75290 Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 8 U.S.C. 1522 of the 

Immigration and Nationality Act (the 

Act) [Title IV, Sec. 412 of the Act] for 

each state agency requesting federal 

funding for refugee resettlement under 8 

U.S.C. 524 [Title IV, Sec. 414 of the 

Act]. 

Mary Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–24185 Filed 11–1–23; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–2809] 

Advisory Committee; Patient 

Engagement Advisory Committee; 

Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of Federal 

advisory committee. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the renewal of the Patient 

Engagement Advisory Committee by the 

Commissioner of Food and Drugs (the 

Commissioner). The Commissioner has 

determined that it is in the public 

interest to renew the Patient 

Engagement Advisory Committee for an 

additional 2 years beyond the charter 

expiration date. The new charter will be 

in effect until the October 6, 2025, 

expiration date. 

DATES: Authority for the Patient 

Engagement Advisory Committee would 

have expired on October 6, 2025, unless 

the Commissioner had formally 

determined that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

Letise Williams, Office of the Center 

Director, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5407, Silver Spring, 

MD 20993–0002, 301–796–8398, 

Letise.Williams@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services and by the General Services 

Administration, FDA is announcing the 

renewal of the Patient Engagement 

Advisory Committee (the Committee). 

The Committee is a discretionary 

Federal advisory committee established 

to provide advice to the Commissioner. 

The Patient Engagement Advisory 

Committee advises the Commissioner or 

designee in discharging responsibilities 

as they relate to helping to ensure safe 

and effective devices for human use 

and, as required, any other product for 

which FDA has regulatory 

responsibility. 

The Committee provides advice to the 

Commissioner of Food and Drugs or 

designee on complex scientific, issues 

relating to medical devices, the 

regulation of devices, and their use by 

patients. Agency guidance and policies, 

clinical trial or registry design, patient 

preference study design, benefit-risk 

determinations, device labeling, unmet 

clinical needs, available alternatives, 

patient reported outcomes, and devicerelated quality of life measures or health 

status issues are among the topics that 

may be considered by the Committee. 

The Committee provides relevant skills 

and perspectives to improve 

communication of benefits, risks, and 

clinical outcomes, and increase 

integration of patient perspectives into 

the regulatory process for medical 

devices. It performs its duties by 

identifying new approaches, promoting 

innovation, recognizing unforeseen risks 

or barriers, and identifying unintended 

consequences that could result from 

FDA policy. 

Pursuant to its Charter, the Committee 

shall consist of a core of nine voting 

members, including the Chair. Members 

and the Chair are selected by the 

Commissioner or designee from among 

authorities who are knowledgeable in 

areas such as clinical research, patient 

experience, and healthcare needs of 

patient groups in the United States, or 

who are experienced in the work of 

patient and health professional 

organizations, methodologies for patient 

reported outcomes and eliciting patient 

preferences, and strategies for 

communicating benefits, risks, and 

clinical outcomes to patients and 

research subjects, as well as other 

relevant areas. Members will be invited 

to serve for overlapping terms of up to 

4 years. Non-Federal members of this 

committee will serve as either as Special 

Government Employees or non-voting 

representatives. Federal members will 

serve as Regular Government 

Employees. The core of voting members 

may include one technically qualified 

member, selected by the Commissioner 

or designee, who serves as an 

individual, but who is identified with 

consumer interests and is recommended 

by either a consortium of consumeroriented organizations or other 

interested persons. The Commissioner 

or designee shall also have the authority 

to select from a group of individuals 

nominated by industry to serve 

temporarily as nonvoting members who 

are identified with industry interests. 

The number of temporary members 

selected for a particular meeting will 

depend on the meeting topic. 

The Commissioner or designee shall 

also have the authority to select 

members of other scientific and 

technical FDA advisory committees 

(normally not to exceed 10 members) to 

serve temporarily as voting members 

and to designate consultants to serve 

temporarily as voting members when: 

(1) expertise is required that is not 

available among current voting standing 

members of the Committee (when 

additional voting members are added to 

the Committee to provide needed 

expertise, a quorum will be based on the 

combined total of regular and added 

members); or (2) to comprise a quorum 

when, because of unforeseen 

circumstances, a quorum is or will be 

lacking. Because of the size of the 

Committee and the variety in the types 

of issues that it will consider, FDA may, 

in connection with a particular 

committee meeting, specify a quorum 

that is less than a majority of the current 

voting members. The Agency’s 

regulations (21 CFR 14.22(d)) authorize 

a committee charter to specify quorum 

requirements. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/ 

committees-and-meeting-materials/ 

patient-engagement-advisory-committee 

or by contacting the Designated Federal 

Officer (see FOR FURTHER INFORMATION

CONTACT). In light of the fact that no 

change has been made to the committee 

name or description of duties, no 

amendment will be made to 21 CFR 

14.100. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 


khammond on DSKJM1Z7X2PROD with NOTICES
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: 


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