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draft guidance was issued; and adding 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
34278 Federal Register / Vol. 87, No. 108 / Monday, June 6, 2022 / Notices 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Santanu Banerjee, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2106, 

Bethesda, MD 20892, (301) 435–5947, 

banerjees5@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.14, Intramural Research 

Training Award; 93.22, Clinical Research 

Loan Repayment Program for Individuals 

from Disadvantaged Backgrounds; 93.232, 

Loan Repayment Program for Research 

Generally; 93.39, Academic Research 

Enhancement Award; 93.936, NIH Acquired 

Immunodeficiency Syndrome Research Loan 

Repayment Program; 93.187, Undergraduate 

Scholarship Program for Individuals from 

Disadvantaged Backgrounds, National 

Institutes of Health, HHS) 

Dated: May 31, 2022. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–12043 Filed 6–3–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Cancer Institute 

Council of Research Advocates. 

The meeting will be held as a virtual 

meeting and is open to the public. 

Individuals who plan to view the virtual 

meeting and need special assistance or 

other reasonable accommodations to 

view the meeting, should notify the 

Contact Person listed below in advance 

of the meeting. The meeting will be 

videocast and can be accessed from the 

NIH Videocasting and Podcasting 

website (http://videocast.nih.gov). 

Name of Committee: National Cancer 

Institute Council of Research Advocates. 

Date: June 29, 2022. 

Time: 12:00 p.m. to 4:00 p.m. 

Agenda: Welcome and Chairman’s 

Remarks, NCI Updates, Legislative Update, 

and Acting Director’s Update. 

Place: National Institutes of Health, 9000 

Rockville Pike, Bethesda, MD 20892 (Virtual 

Meeting). 

Contact Person: Amy Williams, NCI Office 

of Advocacy Relations, National Cancer 

Institute, NIH, 31 Center Drive, Building 31, 

Room 10A28, Bethesda, MD 20892, (301) 

496–9723, williaam@mail.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: NCRA: http:// 

deainfo.nci.nih.gov/advisory/ncra/ncra.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS). 

Dated: May 31, 2022. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–12042 Filed 6–3–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; Notice of 

Proposed Reorganization 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Institute of 

Biomedical Imaging and Bioengineering 

(NIBIB) will host a public hearing to 

enable public discussion of the 

Institute’s proposal to establish the 

Center for Biomedical Imaging and 

Technology Acceleration (bETA). The 

proposed reorganization aims to 

accelerate the development, validation, 

and dissemination of high-impact 

biomedical technologies to address 

urgent national and global health needs. 

DATES: The public hearing will take 

place on June 29, 2022, at 2 p.m. using 

NIBIB’s social media accounts. Any 

interested party may also file written 

comments by sending an email to 

NIBIBorgchange@nih.gov prior or 

during the scheduled public hearing. 

The statement should include the 

individual’s name, and when 

applicable, professional affiliation. 

ADDRESSES: The following email address 

has been established for comments on 

the reorganization: NIBIBorgchange@

nih.gov. The social media platforms that 

will be used and monitored during this 

hearing are: 

• Twitter: @NIBIBgov 

• Facebook: https://www.facebook.com/ 

nibibgov/ 

FOR FURTHER INFORMATION CONTACT: Eva 

Kakoza, Management Analyst, National 

Institute of Biomedical Imaging and 

Bioengineering, NIH, (301) 402–4584, 

NIBIBorgchange@nih.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to the NIH Reform Act of 2006 (42 

U.S.C. Sec.281 (d)(4)), NIBIB will have 

a public hearing to discuss the proposed 

reorganization plans. This 

announcement and the public forum 

serve as that notice. More information 

can be found at https://

www.nibib.nih.gov/about-nibib/ 

proposed-org-changes. 

Jason M. Ford, 

Executive Officer, National Institute of 

Biomedical Imaging and Biomedical 

Engineering, National Institutes of Health. 

[FR Doc. 2022–12073 Filed 6–3–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; 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: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; RFA DK21–012 

SBIR Review. 

Date: June 29, 2022. 

Time: 1:00 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: NIDDK, NIH, 6707 Democracy Blvd., 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Ann A. Jerkins, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 7119, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, 301–594–2242, 

jerkinsa@niddk.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 


lotter on DSK11XQN23PROD with NOTICES1