay
onset of type 2 diabetes. CDC has
conducted a formative and summative
evaluation of this program and used the
evaluation findings and lessons learned
to provide data-driven technical
assistance to the grantees and other
organizations delivering the National
DPP lifestyle change program. The data
and lessons learned from DP12–1212
were also used to inform decisionmaking and policy, including the
development of the Centers for
Medicare & Medicaid Services (CMS)
Medicare Diabetes Prevention Program
(MDPP). As of April 1, 2018, the MDPP
Expanded Model provides coverage for
the National DPP lifestyle change
program for eligible Medicare
beneficiaries.
Despite the fact that over 1,700 CDCrecognized organizations in 50 states,
the District of Columbia, Puerto Rico,
the Virgin Islands, and other U.S.affiliated island jurisdictions/territories
offer the National DPP lifestyle change
program, there are still many geographic
areas with few, or no, in-person delivery
programs. In addition, some
populations, including Medicare
beneficiaries, men, African-Americans,
Asian-Americans, Hispanics, American
Indians, Alaska Natives, Pacific
Islanders, and people with visual
impairment or physical disabilities, are
under-enrolled relative to their
estimated numbers and disease burden.
To address these gaps, CDC funded a
new, five-year cooperative agreement
with ten new national organizations in
September 2017, ‘‘Scaling the National
DPP in Underserved Areas’’ (DP17–
1705). CDC funded 10 national
organizations with affiliate program
delivery sites in at least three states,
each to start new CDC-recognized
organizations in underserved areas and
to enroll both general and priority
populations in new or existing CDCrecognized organizations. The DP17–
1705 grantees will work on activities
designed to accomplish three main
goals:
(1) Build the infrastructure in
underserved areas necessary to deliver
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
the National DPP lifestyle change
program to the general population and
to priority populations, including
Medicare beneficiaries, men, AfricanAmericans, Asian-Americans,
Hispanics, American Indians, Alaska
Natives, Pacific Islanders, and noninstitutionalized people with visual or
physical disabilities;
(2) Tailor and adapt the program to
address the unique needs and
challenges of the enrolled participants;
and
(3) Provide participants with
specialized support needed to
successfully complete the program and
achieve 5–7% weight loss. Through this
new cooperative agreement, it is
anticipated that enrollment, retention,
and achievement of 5–7% weight loss in
the targeted populations will increase.
At this time, CDC requests an
additional three years of OMB approval
to continue collecting information
needed to evaluate the effectiveness of
CDC’s funding for the new grantees. The
data collection will allow CDC to
continue to provide data-driven,
tailored programmatic technical
assistance to ensure continuous quality
improvement for each year of the
cooperative agreement. A number of
additional changes to the evaluation
forms are proposed based on the public
comments received from the previously
published notice on October 4, 2018 to
reduce burden on respondents.
Evaluation data elements have been
modified accordingly to ensure that
reporting and evaluation requirements
are consistent with the aims of the new
cooperative agreement and reflect
lessons learned from the original funded
national organizations and their affiliate
delivery sites. Also, the method of data
collection has changed from an Excel
spreadsheet to a web-based data system
to allow for real-time feedback and
technical assistance. The estimated
reporting burden has increased and is
expected to vary between three and five
hours with an average of four hours per
grantee response (increased from
average of three hours in the previous
notice), and between five and seven
hours with an average of six hours per
affiliate delivery site response
(increased from an average of five hours
in the previous notice). These estimated
burden hours include the time for
reviewing instructions, searching
existing data sources, gathering and
maintaining the data needed, and
entering data in the web-based data
system. The number of respondents will
increase with the increased number of
grantees. These changes result in a net
increase of 478 annualized burden
E:\FR\FM\19MRN1.SGM
19MRN1
10093
Federal Register / Vol. 84, No. 53 / Tuesday, March 19, 2019 / Notices
hours. There are no costs to respondents
other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
National DPP Affiliate Delivery Sites ..............
National DPP Grantees ..................................
Evaluation Form for Sites ..............................
Evaluation Form for Grantees ........................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–05155 Filed 3–18–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–19–1050]
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 Generic
Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery 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 March 23,
2018 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;
VerDate Sep<11>2014
17:54 Mar 18, 2019
Jkt 247001
(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 or
send an email to omb@cdc.gov. 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
Generic Clearance for the Collection
of Qualitative Feedback on Agency
Service Delivery (OMB 0920–1050,
Expiration 6/30/2019)—Revision—
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Executive Order 12862 directs Federal
agencies to provide service to the public
that matches or exceeds the best service
available in the private sector. In order
to work continuously to ensure that our
programs are effective and meet our
customers’ needs, Centers for Disease
Control and Prevention (CDC) seeks to
obtain OMB approval of a generic
clearance to collect qualitative feedback
on our service delivery on collections.
The information collection activity will
garner qualitative customer and
stakeholder feedback in an efficient,
timely manner, in accordance with the
Administration’s commitment to
improving service delivery. By
qualitative feedback we mean
information that provides useful
insights on perceptions and opinions,
but are not statistical surveys that yield
quantitative results that can be
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
100
10
1
1
Average
burden per
response
(in hours)
6
4
generalized to the population of study.
This feedback will provide insights into
customer or stakeholder perceptions,
experiences and expectations, provide
an early warning of issues with service,
or focus attention on areas where
communication, training or changes in
operations might improve delivery of
products or services. These collections
will allow for ongoing, collaborative and
actionable communications between the
Agency and its customers and
stakeholders. It will also allow feedback
to contribute directly to the
improvement of program management.
Feedback collected under this generic
clearance will provide useful
information, but it will not yield data
that can be generalized to the overall
population. This type of generic
clearance for qualitative information
will not be used for quantitative
information collections that are
designed to yield reliably actionable
results, such as monitoring trends over
time or documenting program
performance. Such data uses require
more rigorous designs that address: The
target population to which
generalizations will be made, the
sampling frame, the sample design
(including stratification and clustering),
the precision requirements or power
calculations that justify the proposed
sample size, the expected response rate,
methods for assessing potential nonresponse bias, the protocols for data
collection, and any testing procedures
that were or will be undertaken prior
fielding the study. Depending on the
degree of influence the results are likely
to have, such collections may still be
eligible for submission for other generic
mechanisms that are designed to yield
quantitative results.
The Agency received no comments in
response to the 60-day notice published
in the Federal Register on March 23,
2018 (vol. 83, No. 57, pages 12766–
12768). OMB approval is requested for
three years. The estimated annualized
burden hours are 22,250.
E:\FR\FM\19MRN1.SGM
19MRN1
]]>Agencies
[Federal Register Volume 84, Number 53 (Tuesday, March 19, 2019)]
[Notices]
[Pages 10091-10093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05155]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30 Day-19-1090]
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 Formative and Summative Evaluation of Scaling
the National Diabetes Prevention Program (National DPP) in Underserved
Areas 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 October 4,
2018 to obtain comments from the public and affected agencies. CDC
received and responded to five sets of unique public comments related
to the previous notice. This notice serves to allow an additional 30
[[Page 10092]]
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 agency's 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 or send an email to omb@cdc.gov. 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
Formative and Summative Evaluation of Scaling the National Diabetes
Prevention Program (National DPP) in Underserved Areas (OMB No. 0920-
1090, exp. 12/31/2018)--Reinstatement with Change--National Center for
Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The CDC-led National Diabetes Prevention Program (DPP) is a
partnership of public and private organizations working collectively to
build the infrastructure for nationwide delivery of an evidence-based
lifestyle change program to prevent or delay type 2 diabetes among
adults with prediabetes. The National DPP lifestyle change program is
founded on the science of the Diabetes Prevention Program research
study and several translation studies that followed, which showed that
making modest behavior changes helped people with prediabetes lose 5%
to 7% of their body weight and reduce their risk of developing type 2
diabetes by 58% (71% for people over 60 years old). From 2012 to 2017,
CDC funded six national organizations through a cooperative agreement
to establish and expand multistate networks of over 200 program
delivery organizations that were able to meet national standards and
achieve the outcomes proven to prevent or delay onset of type 2
diabetes. CDC has conducted a formative and summative evaluation of
this program and used the evaluation findings and lessons learned to
provide data-driven technical assistance to the grantees and other
organizations delivering the National DPP lifestyle change program. The
data and lessons learned from DP12-1212 were also used to inform
decision-making and policy, including the development of the Centers
for Medicare & Medicaid Services (CMS) Medicare Diabetes Prevention
Program (MDPP). As of April 1, 2018, the MDPP Expanded Model provides
coverage for the National DPP lifestyle change program for eligible
Medicare beneficiaries.
Despite the fact that over 1,700 CDC-recognized organizations in 50
states, the District of Columbia, Puerto Rico, the Virgin Islands, and
other U.S.-affiliated island jurisdictions/territories offer the
National DPP lifestyle change program, there are still many geographic
areas with few, or no, in-person delivery programs. In addition, some
populations, including Medicare beneficiaries, men, African-Americans,
Asian-Americans, Hispanics, American Indians, Alaska Natives, Pacific
Islanders, and people with visual impairment or physical disabilities,
are under-enrolled relative to their estimated numbers and disease
burden. To address these gaps, CDC funded a new, five-year cooperative
agreement with ten new national organizations in September 2017,
``Scaling the National DPP in Underserved Areas'' (DP17-1705). CDC
funded 10 national organizations with affiliate program delivery sites
in at least three states, each to start new CDC-recognized
organizations in underserved areas and to enroll both general and
priority populations in new or existing CDC-recognized organizations.
The DP17-1705 grantees will work on activities designed to accomplish
three main goals:
(1) Build the infrastructure in underserved areas necessary to
deliver the National DPP lifestyle change program to the general
population and to priority populations, including Medicare
beneficiaries, men, African-Americans, Asian-Americans, Hispanics,
American Indians, Alaska Natives, Pacific Islanders, and non-
institutionalized people with visual or physical disabilities;
(2) Tailor and adapt the program to address the unique needs and
challenges of the enrolled participants; and
(3) Provide participants with specialized support needed to
successfully complete the program and achieve 5-7% weight loss. Through
this new cooperative agreement, it is anticipated that enrollment,
retention, and achievement of 5-7% weight loss in the targeted
populations will increase.
At this time, CDC requests an additional three years of OMB
approval to continue collecting information needed to evaluate the
effectiveness of CDC's funding for the new grantees. The data
collection will allow CDC to continue to provide data-driven, tailored
programmatic technical assistance to ensure continuous quality
improvement for each year of the cooperative agreement. A number of
additional changes to the evaluation forms are proposed based on the
public comments received from the previously published notice on
October 4, 2018 to reduce burden on respondents. Evaluation data
elements have been modified accordingly to ensure that reporting and
evaluation requirements are consistent with the aims of the new
cooperative agreement and reflect lessons learned from the original
funded national organizations and their affiliate delivery sites. Also,
the method of data collection has changed from an Excel spreadsheet to
a web-based data system to allow for real-time feedback and technical
assistance. The estimated reporting burden has increased and is
expected to vary between three and five hours with an average of four
hours per grantee response (increased from average of three hours in
the previous notice), and between five and seven hours with an average
of six hours per affiliate delivery site response (increased from an
average of five hours in the previous notice). These estimated burden
hours include the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and entering
data in the web-based data system. The number of respondents will
increase with the increased number of grantees. These changes result in
a net increase of 478 annualized burden
[[Page 10093]]
hours. There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
National DPP Affiliate Delivery Sites. Evaluation Form for 100 1 6
Sites.
National DPP Grantees................. Evaluation Form for 10 1 4
Grantees.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-05155 Filed 3-18-19; 8:45 am]
BILLING CODE 4163-18-P
