Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Notices 78339 

may also be an alternate industry 

representative. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/ 

pharmacy-compounding-advisorycommittee/pharmacy-compoundingadvisory-committee-charter 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 document is issued under the 

Federal Advisory Committee Act (5 

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

related to FDA advisory committees, 

please check https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: November 30, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26696 Filed 12–3–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2216] 

Revocation of Authorizations of 

Emergency Use of Certain Medical 

Devices During COVID–19; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

revocations of the Emergency Use 

Authorizations (EUAs) (the 

Authorizations) issued to Manufacturers 

of Protective Barrier Enclosures and 

Other Stakeholders for certain 

protective barrier enclosures (‘‘PBE 

Authorization’’) and to Manufacturers of 

Infusion Pumps and Infusion Pump 

Accessories and Other Stakeholders for 

certain infusion pumps and infusion 

pump accessories (‘‘Infusion Pump 

Authorization’’). FDA revoked the PBE 

Authorization on August 20, 2020, and 

the Infusion Pump Authorization on 

September 21, 2020, under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act). The revocations, which include an 

explanation of the reasons for each 

revocation, are reprinted in this 

document. 

DATES: The PBE Authorization is 

revoked as of August 20, 2020. The 

Infusion Pump Authorization is revoked 

as of September 21, 2020. 

ADDRESSES: Submit written requests for 

single copies of the revocations to the 

Office of Counterterrorism and 

Emerging Threats, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4338, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request or 

include a Fax number to which the 

revocations may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the revocations. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer J. Ross, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4332, Silver Spring, MD 20993–0002, 

240–402–8155 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3) allows FDA to 

strengthen the public health protections 

against biological, chemical, nuclear, 

and radiological agents. Among other 

things, section 564 of the FD&C Act 

allows FDA to authorize the use of an 

unapproved medical product or an 

unapproved use of an approved medical 

product in certain situations. On May 1, 

2020, FDA issued the PBE 

Authorization. On May 13, 2020, FDA 

issued the Infusion Pump 

Authorization. Of note, these were both 

‘‘umbrella’’ Authorizations, i.e., for 

certain types of products that met the 

requirements as described in their 

respective Authorizations. Any product 

with an individual Authorization is not 

affected by revocation of these two 

umbrella Authorizations. Notice of the 

issuance of the Authorizations was 

published in the Federal Register on 

July 14, 2020 (85 FR 42407), as required 

by section 564(h)(1) of the FD&C Act. 

Subsequent to the issuance of the PBE 

Authorization, FDA considered new 

information, specifically from new 

preliminary evidence from simulated 

intubation procedure models of 

potential adverse events that could 

occur or complications with protective 

barrier enclosures without negative 

pressure. Subsequent to the issuance of 

the Infusion Pump Authorization, FDA 

considered that no device had been 

listed under the EUA and that 

circumstances instead support allowing 

for tailored requirements of 

authorization in individual EUAs. 

II. EUA Criteria for Issuance No Longer 

Met and Other Circumstances Make 

Revocation Appropriate To Protect the 

Public Health or Safety 

Under section 564(g)(2)(B) and (C) of 

the FD&C Act, the Secretary of the 

Department of Health and Human 

Services may revoke an EUA if, among 

other things, the criteria for issuance are 

no longer met or other circumstances 

make such revocation appropriate to 

protect the public health or safety. On 

August 20, 2020, FDA revoked the PBE 

Authorization because the criteria for 

issuance were no longer met and other 

circumstances make such revocation 

appropriate to protect the public health 

or safety. Under section 564(c)(2) of the 

FD&C Act, an EUA may be issued only 

if FDA concludes that, based on the 

totality of scientific evidence available, 

including data from adequate and wellcontrolled clinical trials, if available, it 

is reasonable to believe that the product 

may be effective in diagnosing, treating, 

or preventing such disease or condition 

and that the known and potential 

benefits of the product, when used to 

diagnose, prevent, or treat such disease 

or condition, outweigh the known and 

potential risks of the product. 

Given the new preliminary evidence 

from simulated intubation procedure 

models of potential adverse events that 

could occur or complications with 

protective barrier enclosures without 

negative pressure recently reported in 

literature articles, FDA has concluded it 

is not reasonable to believe the product 

may be effective in decreasing 

healthcare provider exposure to 

airborne particles and may instead 

contribute to an increase in healthcare 

provider exposure to airborne particles. 

Additionally, the literature articles note 

potential risks of protective barrier 

enclosures, such as increased intubation 

times, lower first-pass intubation 

success rates, damage to personal 

protective equipment from intubation 

boxes, particles escaping from 

intubation boxes through arm access 

holes reaching the face of the healthcare 

provider performing the endotracheal 

intubation, and human factors issues 

contributing to increased endotracheal 

intubation times. Further, based on the 

same information and the risks to public 

health, including from the device’s 

potential contribution to an increase in 

healthcare provider exposure to 

airborne particles, FDA has concluded 

under section 564(g)(2)(C) of the FD&C 

Act that other circumstances make 

revocation appropriate to protect the 

public health or safety. Accordingly, 

FDA has revoked the PBE 

78340 Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Notices 

Authorization, pursuant to section 

564(g)(2)(B) and (C) of the FD&C Act. 

On September 21, 2020, FDA revoked 

the Infusion Pump Authorization 

because other circumstances make such 

revocation appropriate to protect the 

public health or safety (section 

564(g)(2)(C) of the FD&C Act), 

considering that no device has been 

listed under the EUA, and 

circumstances instead support allowing 

for tailored requirements of 

authorization in individual EUAs. 

III. Electronic Access 

An electronic version of this 

document and the full text of the 

revocations are available on the internet 

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

https://www.fda.gov/media/142374/ 

download and https://www.fda.gov/ 

media/141415/download. 

IV. The Revocations 

Having concluded that the criteria for 

revocation of the Authorizations under 

section 564(g) of the FD&C Act are met, 

FDA has revoked the EUAs for certain 

protective barrier enclosures and certain 

infusion pumps and infusion pump 

accessories. The revocations in their 

entirety follow and provide an 

explanation of the reasons for each 

revocation, as required by section 

564(h)(1) of the FD&C Act. 

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BILLING CODE 4164–01–C 

Dated: November 30, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26697 Filed 12–3–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Solicitation of Nominations for 

Appointment to the Advisory 

Committee on Minority Health 

AGENCY: Office of Minority Health, 

Office of the Secretary, Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS), Office of 

Minority Health (OMH) is seeking 

nominations of qualified candidates to 

be considered for appointment as a 

member of the Advisory Committee on 

Minority Health (hereafter referred to as 

the ‘‘Committee or ACMH’’). The 

Committee provides advice to the 

Deputy Assistant Secretary for Minority 

Health on the development of goals and 

specific program activities for 

improving the health and the quality of 

health care minorities receive and 

eliminating racial and ethnic health 

disparities consistent with the Public 

Health Service (PHS) Act. 

DATES: Nominations for membership on 

the Committee must be received no later 

than 5:00 p.m. EST on March 4, 2021, 

at the address listed below. 

ADDRESSES: All nominations should be 

emailed to CAPT Samuel Wu, 

Designated Federal Officer, Advisory 

Committee on Minority Health, Office of 

Minority Health, at SAMUEL.WU@

hhs.gov and copy to OMH-ACMH@

hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

CAPT Samuel Wu, Designated Federal 

Officer, Advisory Committee on 

Minority Health, Office of Minority 

Health, Department of Health and 

Human Services. Phone: 240–453–6173; 

email: SAMUEL.WU@hhs.gov. 

A copy of the ACMH charter and list 

of the current Committee membership 

can be obtained by contacting CAPT Wu 

or by accessing the website managed by 

OMH at www.minorityhealth.hhs.gov. 

Information about ACMH activities also 

can be found on the OMH website under 

the heading, About OMH, Committees 

and Working Groups. 

SUPPLEMENTARY INFORMATION: Pursuant 

to Public Law 105–392, the HHS 

Secretary established the ACMH. The 

Committee provides advice to the 

Deputy Assistant Secretary for Minority 

Health on the development of goals and 

specific program activities for 

improving the health and the quality of 

health care minorities receive and 

eliminating racial and ethnic health 

disparities consistent with Section 1707 

of PHS Act, 42 U.S.C. 300u—6. 

Management and support services for 

the ACMH are provided by OMH. 

Nominations: The Committee is 

composed of 12 voting members. The 

Committee composition also can 

include non-voting ex officio members. 

This announcement is seeking 

nominations for voting members. Voting 

members of the Committee are 

appointed by the Secretary from 

individuals who are not officers or 

employees of the federal government 

and who have expertise regarding issues 

of minority health. To qualify for 

consideration of appointment to the 

Committee, an individual must possess 

demonstrated experience and expertise 

working on issues impacting the health 

of racial and ethnic minority 

populations. The Committee charter 

stipulates that health interests of the 

racial and ethnic minority groups shall 

be equally represented on the 

Committee: Hispanics/Latinos, African 

Americans, American Indians/Alaska 

Natives, and Asian Americans and 

Pacific Islanders (AAPI). 

There will be six vacancies on the 

Committee by early 2021: Three 

vacancies representing American 

Indian/Alaska Native population, one 

vacancy representing Hispanic/Latino 

population, and two vacancies 

representing AAPI populations. OMH is 

particularly seeking nominations for 

individuals who can represent the 

health interests of these racial and 

ethnic minority groups. 

Mandatory Professional/Technical 

Qualifications: Nominees must meet all 

of the following mandatory 

qualifications to be eligible for 

consideration: 

(1) Expertise in minority health and 

racial and ethnic health disparities; 

(2) Expertise in developing or 

contributing to the development of 

science-based or evidence- based health 


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