Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee, 75000-75002 [2023-24123]

Download as PDF ddrumheller on DSK120RN23PROD with NOTICES1 75000 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Notices and Enforcement, Office of Policy, Compliance, and Enforcement, Office of Regulatory Affairs, Food and Drug Administration, at 240–402–8743, or debarments@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In a Federal Register notice dated August 18, 2023 (88 FR 56636), David Winne was permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under section 306(a) of the FD&C Act (21 U.S.C. 335a(a)). The debarment was based on FDA’s finding that Mr. Winne was convicted of a felony under Federal law for conduct relating to the regulation of any drug product under the FD&C Act. On September 7, 2023, Mr. Winne applied for special termination of debarment, under section 306(d)(4) of the FD&C Act. Under section 306(d)(4)(C) of the FD&C Act, FDA may limit the period of debarment of a permanently debarred individual if the Agency finds that the debarred individual has provided substantial assistance in the investigation or prosecution of offenses described in section 306(a) or (b) of the FD&C Act or relating to a matter under FDA’s jurisdiction. In addition, pursuant to section 306(d)(4)(D)(ii) of the FD&C Act, in cases of an individual FDA may limit the period of debarment to less than permanent but to no less than 1 year, whichever serves the interest of justice and protects the integrity of the drug approval process. Special termination of debarment is discretionary with FDA. FDA generally considers a determination by the Department of Justice concerning the substantial assistance of a debarred individual conclusive in most cases. Mr. Winne cooperated with the United States Attorney’s Office in the investigation of several individuals, as substantiated by a letter submitted by the United States Attorney’s Office for the Southern District of New York to the sentencing judge in Mr. Winne’s case and which was submitted to the Agency by Mr. Winne. His cooperation contributed to the successful prosecution of these individuals. Accordingly, FDA finds that Mr. Winne provided substantial assistance as required by section 306(d)(4)(C) of the FD&C Act. The additional requisite showings, i.e., that termination of debarment serves the interest of justice and poses no threat to the integrity of the drug approval process, are difficult standards to satisfy. In determining whether these have been met, the Agency weighs the significance of all favorable and VerDate Sep<11>2014 19:48 Oct 31, 2023 Jkt 262001 unfavorable factors in light of the remedial, public health-related purposes underlying debarment. Termination of debarment will not be granted unless, weighing all favorable and unfavorable information, there is a high level of assurance that the conduct that formed the basis for debarment has not recurred and will not recur, and that the individual will not otherwise pose a threat to the integrity of the drug approval process. The evidence FDA reviewed in support of termination shows that Mr. Winne was convicted for a first offense; that he has no prior or subsequent convictions for conduct described under the FD&C Act and has committed no other wrongful acts affecting the drug approval process. The evidence presented supports the conclusion that the conduct upon which Mr. Winne’s debarment was based is unlikely to recur. For these reasons, the Agency finds that termination of Mr. Winne’s debarment serves the interest of justice and will not pose a threat to the integrity of the drug approval process. Under section 306(d)(4)(D) of the FD&C Act, the period of debarment of an individual who qualifies for special termination may be limited to less than permanent but to no less than 1 year. Mr. Winne’s period of debarment, which commenced on August 18, 2023, has not lasted for at least 1 year. As such, his period of debarment cannot terminate until August 17, 2024. Accordingly, the Assistant Commissioner, Office of Human and Animal Food Operations, under section 306(d)(4) of the FD&C Act and under authority delegated to the Assistant Commissioner, finds that David Winne’s application for special termination of debarment should be granted, and that the period of debarment should terminate on August 18, 2024, thereby allowing him to provide services in any capacity to a person with an approved or pending drug product application after that date. As a result of the foregoing findings, David Winne’s debarment is terminated effective August 17, 2024. Dated: October 26, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–24094 Filed 10–31–23; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–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 December 1, 2023 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by December 1, 2023. 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. SUMMARY: E:\FR\FM\01NON1.SGM 01NON1 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Notices 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 regulation. The panels of the Medical Devices Advisory Committee 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 75001 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 Dental Products Panel .............................................. Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational products for use in dentistry, endodontics, or bone physiology relative to the oral and maxillofacial area and makes appropriate recommendations to the Commissioner. Reviews and evaluate data concerning the safety and effectiveness of marketed and investigational ear, nose, and throat devices and makes appropriate recommendations to the Commissioner. Reviews and evaluate data concerning the safety and effectiveness of marketed and investigational general and plastic surgery devices and makes appropriate recommendations to the Commissioner. Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including pathology, hematology, histopathology, cytotechnology, and molecular biology and makes appropriate recommendations to the Commissioner. Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational orthopedic and rehabilitation devices and makes appropriate recommendations to the Commissioner. Ear, Nose, and Throat Devices Panel ...................... General and Plastic Surgery Devices Panel ............. Hematology and Pathology Devices Panel ............... Orthopedic 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 consulting firms that represent manufacturers, or have similar appropriate ties to industry. ddrumheller on DSK120RN23PROD with NOTICES1 III. Selection Procedure Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should 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 resumes. The letter will also state that it is the responsibility of the interested organizations to confer VerDate Sep<11>2014 19:48 Oct 31, 2023 Jkt 262001 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 re´sume´ 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 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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 E:\FR\FM\01NON1.SGM 01NON1 75002 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Notices U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: October 27, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–24123 Filed 10–31–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–4319] Determination That CALCIUM DISODIUM VERSENATE (Edetate Calcium Disodium) Injection, 200 Milligrams per Milliliter, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993–0002, 301–796–8363, Stacy.Kane@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is generally known as the ‘‘Orange Book.’’ Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug products listed in the table are no longer being marketed. Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant NDA 008922 .... Injectable; Injection ........ Bausch Health US, LLC. 25 mg ................................................. Tablet; Oral .................... Nostrum Labs., Inc. NDA 012546 .... TENUATE DOSPAN ...... 75 mg ................................................. FLUOCINONIDE ............ Tablets, Extended-Release; Oral. Cream; Topical .............. Do. NDA 019117 .... Edetate Calcium Disodium. Diethylpropion Hydrochloride. Diethylpropion Hydrochloride. Fluocinonide .................. 200 Milligrams (mg)/Milliliter (mL) ..... NDA 011722 .... CALCIUM DISODIUM VERSENATE. TENUATE ...................... NDA 019796 .... NDA 020489 .... ELOCON ........................ ANDRODERM ............... Mometasone Furoate .... Testosterone .................. 0.1% ................................................... 2 mg/24 hours; 4 mg/24 hours .......... NDA 020884 .... AGGRENOX ................... Aspirin; Dipyridamole ..... 25 mg; 200 mg .................................. NDA 020903 .... REBETOL ...................... Ribavirin ......................... 200 mg ............................................... Lotion; Topical ............... Film, Extended Release; Transdermal. Capsule, Extended Release; Oral. Capsule; Oral ................. NDA 020907 .... ACTIVELLA ................... 0.5 mg; 0.1 mg .................................. Tablet; Oral .................... NDA 020949 .... ACCUNEB ..................... Estradiol; Norethindrone Acetate. Albuterol Sulfate ............ Boehringer Ingelheim Pharms., Inc. Merck Sharp and Dohme Corp. Amneal Pharms., LLC. Solution; Inhalation ........ Mylan Specialty LP. NDA 021022 .... PENLAC ........................ Ciclopirox ....................... Equivalent to (EQ) 0.021% Base; EQ 0.042% Base. 8% ...................................................... Solution; Topical ............ NDA 021449 .... NDA 022052 .... HEPSERA ...................... ZYFLO CR ..................... Adefovir Dipivoxil ........... Zileuton .......................... 10 mg ................................................. 600 mg ............................................... Valeant International Bermuda. Gilead Sciences, Inc. Chiesi USA, Inc. NDA 022511 .... VIMOVO ........................ NDA 022569 .... LAZANDA ...................... Esomeprazole Magnesium; Naproxen. Fentanyl Citrate ............. NDA 202788 .... SUBSYS ........................ Fentanyl ......................... NDA 213645 .... DAPZURA RT ................ Daptomycin .................... EQ 20 mg Base; 375 mg; EQ 20 mg Base; 500 mg. EQ 0.1mg Base; EQ 0.3 mg Base; EQ 0.4 mg Base. 0.1 mg; 0.2 mg; 0.4 mg; 0.6 mg; 0.8 mg; 1.2 mg; 1.6 mg. 500 mg/Vial ........................................ FDA has reviewed its records and, under § 314.161, has determined that the drug products listed were not VerDate Sep<11>2014 19:48 Oct 31, 2023 Jkt 262001 0.05% ................................................. withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 Tablet; Oral .................... Tablet, Extended Release; Oral. Tablet, Delayed Release; Oral. Spray, Metered; Nasal ... Taro Pharms. U.S.A., Inc. Organon, LLC. AbbVie Inc. Horizon Medicines LLC. BTcP Pharma, LLC. Spray; Sublingual .......... Do. Powder; Intravenous ...... Baxter Healthcare Corp. products in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product E:\FR\FM\01NON1.SGM 01NON1

Agencies

[Federal Register Volume 88, Number 210 (Wednesday, November 1, 2023)]
[Notices]
[Pages 75000-75002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24123]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-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 
December 1, 2023 (see sections I and II of this document for further 
details). Concurrently, nomination materials for prospective candidates 
should be sent to FDA by December 1, 2023.

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.

[[Page 75001]]


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 panels of the Medical Devices 
Advisory Committee 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
------------------------------------------------------------------------
Dental Products Panel...........  Reviews and evaluates data concerning
                                   the safety and effectiveness of
                                   marketed and investigational products
                                   for use in dentistry, endodontics, or
                                   bone physiology relative to the oral
                                   and maxillofacial area and makes
                                   appropriate recommendations to the
                                   Commissioner.
Ear, Nose, and Throat Devices     Reviews and evaluate data concerning
 Panel.                            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 evaluate data concerning
 Devices Panel.                    the safety and effectiveness of
                                   marketed and investigational general
                                   and plastic surgery devices and makes
                                   appropriate recommendations to the
                                   Commissioner.
Hematology and Pathology Devices  Reviews and evaluates data concerning
 Panel.                            the safety and effectiveness of
                                   marketed and investigational in vitro
                                   devices for use in clinical
                                   laboratory medicine including
                                   pathology, hematology,
                                   histopathology, cytotechnology, and
                                   molecular biology and makes
                                   appropriate recommendations to the
                                   Commissioner.
Orthopedic and Rehabilitation     Reviews and evaluates data concerning
 Devices Panel.                    the safety and effectiveness of
                                   marketed and investigational
                                   orthopedic and rehabilitation devices
                                   and makes appropriate recommendations
                                   to the Commissioner.
------------------------------------------------------------------------

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 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

[[Page 75002]]

U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: October 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24123 Filed 10-31-23; 8:45 am]
BILLING CODE 4164-01-P

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