Agency Information Collection Activities: Proposed Collection; Comment Request, 65406-65409 [2020-22795]
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65406
Federal Register / Vol. 85, No. 200 / Thursday, October 15, 2020 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents
Form name
Total ..........................................................................................................
Total burden
hours
255
75
Average
hourly wage
rate *
53.95
Total cost
burden
4,046.78
* National Compensation Survey: Occupational wages in the United States May 2019, ‘‘U.S. Department of Labor, Bureau of Labor Statistics’’,
https://www.bls.gov/oes/current/oes_nat.htm#b29-0000.htm.
a Based on the mean wages for all occupations (00–0000).
b Based on the mean wages for Family Medicine Physicians (29–1215).
Request for Comments
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ’s health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: October 8, 2020.
Marquita Cullom-Stott,
Associate Director.
Proposed Project
[FR Doc. 2020–22837 Filed 10–14–20; 8:45 am]
Programmatic Information Collection
for the AHRQ Initiative To Support
Primary Care To Advance
Cardiovascular Health in States With
High Prevalence of Preventable CVD
Events
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
jbell on DSKJLSW7X2PROD with NOTICES
AGENCY:
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project
SUMMARY:
VerDate Sep<11>2014
17:41 Oct 14, 2020
‘‘Programmatic Information Collection
for the AHRQ Initiative to Support
Primary Care to Advance Cardiovascular
Health in States with High Prevalence of
Preventable CVD Events.’’
This proposed information collection
was previously published in the Federal
Register on August 5th, 2020 and
allowed 60 days for public comment.
AHRQ received no substantive
comments from members of the public.
The purpose of this notice is to allow an
additional 30 days for public comment.
DATES: Comments on this notice must be
received within 30 days of the date of
publication.
ADDRESSES: Written 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.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Jkt 253001
Despite improvements in recent years,
cardiovascular disease (CVD) is a
significant national health burden and
the leading cause of death, involved in
nearly one of every three deaths.
Modifiable risk factors for CVD, such as
high blood pressure, high cholesterol,
and smoking, remain poorly controlled.
Evidence from patient-centered
outcomes research (PCOR) shows that
increasing the delivery of the ABCS of
heart health—Aspirin in high-risk
individuals, Blood pressure control,
Cholesterol management, and Smoking
cessation—can reduce risk and reduce
heart attacks and strokes.
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In 2010, Congress established the
Patient-Centered Outcomes Research
(PCOR) Trust Fund and instructed
AHRQ to support the dissemination of
PCOR findings. In accordance with its
mandated role, AHRQ issued a Request
for Applications (RFA) entitled
Supporting Primary Care to Advance
Cardiovascular Health in States with
High Prevalence of Preventable CVD
Events. AHRQ anticipates investing up
to $18 million to support a maximum of
4 awards. Each grantee will establish a
state-level entity—known as a
Cooperative—to support primary care
improvement and run a Heart Health
Quality Improvement (QI) project. The
expected earliest start date for the grants
is December 30, 2020.
This initiative has the following goals:
1. To improve heart health and help
reduce CVD disparities by engaging
with primary care practices, and
disseminating and implementing PCOR
findings to improve care delivery.
2. To learn how to develop
sustainable state-level primary care QI
infrastructure to improve the uptake of
PCOR evidence in primary care.
3. To disseminate lessons learned,
which take into consideration the
context in which each program
operated, on how to replicate successes
and avoid challenges.
This new grant initiative is being
conducted pursuant to AHRQ’s
statutory authority to support the
agency’s dissemination of PCOR
findings. 42 U.S.C. 299b–37(a)–(c). The
information collection described in this
request is being collected under AHRQ’s
authority in 42 U.S.C. 299b–37(c),
which authorizes AHRQ to gather
feedback about the value of the PCOR
information it disseminates. The
information described in this request
will be collected by AHRQ’s contractor,
Abt Associates.
Method of Collection
To achieve the goals of this project the
following data collections will be
implemented:
1. Key informant interviews. AHRQ
will conduct phone interviews with a
variety of state-level organizations
involved in primary care support and
E:\FR\FM\15OCN1.SGM
15OCN1
Federal Register / Vol. 85, No. 200 / Thursday, October 15, 2020 / Notices
with primary care practices. This
information will be used to develop case
studies for each Cooperative as well as
program-level generalizations and
lessons learned that might inform other
efforts to improve care delivery.
2. Member check-in sessions. AHRQ
will conduct group phone discussions
with a subset of participants in the key
informant interviews to corroborate case
studies and lessons learned, and to
provide additional shared insights
across participants.
Key Informant Interviews
Individual key informant interviews
will be conducted with the following
groups:
• Grantee and Cooperative
leadership, and Cooperative partners—
about decision to participate in the
project, prior collaborations,
organization and governance of the
Cooperative, nature and extent of
partnerships, what worked well and
barriers, changes to the Cooperative and
their impact on provision of quality
improvement (QI) support, QI support
strategies and their perceived
effectiveness, successful strategies for
recruiting practices and types of
practices recruited, success in
establishing state-level capacity to
provide QI support, factors associated
with successful implementation of QI,
longer-term impact of the grant and
sustainability of capacity developed,
suggestions for improvement, and
lessons learned from the project.
• Unaffiliated organizations involved
in or knowledgeable about primary care
in the states—nature and extent of
connection to the Cooperatives,
awareness of the project, views about
the organization and effectiveness of the
Cooperatives and their networks, other
local activities that may have affected
the work of the Cooperatives, views on
changes in practice capacity to deliver
better care and on sustainability of
improvements, benefits to and any
potential adverse consequences for
patients, suggestions for improvement
and lessons learned from the project.
• Practices within the network not
participating in the Heart Health QI
project—prior collaboration and
experience of recruitment to the
network, decision to participate, nature
of engagement with the Cooperative and
network, benefits and drawbacks of
network participation, interest in
participating in Heart Health QI project,
strategies employed to improve heart
health, knowledge of and views on QI
strategies at participating practices,
concurrent efforts to improve care
delivery, plans to continue participating
in the network, suggestions for
improvement and lessons learned.
• Practices within the network
participating in the Heart Health QI
project—prior collaboration and
experience of recruitment to the
network and Heart Health QI project,
decision to participate, nature of
engagement with the Cooperative and
network, benefits and drawbacks of
network participation, weaknesses in
care delivery that QI strategies are
designed to address and how the
practices handle these, expectations for
improvements stemming from QI
projects and any potential challenges,
nature of and satisfaction with support
for Heart Health QI project, contribution
of QI support to practice capacity to
improve heart health outcomes,
concurrent efforts to improve care
delivery, plans to continue
implementing the intervention, other
benefits of participation in the Heart
Health QI project, plans to remain in the
project, suggestions for improvement
and lessons learned.
A total of 200 interviews is
anticipated over the course of three
years.
All interviews will be conducted by
telephone and are expected to take 45–
60 minutes. Grantee and Cooperative
leadership and Cooperative partner
groups will be interviewed annually for
three years, while the grants are active.
Unaffiliated organizations and network
practices, including those participating
in the Heart Health QI project, will be
interviewed in years 2 and 3 of the
grants . This schedule of interviews
reflects the anticipated evolution of the
state-level entity, development of new
partnerships, recruitment of practices to
the network, and implementation of
Heart Health QI project.
All interviews will include at least
one lead interviewer and a note-taker
and will be recorded with respondents’
permission as a back-up. Detailed notes
65407
will be prepared after each interview.
The purpose of the proposed
information collection effort is to
explore each grantee’s primary care
quality improvement, including their
members and partners; and their
experiences and achievements.
Additionally, this information
collection will serve to help synthesize
insights from across grantees, identify
key themes, and distill lessons learned,
taking into consideration the context in
which each program operated.
The following knowledge will be
generated to understand the
contribution of the program to
developing sustainable state-level
capacity to implement PCOR findings in
primary care and the pros and cons of
various Cooperative models, as well as
lessons learned about approaches to
assisting practices in implementing
evidence to improve care.
Estimated Annual Respondent Burden
Table 1 presents estimates of the
reporting burden hours for the
information collection efforts. Time
estimates are based on prior experiences
and what can reasonably be requested of
participating entities.
Key-informant interviews. In-depth
interviews will be conducted with the
total of up to 88 individuals.
Respondents from Grantee and
Cooperative leadership and Cooperative
partner groups will be interviewed
every year for three years. Respondents
from unaffiliated organizations and nonparticipating practices will be
interviewed twice, in years 2 and 3, and
respondents from participating practices
once or twice in years 2 and 3. The
interviews are expected to last for up to
1 hour.
Member-checking sessions. Three
member-checking sessions will be
conducted with a total of up to 36
participants. Grantee and Cooperative
leadership and key Cooperative
organizations and partners will
participate in two sessions, in year 1
and year 3. Network practices (those
participating and not participating in
heart health QI project) will participate
in a member-checking session only in
year 3. The sessions are expected to last
for up to 1.5 hours.
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TABLE 1—ESTIMATED ANNUALIZED BURDEN HOURS
A.
B.
C.
D.
Number of
respondents
Number of
responses per
respondent
Hours per
response
Total burden
hours
A*B*C
Data collection method or project activity
Key Informant Interviews:
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18:52 Oct 14, 2020
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65408
Federal Register / Vol. 85, No. 200 / Thursday, October 15, 2020 / Notices
TABLE 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued
A.
B.
C.
D.
Number of
respondents
Number of
responses per
respondent
Hours per
response
Total burden
hours
A*B*C
Data collection method or project activity
Grantee leadership ...................................................................................
Cooperative leadership .............................................................................
Cooperative partners ................................................................................
Unaffiliated organizations .........................................................................
Practices in network not participating in Heart Health QI project ............
Practices in network participating in Heart Health QI project ..................
Member Checking Sessions:
Grantee leadership ...................................................................................
Cooperative leadership .............................................................................
Cooperative partners ................................................................................
Unaffiliated organizations .........................................................................
Network practices .....................................................................................
12
12
24
12
8
20
3
3
* 2.5
2
2
** 1.4
1
1
1
1
1
1
36
36
60
24
16
28
4
4
2
2
12
2
2
2
2
1
1.5
1.5
1.5
1.5
1.5
12
12
6
6
18
Total ...................................................................................................
112
........................
........................
254
* Note: This number reflects that in Year 1 we will only interview 12 respondents, but 24 in years 2 and 3, hence 2.5 # of responses.
** This number reflects that in Year 2 we will interview 8 respondents and in year 3 we will interview 20 respondents.
Table 2 presents the estimated
annualized cost burden associated with
the respondents’ time to participate in
this research. The total cost burden is
estimated to be $29, 260.96.
TABLE 2—ESTIMATED ANNUALIZED COST BURDEN
A.
B.
C.
D.
Number of
respondents
Total burden
hours
Average
hourly rate
Total cost burden
B*C
Data collection method or project activity
Key Informant Interviews:
Grantee leadership ...................................................................................
Cooperative leadership .............................................................................
Cooperative partners ................................................................................
Unaffiliated organizations .........................................................................
Practices in network not participating in Heart Health QI project ............
Practices in network participating in Heart Health QI project ..................
Member Checking Sessions:
Grantee leadership ...................................................................................
Cooperative leadership .............................................................................
Cooperative partners ................................................................................
Unaffiliated organizations .........................................................................
Network practices .....................................................................................
Total ...................................................................................................
12
12
24
12
8
20
36
36
60
24
16
28
$110.74
110.74
110.74
110.74
136.49
136.49
$3,986.64
3,986.64
6,644.40
2,657.76
2,183.84
3,821.72
4
4
4
2
12
12
12
6
6
18
110.74
110.74
110.74
110.74
110.74
1,328.88
1,328.88
664.44
664.44
1,993.32
112
254
........................
29,260.96
Note: the rates were based on the mean hourly wages from the Bureau of Labor & Statistics for the closest categories of respondents and
doubled to account for overhead and fringe.
jbell on DSKJLSW7X2PROD with NOTICES
The mean hourly wage rates were
obtained from the Bureau of Labor &
Statistics and doubled to account for
overhead and fringe benefits. The
occupational codes used were as
follows:
9111, $53.37), and nurse practitioners
(29–1171, $53.77)
Request for Comments
• For grantee and cooperative
leadership, partners, and unaffiliated
organizations—medical and health
service managers (11–9111, $53.37)
• For practices—an average of
physicians (29–1228, $97.81), medical
and health services managers (11–
VerDate Sep<11>2014
17:41 Oct 14, 2020
Jkt 253001
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ’s health care research and health
care information dissemination
functions, including whether the
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
E:\FR\FM\15OCN1.SGM
15OCN1
Federal Register / Vol. 85, No. 200 / Thursday, October 15, 2020 / Notices
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: October 8, 2020.
Marquita Cullom-Stott,
Associate Director.
[FR Doc. 2020–22795 Filed 10–14–20; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–1261]
Technical Considerations for NonClinical Assessment of Medical
Devices Containing Nitinol; Guidance
for Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Technical
Considerations for Non-Clinical
Assessment of Medical Devices
containing Nitinol.’’ The Agency has
developed this guidance to provide
FDA’s current thinking on technical
considerations specific to devices using
nitinol due to the unique properties of
nitinol. This guidance document is
intended to provide clarity and
consistency in recommended nonclinical assessments across a variety of
medical devices that contain nitinol.
DATES: The announcement of the
guidance is published in the Federal
Register on October 15, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
VerDate Sep<11>2014
17:41 Oct 14, 2020
Jkt 253001
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–1261 for ‘‘Technical
Considerations for Non-Clinical
Assessment of Medical Devices
containing Nitinol.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
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65409
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Technical
Considerations for Non-Clinical
Assessment of Medical Devices
containing Nitinol’’ to the Office of
Policy, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Matthew Di Prima, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 62, Rm. 2124, Silver Spring,
MD 20993–0002, 301–796–2507.
SUPPLEMENTARY INFORMATION:
I. Background
The use of nitinol in medical devices
began over three decades ago in product
areas such as orthodontic archwires,
cardiovascular guidewires, and surgical
instruments. Its use has increased over
the past two decades into different
device areas such as orthopaedic
fracture fixation, coronary stents, and
transcatheter heart valves. With an
increasing trend to treat patients using
minimally invasive procedures, nitinol
has become a popular choice of material
due to its ability to return to its original
shape after being mechanically
deformed or after heat is applied. Given
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]]>Agencies
[Federal Register Volume 85, Number 200 (Thursday, October 15, 2020)]
[Notices]
[Pages 65406-65409]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22795]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve the proposed information collection
project ``Programmatic Information Collection for the AHRQ Initiative
to Support Primary Care to Advance Cardiovascular Health in States with
High Prevalence of Preventable CVD Events.''
This proposed information collection was previously published in
the Federal Register on August 5th, 2020 and allowed 60 days for public
comment. AHRQ received no substantive comments from members of the
public. The purpose of this notice is to allow an additional 30 days
for public comment.
DATES: Comments on this notice must be received within 30 days of the
date of publication.
ADDRESSES: Written 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.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
Programmatic Information Collection for the AHRQ Initiative To Support
Primary Care To Advance Cardiovascular Health in States With High
Prevalence of Preventable CVD Events
Despite improvements in recent years, cardiovascular disease (CVD)
is a significant national health burden and the leading cause of death,
involved in nearly one of every three deaths. Modifiable risk factors
for CVD, such as high blood pressure, high cholesterol, and smoking,
remain poorly controlled. Evidence from patient-centered outcomes
research (PCOR) shows that increasing the delivery of the ABCS of heart
health--Aspirin in high-risk individuals, Blood pressure control,
Cholesterol management, and Smoking cessation--can reduce risk and
reduce heart attacks and strokes.
In 2010, Congress established the Patient-Centered Outcomes
Research (PCOR) Trust Fund and instructed AHRQ to support the
dissemination of PCOR findings. In accordance with its mandated role,
AHRQ issued a Request for Applications (RFA) entitled Supporting
Primary Care to Advance Cardiovascular Health in States with High
Prevalence of Preventable CVD Events. AHRQ anticipates investing up to
$18 million to support a maximum of 4 awards. Each grantee will
establish a state-level entity--known as a Cooperative--to support
primary care improvement and run a Heart Health Quality Improvement
(QI) project. The expected earliest start date for the grants is
December 30, 2020.
This initiative has the following goals:
1. To improve heart health and help reduce CVD disparities by
engaging with primary care practices, and disseminating and
implementing PCOR findings to improve care delivery.
2. To learn how to develop sustainable state-level primary care QI
infrastructure to improve the uptake of PCOR evidence in primary care.
3. To disseminate lessons learned, which take into consideration
the context in which each program operated, on how to replicate
successes and avoid challenges.
This new grant initiative is being conducted pursuant to AHRQ's
statutory authority to support the agency's dissemination of PCOR
findings. 42 U.S.C. 299b-37(a)-(c). The information collection
described in this request is being collected under AHRQ's authority in
42 U.S.C. 299b-37(c), which authorizes AHRQ to gather feedback about
the value of the PCOR information it disseminates. The information
described in this request will be collected by AHRQ's contractor, Abt
Associates.
Method of Collection
To achieve the goals of this project the following data collections
will be implemented:
1. Key informant interviews. AHRQ will conduct phone interviews
with a variety of state-level organizations involved in primary care
support and
[[Page 65407]]
with primary care practices. This information will be used to develop
case studies for each Cooperative as well as program-level
generalizations and lessons learned that might inform other efforts to
improve care delivery.
2. Member check-in sessions. AHRQ will conduct group phone
discussions with a subset of participants in the key informant
interviews to corroborate case studies and lessons learned, and to
provide additional shared insights across participants.
Key Informant Interviews
Individual key informant interviews will be conducted with the
following groups:
Grantee and Cooperative leadership, and Cooperative
partners--about decision to participate in the project, prior
collaborations, organization and governance of the Cooperative, nature
and extent of partnerships, what worked well and barriers, changes to
the Cooperative and their impact on provision of quality improvement
(QI) support, QI support strategies and their perceived effectiveness,
successful strategies for recruiting practices and types of practices
recruited, success in establishing state-level capacity to provide QI
support, factors associated with successful implementation of QI,
longer-term impact of the grant and sustainability of capacity
developed, suggestions for improvement, and lessons learned from the
project.
Unaffiliated organizations involved in or knowledgeable
about primary care in the states--nature and extent of connection to
the Cooperatives, awareness of the project, views about the
organization and effectiveness of the Cooperatives and their networks,
other local activities that may have affected the work of the
Cooperatives, views on changes in practice capacity to deliver better
care and on sustainability of improvements, benefits to and any
potential adverse consequences for patients, suggestions for
improvement and lessons learned from the project.
Practices within the network not participating in the
Heart Health QI project--prior collaboration and experience of
recruitment to the network, decision to participate, nature of
engagement with the Cooperative and network, benefits and drawbacks of
network participation, interest in participating in Heart Health QI
project, strategies employed to improve heart health, knowledge of and
views on QI strategies at participating practices, concurrent efforts
to improve care delivery, plans to continue participating in the
network, suggestions for improvement and lessons learned.
Practices within the network participating in the Heart
Health QI project--prior collaboration and experience of recruitment to
the network and Heart Health QI project, decision to participate,
nature of engagement with the Cooperative and network, benefits and
drawbacks of network participation, weaknesses in care delivery that QI
strategies are designed to address and how the practices handle these,
expectations for improvements stemming from QI projects and any
potential challenges, nature of and satisfaction with support for Heart
Health QI project, contribution of QI support to practice capacity to
improve heart health outcomes, concurrent efforts to improve care
delivery, plans to continue implementing the intervention, other
benefits of participation in the Heart Health QI project, plans to
remain in the project, suggestions for improvement and lessons learned.
A total of 200 interviews is anticipated over the course of three
years.
All interviews will be conducted by telephone and are expected to
take 45-60 minutes. Grantee and Cooperative leadership and Cooperative
partner groups will be interviewed annually for three years, while the
grants are active. Unaffiliated organizations and network practices,
including those participating in the Heart Health QI project, will be
interviewed in years 2 and 3 of the grants . This schedule of
interviews reflects the anticipated evolution of the state-level
entity, development of new partnerships, recruitment of practices to
the network, and implementation of Heart Health QI project.
All interviews will include at least one lead interviewer and a
note-taker and will be recorded with respondents' permission as a back-
up. Detailed notes will be prepared after each interview. The purpose
of the proposed information collection effort is to explore each
grantee's primary care quality improvement, including their members and
partners; and their experiences and achievements. Additionally, this
information collection will serve to help synthesize insights from
across grantees, identify key themes, and distill lessons learned,
taking into consideration the context in which each program operated.
The following knowledge will be generated to understand the
contribution of the program to developing sustainable state-level
capacity to implement PCOR findings in primary care and the pros and
cons of various Cooperative models, as well as lessons learned about
approaches to assisting practices in implementing evidence to improve
care.
Estimated Annual Respondent Burden
Table 1 presents estimates of the reporting burden hours for the
information collection efforts. Time estimates are based on prior
experiences and what can reasonably be requested of participating
entities.
Key-informant interviews. In-depth interviews will be conducted
with the total of up to 88 individuals. Respondents from Grantee and
Cooperative leadership and Cooperative partner groups will be
interviewed every year for three years. Respondents from unaffiliated
organizations and non-participating practices will be interviewed
twice, in years 2 and 3, and respondents from participating practices
once or twice in years 2 and 3. The interviews are expected to last for
up to 1 hour.
Member-checking sessions. Three member-checking sessions will be
conducted with a total of up to 36 participants. Grantee and
Cooperative leadership and key Cooperative organizations and partners
will participate in two sessions, in year 1 and year 3. Network
practices (those participating and not participating in heart health QI
project) will participate in a member-checking session only in year 3.
The sessions are expected to last for up to 1.5 hours.
Table 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Data collection method or project activity A. B. C. D.
Number of Number of Hours per Total burden
respondents responses per response hours
respondent A * B * C
----------------------------------------------------------------------------------------------------------------
Key Informant Interviews:
[[Page 65408]]
Grantee leadership.......................... 12 3 1 36
Cooperative leadership...................... 12 3 1 36
Cooperative partners........................ 24 * 2.5 1 60
Unaffiliated organizations.................. 12 2 1 24
Practices in network not participating in 8 2 1 16
Heart Health QI project....................
Practices in network participating in Heart 20 ** 1.4 1 28
Health QI project..........................
Member Checking Sessions:
Grantee leadership.......................... 4 2 1.5 12
Cooperative leadership...................... 4 2 1.5 12
Cooperative partners........................ 2 2 1.5 6
Unaffiliated organizations.................. 2 2 1.5 6
Network practices........................... 12 1 1.5 18
---------------------------------------------------------------
Total................................... 112 .............. .............. 254
----------------------------------------------------------------------------------------------------------------
* Note: This number reflects that in Year 1 we will only interview 12 respondents, but 24 in years 2 and 3,
hence 2.5 # of responses.
** This number reflects that in Year 2 we will interview 8 respondents and in year 3 we will interview 20
respondents.
Table 2 presents the estimated annualized cost burden associated
with the respondents' time to participate in this research. The total
cost burden is estimated to be $29, 260.96.
Table 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Data collection method or project activity A. B. C. D.
Number of Total burden Average Total cost
respondents hours hourly rate burden
B * C
----------------------------------------------------------------------------------------------------------------
Key Informant Interviews:
Grantee leadership.......................... 12 36 $110.74 $3,986.64
Cooperative leadership...................... 12 36 110.74 3,986.64
Cooperative partners........................ 24 60 110.74 6,644.40
Unaffiliated organizations.................. 12 24 110.74 2,657.76
Practices in network not participating in 8 16 136.49 2,183.84
Heart Health QI project....................
Practices in network participating in Heart 20 28 136.49 3,821.72
Health QI project..........................
Member Checking Sessions:
Grantee leadership.......................... 4 12 110.74 1,328.88
Cooperative leadership...................... 4 12 110.74 1,328.88
Cooperative partners........................ 4 6 110.74 664.44
Unaffiliated organizations.................. 2 6 110.74 664.44
Network practices........................... 12 18 110.74 1,993.32
---------------------------------------------------------------
Total................................... 112 254 .............. 29,260.96
----------------------------------------------------------------------------------------------------------------
Note: the rates were based on the mean hourly wages from the Bureau of Labor & Statistics for the closest
categories of respondents and doubled to account for overhead and fringe.
The mean hourly wage rates were obtained from the Bureau of Labor &
Statistics and doubled to account for overhead and fringe benefits. The
occupational codes used were as follows:
For grantee and cooperative leadership, partners, and
unaffiliated organizations--medical and health service managers (11-
9111, $53.37)
For practices--an average of physicians (29-1228, $97.81),
medical and health services managers (11-9111, $53.37), and nurse
practitioners (29-1171, $53.77)
Request for Comments
In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3520, comments on AHRQ's information collection are requested with
regard to any of the following: (a) Whether the proposed collection of
information is necessary for the proper performance of AHRQ's health
care research and health care information dissemination functions,
including whether the information will have practical utility; (b) the
accuracy of AHRQ's estimate of burden (including hours and costs) of
the proposed collection(s) of information; (c) ways to enhance the
quality, utility and clarity of the information to be collected; and
(d) ways to minimize the burden of the collection of information upon
the respondents, including the use of automated collection techniques
or other forms of information technology.
Comments submitted in response to this notice will be summarized
and
[[Page 65409]]
included in the Agency's subsequent request for OMB approval of the
proposed information collection. All comments will become a matter of
public record.
Dated: October 8, 2020.
Marquita Cullom-Stott,
Associate Director.
[FR Doc. 2020-22795 Filed 10-14-20; 8:45 am]
BILLING CODE 4160-90-P
