Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 106513 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—Continued 

21 CFR part 860, subpart D; 

information collection activity 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses Average burden per response Total hours 

§ 860.250; withdrawal of request ...... 5 1 5 0.17 (10 mins.) ................................. 1 

Total ........................................... ........................ ........................ ........................ ........................................................... 14,379 

1FDA assumes activities associated with review of the Acceptance Checklist are included in burden for submission of requests captured in row 

1. 

Our estimated burden for the 

information collection reflects an 

overall increase of 2,002 hours and a 

corresponding increase of 11 responses. 

We attribute this adjustment to an 

increase in the number of submissions 

we received over the last few years. 

Since the publication of the 60-day 

notice, we issued the guidance 

document entitled ‘‘Electronic 

Submission Template for Medical 

Device De Novo Requests’’ (August 23, 

2024, 89 FR 68166; https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

electronic-submission-templatemedical-device-de-novo-requests) and 

are including it in this information 

collection. Given that all submissions 

were previously received electronically 

and the ability to voluntarily submit De 

Novo requests using eSTAR was 

included in the previous information 

collection request (ICR), inclusion of the 

guidance in this ICR is not expected to 

impact the estimated burden. 

Dated: December 13, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31014 Filed 12–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–0008] 

Request for Nominations of Individuals 

and Industry Organizations for the 

Patient Engagement Advisory 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

requesting that any industry 

organizations interested in participating 

in the selection of a pool of nonvoting 

industry representatives to serve as 

temporary nonvoting members on the 

Patient Engagement Advisory 

Committee (the Committee) in the 

Center for Devices and Radiological 

Health notify FDA in writing. FDA is 

also requesting nominations for 

temporary nonvoting industry 

representatives to be included in a pool 

of individuals to serve on the 

Committee. Nominees recommended to 

serve as a temporary nonvoting industry 

representative may either be selfnominated or nominated by an industry 

organization. This position may be filled 

by representatives from different 

medical device areas based on expertise 

relevant to the topics being considered 

by the Committee. Nominations will be 

accepted for upcoming vacancies 

effective with this notice. FDA seeks to 

include the views of women and men, 

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 January 29, 2025, (see 

sections I and II of this document for 

details). Concurrently, nomination 

materials for prospective candidates 

should be sent to FDA by January 29, 

2025. 

ADDRESSES: All statements of interest 

from 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 should be submitted 

electronically by accessing the FDA 

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. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for a pool of 

nonvoting industry representatives for 

the Committee. The list of needed 

expertise on May 1, 2025, is identified 

below: 

• Cybersecurity 

• Communication of Benefit & Risk 

Information to Patients; Medical 

Device Labeling 

• Digital Health Technology/Artificial 

Intelligence 

• Health Equity 

• Patient Engagement 

• Patient Preference Elicitation 

• Patient-Reported Outcomes 

Development, Validation, and Use in 

Regulatory Studies or Clinical 

Practice 

• Postmarket Studies, Including 

Observational and Registry-Based 

Studies 

• Human Factors 

FDA is publishing separate 

documents regarding: 

1. Request for Nominations for Voting 

Members for the Patient Engagement 

Advisory Committee 

2. Request for Nominations for 

Consumer Representative for the 

Patient Engagement Advisory 

Committee 

I. General Description of the 

Committee’s Duties 

The Committee provides advice on 

complex issues relating to medical 

devices, the regulation of devices, and 

their use by patients. Agency guidance 

and policies, clinical trial or registry 

design, patient preference study design, 

benefit-risk determinations, device 

labeling, unmet clinical needs, available 

alternatives, patient reported outcomes 

and device-related quality of life or 


ddrumheller on DSK120RN23PROD with NOTICES1
106514 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 

health status issues are among the topics 

that may be considered by the 

Committee. Members are knowledgeable 

in areas such as clinical research, 

primary care patient experience, 

healthcare needs of patient groups in 

the United States or are experienced in 

the work of patient and health 

professional organizations, 

methodologies for eliciting patient 

preferences, and strategies for 

communicating benefits, risks and 

clinical outcomes to patients and 

research subjects. The Commissioner of 

Food and Drugs (the Commissioner), or 

designee, shall have the authority to 

select from a group of individuals 

nominated by industry to serve 

temporarily as nonvoting members who 

are identified with industry interests. 

The number of temporary members 

selected for a particular meeting will 

depend on the meeting topic(s). 

II. Qualifications 

Persons nominated for the Patient 

Engagement 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 30 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 re ́sume ́s 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 re ́sume ́ 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). In addition, 

nominations should 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. 1001 et seq.) and 21 CFR part 14, 

relating to advisory committees. 

Dated: December 20, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31272 Filed 12–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–0846] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

National Agriculture and Food Defense 

Strategy Survey 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing that a collection of 

information entitled ‘‘National 

Agriculture and Food Defense Strategy 

Survey’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA). 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On August 

15, 2024, the Agency submitted a 

proposed collection of information 

entitled ‘‘National Agriculture and Food 

Defense Strategy Survey’’ to OMB for 

review and clearance under 44 U.S.C. 

3507. An Agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. OMB has now 

approved the information collection and 

has assigned OMB control number 

0910–0855. The approval expires on 

November 30, 2027. A copy of the 

supporting statement for this 

information collection is available on 

the internet at https://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: December 16, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31298 Filed 12–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4597] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Shortages Data Collection 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing that a collection of 

information entitled ‘‘Shortages Data 

Collection’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA). 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10 a.m.–12 p.m., 

11601 Landsdown St., North Bethesda, 

MD 20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On May 

20, 2024, the Agency submitted a 

proposed collection of information 

entitled ‘‘Shortages Data Collection’’ to 

OMB for review and clearance under 44 

U.S.C. 3507. An Agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 


ddrumheller on DSK120RN23PROD with NOTICES1