39044 Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 

such use outweigh its known and potential risks; 

and (3) there are no adequate, approved, and 

available alternatives to the emergency use of the 

IBU. During the public health emergency, it would 

not be feasible to require healthcare providers to 

limit the IBU use for patients with suspected or 

confirmed COVID–19; therefore, the authorization 

does not restrict use to such patients. 

16As set forth in the EUA, FDA has concluded 

that: (1) SARS–CoV–2, the virus that causes 

COVID–19, can cause a serious or life-threatening 

disease or condition, including severe respiratory 

illness, to humans infected by this virus; (2) based 

on the totality of scientific evidence available to 

FDA, it is reasonable to believe that the SalivaDirect 

At-Home Collection Kit may be effective in 

diagnosing COVID–19, by serving as an appropriate 

means to collect and transport human specimens so 

that an authorized laboratory can detect SARS– 

CoV–2 RNA from the self-collected human 

specimen, and that the known and potential 

benefits of the SalivaDirect At-Home Collection Kit 

when used for diagnosing COVID–19, outweigh the 

known and potential risks of the SalivaDirect AtHome Collection Kit; and (3) there is no adequate, 

approved, and available alternative to the 

emergency use of the SalivaDirect At-Home 

Collection Kit. 

17As set forth in the EUA, FDA has concluded 

that: (1) SARS–CoV–2, the virus that causes 

COVID–19, can cause a serious or life-threatening 

disease or condition, including severe respiratory 

illness, to humans infected by this virus; (2) based 

on the totality of scientific evidence available to 

FDA, it is reasonable to believe that the Color 

COVID–19 Self-Swab Collection Kit with Saline 

may be effective in diagnosing COVID–19, by 

serving as an appropriate means to collect and 

transport human specimens so that an authorized 

laboratory can detect SARS–CoV–2 RNA from the 

self-collected human specimen, and that the known 

and potential benefits of the Color COVID–19 SelfSwab Collection Kit with Saline when used for 

diagnosing COVID–19, outweigh the known and 

potential risks of the Color COVID–19 Self-Swab 

Collection Kit with Saline; and (3) there is no 

adequate, approved, and available alternative to the 

emergency use of the Color COVID–19 Self-Swab 

Collection Kit with Saline. 

18As set forth in the EUA, FDA has concluded: 

(1) SARS–CoV–2 can cause a serious or lifethreatening disease or condition, including severe 

respiratory illness, to humans infected by this virus; 

(2) based on the totality of scientific evidence 

available to FDA, it is reasonable to believe that 

ISOCUBE may be effective in preventing healthcare 

provider exposure to pathogenic biological airborne 

particulates by providing an extra layer of barrier 

protection in addition to personal protective 

equipment, at the time of definitive airway 

management, or when performing airway-related 

medical procedures, or during certain transport of 

patients with suspected or confirmed diagnosis of 

COVID–19 and that the known and potential 

benefits of ISOCUBE for such use outweigh its 

known and potential risks; and (3) there are no 

adequate, approved, and available alternatives to 

the emergency use of the ISOCUBE. During the 

public health emergency, it would not be feasible 

to require healthcare providers to limit the 

ISOCUBE use for patients with suspected or 

confirmed COVID–19; therefore, the authorization 

does not restrict use to such patients. 

19As set forth in the EUA, FDA has concluded: 

(1) SARS–CoV–2 can cause a serious or lifethreatening disease or condition, including severe 

respiratory illness, to humans infected by this virus; 

(2) based on the totality of scientific evidence 

available to FDA, it is reasonable to believe that the 

NPS may be effective in preventing healthcare 

provider exposure to pathogenic biological airborne 

particulates by providing an extra layer of barrier 

protection in addition to personal protective 

equipment, at the time of definitive airway 

management, when performing airway-related 

medical procedures, or during certain transport for 

a maximum duration of use of 1 hour, of patients 

with suspected or confirmed diagnosis of COVID– 

19 and that the known and potential benefits of the 

NPS for such use outweigh its known and potential 

risks; and (3) there are no adequate, approved, and 

available alternatives to the emergency use of the 

NPS. During the public health emergency, it would 

not be feasible to require healthcare providers to 

limit use of the NPS to patients with suspected or 

confirmed COVID–19; therefore, the authorization 

does not restrict use to such patients. 

20As set forth in the EUA, FDA has concluded 

that: (1) SARS–CoV–2, the virus that causes 

COVID–19, can cause a serious or life-threatening 

disease or condition, including severe respiratory 

illness, to humans infected by this virus; (2) based 

on the totality of scientific evidence available to 

FDA, it is reasonable to believe that the Pinpoint 

by Phosphorus COVID–19 Test Home Collection Kit 

DTC may be effective in diagnosing COVID–19, by 

serving as an appropriate means to collect and 

transport human specimens so that an authorized 

laboratory can detect SARS–CoV–2 RNA from the 

self-collected human specimen, and that the known 

and potential benefits of the Pinpoint by 

Phosphorus COVID–19 Test Home Collection Kit 

DTC when used for diagnosing COVID–19, 

outweigh the known and potential risks of the 

Pinpoint by Phosphorus COVID–19 Test Home 

Collection Kit DTC; and (3) there is no adequate, 

approved, and available alternative to the 

emergency use of the Pinpoint by Phosphorus 

COVID–19 Test Home Collection Kit DTC. 

21As set forth in the amendment, FDA has 

concluded (1) SARS–CoV–2 can cause a serious or 

life-threatening disease or condition, including 

severe respiratory illness, to humans infected by 

this virus, (2) based on the totality of scientific 

evidence available to FDA, it is reasonable to 

believe that the authorized tests may be effective in 

diagnosing COVID–19 for the indications set forth 

in the appendices of the amendment letter, and that 

the known and potential benefits of the authorized 

tests when used for such use, outweigh the known 

and potential risks of the authorized tests included 

in the amendment; and (3) there are no adequate, 

approved, and available alternatives to the 

emergency use of the authorized tests included in 

the amendment. 

• Yale School of Public Health, 

Department of Epidemiology of 

Microbial Diseases’ SalivaDirect AtHome Collection Kit, issued April 9, 

2021; 16

• Color Health, Inc.’s Color COVID– 

19 Self-Swab Collection Kit with Saline, 

issued April 14, 2021; 17

• Prep Tech, LLC’s ISOCUBE SS and 

ISOCUBE ONE (‘‘ISOCUBE’’), issued 

May 4, 2021; 18

• Breegi Scientific, Inc.’s Negative 

Pressure SteriDome (NPS), issued May 

6, 2021; 19

• Phosphorus Diagnostics LLC’s 

Pinpoint by Phosphorus COVID–19 Test 

Home Collection Kit DTC, issued May 

17, 2021.20

Finally, FDA is hereby announcing an 

amendment to certain EUAs to allow 

certain authorized molecular diagnostic 

SARS–CoV–2 tests to be distributed and 

used to pool anterior nasal respiratory 

specimens from asymptomatic 

individuals as part of a serial testing 

program after developers submit a 

complete notification, including 

meeting required validation data, as set 

forth in the amendment letter. The 

amendment ‘‘Amending Certain EUAs 

for RT–PCR Molecular-Based Diagnostic 

Tests to Authorize the Detection of 

Nucleic Acid from SARS–CoV–2 from 

Pooled Anterior Nasal Respiratory 

Specimens for Screening When Used as 

Part of a Serial Testing Program,’’ was 

issued to ‘‘Developers of MolecularBased Diagnostic Tests Authorized for 

Emergency Use for Coronavirus Disease 

2019 (COVID–19) as of Today’s Date’’ on 

April 20, 2021.21

Dated: July 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–15680 Filed 7–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6395] 

Request for Applications for New 

Members of the Clinical Trials 

Transformation Initiative/Food and 

Drug Administration Patient 

Engagement Collaborative 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice; request for applications. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency), in 

collaboration with the Clinical Trials 

Transformation Initiative (CTTI), is 

requesting applications of patient 

advocates interested in participating on 

the Patient Engagement Collaborative 

(PEC). The PEC is an ongoing, 

collaborative forum coordinated through 

the Office of Patient Affairs, Office of 

Clinical Policy and Programs (OCPP), 

Office of the Commissioner, and is 

hosted by CTTI. Through the PEC, the 

patient community and regulators are 

able to discuss an array of topics 

regarding increasing meaningful patient 

engagement in medical product 

development and regulatory discussions 

at FDA. The activities of the PEC may 

include, but are not limited to, 

providing diverse perspectives on topics 

such as systematic patient engagement, 

transparency, and communication; 

providing considerations for 

implementing new strategies to enhance 

patient engagement at FDA; and 

proposing new models of collaboration 

in which patients and patient advocates 

are partners in non-product specific 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 39045 

aspects of the medical product 

development and FDA review process. 

DATES: Applications submitted by 11:59 

p.m. Eastern time on August 23, 2021, 

will be considered for membership in 

the PEC. Incomplete applications and 

applications completed after the abovespecified deadline will not be reviewed. 

ADDRESSES: All applications should be 

submitted to FDA’s Office of Patient 

Affairs in OCPP. The preferred 

application method is via the online 

submission system provided by CTTI, 

available at https://duke.qualtrics.com/ 

jfe/form/SV_eLDSvmVIXdsAdVP. For 

those applicants unable to submit an 

application electronically, please call 

FDA’s Office of Patient Affairs at 301– 

796–8460 to arrange for mail or delivery 

service submission. Only complete 

applications, as described under section 

IV of this document, will be considered. 

FOR FURTHER INFORMATION CONTACT: 

Wendy Slavit, Office of the 

Commissioner, Office of Clinical Policy 

and Programs, Office of Patient Affairs, 

Food and Drug Administration, 301– 

796–8460, 

PatientEngagementCollaborative@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background and Purpose 

The CTTI is a public-private 

partnership cofounded by FDA and 

Duke University whose mission is to 

develop and drive adoption of practices 

that will increase the quality and 

efficiency of clinical trials. FDA and 

CTTI have long involved patients and 

considered patient perspectives in their 

work. Furthering the engagement of 

patients as valued partners across the 

medical product research and 

development continuum requires an 

open forum for patients and regulators 

to discuss and exchange ideas. 

The PEC is an ongoing, collaborative 

forum in which the patient community 

and regulators discuss an array of topics 

regarding increasing patient engagement 

in medical product development and 

regulatory discussions at FDA. The PEC 

is a joint endeavor between FDA and 

CTTI. The activities of the PEC may 

inform relevant FDA and CTTI 

activities. The PEC is not intended to 

advise or otherwise direct the activities 

of either organization, and membership 

will not constitute employment by 

either organization. 

The Food and Drug Administration 

Safety and Innovation Act (Pub. L. 112– 

14), section 1137, entitled ‘‘Patient 

Participation in Medical Product 

Discussions,’’ added section 569C to the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360bbb–8c). This provision 

directs the Secretary of Health and 

Human Services to ‘‘develop and 

implement strategies to solicit the views 

of patients during the medical product 

development process and consider the 

perspectives of patients during 

regulatory discussions.’’ On November 

4, 2014, FDA issued a Federal Register 

notice establishing a docket (FDA– 

2014–N–1698) for public commenters to 

submit information related to FDA’s 

implementation of this provision. Upon 

review of the comments received, one 

common theme, among others, included 

establishing an external group to 

provide input on patient engagement 

strategies across FDA’s Centers. After 

considering the comments, FDA formed 

the PEC in 2018 to discuss a variety of 

patient engagement topics. This group is 

consistent with additional legislation 

subsequently enacted in section 3001 of 

the 21st Century Cures Act (Pub. L. 114– 

255) and section 605 of the FDA 

Reauthorization Act of 2017 (Pub. L. 

115–52), further supporting tools for 

fostering patient participation in the 

regulatory process. 

The PEC currently has 16 members. 

To help ensure continuity in its 

activities and organizational knowledge, 

the PEC maintains staggered 

membership terms. As of September 

2021, eight members will complete a 

term and up to eight new members will 

be selected. The purpose of this notice 

is to announce that the application 

process for up to eight new members of 

the PEC is now open, and to invite and 

encourage applications by the 

submission deadline for appropriately 

qualified individuals. 

II. Criteria for Membership 

The PEC includes up to 16 diverse 

representatives of the patient 

community. Eight members from the 

previous application process will 

remain on the PEC. The current 

application process is to select up to 

eight new PEC members. Selected 

members will include the following: (1) 

Patients who have personal disease 

experience; (2) caregivers who support 

patients, such as a parent, child, 

partner, other family member, or friend, 

and who have personal disease 

experience through this caregiver role; 

and, (3) representatives from patient 

groups who, through their role in the 

patient group, have direct or indirect 

disease experience. Please note that for 

purposes of this activity, the term 

‘‘caregiver’’ is not intended to include 

individuals who are engaged in 

caregiving as healthcare professionals; 

and the term ‘‘patient group’’ is used 

herein to encompass patient advocacy 

organizations, disease advocacy 

organizations, voluntary health 

agencies, nonprofit research 

foundations, and public health 

organizations. The ultimate goal of the 

application and selection process is to 

identify individuals who can represent 

a collective patient voice for their 

patient community. 

Selection criteria include the 

applicant’s potential to meaningfully 

contribute to the activities of the PEC, 

ability to represent and express the 

patient voice for his or her constituency, 

ability to work in a constructive manner 

with involved stakeholders, and 

understanding of the clinical research 

enterprise. Consideration will also be 

given to ensuring the PEC includes 

diverse perspectives and experiences, 

including but not limited to 

sociodemographic and disease 

experience diversity. PEC members are 

required to be residents of the United 

States and must be 18 years of age or 

older. 

Financial and other conflicts of 

interest will not necessarily make 

applicants ineligible for membership in 

the PEC. However, applicants cannot be 

direct employees of the medical product 

development industry or a currently 

registered lobbyist for an FDA-regulated 

industry. 

III. Responsibilities and Expectations 

Working meetings of the PEC will 

typically be held two to four times per 

year, either in person (in the 

Washington DC area) or virtually 

(teleconference or webinar). Given the 

ongoing COVID–19 pandemic, meetings 

will be conducted virtually and may 

resume in-person when it is safe to do 

so. Additional meetings may be 

organized as needed, and currently 

include monthly, 1-hour 

teleconferences. 

Reasonable accommodations will be 

made for members with special needs 

for travel or for participation in a 

meeting. Applications for PEC 

membership are encouraged from 

individuals of all racial, ethnic, cultural 

groups, sexual orientations, gender 

identities, with and without disabilities. 

Travel support will be provided as 

applicable. 

To help ensure continuity in its 

activities and organizational knowledge, 

the PEC will maintain staggered 

membership terms for patient 

community representatives. 

Membership terms for new members 

will be 2-year appointments. Members 

may serve up to two terms, with the 

possibility of extensions. 

Additional responsibilities and 

expectations are set forth in the PEC 

Framework, which should be reviewed 


khammond on DSKJM1Z7X2PROD with NOTICES
39046 Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 

prior to submitting an application, 

available at https://www.ctticlinicaltrials.org/framework-cttifdapatient-engagement-collaborative. 

IV. Application Process 

Any interested person may apply for 

membership on the PEC. To apply, go to 

https://duke.qualtrics.com/jfe/form/SV_

eLDSvmVIXdsAdVP. The application 

process is completed online and 

includes answering questions to help 

determine eligibility for the PEC, 

demographic and other background 

questions, and four brief essay 

questions. Many of the demographic 

questions are optional. The brief essay 

questions, which must be answered in 

500 characters or fewer (including 

spaces), are as follows: 

• Please explain why you would have 

an outstanding ability to represent and 

express the patient voice for the disease 

area(s) you selected above. 

• Please give a few examples of 

experiences that demonstrate your 

outstanding ability to work across 

stakeholders in the medical product 

development process. 

• Please explain how you have 

developed a strong understanding of the 

medical product development process. 

• Please tell us why you are 

interested in becoming a member of the 

PEC and how you would be able to 

contribute. 

Completing the application form also 

requires submitting: (1) A current, 

complete curriculum vitae or re ́sume ́

that shows relevant activities and 

experience (PDF format preferred) and 

(2) a letter of endorsement (maximum 

800 words) from a patient group with 

which the applicant has worked closely 

on activities that are relevant to the PEC 

(PDF format preferred). The letter of 

endorsement should emphasize 

information relevant to the criteria for 

membership described above. The letter 

may address topics such as the 

applicant’s involvement in patient 

advocacy activities, experiences that 

stimulated an interest in participating in 

discussions about patient engagement in 

medical product development and 

regulatory decision making, and other 

information that may be helpful in 

evaluating the applicant’s qualifications 

as a potential member of the PEC. Only 

complete applications submitted by the 

deadline (see DATES) will be reviewed. 

Additional information may be 

needed from applicants, including 

information relevant to understanding 

potential sources of conflict of interest, 

in which case applicants will be 

contacted directly. 

Dated: July 19, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–15643 Filed 7–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2326] 

Field Alert Report Submission: 

Questions and Answers; Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled ‘‘Field 

Alert Report Submission: Questions and 

Answers.’’ This guidance provides 

FDA’s current thinking regarding the 

requirements for submission of field 

alert reports (FARs) by applicants of 

new drug applications (NDAs) and 

abbreviated new drug applications 

(ANDAs) and outlines FDA’s 

recommendations for FAR submissions 

to help improve their consistency and 

relevancy. The guidance also addresses 

certain frequently asked questions about 

FARs. This guidance finalizes the draft 

guidance of the same title issued on July 

19, 2018. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on July 23, 2021. 

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– 

2018–D–2326 for ‘‘Field Alert Report 

Submission: Questions and Answers.’’ 

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 


khammond on DSKJM1Z7X2PROD with NOTICES