80_FR_37751 80 FR 37625 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Enterovirus D68; Availability

80 FR 37625 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Enterovirus D68; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 126 (July 1, 2015)

Page Range37625-37633
FR Document2015-16125

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for in an vitro diagnostic device for detection of Enterovirus D68 (EV- D68) strains detected in North America in 2014. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the February 6, 2015, determination by the Department of Health and Human Services (HHS) Secretary that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves EV-D68. On the basis of such determination, the Secretary of HHS also declared on February 6, 2015, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic devices for detection of EV-D68 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 126 (Wednesday, July 1, 2015) 
[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)]
[Notices]
[Pages 37625-37633]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16125]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2044]


Authorization of Emergency Use of an In Vitro Diagnostic Device 
for Detection of Enterovirus D68; 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 in an vitro diagnostic device for detection of Enterovirus D68 (EV-
D68) strains detected in North America in 2014. FDA issued this 
Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act), as requested by the Centers for Disease Control and Prevention 
(CDC). The Authorization contains, among other things, conditions on 
the emergency use of the authorized in vitro diagnostic device. The 
Authorization follows the February 6, 2015, determination by the 
Department of Health and Human Services (HHS) Secretary that there is a 
significant potential for a public health emergency that has a 
significant potential to affect national security or the health and 
security of U.S. citizens living abroad and that involves EV-D68. On 
the basis of such determination, the Secretary of HHS also declared on 
February 6, 2015, that circumstances exist justifying the authorization 
of emergency use of in vitro diagnostic devices for detection of EV-D68 
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 May 12, 2015.

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: Carmen Maher, Acting Assistant 
Commissioner for Counterterrorism Policy and Acting Director, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-
0002, 301-796-8510.

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 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).

[[Page 37626]]

    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 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 EV-
D68

    On February 6, 2015, under section 564(b)(1)(C) of the FD&C Act (21 
U.S.C. 360bbb-3(b)(1)(C)), the Secretary of HHS determined that there 
is a significant potential for a public health emergency that has a 
significant potential to affect national security or the health and 
security of U.S. citizens living abroad and that involves EV-D68. Also 
on February 6, 2015, 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 EV-D68, subject to the terms of any 
authorization issued under section 564 of the FD&C Act. Notice of the 
determination and declaration of the Secretary was published in the 
Federal Register on February 27, 2015 (80 FR 10685). On April 24, 2015, 
CDC requested, and on May 12, 2015, FDA issued, an EUA for the CDC EV-
D68 2014 Real-time RT-PCR Assay, subject to the terms of the 
Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the 
Authorization are available on the Internet at http://www.regulations.gov.

IV. The Authorization

    Having concluded that the criteria for issuance of the 
Authorization 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 EV-D68 strains detected in North America 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:
BILLING CODE 4164-01-P

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    Dated: June 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16125 Filed 6-30-15; 8:45 am]
BILLING CODE 4164-01-C

Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices 37625 TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Activity resulting from Section 510(p) of Number of record- Number of records Total annual Average burden Total hours the FD&C Act as amended by FDAAA keepers per recordkeeper records per recordkeeping One-time preparation of SOP ................ 1,000 1 1,000 40 40,000 SOP maintenance .................................. 3,295 1 3,295 1 3,295 Total ................................................ 43,295 1 There are no capital costs or operating and maintenance costs associated with the collection of information. Dated: June 25, 2015. DATES: The Authorization is effective as Homeland Security that there is a Leslie Kux, of May 12, 2015. domestic emergency, or a significant Associate Commissioner for Policy. ADDRESSES: Submit written requests for potential for a domestic emergency, [FR Doc. 2015–16129 Filed 6–30–15; 8:45 am] single copies of the EUA to the Office involving a heightened risk of attack BILLING CODE 4164–01–P of Counterterrorism and Emerging with a biological, chemical, radiological, Threats, Food and Drug Administration, or nuclear agent or agents; (2) a 10903 New Hampshire Ave., Bldg. 1, determination by the Secretary of DEPARTMENT OF HEALTH AND Rm. 4338, Silver Spring, MD 20993– Defense that there is a military HUMAN SERVICES 0002. Send one self-addressed adhesive emergency, or a significant potential for label to assist that office in processing a military emergency, involving a Food and Drug Administration your request or include a fax number to heightened risk to U.S. military forces of which the Authorization may be sent. attack with a biological, chemical, [Docket No. FDA–2015–N–2044] See the SUPPLEMENTARY INFORMATION radiological, or nuclear agent or agents; section for electronic access to the (3) a determination by the Secretary of Authorization of Emergency Use of an Authorization. HHS that there is a public health In Vitro Diagnostic Device for emergency, or a significant potential for FOR FURTHER INFORMATION CONTACT: a public health emergency, that affects, Detection of Enterovirus D68; Availability Carmen Maher, Acting Assistant or has a significant potential to affect, Commissioner for Counterterrorism national security or the health and AGENCY: Food and Drug Administration, Policy and Acting Director, Office of security of U.S. citizens living abroad, HHS. Counterterrorism and Emerging Threats, and that involves a biological, chemical, ACTION: Notice. Food and Drug Administration, 10903 radiological, or nuclear agent or agents, New Hampshire Ave., Bldg. 1, Rm. or a disease or condition that may be SUMMARY: The Food and Drug 4347, Silver Spring, MD 20993–0002, attributable to such agent or agents; or Administration (FDA) is announcing the 301–796–8510. (4) the identification of a material threat issuance of an Emergency Use SUPPLEMENTARY INFORMATION: by the Secretary of Homeland Security Authorization (EUA) (the Authorization) under section 319F–2 of the Public for in an vitro diagnostic device for I. Background Health Service (PHS) Act (42 U.S.C. detection of Enterovirus D68 (EV–D68) Section 564 of the FD&C Act (21 247d–6b) sufficient to affect national strains detected in North America in U.S.C. 360bbb–3) as amended by the security or the health and security of 2014. FDA issued this Authorization Project BioShield Act of 2004 (Pub. L. U.S. citizens living abroad. under the Federal Food, Drug, and 108–276) and the Pandemic and All- Once the Secretary of HHS has Cosmetic Act (the FD&C Act), as Hazards Preparedness Reauthorization declared that circumstances exist requested by the Centers for Disease Act of 2013 (Pub. L. 113–5) allows FDA justifying an authorization under Control and Prevention (CDC). The to strengthen the public health section 564 of the FD&C Act, FDA may Authorization contains, among other protections against biological, chemical, authorize the emergency use of a drug, things, conditions on the emergency use nuclear, and radiological agents. Among device, or biological product if the of the authorized in vitro diagnostic other things, section 564 of the FD&C Agency concludes that the statutory device. The Authorization follows the Act allows FDA to authorize the use of criteria are satisfied. Under section February 6, 2015, determination by the an unapproved medical product or an 564(h)(1) of the FD&C Act, FDA is Department of Health and Human unapproved use of an approved medical required to publish in the Federal Services (HHS) Secretary that there is a product in certain situations. With this Register a notice of each authorization, significant potential for a public health EUA authority, FDA can help assure and each termination or revocation of an emergency that has a significant that medical countermeasures may be authorization, and an explanation of the potential to affect national security or used in emergencies to diagnose, treat, reasons for the action. Section 564 of the the health and security of U.S. citizens or prevent serious or life-threatening FD&C Act permits FDA to authorize the living abroad and that involves EV–D68. diseases or conditions caused by introduction into interstate commerce of On the basis of such determination, the biological, chemical, nuclear, or a drug, device, or biological product Secretary of HHS also declared on radiological agents when there are no intended for use when the Secretary of February 6, 2015, that circumstances adequate, approved, and available HHS has declared that circumstances exist justifying the authorization of alternatives. exist justifying the authorization of tkelley on DSK3SPTVN1PROD with NOTICES emergency use of in vitro diagnostic Section 564(b)(1) of the FD&C Act emergency use. Products appropriate for devices for detection of EV–D68 subject provides that, before an EUA may be emergency use may include products to the terms of any authorization issued issued, the Secretary of HHS must and uses that are not approved, cleared, under the FD&C Act. The Authorization, declare that circumstances exist or licensed under sections 505, 510(k), which includes an explanation of the justifying the authorization based on or 515 of the FD&C Act (21 U.S.C. 355, reasons for issuance, is reprinted in this one of the following grounds: (1) A 360(k), and 360e) or section 351 of the document. determination by the Secretary of PHS Act (42 U.S.C. 262). VerDate Sep<11>2014 18:30 Jun 30, 2015 Jkt 235001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\01JYN1.SGM 01JYN1

37626 Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices FDA may issue an EUA only if, after into consideration the material threat vitro diagnostics for detection of EV– consultation with the HHS Assistant posed by the agent or agents identified D68, subject to the terms of any Secretary for Preparedness and in a declaration under section authorization issued under section 564 Response, the Director of the National 564(b)(1)(D) of the FD&C Act, if of the FD&C Act. Notice of the Institutes of Health, and the Director of applicable; (3) that there is no adequate, determination and declaration of the CDC (to the extent feasible and approved, and available alternative to Secretary was published in the Federal appropriate given the applicable the product for diagnosing, preventing, Register on February 27, 2015 (80 FR circumstances), FDA 1 concludes: (1) or treating such disease or condition; 10685). On April 24, 2015, CDC That an agent referred to in a and (4) that such other criteria as may requested, and on May 12, 2015, FDA declaration of emergency or threat can be prescribed by regulation are satisfied. issued, an EUA for the CDC EV–D68 cause a serious or life-threatening No other criteria for issuance have 2014 Real-time RT–PCR Assay, subject disease or condition; (2) that, based on been prescribed by regulation under to the terms of the Authorization. the totality of scientific evidence section 564(c)(4) of the FD&C Act. available to FDA, including data from Because the statute is self-executing, III. Electronic Access adequate and well-controlled clinical regulations or guidance are not required An electronic version of this trials, if available, it is reasonable to for FDA to implement the EUA document and the full text of the believe that: (A) The product may be authority. Authorization are available on the effective in diagnosing, treating, or II. EUA Request for an In Vitro Internet at http://www.regulations.gov. preventing (i) such disease or condition; Diagnostic Device for Detection of or (ii) a serious or life-threatening IV. The Authorization EV–D68 disease or condition caused by a Having concluded that the criteria for product authorized under section 564, On February 6, 2015, under section 564(b)(1)(C) of the FD&C Act (21 U.S.C. issuance of the Authorization under approved or cleared under the FD&C section 564(c) of the FD&C Act are met, Act, or licensed under section 351 of the 360bbb–3(b)(1)(C)), the Secretary of HHS determined that there is a FDA has authorized the emergency use PHS Act, for diagnosing, treating, or of an in vitro diagnostic device for preventing such a disease or condition significant potential for a public health emergency that has a significant detection of EV–D68 strains detected in caused by such an agent; and (B) the North America in 2014 subject to the known and potential benefits of the potential to affect national security or the health and security of U.S. citizens terms of the Authorization. The product, when used to diagnose, Authorization in its entirety (not prevent, or treat such disease or living abroad and that involves EV–D68. Also on February 6, 2015, under section including the authorized versions of the condition, outweigh the known and fact sheets and other written materials) potential risks of the product, taking 564(b)(1) of the FD&C Act and on the basis of such determination, the follows and provides an explanation of 1 The Secretary of HHS has delegated the Secretary of HHS declared that the reasons for its issuance, as required authority to issue an EUA under section 564 of the circumstances exist justifying the by section 564(h)(1) of the FD&C Act: FD&C Act to the Commissioner of Food and Drugs. authorization of emergency use of in BILLING CODE 4164–01–P tkelley on DSK3SPTVN1PROD with NOTICES VerDate Sep<11>2014 18:30 Jun 30, 2015 Jkt 235001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\01JYN1.SGM 01JYN1

Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices 37627 DEPARTMENT OF HEALTH Prevention tkelley on DSK3SPTVN1PROD with NOTICES EN01JY15.005</GPH> VerDate Sep<11>2014 18:30 Jun 30, 2015 Jkt 235001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4725 E:\FR\FM\01JYN1.SGM 01JYN1

37628 Federal Register/Vol. 80, No. 126 /Wednesday, July 1, 2015 /Notices Page 2 —Dr. Frieden, Centers for Disease Control and Prevention 1. Criteria for Issuance of Authorization I have concluded that the emergency use of the EV—D68 2014 rRT—PCR for the in vitro qualitative detection of EV—D68 strains detected in North America in 2014 in the specified population meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have coneluded that: 1. EV—D68 can cause EV—D68 infection, a serious or life—threatening disease or condition to humans infected with this virus; 2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the EV—D68 2014 rRT—PCR, when used with the specified instruments, may be effective in diagnosing EV—D6§ infection, and that the known and potential benefits of the EV—D6§8 2014 rRT—PCR for diagnosing EV—D68 infection outweigh the known and potential risks of such product; and 3. Thereis no adequate, approved, and available alternative to the emergency use of the EV— D68 2014 rRT—PCR for diagnosing EV—D6§ infection." IT,. Scope of Authorization 1 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 EV—D68 2014 rRT—PCR by qualified laboratories designated by CDC for the in vitro qualitative detection of EV—D68 strains detected in North America in 2014 in individuals with signs and symptoms of EV—D68 infection and/or epidemiclogic risk factors. The Authorized Enterovirus D68 2014 Real—time RT—PCR Assay The EV—D68 2014 rRT—PCR is a real—time reverse transcriptase PCR (rRT—PCR) for the fn vitro qualitative detection of EV—D68 strains detected in North America in 2014 in upper respiratory specimens (such as NP swabs, OP swabs, dual NP/OP swabs, and/or nasal washes), sera in conjunction with patient—matched upper respiratory specimen(s), and other authorized specimen types from individuals with signs and symptoms of EV—D68 infection and/or epidemiologic risk factors. The test procedure consists of nuclei¢ acid extraction using the QlAamp Viral RNA Mini Kit, Ql¥Aamp DSP Viral RNA Mim Kit, bioMérieux easyMAG, or other authorized extraction methods, followed by rRT—PCR on Applied Biosystems PCR instrument systems (i.e., AB 7500, AB 7500 Fast, and AB 7500 Fast Dx Real—Time PCR Systems with SDS software) or other authorized instruments. The EV—D68 2014 rRT—PCR is based on one—step real—time reverse transcription polymerase chain reaction. The Assay employs one primer and probe set (VP1.2014) that targets the viral protein 1 (VP1) gene of the EV—D68 genome, and one primer and probe set.(RP) that targets the human RNase P gene. * No other criteria ofissuance have been prescribed by regulation under section 564(0)(4) of the Act.

u& wz & Page 3 —Dr. Frieden, Centers for Disease Control and Prevention The EV—D68 2014 rRT—PCR uses the following primer/‘probe sets: VP1.2014+ targets the EV—D68 viral protein 1 {(VPI) gene RP"*: targets the human Ribonuclease P gene. This primer and probe set is included as a control for specimen quality, to confirm that human nucleic acid was successfully extracted from the clinical specimen. The EV—D68 2014 RT—PCHR includes the following assay controls: 1. EV—D68 2014 tRT—PCER Positive Control is comprised of synthetic, in vitro transcribed single—stranded, positive—sense RNA transcript. 2. RNase P Primer and Probe Set is run on all clinical specimens tested with the EV—D68 2014 rRT—PCR as a measure of the presence and quality of nucleic acid resulting from extraction of the clinical specimens. The above—described EV—D68 2014 rRT—PCR, when labeled consistently with the labeling authorized by FDA entifled "Enterovirus D68 2014 Real—time RT—PCR Assay Instructions for Use" {available at hitpIwww.fda. gov/MedicalDevices/Safety/EmergencySituations/uem 161 496.htm), which may be revised by CDC in consultation with FDA, is authorized to be distributed to, and used by, qualified laboratories designated by CDC under this EUA, despite the faet that it does not meet certain requirements otherwise required by federal law. The above described EV—D68 2014 tRT—PCR is authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be made available to health care providers and patients: a Fact Sheet for Health Care Providers: Interpreting CDC‘s Enterovirus D68 2014 Real—time RT—PCR Assay (EV—D68 2014 rRT—PCR) Results +« Fact Sheet for Patients: Understanding Results from the Enterovirus D68 2014 Real—time RT— PCR Assay (EV—D6§ 2014 rRT—PCR) As described in section IV below, CDC and any authorized distributor(s) are also authorized to make available additional information relating to the emergency use of the authorized EV—D68 2014 rRT—PCR that is consistent with, and does not exceed, the terms ofthis letfter of authorization. I have concluded, pursuant to section 564(d)(2) of the Act; that it is reasonable to belfeve that the known and potential benefits of the authorized EV—D68 2014 rRT—PCR in the specified populathon, when used for the in vitro qualitative detection of EV—D68 strains detected in North America in 2014, outweigh the known and potential risks of such a product. 1 bave 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 EV—D68 2014 rRT—

37630 Federal Register/Vol. 80, No. 126 /Wednesday, July 1, 2015 /Notices Page 4A —Dr. Frieden, Centers for Disease Control and Prevention PCR may be effective in the diagnosis of EV—D68 infection pursuant to section 564(c)(2){(A) of the 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 EV—D68 2014 rRT—PCR, when used to diagnose EV—D68 infection in the specified population, meets the criteria set forth in section 564(c) ofthe Act concerning safety and potential effectiveness. The emergency use of the authorized EV—D68 2014 rRT—PCR under this EUA must be consistent with, and may not ex¢eed, the terms of this letter, including the Seope of Authorization (section 1) and the Conditions of Authorization (section IV). Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS‘s determination described above and the Secretary of HHS‘s —corresponding declaration under section 564(b){1), the EV—D68 2014 rRT— PCR described above is authorized to diagnose EV—D68 infection in individuals with signs and symptoms of EV—D68 infection and/or epidemiologic risk factors. This EUA will cease to beseffective when the HHS declaration that ctreumstances exist to fustify the EUA is terminated under section 564(b)(2) of the Act—or when the EUA is revoked under section 564(g) of the Act. 111. Waiver of Certain Requirements I am waiving the following requirements for the EV—D68 2014 rRT—PCR during the duration of this EUA: «_ Currentgood 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 EV—D68 2014—rRT—PCR. » 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 §09.10(a)(4), and any available information regarding performance of the device; including requirements under 21 CFR 809.10(b)(12). ITIV. Conditions of Authorization Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization: CDC and Any Authorized Distributor(s) A. CDC and any authorized distributor(s) will distribute the authorized EV—D68 2014 rRT— PCR with the authorized labeling, as may be revised only by CDC in consultation with FDA, to qualified laboratories designated by CDC.

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37632 Federal Register/Vol. 80, No. 126 /Wednesday, July 1, 2015 /Notices Page 6 —Dr. Frieden, Centers for Disease Control and Prevention M. CDBC may request the addition of other extraction methods for use with the authorized EV—D68 2014 rRT—PCR, Suchrequests will be made by CDC in consultation with, and require concurrence of, FDA. N. CDC may request the addition of other real—time PCR instruments for use with the authorized EV—D658 2014 rRT—PCR. Such requests will be made by CDC in consultation with, and require concurrence of, FDA. 0. CDC will track adverse events and report to FDA under 21 CFR part 803. Qualified Laboratories Designated by CDC P. Qualified laboratories designated by CDC will include with reports of the results of the EV—D68 2014 rRT—PCR 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, . Qualified laboratories designated by CDC. will have a process in place for reporting test results to health care professionals and relevant public health authorities, as appropriate. R. Qualified laboratories designated by CDC will collect information on the performance of the assay, and report to CDC and any authorized distributor(s) any suspected occurrence of false positive or false negative results of which they become aware. S, All laboratory personnel using the assay will be appropriately trained on the use ofthe EV—D68 2014 rRT—PCR on the specified Applied Biosystems PCR instrument systems or other authorized instruments, and use appropriate laboratory and personal protective equipment when handling this test. CDC, Any Authorized Distributors, and Qualified Laboratories Designated by CDC T. CDC, any authorized distributor(s), and qualified laboratories designated by. CDC 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 U. All advertising and promotional descriptive printed matter relating to the use of the authorized EV—D68 2014 rRT—PCR 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. ¥. All advertising and promotional descriptive printed matter relating to the use of the authorized EV—D68 2014 rRT—PCR shall clearly and conspicuously state that: e This test has not been FDA cleared or approved;

Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices 37633 Dated: June 25, 2015. availability of the guidance entitled information on electronic access to the Leslie Kux, ‘‘Intent to Exempt Certain Unclassified, guidance. Submit written requests for a Associate Commissioner for Policy. Class II, and Class I Reserved Medical single hard copy of the guidance [FR Doc. 2015–16125 Filed 6–30–15; 8:45 am] Devices from Premarket Notification document entitled ‘‘Intent to Exempt BILLING CODE 4164–01–C Requirements.’’ This guidance describes Certain Unclassified, Class II, and Class FDA’s intent to exempt certain I Reserved Medical Devices from unclassified medical devices (that FDA Premarket Notification Requirements’’ DEPARTMENT OF HEALTH AND intends to classify into class I or II), to the Office of the Center Director, HUMAN SERVICES certain class II medical devices, and Guidance and Policy Development, certain class I medical devices from Center for Devices and Radiological Food and Drug Administration premarket notification requirements. Health, Food and Drug Administration, [Docket No. FDA–2014–D–0967] FDA believes the devices identified in 10903 New Hampshire Ave., Bldg. 66, this guidance document are sufficiently Rm. 5431, Silver Spring, MD 20993– Intent to Exempt Certain Unclassified, well understood and do not require 0002. Send one self-addressed adhesive Class II, and Class I Reserved Medical premarket notification to assure their label to assist that office in processing Devices From Premarket Notification safety and effectiveness. your request. Requirements; Guidance for Industry DATES: Submit either electronic or Submit electronic comments on the and Food and Drug Administration written comments on this guidance at guidance to http://www.regulations.gov. Staff; Availability any time. General comments on Agency tkelley on DSK3SPTVN1PROD with NOTICES Submit written comments to the AGENCY: Food and Drug Administration, guidance documents are welcome at any Division of Dockets Management (HFA– HHS. time. 305), Food and Drug Administration, ACTION: Notice. ADDRESSES: An electronic copy of the 5630 Fishers Lane, Rm. 1061, Rockville, guidance document is available for MD 20852. Identify comments with the SUMMARY: The Food and Drug download from the Internet. See the docket number found in brackets in the Administration (FDA) is announcing the SUPPLEMENTARY INFORMATION section for heading of this document. EN01JY15.011</GPH> VerDate Sep<11>2014 18:30 Jun 30, 2015 Jkt 235001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\01JYN1.SGM 01JYN1


Document Created: 2015-12-15 13:19:13
Document Modified: 2015-12-15 13:19:13
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 May 12, 2015.
ContactCarmen Maher, Acting Assistant Commissioner for Counterterrorism Policy and Acting Director, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993- 0002, 301-796-8510.
FR Citation80 FR 37625 
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