38636 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

Participants randomly assigned into 

the intervention arms will receive 

comprehensive or brief interventional 

services from two trained 

interventionists. The interventions will 

be delivered in face-to-face encounters 

as well as over the telephone and the 

first dose of the intervention will be 

delivered on the day the participant is 

enrolled into study. During the first 

face-to-face encounter, an 

interventionist will administer a 

retention risk screener. This screener is 

a clinical tool that will help identify 

attitudes, barriers, and unmet needs that 

might prevent a patient from staying in 

care. The screener contains three 

sections: (1) Attitudes and beliefs about 

HIV care and treatment, (2) barriers to 

consistent clinic attendance (e.g., 

transportation, child care, housing 

instability, scheduling problems, and 

lack of social support), and (3) recent 

drug/alcohol use and mental health. The 

information obtained from the risk 

screener will be used to tailor the 

interventions to each individual 

patient’s needs. Because a patient’s 

situation or needs may change over 

time, the screener will be readministered to intervention arm 

participants at a minimum every 3–4 

months during a clinic visit or other 

arranged face-to-face meetings outside 

of the clinic. In addition, the study 

coordinator will obtain contact/locator 

information for all participants enrolled 

in the intervention arm. Contact 

information will be updated as 

necessary by the intervention staff. 

The response burden for the six 

participating sites and patients enrolled 

in the study is estimated as: 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of form by phase Number of 

respondents 

Number of 

responses 

per 

respondent 

Total 

responses 

Average burden per 

response 

(in hours) 

Total burden 

(in hours) 

Phase 1 

Primary Care Provider Survey ........................................................ 150 4 600 0 .167 100 

Clinic Staff Survey .......................................................................... 270 4 1,080 0 .167 180 

Patient Exit Survey ......................................................................... 1,800 1 1,800 0 .033 60 

.........................................................................................................

Electronic data abstraction ............................................................. 6 4 24 40 .0 960 

Phase 1 Burden ....................................................................... 2,226 .................... 3,504 ...................... 1,300 

Phase 2 

Primary Care Provider Survey ........................................................ 150 2 300 0 .167 50 

Clinic Staff Survey .......................................................................... 270 2 540 0 .167 90 

Patient Exit Survey ......................................................................... 1,800 1 1,800 0 .033 60 

Patient Eligibility Screener * ............................................................ 3,000 1 3,000 0 .083 249 

Patient Baseline Survey * ............................................................... 1,800 1 1,800 0 .50 900 

Retention Risk Screener ................................................................. 1,200 4 4,800 0 .25 1,200 

Retention Specialist/Patient Navigator Encounter .......................... 12 300 3,600 0 .017 61 

Contact/locator information ............................................................. 1,200 4 4,800 0 .083 398 

Electronic data abstraction ............................................................. 6 4 24 40 .0 960 

Phase 2 ................................................................................... 8,238 .................... 20,664 ...................... 3,968 

Total Burden ..................................................................... 11,664 .................... 24,168 ...................... 5,268 

* Only administered one time during the entire project period. 

Written comments and 

recommendations concerning this 

proposed information collection should 

be sent within 30 days of this notice to: 

Office of Management and Budget, 

Office of Regulatory Affairs, New 

Executive Office Building, Room 10235, 

Washington, DC 20503, Attention: Desk 

Officer for HRSA. 

Dated: July 27, 2009. 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E9–18524 Filed 8–3–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0277] 

Authorization of Emergency Use of 

Certain In Vitro Diagnostic Devices; 

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), one of which was 

amended, for certain in vitro diagnostic 

devices. 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 in vitro diagnostics. 

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 in vitro 

diagnostics, accompanied by emergency 

use information subject to the terms of 

any authorization issued under the act. 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 38637 

1The Secretary has delegated his authority to 

issue an EUA under section 564 of the act to the 

Commissioner of Food and Drugs. 

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 antiviral 

drug products and the issuance of an 

EUA for certain personal respiratory 

protection devices. 

DATES: The authorization for the Swine 

Influenza Virus Real-time RT–PCR 

Detection Panel (rRT-PCR Swine Flu 

Panel) is effective as of April 27, 2009. 

The Authorization for the previouslycleared CDC Human Influenza Virus 

Real-time RT–PCR Detection and 

Characterization Panel for Respiratory 

Specimens (NPS, NS, TS, NPS/TS, NA2) 

and Viral Culture is effective as of May 

2, 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 

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 

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), FDA1 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 

Public Health Service Act (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 In Vitro 

Diagnostic Products 

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 certain in vitro 

diagnostics for detection of Swine 

Influenza A (2009 H1N1 flu virus), 

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, in response to a 

CDC request, FDA issued an EUA for the 

Swine Influenza Virus Real-time RT– 

PCR Detection Panel (rRT-PCR Swine 

Flu Panel) with certain written 

mstockstill on DSKH9S0YB1PROD with NOTICES

38638 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

information, including fact sheets for 

healthcare providers and patients and 

adequate directions for use, which are 

authorized under the EUA. On May 2, 

2009, in response to a CDC request to 

allow use of the rRT-PCR Swine Flu 

Panel for different sample types and 

different reagents, FDA amended the 

rRT-PCR Swine Flu Panel Authorization 

letter and reissued the Authorization 

letter in its entirety, with amended 

written information, including adequate 

directions for use. In addition, on May 

2, 2009, in response to a CDC request, 

FDA issued an EUA with certain written 

information, including adequate 

directions for use, to allow the use of 

the FDA-cleared in vitro diagnostic 

device, CDC Human Influenza Virus 

Real-time RT–PCR Detection and 

Characterization Panel for Respiratory 

Specimens (NPS, NS, TS, NPS/TS, NA2) 

and Viral Culture) (CDC rRT-PCR flu 

panel), for patient specimen types and 

reagents in addition to those of the 

cleared CDC rRT-PCR flu panel. 

III. Electronic Access 

An electronic version of this 

document and the full text of the 

Authorizations are available on the 

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

IV. The Authorizations 

Having concluded that the criteria for 

issuance of the Authorizations, one as 

amended, under section 564(c) of the act 

are met, FDA has authorized the 

emergency use of certain in vitro 

diagnostic devices. 

The Authorization for the rRT-PCR 

Swine Flu Panel, as amended and 

reissued in its entirety on May 2, 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, MD 

Acting Director 

Centers for Disease Control and Prevention 

1600 Clifton Road, MS C-12 

Atlanta, GA 30333 

Clifton, Bldg. 1, Room 6430 

Dear Dr. Besser: 

On April 27, 2009, FDA issued a letter authorizing the emergency use of the Swine Influenza Virus Real-time RT-PCR Detection 

Panel (rRT-PCR Swine Flu Panel) for the presumptive diagnosis of swine influenza A (H1N1), pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3) by public health and other qualified laboratories. On May 1, 

2009, CDC submitted a request for an amendment to the Emergency Use Authorization. In response to that request, the letter authorizing emergency use of the rRT-PCR Swine Flu Panel is being reissued in its entirety with the amendments, as requested by 

CDC, incorporated.1

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 there is a public health emergency under 42 U.S.C. § 247d 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 an agent or agents -- in this case, swine influenza A (H1N1).2 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 the Department of Health and Human Services then declared an emergency justifying the authorization of the emergency use of the Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel) 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(c)) are 

met, I am authorizing the emergency use of the Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu 

Panel)3 for the presumptive diagnosis of swine influenza A (H1N1) virus infection in human individuals who have been diagnosed 

with influenza A caused by a virus not subtypeable by currently available FDA-cleared devices, subject to the terms of this authorization. 

I. Criteria for Issuance of Authorization 

I have concluded that the emergency use of the rRT-PCR Swine Flu Panel for the presumptive diagnosis of swine influenza A 

(H1N1) virus infection for human individuals who are diagnosed with influenza A caused by a virus that is not subtypeable by currently available FDA-cleared devices meets the criteria for issuance of an authorization under section 564(c) of the Act, because I 

have concluded that: 

(1) The recently isolated novel 2009 influenza A (H1N1), or swine flu, virus can cause influenza, a serious or life threatening

disease or condition to humans infected by this virus; 

(2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that the rRT-PCR Swine Flu Panel

may be effective in the presumptive diagnosis of swine influenza A (H1N1) virus infection, and that the known and potential 

benefits of the rRT-PCR Swine Flu Panel, when used in the presumptive diagnosis of swine influenza A (H1N1) virus infection, outweigh the known and potential risks of such products; and 

(3) there is no adequate, approved, and available alternative to the emergency use of the rRT-PCR Swine Flu Panel for the 

presumptive diagnosis of swine influenza A (H1N1) virus infection.4

Therefore, I have concluded that the emergency use of the rRT-PCR Swine Flu Panel for the presumptive diagnosis of swine influenza A (H1N1) virus infection in human individuals who are diagnosed with influenza A infections not subtypeable by currently 

available FDA-cleared devices meets the above criteria for issuance of an authorization. 

II. Scope of Authorization 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 38639 

I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the authorized rRT-PCR Swine Flu Panel for the presumptive diagnosis of 2009 H1N1 influenza A virus infection for individuals who are diagnosed with influenza A caused by a virus not subtypeable by currently available FDA-cleared devices. 

The authorized rRT-PCR Swine Flu Panel is as follows: 

The Swine Influenza Virus Real-time RT-PCR Detection Panel is a panel of oligonucleotide primers and dual-labeled hydrolysis 

(Taqman®) probes for use in the real-time RT-PCR assay on the ABI 7500 Fast Dx Real-Time PCR instrument for the in vitro 

qualitative detection of 2009 H1N1 influenza viral RNA in nasopharyngeal swabs (NPS), nasal swabs (NS), throat swabs (TS), 

dual NPS/TS swab, or nasal aspirate (NA) specimens from patients with signs and symptoms of respiratory infection and viral culture. The universal 2009 H1N1 influenza swInfA (NP gene) and swH1 (HA gene) primer and probe sets are designed for detection of 2009 A/H1N1 influenza viruses. In addition rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) authorized for emergency use 

utilizes the AgPath-IDTM One-Step RT-PCR Kit Human amplification reagents. 

The rRT-PCR Swine Flu Panel includes the following primer and probe sets: 

• InfA detects universal influenza A strains in nasopharyngeal swabs (NPS), nasal swabs (NS), throat swabs (TS), dual NPS/ 

TS swab, or nasal aspirate (NA) specimens from patients with signs and symptoms of respiratory infection, and virus culture. 

• swInfA specifically detects swine influenza A strains (NP gene) in nasopharyngeal swabs (NPS), nasal swabs (NS), throat 

swabs (TS), dual NPS/TS swab, or nasal aspirate (NA) specimens from patients with signs and symptoms of respiratory infection, and virus culture. 

• swH1 is specific for swine influenza A, subtype H1 (HA gene) in nasopharyngeal swabs (NPS), nasal swabs (NS), throat 

swabs (TS), dual NPS/TS swab, or nasal aspirate (NA) specimens from patients with signs and symptoms of respiratory infection, and viral culture. 

The rRT-PCR Swine Flu Panel also includes control materials: 

• RNase P (RP) detects human RNase P and is used as a positive control with human clinical specimens to indicate that adequate isolation of nucleic acid resulted from the extraction of the clinical specimen. 

• Swine Influenza Panel Real-Time RT-PCR Positive Control (SIPC) is a positive control designed to react with all the primer and probe sets including RNase P. 

The above rRT-PCR Swine Flu Panel, when labeled consistent with the attached template is authorized to be distributed to public

health and other qualified laboratories5 under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law. 

The following written information pertaining to the emergency use of the authorized rRT-PCR Swine Flu Panel is authorized to be made available to health care providers and patients: 

• Fact Sheet For Healthcare Providers: Interpreting Swine Influenza Rt-Pcr Detection Panel Test Results 

• Fact Sheet For Patients: Understanding Swine Influenza Kit Test Results 

See attached. As described in section IV below, 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 the authorized rRT-PCR Swine Flu Panel 

that is consistent with, and does not exceed, the terms of this letter of authorization. 

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 

the authorized rRT-PCR Swine Flu Panel in the specified population, when used in the presumptive diagnosis of swine influenza 

A (H1N1) virus infection, outweigh the known and potential risks of such product. 

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 rRT-PCR Swine Flu Panel may be effective in the presumptive diagnosis of swine influenza A (H1N1) virus infection 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 rRT-PCR 

Swine Flu Panel, when used to presumptively diagnose swine influenza A (H1N1) virus infection in the specified population, 

meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness. 

The emergency use of the authorized rRT-PCR Swine Flu Panel 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 rRT-PCR Swine Flu Panel described above is authorized to presumptively diagnose swine influenza A (H1N1) virus infection in human individuals who are diagnosed with influenza A caused by a virus not subtypeable by currently available FDA cleared devices. 

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. Waiver of Certain Requirements 

I am waiving the following requirements for the rRT-PCR Swine Flu Panel during the duration of this emergency use authorization: 

• current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of the rRT-PCR Swine Flu Panel; 

• registration and listing requirements under section 510 of the Act; 

• labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 

and 809.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 

352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information required 

under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 

21 CFR 809.10(b)(12); 

mstockstill on DSKH9S0YB1PROD with NOTICES

38640 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

• investigational device requirements, including requirements under 21 CFR Part 812; and 

• reporting requirements that apply to cleared or approved devices, including requirements under 21 CFR Parts 803 and 806. 

IV. Conditions of Authorization 

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

CDC 

A. CDC will distribute the rRT-PCR Swine Flu Panel labeled with the intended use statement, adequate directions for use, any 

appropriate limitations on the use of the device, and any available information regarding performance of the device only to 

qualified laboratories. 

C. CDC will provide to the qualified state and/or local public health authority(ies) the authorized rRT-PCR Swine Flu Panel Fact 

Sheets for health care providers, and the authorized rRT-PCR Swine Flu Panel Fact Sheets for patients. 

D. CDC will make available on its website the authorized rRT-PCR Swine Flu Panel Fact Sheets for health care providers, and 

the authorized rRT-PCR Swine Flu Panel Fact Sheets for patients. 

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

F. CDC will ensure qualified laboratories have a process in place for reporting test results to health care providers and federal, 

state and/or local public health authorities, as appropriate. 

G. CDC will track adverse events. 

H. Through a process of inventory control, CDC will maintain records of device usage. 

I. CDC will collect information on the performance of the assay, to include the incidence of false positive and negative results. 

Public Health and Other Qualified Laboratories 

J. Qualified laboratories will perform the assay on an Applied Biosystems 7500 Fast Dx Real-time PCR instrument or the RUO 

marketed Applied Biosystems 7500 Real-time PCR instrument that is validated by Applied Biosystems with regard to the updated software but only partially qualified regarding its laboratory performance (proficiency testing with the CDC sample panel

not performed). 

K. Qualified laboratories will have a process in place for reporting test results to health care providers and federal, state and/or 

local public health authorities, as appropriate. 

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

M. CDC and the appropriate state and/or local public health authority(ies) are authorized to make available additional information 

relating to the emergency use of the authorized rRT-PCR Swine Flu Panel that is consistent with, and does not exceed, the 

terms of this letter of authorization. 

N. Only CDC may request changes to the authorized Fact Sheet for health care providers or the authorized rRT-PCR Swine Flu 

Panel Fact Sheet for patients. Such requests will be made by contacting FDA concerning FDA review and approval. 

O. CDC and the appropriate state/and or local public health authority(ies) will ensure that records associated with this EUA are 

maintained until notified by FDA. Such records will be made available to FDA for inspection upon request. 

The emergency use of the authorized rRT-PCR Swine Flu Panel 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, MD 

Principal Deputy Commissioner 

Acting Commissioner 

1The amendments to the April 27, 2009 letter allow use of different sample types (throat swabs (TS), dual NPS/TS swab, or nasal 

aspirate (NA) specimens) and different reagents. 2 Memorandum, Determination Pursuant to § 564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009). 

3FDA is authorizing the emergency use of the Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu 

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

Swine Flu Panel.’’ 4 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act. 

5All 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. 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 38641 

The Authorization for the cleared 

CDC rRT-PCR flu panel follows and 

provides an explanation of the reasons 

for its issuance, as required by section 

564(h)(1) of the act: 

Richard E. Besser, MD 

Acting Director 

Centers for Disease Control and Prevention 

1600 Clifton Road, MS C-12 

Atlanta, GA 30333 

Clifton, Bldg. 1, Room 6430 

Dear Dr. Besser: 

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

(EUA) for emergency use of the CDC1 Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel for Respiratory Specimens (NPS, NS, TS, NPS/TS, NA2) and Viral Culture (rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA)) as a first 

tier test for the qualitative detection of influenza virus type A or B and subtype determination of seasonal human influenza A virus 

(seasonal A/H1 or A/H3) for individuals suspected of having a 2009 H1N1 influenza virus infection, pursuant to section 564 of the 

Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3) by public health and other qualified laboratories. 

The CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel) was cleared by 

FDA on September 30, 2008 for use with nasopharyngeal and/or nasal swab specimens. Because of issues of availability and 

adequacy of the cleared test associated with the need for testing additional specimen types, this letter authorizes the emergency 

use of the rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) with specimen types and reagents in addition to those of the cleared 

test, as described below. The rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) is authorized as a first tier test for patient specimens with suspected 2009 H1N1 influenza virus and is an integral component of the testing algorithm for the rRT-PCR Swine Flu 

Panel authorized for use under an April 27, 2009 Emergency Use Authorization. 

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 there is a public health emergency under 42 U.S.C. § 247d 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 an agent or agents -- in this case, 2009 

H1N1 influenza virus.3 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 the Department of Health and Human Services then declared an emergency justifying the authorization of 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 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(c)) are 

met, I am 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))4 as a first tier test for the qualitative detection of influenza virus type A or B and subtype determination of seasonal human 

influenza A virus (seasonal A/H1 or A/H3) in individuals suspected of having a 2009 H1N1 influenza virus infection. The rRT-PCR

Flu Panel (NPS, NS, TS, NPS/TS, NA) is a first tier test because it should be used to test specimens from such individuals first. If 

the test result of the rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) is positive for influenza A and negative for H1 (seasonal) 

and H3 subtypes, then the laboratory should test the specimen with the rRT-PCR Swine Flu Panel. 

I. Criteria for Issuance of Authorization 

I have concluded that the emergency use of the rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) as a first tier test for the qualitative detection of influenza virus type A or B and subtype determination of seasonal human influenza A virus (seasonal A/H1 or

A/H3) for individuals suspected of having a 2009 H1N1 influenza virus infection meets the criteria for issuance of an authorization 

under section 564(c) of the Act, because I have concluded that: 

(1) The recently isolated novel 2009 influenza A (H1N1), or swine flu, virus can cause influenza, a serious or life threatening

disease or condition to humans infected by this virus; 

(2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that the rRT-PCR Flu Panel (NPS, 

NS, TS, NPS/TS, NA) may be effective as a first tier test for the qualitative detection of influenza virus type A or B and 

subtype determination of seasonal human influenza A virus (seasonal A/H1 or A/H3) in nasopharyngeal swabs (NPS), nasal 

swabs (NS), throat swabs (TS), and/or dual NPS/TS swab specimens and nasal aspirates (NA) from patients with signs and 

symptoms of respiratory infection suspected of having a 2009 H1N1 influenza virus infection and/or from viral culture, and 

that the known and potential benefits of the rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA), when used as a first tier test in 

the qualitative detection of influenza virus type A or B and subtype determination of seasonal human influenza A virus (seasonal A/H1 or A/H3), outweigh the known and potential risks of such products; and 

(3) there is no adequate, approved, and available alternative to the emergency use of the rRT-PCR Flu Panel (NPS, NS, TS, 

NPS/TS, NA) as a first tier test for the qualitative detection of influenza virus type A or B and subtype determination of seasonal human influenza A virus (seasonal A/H1 or A/H3) in nasopharyngeal swabs (NPS), nasal swabs (NS), throat swabs 

(TS), and/or dual NPS/TS swab specimens and nasal aspirates (NA) from patients with signs and symptoms of respiratory infection and/or from viral culture specimens suspected of having a 2009 H1N1 influenza virus infection.5

Therefore, I have concluded that the emergency use of the rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) as a first tier test for 

the qualitative detection of influenza virus type A or B and subtype determination of seasonal human influenza A virus (seasonal 

A/H1 or A/H3) for individuals suspected of having a 2009 H1N1 influenza virus infection meets the above criteria for issuance of 

an authorization. 

mstockstill on DSKH9S0YB1PROD with NOTICES

38642 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

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 of the authorized rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) for the qualitative detection of influenza virus type A or B and subtype determination of seasonal human influenza A virus (seasonal A/H1 or A/H3) for individuals suspected of having a 2009 H1N1 influenza virus infection. 

The authorized rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA): 

CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel for Respiratory Specimens (NPS, NS, TS, 

NPS/TS, NA) and Viral Culture is a panel of oligonucleotide primers and dual-labeled hydrolysis probes for use in the real-time 

RT-PCR assay on the ABI 7500 Fast Dx Real-Time PCR instrument for the in vitro qualitative detection of human influenza viral 

RNA in nasopharyngeal swabs (NPS), nasal swabs (NS), throat swabs (TS), and/or dual NPS/TS swab specimens and nasal aspirates (NA) from patients with signs and symptoms of respiratory infection and/or from viral culture.6

The rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) uses the same primer and probe sequences as the CDC Human Influenza 

Virus Real-time RT-PCR Detection and Characterization Panel as the device cleared under K080570 except that the rRT-PCR Flu 

Panel (NPS, NS, TS, NPS/TS, NA) authorized for emergency use also utilizes the AgPath-IDTM One-Step RT-PCR Kit Human 

amplification reagents. 

Assay principle 

• The rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) is used in real-time RT-PCR assays on the ABI 7500 Fast instruments. The primer and probe sets are designed for detection and subtyping of influenza A viruses. 

• One-step RT-PCR assays are one-tube assays that first reverse-transcribe specific Ribonucleic acid (RNA) templates into 

cDNA copies. The complementary deoxyribonucleic acid (cDNA) then undergoes a polymerase chain reaction (PCR) that utilizes a thermocyclic heating and cooling of the reaction to logarithmically amplify a specific region of DNA. The probe anneals

to a specific target sequence located between the forward and reverse primers. During the extension phase of the PCR 

cycle, the 5’ nuclease activity of Taq polymerase degrades the probe, causing the reporter dye to separate from the quencher dye, generating a fluorescent signal. With each cycle, additional reporter dye molecules are cleaved from their respective 

probes, increasing the fluorescence intensity. Fluorescence intensity is monitored at each PCR cycle. 

• No template controls (NTCs) and positive template controls for all primer and probe sets are included in each run. An extraction control (HSC) provides a secondary negative control that validates the extraction procedure and reagent integrity. The 

RNase P assay serves as a control to ensure adequate RNA resulted from extraction of each clinical specimen and that no 

inhibitors were present in the specimen. RNA extracted from clinical samples contains human RNA. The RP primer and 

probe set targets the human ribonuclease P gene. Therefore, the level of the RNase P primer and probe set reaction reflects 

the relative amount of human RNA recovered from the specimen and its suitability for clinical testing. 

The above rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA), when labeled consistent with the attached template, is authorized to 

be distributed to public health and other qualified laboratories7 under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law. 

The following written information pertaining to the emergency use of the authorized rRT-PCR Swine Flu Panel is authorized to be made available to health care providers and patients: 

• Fact Sheet For Healthcare Providers: Interpreting rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) Test Results 

• Fact Sheet For Patients: Understanding rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) Kit Test Results 

See attached. As described in section IV below, 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 the authorized rRT-PCR Flu Panel (NPS, 

NS, TS, NPS/TS, NA) that is consistent with, and does not exceed, the terms of this letter of authorization. 

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 

the authorized rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) in the specified population, when used as a first tier test in the 

qualitative detection of influenza virus type A or B and subtype determination of seasonal human influenza A virus (seasonal A/H1 

or A/H3) for individuals suspected of having a 2009 H1N1 influenza virus infection, outweigh the known and potential risks of 

such product. 

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 rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) may be effective as a first tier test in 

the qualitative detection of influenza virus type A or B and subtype determination of seasonal human influenza A virus (seasonal 

A/H1 or A/H3) for individuals suspected of having a 2009 H1N1 influenza virus infection 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 rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA), when used for qualitative detection of influenza virus types A or B and subtype determination of seasonal human influenza A virus (seasonal A/H1 or A/H3) from

individuals suspected of having a 2009 H1N1 influenza virus infection in the specified population, meets the criteria set forth in 

section 564(c) of the Act concerning safety and potential effectiveness. 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 38643 

The emergency use of the authorized rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) 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 rRT-PCR Flu Panel (NPS, 

NS, TS, NPS/TS, NA) described above is authorized as a first tier test to qualitatively detect influenza virus types A or B and 

subtype seasonal human influenza A virus (seasonal A/H1 or A/H3) for individuals suspected of having a 2009 H1N1 influenza 

virus infection. 

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. Waiver of Certain Requirements 

I am waiving the following requirements for the rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) during the duration of this emergency use authorization8: 

• current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of the rRT-PCR Flu Panel (NPS, NS, TS, 

NPS/TS, NA); 

• registration and listing requirements under section 510 of the Act; 

• labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 

and 809.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 

352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information required 

under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 

21 CFR 809.10(b)(12); 

• investigational device requirements, including requirements under 21 CFR Part 812; and 

• reporting requirements that apply to cleared or approved devices, including requirements under 21 CFR Parts 803 and 806. 

IV. Conditions of Authorization 

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

CDC 

A. CDC will distribute the rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) labeled with the intended use statement, adequate directions for use, any appropriate limitations on the use of the device, and any available information regarding performance of 

the device only to qualified laboratories. 

B. CDC will provide to the qualified state and/or local public health authority(ies) the authorized rRT-PCR Flu Panel (NPS, NS, 

TS, NPS/TS, NA) Fact Sheets for health care providers, and the authorized rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) 

Fact Sheets for patients. 

C. CDC will make available on its website the authorized rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) Fact Sheets for health 

care providers, and the authorized rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) Fact Sheets for patients. 

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

E. CDC will ensure qualified laboratories have a process in place for reporting test results to health care providers and federal, 

state and/or local public health authorities, as appropriate. 

F. CDC will track adverse events. 

G. Through a process of inventory control, CDC will maintain records of device usage. 

H. CDC will collect information on the performance of the assay, to include the incidence of false positive results. 

Public Health and Other Qualified Laboratories 

I. Qualified laboratories will perform the assay on an Applied Biosystems 7500 Fast Dx Real-time PCR instrument or the RUO 

marketed Applied Biosystems 7500 Real-time PCR instrument that is validated by Applied Biosystems with regard to the updated software but only partially qualified regarding its laboratory performance (proficiency testing with the CDC sample panel

not performed). 

J. Qualified laboratories will have a process in place for reporting test results to health care providers and federal, state and/or 

local public health authorities, as appropriate. 

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

K. CDC and the appropriate state and/or local public health authority(ies) are authorized to make available additional information 

relating to the emergency use of the authorized rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) that is consistent with, and 

does not exceed, the terms of this letter of authorization. 

L. Only CDC may request changes to the authorized Fact Sheet for health care providers or the authorized rRT-PCR Flu Panel 

(NPS, NS, TS, NPS/TS, NA) Fact Sheet for patients. Such requests will be made by contacting FDA concerning FDA review 

and approval. 

M. CDC and the appropriate state/and or local public health authority(ies) will ensure that records associated with this EUA are 

maintained until notified by FDA. Such records will be made available to FDA for inspection upon request. 

The emergency use of the authorized rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA) 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. 

mstockstill on DSKH9S0YB1PROD with NOTICES

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 

mstockstill on DSKH9S0YB1PROD with NOTICES