Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation), 106512-106513 [2024-31014]

Download as PDF 106512 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices Dated: December 17, 2024. P. Ritu Nalubola, Associate Commissioner for Policy. 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. [FR Doc. 2024–31261 Filed 12–27–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES De Novo Classification Process (Evaluation of Automatic Class III Designation)—21 CFR Part 860, Subpart D 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. 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. SUMMARY: 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 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: ddrumheller on DSK120RN23PROD with NOTICES1 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 21 CFR part 860, subpart D; information collection activity §§ 860.210, 860.220, 860.230; De Novo requests—format, content, and acceptance elements. § 860.230; FDA acceptance of request (GFI Acceptance Checklist; Appendix A) 1. VerDate Sep<11>2014 23:58 Dec 27, 2024 Number of responses per respondent Number of respondents Jkt 265001 Total annual responses Average burden per response Total hours 79 1 79 182 ................................................... 14,378 79 1 79 ........................................................... ........................ PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1 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 responses per respondent Number of respondents 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 1 FDA 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. ddrumheller on DSK120RN23PROD with NOTICES1 ACTION: Notice. 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 SUMMARY: VerDate Sep<11>2014 23:58 Dec 27, 2024 Jkt 265001 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 PO 00000 Frm 00108 Fmt 4703 Sfmt 4703 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 E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Pages 106512-106513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31014]


-----------------------------------------------------------------------

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, 
[email protected].

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) (Sec. Sec.  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 Sec.  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 for-profit 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;                      Number of
    information collection         Number of     responses per   Total annual    Average burden     Total hours
           activity               respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Sec.  Sec.   860.210, 860.220,              79               1              79  182.............          14,378
 860.230; De Novo requests--
 format, content, and
 acceptance elements.
Sec.   860.230; FDA acceptance              79               1              79  ................  ..............
 of request (GFI Acceptance
 Checklist; Appendix A) \1\.

[[Page 106513]]

 
Sec.   860.250; withdrawal of                5               1               5  0.17 (10 mins.).               1
 request.
                                                                                                 ---------------
    Total.....................  ..............  ..............  ..............  ................          14,379
----------------------------------------------------------------------------------------------------------------
\1\ FDA 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-template-medical-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


This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.