78338 Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Notices 

CDRH and CBER and the formal 

meetings used in CDER and CBER, or 

through CPAMs, as appropriate. 

FDA is publishing this guidance 

consistent with the Agency’s ongoing 

commitment to enhancing clarity and 

transparency regarding regulatory 

considerations for combination 

products, and in accordance with the 

mandate under section 503(g)(8)(C)(vi) 

of the Federal Food, Drug, and 

Cosmetics Act (FD&C Act) (21 U.S.C. 

353(g)(8)(C)(vi)), which was added by 

section 3038 of the 21st Century Cures 

Act (Pub. L. 114–255). Section 

503(g)(8)(C)(vi) of the FD&C Act requires 

FDA to issue a final guidance 

addressing: (1) The structured process 

for managing pre-submission 

interactions with sponsors developing 

combination products; (2) best practices 

to ensure FDA feedback in such presubmission interactions represents the 

Agency’s best advice based on the 

information provided during these presubmission interactions; and (3) how 

CPAMs relate to other FDA meeting 

types, what information should be 

submitted prior to a CPAM, and the 

form and content of agreements reached 

through a CPAM. 

In response to comments received on 

the draft guidance, this final guidance 

includes additional information on use 

of CPAMs and application-based 

mechanisms. The guidance also 

provides additional clarity on how 

CPAMs will be conducted, including 

expected timelines for CPAM-related 

activities. 

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 ‘‘Requesting FDA 

Feedback on Combination Products.’’ 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. Paperwork Reduction Act of 1995 

While this guidance contains no 

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 pertaining to orphan drug 

provisions in 21 CFR part 316 are 

approved under OMB control number 

0910–0167; the collections of 

information pertaining to investigational 

device exemption submission 

provisions in 21 CFR part 812 are 

approved under OMB control number 

0910–0078; the collections of 

information pertaining to investigational 

new drug submission provisions in 21 

CFR part 312 are approved under OMB 

control number 0910–0014; the 

collections of information pertaining to 

biologics licensing submission 

provisions in 21 CFR part 601 are 

approved under OMB control number 

0910–0338; and the collections of 

information pertaining to combination 

product agreement meetings are 

approved under OMB control number 

0910–0523. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/combinationproducts/guidance-regulatoryinformation/combination-productsguidance-documents or https://

www.regulations.gov. 

Dated: November 30, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26700 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–2018–N–1768] 

Advisory Committee; Pharmacy 

Compounding Advisory Committee; 

Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of advisory 

committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the Pharmacy Compounding 

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 Pharmacy 

Compounding Advisory Committee for 

an additional 2 years beyond the charter 

expiration date. The new charter will be 

in effect until April 25, 2022. 

DATES: Authority for the Pharmacy 

Compounding Advisory Committee will 

expire on April 25, 2022, unless the 

Commissioner formally determines that 

renewal is in the public interest. 

FOR FURTHER INFORMATION CONTACT: 

Yvette Waples, Division of Advisory 

Committee and Consultant 

Management, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, email: PCAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3, FDA is announcing 

the renewal of the Pharmacy 

Compounding Advisory Committee 

(Committee). The Committee is a nondiscretionary Federal advisory 

committee established to provide advice 

to the Commissioner. 

The Committee advises the 

Commissioner or designee in 

discharging responsibilities as they 

relate to compounding drugs for human 

use and, as required, any other product 

for which FDA has regulatory 

responsibility. 

The Committee shall provide advice 

on scientific, technical, and medical 

issues concerning drug compounding 

under sections 503A and 503B of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 353a and 353b), and, as 

required, any other product for which 

FDA has regulatory responsibility and 

make appropriate recommendations to 

the Commissioner of Food and Drugs. 

Pursuant to its Charter, the Committee 

shall consist of a core of 12 voting 

members including the Chair. Members 

and the Chair are selected by the 

Commissioner or designee from among 

authorities knowledgeable in the fields 

of pharmaceutical compounding, 

pharmaceutical manufacturing, 

pharmacy, medicine, and related 

specialties. These members will include 

representatives from the National 

Association of Boards of Pharmacy, the 

United States Pharmacopeia, 

pharmacists with current experience 

and expertise in compounding, 

physicians with background and 

knowledge in compounding, and patient 

and public health advocacy 

organizations. Members will be invited 

to serve for overlapping terms of up to 

four years. Almost all non-Federal 

members of this committee serve as 

Special Government Employees. The 

core of voting members may include one 

or more technically qualified members, 

selected by the Commissioner or 

designee, who are identified with 

consumer interests and are 

recommended by either a consortium of 

consumer-oriented organizations or 

other interested persons. In addition to 

the voting members, the Committee may 

include one or more non-voting 

representative members who are 

identified with industry interests. There 

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