81 FR 10878 - Determination and Declaration Regarding Emergency Use of in Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 41 (March 2, 2016)

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3. On February 26, 2016, the Secretary 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 United States citizens living abroad and that involves Zika virus. On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.

[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Pages 10878-10879]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-04624]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Determination and Declaration Regarding Emergency Use of in Vitro 
Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika 
Virus Infection

AGENCY: Office of the Secretary, Department of Health and Human 
Services.

ACTION: Notice.

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SUMMARY: The Secretary of Health and Human Services (HHS) is issuing 
this notice pursuant to section 564 of the Federal Food, Drug, and 
Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3. On February 26, 2016, the 
Secretary 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 United States citizens living 
abroad and that involves Zika virus.
    On the basis of this determination, she also declared that 
circumstances exist justifying the authorization of emergency use of in 
vitro diagnostic tests for detection of Zika virus and/or diagnosis of 
Zika virus infection pursuant to section 564 of the FD&C Act, subject 
to the terms of any authorization issued under that section.

DATES: The determination and declaration are effective February 26, 
2016.

FOR FURTHER INFORMATION CONTACT: Nicole Lurie, M.D., MSPH, Assistant 
Secretary for Preparedness and Response, Office of the Secretary, 
Department of Health and Human Services, 200 Independence Avenue SW., 
Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll free 
number).

SUPPLEMENTARY INFORMATION:

I. Background

    Under Section 564 of the FD&C Act, the Commissioner of the Food and 
Drug Administration (FDA), acting under delegated authority from the 
Secretary of HHS, may issue an Emergency Use Authorization (EUA) 
authorizing (1) the emergency use of an unapproved drug, an unapproved 
or uncleared device, or an unlicensed biological product; or (2) an 
unapproved use of an approved drug, approved or cleared device, or 
licensed biological product. Before an EUA may be issued, the Secretary 
of HHS must declare that circumstances exist justifying the 
authorization based on one of four determinations: (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 chemical, biological, 
radiological, or nuclear (CBRN) agent or agents; (2) the identification 
of a material threat by the Secretary of Homeland Security pursuant to 
section 319F-2 of the Public Health Service (PHS) Act \1\ sufficient to 
affect national security or the health and security of United States 
citizens living abroad; (3) a determination by the Secretary of Defense 
that there is a military emergency, or a significant potential for a 
military emergency, involving a heightened risk to United States 
military forces of attack with a CBRN agent or agents; or (4) 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 United States citizens living 
abroad, and that involves a CBRN agent or agents, or

[[Page 10879]]

a disease or condition that may be attributable to such agent or 
agents.\2\
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    \1\ 42 U.S.C. 247d-6b.
    \2\ As amended by the Pandemic and All-Hazards Preparedness 
Reauthorization Act, Public Law 113-5, the Secretary may make 
determination of a public health emergency, or a significant 
potential for a public health emergency, under section 564 of the 
FD&C Act. The Secretary is no longer required to make a 
determination of a public health emergency in accordance with 
section 319 of the PHS Act, 42 U.S.C. 247d to support a 
determination or declaration made under section 564 of the FD&C Act.
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    Based on any of these four determinations, the Secretary of HHS may 
then declare that circumstances exist that justify the EUA, at which 
point the FDA Commissioner may issue an EUA if the criteria for 
issuance of an authorization under section 564 of the FD&C Act are met. 
The Centers for Disease Control and Prevention (CDC) requested that the 
FDA issue an EUA for in vitro diagnostic tests for detection of Zika 
virus and/or diagnosis of Zika virus infection to allow the Department 
to take preparedness measures based on information currently available 
about the active transmission of Zika virus, as of February 24, 2016, 
in the Commonwealth of Puerto Rico, the U.S. Virgin Islands, American 
Samoa, 31 countries in the Americas, Pacific Islands, and Africa. On 
February 1, 2016, the World Health Organization declared a Public 
Health Emergency of International Concern because of clusters of 
microcephaly and other neurological disorders in some areas affected by 
Zika virus. On January 22, 2016, CDC activated its Incident Management 
System and, working through the Emergency Operations Center, 
centralized its response to the outbreaks of Zika occurring in the 
Americas and increased reports of birth defects and Guillain-
Barr[eacute] syndrome in areas affected by Zika virus. On February 8, 
2016, CDC elevated its response efforts to a Level 1 activation, the 
highest response level. The Secretary's Operations Center, which is 
operated by the Office of the Assistant Secretary of Preparedness and 
Response, is also activated. The determination of a significant 
potential for a public health emergency, and the declaration that 
circumstances exist justifying the authorization of emergency use of in 
vitro diagnostic tests for detection of Zika virus and/or diagnosis of 
Zika virus infection by the Secretary of HHS, as described below, 
enable the FDA Commissioner to issue an EUA for certain diagnostic 
tests for emergency use under section 564 of the FD&C Act.

II. Determination by the Secretary of Health and Human Services

    On February 26, 2016, pursuant to section 564 of the FD&C Act, I 
determined that a 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 United States citizens living abroad and 
that involves Zika virus.

III. Declaration of the Secretary of Health and Human Services

    Also on February 26, 2016, on the basis of my determination of a 
significant potential for a public health emergency that has a 
significant potential to affect national security or the health and 
security of United States citizens living abroad and that involves Zika 
virus, I declared that circumstances exist justifying the authorization 
of emergency use of in vitro diagnostic tests for detection of Zika 
virus and/or diagnosis of Zika virus infection pursuant to section 564 
of the FD&C Act, subject to the terms of any authorization issued under 
that section.
    Notice of any EUAs issued by the FDA Commissioner pursuant to this 
determination and declaration will be provided promptly in the Federal 
Register as required under section 564 of the FD&C Act.

    Dated: February 26, 2016.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2016-04624 Filed 3-1-16; 8:45 am]
 BILLING CODE 4150-37-P