Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10289 

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 


tkelley on DSKBCP9HB2PROD with NOTICES
10290 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 

1 In the case of a determination by the Secretary 

of Defense, the Secretary of HHS shall determine 

within 45 calendar days of such determination, 

whether to make a declaration under section 

564(b)(1) of the FD&C Act, and, if appropriate, shall 

promptly make such a declaration. 

scientific and academic experts, notify 

FDA of their intent to participate in the 

periodic stakeholder consultation 

meetings on MDUFA reauthorization. 

FDA believes that consistent 

stakeholder representation at these 

meetings will be important to ensure 

progress in these discussions. If you 

wish to participate in the stakeholder 

consultation meetings, please designate 

one or more representatives from your 

organization who will commit to 

attending these meetings and preparing 

for the discussions. Stakeholders who 

identify themselves through this notice, 

and are otherwise eligible to attend, may 

participate in all stakeholder 

consultation discussions while FDA 

negotiates with the regulated industry. 

These stakeholder discussions will 

satisfy the consultation requirement in 

section 738A(b)(3) of the FD&C Act. 

II. Notification of Intent To Participate 

in Periodic Stakeholder Consultation 

Meetings 

If you intend to participate in 

continued periodic stakeholder 

consultation meetings regarding 

MDUFA reauthorization, please provide 

notification by email to 

MDUFAVReauthorization@fda.hhs.gov 

by February 26, 2021. Your email 

should contain complete contact 

information, including name, title, 

affiliation, address, email address, 

phone number, and notice of any 

special accommodations required 

because of disability. Stakeholders will 

receive confirmation and additional 

information about the first meeting from 

FDA after the Agency receives this 

notification. 

Dated: February 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03428 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–2305] 

Authorizations of Emergency Use of 

Certain Drug and Biological Products 

During the COVID–19 Pandemic; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of five Emergency Use 

Authorizations (EUAs) (the 

Authorizations) under the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) for 

drug and biological products for use 

during the COVID–19 pandemic. FDA 

issued one Authorization for a drug as 

requested by Baxter Healthcare 

Corporation (Baxter); one Authorization 

for a biological product as requested by 

the Office of the Assistant Secretary for 

Preparedness and Response at the U.S. 

Department of Health and Human 

Services (ASPR/HHS); an Authorization 

for a drug and an Authorization for a 

biological product as requested by Eli 

Lilly and Company; and one 

Authorization for biological products as 

requested by Regeneron 

Pharmaceuticals, Inc. The 

Authorizations contain, among other 

things, conditions on the emergency use 

of the authorized products. The 

Authorizations follow the February 4, 

2020, determination by the Secretary of 

HHS that there is a public health 

emergency that has a significant 

potential to affect national security or 

the health and security of U.S. citizens 

living abroad and that involves a novel 

(new) coronavirus. The virus, now 

named SARS–CoV–2, causes the illness 

COVID–19. On the basis of such 

determination, the Secretary of HHS 

declared on March 27, 2020, that 

circumstances exist justifying the 

authorization of emergency use of drugs 

and biological products during the 

COVID–19 pandemic, pursuant to the 

FD&C Act, subject to the terms of any 

authorization issued under that section. 

The Authorizations, which include an 

explanation of the reasons for issuance, 

are reprinted in this document. 

DATES: The Authorization for Baxter is 

effective as of August 13, 2020; the 

Authorization for ASPR/HHS is 

effective as of August 23, 2020; the 

Authorizations for Eli Lilly and 

Company are effective as of November 

9, 2020, and November 19, 2020, 

respectively; and the Authorization for 

Regeneron Pharmaceuticals, Inc. is 

effective as of November 21, 2020. 

ADDRESSES: Submit written requests for 

single copies of the EUAs 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 self-addressed adhesive 

label to assist that office in processing 

your request or include a Fax number to 

which the Authorizations may be sent. 

See the SUPPLEMENTARY INFORMATION

section for electronic access to the 

Authorizations. 

FOR FURTHER INFORMATION CONTACT: 

Michael Mair, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4340, Silver Spring, MD 20993–0002, 

301–796–8510 (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. With this 

EUA authority, FDA can help ensure 

that medical countermeasures may be 

used in emergencies to diagnose, treat, 

or prevent serious or life-threatening 

diseases or conditions caused by 

biological, chemical, nuclear, or 

radiological agents when there are no 

adequate, approved, and available 

alternatives. 

II. Criteria for EUA Authorization 

Section 564(b)(1) of the FD&C Act 

provides that, before an EUA may be 

issued, the Secretary of HHS must 

declare that circumstances exist 

justifying the authorization based on 

one of the following grounds: (1) A 

determination by the Secretary of 

Homeland Security that there is a 

domestic emergency, or a significant 

potential for a domestic emergency, 

involving a heightened risk of attack 

with a biological, chemical, radiological, 

or nuclear agent or agents; (2) a 

determination by the Secretary of 

Defense that there is a military 

emergency, or a significant potential for 

a military emergency, involving a 

heightened risk to U.S. military forces, 

including personnel operating under the 

authority of title 10 or title 50, U.S. 

Code, of attack with (A) a biological, 

chemical, radiological, or nuclear agent 

or agents; or (B) an agent or agents that 

may cause, or are otherwise associated 

with, an imminently life-threatening 

and specific risk to U.S. military 

forces; 1 (3) a determination by the 

Secretary of HHS that there is a public 

health emergency, or a significant 

potential for a public health emergency, 

that affects, or has a significant potential 

to affect, national security or the health 

and security of U.S. citizens living 


tkelley on DSKBCP9HB2PROD with NOTICES