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)

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, Number 126 (Wednesday, July 1, 2015)]
[Notices]
[Pages 37625-37633]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16125]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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

[[Page 37627]]

[GRAPHIC] [TIFF OMITTED] TN01JY15.005


[[Page 37628]]


[GRAPHIC] [TIFF OMITTED] TN01JY15.006


[[Page 37629]]


[GRAPHIC] [TIFF OMITTED] TN01JY15.007


[[Page 37630]]


[GRAPHIC] [TIFF OMITTED] TN01JY15.008


[[Page 37631]]


[GRAPHIC] [TIFF OMITTED] TN01JY15.009


[[Page 37632]]


[GRAPHIC] [TIFF OMITTED] TN01JY15.010


[[Page 37633]]


[GRAPHIC] [TIFF OMITTED] TN01JY15.011


    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