Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee, 44995-44996 [2024-11178]

Download as PDF Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–0008] Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC or the Committee) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice. DATES: Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to the FDA by June 21, 2024 (see sections I and II of this document for further details). Concurrently, nomination SUMMARY: materials for prospective candidates should be sent to FDA by June 21, 2024. ADDRESSES: All statements of interest from industry organizations interested in participating in the selection process of nonvoting industry representative nomination should be sent 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 of 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, 301–796–5960, email: margaret.ames@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The Agency is requesting nominations for nonvoting industry representatives to the panels listed in table 1. I. Medical Devices Advisory Committee The Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their 44995 regulation. The Committee’s panels engage in a number of activities to fulfill the functions the Federal Food, Drug, and Cosmetic Act (FD&C Act) envisions for device advisory panels. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, advises the Commissioner of Food and Drugs (the Commissioner) regarding recommended classification or reclassification of devices into one of three regulatory categories; advises on any possible risks to health associated with the use of devices; advises on formulation of product development protocols; reviews premarket approval applications for medical devices; reviews guidelines and guidance documents; recommends exemption of certain devices from the application of portions of the FD&C Act; advises on the necessity to ban a device; and responds to requests from the Agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, may also make appropriate recommendations to the Commissioner on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices. The Committee also provides recommendations to the Commissioner or designee on complexity categorization of in vitro diagnostics under the Clinical Laboratory Improvement Amendments of 1988. TABLE 1—PANELS AND FUNCTIONS Panels Function Ear, Nose, and Throat Devices Panel .......................... Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational ear, nose, and throat devices and makes appropriate recommendations to the Commissioner. Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational general and plastic surgery devices and makes appropriate recommendations to the Commissioner. The Medical Devices Dispute Resolution Panel (MDDRP) provides advice to the Center Director on complex or contested scientific issues between the FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, regulatory decisions and actions by FDA, and Agency guidance and policies. The Panel makes recommendations on issues that are lacking resolution, are highly complex in nature, or result from challenges to Agency decisions or actions. Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational orthopedic and rehabilitation devices and makes appropriate recommendations to the Commissioner of Food and Drugs. General and Plastic Surgery Devices Panel ................ Medical Devices Dispute Resolution Panel .................. khammond on DSKJM1Z7X2PROD with NOTICES Orthopaedic and Rehabilitation Devices Panel ............ II. Qualifications Persons nominated for the device panels should be full-time employees of firms that manufacture products that would come before the panel, or VerDate Sep<11>2014 17:06 May 21, 2024 Jkt 262001 consulting firms that represent manufacturers, or have similar appropriate ties to industry. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 III. Selection Procedure Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send E:\FR\FM\22MYN1.SGM 22MYN1 44996 Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices 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 resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry interests for a particular device panel. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days, the Commissioner will select the nonvoting member to represent industry interests. IV. Application Procedure Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Nomination must include a current, complete résumé or curriculum vitae for each nominee including current business address and telephone number, 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) within 30 days of publication of this document (see DATES). Nominations must also specify the advisory panel for which the nominee is recommended. Nominations must 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 particular device panels listed in table 1. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process.) 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. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq.), relating to advisory committees. Dated: May 16, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–11178 Filed 5–21–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2021–N–0403, FDA– 2023–N–4181, and FDA–2021–N–0584] ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. 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 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/ PRAMain. 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. SUPPLEMENTARY INFORMATION: Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB Control No. Title of collection Food Additives; Food Contact Substances Notification System ............................................................................. Cattle Materials Prohibited From Use in Animal Food or Feed .............................................................................. Standardized Reporting Forms for Federally Funded Public Health Projects and Agreements ............................ Dated: May 16, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–11180 Filed 5–21–24; 8:45 am] Food and Drug Administration [Docket No. FDA–2024–N–0970] BILLING CODE 4164–01–P khammond on DSKJM1Z7X2PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Vaccines and Related Biological Products Advisory Committee; Amendment of Notice—Selection of the 2024 to 2025 Formula for COVID– 19 Vaccines AGENCY: Food and Drug Administration, HHS. ACTION: VerDate Sep<11>2014 17:06 May 21, 2024 Jkt 262001 PO 00000 Fmt 4703 4/30/2027 4/30/2027 4/30/2027 The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Vaccines and Related Biological Products Advisory Committee. This meeting was announced in the Federal Register of March 4, 2024. The amendment is being made to reflect a change in the meeting date in the SUMMARY and DATES portions of the document from May 16, 2024, to June 5, 2024. There are no other changes. SUMMARY: FOR FURTHER INFORMATION CONTACT: Kathleen Hayes or Prabhakara Atreya, Center for Biologics Evaluation and Notice. Frm 00041 0910–0495 0910–0627 0910–0909 Date approval expires Sfmt 4703 E:\FR\FM\22MYN1.SGM 22MYN1

Agencies

[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 44995-44996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11178]



[[Page 44995]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-0008]


Request for Nominations on Public Advisory Panels of the Medical 
Devices 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 nonvoting industry representatives to serve on 
certain panels of the Medical Devices Advisory Committee (MDAC or the 
Committee) in the Center for Devices and Radiological Health (CDRH) 
notify FDA in writing. FDA is also requesting nominations for nonvoting 
industry representatives to serve on certain device panels of the MDAC 
in the CDRH. A nominee may either be self-nominated or nominated by an 
organization to serve as a nonvoting industry representative. 
Nominations will be accepted for current and upcoming vacancies 
effective with this notice.

DATES: Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests must send a letter stating that interest to the FDA by June 
21, 2024 (see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by June 21, 2024.

ADDRESSES: All statements of interest from industry organizations 
interested in participating in the selection process of nonvoting 
industry representative nomination should be sent 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 of 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, 301-796-5960, email: 
[email protected].

SUPPLEMENTARY INFORMATION: The Agency is requesting nominations for 
nonvoting industry representatives to the panels listed in table 1.

I. Medical Devices Advisory Committee

    The Committee reviews and evaluates data on the safety and 
effectiveness of marketed and investigational devices and makes 
recommendations for their regulation. The Committee's panels engage in 
a number of activities to fulfill the functions the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) envisions for device advisory panels. With 
the exception of the Medical Devices Dispute Resolution Panel, each 
panel, according to its specialty area, advises the Commissioner of 
Food and Drugs (the Commissioner) regarding recommended classification 
or reclassification of devices into one of three regulatory categories; 
advises on any possible risks to health associated with the use of 
devices; advises on formulation of product development protocols; 
reviews premarket approval applications for medical devices; reviews 
guidelines and guidance documents; recommends exemption of certain 
devices from the application of portions of the FD&C Act; advises on 
the necessity to ban a device; and responds to requests from the Agency 
to review and make recommendations on specific issues or problems 
concerning the safety and effectiveness of devices. With the exception 
of the Medical Devices Dispute Resolution Panel, each panel, according 
to its specialty area, may also make appropriate recommendations to the 
Commissioner on issues relating to the design of clinical studies 
regarding the safety and effectiveness of marketed and investigational 
devices. The Committee also provides recommendations to the 
Commissioner or designee on complexity categorization of in vitro 
diagnostics under the Clinical Laboratory Improvement Amendments of 
1988.

                      Table 1--Panels and Functions
------------------------------------------------------------------------
              Panels                              Function
------------------------------------------------------------------------
Ear, Nose, and Throat Devices       Reviews and evaluates data
 Panel.                              concerning the safety and
                                     effectiveness of marketed and
                                     investigational ear, nose, and
                                     throat devices and makes
                                     appropriate recommendations to the
                                     Commissioner.
General and Plastic Surgery         Reviews and evaluates data
 Devices Panel.                      concerning the safety and
                                     effectiveness of marketed and
                                     investigational general and plastic
                                     surgery devices and makes
                                     appropriate recommendations to the
                                     Commissioner.
Medical Devices Dispute Resolution  The Medical Devices Dispute
 Panel.                              Resolution Panel (MDDRP) provides
                                     advice to the Center Director on
                                     complex or contested scientific
                                     issues between the FDA and medical
                                     device sponsors, applicants, or
                                     manufacturers relating to specific
                                     products, marketing applications,
                                     regulatory decisions and actions by
                                     FDA, and Agency guidance and
                                     policies. The Panel makes
                                     recommendations on issues that are
                                     lacking resolution, are highly
                                     complex in nature, or result from
                                     challenges to Agency decisions or
                                     actions.
Orthopaedic and Rehabilitation      Reviews and evaluates data
 Devices Panel.                      concerning the safety and
                                     effectiveness of marketed and
                                     investigational orthopedic and
                                     rehabilitation devices and makes
                                     appropriate recommendations to the
                                     Commissioner of Food and Drugs.
------------------------------------------------------------------------

II. Qualifications

    Persons nominated for the device panels should be full-time 
employees of firms that manufacture products that would come before the 
panel, 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 
interests should send

[[Page 44996]]

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 resumes. The letter will also state that it is the 
responsibility of the interested organizations to confer with one 
another and to select a candidate, within 60 days after the receipt of 
the FDA letter, to serve as the nonvoting member to represent industry 
interests for a particular device panel. The interested organizations 
are not bound by the list of nominees in selecting a candidate. 
However, if no individual is selected within 60 days, the Commissioner 
will select the nonvoting member to represent industry interests.

IV. Application Procedure

    Individuals may self-nominate and/or an organization may nominate 
one or more individuals to serve as a nonvoting industry 
representative. Nomination must include a current, complete 
r[eacute]sum[eacute] or curriculum vitae for each nominee including 
current business address and telephone number, 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) within 30 days of publication of this document (see 
DATES). Nominations must also specify the advisory panel for which the 
nominee is recommended. Nominations must 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 particular device panels 
listed in table 1. (Persons who nominate themselves as nonvoting 
industry representatives will not participate in the selection 
process.)
    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.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. 1001 et seq.), relating to advisory committees.

    Dated: May 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11178 Filed 5-21-24; 8:45 am]
BILLING CODE 4164-01-P

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