Federal Register / Vol. 87, No. 108 / Monday, June 6, 2022 / Notices 34275 

education of providers and stakeholders 

with respect to health care reform and 

certain provisions of the HITECH Act 

enacted as part of the ARRA. 

The charter will terminate on January 

19, 2023, unless renewed by appropriate 

action. The APOE was chartered under 

42 U.S.C. 217a, section 222 of the Public 

Health Service Act, as amended. The 

APOE is governed by provisions of 

Public Law 92–463, as amended (5 

U.S.C. Appendix 2), which sets forth 

standards for the formation and use of 

advisory committees. 

In accordance with the renewed 

charter, the APOE will advise the 

Secretary and the CMS Administrator 

concerning optimal strategies for the 

following: 

• Developing and implementing 

education and outreach programs for 

individuals enrolled in, or eligible for, 

Medicare, Medicaid, the CHIP, and 

coverage available through the Health 

Insurance Marketplace® and other CMS 

programs. 

• Enhancing the federal government’s 

effectiveness in informing Medicare, 

Medicaid, CHIP, or the Health Insurance 

Marketplace® consumers, issuers, 

providers, and stakeholders, pursuant to 

education and outreach programs of 

issues regarding these programs, 

including the appropriate use of publicprivate partnerships to leverage the 

resources of the private sector in 

educating beneficiaries, providers, 

partners and stakeholders. 

• Expanding outreach to minority and 

underserved communities, including 

racial and ethnic minorities, in the 

context of Medicare, Medicaid, CHIP, 

and the Health Insurance Marketplace®

education programs and other CMS 

programs as designated. 

• Assembling and sharing an 

information base of ‘‘best practices’’ for 

helping consumers evaluate health 

coverage options. 

• Building and leveraging existing 

community infrastructures for 

information, counseling, and assistance. 

• Drawing the program link between 

outreach and education, promoting 

consumer understanding of health care 

coverage choices, and facilitating 

consumer selection/enrollment, which 

in turn support the overarching goal of 

improved access to quality care, 

including prevention services, 

envisioned under the Affordable Care 

Act. 

The current members of the Panel as 

of April 7, 2022, are as follows: 

• Julie Carter, Senior Federal Policy 

Associate, Medicare Rights Center. 

• Scott Ferguson, Psychotherapist, 

Scott Ferguson Psychotherapy. 

• Jean-Venable Robertson Goode, 

Professor, Department of 

Pharmacotherapy and Outcomes 

Science, School of Pharmacy, Virginia 

Commonwealth University. 

• Ted Henson, Director of Health 

Center Performance and Innovation, 

National Association of Community 

Health Centers. 

• Joan Ilardo, Director of Research 

Initiatives, Michigan State University, 

College of Human Medicine. 

• Daisy Kim, Policy Manager, Asian & 

Pacific Islander American Health 

Forum. 

• Cheri Lattimer, Executive Director, 

National Transitions of Care Coalition. 

• Cori McMahon, Vice President, 

Tridiuum. 

• Alan Meade, Director of 

Rehabilitation Services, Holston 

Medical Group. 

• Neil Meltzer, President and CEO, 

LifeBridge Health. 

• Michael Minor, National Director, 

H.O.P.E. HHS Partnership, National 

Baptist Convention USA, Incorporated. 

• Jina Ragland, Associate State 

Director of Advocacy and Outreach, 

AARP Nebraska. 

• Morgan Reed, Executive Director, 

Association for Competitive 

Technology. 

• Margot Savoy, Senior Vice 

President, American Academy of Family 

Physicians. 

• Congresswoman Allyson Schwartz, 

Senior Advisor, FTI Consulting. 

• Matthew Snider, JD, Senior Policy 

Analyst, Unidos US. 

• Tia Whitaker, Statewide Director, 

Outreach and Enrollment, Pennsylvania 

Association of Community Health 

Centers. 

II. Provisions of This Notice 

In accordance with section 10(a) of 

the FACA, this notice announces a 

meeting of the APOE. The agenda for 

the June 23, 2022 meeting will include 

the following: 

• Welcome and listening session with 

CMS leadership 

• Recap of the previous (April 7, 2022) 

meeting 

• CMS programs, initiatives, and 

priorities 

• An opportunity for public comment 

• Meeting summary, review of 

recommendations, and next steps 

Individuals or organizations that wish 

to make a 5-minute oral presentation on 

an agenda topic should submit a written 

copy of the oral presentation to the DFO 

at the address listed in the ADDRESSES

section of this notice by the date listed 

in the DATES section of this notice. The 

number of oral presentations may be 

limited by the time available. 

Individuals not wishing to make an oral 

presentation may submit written 

comments to the DFO at the address 

listed in the ADDRESSES section of this 

notice by the date listed in the DATES

section of this notice. 

III. Meeting Participation 

The meeting is open to the public, but 

attendance is limited to registered 

participants. Persons wishing to attend 

this meeting must register at the website 

https://www.eventbrite.com/e/apoejune-23-2022-virtual-meeting-tickets323499494697 or contact the DFO at the 

address or number listed in the FOR

FURTHER INFORMATION CONTACT section of 

this notice by the date specified in the 

DATES section of this notice. This 

meeting will be held virtually. 

Individuals who are not registered in 

advance will be unable to attend the 

meeting. 

IV. Collection of Information 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping, or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. chapter 35). 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Lynette Wilson, who is the 

Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Dated: June 1, 2022. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2022–12136 Filed 6–3–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–3787] 

Electromagnetic Compatibility of 

Medical Devices; 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 


lotter on DSK11XQN23PROD with NOTICES1
34276 Federal Register / Vol. 87, No. 108 / Monday, June 6, 2022 / Notices 

announcing the availability of a final 

guidance entitled ‘‘Electromagnetic 

Compatibility (EMC) of Medical 

Devices.’’ FDA has developed this 

guidance document to recommend 

information that should be provided in 

a premarket submission (i.e., premarket 

approval application (PMA), 

humanitarian device exemption (HDE), 

premarket notification (510(k)) 

submission, investigational device 

exemption (IDE), De Novo request, and 

certain biologics license applications 

(BLAs) and investigational new drug 

(IND) applications to demonstrate 

electromagnetic compatibility (EMC) for 

electrically powered medical devices 

and medical devices with electrical or 

electronic functions. This guidance 

provides specific technical information 

to address the recommendations 

originally described in the guidance 

entitled ‘‘Information to Support a 

Claim of Electromagnetic Compatibility 

(EMC) of Electrically-Powered Medical 

Devices,’’ which was published July 11, 

2016 (2016 EMC guidance). 

DATES: The announcement of the 

guidance is published in the Federal 

Register on June 6, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2015–D–3787 for ‘‘Electromagnetic 

Compatibility (EMC) of Medical 

Devices.’’ 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 ‘‘Electromagnetic 

Compatibility (EMC) of Medical 

Devices’’ 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, 

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: Seth 

J. Seidman, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 62, Rm. 1108, Silver Spring, 

MD 20993–0002, 301–796–2477; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

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

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA has developed this guidance 

document to recommend information 

that should be provided in a premarket 

submission (i.e., PMA, HDE, 510(k), 

IDE, De Novo request, and certain BLAs 

and IND applications) to demonstrate 

EMC for electrically powered medical 

devices and medical devices with 

electrical or electronic functions. 

Typically, the review of EMC 

information in a submission is based on 

the risk associated with malfunction or 

degradation of the medical device under 

consideration, where malfunction or 

degradation could be caused by 

inadequate EMC. The review is also 

based on the use of appropriate 

consensus standards. This guidance, 

when final, will replace the FDA 

guidance entitled ‘‘Information to 

Support a Claim of Electromagnetic 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 108 / Monday, June 6, 2022 / Notices 34277 

1Available at https://www.fda.gov/medicaldevices/premarket-notification-510k/voluntaryestar-program. 

Compatibility (EMC) of ElectricallyPowered Medical Devices’’ (2016 EMC 

guidance), which was published July 11, 

2016. This guidance provides additional 

technical information to address the 

recommendations in the 2016 EMC 

guidance. 

FDA recognizes and anticipates that 

the Agency and industry may need up 

to 1 year to perform activities to 

operationalize the policies within the 

guidance, only for in vitro diagnostic 

products. Because this guidance 

generally reflects current practice for the 

assessment of EMC for other device 

types, but some activities to fully 

operationalize the policies are needed 

(e.g., updates to eSTAR1), FDA intends 

to implement this guidance 60 days 

after issuance for device types within 

the scope of this guidance, excluding in 

vitro diagnostic products. If new 

information regarding electromagnetic 

compatibility as outlined in this 

guidance is not included in a premarket 

submission for an in vitro diagnostic 

received by FDA before or up to 1 year 

after the publication of this guidance or 

for other device types within the scope 

of this guidance before or up to 60 days 

after the publication of this guidance, 

FDA does not generally intend to 

request such information during the 

review of the submission. FDA does, 

however, intend to review any such 

information if submitted. 

A notice of availability of the draft 

guidance appeared in the Federal 

Register of November 17, 2020 (85 FR 

73276). FDA considered comments 

received and revised the guidance as 

appropriate in response to the 

comments, including clarification of 

scope; addressing the use of IEC 60601– 

1–2:2020, which was published after the 

draft guidance was issued; and adding 

a transition period to facilitate the 

implementation of the guidance. 

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 EMC of medical 

devices. 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 or from the 

Center for Biologics Evaluation and 

Research at https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances. This 

guidance document is also available at 

https://www.regulations.gov and https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Persons unable to download an 

electronic copy of ‘‘Electromagnetic 

Compatibility (EMC) of Medical 

Devices’’ may send an email request to 

CDRH-Guidance@fda.hhs.gov to receive 

an electronic copy of the document. 

Please use the document number 

1400057 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. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in the following FDA 

regulations have been approved by OMB 

as listed in the following table: 

21 CFR part Topic OMB Control No. 

807, subpart E .......................................... Premarket notification ............................................................................................. 0910–0120 

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

814, subpart H ......................................... Humanitarian Device Exemption ............................................................................ 0910–0332 

812 ........................................................... Investigational Device Exemption ........................................................................... 0910–0078 

860, subpart D ......................................... De Novo classification process .............................................................................. 0910–0844 

800, 801, and 809 .................................... Medical Device Labeling Regulations .................................................................... 0910–0485 

803 ........................................................... Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility reporting, distributor reporting.0910–0437 

820 ........................................................... Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation 0910–0073 

Dated: May 31, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12099 Filed 6–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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: Scientific and 

Technical Review Board on Biomedical and 

Behavioral Research Facilities. 

Date: June 28–29, 2022. 

Time: 9:00 a.m. to 8:00 p.m. 


lotter on DSK11XQN23PROD with NOTICES1