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in the future. The activities and 

products from this project will help 

ACF to fulfill the ongoing legislative 

mandate for program evaluation 

specified in the Foster Care 

Independence Act of 1999. 

Respondents: Semi-structured 

interviews will be held with program 

leaders, partners and stakeholders, and 

front-line staff as well as young adults 

being served by the programs. 

ANNUAL BURDEN ESTIMATES

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Avg. burden 

per response 

(in hours) 

Total burden 

(in hours) 

Annual burden 

(in hours) 

Outreach email for discussion with program administrators 

and staff ............................................................................... 38 1 8 304 152 

Outreach email for Focus Group Recruiters ....................... 96 1 8 768 384 

Discussion Guide for program leaders ................................ 23 1 1 23 12 

Discussion Guide for program partners and stakeholders .. 14 1 1 14 7 

Discussion Guide for program front-line staff ...................... 66 1 1 66 33 

Focus Group Guide for program participants ...................... 240 1 2 480 240 

Estimated Total Annual Burden 

Hours: 828. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: Title IV–E of the Social Security 

Act, IV–E § 477(g) (1–2), as amended by the 

Foster Care Independence Act of 1999. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–01086 Filed 1–15–21; 8:45 am] 

BILLING CODE 4184–73–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2358] 

Authorizations of Emergency Use of 

Two 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 two Emergency Use 

Authorizations (EUAs) (the 

Authorizations) under the Federal Food, 

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

biological products for use during the 

COVID–19 pandemic. FDA issued one 

Authorization for a biological product as 

requested by Pfizer, Inc, and one 

Authorization for a biological product as 

requested by ModernaTX, 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 

Health and Human Services (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 Pfizer, Inc. 

is effective as of December 11, 2020; the 

Authorization for ModernaTX, Inc. is 

effective as of December 18, 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 


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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. 

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. 

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, United 

States Code, of attack with (i) a 

biological, chemical, radiological, or 

nuclear agent or agents; or (ii) 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 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 of 

HHS’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 of HHS’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 two authorizations for the 

emergency use of biological products 

during the COVID–19 pandemic. On 

December 11, 2020, FDA issued an EUA 

to Pfizer, Inc. for the Pfizer-BioNTech 

COVID–19 Vaccine, subject to the terms 

of the Authorization. On December 18, 

2020, FDA issued an EUA to 

ModernaTX, Inc. for the Moderna 

COVID–19 Vaccine, subject to the terms 

of the Authorization. The 

Authorizations, which are included 

below after section IV. Electronic Access 

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 


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Dated: January 12, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–01022 Filed 1–15–21; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0345] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Data To Support 

Drug Product Communications as 

Used by the Food and Drug 

Administration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by February 

18, 2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0695. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Data to Support Drug Product 

Communications as Used by the Food 

and Drug Administration 

OMB Control Number 0910–0695— 

Extension 

This information collection supports 

Agency outreach efforts. Testing of 

communication messages in advance of 

a communication campaign provides an 

important role in improving FDA 

communications as they allow for an 

indepth understanding of individuals’ 

attitudes, beliefs, motivations, and 

feelings. The methods to be employed 

include individual indepth interviews, 

general public focus group interviews, 

intercept interviews, self-administered 

surveys, gatekeeper surveys, and 

professional clinician focus group 

interviews, all on a voluntary basis. 

The methods to be used serve the 

narrowly defined need for direct and 

informal opinion on a specific topic 

and, as a qualitative research tool, have 

two major purposes: (1) To obtain 

information that is useful for developing 

variables and measures for formulating 

the basic objectives of risk 


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