106512 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 

Dated: December 17, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31261 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–2149] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; De Novo 

Classification Process (Evaluation of 

Automatic Class III Designation) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by January 29, 

2025. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0844. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

De Novo Classification Process 

(Evaluation of Automatic Class III 

Designation)—21 CFR Part 860, Subpart 

D 

OMB Control Number 0910–0844— 

Revision 

This information collection supports 

FDA regulations and information 

collection discussed in associated 

guidance. Sections 201(h), 513(a) and 

(f), 701(a), and 704 of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 321(h), 360c(a) and (f), 371(a), 

and 374) establish a comprehensive 

system for the regulation of medical 

devices intended for human use. 

Section 513(f)(2) of the FD&C Act 

provides for a ‘‘De Novo’’ classification 

process, most recently amended by 

section 3101 of the 21st Century Cures 

Act (Pub. L. 114–255). The final rule 

‘‘Medical Device De Novo Classification 

Process’’ (86 FR 54826), established part 

860, subpart D (21 CFR part 860, subpart 

D) (§§ 860.200 through 860.260) to 

implement provisions in section 

513(f)(2) of the FD&C Act. These 

regulations govern format and content 

elements for De Novo device 

classification requests, as well as 

withdrawal of the requests, and explain 

FDA procedures for acceptance, review, 

and granting or denying a request. 

FDA’s guidance for industry and FDA 

staff, ‘‘De Novo Classification Process 

(Evaluation of Automatic Class III 

Designation)’’, provides guidance on the 

process for the submission and review 

of a De Novo classification request 

under section 513(f)(2) of the FD&C Act, 

also known as the De Novo 

classification process. This process 

provides a pathway to class I or class II 

classification for medical devices for 

which general controls or general and 

special controls provide a reasonable 

assurance of safety and effectiveness, 

but for which there is no legally 

marketed predicate device. 

In addition to regulatory requirements 

set forth in part 860, subpart D, the 

guidance document entitled 

‘‘Acceptance Review for De Novo 

Classification Requests’’ communicates 

our thinking on criteria set out in 

§ 860.230, in assessing whether a De 

Novo request should be accepted for 

substantive review. The guidance 

document includes an ‘‘Acceptance 

Checklist’’ to assist respondents in this 

regard. 

The guidance document ‘‘Electronic 

Submission Template for Medical 

Device De Novo Requests,’’ provides the 

standards for the submission of De Novo 

requests by electronic format, a 

timetable for establishment of these 

standards, and criteria for waivers of 

and exemptions from the requirements 

to meet a statutory requirement. This 

guidance is also intended to represent 

one of several steps in meeting FDA’s 

commitment to the development of 

electronic submission templates to serve 

as guided submission preparation tools 

for industry to improve submission 

consistency and enhance efficiency in 

the review process. 

The collections of information 

described by this notice are necessary to 

satisfy the previously mentioned 

statutory requirements for 

administration of this voluntary 

submission program. FDA uses the 

information to evaluate whether a 

medical device may be reclassified from 

class III into class I or II and, if 

applicable, to determine the general 

and/or special controls necessary to 

sufficiently regulate the medical device. 

Respondents to this information 

collection are private sector or other forprofit businesses. 

In the Federal Register of May 29, 

2024 (89 FR 46402), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

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 

§§ 860.210, 860.220, 860.230; De 

Novo requests—format, content, 

and acceptance elements.

79 1 79 182 ................................................... 14,378 

§ 860.230; FDA acceptance of request (GFI Acceptance Checklist; 

Appendix A) 1.

79 1 79 ........................................................... ........................


ddrumheller on DSK120RN23PROD with NOTICES1
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