Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 75291 

please visit us at https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: October 30, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–24212 Filed 11–1–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–4595] 

Enforcement Policy for Certain 

Supplements for Approved Premarket 

Approval or Humanitarian Device 

Exemption Submissions; 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 ‘‘Enforcement Policy 

for Certain Supplements for Approved 

Premarket Approval (PMA) or 

Humanitarian Device Exemption (HDE) 

Submissions.’’ This guidance outlines 

FDA’s policies and regulatory review 

expectations after the COVID–19 public 

health emergency (PHE) for certain 

limited modifications affecting the 

safety and effectiveness of a device 

required to have an approved PMA or 

the safety and probable benefit of a 

device required to have an approved 

HDE. This guidance has been 

implemented without prior comment, 

but it remains subject to comment in 

accordance with the Agency’s good 

guidance practices. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on November 2, 2023. 

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– 

2023–D–4595 for ‘‘Enforcement Policy 

for Certain Supplements for Approved 

Premarket Approval (PMA) or 

Humanitarian Device Exemption (HDE) 

Submissions.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov 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 guidance 

document entitled ‘‘Enforcement Policy 

for Certain Supplements for Approved 

Premarket Approval (PMA) or 

Humanitarian Device Exemption (HDE) 

Submissions’’ 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 the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research 

(CBER), 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: 

Jhumur Banik, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2448, Silver Spring, 

MD 20993–0002, 240–402–5239 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: 


khammond on DSKJM1Z7X2PROD with NOTICES
75292 Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 

I. Background 

FDA is announcing the availability of 

a final guidance entitled ‘‘Enforcement 

Policy for Certain Supplements for 

Approved Premarket Approval (PMA) or 

Humanitarian Device Exemption (HDE) 

Submissions.’’ This guidance describes 

FDA’s general recommendations for 

limited modifications to devices 

required to have an approved PMA or 

HDE to help address manufacturing 

limitations or supply chain disruptions. 

This guidance supersedes 

‘‘Supplements for Approved Premarket 

Approval (PMA) or Humanitarian 

Device Exemption (HDE) Submissions 

During the Coronavirus Disease 2019 

(COVID–19) Public Health Emergency 

(Revised)’’, issued in May 2020 and 

updated in May 2022 (COVID–19 PMA/ 

HDE guidance). In the Federal Register 

of March 13, 2023 (88 FR 15417), FDA 

announced that COVID–19 PMA/HDE 

guidance was being revised to continue 

in effect for 180 days after the expiration 

of the COVID–19 PHE declaration 

issued under the Public Health Service 

Act, during which time FDA intended to 

further revise the guidance. 

Following expiration of the PHE 

declaration on May 11, 2023, FDA has 

continued to observe supply chain 

challenges and shortages of medical 

devices remain widespread. Therefore, 

consistent with the Federal Register of 

March 13, 2023, FDA is issuing this 

final guidance. Although this guidance 

has been revised to remove any 

expiration date for the enforcement 

policy, the Agency will continue to 

monitor the situation and may make 

further revisions to the guidance, 

withdraw the guidance, or pursue other 

regulatory actions, as appropriate. 

FDA has determined that this 

guidance document presents a less 

burdensome policy that is consistent 

with public health. This guidance is 

being implemented without prior public 

comment because FDA has determined 

that prior public participation for this 

less burdensome policy is neither 

feasible nor appropriate (see section 

701(h)(1)(C) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

371(h)(1)(C)) and 21 CFR 10.115(g)(2)) 

because delaying this policy is likely to 

exacerbate ongoing supply chain issues. 

This guidance document is being 

implemented immediately, but it 

remains subject to comment in 

accordance with the Agency’s good 

guidance practices. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Enforcement 

Policy for Certain Supplements for 

Approved Premarket Approval (PMA) or 

Humanitarian Device Exemption (HDE) 

Submissions.’’ It does 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 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 ‘‘Enforcement Policy 

for Certain Supplements for Approved 

Premarket Approval (PMA) or 

Humanitarian Device Exemption (HDE) 

Submissions’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number GUI00020028 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: 

21 CFR part; guidance; or FDA form Topic OMB 

control No. 

814, subparts A through E ........................................................................................... Premarket approval .................................. 0910–0231 

814, subpart H .............................................................................................................. Humanitarian Use Devices; Humanitarian 

Device Exemption.

0910–0332 

800, 801, and 809 ........................................................................................................ Medical Device Labeling Requirements; 

Unique Device Identification.

0910–0485 

820 ................................................................................................................................ Current Good Manufacturing Practice; 

Quality Systems.

0910–0073 

807, subparts A through D ........................................................................................... Medical Device Registration and Listing .. 0910–0625 

‘‘Fostering Medical Device Improvement: FDA Activities and Engagement with the 

Voluntary Improvement Program’’.

Medical Devices—Voluntary Improvement 

Program.

0910–0922 

Dated: October 30, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–24213 Filed 11–1–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

2023 Publication of Senior Executive 

Service Candidates for Health and 

Human Services Performance Review 

Board 

AGENCY: Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) is publishing the 

names of the Performance Review Board 

Members (PRB) who are reviewing 

performance of Senior Executive Service 

members, title 42 executives, Senior 

Level, and Scientific Professional 

employees for fiscal year 2023 

FOR FURTHER INFORMATION CONTACT: 

Monique Pollard, Program Manager, 

Executive Performance Management, 

Department of Health and Human 


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