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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 75293 

Services, 330 C Street SW, Washington, 

DC 20201, (202) 729–8797. 

SUPPLEMENTARY INFORMATION: Title 5 

U.S.C. 4314(c)(4) of the Civil Service 

Reform Act of 1978, Public Law 95–454, 

requires that the appointment of 

Performance Review Board Members be 

published in the Federal Register. The 

following individuals are being 

appointed to a roster, from which the 

PRB members will be appointed to serve 

on the HHS PRB from CY 2023 through 

CY 2025. The PRB provides 

performance rating and rating-based 

compensation recommendations to the 

HHS Secretary based on the individual 

performance appraisals for Senior 

Executive Service, Senior Level/Senior 

Technical, and Title 42 executive 

equivalent employees and the 

organizational assessments of the 

Operating and Staff Divisions they 

serve. 

Last name First name 

ADAMS ..................... STEVEN. 

AKPA ......................... STEPHANIE. 

ALTMAN .................... BRIAN. 

ALVAREZ .................. KATHRYN. 

AMES ........................ KAREN. 

ANOKA ...................... JEFFERY. 

ANTHONY ................. ELISE. 

ARNOLD ................... SHARON. 

BACKFIELD .............. KATLIN. 

BALLANCE ............... CHRISTINA. 

BARKOFF ................. ALISON. 

BARLOW ................... AMANDA. 

BARRY ...................... DANIEL. 

BELL ......................... WILLIAM. 

BENFORD ................. JOFFREY. 

BHARGAVA .............. DEEPAK. 

BLACKWELL ............. EDITH. 

BLUM ........................ JONATHAN. 

BOATENG ................. SARAH. 

BODDEN ................... CHERYL. 

BOTTICELLA ............ ANGELA. 

BRATCHER-BOWMAN.NIKKI. 

BRAXTON ................. MAKOTO. 

BRISBON .................. HENRIETTA. 

BROWN .................... MARK. 

BRUCE ...................... DUANE. 

BURNS ...................... SAMIRA. 

BURNSZYNSKI ......... JENNIFER. 

BUSH ........................ LAINA. 

CABEZAS ................. MIRIAM. 

CALSYN .................... MAURA. 

CAMPBELL ............... CHERYL. 

CANNISTRA ............. JENNIFER. 

CARNIVAL ................ DANIELLE. 

CHA ........................... STEPHEN. 

CHAMBERS .............. GEORGE. 

CHAMP-GELBMANN JANE. 

CHESLEY ................. FRANCIS. 

CHESSEN ................. SONIA. 

CLIFFORD ................ CHAD. 

COCHRAN ................ NORRIS. 

COMFORT ................ KAREN. 

CONLEY ................... MARY. 

COOPER ................... RENEE. 

CRONIN .................... KELLY. 

CURTIS ..................... MICHAEL. 

Last name First name 

DALY ......................... MADELINE. 

DAVIS ....................... MICHELLE. 

DEL VECCHIO .......... PAOLO. 

DELEW ..................... NANCY. 

DESPRES ................. SARAH. 

DISRAELLY .............. DEENA. 

DOOLEY ................... SEAN. 

DORN ........................ ALAN. 

DRIGGS .................... SCOTT. 

DUNN MARCOS ....... ROBIN. 

DUPRE ...................... BRIAN. 

ESPINOSA ................ KIMBERLY. 

FIGUEROA ............... MARVIN. 

FINK .......................... DOROTHY. 

FITZGERALD ............ DENIS. 

FLAGG ...................... ANN. 

FORBER–PRATT ..... ANJALI. 

FRIEDMAN ............... RUTH. 

FROHBOESE ............ ROBINSUE. 

FROSS ...................... CAITLIN. 

FRYE ......................... EUGENE. 

GALLOWAY .............. SUMMER. 

GARRITY .................. SHEILA. 

GARVIN .................... KHARI. 

GOLDHABER ............ BEN. 

GOLDSTEIN ............. ANDREA. 

GOTTLICH ................ VICKI. 

GOULDING ............... MICHAEL. 

GRAF ........................ ALEXANDER. 

GRAMLING ............... ELIZABETH. 

GRAY ........................ TANGULER. 

GREENBERG ........... MARK. 

GREENE ................... JONATHAN. 

GRIFFIN .................... ELIZABETH. 

GROSSMAN ............. JORDAN. 

GUERRERO ............. BERTHA. 

HAFFAJEE ................ REBECCA. 

HALL ......................... RANDALL. 

HALL ......................... WAYNE. 

HAMAMOTO ............. PAMELA. 

HAMM ....................... KATHLEEN. 

HANDERHAN ........... LAWRENCE. 

HARPER ................... VICTOR. 

HAYES WALLER ...... BERNITA. 

HENDERSON ........... GRAEME. 

HERNANDEZ ............ PATRICK. 

HILD .......................... STEVEN. 

HILL ........................... KRISTI. 

HOFFMAN ................ JANICE. 

HOLLAND ................. HOWARD. 

HOLZERLAND .......... WILLIAM. 

HORN ........................ DAVID. 

HOWARD .................. LANIKQUE. 

HUTCHINSON .......... KIM. 

JACKSON ................. SHANNON. 

JACOBS .................... JILL. 

JEE ............................ LAUREN. 

JOHN ........................ KURT. 

JOHNSON ................. DAVID. 

JOHNSON ................. DEBRA. 

JOHNSON ................. JENNIFER. 

JONES ...................... CHRISTINE. 

JONES ...................... KAMARA. 

JONES ...................... WANDA. 

JOYNER .................... ARLENE. 

KACHINSKI ............... KEVIN. 

KADISH ..................... ANDREA. 

KENNEDY ................. GAVIN. 

KEVENEY ................. SEAN. 

KIM ............................ HANNAH. 

KIM ............................ SUSAN. 

KOSSALLY ............... CONSTANCE. 

KRAM ........................ ANTHONY. 

KRAMER ................... DEBORAH. 

Last name First name 

LANKFORD ............... DAVID. 

LEAVITT .................... WILLIAM. 

LEE ........................... PAULA. 

LESKO ...................... MAX. 

LIMAGE ..................... JULIA. 

LONNERDAL ............ NILS. 

LOPEZ ...................... ELIZABETH. 

LYNCH-SMITH .......... MIRANDA. 

LYONS ...................... SUSAN. 

MALONEY ................. CAROL. 

MARCELLA ............... JESSICA. 

MATAKA ................... ARSENIO. 

MATHIAS .................. KARL. 

MAZANEC ................. BRIAN. 

MCCLUSKIE ............. SEAN. 

MCDANIEL ................ EILEEN. 

MCIFF ....................... COLIN. 

MIRANDA .................. TERESA. 

MOHIUDDIN ............. SYED. 

MOTSIOPOULOS ..... CHRISTOS. 

MUSE ........................ AVERY. 

NAIMON .................... DAVID. 

NICHOLLS ................ RICHARD. 

NOLAN ...................... JANET. 

NOONAN .................. TIMOTHY. 

NOVY ........................ STEVEN. 

PACE ........................ LOYCE. 

PARK ........................ RACHEL. 

PARKER HALVERSON.PAMELA. 

PECK ........................ JOSHUA. 

PEREZ ...................... LUIS. 

PERSON ................... LISA. 

PETILLO ................... JOHN. 

PIERCE ..................... JULIA. 

POSNACK ................. STEVEN. 

PRYOR ..................... RACHEL. 

PURDUE ................... MICHELE. 

RABIN ....................... BRIAN. 

RAINER ..................... MELANIE. 

RAMIREZ .................. ANGELA. 

RATHGEB ................. COLLEEN. 

RECHTER ................. PETER. 

ROBINSON ............... WILMA. 

RODRIGUEZ ............. PAUL. 

ROSENTHAL ............ SARAH. 

SANDERS ................. STACY. 

SAUNDERS .............. MICHAEL. 

SCHOMBURG .......... AYSHA. 

SCHUHAM ................ AARON. 

SCOTT ...................... MARIE. 

SESHASAI ................ KARUNA. 

SHA ........................... LYNN. 

SHANBHAG .............. KRISHNAKANT. 

SHERRY ................... TISAMARIE. 

SKEADAS ................. CHRISTOS. 

SMITH ....................... JENNIFER. 

SMITH ....................... JESSICA. 

STEIDE ..................... KIMBERLY. 

SULLIVAN ................. MEG. 

SULLIVAN ................. ROSE. 

SUPPLEE .................. LAUREN. 

TAYLOR .................... CAROLYN. 

TOBIAS ..................... CONSTANCE. 

TOMOYASU .............. NAOMI. 

TOVEN ...................... JEFFREY. 

TRAUTMAN .............. TRACEY. 

TRESS ...................... DEBORAH. 

TRIPATHI .................. SUHAS. 

VALDEZ .................... ROBERT. 

WALKER ................... EDWIN. 

WALLER ................... KIMBERLY. 

WEAVER ................... GRETCHEN. 

WEBB ........................ SANDRA. 


khammond on DSKJM1Z7X2PROD with NOTICES
75294 Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 

Last name First name 

WENDEL ................... JENNIFER. 

WESLEY ................... KENYATA. 

WILLIAMS ................. CARLIS. 

WILLIAMS ................. RASHEED. 

WULFF ...................... KATHARINE. 

YARBOROUGH ........ LA MONTE. 

Michelle Monroe, 

Director, Executive Resources. 

[FR Doc. 2023–24207 Filed 11–1–23; 8:45 am] 

BILLING CODE 4151–17–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Board of Scientific 

Counselors, NIDDK. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public as indicated below in accordance 

with the provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended for the review, discussion, 

and evaluation of individual grant 

applications conducted by the National 

Institute of Diabetes and Digestive and 

Kidney Diseases, including 

consideration of personnel 

qualifications and performance, and the 

competence of individual investigators, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Board of Scientific 

Counselors, NIDDK. 

Date: April 19–20, 2024. 

Open: April 19, 2024, 10:00 a.m. to 10:20 

a.m. 

Agenda: Introductions and Overview. 

Place: National Institutes of Health, 

Building 10, 10 Center Drive, Bethesda, MD 

20892 (Virtual Meeting). 

Closed: April 19, 2024, 10:30 a.m. to 5:00 

p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual Investigators. 

Place: National Institutes of Health, 

Building 10, 10 Center Drive, Bethesda, MD 

20892 (Virtual Meeting). 

Contact Person: Michael W. Krause, Ph.D., 

Scientific Director, NIDDK, National Institute 

of Diabetes and Digestive and Kidney 

Diseases, National Institute of Health, 

Building 5, Room B104, Bethesda, MD 

20892–1818, (301) 402–4633, mwkrause@

helix.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: October 27, 2023. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–24139 Filed 11–1–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Molecular 

and Cellular Analysis Technologies. 

Date: December 14–15, 2023. 

Time: 10:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

7W608, Rockville, Maryland 20850 (Virtual 

Meeting). 

Contact Person: Nadeem Khan, Ph.D., 

Scientific Review Officer, Research 

Technology and Contract Review Branch, 

Division of Extramural Activities, National 

Cancer Institute, NIH, 9609 Medical Center 

Drive, Room 7W608, Rockville, Maryland 

20850, 240–276–5856, nadeem.khan@

nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; 

Survivorship Needs of Individuals Living 

with Advanced Cancer (R01). 

Date: January 11, 2024. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

7W108, Rockville, Maryland 20850 (Virtual 

Meeting). 

Contact Person: Clifford W. Schweinfest, 

Ph.D., Scientific Review Officer, Special 

Review Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

9609 Medical Center Drive, Room 7W108, 

Rockville, Maryland 20850, 240–276–6343, 

schweinfestcw@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; IMAT 

Biospecimen Research. 

Date: January 11, 2024. 

Time: 11:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

7W246, Rockville, Maryland 20850 (Virtual 

Meeting). 

Contact Person: Jun Fang, Ph.D., Scientific 

Review Officer, Research Technology and 

Contract Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, NIH, 9609 Medical Center Drive, 

Room 7W246, Rockville, Maryland 20850, 

240–276–5460, jfang@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; 

Technologies for Cancer Research. 

Date: January 25–26, 2024. 

Time: 10:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

7W608, Rockville, Maryland 20850 (Virtual 

Meeting). 

Contact Person: Nadeem Khan, Ph.D., 

Scientific Review Officer, Research 

Technology and Contract Review Branch, 

Division of Extramural Activities, National 

Cancer Institute, NIH, 9609 Medical Center 

Drive, Room 7W608, Rockville, Maryland 

20850, 240–276–5856, nadeem.khan@

nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; NCI 

Transition Career Development Award and 

Institutional Research Training and 

Education Grants. 

Date: January 25, 2024. 

Time: 10:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

7W234, Rockville, Maryland 20850 (Virtual 

Meeting). 

Contact Person: Adriana Stoica, Ph.D., 

Scientific Review Officer, Resources and 

Training Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, NIH, 9609 Medical Center Drive, 

Room 7W234, Rockville, Maryland 20850, 

240–276–6368, Stoicaa2@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; NCI SPORE 

(P50) Review SEP–II. 

Date: February 1–2, 2024. 

Time: 9:30 a.m. to 5:30 p.m. 


khammond on DSKJM1Z7X2PROD with NOTICES