Supplemental Evidence and Data Request on Evaluation of Mental Health Applications, 28601-28602 [2021-11186]
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Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
developed based on the Consolidated
Framework for Implementation
Research framework will be used to
conduct the interviews, together with a
corresponding consent form.
Estimated Annual Respondent Burden
Exhibit 1 shows only the estimated
annualized burden hours for the
respondents’ time to participate in
updates to the information collection of
the SPPC–II Demonstration Project.
One-hour qualitative interviews will
be conducted with a total of 8 AIM
Team Leads and 30-minute qualitative
interviews with 32 frontline staff in 8
hospitals. We will also conduct 8 one-
hour focus group discussions with a
total of 40 AIM Team Leads and
frontline staff in the same hospitals.
The total burden hours resulting from
the proposed updates to the SPPC–II
data collection is 64 hours. The total
annual burden hours are estimated to be
54,693 hours.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Hours per
response
Total
burden
hours
Qualitative semi-structured interviews with AIM Team Leads ........................
Qualitative semi-structured interviews with frontline staff ...............................
Focus group discussions with AIM Team Leads and frontline staff ...............
8
32
40
1
1
1
1.00
0.50
1
8
16
40
Total ..........................................................................................................
80
NA
NA
64
Exhibit 2 shows only the hours and
cost of updates to the collection. The
total cost burden of the updated
collection is estimated to be
$1,421,576.68 annually.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form name
Total
burden
hours
Average
hourly
wage rate *
Total cost
burden
Qualitative semi-structured interviews with AIM Team Leads ........................
Qualitative semi-structured interviews with frontline staff ...............................
Focus group discussions with AIM Team Leads and frontline staff ...............
8
32
40
8
16
40
$49.83
49.83
49.83
$398.64
797.28
1,993.20
Total ..........................................................................................................
80
64
........................
3,189.12
jbell on DSKJLSW7X2PROD with NOTICES
* National Compensation Survey: Occupational wages in the United States May 2017 ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
Weighted mean hourly wage for obstetrician-gynecologists ($113.10; occupation code 29–1064; 30%); nurse-midwives ($49.83; occupation code
29–1161; 30%); registered nurses ($35.36; occupation code 29–1161; 20%); and nurse practitioners ($51.86; occupation code 29–1171; 20%).
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
VerDate Sep<11>2014
17:29 May 26, 2021
Jkt 253001
comments will become a matter of
public record.
Dated: May 21, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–11195 Filed 5–26–21; 8:45 am]
BILLING CODE 4160–90–P
Evaluation of Mental Health
Applications, which is currently being
conducted by the AHRQ’s Evidencebased Practice Centers (EPC) Program.
Access to published and unpublished
pertinent scientific information will
improve the quality of this review.
Submission Deadline on or
before June 28, 2021.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Evaluation of Mental
Health Applications
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
the public. Scientific information is
being solicited to inform our review on
SUMMARY:
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
ADDRESSES:
Email submissions: epc@
ahrq.hhs.gov.
Print submissions:
Mailing Address: Center for Evidence
and Practice Improvement, Agency for
Healthcare Research and Quality,
ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A,
Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.):
Center for Evidence and Practice
Improvement, Agency for Healthcare
Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane,
Mail Stop 06E77D, Rockville, MD
20857.
E:\FR\FM\27MYN1.SGM
27MYN1
28602
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Jenae Benns, Telephone: 301–427–1496
or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Evaluation of Mental
Health Applications. AHRQ is
conducting this technical brief pursuant
to Section 902 of the Public Health
Service Act, 42 U.S.C. 299a.
The EPC Program is dedicated to
identifying as many studies as possible
that are relevant to the questions for
each of its reviews. In order to do so, we
are supplementing the usual manual
and electronic database searches of the
literature by requesting information
from the public (e.g., details of studies
conducted). We are looking for studies
that report on Evaluation of Mental
Health Applications, specifically the
following:
• Characteristics and minimal
standards in terms of appropriateness
and effectiveness of available behavioral
health applications including adverse
events.
• Behavioral health applications
assessment frameworks for evaluation/
scoring tools.
• The entire research protocol is
available online at: https://
effectivehealthcare.ahrq.gov/products/
mental-health-apps/protocol.
This is to notify the public that the
EPC Program would find the following
information on Evaluation of Mental
Health Applications helpful:
D A list of completed studies that
your organization has sponsored for this
indication. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov, a
summary, including the following
elements: study number, study period,
design, methodology, indication and
diagnosis, proper use instructions,
inclusion and exclusion criteria,
primary and secondary outcomes,
baseline characteristics, number of
patients screened/eligible/enrolled/lost
to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
D A list of ongoing studies that your
organization has sponsored for this
indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including a study number, the
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
VerDate Sep<11>2014
17:29 May 26, 2021
Jkt 253001
criteria, and primary and secondary
outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this indication and an
index outlining the relevant information
in each submitted file.
Your contribution is very beneficial to
the Program. Materials submitted must
be publicly available or able to be made
public. Materials that are considered
confidential; marketing materials; study
types not included in the review; or
information on indications not included
in the review cannot be used by the EPC
Program. This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter.
The draft of this review will be posted
on AHRQ’s EPC Program website and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://
www.effectivehealthcare.ahrq.gov/
email-updates.
The technical brief will answer the
following questions. This information is
provided as background. AHRQ is not
requesting that the public provide
answers to these questions.
Guiding Key Questions (KQs)
1. What characteristics and minimal
standards of available behavioral health
mobile applications need to be analyzed
in existing tools to assess the
appropriateness (to various
stakeholders) and effectiveness of
available apps to include, but not
limited to:
• Accessibility including ease of use,
health literacy, 508 compliance,
digital equity, cost
• App background including funding
source, purpose
• Security features and privacy policy
such as data ownership/usage
• Clinical foundation and linkage to
current evidence-base
• Usability, including interoperability
across platforms, stability
• Therapeutic goals, linkage to the
provider, crisis warning notification/
alert system
2. Identify or develop an assessment
framework for evaluation/scoring tools
(e.g., websites) and apply the framework
to help consumers, family members and
peer supports, providers and health
systems select behavioral health mobile
applications. The framework will take
into account current FDA status on the
use and classification of risks of apps in
healthcare.
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
Dated: May 21, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–11186 Filed 5–26–21; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0514]
Postmarket Surveillance Under Section
522 of the Federal Food, Drug, and
Cosmetic Act; Draft 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 the draft
guidance entitled ‘‘Postmarket
Surveillance Under Section 522 of the
Federal Food, Drug, and Cosmetic Act.’’
The existing postmarket surveillance
guidance was issued in May 2016 to
address certain postmarket surveillance
requirements. This draft guidance is
intended to update the 2016 guidance to
increase transparency to stakeholders on
FDA’s approach to the issuance and
tracking of these postmarket
surveillance orders, and expectations for
timely study completion. 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 July 26, 2021 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:
SUMMARY:
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
E:\FR\FM\27MYN1.SGM
27MYN1
]]>Agencies
[Federal Register Volume 86, Number 101 (Thursday, May 27, 2021)]
[Notices]
[Pages 28601-28602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11186]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Evaluation of Mental
Health Applications
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submissions.
-----------------------------------------------------------------------
SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on Evaluation of
Mental Health Applications, which is currently being conducted by the
AHRQ's Evidence-based Practice Centers (EPC) Program. Access to
published and unpublished pertinent scientific information will improve
the quality of this review.
DATES: Submission Deadline on or before June 28, 2021.
ADDRESSES:
Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement,
Agency for Healthcare Research and Quality, ATTN: EPC SEADs
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.): Center for Evidence and
Practice Improvement, Agency for Healthcare Research and Quality, ATTN:
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville,
MD 20857.
[[Page 28602]]
FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Evaluation of Mental
Health Applications. AHRQ is conducting this technical brief pursuant
to Section 902 of the Public Health Service Act, 42 U.S.C. 299a.
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Evaluation of Mental Health Applications, specifically
the following:
Characteristics and minimal standards in terms of
appropriateness and effectiveness of available behavioral health
applications including adverse events.
Behavioral health applications assessment frameworks for
evaluation/scoring tools.
The entire research protocol is available online at:
https://effectivehealthcare.ahrq.gov/products/mental-health-apps/protocol.
This is to notify the public that the EPC Program would find the
following information on Evaluation of Mental Health Applications
helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
[ssquf] For completed studies that do not have results on
ClinicalTrials.gov, a summary, including the following elements: study
number, study period, design, methodology, indication and diagnosis,
proper use instructions, inclusion and exclusion criteria, primary and
secondary outcomes, baseline characteristics, number of patients
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including a study number, the study period,
design, methodology, indication and diagnosis, proper use instructions,
inclusion and exclusion criteria, and primary and secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this indication and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on indications not
included in the review cannot be used by the EPC Program. This is a
voluntary request for information, and all costs for complying with
this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
The technical brief will answer the following questions. This
information is provided as background. AHRQ is not requesting that the
public provide answers to these questions.
Guiding Key Questions (KQs)
1. What characteristics and minimal standards of available
behavioral health mobile applications need to be analyzed in existing
tools to assess the appropriateness (to various stakeholders) and
effectiveness of available apps to include, but not limited to:
Accessibility including ease of use, health literacy, 508
compliance, digital equity, cost
App background including funding source, purpose
Security features and privacy policy such as data ownership/
usage
Clinical foundation and linkage to current evidence-base
Usability, including interoperability across platforms,
stability
Therapeutic goals, linkage to the provider, crisis warning
notification/alert system
2. Identify or develop an assessment framework for evaluation/
scoring tools (e.g., websites) and apply the framework to help
consumers, family members and peer supports, providers and health
systems select behavioral health mobile applications. The framework
will take into account current FDA status on the use and classification
of risks of apps in healthcare.
Dated: May 21, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-11186 Filed 5-26-21; 8:45 am]
BILLING CODE 4160-90-P
