Attachment 6 -- Federal Register Notice

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Federal Register / Vol. 85, No. 135 / Tuesday, July 14, 2020 / Notices

Exclude comparisons with different
accessories, titration methods, features
to improve comfort or adherence, other
non-CPAP interventions (e.g., different
times of monitoring, scoring), including
noninvasive
Outcomes
• As listed above, for both KQs
• Sleep and breathing measures (e.g.,
AHI) and validated sleep
questionnaires (e.g., Epworth
Sleepiness Scale) (only for the
purpose of addressing KQ 1b, not as
outcomes of interest)
• Adverse events related to CPAP use
Mediators of treatment effect (e.g.,
subgroup analyses; see note above about
mediators)
• As listed above, for both KQs
• New or prior OSA diagnosis
• Treatment naı¨ve versus failed prior
treatment
• First versus second or more use of
CPAP
• Treatment (CPAP) compliance
• Treatment (CPAP) discontinuation
Design
• Randomized controlled trials (RCT)
Æ Consider whether study met power
calculation for the outcome(s) of
interest (including adverse events)
• Nonrandomized comparative studies
(NRCS)
Æ Restrict to studies that use
modeling or other analytic methods
to minimize confounding bias (due
to inherent differences between
people who receive one or the other
intervention)
Æ Exclude case-control design
Æ Exclude ‘‘pre-post’’ design
(comparison of before and after
CPAP treatment in a single group of
participants)
• Longitudinal
Æ Exclude cross-sectional
Additional Eligibility Criteria Specific to
KQ 2
For KQ 2, we will include studies that
measure a change in the intermediate/
surrogate measure (e.g., AHI) over a
period of time and report on outcomes
of interest. We will include studies that
provide formal evaluation of validity of
the intermediate/surrogate measure for
the clinical outcome and other studies
that report sufficient data to analyze a
potential association between the
change in the measure and the clinical
outcome.
Population
• Adults
Æ Do not require a diagnosis of OSA
(for evaluations of associations of
measures)

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Æ Exclude populations as described
under ‘‘Eligibility Criteria relevant
to Both KQs’’
Intermediate/Surrogate measures
(variables of interest evaluated regarding
their association with clinical outcomes)
• Sleep and breathing measures
Æ Indices based on apneas or
hypopneas (e.g., AHI, RDI) or other
respiratory events such as RERAs,
oxygen desaturations
• Exclude evaluations of isolated
neurophysiologic parameters of
sleep (e.g., respiratory effort, heart
rate, air flow, pulse oximetry alone)
and cardiac electrophysiology
indices (e.g., heart rate variability)
Outcomes
• As listed above, for both KQs
• Each study must report both one or
more intermediate/surrogate measures
(i.e., sleep and breathing measures)
and one or more outcomes of interest
Additional mediators of association
(e.g., analyzed by subgroup analyses)
• As listed above, for both KQs
• Definition of sleep and breathing
measure
Study Design
• Longitudinal studies informing on
person-level associations of sleep
and breathing measure(s) with
outcome(s)
Æ Patient-level association between
change in measure and change or
incident outcome (i.e., evaluation of
association reported within study)
Æ Exclude cross-sectional studies
• Comparative or noncomparative
(single group) studies
• N ≥ 30 analyzed for a given
association between intermediate/
surrogate measure and outcome
Dated: July 9, 2020.
Virginia Mackay-Smith,
Associate Director.
[FR Doc. 2020–15172 Filed 7–13–20; 8:45 am]
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.
AGENCY:

This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request

SUMMARY:

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that the Office of Management and
Budget (OMB) approve the proposed
information collection project ‘‘Clinical
Decision Support (CDS) for Chronic
Pain Management.’’
DATES: Comments on this notice must be
received by 60 days after date of
publication of this notice.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
emails at doris.lefkowitz@
AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:

Proposed Project
Clinical Decision Support (CDS) for
Chronic Pain Management
Prescription opioid pain medication
overuse, misuse, and abuse have been a
significant contributing factor in the
opioid epidemic. The goal of this project
is to develop, implement, disseminate,
and evaluate clinical decision support
(CDS) tools for both patients and
clinicians in the management of chronic
pain. The CDS tools are intended to be
interoperable and publicly-shareable,
and will be designed to meet the needs
of patients and clinicians through both
patient-facing and clinician-facing
channels and formats.
The development and deployment of
CDS tools designed to optimize opioid
dose reduction is intended to support
primary care physicians who are not
pain-management specialists as they
care for patients who are at high risk of
harm from opioids. This goal will be
achieved through the design,
development, implementation, and
evaluation of a clinician-facing CDS tool
for chronic pain management that
optimize presentation of patient data
and evidence-based guidelines to
support opioid tapering. The clinicianfacing CDS tool will help non-pain
specialists detect patients at high risk of
harm from opioids, provide
personalized evidence-based guidelines
to support opioid tapering, optimize the
presentation of patient data, and reduce
unnecessary variation in clinical
practice.
The clinician-facing CDS tool will
also assist non-pain specialists in
determining if an opioid taper is
necessary for a specific patient, aid in

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Federal Register / Vol. 85, No. 135 / Tuesday, July 14, 2020 / Notices
performing the taper, and aid in
providing follow-up and support during
the taper. The clinician-facing CDS tools
are meant to accomplish three goals: (1)
Better monitor the patient’s functional
pain and opioid use, (2) visualize
patient data, and (3) incorporate
guidelines for prescribing and tapering
opioids for chronic pain. The patientfacing CDS tool will be used to help
patients at high-risk of harm from
opioids track and manage chronic pain
and daily function to support reduced
opioid use. This goal will be achieved
through the design, development,
implementation, and evaluation of a
CDS tool that facilitates continued
patient provider engagement. This
patient-facing CDS tool will deliver
support in ways that enhance patient
activation, education and engagement,
and collaborative decisions and actions
between patients and their care teams.
The patient-facing CDS tool should
enhance the quality of clinical
discussion between healthcare
providers and patients by allowing for
continued patient engagement outside
of the clinical setting.
This study is being conducted by
AHRQ through its contractor, MedStar
Health, pursuant to AHRQ’s statutory
authority to assist users of health
information technology focused on CDS
to promote the timely incorporation of

comparative clinical effectiveness
research into clinical practices. 42 U.S.C
299b–37(c).
Method of Collection
To achieve the goals of this project the
following data collections will be
implemented.
(1) Post-Use Survey with Primary Care
Providers ‘‘Evaluation Provider
Survey’’: This evaluation includes the
collection of qualitative data through a
short survey with primary care
providers who used the clinician-facing
CDS tool for chronic pain management
(up to a maximum of 60). The research
team will collect insights from providers
on their experience of implementing
and using the clinician-facing CDS tool
for chronic pain management. The
survey will be accessible in both online
and paper formats.
(2) Post-Use Survey with Patients
‘‘Evaluation Patient Survey’’: This
evaluation includes the collection of
qualitative data through a short survey
with patients who used the patientfacing CDS tool for pain management
(up to a maximum of 150). The research
team will collect insights from patients
on their experience of implementing
and using patient-facing CDS. The
survey will be accessible in both online
and paper formats.
(3) Post-Use Interview with Primary
Care Providers ‘‘Evaluation Provider

Interview’’: This evaluation component
includes the collection of qualitative
data through an in-depth thirty-minute
interview with primary care providers
who used the clinician-facing CDS tool
for chronic pain management (up to a
maximum of 10). The research team will
collect insights from providers on their
experience of implementing and using
this clinician-facing CDS tool.
(4) Post-Use Interviews with Patients
‘‘Evaluation Patient Interview’’: This
evaluation component includes the
collection of qualitative data through an
in-depth thirty-minute interview with
patients who used the patient-facing
CDS tool for pain management (up to a
maximum of 20). The research team will
collect insights from patients on their
experience of implementing and using
the patient-facing CDS tool.
(5) Post-Use Interviews with Site
Champions ‘‘Evaluation Site Champion
Interview’’: This evaluation component
includes the collection of qualitative
data through thirty-minute interviews
with site leads (up to a maximum of 15)
and site visits during which the research
team will collect insights from providers
and patients on their experience of
implementing and using the clinicalfacing and patient-facing CDS tools from
the perspective of the site champions.
Estimated Annual Respondent Burden

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name
Post-Use
Post-Use
Post-Use
Post-Use
Post-Use

Number of
responses per
respondent

Hours per
response

Total burden
hours

Survey with Providers ......................................................................
Survey with Patients ........................................................................
Interview with Providers ...................................................................
Interview with Patients .....................................................................
Interview with Site Champions ........................................................

60
150
10
20
15

1
1
1
1
1

0.25
0.25
0.5
0.5
0.5

15
37.5
5
10
7.5

Total ..........................................................................................................

255

5

2

75

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Form name

Total burden
hours

Average
hourly
wage rate *

Total cost
burden

Survey with Providers ......................................................................
Survey with Patients ........................................................................
Interview with Providers ...................................................................
Interview with Patients .....................................................................
Interview with Site Champions ........................................................

60
150
10
20
15

15
37.5
5
10
7.5

b $102.73

b 102.73

$1,540.95
964.50
513.65
257.20
770.48

Total ..........................................................................................................

255

75

53.95

4,046.78

Post-Use
Post-Use
Post-Use
Post-Use
Post-Use

a 25.72
b 102.73
a 25.72

* 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).

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Federal Register / Vol. 85, No. 135 / Tuesday, July 14, 2020 / Notices

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: July 8, 2020.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2020–15147 Filed 7–13–20; 8:45 am]
BILLING CODE 4160–90–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1118]

Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:

The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Select Updates for
Guidance for the Non-Clinical and
Clinical Investigation of Devices Used
for the Treatment of Benign Prostatic
Hyperplasia (BPH).’’ FDA has developed
this draft guidance to propose select
updates to certain sections of the
existing FDA guidance document
‘‘Guidance for the Non-Clinical and
Clinical Investigation of Devices Used
for the Treatment of Benign Prostatic

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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
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’’).
Written/Paper Submissions

Select Updates for Guidance for the
Non-Clinical and Clinical Investigation
of Devices Used for the Treatment of
Benign Prostatic Hyperplasia; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability

SUMMARY:

Hyperplasia (BPH).’’ This draft guidance
is not final nor is it in effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by September 14, 2020 to ensure that
the Agency considers your comment on
this draft guidance before it begins work
on the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:

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–
2020–D–1118 for ‘‘Select Updates for
Guidance for the Non-Clinical and
Clinical Investigation of Devices Used
for the Treatment of Benign Prostatic
Hyperplasia (BPH).’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly

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viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• 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
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.
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 draft guidance
document entitled ‘‘Select Updates for
Guidance for the Non-Clinical and
Clinical Investigation of Devices Used
for the Treatment of Benign Prostatic
Hyperplasia (BPH)’’ to the Office of
Policy, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug

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