Supplemental Evidence and Data Request on Evaluation of Mental Health Applications, 28601-28602 [2021-11186]

Download as PDF 28601 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