Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices 80307 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website and at the location of the 

advisory committee meeting, and the 

background material will be posted on 

FDA’s website after the meeting. 

Background material will be available at 

https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the Committee. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

January 16, 2024, will be provided to 

the Committee. Oral presentations from 

the public will be scheduled on 

February 6, 2024, between 

approximately 1 p.m. and 2 p.m. Eastern 

Time. Those individuals interested in 

making formal oral presentations should 

notify the contact person and submit a 

brief statement of the general nature of 

the evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before January 5, 2024. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by January 8, 2024. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Artair Mallett 

at Artair.Mallett@fda.hhs.gov or 301– 

796–9638 at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.htm for 

procedures on public conduct during 

advisory committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). 

Dated: November 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25459 Filed 11–16–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–3926] 

Request for Nominations for Voting 

Members on Public Advisory Panels or 

Committees; Device Good 

Manufacturing Practice Advisory 

Committee and the Medical Devices 

Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for voting members to 

serve on the Device Good 

Manufacturing Practice Advisory 

Committee (DGMPAC) and the Medical 

Devices Advisory Committee (MDAC) 

device panels in the Center for Devices 

and Radiological Health. This annual 

notice is also in accordance with the 

21st Century Cures Act, which requires 

the Secretary of Health and Human 

Services (the Secretary) to provide an 

annual opportunity for patients, 

representatives of patients, and sponsors 

of medical devices that may be 

specifically the subject of a review by a 

classification panel to provide 

recommendations for individuals with 

appropriate expertise to fill voting 

member positions on classification 

panels. 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: Nominations received on or 

before January 16, 2024, will be given 

first consideration for membership on 

the DGMPAC and Panels of the MDAC. 

Nominations received after January 16, 

2024, will be considered for nomination 

to the committee as later vacancies 

occur. 

ADDRESSES: All nominations for 

membership should be submitted 

electronically by logging into the FDA 

Advisory Nomination Portal at 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: 

Regarding all nomination questions for 

membership, contact the following 

persons listed in table 1: 

TABLE 1—PRIMARY CONTACT AND PANEL

Primary contact person Committee or panel 

Joannie Adams-White, Office of the Center Director, Center for Devices 

and Radiological Health, Food and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5561, Silver Spring, MD 20993, 301– 

796–5421, Joannie.Adams-White@fda.hhs.gov.

Medical Devices Dispute Resolution Panel. 

James P. Swink, Office of Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993, 301–796–6313, 

James.Swink@fda.hhs.gov.

Circulatory System Devices Panel, Ophthalmic Devices Panel. 

Akinola Awojope, Office of Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993, 301–636– 

0512, Akinola.Awojope@fda.hhs.gov.

Dental Products Panel, Neurological Devices Panel, Obstetrics and 

Gynecology Devices Panel, Orthopaedic and Rehabilitation Devices 

Panel. 


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80308 Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices 

TABLE 1—PRIMARY CONTACT AND PANEL—Continued 

Primary contact person Committee or panel 

Jarrod Collier, Office of Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993, 240–672–5763, 

Jarrod.Collier@fda.hhs.gov.

DGMPAC, General Hospital and Personal Use Devices Panel, Hematology and Pathology Devices Panel, Molecular and Clinical Genetics 

Panel. 

Candace Nalls, Office of Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993, 301–636–0510, 

Candace.Nalls@fda.hhs.gov.

Anesthesiology and Respiratory Therapy Devices Panel; Ear, Nose, 

and Throat Devices Panel; Gastroenterology and Urology Devices 

Panel. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for voting 

members for vacancies listed in table 2: 

TABLE 2—EXPERTISE NEEDED, VACANCIES, AND APPROXIMATE DATE NEEDED

Expertise needed Vacancies Approximate date needed 

Device Good Manufacturing Practice Advisory Committee—Experts in medical device quality 

management system requirements/current good manufacturing practices, with experience in 

both part 820 (21 CFR part 820) and International Organization for Standardization (ISO) 

13485, are needed to provide cross-cutting scientific or clinical expertise concerning the particular issue in dispute. Vacancies include representatives of the interests of the general public 

and government.

1 

2 

Immediately. 

June 1, 2024. 

Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee—Anesthesiologists, pulmonary medicine specialists, or other experts who have specialized interests in ventilator support, sleep medicine, pharmacology, physiology, or the effects 

and complications of anesthesia. FDA is also seeking applicants with pediatric expertise in 

these areas.

1 December 1, 2024. 

Circulatory System Devices Panel of the Medical Devices Advisory Committee—Interventional 

cardiologists, electrophysiologists, invasive (vascular) radiologists, vascular and cardiothoracic 

surgeons, and cardiologists with special interest in congestive heart failure.

3 July 1, 2024. 

Dental Products Panel of the Medical Devices Advisory Committee—Dentists, engineers and scientists who have expertise in the areas of dental implants, dental materials, oral and maxillofacial surgery, endodontics, periodontology, tissue engineering, snoring/sleep therapy, and dental anatomy.7 Immediately. 

Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee—Otologists, 

neurotologists, and audiologists.

7 Immediately. 

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee—Gastroenterologists, urologists, and nephrologists.2 January 1, 2024. 

General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee— 

Internists, pediatricians, neonatologists, endocrinologists, gerontologists, nurses, biomedical engineers, human factors experts, or microbiologists/infection control practitioners or experts.

1 

2 

Immediately. 

January 1, 2024. 

Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee—Hematologists (benign and/or malignant hematology), hematopathologists (general and special hematology, coagulation and hemostasis, and hematological oncology), gynecologists with special 

interests in gynecological oncology, cytopathologists, and molecular pathologists with special 

interests in development of predictive and prognostic biomarkers, molecular oncology, cancer 

screening, cancer risk, digital pathology, whole slide imaging; devices utilizing artificial intelligence/machine learning.

4 Immediately. 

Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee—Experts 

with cross-cutting scientific, clinical, analytical or mediation skills.

1 

1 

Immediately. 

October 1, 2024. 

Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee—Experts in 

human genetics, molecular diagnostics, and in the clinical management of patients with genetic 

disorders, and (e.g., pediatricians, obstetricians, neonatologists). Individuals with training in inborn errors of metabolism, biochemical and/or molecular genetics, population genetics, epidemiology and related statistical training, bioinformatics, computational genetics/genomics, variant 

classification, cancer genetics/genomics, molecular oncology, radiation biology, and clinical molecular genetics testing, (e.g., sequencing, whole exome sequencing, whole genome sequencing, non-invasive prenatal testing, cancer screening, circulating cell free/circulating tumor nucleic acid testing, digital polymerase chain reaction, genotyping, array comparative genomic hybridization, etc.). Individuals with experience in genetics counseling, medical ethics are also desired, and individuals with experience in ancillary fields of study will be considered.

2 Immediately. 

Neurological Devices Panel of the Medical Devices Advisory Committee—Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain management, and movement 

disorders), interventional neuroradiologists, psychiatrists, and biostatisticians.

2 

2 

Immediately. 

December 1, 2023. 


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Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices 80309 

TABLE 2—EXPERTISE NEEDED, VACANCIES, AND APPROXIMATE DATE NEEDED—Continued 

Expertise needed Vacancies Approximate date needed 

Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee—Experts 

in perinatology, embryology, reproductive endocrinology, pediatric gynecology, gynecological 

oncology, operative hysteroscopy, pelviscopy, electrosurgery, laser surgery, assisted reproductive technologies, contraception, postoperative adhesions, and cervical cancer and colposcopy; 

biostatisticians and engineers with experience in obstetrics/gynecology devices; 

urogynecologists; experts in breast care; experts in gynecology in the older patient; experts in 

diagnostic (optical) spectroscopy; experts in midwifery; labor and delivery nursing.

2 February 1, 2024. 

Ophthalmic Devices Panel of the Medical Devices Advisory Committee—Ophthalmologists with 

expertise in corneal-external disease, vitreo-retinal surgery, glaucoma, ocular immunology, ocular pathology; optometrists; vision scientists; and ophthalmic professionals with expertise in 

clinical trial design, quality of life assessment, electrophysiology, low vision rehabilitation, and 

biostatistics.

3 November 1, 2024. 

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee— 

Orthopaedic surgeons (joint, spine, trauma, reconstruction, sports medicine, hand, foot and 

ankle, and pediatric orthopaedic surgeons); rheumatologists; engineers (biomedical, biomaterials, and biomechanical); experts in rehabilitation medicine, and musculoskeletal engineering; 

radiologists specializing in musculoskeletal imaging and analyses and biostatisticians.

1 

2 

Immediately. 

September 1, 2024. 

I. General Description of the 

Committees Duties 

A. DGMPAC 

The DGMPAC reviews regulations 

proposed for promulgation regarding 

good manufacturing practices governing 

the methods used in, and the facilities 

and controls used for, the manufacture, 

packing, storage and installation of 

devices, and makes recommendations to 

the Commissioner of Food and Drugs 

(the Commissioner) regarding the 

feasibility and reasonableness of those 

proposed regulations. The DGMPAC 

also advises the Commissioner on any 

petition submitted by a manufacturer for 

an exemption or variance from good 

manufacturing practice regulations that 

is referred to the committee. 

B. Panels of MDAC 

The MDAC reviews and evaluates 

data on the safety and effectiveness of 

marketed and investigational devices 

and makes recommendations for their 

regulation. The panels engage in many 

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, performs the following 

duties: (1) advises the Commissioner 

regarding recommended classification 

or reclassification of devices into one of 

three regulatory categories, (2) advises 

on any possible risks to health 

associated with the use of devices, (3) 

advises on formulation of product 

development protocols, (4) reviews 

premarket approval applications for 

medical devices, (5) reviews guidelines 

and guidance documents, (6) 

recommends exemption of certain 

devices from the application of portions 

of the FD&C Act, (7) advises on the 

necessity to ban a device, and (8) 

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 Dental Products Panel also 

functions at times as a dental drug 

panel. The functions of the dental drug 

panel are to evaluate and recommend 

whether various prescription drug 

products should be changed to over-thecounter status and to evaluate data and 

make recommendations concerning the 

approval of new dental drug products 

for human use. 

The Medical Devices Dispute 

Resolution Panel provides advice to the 

Commissioner on complex or contested 

scientific issues between 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 

regular advisory panel proceedings or 

Agency decisions or actions. 

II. Criteria for Voting Members 

A. DGMPAC 

The DGMPAC consists of a core of 

nine members including the Chair. 

Members and the Chair are selected by 

the Secretary. Persons nominated for 

membership as a health professional or 

officer or employee of any Federal, 

State, or local government should have 

knowledge of or expertise in any one or 

more of the following areas: quality 

assurance concerning the design, 

manufacture, and use of medical 

devices in accordance with part 820 

and/or ISO 13485. To be eligible for 

selection as a representative of the 

general public, nominees should 

possess appropriate qualifications to 

understand and contribute to the 

DGMPAC’s work. Three of the members 

shall be officers or employees of any 

State or local government or of the 

Federal Government; two shall be 

representative of the interests of the 

device manufacturing industry; two 

shall be representatives of the interests 

of physicians and other health 

professionals; and two shall be 

representatives of the interests of the 

general public. FDA is publishing a 

separate document announcing the 

Request for Nominations Notification 

for Non-Voting Representatives of the 

interests of the device manufacturing 

industry. Almost all non-Federal 

members of this committee serve as 

Special Government Employees. 

Members are invited to serve for 

overlapping terms of 4 years. The 

current needs for the DGMPAC are 

listed in table 2. 

B. Panels of the MDAC 

The MDAC with its 18 panels shall 

consist of a maximum of 159 standing 

members. Members are selected by the 

Commissioner or designee from among 

authorities in clinical and 

administrative medicine, engineering, 

biological and physical sciences, and 

other related professions. Almost all 

non-Federal members of this committee 

serve as Special Government 


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80310 Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices 

Employees. A maximum of 122 

members shall be standing voting 

members and 37 shall be nonvoting 

members who serve as representatives 

of consumer interests and of industry 

interests. FDA is publishing separate 

documents announcing the Request for 

Nominations Notification for Nonvoting 

Representatives on certain panels of the 

MDAC. Persons nominated for 

membership on the panels should have 

adequately diversified experience 

appropriate to the work of the panel in 

such fields as clinical and 

administrative medicine, engineering, 

biological and physical sciences, 

statistics, and other related professions. 

The nature of specialized training and 

experience necessary to qualify the 

nominee as an expert suitable for 

appointment may include experience in 

medical practice, teaching, and/or 

research relevant to the field of activity 

of the panel. The current needs for each 

panel are listed in table 2. Members will 

be invited to serve for terms of up to 4 

years. 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified individuals for 

membership on one or more of the 

advisory panels or advisory committees. 

Self-nominations are also accepted. 

Nominations must include a current, 

complete re ́sume ́ or curriculum vitae for 

each nominee, including current 

business address, telephone number, 

and email address if available and a 

signed copy of the Acknowledgement 

and Consent form available at the FDA 

Advisory Nomination Portal (see 

ADDRESSES). Nominations must also 

specify the advisory committees or 

panel(s) for which the nominee is 

recommended. Nominations must also 

acknowledge that the nominee is aware 

of the nomination unless selfnominated. FDA will ask potential 

candidates to provide detailed 

information concerning such matters 

related to financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflict of interest. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: November 6, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25367 Filed 11–16–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0053] 

Notifying the Food and Drug 

Administration of a Permanent 

Discontinuance or Interruption in 

Manufacturing of a Device Under 

Section 506J of the Federal Food, 

Drug, and Cosmetic Act; Final 

Guidance for Industry and Food and 

Drug Administration Staff; and Select 

Updates for the 506J Guidance: 506J 

Device List and Additional 

Notifications; Draft Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the final 

guidance entitled ‘‘Notifying FDA of a 

Permanent Discontinuance or 

Interruption in Manufacturing of a 

Device Under Section 506J of the FD&C 

Act’’ and the draft guidance entitled 

‘‘Select Updates for the 506J Guidance: 

506J Device List and Additional 

Notifications.’’ The Federal Food, Drug, 

and Cosmetic Act (FD&C Act) requires 

manufacturers to notify FDA of a 

permanent discontinuance or an 

interruption in the manufacture of 

certain devices that is likely to lead to 

a meaningful disruption in supply of 

that device in the United States during 

or in advance of a public health 

emergency (PHE). This final guidance is 

intended to assist manufacturers in 

providing timely, informative 

notifications about changes in the 

production of certain medical device 

products that will help prevent or 

mitigate shortages of such devices. FDA 

is concurrently issuing a draft guidance 

to propose select updates to the final 

guidance ‘‘Notifying FDA of a 

Permanent Discontinuance or 

Interruption in Manufacturing of a 

Device Under Section 506J of the FD&C 

Act.’’ This draft guidance proposes a list 

of device product codes for which a 

manufacturer of such devices is 

required to notify FDA in accordance 

with the FD&C Act (hereafter referred to 

as the ‘‘506J Device List’’) and clarifies 

that manufacturers may submit 

voluntary notifications regarding supply 

chain issues at any time, unrelated to 

the declaration or potential declaration 

of a PHE. This draft guidance is not final 

nor is it for implementation at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by February 15, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2022–D–0053 for ‘‘Notifying FDA of a 

Permanent Discontinuance or 

Interruption in Manufacturing of a 

Device Under Section 506J of the FD&C 

Act’’ or ‘‘Select Updates for the 506J 

Guidance: 506J Device List and 

Additional Notifications.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 


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