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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Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices 80311 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the final guidance 

document entitled ‘‘Notifying FDA of a 

Permanent Discontinuance or 

Interruption in Manufacturing of a 

Device Under Section 506J of the FD&C 

Act’’ or draft guidance document 

entitled ‘‘Select Updates for the 506J 

Guidance: 506J Device List and 

Additional Notifications’’ to the Office 

of Policy, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002; or to Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Tammy Beckham, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5550, Silver Spring, 

MD 20993–0002, 301–796–9081; or 

Anne Taylor, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993, 240–402– 

7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On March 27, 2020, the Coronavirus 

Aid, Relief, and Economic Security Act 

(CARES Act) was signed into law. 

Section 3121 of the CARES Act amends 

the FD&C Act by adding section 506J to 

the statute. Section 506J of the FD&C 

Act (21 U.S.C. 356j) provides FDA with 

new authorities intended to help 

prevent or mitigate device shortages 

‘‘during, or in advance of, a public 

health emergency’’ declared under 

section 319 of the Public Health Service 

Act (PHS Act) (42 U.S.C. 247d). 

Additionally, on December 29, 2022, the 

Prepare for and Respond to Existing 

Viruses, Emerging New Threats, and 

Pandemics Act (‘‘PREVENT Pandemics 

Act’’) was signed into law as part of the 

Consolidated Appropriations Act, 2023, 

Pub. L. 117–328 (hereafter referred to as 

the ‘‘FY 2023 Omnibus’’). Section 

2514(c) of the FY 2023 Omnibus 

directed FDA to issue or revise guidance 

regarding requirements under section 

506J and include a list of each device 

product code for which a manufacturer 

of such device is required to notify FDA 

in accordance with section 506J. Section 

2514 the FY 2023 Omnibus amended 

section 506J to add section 506J(h), 

‘‘Additional Notifications’’ and directed 

FDA to issue guidance ‘‘to facilitate 

voluntary notifications.’’ 

FDA is issuing this final guidance, 

‘‘Notifying FDA of a Permanent 

Discontinuance or Interruption in 

Manufacturing of a Device Under 

Section 506J of the FD&C Act’’ (hereafter 

referred to as the ‘‘506J Guidance’’) to 

assist stakeholders in the Agency’s 

implementation of section 506J. This 

guidance serves as the baseline for 

information about notifications under 

section 506J during or in advance of any 

PHE. FDA provides additional 

clarification on who is required to notify 

FDA, when such notifications are 

required, what information FDA expects 

manufacturers to include in such 

notifications, and how to submit 

notifications. Additionally, FDA 

describes how FDA determines that a 

device is in shortage and additional 

actions FDA may take to help prevent or 

mitigate a potential device shortage. 

In the draft guidance ‘‘Select Updates 

for the 506J Guidance: 506J Device List 

and Additional Notifications,’’ FDA 

proposes updates to the 506J Guidance. 

Specifically, FDA has developed a list of 

devices, by FDA product code, for 

which a manufacturer of such devices is 

required to notify FDA in accordance 

with section 506J (hereafter referred to 

as the ‘‘506J Device List’’). The 506J 

Device List is based on the requirements 

under section 506J(a). In section 2514 of 

the FY 2023 Omnibus, Congress 

directed FDA to issue guidance on the 

requirements under section 506J and to 

include ‘‘a list of each device product 

code for which a manufacturer of such 

device is required to notify the Secretary 

in accordance with section 506J.’’ Thus, 

manufacturers of a device on the 506J 

Device List must notify FDA in 

accordance with 506J for each such 

device. For more information, 

manufacturers should see the 506J 

Device List web page, available at 

https://www.fda.gov/medical-devices/ 

medical-device-supply-chain-andshortages/506j-device-list. Additionally, 

consistent with section 506J(h), FDA is 

proposing to clarify for stakeholders that 

manufacturers may submit, and FDA 

may receive, voluntary notifications 

regarding supply chain issues at any 

time, unrelated to the declaration or 

potential declaration of a PHE. The 

Agency invites comments on both the 

506J Device List and the clarification for 

stakeholders on voluntary notifications. 

A notice of availability of the draft 

guidance, ‘‘Notifying FDA of a 

Permanent Discontinuance or 

Interruption in Manufacturing of a 

Device Under Section 506J of the FD&C 

Act,’’ appeared in the Federal Register 

of January 11, 2022 (87 FR 1417). FDA 

considered comments received and 

revised the guidance as appropriate in 

response to the comments, including 

providing additional clarifications such 

as when manufactures should notify 

FDA of changes in status and when 

manufacturers should provide 506J 

notification updates, and what 

information is required by section 506J 


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80312 Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices 

and what additional information is 

helpful to FDA. Additionally, FDA 

provided additional transparency 

regarding how FDA uses information 

from 506J notifications. 

These guidances are being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, ‘‘Select Updates for 

the 506J Guidance: 506J Device List and 

Additional Notifications,’’ when 

finalized, will represent the current 

thinking of FDA on ‘‘Notifying FDA of 

a Permanent Discontinuance or 

Interruption in Manufacturing of a 

Device Under Section 506J of the FD&C 

Act.’’ These guidances do not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents or 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics. 

Persons unable to download an 

electronic copy of ‘‘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’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number GUI00021003 and 

complete title to identify the guidance 

you are requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no new 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in the following table have 

been approved by OMB: 

Guidance Topic OMB control No. 

‘‘Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of 

the FD&C Act’’.

Shortages Data Collection ...................................................... 0910–0491 

Dated: November 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25458 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–2023–N–4916] 

Anesthesiology and Respiratory 

Therapy Devices Panel of the Medical 

Devices Advisory Committee; Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments—Pulse 

Oximeters 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Anesthesiology and 

Respiratory Therapy Devices Panel of 

the Medical Devices Advisory 

Committee (the Committee). The general 

function of the Committee is to provide 

advice and recommendations to FDA on 

regulatory issues. The Committee will 

discuss an approach to improve the 

quality of premarket studies and 

associated methods used to evaluate the 

performance of pulse oximeters 

submitted for premarket review, taking 

into consideration a patient’s skin 

pigmentation, and patient-reported race 

and ethnicity. The meeting will be open 

to the public. FDA is establishing a 

docket for public comment on this 

document. 

DATES: The meeting will be held on 

February 2, 2024, from 9 a.m. to 6:30 

p.m. Eastern Time. 

ADDRESSES: All meeting participants 

will be heard, viewed, captioned, and 

recorded for this advisory committee 

meeting via an online teleconferencing 

and/or video conferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2023–N–4916. 

The docket will close on March 4, 2024. 

Please note that late, untimely filed 

comments will not be considered. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until 11:59 p.m. Eastern Time at the end 

of March 4, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Comments received on or before 

January 19, 2024, will be provided to 

the Committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is canceled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments 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. 


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