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)

Page Range		10878-10879
FR Document		2016-04624

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 Issue 41 (Wednesday, March 2, 2016)

[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]


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

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.

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

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\
---------------------------------------------------------------------------

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

    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

10878 Federal Register / Vol. 81, No. 41 / Wednesday, March 2, 2016 / Notices

September 18, 2014, authority was given on the Advisory Council Web site at emergency use of in vitro diagnostic
to the Secretary of Health and Human http://www.hhs.gov/ash/carb when it tests for detection of Zika virus and/or
Services to establish the Presidential has been finalized. diagnosis of Zika virus infection
Advisory Council on Combating Public attendance at the meeting is pursuant to section 564 of the FD&C
Antibiotic-Resistant Bacteria (Advisory limited to the available space. Act, subject to the terms of any
Council), in consultation with the Individuals who plan to attend and authorization issued under that section.
Secretaries of Defense (DoD) and need special assistance, such as sign DATES: The determination and
Agriculture (USDA). Activities of the language interpretation or other declaration are effective February 26,
Advisory Council are governed by the reasonable accommodations, should 2016.
provisions of Public Law 92–463, as notify the Advisory Council at the
amended (5 U.S.C. App.), which sets address/telephone number listed above FOR FURTHER INFORMATION CONTACT:
forth standards for the formation and at least one week prior to the meeting. Nicole Lurie, M.D., MSPH, Assistant
use of federal advisory committees. For those unable to attend in person, a Secretary for Preparedness and
The Advisory Council will provide live webcast will be available. More Response, Office of the Secretary,
advice, information, and information on registration and Department of Health and Human
recommendations to the Secretary of accessing the webcast can be found at Services, 200 Independence Avenue
HHS regarding programs and policies http://www.hhs.gov/ash/carb/. SW., Washington, DC 20201, Telephone
intended to support and evaluate the Members of the public will have the (202) 205–2882 (this is not a toll free
implementation of Executive Order opportunity to provide comments prior number).
13676, including the National Strategy to the Advisory Council meeting by SUPPLEMENTARY INFORMATION:
for Combating Antibiotic-Resistant emailing CARB@hhs.gov. Public
Bacteria (Strategy) and the National comments should be sent in by I. Background
Action Plan for Combating Antibiotic- midnight March 21, 2016, and should be Under Section 564 of the FD&C Act,
Resistant Bacteria (Action Plan). The limited to no more than one page. All the Commissioner of the Food and Drug
Advisory Council shall function solely public comments received prior to Administration (FDA), acting under
for advisory purposes. March 21, 2016, will be provided to delegated authority from the Secretary
In carrying out its mission, the Advisory Council members and read of HHS, may issue an Emergency Use
Advisory Council will provide advice, during the public comment period Authorization (EUA) authorizing (1) the
information, and recommendations to designated on the agenda; comments are emergency use of an unapproved drug,
the Secretary regarding programs and limited to two minutes per speaker. an unapproved or uncleared device, or
policies intended to preserve the
Dated: February 25, 2016. an unlicensed biological product; or (2)
effectiveness of antibiotics by
optimizing their use; advance research Bruce Gellin, an unapproved use of an approved drug,
to develop improved methods for Designated Federal Officer, Presidential approved or cleared device, or licensed
combating antibiotic resistance and Advisory Council on Combating Antibiotic- biological product. Before an EUA may
conducting antibiotic stewardship; Resistant Bacteria, Deputy Assistant Secretary be issued, the Secretary of HHS must
strengthen surveillance of antibiotic- for Health. declare that circumstances exist
resistant bacterial infections; prevent [FR Doc. 2016–04473 Filed 3–1–16; 8:45 am] justifying the authorization based on
the transmission of antibiotic-resistant BILLING CODE 4150–44–P one of four determinations: (1) A
bacterial infections; advance the determination by the Secretary of
development of rapid point-of-care and Homeland Security that there is a
agricultural diagnostics; further research DEPARTMENT OF HEALTH AND domestic emergency, or a significant
on new treatments for bacterial HUMAN SERVICES potential for a domestic emergency,
infections; develop alternatives to involving a heightened risk of attack
Determination and Declaration with a chemical, biological, radiological,
antibiotics for agricultural purposes;
Regarding Emergency Use of in Vitro or nuclear (CBRN) agent or agents; (2)
maximize the dissemination of up-to-
Diagnostic Tests for Detection of Zika the identification of a material threat by
date information on the appropriate and
Virus and/or Diagnosis of Zika Virus the Secretary of Homeland Security
proper use of antibiotics to the general
Infection pursuant to section 319F–2 of the Public
public and human and animal
healthcare providers; and improve AGENCY: Office of the Secretary, Health Service (PHS) Act 1 sufficient to
international coordination of efforts to Department of Health and Human affect national security or the health and
combat antibiotic resistance. Services. security of United States citizens living
The March public meeting will be abroad; (3) a determination by the
ACTION: Notice.
dedicated to presentations by the five Secretary of Defense that there is a
currently active working groups of the SUMMARY: The Secretary of Health and military emergency, or a significant
Advisory Council, which are: Antibiotic Human Services (HHS) is issuing this potential for a military emergency,
Stewardship; One Health Surveillance; notice pursuant to section 564 of the involving a heightened risk to United
Diagnostic Innovations; Treatment, Federal Food, Drug, and Cosmetic States military forces of attack with a
Prevention and Control Research and (FD&C) Act, 21 U.S.C. 360bbb–3. On CBRN agent or agents; or (4) a
Development; and International February 26, 2016, the Secretary determination by the Secretary of HHS
Collaboration on Combating Antibiotic- determined that there is a significant that there is a public health emergency,
or a significant potential for a public
mstockstill on DSK4VPTVN1PROD with NOTICES

Resistant Bacteria (CARB). The potential for a public health emergency
Advisory Council will deliberate and that has a significant potential to affect health emergency, that affects, or has a
vote on the working groups’ findings national security or the health and significant potential to affect, national
and recommendations. In addition, the security of United States citizens living security or the health and security of
Advisory Council will be presented abroad and that involves Zika virus. United States citizens living abroad, and
with a new task(s) from the Secretary of On the basis of this determination, that involves a CBRN agent or agents, or
HHS, in consultation with USDA and she also declared that circumstances
DoD. The meeting agenda will be posted exist justifying the authorization of 1 42 U.S.C. 247d–6b.

VerDate Sep<11>2014 19:10 Mar 01, 2016 Jkt 238001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\02MRN1.SGM 02MRN1

Federal Register / Vol. 81, No. 41 / Wednesday, March 2, 2016 / Notices 10879

a disease or condition that may be II. Determination by the Secretary of receive any personally identifying
attributable to such agent or agents.2 Health and Human Services information. As part of its core mission,
Based on any of these four On February 26, 2016, pursuant to DHS is tasked with preventing terrorism
determinations, the Secretary of HHS section 564 of the FD&C Act, I and enhancing security, securing and
may then declare that circumstances determined that a there is a significant managing our borders, and ensuring
potential for a public health emergency resilience to disasters. In order to assist
exist that justify the EUA, at which
that has a significant potential to affect in those key mission spaces, the S&T
point the FDA Commissioner may issue
national security or the health and managed work to create a Rapid DNA
an EUA if the criteria for issuance of an Technology that allows field testing of
authorization under section 564 of the security of United States citizens living
abroad and that involves Zika virus. DNA that is inexpensive and quick
FD&C Act are met. The Centers for while performing with high accuracy in
Disease Control and Prevention (CDC) III. Declaration of the Secretary of a non-laboratory setting. To ensure the
requested that the FDA issue an EUA for Health and Human Services effective implementation and diffusion
in vitro diagnostic tests for detection of Also on February 26, 2016, on the of this new technology, DHS S&T seeks
Zika virus and/or diagnosis of Zika basis of my determination of a to better understand public perceptions
virus infection to allow the Department significant potential for a public health of Rapid DNA, its use cases, and its
to take preparedness measures based on emergency that has a significant collection through the TAE Survey. This
information currently available about potential to affect national security or notice and request for comments is
the active transmission of Zika virus, as the health and security of United States required by the Paperwork Reduction
of February 24, 2016, in the citizens living abroad and that involves Act of 1995 (Pub. L. 104–13, 44 U.S.C.
Commonwealth of Puerto Rico, the U.S. Zika virus, I declared that circumstances chapter 35).
Virgin Islands, American Samoa, 31 exist justifying the authorization of DATES: Comments are encouraged and
countries in the Americas, Pacific emergency use of in vitro diagnostic will be accepted until May 2, 2016.
Islands, and Africa. On February 1, tests for detection of Zika virus and/or ADDRESSES: Interested persons are
2016, the World Health Organization diagnosis of Zika virus infection invited to submit comments, identified
declared a Public Health Emergency of pursuant to section 564 of the FD&C by docket number DHS–2016–0019, by
International Concern because of Act, subject to the terms of any one of the following methods:
clusters of microcephaly and other authorization issued under that section. • Federal eRulemaking Portal: http://
neurological disorders in some areas Notice of any EUAs issued by the www.regulations.gov. Please follow the
affected by Zika virus. On January 22, FDA Commissioner pursuant to this instructions for submitting comments.
2016, CDC activated its Incident determination and declaration will be • Email:
Management System and, working provided promptly in the Federal Kathleen.Deloughery@hq.dhs.gov.
through the Emergency Operations Register as required under section 564 Please include docket number DHS–
Center, centralized its response to the of the FD&C Act. DHS–2016–0019 in the subject line of
outbreaks of Zika occurring in the Dated: February 26, 2016. the message.
Americas and increased reports of birth Sylvia M. Burwell, • Fax: (202) 254–6911. (Not a toll-free
defects and Guillain-Barré syndrome in Secretary. number).
areas affected by Zika virus. On • Mail: Science and Technology
[FR Doc. 2016–04624 Filed 3–1–16; 8:45 am]
February 8, 2016, CDC elevated its Directorate, ATTN: Kathleen
BILLING CODE 4150–37–P
Deloughery 6–055, 245 Murray Lane,
response efforts to a Level 1 activation,
Mail Stop 0210, Washington, DC 20528–
the highest response level. The
0210.
Secretary’s Operations Center, which is DEPARTMENT OF HOMELAND
FOR FURTHER INFORMATION CONTACT: DHS
operated by the Office of the Assistant SECURITY
Secretary of Preparedness and FRCoP Contact Kathleen Deloughery
[Docket No. DHS–DHS–2016–0019] (202) 254–6189 (Not a toll free number).
Response, is also activated. The
determination of a significant potential SUPPLEMENTARY INFORMATION: The
Agency Information Collection
for a public health emergency, and the Department is committed to improving
Activities: Submission for Review;
declaration that circumstances exist its information collection and urges all
Information Collection Request for the
justifying the authorization of interested parties to suggest how these
Department of Homeland Security
materials can further reduce burden
emergency use of in vitro diagnostic Science & Technology Technology
while seeking necessary information
tests for detection of Zika virus and/or Acceptance and Evaluation Survey
under the Act.
diagnosis of Zika virus infection by the DHS is particularly interested in
AGENCY: Science and Technology
Secretary of HHS, as described below, comments that:
Directorate, DHS.
enable the FDA Commissioner to issue (1) Evaluate whether the proposed
ACTION: 60-Day notice and request for
an EUA for certain diagnostic tests for collection of information is necessary
comment.
emergency use under section 564 of the for the proper performance of the
FD&C Act. SUMMARY: The Department of Homeland functions of the agency, including
Security (DHS) invites the general whether the information will have
2 As amended by the Pandemic and All-Hazards public to comment on the data practical utility;
Preparedness Reauthorization Act, Public Law 113–
mstockstill on DSK4VPTVN1PROD with NOTICES

collection form for the DHS Science & (2) Evaluate the accuracy of the
5, the Secretary may make determination of a public
health emergency, or a significant potential for a
Technology Directorate (S&T) agency’s estimate of the burden of the
public health emergency, under section 564 of the Technology Acceptance and Evaluation proposed collection of information,
FD&C Act. The Secretary is no longer required to (TAE) Survey. The TAE web based tool including the validity of the
make a determination of a public health emergency proposes to collect information from methodology and assumptions used;
in accordance with section 319 of the PHS Act, 42
U.S.C. 247d to support a determination or
1,200 members of an online Internet (3) Suggest ways to enhance the
declaration made under section 564 of the FD&C panel. All information collected will be quality, utility, and clarity of the
Act. on a voluntary basis. DHS will not information to be collected; and

VerDate Sep<11>2014 19:10 Mar 01, 2016 Jkt 238001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\02MRN1.SGM 02MRN1

Document Created: 2018-02-02 15:04:28
Document Modified: 2018-02-02 15:04:28

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The determination and declaration are effective February 26, 2016.
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).
FR Citation		81 FR 10878