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
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10291 

2The Secretary of HHS has delegated the 

authority to issue an EUA under section 564 of the 

FD&C Act to the Commissioner of Food and Drugs. 

abroad, and that involves a biological, 

chemical, radiological, or nuclear agent 

or agents, or a disease or condition that 

may be attributable to such agent or 

agents; or (4) the identification of a 

material threat by the Secretary of 

Homeland Security pursuant to section 

319F–2 of the Public Health Service 

(PHS) Act (42 U.S.C. 247d–6b) sufficient 

to affect national security or the health 

and security of U.S. citizens living 

abroad. 

Once the Secretary of HHS has 

declared that circumstances exist 

justifying an authorization under 

section 564 of the FD&C Act, FDA may 

authorize the emergency use of a drug, 

device, or biological product if the 

Agency concludes that the statutory 

criteria are satisfied. Under section 

564(h)(1) of the FD&C Act, FDA is 

required to publish in the Federal 

Register a notice of each authorization, 

and each termination or revocation of an 

authorization, and an explanation of the 

reasons for the action. Section 564 of the 

FD&C Act permits FDA to authorize the 

introduction into interstate commerce of 

a drug, device, or biological product 

intended for use when the Secretary of 

HHS has declared that circumstances 

exist justifying the authorization of 

emergency use. Products appropriate for 

emergency use may include products 

and uses that are not approved, cleared, 

or licensed under sections 505, 510(k), 

512, or 515 of the FD&C Act (21 U.S.C. 

355, 360(k), 360b, and 360e) or section 

351 of the PHS Act (42 U.S.C. 262), or 

conditionally approved under section 

571 of the FD&C Act (21 U.S.C. 360ccc). 

FDA may issue an EUA only if, after 

consultation with the HHS Assistant 

Secretary for Preparedness and 

Response, the Director of the National 

Institutes of Health, and the Director of 

the Centers for Disease Control and 

Prevention (to the extent feasible and 

appropriate given the applicable 

circumstances), FDA 2 concludes: (1) 

That an agent referred to in a 

declaration of emergency or threat can 

cause a serious or life-threatening 

disease or condition; (2) that, based on 

the totality of scientific evidence 

available to FDA, including data from 

adequate and well-controlled clinical 

trials, if available, it is reasonable to 

believe that: (A) The product may be 

effective in diagnosing, treating, or 

preventing (i) such disease or condition; 

or (ii) a serious or life-threatening 

disease or condition caused by a 

product authorized under section 564, 

approved or cleared under the FD&C 

Act, or licensed under section 351 of the 

PHS Act, for diagnosing, treating, or 

preventing such a disease or condition 

caused by such an agent; and (B) 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, taking 

into consideration the material threat 

posed by the agent or agents identified 

in a declaration under section 

564(b)(1)(D) of the FD&C Act, if 

applicable; (3) that there is no adequate, 

approved, and available alternative to 

the product for diagnosing, preventing, 

or treating such disease or condition; (4) 

in the case of a determination described 

in section 564(b)(1)(B)(ii), that the 

request for emergency use is made by 

the Secretary of Defense; and (5) that 

such other criteria as may be prescribed 

by regulation are satisfied. 

No other criteria for issuance have 

been prescribed by regulation under 

section 564(c)(4) of the FD&C Act. 

III. The Authorizations 

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. Notice of the Secretary’s 

determination was provided in the 

Federal Register on February 7, 2020 

(85 FR 7316). 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 

section 564 of the FD&C Act, subject to 

the terms of any authorization issued 

under that section. Notice of the 

Secretary’s declaration was provided in 

the Federal Register on April 1, 2020 

(85 FR 18250). Having concluded that 

the criteria for issuance of the 

Authorizations under section 564(c) of 

the FD&C Act are met, FDA issued five 

authorizations for the emergency use of 

drug and biological products during the 

COVID–19 pandemic. On August 13, 

2020, FDA issued an EUA to Baxter for 

REGIOCIT, subject to the terms of the 

Authorization. On August 23, 2020, 

FDA issued an EUA to ASPR/HHS for 

COVID–19 convalescent plasma, subject 

to the terms of the Authorization. On 

November 9, 2020, FDA issued an EUA 

to Eli Lilly and Company for 

bamlanivimab, subject to the terms of 

the Authorization (technical correction 

on November 10, 2020). On November 

19, 2020, FDA issued an EUA to Eli 

Lilly and Company for OLUMIANT 

(baricitinib), for use in combination 

with VEKLURY (remdesivir), subject to 

the terms of the Authorization. On 

November 21, 2020, FDA issued an EUA 

to Regeneron Pharmaceuticals, Inc. for 

casirivimab and imdevimab, 

administered together, subject to the 

terms of the Authorization. The 

Authorizations, which are included 

after section IV of this document in their 

entirety (not including the authorized 

versions of the fact sheets and other 

written materials), provide an 

explanation of the reasons for issuance, 

as required by section 564(h)(1) of the 

FD&C Act. Any subsequent reissuances 

of these Authorizations can be found on 

FDA’s web page: https://www.fda.gov/ 

emergency-preparedness-and-response/ 

mcm-legal-regulatory-and-policyframework/emergency-useauthorization. 

IV. Electronic Access 

An electronic version of this 

document and the full text of the 

Authorizations are available on the 

internet at https://www.fda.gov/ 

emergency-preparedness-and-response/ 

mcm-legal-regulatory-and-policyframework/emergency-useauthorization. 

BILLING CODE 4164–01–P 


tkelley on DSKBCP9HB2PROD with NOTICES
10292 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.000</GPH>
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10293 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.001</GPH>
10294 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.002</GPH>
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10295 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.003</GPH>
10296 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.004</GPH>
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10297 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.005</GPH>
10298 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.006</GPH>
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10299 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.007</GPH>
10300 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.008</GPH>
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10301 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.009</GPH>
10302 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.010</GPH>
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10303 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.011</GPH>
10304 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.012</GPH>
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10305 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.013</GPH>
10306 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.014</GPH>
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10307 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.015</GPH>
10308 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.016</GPH>
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10309 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.017</GPH>
10310 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.018</GPH>
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10311 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.019</GPH>
10312 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.020</GPH>
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10313 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.021</GPH>
10314 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.022</GPH>
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10315 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.023</GPH>
10316 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.024</GPH>
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10317 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.025</GPH>
10318 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.026</GPH>
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10319 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.027</GPH>
10320 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.028</GPH>
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10321 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.029</GPH>
10322 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.030</GPH>
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10323 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.031</GPH>
10324 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.032</GPH>
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10325 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.033</GPH>
10326 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.034</GPH>
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10327 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.035</GPH>
10328 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 

Dated: February 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03429 Filed 2–18–21; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; RFP–NIH–NIAID–DAIT– 

75N93020R00018: Transplantation Statistical 

and Clinical Coordinating Center (T–SCCC). 

Date: March 18, 2021. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G53, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Konrad Krzewski, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3G53, Rockville, MD 

20852, 240–747–7526, konrad.krzewski@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: February 12, 2021. 

Tyeshia M. Roberson, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–03387 Filed 2–18–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Microbiology, 

Infectious Diseases and AIDS Initial Review 

Group; Microbiology and Infectious Diseases 

B Subcommittee MID–B Review Committee 

03/2021. 

Date: March 15–17, 2021. 

Time: 11:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F30, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Ellen S. Buczko, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3F30, Rockville, MD 

20852, 301–451–2676, ebuczko1@

niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 


tkelley on DSKBCP9HB2PROD with NOTICESEN19FE21.036</GPH>