80_FR_13905 80 FR 13854 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability

80 FR 13854 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 51 (March 17, 2015)

Page Range13854-13862
FR Document2015-06039

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Ebola Zaire virus in response to the 2014 Ebola virus outbreak in West Africa. FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Roche Molecular Systems, Inc. (Roche). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

Federal Register, Volume 80 Issue 51 (Tuesday, March 17, 2015) 
[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Notices]
[Pages 13854-13862]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-06039]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1206]


Authorization of Emergency Use of an In Vitro Diagnostic Device 
for Detection of Ebola Zaire Virus; 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 an Emergency Use Authorization (EUA) (the Authorization) 
for an in vitro diagnostic device for detection of the Ebola Zaire 
virus in response to the 2014 Ebola virus outbreak in West Africa. FDA 
is issuing this Authorization under the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act), as requested by Roche Molecular Systems, 
Inc. (Roche). The Authorization contains, among other things, 
conditions on the emergency use of the authorized in vitro diagnostic 
device. The Authorization follows the September 22, 2006, determination 
by then-Secretary of the Department of Homeland Security (DHS), Michael 
Chertoff, that the Ebola virus presents a material threat against the 
U.S. population sufficient to affect national security. On the basis of 
such determination, the Secretary of Health and Human Services (HHS) 
declared on August 5, 2014, that circumstances exist justifying the 
authorization of emergency use of in vitro diagnostics for detection of 
Ebola virus subject to the terms of any authorization issued under the 
FD&C Act. The Authorization, which includes an explanation of the 
reasons for issuance, is reprinted in this document.

DATES: The Authorization is effective as of December 23, 2014.

ADDRESSES: Submit written requests for single copies of the EUA to the 
Office of Counterterrorism and Emerging Threats, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, rm. 4338, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request or include a fax number to which 
the Authorization may be sent. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Luciana Borio, Assistant Commissioner 
for Counterterrorism Policy, Office of Counterterrorism and Emerging 
Threats, and Acting Deputy Chief Scientist, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, rm. 4340, Silver 
Spring, MD 20993-0002, 301-796-8510 (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the 
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and 
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) 
allows FDA to strengthen the public health protections against 
biological, chemical, nuclear, and radiological agents. Among other 
things, section 564 of the FD&C Act allows FDA to authorize the use of 
an unapproved medical product or an unapproved use of an approved 
medical product in certain situations. With this EUA authority, FDA can 
help assure that medical countermeasures may be used in emergencies to 
diagnose, treat, or prevent serious or life-threatening diseases or 
conditions caused by biological, chemical, nuclear, or radiological 
agents when there are no adequate, approved, and available 
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may 
be issued, the Secretary of HHS must declare that circumstances exist 
justifying the authorization based on one of the following grounds: (1) 
A determination by the Secretary of Homeland Security that there is a 
domestic emergency, or a significant potential for a domestic 
emergency, involving a heightened risk of attack with a biological, 
chemical, radiological, or nuclear agent or agents; (2) a determination 
by the Secretary of Defense that there is a military emergency, or a 
significant potential for a military emergency, involving a heightened 
risk to U.S. military forces of attack with a biological, chemical, 
radiological, or nuclear agent or agents; (3) a determination by the 
Secretary of HHS that there is a public health emergency, or a 
significant potential for a public health emergency, that affects, or 
has a significant potential to affect, national security or the health 
and security of U.S. citizens living abroad, and that involves a 
biological, chemical, radiological, or nuclear agent or agents, or a 
disease or condition that may be

[[Page 13855]]

attributable to such agent or agents; or (4) the identification of a 
material threat by the Secretary of Homeland Security under section 
319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6b) 
sufficient to affect national security or the health and security of 
U.S. citizens living abroad.
    Once the Secretary of HHS has declared that circumstances exist 
justifying an authorization under section 564 of the FD&C Act, FDA may 
authorize the emergency use of a drug, device, or biological product if 
the Agency concludes that the statutory criteria are satisfied. Under 
section 564(h)(1) of the FD&C Act, FDA is required to publish in the 
Federal Register a notice of each authorization, and each termination 
or revocation of an authorization, and an explanation of the reasons 
for the action. Section 564 of the FD&C Act permits FDA to authorize 
the introduction into interstate commerce of a drug, device, or 
biological product intended for use when the Secretary of HHS has 
declared that circumstances exist justifying the authorization of 
emergency use. Products appropriate for emergency use may include 
products and uses that are not approved, cleared, or licensed under 
sections 505, 510(k), or 515 of the FD&C 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 HHS Assistant Secretary for 
Preparedness and Response, the Director of the National Institutes of 
Health, and the Director of the CDC (to the extent feasible and 
appropriate given the applicable circumstances), FDA \1\ concludes: (1) 
That an agent referred to in a declaration of emergency or threat can 
cause a serious or life-threatening disease or condition; (2) that, 
based on the totality of scientific evidence available to FDA, 
including data from adequate and well-controlled clinical trials, if 
available, it is reasonable to believe that: (A) The product may be 
effective in diagnosing, treating, or preventing (i) such disease or 
condition; or (ii) a serious or life-threatening disease or condition 
caused by a product authorized under section 564, approved or cleared 
under the FD&C Act, or licensed under section 351 of the PHS Act, for 
diagnosing, treating, or preventing such a disease or condition caused 
by such an agent; and (B) the known and potential benefits of the 
product, when used to diagnose, prevent, or treat such disease or 
condition, outweigh the known and potential risks of the product, 
taking into consideration the material threat posed by the agent or 
agents identified in a declaration under section 564(b)(1)(D) of the 
FD&C Act, if applicable; (3) that there is no adequate, approved, and 
available alternative to the product for diagnosing, preventing, or 
treating such disease or condition; and (4) that such other criteria as 
may be prescribed by regulation are satisfied.
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    \1\ The Secretary of HHS has delegated the authority to issue an 
EUA under section 564 of the FD&C Act to the Commissioner of Food 
and Drugs.
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    No other criteria for issuance have been prescribed by regulation 
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to 
implement the EUA authority.

II. EUA Request for an In Vitro Diagnostic Device for Detection of the 
Ebola Zaire Virus

    On September 22, 2006, then-Secretary of Homeland Security, Michael 
Chertoff, determined that the Ebola virus presents a material threat 
against the U.S. population sufficient to affect national security.\2\ 
On August 5, 2014, under section 564(b)(1) of the FD&C Act, and on the 
basis of such determination, the Secretary of HHS declared that 
circumstances exist justifying the authorization of emergency use of in 
vitro diagnostics for detection of Ebola virus, subject to the terms of 
any authorization issued under section 564 of the FD&C Act. Notice of 
the declaration of the Secretary was published in the Federal Register 
on August 12, 2014 (79 FR 47141). On December 19, 2014, Roche submitted 
a complete request for, and on December 23, 2014, FDA issued, an EUA 
for the LightMix[supreg] Ebola Zaire rRT-PCR Test, subject to the terms 
of this authorization.
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    \2\ Under section 564(b)(1) of the FD&C Act, the HHS Secretary's 
declaration that supports EUA issuance must be based on one of four 
determinations, including the identification by the DHS Secretary of 
a material threat under section 319F-2 of the PHS Act sufficient to 
affect national security or the health and security of U.S. citizens 
living abroad (section 564(b)(1)(D) of the FD&C Act).
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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 under section 564(c) of the FD&C Act are met, FDA has 
authorized the emergency use of an in vitro diagnostic device for 
detection of the Ebola Zaire virus (detected in the West Africa 
outbreak in 2014) subject to the terms of the Authorization. The 
Authorization in its entirety (not including the authorized versions of 
the fact sheets and other written materials) follows and provides an 
explanation of the reasons for its issuance, as required by section 
564(h)(1) of the FD&C Act.

    Dated: March 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.

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[FR Doc. 2015-06039 Filed 3-16-15; 8:45 am]
 BILLING CODE 4164-01-P

13854 Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices for people with intellectual disabilities: Dated: March 11, 2015. See the SUPPLEMENTARY INFORMATION (A) Expansion of educational Carolyn Baum, section for electronic access to the opportunities; (B) promotion of Program Analyst, Office of Federal Advisory Authorization. homeownership; (C) assurance of Committee Policy. FOR FURTHER INFORMATION CONTACT: workplace integration; (D) improvement [FR Doc. 2015–05968 Filed 3–16–15; 8:45 am] Luciana Borio, Assistant Commissioner of transportation options; (E) expansion BILLING CODE 4140–01–P for Counterterrorism Policy, Office of of full access to community living; and Counterterrorism and Emerging Threats, (F) increasing access to assistive and and Acting Deputy Chief Scientist, Food universally designed technologies. DEPARTMENT OF HEALTH AND and Drug Administration, 10903 New HUMAN SERVICES Hampshire Ave., Bldg. 1, rm. 4340, Dated: March 11, 2015. Food and Drug Administration Silver Spring, MD 20993–0002, 301– Aaron Bishop, 796–8510 (this is not a toll free number). Commissioner, Administration on Intellectual [Docket No. FDA–2014–N–1206] SUPPLEMENTARY INFORMATION: and Developmental Disabilities. [FR Doc. 2015–06085 Filed 3–16–15; 8:45 am] Authorization of Emergency Use of an I. Background BILLING CODE 4154–01–P In Vitro Diagnostic Device for Section 564 of the FD&C Act (21 Detection of Ebola Zaire Virus; U.S.C. 360bbb–3) as amended by the Availability Project BioShield Act of 2004 (Pub. L. DEPARTMENT OF HEALTH AND AGENCY: Food and Drug Administration, 108–276) and the Pandemic and All- HUMAN SERVICES HHS. Hazards Preparedness Reauthorization ACTION: Notice. Act of 2013 (Pub. L. 113–5) allows FDA National Institutes of Health to strengthen the public health SUMMARY: The Food and Drug protections against biological, chemical, National Institute of Neurological Administration (FDA) is announcing the nuclear, and radiological agents. Among Disorders and Stroke; Notice of Closed issuance of an Emergency Use other things, section 564 of the FD&C Meeting Authorization (EUA) (the Authorization) Act allows FDA to authorize the use of for an in vitro diagnostic device for an unapproved medical product or an Pursuant to section 10(d) of the detection of the Ebola Zaire virus in unapproved use of an approved medical Federal Advisory Committee Act, as response to the 2014 Ebola virus product in certain situations. With this amended (5 U.S.C. App.), notice is outbreak in West Africa. FDA is issuing EUA authority, FDA can help assure hereby given of the following meeting. this Authorization under the Federal that medical countermeasures may be The meeting will be closed to the Food, Drug, and Cosmetic Act (the used in emergencies to diagnose, treat, public in accordance with the FD&C Act), as requested by Roche or prevent serious or life-threatening Molecular Systems, Inc. (Roche). The diseases or conditions caused by provisions set forth in sections Authorization contains, among other biological, chemical, nuclear, or 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., things, conditions on the emergency use radiological agents when there are no as amended. The grant applications and of the authorized in vitro diagnostic the discussions could disclose adequate, approved, and available device. The Authorization follows the alternatives. confidential trade secrets or commercial September 22, 2006, determination by Section 564(b)(1) of the FD&C Act property such as patentable material, then-Secretary of the Department of provides that, before an EUA may be and personal information concerning Homeland Security (DHS), Michael issued, the Secretary of HHS must individuals associated with the grant Chertoff, that the Ebola virus presents a declare that circumstances exist applications, the disclosure of which material threat against the U.S. justifying the authorization based on would constitute a clearly unwarranted population sufficient to affect national one of the following grounds: (1) A invasion of personal privacy. security. On the basis of such determination by the Secretary of Name of Committee: National Institute of determination, the Secretary of Health Homeland Security that there is a Neurological Disorders and Stroke Special and Human Services (HHS) declared on domestic emergency, or a significant Emphasis Panel; NINDS Center Core (P30) August 5, 2014, that circumstances exist potential for a domestic emergency, and Research Resource (R24) Review. justifying the authorization of involving a heightened risk of attack Date: April 17, 2015. emergency use of in vitro diagnostics for with a biological, chemical, radiological, Time: 8:00 a.m. to 6:00 p.m. detection of Ebola virus subject to the or nuclear agent or agents; (2) a Agenda: To review and evaluate grant terms of any authorization issued under determination by the Secretary of applications. the FD&C Act. The Authorization, Defense that there is a military Place: Washington Plaza Hotel, 10 Thomas which includes an explanation of the emergency, or a significant potential for Circle NW., Washington, DC 20005. reasons for issuance, is reprinted in this a military emergency, involving a Contact Person: Natalia Strunnikova, document. heightened risk to U.S. military forces of Ph.D., Scientific Review Officer, Scientific DATES: The Authorization is effective as attack with a biological, chemical, Review Branch, Division of Extramural of December 23, 2014. radiological, or nuclear agent or agents; Research, NINDS/NIH/DHHS/Neuroscience ADDRESSES: Submit written requests for (3) a determination by the Secretary of Center, 6001 Executive Boulevard, Suite single copies of the EUA to the Office HHS that there is a public health 3208, MSC 9529, Bethesda, MD 20892–9529, mstockstill on DSK4VPTVN1PROD with NOTICES of Counterterrorism and Emerging emergency, or a significant potential for 301–402–0288, natalia.strunnikova@nih.gov. Threats, Food and Drug Administration, a public health emergency, that affects, (Catalogue of Federal Domestic Assistance 10903 New Hampshire Ave., Bldg. 1, or has a significant potential to affect, Program Nos. 93.853, Clinical Research rm. 4338, Silver Spring, MD 20993– national security or the health and Related to Neurological Disorders; 93.854, 0002. Send one self-addressed adhesive security of U.S. citizens living abroad, Biological Basis Research in the label to assist that office in processing and that involves a biological, chemical, Neurosciences, National Institutes of Health, your request or include a fax number to radiological, or nuclear agent or agents, HHS) which the Authorization may be sent. or a disease or condition that may be VerDate Sep<11>2014 18:09 Mar 16, 2015 Jkt 235001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.SGM 17MRN1

Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices 13855 attributable to such agent or agents; or evidence available to FDA, including 2014, under section 564(b)(1) of the (4) the identification of a material threat data from adequate and well-controlled FD&C Act, and on the basis of such by the Secretary of Homeland Security clinical trials, if available, it is determination, the Secretary of HHS under section 319F–2 of the Public reasonable to believe that: (A) The declared that circumstances exist Health Service (PHS) Act (42 U.S.C. product may be effective in diagnosing, justifying the authorization of 247d–6b) sufficient to affect national treating, or preventing (i) such disease emergency use of in vitro diagnostics for security or the health and security of or condition; or (ii) a serious or life- detection of Ebola virus, subject to the U.S. citizens living abroad. threatening disease or condition caused terms of any authorization issued under Once the Secretary of HHS has by a product authorized under section section 564 of the FD&C Act. Notice of declared that circumstances exist 564, approved or cleared under the the declaration of the Secretary was justifying an authorization under FD&C Act, or licensed under section 351 published in the Federal Register on section 564 of the FD&C Act, FDA may of the PHS Act, for diagnosing, treating, August 12, 2014 (79 FR 47141). On authorize the emergency use of a drug, or preventing such a disease or December 19, 2014, Roche submitted a device, or biological product if the condition caused by such an agent; and complete request for, and on December Agency concludes that the statutory (B) the known and potential benefits of 23, 2014, FDA issued, an EUA for the criteria are satisfied. Under section the product, when used to diagnose, LightMix® Ebola Zaire rRT–PCR Test, 564(h)(1) of the FD&C Act, FDA is prevent, or treat such disease or subject to the terms of this required to publish in the Federal condition, outweigh the known and authorization. Register a notice of each authorization, potential risks of the product, taking and each termination or revocation of an into consideration the material threat III. Electronic Access authorization, and an explanation of the posed by the agent or agents identified An electronic version of this reasons for the action. Section 564 of the in a declaration under section document and the full text of the FD&C Act permits FDA to authorize the 564(b)(1)(D) of the FD&C Act, if Authorizations are available on the introduction into interstate commerce of applicable; (3) that there is no adequate, Internet at http://www.regulations.gov. a drug, device, or biological product approved, and available alternative to intended for use when the Secretary of the product for diagnosing, preventing, IV. The Authorizations HHS has declared that circumstances or treating such disease or condition; Having concluded that the criteria for exist justifying the authorization of and (4) that such other criteria as may issuance of the Authorizations under emergency use. Products appropriate for be prescribed by regulation are satisfied. section 564(c) of the FD&C Act are met, emergency use may include products No other criteria for issuance have FDA has authorized the emergency use and uses that are not approved, cleared, been prescribed by regulation under of an in vitro diagnostic device for or licensed under sections 505, 510(k), section 564(c)(4) of the FD&C Act. or 515 of the FD&C Act (21 U.S.C. 355, detection of the Ebola Zaire virus Because the statute is self-executing, (detected in the West Africa outbreak in 360(k), and 360e) or section 351 of the regulations or guidance are not required PHS Act (42 U.S.C. 262). FDA may issue 2014) subject to the terms of the for FDA to implement the EUA Authorization. The Authorization in its an EUA only if, after consultation with authority. the HHS Assistant Secretary for entirety (not including the authorized Preparedness and Response, the II. EUA Request for an In Vitro versions of the fact sheets and other Director of the National Institutes of Diagnostic Device for Detection of the written materials) follows and provides Health, and the Director of the CDC (to Ebola Zaire Virus an explanation of the reasons for its the extent feasible and appropriate issuance, as required by section On September 22, 2006, then- given the applicable circumstances), 564(h)(1) of the FD&C Act. Secretary of Homeland Security, FDA 1 concludes: (1) That an agent Michael Chertoff, determined that the Dated: March 11, 2015. referred to in a declaration of emergency Ebola virus presents a material threat Leslie Kux, or threat can cause a serious or life- against the U.S. population sufficient to Associate Commissioner for Policy. threatening disease or condition; (2) affect national security.2 On August 5, that, based on the totality of scientific DHS Secretary of a material threat under section 2 Under section 564(b)(1) of the FD&C Act, the 319F–2 of the PHS Act sufficient to affect national 1 The Secretary of HHS has delegated the HHS Secretary’s declaration that supports EUA security or the health and security of U.S. citizens authority to issue an EUA under section 564 of the issuance must be based on one of four living abroad (section 564(b)(1)(D) of the FD&C FD&C Act to the Commissioner of Food and Drugs. determinations, including the identification by the Act). mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 18:09 Mar 16, 2015 Jkt 235001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.SGM 17MRN1

13856 Federal Register/Vol. 80, No. 51/ Tuesday, March 17, 2015 / Notices w3 siitiy,* caint in2 ‘/(é DEPARTMENT OF HEALTH & HUMAN SERVICES % Thul fivava Food and Drug Administration Silver Spring, MD 20993 December 23, 2014 —Jintao Chen, Ph.D. Director, Regulatory Affairs Rochke Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 Dear Dr. Chen: ~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 LightMix® Ebola Zaire rRT—PCR Test for the presumptive detection of RNA from Ebola Zaire virus (detectedin the West Africa outbreak of 2014) on specified instruments in EDTA whole blood or whole blood inactivated with TriPure fromindividuals with signs and symptoms of Ebola virusinfection in conjunction with epidemiological risk factors, by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C, §263a, to perform high complexity tests," or similarly qualified non—U.S. laboratories, pursuantto section 564 ofthe Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb—3). | . — ~ On September 22, 2006, then—Secretaryof the Department of Homeland Security (DHS), Michael Chertoff, determined, pursuant to section 319F—2 of the Public Health Service (PHS) Act(42 U.S.C. § 2474—6b), that the Ebola virus presents a material threat against the United States population —~ sufficient to affect national security." Pursuant to section 564(b)(1) ofthe Act (21 U.S.C. § 360bbb— 3(b)(1)), and on the basis of such determination, the Secretary of HHS declared on August 5. 2014, that circumstances exist justifying the authorization of emergenicy use ofin vitro diagnostics for df:iegtion of Ebolavirus, subject to the terms of any authorization issued under 21 U.S.C. § 360bbb— 3(a). ~ C 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 LightMix® Ebola _ Zaire rRT—PCR Test (as described in the Scope of Authorization section ofthis letter (Section II}) in "Roche Diagnostics is the exclusive distributor ofthe LightMix® Ebola Zaire rRT—PCR Test, manufactured by TIB MOLBIOL: The Conditions of Authorization (Section TV), unless otherwise specified, apply to Rocke Diagnostics or Roche Molecular Systems, Inc: as the responsible parties for satisfying the Conditions of Authorization. * For ease ofreference, this letter will refer to this type of laboratory as "CLIA High Complexity Laboratories." * Pursuant to section 564(b)(1) of the Act (21 U.S.C. § 360bbb—3(b)(1)), the HHS Secretary‘s declaration that supports EUA issuance must be based on one offour determinations, including the identification bythe DHS Secretary of a material threat pursuant to section 319F—2 ofthe PHS Act sufficient to affect national security or the health and security of United States citizens living abroad (section 564(b)(D(D) of the Act). — *1.9. Department of Health and Human Services.. Declaration Regarding Emergency Use ofIn Vitro Diagnosticsfor Detection ofEbola Virus, 79 Fed, Reg, 47141 (August 12, 2014).

Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices 13857 Page 2- Dr. Jintao Chen, Roche Molecular Inc. individuals with and symptoms ofEbola virus iniection in with '-!J'"'"·u"Jiu;.;'"·"' risk factors (as described in the of Authorization section ofthis letter (Section II)) for the presumptive detection of RNA from Ebola Zaire vims (detected in the West Africa outbreak of 2014) CLIA High Complexity or similarly qualified non-U.S. l::.n•cw::.1Tu'""" to the terms of this authorization. I. Criteria for Issuance of Authorization I have concluded that the emergency use of the Ebola Zaire rRT -PCR Test for the detection of RNA from Ebola Zaire virus (detected in the West Africa outbreak of the specified population meets the criteria for issuance of an authorization under section of the because I have concluded that: I. Ebola Zaire virus in the West Africa outbreak can cause Ebola virus te-1tlm:ate:ninlg disease or condition to humans infected with this 2. of scientmc evidence available to it is reasonable to believe that when used with the may ,.,,.,,.,...,,,., in the West Africa outbreak benefits ofthe Ebola Zaire rRT-PCR spE:el!tea ""'''u""''"'"' for Ebola virus in the the known and risks of such 3. and available alternative to the emergency use of the Zaire rRT-PCR for Ebola virus in the West outbreak of 20 14) infection. II. Scope of Authorization of the that the scope of this authorization is Ebola Zaire rRT·PCR Test CUA w'""'"'"J 1.-!U·dWCI<::V non-U.S. for the Ul<O:>O.UIIHJLI of RNA from Ebola Zaire vims in the West Africa outbreak of 201 and ofEbola virus infection in with The Authorized Ebola Zaire rRT-PCR Test: The '"'"'uu••u.-.·., EbolaZaire rRT-PCR Test is a real-time reverse traJnseriptiOl nnrvm,"""''" chain intended fbr the detection ofEbola Zaire virus in the West Africa outbreak in from whole blood or whole blood inactivated ·with TriPure. The assay is on nucleic acid extracted either Pure 96 DNA and Viral Nucleic the automated Pure 96 mstockstill on DSK4VPTVN1PROD with NOTICES EN17MR15.003</GPH> VerDate Sep<11>2014 18:09 Mar 16, 2015 Jkt 235001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4725 E:\FR\FM\17MRN1.SGM 17MRN1

13858 Federal Register/Vol. 80, No. 51/ Tuesday, March 17, 2015 / Notices Page 3 — Dr. Jintao Chen, Roche Molecular Systems, Inc. System or with the manual High Pure Viral Nucleic Acid Kit using the LightCycler® 480 Instrument or cobas z 480 Analyzer with LightCycler® Multiplex RNA Virus Master reagents for amplification and detection. The LightMix® Ebola Zaire rRT—PCR Test kit includes the following components: «1 Vial Ebola Zaire Mix (96 reactions), containing: 1) lyophilized primer and FAM—labeled probe sequences that specifically detect Ebola Zaire virus in whole blood; and 2) Iyophilized primer and R6G—labeled probe sequences that specifically detect an endogenous human house—keeping gene, RNase P, used as an internal process control with each clinical specimen to indicate that adequate isolation of nucleic acid resulted from the clinical specimen and PCR has worked properly fromthe extracted nucleic acid. «1 Vial Ebola Positive Control (RNA) (32 reactions), containing lyophilized synthetic RNA, designed to react with the Ebola Zaire Mix to indicate whether the Ebola Zaire RT—PCR has worked properly. The above described LightMix® Ebola Zaire rRT—PCR Test, when labeled consistently with the labeling authorized by FDA entifled "LightMix® Ebola Zaire rRT—PCR Test Instructions for Use" {available at hittp://wwow. fda.gov/MedicalDevices/Safety/EmergencySituations/ucm 161496 .htm#ebola), which may be revised only by Roche Molecular Systems, Inc. in consultation with FDA, is authorized to be distributed to and used by CLIA High Complexity Laboratories, or similarly qualified non—U.S: laboratories, under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law. The above described LightMix® Ebola Zaire rRT—PCR Test is anuthorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be made available to health care professionals and patients: * Fact Sheet for Health Care Providers: Interpreting LightMix®Ebola Zaire rRT—PCR Test Results s Fact Sheet for Patients: Understanding Results from the LightMix® Ebola Zaire rRT— PCR Test As described in Section TV below, Roche Diagnostics and Rocke Molecular Systems, Inc. are also authorized to make available additional information relating to the emergency use ofthe authorized LightMix® Ebola Zaire rRT—PCR Test that is consistent with, and does not exceed, the terms ofthis letter ofauthorization. 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 LightMix® Ebola Zaire rRT—PCR Test in the specified population, when used for presumptive detection of RNA from Ebola Zaire virus (detected in the West Africa outbreak of2014) outweigh the known and potential risks of such a product.

Federal Register/Vol. 80, No. 51/ Tuesday, March 17, 2015 / Notices 13859 Page 4 — Dr. Jintao Chen, Roche Molecular Systems, Inc. I have concluded, pursuant to section 564(d)(3) of the Act, based onthe totality of scientific evidence available to FDA, thatit is reasonable t6 believe that the authorized LightMix® Ebola Zaire rRT—PCR Test may be effective in the diagnosis of infection with Ebola Zaire virus {detected in the West Africa outbreak of 2014) pursuantto section 564(c)(2)(A) ofthe Act. FDA has reviewed the scientific information available to FDA including the information supporting the conclusions described in Section I above, and concludes that the authorized LightMix® Ebola Zaire rRT—PCR Test, when used to diagnose infection with Ebola Zaire virus {detected in the West Africa outbreak of 2014) in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness; The emergency use ofthe authorized LightMix® Ebola Zaire rRT—PCR Test under this EUA must be consistent with, and may not exceed, the terms of this letter, including the Scope of Authorization (Section 11) and the Conditions of Authorization (Section IV). Subject to the terms of this EUA and under the circumstances set forth in the Secretary of DHS‘s determination described above and the Secretary of HHS‘s corresponding declaration under section 564(b)(1), the LightMix® Ebola Zaire rRT—PCR Test described above is authorized to diagnose infection with in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors, This EUA will cease to be effective when the HHS declaration that cireumstances exist to justify the EUA is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) ofthe Act. IH,. Waiver of Certain Requirements I am waivingthe following requirements for the LightMix® Ebola Zaire rRT—PCR Test during the duration of this EUA: * Current good manufacturing practice requirements, including the quality system — requirements under 21 CFR Part 820 with respect to the design, manufacmreg packaging, labeling, storage, and distribution of the LightMix® Ebola Zaire rRT—PCR Test. «_ Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 21 CFR 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), (7), 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, includingrequirements under 21 CFR $09.10(b)(12). IV. Conditions of Authorization Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization: Roche Diagnostics or Roche Molecular Systems, Inc.

13860 Federal Register/Vol. 80, No. 51/ Tuesday, March 17, 2015 / Notices Page 5 — Dr. Jintao Chen, Roche Molecular Systems, Inc. A. Roche Diagnostics will distribute the authorized LightMix® Ebola Zaire rRT—PCR Test with the authorized labeling, as may be revised only by Roche Molecular Systems, fnc. in consultation with FDA, onlyto CLIA High Complexity Laboratories or similarlyqualified non—U.S. laboratories. ‘B. Roche Diagnostics will provide to CLIA High Complexity Laboratories or similarly qualified non—U.S. laboratories the authorized LightMix® Ebola Zaire rRT—PCR Test Fact Sheet for Health Care Providers and the authorized LightMix® Ebola ZairerRT—PCR Test Fact Sheet for Patients. . Roche Diagnostics will make available on its website the LightMix® Ebola Zaire rRT—PCR Test Fact Sheet for Health Care Providers and the authorized LightMix® Ebola Zaire rRT— PCR Test Fact Sheet for Patients. . Roche Diagnostics will inform CLIA High Complexity Laboratories or similarly qualified non—U.S. laboratories and relevant public health authority(ies) of this EUA, including the terms and conditions herein. . Roche Diagnostics will ensure that CLIA High Complexity Laboratories or similarly qualified non—U.S. laboratories using the authorized LightMix® Ebola Zaire rRT—PCR Test have a process in place for reporting test results to health care professionals and relevant public health authorities, as appropriate. . Through a process of inventory control, Roche Diagnostics will maintain records of device usage. . Roche Diagnostics 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 Roche Molecular Systems, Inc. becomes aware. « Roche Diagnostics is authorized to make available additional information relating to the emergency use of the authorized LightMix® Ebola Zaire rRT—PCR Test that is consistent with, and does not exceed, the terms ofthis letter of authorization. Rocke Molecular Systems, Inc. will provide TIB MOLBIOL with a copy of this EUA, and communicate to TIB MOLBIOL any subsequent amendments that might be made to this EUA and its authorized accompanying materials (e.g., Fact Sheets, Instructions For Use}. . Roche Molecular Systems, Inc. only may request changes to the authorized LightMix® Ebola Zaire rRT—PCR Test Fact Sheet for Health Care Providers or the authorized LightMix® Ebola Zaire rRT—PCR Test Fact Sheet for Patients. Such requests will be made only by Roche Molecular Systems, Inc. in consultation with FDA. . Roche Diagnostics, assuming the medical device reportingresponsibilities ofthe manufacturer of the LightMix® Ebola Zaire rRT—PCR Test, will track adverse eventsand report to FDA as described in 21 CFR Part 803.

Federal Register/Vol. 80, No. 51/ Tuesday, March 17, 2015 / Notices 13861 Page 6 — Dr. Jintao Chen, Roche Molecular Systems, Inc. L. Roche Molecular Systems, Inc. will comply with the applicable labeling requirements specified in the Waiver of Certain Requirements (Section III). M. Roche Molecular Systems, Inc. will notify FDA of any proposed change in its status as exclusive distributor of the LightMix® Ebola ZairerRT—PCR Test, including any proposed authorization of additional distributors. CLIA High Complexity Laboratories and Similarly Qualified Non—U.S. Laboratories N. CLI[A High Complexity Laboratories and similarly qualified non—U.8. laboratories will include with reports of the results of the LightMix® Ebola Zaire rRT—PCR Test the authorized Fact Sheet for Health Care Providers and the authorized Fact Sheet for Patients. Under exigent cireumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media. 0. CLIA High Complexity Laboratories and similarly qualified non—U.S. laboratories will perform the LightMix® Ebola Zaire rRT—PCR Test on only the LightCycler® 480 Instrument and cobas # 480 Analyzer. P. CLIA HighComplexity Laboratories and similarly qualified non—U.S. laboratories will have a process in place for reporting test results to health careprofessionals and relevant public health authorities, as appropriate. Q. CLIA High Complexity Laboratories and similarly qualified non—U.S. laboratories will collect information on the performance of the assay, and report to Roche Diagnostics any suspected occurrence of false positive or false negative results of which they become aware. R. All laboratory personnel using the assay should be appropriately trained in LightMix® Ebola Zaire rRT—PCR Test on the specified instruments and use appropriate laboratory and personal protective equipment when handling thiskit. Rocke Diagnostics, Rocke Molecular Systems, Inc., CLIA High Complexity Laboratories, and Similarly Qualified Non—U.S. Laboratories S. Roche Diagnostics, Roche Molecular Systems, Inc., CLIA High Complexity Laboratories, and similarly qualified non—U.S. 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. Conditions Related to Advertising and Promotion T. All advertisingand promotional descriptive printed matter relating to the use of the authorized LightMix® Ebola Zaire rRT—PCR Test shall be consistent with the Fact Sheets and authorized labeling, as well as the terms set forth in this EUA and the applicable requirements set forth in the Act and FDA regulations.

13862 Federal Register/Vol. 80, No. 51 /Tuesday, March 17, 2015 / Notices Page 7 — Dr. Jintao Chen, Rocke Molecular Systems, Inc. U. All advertising and promotional descriptive printed matter relating to the use of the authorized LightMix® Ebola Zaire rRT—PCR Test shall clearly and conspicuously state that: e This test has not been FDA cleared or approved; * This test has been authorized by FDA under an Emergency Use Authorization for use by CLIA High Complexity Laboratories and similarly qualified non—U.S. faboratories; a This test has been authorized only for the detection of RNA from Ebola Zaire virus {detected in the West Africa outbreak of 2014) and not for any other viruses or pathogens; and *« This testis only authorized for the duration of the declaration that circumstances exist justifying the authorization ofthe emergency use of in vitro diagnostics for detection of Ebola Zaire virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb—3(b)(1), unless the authorization is terminated or revoked sooner. No advertising or promotional descriptive printed matterrelating to the use of the authorized . LightMix® Ebola Zaire rRT—PCR Test may represent or suggest that this test is safe or effective for the diagnosts of infection with Ebola virus. The emergency use of the authorized LightMix® Ebola Zaire rRT—PCR Test described in this letter of authorization must comply with the conditions and all other terms of this authorization. ¥. Duration of Authorization This EUA will be effective until the declaration that circumstances existjustifying the authorization of the emergency use of in vitro diagnosties for detection of Ebola virus is terminated under section 564(b)(2) ofthe Act or the EUA is revoked under section 564(g) of the Act. Sincerely, ,w,f'}iffl ::;/ //ff _ ZaRmro) [Mctubctsp /Tig»" Margafet A. Hamburg, M.D. Commissioner of Food and Drugs Enclosures [FR Doc. 2015—06039 Filed 3—16—15; 8:45 am] BILLING CODE 4164—01—P


Document Created: 2015-12-18 12:01:47
Document Modified: 2015-12-18 12:01:47
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe Authorization is effective as of December 23, 2014.
ContactLuciana Borio, Assistant Commissioner for Counterterrorism Policy, Office of Counterterrorism and Emerging Threats, and Acting Deputy Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, rm. 4340, Silver Spring, MD 20993-0002, 301-796-8510 (this is not a toll free number).
FR Citation80 FR 13854 
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