Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2023-N-0008]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# SUMMARY:

The Food and Drug Administration (FDA or Agency) is requesting nominations for temporary nonvoting industry representatives to be included in a pool of individuals to serve on the Digital Health Advisory Committee. FDA is also requesting that industry organizations interested in participating in the selection of a pool of nonvoting industry representatives to serve as temporary nonvoting members on the Digital Health Advisory Committee (the Committee) in the Center for Devices and Radiological Health notify FDA in writing. Nominees recommended to serve as a temporary nonvoting industry representative may either be self-nominated or nominated by an industry organization. This position may be filled by representatives of different medical device areas based on areas of expertise relevant to the topics being considered by the Committee. Nominations will be accepted for current vacancies effective with this notice. FDA seeks to include the views of members of all gender groups, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups.

# DATES:

                        Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interest, must send a letter stating that interest to the FDA by                         *November 13, 2023,*                         (see sections I and II of this document for details). Concurrently, nomination materials for prospective candidates should be sent to FDA by                         *November 13, 2023.*

# ADDRESSES:

                        All statements of interest from interested industry organizations interested in participating in the selection process of a pool of nonvoting industry representatives should be sent electronically to Margaret Ames (see                         **FOR FURTHER INFORMATION CONTACT**                        ). All nominations for nonvoting industry representatives may be submitted electronically by accessing the FDA                               ( print page 70676)                            Advisory Committee Membership Nomination Portal:                         *https://www.accessdata.fda.gov/​scripts/​FACTRSPortal/​FACTRS/​index.cfm*                         or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002.                    

                        Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA's website at                         *https://www.fda.gov/​AdvisoryCommittees/​default.htm.*

# FOR FURTHER INFORMATION CONTACT:

                        Margaret Ames, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5213, Silver Spring, MD 20993-0002, 301-796-5960, email:                         *margaret.ames@fda.hhs.gov.*

                        For questions relating to the Digital Health Advisory Committee, contact James Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Room 5211, Silver Spring, MD 20993-0002, 301-796-6313,                         *James.swink@fda.hhs.gov.*

# SUPPLEMENTARY INFORMATION:

FDA is requesting nominations for a pool of nonvoting industry representatives for the Digital Health Advisory Committee (this position may be filled by representatives of different medical device areas based on areas of expertise relevant to the topics being considered by the Advisory Committee).

                    Elsewhere in this                     **Federal Register**                    , FDA is publishing separate documents regarding:                

1. Digital Health Advisory Committee; Notice of Establishment

2. Request for Nominations for Voting Members for the Digital Health Advisory Committee

3. Request for Nominations of Individuals and Consumer Organizations for the Digital Health Advisory Committee

## I. General Description of the Committee's Duties

The Committee provides advice on complex scientific and technical issues related to Digital Health Technologies (DHTs). This also may include advice on the regulation of DHTs, and/or their use, including use of DHTs in clinical trials or postmarket studies subject to FDA regulation. Topics relating to DHTs, such as artificial intelligence/machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software, may be considered by the Committee. The Committee advises the Commissioner on issues related to DHTs, including, for example, real-world data, real-world evidence, patient-generated health data, interoperability, personalized medicine/genetics, decentralized clinical trials, use of DHTs in clinical trials for medical products, cybersecurity, DHT user experience, and Agency policies and regulations regarding these technologies. The Committee provides relevant expertise and perspective to improve Agency understanding of the benefits, risks, and clinical outcomes associated with use of DHTs. The Committee performs its duties by providing advice and recommendations on new approaches to develop and evaluate DHTs and to promote innovation of DHTs, as well as identifying risks, barriers, or unintended consequences that could result from proposed or established Agency policy or regulation for topics related to DHTs.

## II. Qualifications

Persons nominated for the Digital Health Advisory Committee should be full-time employees of firms that manufacture medical device products, or consulting firms that represent manufacturers or have similar appropriate ties to industry.

## III. Selection Procedure

                    Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interest must send a letter stating that interest to the FDA contact (see                     **FOR FURTHER INFORMATION CONTACT**                    ) within 30 days of publication of this document (see                     **DATES**                    ). Within the subsequent 45 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations; and a list of all nominees along with their current resumes or                     *curriculum vitae.*                     The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate or candidates (to serve in a pool of individuals, with varying areas of expertise), to represent industry interest for the committee, within 60 days after the receipt of the FDA letter. The interested organizations are not bound by the list of nominees in selecting a candidate or candidates. However, if no individual is selected within 60 days, the Commissioner will select temporary nonvoting members (or pool of individuals) to represent industry interests.                

## IV. Nomination Procedure

                    Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a temporary nonvoting industry representative. Nominations must include a cover letter and a current, complete résumé or                     *curriculum vitae*                     for each nominee, including current business and/or home address, telephone number, and email address if available; and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Committee Membership Nomination Portal (see                     **ADDRESSES**                    ). Nominations should specify the advisory committee for which the nominee is recommended within 30 days of publication of this document (see                     **DATES**                    ). Nominations should also acknowledge that the nominee is aware of the nomination, unless self-nominated. FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee. Only interested industry organizations participate in the selection process. Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process.                

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

Dated: October 6, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.

[FR Doc. 2023-22568 Filed 10-11-23; 8:45 am]

BILLING CODE 4164-01-P