Authorization of Emergency Use of Certain In Vitro Diagnostic Devices; Availability, 35045-35070 [2010-14881]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 75, Number 118 (Monday, June 21, 2010)]
[Notices]
[Pages 35045-35070]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14881]


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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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of seven Emergency Use Authorizations (EUAs) (the 
Authorizations), two of which were amended after initial issuance, for 
certain in vitro diagnostic devices. FDA is issuing the Authorizations 
and amendments thereto under the Federal Food, Drug, and Cosmetic Act 
(the act). The Authorizations contain, among other things, conditions 
on the emergency use of the authorized in vitro diagnostics. The 
Authorizations follow the determination by the then Acting Secretary of 
the U.S. 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. The Authorizations, which include explanations of the reasons for 
their issuance or reissuance, are reprinted in this document.

DATES: See the SUPPLEMENTARY INFORMATION section of this document for 
effective dates of the Authorizations.

ADDRESSES: Submit written requests for single copies of the Emergency 
Use Authorization(s) to the Office of Counterterrorism and Emerging 
Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, rm. 4140, Silver Spring, MD 20993. 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: RADM Boris Lushniak, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 32, rm. 4140, Silver Spring, MD 20993, 
301-796-8510.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the act (21 U.S.C. Sec.  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:
    (1) A determination by the Secretary of Homeland Security that 
there is a domestic emergency, or a significant potential for a 
domestic emergency, involving a heightened risk of attack with a 
specified 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 United States military forces 
of attack with a specified biological, chemical, radiological, or 
nuclear agent or agents; or
    (3) A determination by the Secretary of a public health emergency 
under section 319 of the Public Health Service Act (PHS Act) (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 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, respectively) 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 the Center for Disease 
Control and Prevention (to the extent feasible and appropriate given 
the circumstances of the emergency), FDA\1\ concludes:
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    \1\ The Secretary has delegated his authority to issue an EUA 
under section 564 of the act to the Commissioner of Food and Drugs.
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    (1) that an agent specified in a declaration of emergency 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--
    (1) such disease or condition; or
    (2) a serious or life-threatening disease or condition caused by a 
product authorized under section 564 of the act, approved or cleared 
under the 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

[[Page 35046]]

    (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, FDA published guidance in July 2007 
entitled ``Emergency Use Authorization of Medical Products'' to provide 
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 (21 U.S.C. 
360bbb-3(b)(1)(C)), 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. The determination 
has been renewed. 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), 
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 was published 
in the Federal Register on August 4, 2009 (74 FR 38628).
    (1) On January 21, 2010, in response to a request from ViraCor 
Laboratories, FDA issued an EUA for the ViraCor 2009 H1N1 Influenza A 
Real-time RT-PCR test with certain written information, including fact 
sheets for healthcare providers and patients, which are authorized 
under the EUA. The Authorization letter, which includes an explanation 
for its issuance, is reprinted in this document.
    (2) On November 13, 2009, in response to a request from Epoch 
BioSciences, FDA issued an EUA for the ELITech Molecular Diagnostics 
2009-H1N1 Influenza A virus Real-Time RT-PCR test for distribution to 
Associated Regional and University Pathologists (ARUP) Laboratories, 
with certain written information, including fact sheets for healthcare 
providers and patients, which are authorized under the EUA. On April 
19, 2010, notice of the initial Authorization was published in the 
Federal Register (75 FR 20441). On February 1, 2010, in response to a 
request from Epoch BioSciences, FDA amended the Authorization letter to 
authorize use of additional upper respiratory tract samples and lower 
respiratory tract specimens, and for other reasons, and reissued the 
Authorization letter in its entirety. The Authorization letter, as 
amended and reissued on February 1, 2009, which includes an explanation 
for its reissuance, is reprinted in this document. The original August 
2009 Authorization letter is not reprinted in this document.
    (3) On February 16, 2010, in response to a request from Longhorn 
Vaccines and Diagnostics, FDA issued an EUA for the Longhorn Influenza 
A/H1N1-09 Prime RRT-PCR Assay with certain written information, 
including fact sheets for healthcare providers and patients, which are 
authorized under the EUA. On March 23, 2010, in response to a request 
from Longhorn Vaccines and Diagnostics, FDA amended the Authorization 
letter to authorize use of additional upper respiratory tract samples 
and for other reasons, and reissued the Authorization letter in its 
entirety. The Authorization letter, as amended and reissued on March 
23, 2010, which includes an explanation for its original issuance and 
its reissuance, is reprinted in this document. The original February 
16, 2010 Authorization letter is not reprinted in this document.
    (4) On February 16, 2010, in response to a request from Diagnostic 
Hybrids, Inc., FDA issued an EUA for the Diagnostic Hybrids, Inc. D\3\ 
Ultra 2009 H1N1 Influenza A Virus ID Kit with certain written 
information, including fact sheets for healthcare providers and 
patients, which are authorized under the EUA. The Authorization letter, 
which includes an explanation for its issuance, is reprinted in this 
document.
    (5) On March 11, 2010, in response to a request from Qiagen, FDA 
issued an EUA for the artus[reg] Inf. A H1N1 2009 LC RT-PCR Kit with 
certain written information, including fact sheets for healthcare 
providers and patients, which are authorized under the EUA. The 
Authorization letter, which includes an explanation for its issuance, 
is reprinted in this document.
    (6) On March 22, 2010, in response to a request from 
IntelligentMDX, FDA issued an EUA for the IMDx 2009 Influenza A H1N1 
Real-Time RT-PCR Assay with certain written information, including fact 
sheets for healthcare providers and patients, which are authorized 
under the EUA. The Authorization letter, which includes an explanation 
for its issuance, is reprinted in this document.
    (7) On May 4, 2010, in response to a request from IQuum, Inc., FDA 
issued an EUA for the Liat Influenza A/2009 H1N1 Assay with certain 
written information, including fact sheets for healthcare providers and 
patients, which are authorized under the EUA. The Authorization letter, 
which includes an explanation for its issuance, is reprinted in this 
document.

III. Electronic Access

    An electronic version of this document and the full text of the 
Authorizations are available on the Internet at https://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.
    (1) The Authorization for ViraCor 2009 H1N1 Influenza A Real-time 
RT-PCR test issued on January 21, 2010, follows and provides an 
explanation of the reasons for its issuance, as required by section 
564(h)(1) of the act:

 Ren[eacute]e Forsberg, ASQ CQA
 Director, Regulatory Affairs and Quality Assurance
 ViraCor Laboratories
 1001 NW Technology Drive
 Lee's Summit, MO 64086
 
 
 Dear Ms. Forsberg:
 

[[Page 35047]]

 
 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 ViraCor 2009 H1N1 Influenza A Real-
 time RT-PCR test by ViraCor Laboratories for the diagnosis of 2009 H1N1 influenza virus infection in patients with signs and symptoms of respiratory infection, pursuant to section 564 of the
 Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. Sec.   360bbb-3). ViraCor Laboratories is certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. Sec.
 263a, to perform high complexity tests (a CLIA High Complexity Laboratory).
 
 On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. Sec.   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. Sec.   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.\1\ Pursuant to
 section 564(b) of the Act (21 U.S.C. Sec.   360bbb-3(b)), and on the basis of such determination, the Secretary of HHS then declared an emergency justifying the authorization of the emergency
 use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. Sec.   360bbb-3(a).
 
 Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. Sec.   360bbb-3(c)) are met, I am authorizing the emergency use of the ViraCor
 2009 H1N1 Influenza A Real-time RT-PCR test (as described in the scope section of this letter (Section II)) for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs
 and symptoms of respiratory infection, subject to the terms of this authorization.
 
 I. Criteria for Issuance of Authorization
 
 I have concluded that the emergency use of the ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and
 symptoms of respiratory infection meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
 
    1. The 2009 H1N1 influenza 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 ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test may be effective for the
     diagnosis of 2009 H1N1 influenza virus infection, and that the known and potential benefits of the ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test, when used in the diagnosis of 2009
     H1N1 influenza virus infection, outweigh the known and potential risks of such product; and
 
    3. There is no adequate, approved, and available alternative to the emergency use of the ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test for the diagnosis of 2009 H1N1 influenza virus
     infection.\2\
 
 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 ViraCor Laboratories' use of the authorized ViraCor 2009 H1N1 Influenza A Real-
 time RT-PCR test for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.
 
 The Authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test:
 
 The ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test is a real-time reverse transcriptase PCR (rRT-PCR) for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA in upper
 respiratory tract specimens (such as nasopharyngeal swabs (NPS), nasal swabs (NS), throat swabs (TS), nasal aspirates (NA), nasal washes (NW), and dual nasopharyngeal/throat swabs (NPS/TS)),
 and lower respiratory tract specimens (such as broncheoalveolar lavage (BAL), bronchial aspirate (BA), bronchial wash (BW), endotracheal aspirate (EA), endotracheal wash (EW), tracheal
 aspirate (TA), and lung tissue) from patients with signs and symptoms of respiratory infection. The testing procedure consists of nucleic acid extraction on the NucliSENS[reg] easyMAG[reg]
 system (bioM[eacute]rieux, Inc.) followed by rRT-PCR on the Applied Biosystems 7500 Real-Time PCR System.
 
 The ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test includes the following primer and probe sets:
     INFA: detects a conserved region of the matrix (M) gene that is present in both seasonal and 2009 H1N1 influenza A viruses.
     2009 H1N1: detects a region of the hemagglutinin (H) gene found in the 2009 H1N1 influenza virus. This primer/probe set may react with other swine origin influenza A strains.
     IC (Internal Control): detects an RNA sequence in whole bacteriophage MS2 that is noncompetitive with the INFA and 2009 H1N1 2009 targets.
 
 The ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test also includes the following control materials:
     Bacteriophage MS2 Internal Control (IC) is added to every patient sample and is carried through all steps of the procedure from nucleic acid isolation and purification through
     amplification to ensure that effective nucleic acid extraction is achieved and to monitor for inhibition of rRT-PCR.
     Negative Control consists of a known negative sample and is taken through both nucleic acid extraction and rRT-PCR processes to demonstrate that all extraction and amplification
     reagents are free of target RNA and amplicons and to ensure that detection of target genes is not due to false positive results.
     Positive Controls consist of separate in vitro transcribed RNAs containing targets recognized by the INFA and 2009 H1N1 detection systems and are included in each rRT-PCR run to
     demonstrate that these detection systems are operating at the required level of sensitivity.
 
 The ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test requires the following hardware with corresponding software:
     Applied Biosystems 7500 Real-Time PCR System with ABI Software: SDS software version 1.4.
     bioM[eacute]rieux NucliSENS[reg] easyMAG[reg] extraction system with software version 2.0
 

[[Page 35048]]

 
 The ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test requires the use of the following additional reagents/materials:
     SuperScript\TM\ III Platinum[reg] One-Step qRT-PCR kit (Invitrogen Cat. No. 11732-088)
     Extraction Reagents for NucliSENS[reg] easyMAG[reg] system (bioM[eacute]rieux Cat. Nos. 280130, 280131, 280132, 280133, 280134).
 
 The above described ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test, when labeled consistently with the labeling authorized by FDA, entitled ViraCor 2009 H1N1 Influenza A Real-time RT-PCR
 Package Insert (available at https://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to be used by ViraCor
 Laboratories,\3\ under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.
 
 The above described ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test is authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be
 made available to healthcare providers and patients:
 
     Fact Sheet for Healthcare Providers: Interpreting ViraCor 2009 H1N1 Influenza A Real-time RT-PCR Test Results
 
     Fact Sheet for Patients: Understanding ViraCor 2009 H1N1 Influenza A Real-time RT-PCR Test Results
 
 As described in section IV below, ViraCor Laboratories is also authorized to make available additional information relating to the emergency use of the authorized ViraCor 2009 H1N1 Influenza
 A Real-time RT-PCR test 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 ViraCor 2009 H1N1 Influenza A Real-time RT-
 PCR test in the specified population, when used for diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such a 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 ViraCor 2009
 H1N1 Influenza A Real-time RT-PCR test may be effective in the diagnosis of 2009 H1N1 influenza virus infection pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the
 scientific information available including the information supporting the conclusions described in Section I above, and concludes that the authorized ViraCor 2009 H1N1 Influenza A Real-time
 RT-PCR test, when used to diagnose 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.
 
 The emergency use of the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test 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 ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test described above is
 authorized to diagnose 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory 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 ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test 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 ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test.
 
     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).
 
 IV. Conditions of Authorization
 
 Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
 
    ViraCor Laboratories
 
    A. ViraCor Laboratories, Inc., will not sell or distribute the ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test to other laboratories.
 
    B. ViraCor Laboratories will include with reports of the results of the ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR
     test Fact Sheet for Healthcare Providers and the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test Fact Sheet for Patients.
 
    C. ViraCor Laboratories will make available on its Web site the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test Fact Sheet for Healthcare Providers and the authorized
     ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test Fact Sheet for Patients.
 

[[Page 35049]]

 
    D. ViraCor Laboratories will clearly and conspicuously state on reports of the results of the ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test that this test is only authorized for the
     diagnosis of 2009 H1N1 influenza virus and not for seasonal influenza A, B, or any other virus or pathogen.
 
    E. ViraCor Laboratories will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
 
    F. All advertising and promotional descriptive printed matter relating to the use of the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test shall be consistent with the Fact
     Sheets and authorized labeling, as well as the terms set forth in this EUA and other requirements set forth in the Act and FDA regulations.
 
    G. All advertising and promotional descriptive printed matter relating to the use of the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test shall clearly and conspicuously
     state that:
 
       This test has not been FDA cleared or approved;
 
       This test has been authorized by FDA under an Emergency Use Authorization;
 
       This test has been authorized only for the detection of 2009 H1N1 influenza virus and not for any other viruses or pathogens;
 
       This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Sec.   360bbb-
       3(b)(1); and
 
       The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.
 
    H. No advertising or promotional descriptive printed matter relating to the use of the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test may represent or suggest that this
     test is safe or effective for the diagnosis of 2009 H1N1 influenza virus.
 
    I. ViraCor Laboratories will have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as appropriate.
 
    J. ViraCor Laboratories will track adverse events and report to FDA as required under 21 CFR part 803.
 
    K. Through a process of inventory control, ViraCor Laboratories will maintain records of device usage.
 
    L. ViraCor Laboratories will collect information on the performance of the assay and report to FDA any suspected occurrence of false positive or false negative results of which ViraCor
     Laboratories becomes aware.
 
    M. ViraCor Laboratories is authorized to make available additional information relating to the emergency use of the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test that is
     consistent with, and does not exceed, the terms of this letter of authorization.
 
    N. Only ViraCor Laboratories may request changes to the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test Fact Sheet for Healthcare Providers or the authorized ViraCor 2009
     H1N1 Influenza A Real-time RT-PCR test Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.
 
    O. ViraCor Laboratories will perform the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test on the bioM[eacute]rieux NucliSENS[reg] easyMAG[reg] extraction system with software
     version 2.0 and Applied Biosystems 7500 Real-Time PCR System with SDS software version 1.4.
 
    P. ViraCor Laboratories will ensure that any 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 ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test 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
 
                   Margaret A. Hamburg, M.D.
                   Commissioner of Food and Drugs
 
 
 \1\ Memorandum, Determination Pursuant to Sec.   564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009).
\2\ No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
\3\ This EUA does not authorize the ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test to be sold or distributed to or used by other laboratories.

    (2) The Authorization for the ELITech Molecular Diagnostics 2009-
H1N1 Influenza A virus Real-Time RT-PCR test issued on November 13, 
2009, as amended and reissued in its entirety on February 1, 2010, 
follows and provides an explanation of the reasons for its issuance, as 
required by section 564(h)(1) of the act:

[[Page 35050]]



 Dr. Walt Mahoney
 VP R&D and Operations
 Managing Director
 Epoch BioSciences
 21720 23rd Drive S.E. Suite 150
 Bothell, WA 98021
 
 Dear Dr. Mahoney:
 
 On November 13, 2009 FDA issued a letter authorizing the emergency use of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test for the diagnosis of 2009 H1N1
 influenza virus infection, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. Sec.   360bbb-3) by laboratories certified under the Clinical Laboratory
 Improvement Amendments of 1988, 42 U.S.C. Sec.   263a, to perform high complexity tests (CLIA High Complexity Laboratories). On December 22, 2009, Epoch Biosciences submitted a request for an
 amendment to the Emergency Use Authorization. In response to that request, the letter authorizing emergency use of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-
 PCR test is being reissued in its entirety with the amendments incorporated.\1\
 
 On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. Sec.   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. Sec.   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.\2\ Pursuant to
 section 564(b) of the Act (21 U.S.C. Sec.   360bbb-3(b)), and on the basis of such determination, the Secretary of HHS then declared an emergency justifying the authorization of the emergency
 use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. Sec.   360bbb-3(a).
 
 Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. Sec.   360bbb-3(c)) are met, I am authorizing the emergency use of the ELITech
 Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory
 infection, subject to the terms of this authorization.
 
 I. Criteria for Issuance of Authorization
 
 I have concluded that the emergency use of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test for the diagnosis of 2009 H1N1 influenza virus infection in
 individuals with signs and symptoms of respiratory infection meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
 
    1. The 2009 H1N1 influenza 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 ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test may
     be effective for the diagnosis of 2009 H1N1 influenza virus infection, and that the known and potential benefits of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time
     RT-PCR test, when used in the diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such product; and
 
    3. There is no adequate, approved, and available alternative to the emergency use of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test for the diagnosis
     of 2009 H1N1 influenza virus infection.\3\
 
 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 ELITech Molecular Diagnostics 2009-H1N1 Influenza A
 virus Real-Time RT-PCR test for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.
 
 The Authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR Test:
 
 The ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test is a real-time reverse-transcription PCR for the in vitro qualitative detection of 2009 H1N1 influenza
 viral RNA in upper respiratory tract specimens (such as nasopharyngeal swabs (NPS), nasal swabs (NS), throat swabs (TS), nasal aspirates (NA), nasal washes (NW), and dual nasopharyngeal/
 throat swabs (NPS/TS)), and lower respiratory tract specimens (such as broncheoalveolar lavage (BAL), bronchial aspirate (BA), bronchial wash (BW), endotracheal aspirate (EA), endotracheal
 wash (EW), tracheal aspirate (TA), and lung tissue) from patients with signs and symptoms of respiratory infection. Amplification and detection are accomplished using PCR primers and Pleiades
 hybridization probes manufactured by Epoch BioSciences, a Division of Wescor, Inc. The testing procedure consists of nucleic acid extraction on the Qiagen BioRobot 9604 instrument followed by
 real-time reverse-transcription PCR on the Applied Biosystems 7900HT Real-Time PCR System.
 
 The ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test includes the following primer and probe sets:
 
     2009H1: detects the presence of the hemagglutinin (HA) gene specifically found in the 2009 H1N1 influenza A virus.
 
     M1: detects a conserved region of the Matrix Protein 1 (M1) gene that is present in seasonal and 2009-H1N1 influenza A viruses.
 
     Bacteriophage MS2 Internal Control: detects RNA sequence in whole bacteriophage MS2 that is noncompetitive with the 2009-H1N1 and M1 targets.

[[Page 35051]]

 
 
 The ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test also includes the following control materials:
 
     Bacteriophage MS2 Internal Control (IC) is added to every patient sample and is carried through all steps of the procedure from nucleic acid isolation and purification through
     amplification to monitor for inhibitors present in the specimen or reaction tube. The IC also serves as a general process control ensuring that each step of the procedure was performed
     correctly, assay and instrument parameters were set correctly, and that general reagents were working.
 
     Negative Control consists of IC diluted with water and is taken through both nucleic acid extraction and PCR processes to demonstrate that no carryover contamination has occurred
     during the test process (rule out false positives caused by contamination). The Negative Control is incorporated into each batch of patient specimen processing.
 
     Positive Controls consist of separate RNA templates containing targets recognized by the 2009H1 and M1 detection systems. Each Positive Control is taken through both nucleic acid
     extraction and PCR processes to demonstrate that nucleic acid extraction and PCR are effective (rule out false negatives caused by test failure). The Positive Controls are incorporated
     into each batch of patient specimen processing.
 
 The ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test requires the following hardware with corresponding software:
 
     Applied Biosystems 7900HT Real-Time PCR System with ABI Software: SDS 7900HT, v2.2.2 or v2.3.
 
     Qiagen BioRobot 9604 with QIAsoft 3.0 PLUS software.
 
 The ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test requires the use of the following additional reagents/materials:
 
     Qiagen QuantiTect Probe RT-PCR Master mix (Qiagen Cat. No 204443)
 
     Consumables for Qiagen BioRobot 9604
 
     QIAamp Virus BioRobot 9604 Kit (Qiagen Cat. No 965662)
 
     RNase Inhibitor (Applied Biosystems Cat. No N8080119)
 
     Heat-labile Uracil N-Glycosylase (Roche Cat No 11775367001)
 
     MasterAmp 10X PCR Enhancer (Epicentre Cat No ME81210)
 
 The above described ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test, when labeled consistently with the labeling authorized by FDA, entitled ELITech Molecular
 Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Package Insert (available at https://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm), as may be revised with
 written permission of FDA, is authorized to be distributed to and used by ARUP Laboratories,\4\ under this EUA, despite the fact that it does not meet certain requirements otherwise required
 by federal law.
 
 The above described ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test is authorized to be accompanied by the following information pertaining to the emergency
 use, which is authorized to be made available to healthcare providers and patients:
 
     Fact Sheet for Healthcare Providers: Interpretation of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR Test Results
 
     Fact Sheet for Patients: Understanding the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR Test Results
 
 As described in section IV below, Epoch Biosciences, is also authorized to make available additional information relating to the emergency use of the authorized ELITech Molecular Diagnostics
 2009-H1N1 Influenza A virus Real-Time RT-PCR test 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 ELITech Molecular Diagnostics 2009-H1N1
 Influenza A virus Real-Time RT-PCR test in the specified population, when used for diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such a 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 ELITech
 Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test may be effective in the diagnosis of 2009 H1N1 influenza virus infection pursuant to section 564(c)(2)(A) of the Act.
 The FDA has reviewed the scientific information available including the information supporting the conclusions described in Section I above, and concludes that the authorized ELITech
 Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test, when used to diagnose 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.
 

[[Page 35052]]

 
 The emergency use of the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test 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 ELITech Molecular Diagnostics 2009-H1N1 Influenza A
 virus Real-Time RT-PCR test described above is authorized to diagnose 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory 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 ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test 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 ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test.
 
     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).
 
 IV. Conditions of Authorization
 
 Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
 
 Epoch Biosciences
 
    A. Epoch Biosciences will distribute the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test with the authorized labeling, as may be revised with written
     permission of FDA, only to ARUP Laboratories.
 
    B. Epoch Biosciences will provide to ARUP Laboratories the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheet for Healthcare Providers
     and the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheet for Patients.
 
    C. Epoch Biosciences will make available on its website the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheet for Healthcare Providers
     and the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheet for Patients.
 
    D. Epoch Biosciences will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
 
    E. Epoch Biosciences will ensure ARUP Laboratories has a process in place for reporting test results to health care providers and federal, state, and/or local public health authorities, as
     appropriate.
 
    F. Epoch Biosciences will track adverse events and report to FDA as required under 21 CFR part 803.
 
    G. Through a process of inventory control, Epoch Biosciences will maintain records of device usage.
 
    H. Epoch Biosciences will collect information on the performance of the assay, and report to FDA any suspected occurrence of false positive or false negative results of which Epoch
     Biosciences becomes aware.
 
    I. Epoch Biosciences is authorized to make available additional information relating to the emergency use of the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-
     Time RT-PCR test that is consistent with, and does not exceed, the terms of this letter of authorization.
 
    J. Only Epoch Biosciences may request changes to the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheet for Healthcare Providers or the
     authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and
     approval.
 
 ARUP Laboratories
 
    K. ARUP Laboratories will include with reports of the results of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test the authorized ELITech Molecular
     Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheets for Healthcare Providers and the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time
     RT-PCR test Fact Sheets for Patients.
 
    L. ARUP Laboratories will clearly and conspicuously state on reports of the results of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test that this test is
     only authorized for the diagnosis of 2009 H1N1 influenza virus and not for seasonal influenza A, B, respiratory syncytial virus (RSV) or any other pathogen.
 

[[Page 35053]]

 
    M. ARUP Laboratories will use the Qiagen BioRobot 9604 for nucleic acid extraction and perform the assay on the Applied Biosystems 7900HT Real-time PCR instrument.
 
    N. ARUP 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.
 
    O. ARUP Laboratories will collect information on the performance of the assay, and report to Epoch Biosciences any suspected occurrence of false positive or false negative results of which
     ARUP Laboratories becomes aware.
 
 Epoch Biosciences and ARUP Laboratories
 
    P. Epoch Biosciences and ARUP Laboratories will make available on their Web sites the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheets
     for Healthcare Providers and the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheets for Patients.
 
    Q. Epoch Biosciences and ARUP Laboratories will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for
     inspection upon request.
 
    R. All advertising and promotional descriptive printed matter relating to the use of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test shall be consistent
     with the Fact Sheets and authorized labeling, as well as the terms set forth in this EUA and other requirements set forth in the Act and FDA regulations.
 
    S. All advertising and promotional descriptive printed matter relating to the use of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test shall clearly and
     conspicuously state that:
 
       This test has not been FDA cleared or approved;
 
       This test has been authorized by FDA under an Emergency Use Authorization;
 
       This test has been authorized only for the detection of 2009 H1N1 influenza virus and not for any other viruses or pathogens;
 
       This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. Sec.   360bbb-3(b)(1); and
 
       The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.
 
    T. No advertising or promotional descriptive printed matter relating to the use of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test may represent or
     suggest that this test is safe or effective for the diagnosis of 2009 H1N1 influenza virus.
 
 The emergency use of the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test 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.
 
                   Margaret A. Hamburg, M.D.
                   Commissioner of Food and Drugs
 
 
 \1\ The amendments to the October 16, 2009 letter authorize use of a) additional upper respiratory tract samples, such as nasal swabs (NS), throat swabs (TS), nasal aspirates (NA), nasal
  washes (NW), and dual nasopharyngeal / throat swabs (NPS/TS), and lower respiratory tract specimens, such as broncheoalveolar lavage (BAL), bronchial aspirate (BA), bronchial wash (BW),
  endotracheal aspirate (EA), endotracheal wash (EW), tracheal aspirate (TA), and lung tissue and b) ABI Software SDS 7900HT v2.3 on the Applied Biosystems 7900HT real-Time PCR System. There
  are also minor wording changes made to be consistent with more recently issued Emergency Use Authorizations for in vitro diagnostic devices.
\2\ Memorandum, Determination Pursuant to Sec.  564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009).
\3\ No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
\4\ This EUA does not authorize the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test to be sold or distributed to or used by other laboratories.

    (3) The Authorization for the Longhorn Influenza A/H1N1-09 Prime 
RRT-PCR Assay issued on February 16, 2010, as amended and reissued in 
its entirety on March 23, 2010, follows and provides an explanation of 
the reasons for its issuance, as required by section 564(h)(1) of the 
act:

 Gerald W. Fischer, M.D.
 Executive Director and Chief Medical Officer
 Longhorn Vaccines and Diagnostics
 3 Bethesda Metro Center, Suite 375
 Bethesda, MD 20814
 
 Dear Dr. Fischer:
 

[[Page 35054]]

 
 On February 16, 2010 FDA issued a letter authorizing the emergency use of the Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay\TM\ for the diagnosis of 2009 H1N1 influenza virus infection in
 patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act
 (the Act) (21 U.S.C. Sec.   360bbb-3) by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. Sec.   263a, to perform high complexity tests (CLIA
 High Complexity Laboratories). On February 26, 2010, Longhorn Vaccines and Diagnostics submitted a request for an amendment to the Emergency Use Authorization. In response to that request,
 the letter authorizing emergency use of the Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay is being reissued in its entirety with the amendments incorporated.\1\
 
 On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. Sec.   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. Sec.   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.\2\ Pursuant to
 section 564(b) of the Act (21 U.S.C. Sec.   360bbb-3(b)), and on the basis of such determination, the Secretary of HHS then declared an emergency justifying the authorization of the emergency
 use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. Sec.   360bbb-3(a).
 
 Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. Sec.   360bbb-3(c)) are met, I am authorizing the emergency use of the
 Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay (as described in the scope section of this letter (Section II)) for the diagnosis of 2009 H1N1 influenza virus infection in individuals with
 signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors, subject to the terms of this authorization.
 
 I. Criteria for Issuance of Authorization
 
 I have concluded that the emergency use of the Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms
 of respiratory infection meets in conjunction with clinical and epidemiological risk factors the criteria for issuance of an authorization under section 564(c) of the Act, because I have
 concluded that:
 
 1. The 2009 H1N1 influenza 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 Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay may be effective for the diagnosis of
 2009 H1N1 influenza virus infection, and that the known and potential benefits of the Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay, when used in the diagnosis of 2009 H1N1 influenza virus
 infection, outweigh the known and potential risks of such product; and
 
 3. There is no adequate, approved, and available alternative to the emergency use of the Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay for the diagnosis of 2009 H1N1 influenza virus
 infection\3\.
 
 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 Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay for
 the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.
 
 The Authorized Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay:
 
 The Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay is a real-time reverse transcriptase PCR (RRT-PCR) for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA in upper
 respiratory tract samples, such as nasal swabs (NS), throat swabs (TS), nasal aspirates (NA), nasal washes (NW), and dual nasopharyngeal / throat swabs (NPS/TS) from patients with signs and
 symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The testing procedure consists of nucleic acid extraction on the RNAqueous system (Ambion,
 Inc.) or QIAamp Viral RNA Minikit (Qiagen) followed by RRT-PCR on the Applied Biosystems 7500 Real-Time PCR System.
 
 The Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay includes the following primer and probe sets:
     FluA: detects a conserved region of the matrix (M) gene that is present in pan A, seasonal and 2009 H1N1 influenza A viruses.
     H1-09: detects a region of the hemagglutinin (HA) gene found in the 2009 H1N1 influenza virus.
     IPC (Internal Positive Control): detects a nonsense RNA sequence contained in the PrimeStore reagent.
 
 The Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay also includes the following control materials:
     Internal Positive Control (IPC) is contained in the PrimeStore reagent that is added to every patient sample before beginning nucleic acid isolation and purification, and is
     present through amplification to ensure that effective nucleic acid preservation and recovery is achieved and to monitor for inhibition of RRT-PCR.
     Negative Control consists of PrimeStore reagent and is taken through both nucleic acid extraction and RRT-PCR processes to demonstrate that all extraction and amplification
     reagents are free of target RNA and amplicons and to ensure that detection of target genes is not due to false positive results.
     Positive Controls consist of separate RNA templates containing targets recognized by the FluA and H1-09 detection systems and are included in each RRT-PCR run to demonstrate that
     these detection systems are operating at the required level of sensitivity.
 
 The Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay requires the following hardware with corresponding software:
     Applied Biosystems 7500 Real-Time PCR System with SDS v1.4 software
 

[[Page 35055]]

 
 The Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay requires the use of the following additional reagents/materials:
     Nucleic acid isolation kit, RNAqueous[reg] Micro Kit or QIAamp Viral RNA Minikit
 
 The above described Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay, when labeled consistently with the labeling authorized by FDA, entitled Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay
 Package Insert (available at https://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to be distributed to
 and used by CLIA High Complexity Laboratories, under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.
 
 The above described Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay is authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be
 made available to healthcare providers and patients:
 
     Fact Sheet for Healthcare Providers: Interpreting Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay Results
     Fact Sheet for Patients: Understanding Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay Results
 
 As described in section IV below, Longhorn Vaccines and Diagnostics is also authorized to make available additional information relating to the emergency use of the authorized Longhorn
 Influenza A/H1N1-09 Prime RRT-PCR Assay 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 Longhorn Influenza A/H1N1-09 Prime RRT-PCR
 Assay in the specified population, when used for diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such a 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 Longhorn
 Influenza A/H1N1-09 Prime RRT-PCR Assay may be effective in the diagnosis of 2009 H1N1 influenza virus infection pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the
 scientific information available including the information supporting the conclusions described in Section I above, and concludes that the authorized Longhorn Influenza A/H1N1-09 Prime RRT-
 PCR Assay, when used to diagnose 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.
 
 The emergency use of the authorized Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay 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 Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay described above is authorized to diagnose
 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory 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 Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay 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 Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay.
 
     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).
 
 IV. Conditions of Authorization
 
 Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
 
 Longhorn Vaccines and Diagnostics
    A. Longhorn Vaccines and Diagnostics will distribute the authorized Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay with the authorized labeling, as may be revised with written permission
     of FDA, only to CLIA High Complexity Laboratories.
 
    B. Longhorn Vaccines and Diagnostics will provide to the CLIA High Complexity Laboratories the authorized Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay Fact Sheet for Healthcare
     Providers and the authorized Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay Fact Sheet for Patients.
 
    C. Longhorn Vaccines and Diagnostics will make available on its website the authorized Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay Fact Sheet for Healthcare Providers and the
     authorized Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay Fact Sheet for Patients.
 
    D. Longhorn Vaccines and Diagnostics will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
 

[[Page 35056]]

 
    E. All advertising and promotional descriptive printed matter relating to the use of the authorized Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay shall be consistent with the Fact
     Sheets and authorized labeling, as well as the terms set forth in this EUA and other requirements set forth in the Act and FDA regulations.
 
    F. All advertising and promotional descriptive printed matter relating to the use of the authorized Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay shall clearly and conspicuously state
     that:
 
       This test has not been FDA cleared or approved;
 
       FDA has not determined that this test may be performed in settings with certificates of waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.
       Sec.   263a;
 
       This test has been authorized by FDA under an Emergency Use Authorization;
 
       This test has been authorized only for the diagnosis of 2009 H1N1 influenza virus and not for the diagnosis of any other viruses or pathogens;
 
       This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Sec.   360bbb-
       3(b)(1), unless the au