Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10285 

propose a legislative priority project 

should include the priority area(s) in the 

project goal, all objectives and 

indicators as reflected in the project’s 

framework, project approach, Objective 

Work Plan and Outcome Tracker. 

Reviewers should provide 10 points if 

all elements are included in the 

application to address one or more of 

the economic development priority 

areas. 

In addition, during tribal 

consultation, additional social 

development priorities areas were 

identified by Native communities to 

potentially fund through the SEDS 

program. Therefore, 5 bonus points will 

be awarded to applications that address 

one or more of the following Native 

community priority areas: Native 

Veterans, Missing and Murdered Native 

Americans (MMNA), or Emergency 

Preparedness and Response. 

Applications that address one of more of 

these priorities areas should include the 

priority area in the project goal, all 

objectives, indicator(s), and target 

population (either as participants or 

beneficiaries). Reviewers should 

provide 5 points if all elements are 

included in the application to address 

one or more priority areas. Since social 

and economic development projects 

have different project goals, no 

application will be eligible to receive 

both sets of bonus points. In addition, 

the SEDS program areas of interest will 

be expanded to include MMNA and 

Anti-Human Trafficking. 

7. Changes to SEDS–AK FOA— 

Section 803 of NAPA, 42 U.S.C. 2991b. 

ANA will also incorporate the new 

legislative economic development 

priorities into the SEDS–AK FOA. 

Therefore, new program areas of interest 

for SEDS–AK will include the 

following: (1) The development of a 

Tribal code or court system for purposes 

of economic development, including 

commercial codes, training for court 

personnel, and the development of 

nonprofit subsidiaries or other tribal 

business structures; (2) the development 

of native community development 

financial institutions, including training 

and administrative expenses; (3) the 

development of a tribal master plans for 

community and economic development 

and infrastructure. Therefore, 10 bonus 

points will be awarded to applications 

that address one or more of these 

priority areas. Applications that propose 

a legislative priority project should have 

it included in the project goal, all 

objectives and indicators as reflected in 

the project’s framework, the project 

approach, and the Objective Work Plan 

and Outcome Tracker. Reviewers should 

provide 10 points if all elements are 

included in the application to address 

one or more of the economic 

development priority areas. In addition, 

ANA plans to modify the description of 

the program purpose for the SEDS–AK 

FOA to provide a competitive advantage 

for smaller Alaska Native villages or 

organizations that have never received 

ANA funding. Therefore, the FOA will 

state that reviewers should award 5 

bonus points in the scoring criteria if an 

eligible entity has never received an 

ANA award. ANA staff will confirm 

during the objective review process if an 

applicant organization for SEDS–AK has 

received a past ANA award. 

8. Changes to EMI FOA—Section 

803C of NAPA, 42 U.S.C. 2991b–3. In 

accordance with 42 U.S.C. 2991b– 

3(c)(7), applicants for an EMI grant must 

submit an official document that 

certifies the applicant has at least 3 

years of experience in operating and 

administering a Native American 

language survival school, a Native 

American language nest, or any other 

educational program in which 

instruction is conducted in a Native 

American language, in accordance with 

Public Law 109–394. Therefore, the EMI 

FOA will have a new evaluation 

criterion to score 10 points to ensure the 

application includes a certification 

document that demonstrates the 

applicant has at least 3 years of 

experience in operating a language nest, 

survival school, or other native language 

educational program. As a result, the 

EMI FOA’s scoring criteria will change 

as follows: 

Approach for a maximum of 75 

points, to consist of the following: Nest 

or Survival School Certification (10 

points); Long Term Community Goal (2 

points); Current Community Condition 

(3 points); Project Goal (2 points); 

Objectives (6 points); Outcomes and 

Indicators (5 points); Outputs (3 points); 

Outcome Tracker and Outcome 

Tracking Strategy (7 points); 

Community-Based Strategy (8 points); 

Readiness and Implementation Strategy 

(16 points); and the Objective Work Plan 

(OWP) (13 points). 

Organizational Capacity for a 

maximum of 10 points. 

Budget and Budget Justification for a 

maximum of 15 points, to consist of the 

following: Line Item Budget (5 points) 

and Budget Justification (10 points). 

9. Changes to SEDS–GO FOA— 

Sections 803 and 803B of NAPA, 42 

U.S.C. 2991b; 2991b–2. In FY 2020, 

ANA introduced a new FOA as a special 

initiative under the SEDS program to 

support growing organizations to 

provide funding to enhance their 

internal capacity and infrastructure to 

better serve their members or their 

communities. There will be no 

substantive changes to application 

requirements in the FY 2021 SEDS–GO 

FOA. There will be slight changes to the 

evaluation scoring criteria, which will 

be as follows: 

Approach (for a maximum of 70 

points) to consist of the following: 

Introduction to the Applicant 

Organization (6 points); Targeted 

Challenge (6 points); Project Goal (6 

points); SMART Objectives (6 points); 

Outcomes and Indicators (6 points); 

Description of Project Implementation 

Strategy (25 points); Objective Work 

Plan (OWP) (15 points). 

Organizational Capacity—15 points. 

Budget and Budget Justification (for a 

maximum of 15 points) to consist of a 

Line Item Budget (5 points) and a 

Budget Justification (10 points). 

Bonus Points—5 bonus points may be 

provided to applicants that have never 

received an ANA grant award. 

Statutory Authority: Section 814 of 

the Native American Programs Act of 

1974, as amended. 

Elizabeth Leo, 

Senior Grant Policy Specialist, Office of 

Administration, Administration for Children 

and Families. 

[FR Doc. 2021–03345 Filed 2–18–21; 8:45 am] 

BILLING CODE 4184–34–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–1136] 

Guidance Documents Related to 

Coronavirus Disease 2019; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of FDA 

guidance documents related to the 

Coronavirus Disease 2019 (COVID–19) 

public health emergency (PHE). This 

notice of availability (NOA) is pursuant 

to the process that FDA announced, in 

the Federal Register of March 25, 2020, 

for making available to the public 

COVID–19-related guidances. The 

guidances identified in this notice 

address issues related to the COVID–19 

PHE and have been issued in 

accordance with the process announced 

in the March 25, 2020, notice. The 

guidances have been implemented 

without prior comment, but they remain 

subject to comment in accordance with 

the Agency’s good guidance practices. 


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1Secretary of Health and Human Services, 

‘‘Determination that a Public Health Emergency 

Exists’’ (originally issued on January 31, 2020, and 

subsequently renewed), available at: https://

www.phe.gov/emergency/news/healthactions/phe/ 

Pages/default.aspx. 

2Proclamation on Declaring a National 

Emergency Concerning the Novel Coronavirus 

Disease (COVID–19) Outbreak (March 13, 2020), 

available at: https://trumpwhitehouse.archives.gov/ 

presidential-actions/proclamation-declaringnational-emergency-concerning-novel-coronavirusdisease-covid-19-outbreak/. 

DATES: The announcement of the 

guidances is published in the Federal 

Register on February 19, 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 name of the guidance 

document that the comments address 

and the docket number for the guidance 

(see table 1). Received comments will be 

placed in the docket(s) 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 

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 § 10.115(g)(5) 

(21 CFR 10.115(g)(5))). 

Submit written requests for single 

copies of these guidances to the address 

noted in table 1. Send two selfaddressed adhesive labels to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Stephen Ripley, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911, Kimberly Thomas, Center for 

Drug Evaluation and Research (CDER), 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 51, Rm. 

6220, Silver Spring, MD 20993–0002, 

301–796–2357, or Erica Takai, Center 

for Devices and Radiological Health 

(CDRH), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5456, Silver Spring, MD 20993– 

0002, 301–796–6353. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On January 31, 2020, as a result of 

confirmed cases of COVID–19, and after 

consultation with public health officials 

as necessary, the Secretary of Health 

and Human Services (HHS), pursuant to 

the authority under section 319 of the 

Public Health Service Act (42 U.S.C. 

247d), determined that a PHE exists and 

has existed since January 27, 2020, 

nationwide.1 On March 13, 2020, there 

was a Presidential declaration that the 

COVID–19 outbreak in the United States 

constitutes a national emergency, 

beginning March 1, 2020.2

In the Federal Register of March 25, 

2020 (85 FR 16949) (the March 25, 2020, 

notice) (available at https://

www.govinfo.gov/content/pkg/FR-2020- 

03-25/pdf/2020-06222.pdf), FDA 

announced procedures for making 

available FDA guidances related to the 

COVID–19 PHE. These procedures, 

which operate within FDA’s established 

good guidance practices regulations, are 

intended to allow FDA to rapidly 

disseminate Agency recommendations 

and policies related to COVID–19 to 

industry, FDA staff, and other 

stakeholders. The March 25, 2020, 

notice stated that due to the need to act 

quickly and efficiently to respond to the 

COVID–19 PHE, FDA believes that prior 

public participation will not be feasible 

or appropriate before FDA implements 

COVID–19-related guidances. Therefore, 

FDA will issue COVID–19-related 

guidances for immediate 

implementation without prior public 

comment (see section 701(h)(1)(C) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 371(h)(1)(C)) and 

§ 10.115(g)(2)). The guidances are 

available on FDA’s web pages entitled 

‘‘COVID–19-Related Guidance 

Documents for Industry, FDA Staff, and 

Other Stakeholders’’ (available at 

https://www.fda.gov/emergencypreparedness-and-response/mcmissues/covid-19-related-guidancedocuments-industry-fda-staff-and-otherVerDate Sep<11>2014 21:07 Feb 18, 2021 Jkt 253001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\19FEN1.SGM 19FEN1

tkelley on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10287 

stakeholders) and ‘‘Search for FDA 

Guidance Documents’’ (available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments). 

The March 25, 2020, notice further 

stated that, in general, rather than 

publishing a separate NOA for each 

COVID–19-related guidance, FDA 

intends to publish periodically a 

consolidated NOA announcing the 

availability of certain COVID–19-related 

guidances that FDA issued during the 

relevant period, as included in table 1. 

This notice announces COVID–19- 

related guidances that are posted on 

FDA’s website. 

II. Availability of COVID–19-Related 

Guidance Documents 

Pursuant to the process described in 

the March 25, 2020, notice, FDA is 

announcing the availability of the 

following COVID–19-related guidances: 

TABLE 1—GUIDANCES RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY

Docket No. Center Title of guidance Contact information to request single copies 

FDA–2020–D–1825 CBER ..... Investigational COVID–19 Convalescent Plasma (Updated January 2021).Office of Communication, Outreach and Development, 10903 New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002, 1–800–835– 

4709 or 240–402–8010; email ocod@fda.hhs.gov. 

FDA–2020–D–1137 CBER ..... Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products 

During COVID–19 Public Health Emergency (January 2021).

Office of Communication, Outreach and Development, 10903 New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002, 1–800–835– 

4709 or 240–402–8010; email ocod@fda.hhs.gov. 

FDA–2020–D–1136 CDER ..... Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID–19 Public 

Health Emergency (December 2020).

druginfo@fda.hhs.gov. Please include the docket 

number FDA–2020–D–1136 and complete title of 

the guidance in the request. 

FDA–2020–D–1136 CDER ..... Protecting Participants in Bioequivalence Studies for 

Abbreviated New Drug Applications During the 

COVID–19 Public Health Emergency (January 

2021).

druginfo@fda.hhs.gov. Please include the docket 

number FDA–2020–D–1136 and complete title of 

the guidance in the request. 

FDA–2020–D–1136 CDER ..... COVID–19: Potency Assay Considerations for 

Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV–2 Infectivity (January 

2021).

druginfo@fda.hhs.gov. Please include the docket 

number FDA–2020–D–1136 and complete title of 

the guidance in the request. 

FDA–2020–D–1138 CDRH .... Coagulation Systems for Measurement of 

Viscoelastic Properties: Enforcement Policy During 

the Coronavirus Disease 2019 (COVID–19) Public 

Health Emergency (January 2021).

CDRH-Guidance@fda.hhs.gov. Please include the 

document number 20041–R1 and complete title of 

the guidance in the request. 

Although these guidances have been 

implemented immediately without prior 

comment, FDA will consider all 

comments received and revise the 

guidances as appropriate (see 

§ 10.115(g)(3)). 

These guidances are being issued 

consistent with FDA’s good guidance 

practices regulation (§ 10.115). The 

guidances represent the current thinking 

of FDA. They do not establish any rights 

for any person and are not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

III. Paperwork Reduction Act of 1995 

A. CBER Guidances 

While these guidances contain no 

collection of information, they do refer 

to previously approved FDA collections 

of information (listed in table 2). 

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 these guidances. The 

previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in the following FDA 

regulations and guidances have been 

approved by OMB as listed in the 

following table: 

TABLE 2—CBER GUIDANCES AND COLLECTIONS

COVID–19 guidance title CFR cite referenced in 

COVID–19 guidance 

Another guidance title 

referenced in COVID–19 

guidance 

OMB control 

No(s). 

Investigational COVID–19 Convalescent Plasma; Guidance for Industry (Updated: January 15, 2021).21 CFR part 312, 21 CFR 

parts 606 and 630.

Form FDA 3926 ...................... 0910–0014, 0910–0116, 

0910–0814. 

Manufacturing Considerations for Licensed 

and Investigational Cellular and Gene Therapy Products During COVID–19 Public 

Health Emergency (January 2021).

21 CFR 1271.50, 21 CFR part 

211, 21 CFR part 312 

(INDs), 21 CFR part 601 

(BLAs), 21 CFR 314.420 

(Master Files).

................................................. 0910–0543, 0910–0139, 

0910–0014, 0910–0338, 

0910–0001. 


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B. CDER Guidances 

While these guidances contain no 

collection of information, they do refer 

to previously approved FDA collections 

of information (listed in table 3). 

Therefore, clearance by OMB under the 

PRA (44 U.S.C. 3501–3521) is not 

required for these guidances. The 

previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in the following FDA 

regulations and guidances have been 

approved by OMB as listed in the 

following table: 

TABLE 3—CDER GUIDANCES AND COLLECTIONS

COVID–19 guidance title CFR cite referenced in 

COVID–19 guidance 

Another guidance title 

referenced in COVID–19 

guidance 

OMB control 

No(s). 

Review Timelines for Applicant Responses to 

Complete Response Letters When a Facility 

Assessment Is Needed During the COVID– 

19 Public Health Emergency (December 

2020).

21 CFR 314.3(b), 21 CFR 

600.3 and 600.21, 21 CFR 

601.20(d).

Manufacturing, Supply Chain, 

and Drug and Biological 

Product Inspections During 

COVID–19 Public Health 

Emergency: Questions and 

Answers.

0910–0001, 0910–0338, 

0910–0139. 

Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications 

During the COVID–19 Public Health Emergency.

21 CFR 50, 21 CFR 312, 21 

CFR 314.3, 21 CFR 

314.101, 21 CFR 314.105, 

21 CFR 320.1, 21 CFR 

320.23(b), 21 CFR 320.24– 

26, 21 CFR 320.31, 21 

CFR 314.94, 314.101, 

314.105.

Referencing Approved Drug 

Products in ANDA Submissions.

Bioequivalence Studies With 

Pharmacokinetic Endpoints 

for Drugs Submitted Under 

an Abbreviated New Drug 

Application.

Conduct of Clinical Trials of 

Medical Products during the 

COVID–19 Public Health 

Emergency.

0910–0001, 0910–0014, 

0910–0130, 0910–0139, 

0910–0303, 0910–0572, 

0910–0755, 0910–0797. 

ANDA Submissions—Content 

and Format of Abbreviated 

New Drug Application.

Controlled Correspondence 

Related to Generic Drug 

Development.

Formal Meetings Between 

FDA and ANDA Applicants 

of Complex Products Under 

GDUFA.

Use of Electronic Informed 

Consent in Clinical Investigations—Questions and 

Answers.

Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring.

COVID–19: Potency Assay Considerations for 

Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS–CoV–2 Infectivity.

21 CFR 211.165, 21 CFR 

211.194, 21 CFR 601.2, 21 

CFR 610.3, 21 CFR 610.10.

ICH guidance for Industry 

Q6B Specifications: Test 

Procedures and Acceptance 

Criteria for Biotechnological/ 

Biological Products.

Analytical Procedures and 

Methods Validation for 

Drugs and Biologics.

0910–0001, 0910–0014, 

0910–0338, 0910–0139, 

0910–0303. 

ICH guidance for industry 

Q2(R1) Validation of Analytical Procedures: Text and 

Methodology.

Emergency Use Authorization 

of Medical Products and 

Related Authorities.

Bioanalytical Method Validation.

ICH guidance for industry 

M4Q: The CTD—Quality.

ICH guidance for industry 

Q5C Quality of Biotechnological Products: Stability 

Testing of Biotechnological/ 

Biological Products.

ICH guidance for industry 

Q8(R2) Pharmaceutical Development.


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C. CDRH Guidance 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information (listed in table 4). 

Therefore, clearance by OMB under the 

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: 

TABLE 4—CDRH GUIDANCE AND COLLECTIONS

COVID–19 guidance title CFR cite referenced in 

COVID–19 guidance 

Another guidance title 

referenced in COVID–19 

guidance 

OMB control 

No(s). 

Coagulation Systems for Measurement of 

Viscoelastic Properties: Enforcement Policy 

During the Coronavirus Disease 2019 

(COVID–19) Public Health Emergency (January 2021).

800, 801, and 809 ..................

807, subparts A through D .....

807, subpart E ........................

803 ..........................................

806 ..........................................

820 ..........................................

................................................. 0910–0485. 

0910–0625. 

0910–0120. 

0910–0437. 

0910–0359. 

0910–0073. 

IV. Electronic Access 

Persons with access to the internet 

may obtain COVID–19-related guidances 

at: 

• FDA web page entitled ‘‘COVID–19- 

Related Guidance Documents for 

Industry, FDA Staff, and Other 

Stakeholders,’’ available at https://

www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19- 

related-guidance-documents-industryfda-staff-and-other-stakeholders; 

• FDA web page entitled ‘‘Search for 

FDA Guidance Documents’’ available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or 

• https://www.regulations.gov. 

Dated: February 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03421 Filed 2–18–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2253] 

Medical Device User Fees; Stakeholder 

Meetings on Medical Device User Fee 

Amendments of Fiscal Years 2023 to 

2027 Reauthorization; Request for 

Notification of Stakeholder Intention to 

Participate 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for notification 

of participation. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

issuing this notice to request that public 

stakeholders—including patient and 

consumer advocacy groups, healthcare 

professionals, and scientific and 

academic experts—notify FDA of their 

intent to participate in periodic 

consultation meetings on the 

reauthorization of the Medical Device 

User Fee Amendments (MDUFA). The 

statutory authority for MDUFA expires 

in September 2022. At that time, new 

legislation will be required for FDA to 

continue collecting user fees for the 

medical device program. The Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) requires that FDA consult with a 

range of stakeholders in developing 

recommendations for the next MDUFA 

program. The FD&C Act also requires 

that FDA hold discussions (at least 

every month) with patient and 

consumer advocacy groups during 

FDA’s negotiations with the regulated 

industry. The purpose of this request for 

notification is to ensure continuity and 

progress in these monthly discussions 

by establishing consistent public 

stakeholder representation. 

DATES: Submit notification of intention 

to participate in these series of meetings 

by February 26, 2021. Stakeholder 

meetings will be held monthly. It is 

anticipated that they will commence in 

March 2021. See the SUPPLEMENTARY

INFORMATION section for registration date 

and information. 

ADDRESSES: The meetings will take 

place virtually and will be held by 

webcast only. Submit notification of 

intention to participate in monthly 

stakeholder meetings by email to 

MDUFAVReauthorization@fda.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Ellen Olson, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1664, Silver Spring, 

MD 20993, 301–796–4322, 

MDUFAVReauthorization@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is requesting that public 

stakeholders—including patient and 

consumer advocacy groups, healthcare 

professionals, and scientific and 

academic experts—notify the Agency of 

their intent to participate in periodic 

stakeholder consultation meetings on 

the reauthorization of MDUFA. MDUFA 

authorizes FDA to collect user fees from 

the regulated industry for the process 

for the review of medical devices. The 

authorization for the current program 

(MDUFA IV) expires in September 2022. 

Without new legislation, FDA will no 

longer be able to collect user fees for 

future fiscal years to fund the medical 

device review process. 

Section 738A(b)(1) of the FD&C Act 

(21 U.S.C. 379j–1(b)(1)) requires that 

FDA consult with a range of 

stakeholders, including representatives 

from patient and consumer advocacy 

groups, healthcare professionals, and 

scientific and academic experts, in 

developing recommendations for the 

next MDUFA program. FDA initiated 

the reauthorization process by holding a 

public meeting on October 27, 2020, 

where stakeholders and other members 

of the public were given an opportunity 

to present their views on the 

reauthorization. The FD&C Act further 

requires that FDA continue meeting 

with the representatives of patient and 

consumer advocacy groups at least once 

every month during negotiations with 

the regulated industry to continue 

discussions of stakeholder views on the 

reauthorization and their suggestions for 

changes. It is anticipated that these 

monthly stakeholder consultation 

meetings will commence in March 2021. 

FDA is issuing this Federal Register 

notice to request that stakeholder 

representatives from patient and 

consumer advocacy groups, healthcare 

professional associations, as well as 


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