38644 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

1The Authorization covers certain disposable 

respirators certified by the National Institute for 

Occupational Safety and Health (NIOSH), in 

accordance with 42 CFR part 84, as non-powered 

air-purifying particulate respirators with a 

minimum filtration efficiency classification of N95 

(certain disposable NIOSH certified N95 

respirators). 

Joshua M. Sharfstein, MD 

Principal Deputy Commissioner 

Acting Commissioner 

1 Centers for Disease Control and Prevention 

2 Nasopharyngeal swabs, nasal swabs, throat swabs, dual nasopharyngeal swabs/throat swabs, nasal aspirates. 

3 Memorandum, Determination Pursuant to § 564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009). 

4FDA is authorizing the emergency use of the CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization 

Panel for Respiratory Specimens (NPS, NS, TS, NPS/TS, NA) and Viral Culture (rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) as 

described in the scope section of this letter (Section II). For ease of reference, this letter will use the term the ‘‘rRT-PCR Flu Panel 

(NPS, NS, TS, NPS/TS, NA).’’ 5The cleared test for in vitro qualitative detection of human influenza viral RNA (The CDC rRT-PCR Flu Panel (IVD) 510(K) 

080570) is not adequate because of the need to test additional types of samples during this emergency and it is not sufficiently available because of limited availability of certain reagents. No other criteria of issuance have been prescribed by regulation under section 

564(c)(4) of the Act. 6The CDC rRT-PCR Flu Panel (IVD) 510(K) 080570 is indicated for the in vitro qualitative detection of human influenza viral RNA 

in nasopharyngeal swabs (NPS) and nasal swabs (NS) only. 7All users, analysts, and any person reporting diagnostic results from use of this device should be trained to perform and interpret 

the results from this procedure by a CDC instructor or designee prior to use. CDC Influenza Division will limit the distribution of this 

device to those users who have successfully completed training provided by CDC instructors or designees. Use is limited to designated laboratories that are qualified to receive and use the CDC rRT-PCR Flu Panel (IVD) 510(K) 080570. See ‘‘Conditions of Authorization’’ below. 8These requirements are waived only for the rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) that is authorized for emergency 

use. These requirements, and all other applicable statutory and regulatory requirements, continue to apply to the CDC rRT-PCR Flu 

Panel (IVD) 510(K) 080570. 

Dated: June 30, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–18569 Filed 8–3–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0278] 

Authorization of Emergency Use of 

Certain Personal Respiratory 

Protection Devices; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of an Emergency Use 

Authorization (EUA) (the 

Authorization), as amended, for certain 

personal respiratory protection devices.1

FDA is issuing this Authorization under 

the Federal Food, Drug, and Cosmetic 

Act (the act), as requested by the Centers 

for Disease Control and Prevention 

(CDC). The Authorization contains, 

among other things, conditions on the 

emergency use of the authorized 

personal respiratory protection devices. 

The Authorization follows the 

determination by the Acting Secretary of 

the Department of Health and Human 

Services, Charles E. Johnson (the Acting 

Secretary), that a public health 

emergency exists involving Swine 

Influenza A (now known as 2009 H1N1 

Influenza A or 2009 H1N1 flu) that 

affects, or has the significant potential to 

affect, national security. On the basis of 

such determination, the Acting 

Secretary declared an emergency 

justifying the authorization of the 

emergency use of certain disposable 

National Institute for Occupational 

Safety and Health (NIOSH) certified N95 

respirators, accompanied by emergency 

use information subject to the terms of 

any authorization issued under the act. 

The Authorization, as amended, which 

includes an explanation of the reasons 

for its issuance, is reprinted in this 

document. Elsewhere in this issue of the 

Federal Register, FDA is announcing 

the issuance of EUAs for certain 

products from the neuraminidase class 

of antivirals, zanamivir and oseltamivir 

phosphate and the issuance of EUAs for 

certain in vitro diagnostic devices. 

DATES: The Authorization is effective as 

of April 27, 2009. 

ADDRESSES: Submit written requests for 

single copies of the EUA to the Office 

of Counterterrorism and Emerging 

Threats (HF–29), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

14C–26, Rockville, MD 20857. Send one 

self-addressed adhesive label to assist 

that office in processing your request or 

include a fax number to which the 

Authorization may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the Authorization. 

FOR FURTHER INFORMATION CONTACT: 

Boris Lushniak, Office of 

Counterterrorism and Emerging Threats 

(HF–29), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–4067. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the act (21 U.S.C. 

360bbb–3), as amended by the Project 

BioShield Act of 2004 (Public Law 108– 

276), allows FDA to strengthen the 

public health protections against 

biological, chemical, nuclear, and 

radiological agents. Among other things, 

section 564 of the act allows FDA to 

authorize the use of an unapproved 

medical product or an unapproved use 

of an approved medical product during 

a public health emergency that affects, 

or has a significant potential to affect, 

national security, and that involves 

biological, chemical, radiological, or 

nuclear agent or agents, or a specified 

disease or condition that may be 

attributable to such agent or agents. 

With this EUA authority, FDA can help 

assure that medical countermeasures 

may be used in an emergency to 

diagnose, treat, or prevent serious or 

life-threatening diseases or conditions 

caused by such agents, when there are 

no adequate, approved, and available 

alternatives. 

Section 564(b)(1) of the act provides 

that, before an EUA may be issued, the 

Secretary must declare an emergency 

justifying the authorization based on 

one of the following grounds: ‘‘(A) 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 specified biological, chemical, 

radiological, or nuclear agent or agents; 

(B) a determination by the Secretary of 

Defense that there is a military 

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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 38645 

2The Secretary has delegated his authority to 

issue an EUA under section 564 of the act to the 

Commissioner of Food and Drugs. 

emergency, or a significant potential for 

a military emergency, involving a 

heightened risk to United States military 

forces of attack with a specified 

biological, chemical, radiological, or 

nuclear agent or agents; or (C) a 

determination by the Secretary of a 

public health emergency under section 

319 of the Public Health Service Act 

that affects, or has a significant potential 

to affect, national security, and that 

involves a specified biological, 

chemical, radiological, or nuclear agent 

or agents, or a specified disease or 

condition that may be attributable to 

such agent or agents.’’ 

Once the Secretary has declared an 

emergency justifying an authorization 

under section 564 of the 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 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 

act permits FDA to authorize the 

introduction into interstate commerce of 

a drug, device, or biological product 

intended for use in a declared 

emergency. Products appropriate for 

emergency use may include products 

and uses that are not approved, cleared, 

or licensed under sections 505, 510(k), 

and 515 of the act (21 U.S.C. 355, 

360(k), and 360e) or section 351 of the 

Public Health Service Act (PHS Act) (42 

U.S.C. 262). FDA may issue an EUA 

only if, after consultation with the 

National Institutes of Health and CDC 

(to the extent feasible and appropriate 

given the circumstances of the 

emergency), FDA2 concludes: (1) That 

an agent specified in a declaration of 

emergency can cause a serious or lifethreatening 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—(1) such disease 

or condition; or (2) a serious or lifethreatening disease or condition caused 

by a product authorized under Section 

564, approved or cleared under this 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; (3) that 

there is no adequate, approved, and 

available alternative to the product for 

diagnosing, preventing, or treating such 

disease or condition; and (4) that such 

other criteria as the Secretary may by 

regulation prescribe are satisfied. 

No other criteria of issuance have 

been prescribed by regulation under 

section 564(c)(4) of the act. Because the 

statute is self-executing, FDA does not 

require regulations or guidance to 

implement the EUA authority. However, 

in the Federal Register of July 26, 2007 

(72 FR 41083), FDA announced the 

availability of a guidance entitled 

‘‘Emergency Use Authorization of 

Medical Products.’’ The guidance 

provides more information for 

stakeholders and the public about the 

EUA authority and the agency’s process 

for the consideration of EUA requests. 

II. EUA Request for Certain Personal 

Respiratory Protection Devices 

On April 26, 2009, under section 

564(b)(1)(C) of the act, the Acting 

Secretary determined that a public 

health emergency exists involving 

Swine Influenza A (now known as 2009 

H1N1 Influenza A or 2009 H1N1 flu) 

that affects, or has the significant 

potential to affect, national security. On 

April 26, 2009, under section 564(b) of 

the act, and on the basis of such 

determination, the Acting Secretary 

declared an emergency justifying the 

authorization of the emergency use of 

certain disposable NIOSH certified N95 

respirators, accompanied by emergency 

use information subject to the terms of 

any authorization issued under 21 

U.S.C. 360bbb–3(a). Notice of the 

determination and the declaration of the 

Acting Secretary is published elsewhere 

in this issue of the Federal Register. On 

April 27, 2009, the CDC requested and 

FDA issued an EUA for certain 

disposable NIOSH certified N95 

respirators, deployed from the Strategic 

National Stockpile with certain written 

information, including emergency use 

instructions, which are authorized 

under this EUA. On May 1, 2009, in 

response to a CDC request to make 

certain clarifications, FDA amended the 

authorization letter and reissued the 

Authorization letter in its entirety. 

III. Electronic Access 

An electronic version of this 

document and the full text of the 

Authorization are available on the 

Internet at http://www.regulations.gov. 

IV. The Authorization 

Having concluded that the criteria for 

issuance of this Authorization under 

section 564(c) of the act are met, FDA 

has authorized the emergency use of 

certain disposable NIOSH certified N95 

respirators. The Authorization, as 

amended and reissued in its entirety on 

May 1, 2009, follows and provides an 

explanation of the reasons for its 

issuance, as required by section 

564(h)(1) of the act: 

Richard E. Besser, M.D. 

Acting Director 

Centers for Disease Control and Prevention 

Clifton Building 1, Room 6430 

1600 Clifton Road, NE MS C-12 

Atlanta, GA 30333 

Dear Dr. Besser: 

This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization 

(EUA) pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3), for the emergency 

use of certain personal respiratory protection devices deployed from the Strategic National Stockpile, specifically certain disposable respirators certified by the National Institute for Occupational Safety and Health (NIOSH), in accordance with 42 CFR part

84, as non-powered air-purifying particulate respirators with a minimum filtration efficiency classification of N95.1,2

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38646 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 360bbb-3(b)(1)(C)), the Secretary of the Department of 

Health and Human Services (HHS) determined that a public health emergency exists involving Swine Influenza A that affects, or 

has a significant potential to affect, national security. Pursuant to section 564(b) of the Act (21 U.S.C. § 360bbb-3(b)), and on the 

basis of such determination, the Secretary of HHS then on April 27 declared an emergency justifying the authorization of the 

emergency use of certain personal respiratory protection devices, accompanied by emergency use information subject to the 

terms of any authorization issued under 21 U.S.C. § 360bbb-3(a). 

Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. § 360bbb-3(b)) are 

met, I am authorizing the emergency use, by the general public,3 of certain N95 respirators to help reduce wearer exposure to 

pathogenic biological airborne particulates during a public health medical emergency involving Swine Influenza A, subject to the 

terms of this authorization.4

I. Criteria for Issuance of Authorization 

I have concluded that the emergency use of certain N95 respirators meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that: 

(1) Swine Influenza A can cause influenza, a serious or life-threatening disease or condition; 

(2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that certain N95 respirators may be 

effective in preventing influenza by reducing wearer exposure to pathogenic biological airborne particulates, and that the 

known and potential benefits of certain N95 respirators, when used for the prevention of influenza, outweigh the known and 

potential risks of such products; and 

(3) there is no adequate, approved, and available alternative to the emergency use of certain N95 respirators in the prevention

of influenza.5,6

Therefore, I have concluded that the emergency use of certain N95 respirators for the prevention of influenza through reduced 

wearer exposure to pathogenic biological airborne particulates meets the above statutory criteria for issuance of an authorization. 

II. Scope of Authorization 

I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use, by the general 

public, of authorized N95 respirators to help reduce wearer exposure to pathogenic biological airborne particulates during a public 

health medical emergency involving Swine Influenza A. 

The authorized N95 respirators are as follows: 

Manufacturer Model 

3M 8210 

8000 

9210 

1860 

1870 

Moldex 2200 

2212 

2201 

Moldex-Metrics 3000 

3001 

3002 

3003 

Gerson 1730 

Kimberley-Clark PFR95–170 

PFR95–174 

The above products, as deployed from the Strategic National Stockpile before or after the signing of this letter of authorization, 

are authorized to be made available to recipients when accompanied by the following written information pertaining to the emergency use: 

• Summary Fact Sheet for Disposable Respirators for Use During the Swine Flu Emergency, as attached7

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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 38647 

In addition, they may be made available to recipients in the form (i.e., with the packaging and labeling) in which they are customarily sold for use, as long as they are accompanied by the above-mentioned Summary Fact Sheet.8

I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of 

authorized N95 respirators, when used to prevent influenza by reducing wearer exposure to pathogenic biological airborne particulates, outweigh the known and potential risks of such products. 

I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is 

reasonable to believe that the authorized N95 respirators may be effective for the prevention of influenza pursuant to section 

564(c)(2)(A) of the Act. FDA has reviewed the scientific information available, including the information supporting the conclusions 

described in Section I above, and concludes that the authorized N95 respirators, when used for the prevention of influenza by reducing wearer exposure to pathogenic biological airborne particulates, meet the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness. 

The emergency use of authorized N95 respirators under this EUA must be consistent with, and may not exceed, the terms of this 

letter, including the scope and the conditions of authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS’s determination under section 564(b)(1)(C) described above and the Secretary of 

HHS’s corresponding declaration under section 564(b)(1), the N95 respirators described above are authorized for use, by the 

general public, to help reduce wearer exposure to pathogenic biological airborne particulates during a public health medical emergency involving Swine Influenza A. 

This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when 

the EUA is revoked under section 564(g) of the Act. 

III. Current Good Manufacturing Practice 

I am waiving current good manufacturing practice requirements with respect to the authorized N95 respirators that are used in accordance with this emergency use authorization. 

IV. Conditions of Authorization 

Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization: 

CDC 

A. CDC will ensure that the state and/or local public health authority(ies) are informed of this EUA, including the terms and conditions herein. 

B. CDC will make available to state and/or local health authority(ies) through appropriate means the authorized Summary Fact 

Sheet, as attached. 

C. CDC will make available to the public through appropriate means, including through internet posting, general instructions for 

use to assist with donning the respirators. These instructions will be categorized, or adjusted as necessary, to account for any 

differences related to the following different respirator designs: molded/cone, folded, and duckbill respirators. 

State and/or Local Public Health Authority(ies) 

D. The appropriate state and/or local public health authorities will make available through appropriate means the authorized Summary Fact Sheet, as attached. 

E. The appropriate state and/or local public health authority(ies) will ensure that authorized N95 respirators are distributed to recipients in accordance with applicable state and local laws and/or in accordance with the public health and medical emergency 

response of the Authority Having Jurisdiction to deliver, distribute, or dispense the covered countermeasures, and their officials, 

agents, employees, contractors, or volunteers following a declaration of an emergency. 

CDC and State and/or Local Public Health Authority(ies) 

F. CDC and the appropriate state and/or local public health authority(ies) are also authorized to make available additional information relating to the emergency use of authorized N95 respirators that is consistent with, and does not exceed, the terms of 

this letter of authorization. 

The emergency use of authorized N95 respirators as described in this letter of authorization must comply with the conditions 

above and all other terms of this authorization. 

V. Duration of Authorization 

This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act. 

Joshua M. Sharfstein, M.D. 

Principal Deputy Commissioner 

Acting Commissioner of Food and Drugs 

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38648 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

1The specific products covered are listed below, in Section II (scope of authorization). For purposes of this document, we will refer 

to the devices covered by this authorization as ‘‘certain N95 respirators.’’ Only respirators that have passed specific testing by NIOSH 

may be labeled as NIOSH-certified. Each NIOSH-certified respirator (also called a filtering facepiece) bears a rating which refers to 

its certified level of filtration efficiency: for example, N95 signifies that the respirator filters at least 95% of airborne particles (and is 

not resistant to oil). 42 CFR 84.170. For more information on disposable NIOSH-certified respirators, see http://www.cdc.gov/niosh/ 

npptl/topics/respirators/disp_part/. 2FDA has cleared four models of disposable N95 respirators for use by the general public in public health medical emergencies, 

such as influenza pandemic: 3M Respirators 8612F and 8670F, and Pasture Pharma Respirators F550G and A520G. See 21 CFR 

880.6260 (product code NZJ) and http://www.fda.gov/cdrh/ode/guidance/1626.pdf. These four models of N95 respirators are already

FDA-cleared for a use contemplated by this letter of authorization. 3For purposes of this letter of authorization, the term ‘‘general public’’ is broad and includes people performing work-related duties. 

This authorization affects only requirements applicable under the Federal Food, Drug, and Cosmetic Act. If respirators are used for 

people performing work-related duties, employers must comply with the Occupational Safety and Health Administration (OSHA) Respiratory Protection Standard, 29 CFR 1910.134, found at www.OSHA.gov. 4FDA is authorizing the emergency use of certain N95 respirators as described in the scope section of this letter (Section II). 

5As described in footnote 2, FDA has cleared four models of N95 respirators for use by the general public in public health medical 

emergencies, such as influenza pandemic. A shortage of FDA-cleared respirators is nonetheless expected for the following reasons: 

not all of the four cleared models have been marketed extensively to date, and in fact two such models were only recently cleared by 

FDA; the respirators are disposable, and so one user is expected to use multiple respirators over a span of time; and, to ensure 

proper fit, each user may need to try on various sizes and models of respirators before selecting one for use. There are also some 

models of N95 respirators that are cleared by FDA for use in certain workplace settings. However, under the circumstances of this 

emergency, shortage of supplies of these models is expected. 6 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act. 

7This Summary Fact Sheet contains, among other information, known and potential risks of use, including risks to children as a result of breathing difficulties and improper fit. 8 In a work setting, OSHA requirements also apply (see note 3 of this letter). 

Dated: June 30, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–18570 Filed 8–3–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0276] 

Authorizations of Emergency Use of 

Certain Antiviral Drugs—Zanamivir and 

Oseltamivir Phosphate; 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) for certain products 

from the neuraminidase class of 

antivirals—Zanamivir and oseltamivir 

phosphate. FDA is issuing the 

Authorizations under the Federal Food, 

Drug, and Cosmetic Act (the act), as 

requested by the Centers for Disease 

Control and Prevention (CDC). The 

Authorizations contain, among other 

things, conditions on the emergency use 

of the authorized zanamivir and 

oseltamivir phosphate products. The 

Authorizations follow the determination 

by the Acting Secretary of the 

Department of Health and Human 

Services, Charles E. Johnson (the Acting 

Secretary), that a public health 

emergency exists involving Swine 

Influenza A (now known as 2009 H1N1 

Influenza A or 2009 H1N1 flu) that 

affects, or has the significant potential to 

affect, national security. On the basis of 

such determination, the Acting 

Secretary declared an emergency 

justifying the authorization of the 

emergency use of certain products from 

the neuraminidase class of antivirals— 

Zanamivir and oseltamivir phosphate, 

accompanied by emergency use 

information subject to the terms of any 

authorization issued under the act. The 

Authorizations, which include an 

explanation of the reasons for issuance, 

are reprinted in this document. 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

issuance of EUAs for certain in vitro 

diagnostic devices and the issuance of 

an EUA for certain personal respiratory 

protection devices. 

DATES: The Authorizations are effective 

as of April 27, 2009. 

ADDRESSES: Submit written requests for 

single copies of the EUAs to the Office 

of Counterterrorism and Emerging 

Threats (HF–29), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

14C–26, Rockville, MD 20857. Send one 

self-addressed adhesive label to assist 

that office in processing your request or 

include a fax number to which the 

Authorization(s) may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the Authorizations. 

FOR FURTHER INFORMATION CONTACT: 

Boris Lushniak, Office of 

Counterterrorism and Emerging Threats 

(HF–29), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–4067. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the act (21 U.S.C. 

360bbb–3), as amended by the Project 

BioShield Act of 2004 (Public Law 108– 

276), allows FDA to strengthen the 

public health protections against 

biological, chemical, nuclear, and 

radiological agents. Among other things, 

section 564 of the act allows FDA to 

authorize the use of an unapproved 

medical product or an unapproved use 

of an approved medical product during 

a public health emergency that affects, 

or has a significant potential to affect, 

national security, and that involves 

biological, chemical, radiological, or 

nuclear agent or agents, or a specified 

disease or condition that may be 

attributable to such agent or agents. 

With this EUA authority, FDA can help 

assure that medical countermeasures 

may be used in an emergency to 

diagnose, treat, or prevent serious or 

life-threatening diseases or conditions 

caused by such agents, when there are 

no adequate, approved, and available 

alternatives. 

Section 564(b)(1) of the act provides 

that, before an EUA may be issued, the 

Secretary must declare an emergency 

justifying the authorization based on 

one of the following grounds: ‘‘(A) 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 specified biological, chemical, 

radiological, or nuclear agent or agents; 

(B) 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 United States military 

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