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
Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 39047 

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)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, 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 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Mohamed Ghorab, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 3141, 

Silver Spring, MD, 20993–0002, 240– 

402–8940; 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 is announcing the availability of 

a guidance for industry entitled ‘‘Field 

Alert Report Submission: Questions and 

Answers.’’ The FAR regulations found 

in § 314.81(b)(1) (21 CFR 314.81(b)(1)) 

and 21 CFR 314.98(b) establish an early 

warning system to help FDA fulfill its 

responsibility to protect patient health. 

Under these regulations, NDA and 

ANDA applicants must submit certain 

information to FDA about distributed 

drug products regulated by the Center 

for Drug Evaluation and Research or the 

Center for Biologics Evaluation and 

Research. 

The guidance addresses the FAR 

submission requirements and focuses on 

topics such as the incidents and 

possible/actual quality issues that 

require submission of a FAR, the 

contents of the FAR, who submits the 

FAR, and when, where, and how they 

should submit it. The guidance also 

addresses followup and final FARs, 

which are not required under 

§ 314.81(b), and recommends their 

submission to inform FDA of the status 

of root cause investigations and 

corrective actions taken, if any. 

This guidance finalizes the draft 

guidance issued on July 19, 2018 (83 FR 

34142). In response to public comments, 

FDA made minor editorial changes and 

clarified that the FAR requirements 

apply to all products under an NDA or 

ANDA, including positron emission 

tomography drugs, designated medical 

gases, and combination products 

containing a drug constituent part. 

Although not the focus of this guidance, 

FDA notes that FAR requirements also 

apply to certain combination products 

under 21 CFR part 4, subpart B. For 

additional information about these 

products, see the guidance for industry 

and FDA staff ‘‘Postmarketing Safety 

Reporting for Combination Products,’’ 

available at https://www.fda.gov/media/ 

111788/download, and the 

Postmarketing Safety Reporting for 

Combination Products web page at 

https://www.fda.gov/combinationproducts/guidance-regulatoryinformation/postmarketing-safetyreporting-combination-products. FDA 

may consider whether additional 

adjustments are needed to guidance or 

FAR-related instructions for biologics 

license applications or device 

applications for combination products 

that contain a drug constituent part as 

the Agency gains experience with safety 

reporting for such products. 

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 ‘‘Field Report Alert 

Submission.’’ 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 in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: July 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–15645 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–2021–P–0424] 

Medical Devices; Exemption From 

Premarket Notification: Powered 

Patient Transport, All Other Powered 

Patient Transport; Extension of 

Comment Period 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

notice that appeared in the Federal 

Register of June 15, 2021. In the notice, 

FDA requested comments by August 16, 

2021. The Agency is taking this action 

in response to a correction to the 

notice’s docket number that appeared in 

the Federal Register of June 30, 2021, to 

allow interested persons time to submit 

comments in response to the corrected 

notice. 

DATES: FDA is extending the comment 

period on the notice published June 15, 

2021 (86 FR 31722). Submit either 

electronic or written comments by 

August 30, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before August 30, 

2021. The https://www.regulations.gov 


khammond on DSKJM1Z7X2PROD with NOTICES