81 FR 44629 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 131 (July 8, 2016)

Page Range		44629-44639
FR Document		2016-16177

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 Zika virus in response to the Zika virus outbreak in the Americas. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Hologic, Inc. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) 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 Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, 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, 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 81 Issue 131 (Friday, July 8, 2016)

[Federal Register Volume 81, Number 131 (Friday, July 8, 2016)]
[Notices]
[Pages 44629-44639]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16177]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1486]


Authorization of Emergency Use of an In Vitro Diagnostic Device 
for Detection of Zika Virus; 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 an in vitro diagnostic device for detection of the Zika virus in 
response to the Zika virus outbreak in the Americas. FDA issued this 
Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act), as requested by Hologic, Inc. The Authorization contains, among 
other things, conditions on the emergency use of the authorized in 
vitro diagnostic device. The Authorization follows the February 26, 
2016, determination by the Secretary of Health and Human Services (HHS) 
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 
Zika virus. On the basis of such determination, the Secretary of HHS 
declared on February 26, 2016, 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, 
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 June 17, 2016.

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, 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 (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,

[[Page 44630]]

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). 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 Centers for Disease Control and 
Prevention (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 the 
Zika Virus

    On February 26, 2016, 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 Zika virus. 
On February 26, 2016, 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 diagnostic tests for detection of Zika virus and/or diagnosis of 
Zika virus infection, 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 
March 2, 2016 (81 FR 10878). On June 15, 2016, Hologic, Inc. requested, 
and on June 17, 2016, FDA issued, an EUA for the Aptima[supreg] Zika 
Virus 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 Zika virus 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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[[Page 44639]]


    Dated: July 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16177 Filed 7-7-16; 8:45 am]
 BILLING CODE 4164-01-C

Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices 44629

by industry and regulators alike to accommodations because of a disability, 0002. Send one self-addressed adhesive
enable a harmonized and smooth please contact Amanda Roache (see FOR label to assist that office in processing
implementation of Q3D on a global FURTHER INFORMATION CONTACT) at least 7 your request or include a fax number to
basis. days before the meeting. which the Authorization may be sent.
The U.S. regional workshop is Dated: July 1, 2016. See the SUPPLEMENTARY INFORMATION
intended to clarify key aspects of ICH section for electronic access to the
Leslie Kux,
Q3D: Guideline on Elemental Impurities Authorization.
by elaborating on those key topics. It Associate Commissioner for Policy.
[FR Doc. 2016–16152 Filed 7–7–16; 8:45 am] FOR FURTHER INFORMATION CONTACT:
will include: (1) A discussion of how to Carmen Maher, Office of
apply Q3D concepts to routes of BILLING CODE 4164–01–P
Counterterrorism and Emerging Threats,
administration, not addressed in Q3D, Food and Drug Administration, 10903
(2) justification for elemental impurity New Hampshire Ave., Bldg. 1, Rm.
levels higher than an established DEPARTMENT OF HEALTH AND
HUMAN SERVICES 4347, Silver Spring, MD 20993–0002,
permissible daily exposure (PDE) (3) 301–796–8510 (this is not a toll free
application of Q3D concepts to number).
determine safe levels of elements not Food and Drug Administration
included in Q3D, (4) discussion of the [Docket No. FDA–2016–N–1486] SUPPLEMENTARY INFORMATION:
rationale for limits on large volume I. Background
parenterals, (5) elaboration of the Authorization of Emergency Use of an
concepts outlined in the Q3D Sections In Vitro Diagnostic Device for Section 564 of the FD&C Act (21
on Risk Assessment and Control of Detection of Zika Virus; Availability U.S.C. 360bbb–3) as amended by the
Elemental Impurities and (6) options for Project BioShield Act of 2004 (Pub. L.
AGENCY: Food and Drug Administration, 108–276) and the Pandemic and All-
converting between PDEs and HHS.
concentrations. Hazards Preparedness Reauthorization
In addition, case studies may be ACTION: Notice. Act of 2013 (Pub. L. 113–5) allows FDA
presented to illustrate the concepts to strengthen the public health
SUMMARY: The Food and Drug protections against biological, chemical,
described previously, and frequently Administration (FDA) is announcing the
asked questions will be discussed. The nuclear, and radiological agents. Among
issuance of an Emergency Use other things, section 564 of the FD&C
presentation of the material will follow Authorization (EUA) (the Authorization)
the modules that are available on the Act allows FDA to authorize the use of
for an in vitro diagnostic device for an unapproved medical product or an
ICH Web site, www.ich.org, and will detection of the Zika virus in response
include time for questions and unapproved use of an approved medical
to the Zika virus outbreak in the product in certain situations. With this
discussion. Breakout sessions will be Americas. FDA issued this
provided to discuss key topics and EUA authority, FDA can help assure
Authorization under the Federal Food, that medical countermeasures may be
provide feedback to participants. Drug, and Cosmetic Act (the FD&C Act),
Material will be presented by members used in emergencies to diagnose, treat,
as requested by Hologic, Inc. The or prevent serious or life-threatening
of the ICH Q3D Implementation Authorization contains, among other
Working Group. The agenda for the diseases or conditions caused by
things, conditions on the emergency use biological, chemical, nuclear, or
workshop will be made available on the of the authorized in vitro diagnostic
internet at http://www.fda.gov/Drugs/ radiological agents when there are no
device. The Authorization follows the adequate, approved, and available
NewsEvents/ucm498553.htm.
February 26, 2016, determination by the alternatives.
Registration: If you wish to attend this
Secretary of Health and Human Services Section 564(b)(1) of the FD&C Act
meeting, visit the following Web site to
register: https://www.eventbrite.com/e/ (HHS) that there is a significant provides that, before an EUA may be
regional-public-workshop-on-ich-q3d- potential for a public health emergency issued, the Secretary of HHS must
implementation-of-guideline-for- that has a significant potential to affect declare that circumstances exist
elemental-impurities-tickets- national security or the health and justifying the authorization based on
25492458630. Please register by August security of U.S. citizens living abroad one of the following grounds: (1) A
15, 2016. If you are unable to attend the and that involves Zika virus. On the determination by the Secretary of
meeting in person, you can register to basis of such determination, the Homeland Security that there is a
view a live Webcast on the meeting. You Secretary of HHS declared on February domestic emergency, or a significant
will be asked to indicate in your 26, 2016, that circumstances exist potential for a domestic emergency,
registration if you plan to attend in justifying the authorization of involving a heightened risk of attack
person or via the Webcast. Your emergency use of in vitro diagnostic with a biological, chemical, radiological,
registration must also contain your tests for detection of Zika virus and/or or nuclear agent or agents; (2) a
complete contact information, including diagnosis of Zika virus infection, subject determination by the Secretary of
name, title, affiliation, address, email to the terms of any authorization issued Defense that there is a military
address, and phone number. under the FD&C Act. The Authorization, emergency, or a significant potential for
Registrations may be limited, so early which includes an explanation of the a military emergency, involving a
registration is recommended. reasons for issuance, is reprinted in this heightened risk to U.S. military forces of
Registration is free and will be on a first- document. attack with a biological, chemical,
asabaliauskas on DSK3SPTVN1PROD with NOTICES

come, first-served basis. However, the DATES: The Authorization is effective as radiological, or nuclear agent or agents;
number of participants from each of June 17, 2016. (3) a determination by the Secretary of
organization may be limited based on ADDRESSES: Submit written requests for HHS that there is a public health
space limitations. Registrants will single copies of the EUA to the Office emergency, or a significant potential for
receive confirmation once they have of Counterterrorism and Emerging a public health emergency, that affects,
been accepted. Onsite registration on Threats, Food and Drug Administration, or has a significant potential to affect,
the day of the meeting will be based on 10903 New Hampshire Ave., Bldg. 1, national security or the health and
space availability. If you need special Rm. 4338, Silver Spring, MD 20993– security of U.S. citizens living abroad,

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44630 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices

and that involves a biological, chemical, FDA 1 concludes: (1) That an agent significant potential for a public health
radiological, or nuclear agent or agents, referred to in a declaration of emergency emergency that has a significant
or a disease or condition that may be or threat can cause a serious or life- potential to affect national security or
attributable to such agent or agents; or threatening disease or condition; (2) the health and security of U.S. citizens
(4) the identification of a material threat that, based on the totality of scientific living abroad and that involves Zika
by the Secretary of Homeland Security evidence available to FDA, including virus. On February 26, 2016, under
under section 319F–2 of the Public data from adequate and well-controlled section 564(b)(1) of the FD&C Act, and
Health Service (PHS) Act (42 U.S.C. clinical trials, if available, it is on the basis of such determination, the
247d–6b) sufficient to affect national reasonable to believe that: (A) The Secretary of HHS declared that
product may be effective in diagnosing,
security or the health and security of circumstances exist justifying the
treating, or preventing (i) such disease
U.S. citizens living abroad. authorization of emergency use of in
or condition; or (ii) a serious or life-
Once the Secretary of HHS has threatening disease or condition caused vitro diagnostic tests for detection of
declared that circumstances exist by a product authorized under section Zika virus and/or diagnosis of Zika
justifying an authorization under 564, approved or cleared under the virus infection, subject to the terms of
section 564 of the FD&C Act, FDA may FD&C Act, or licensed under section 351 any authorization issued under section
authorize the emergency use of a drug, of the PHS Act, for diagnosing, treating, 564 of the FD&C Act. Notice of the
device, or biological product if the or preventing such a disease or determination and declaration of the
Agency concludes that the statutory condition caused by such an agent; and Secretary was published in the Federal
criteria are satisfied. Under section (B) the known and potential benefits of Register on March 2, 2016 (81 FR
564(h)(1) of the FD&C Act, FDA is the product, when used to diagnose, 10878). On June 15, 2016, Hologic, Inc.
required to publish in the Federal prevent, or treat such disease or requested, and on June 17, 2016, FDA
Register a notice of each authorization, condition, outweigh the known and issued, an EUA for the Aptima® Zika
and each termination or revocation of an potential risks of the product, taking Virus assay, subject to the terms of the
authorization, and an explanation of the into consideration the material threat Authorization.
posed by the agent or agents identified
reasons for the action. Section 564 of the III. Electronic Access
in a declaration under section
FD&C Act permits FDA to authorize the
564(b)(1)(D) of the FD&C Act, if
introduction into interstate commerce of An electronic version of this
applicable; (3) that there is no adequate,
a drug, device, or biological product approved, and available alternative to document and the full text of the
intended for use when the Secretary of the product for diagnosing, preventing, Authorization are available on the
HHS has declared that circumstances or treating such disease or condition; Internet at http://www.regulations.gov.
exist justifying the authorization of and (4) that such other criteria as may IV. The Authorization
emergency use. Products appropriate for be prescribed by regulation are satisfied.
emergency use may include products No other criteria for issuance have Having concluded that the criteria for
and uses that are not approved, cleared, been prescribed by regulation under issuance of the Authorization under
or licensed under sections 505, 510(k), section 564(c)(4) of the FD&C Act. section 564(c) of the FD&C Act are met,
or 515 of the FD&C Act (21 U.S.C. 355, Because the statute is self-executing, FDA has authorized the emergency use
360(k), and 360e) or section 351 of the regulations or guidance are not required of an in vitro diagnostic device for
PHS Act (42 U.S.C. 262). FDA may issue for FDA to implement the EUA detection of Zika virus subject to the
an EUA only if, after consultation with authority. terms of the Authorization. The
the HHS Assistant Secretary for II. EUA Request for an In Vitro Authorization in its entirety (not
Preparedness and Response, the Diagnostic Device for Detection of the including the authorized versions of the
Director of the National Institutes of Zika Virus fact sheets and other written materials)
Health, and the Director of the Centers On February 26, 2016, the Secretary of follows and provides an explanation of
for Disease Control and Prevention (to HHS determined that there is a the reasons for its issuance, as required
the extent feasible and appropriate by section 564(h)(1) of the FD&C Act:
given the applicable circumstances), 1 The Secretary of HHS has delegated the BILLING CODE 4164–01–P
authority to issue an EUA under section 564 of the
FD&C Act to the Commissioner of Food and Drugs.
asabaliauskas on DSK3SPTVN1PROD with NOTICES

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Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices 44639

Dated: July 1, 2016. regarding the privacy, security and the discussion may include information
Leslie Kux, scalability of health records. Critics regarding meeting privacy and security
Associate Commissioner for Policy. ascertain that it would take enormous standards, implementation and
[FR Doc. 2016–16177 Filed 7–7–16; 8:45 am] processing power and specialized potential performance issues, and cost
BILLING CODE 4164–01–C equipment that far exceeds the benefits. implications. Risk analysis and
Although most would acknowledge mitigation would be appropriate to
blockchain’s potential it is still evolving include here as well.
DEPARTMENT OF HEALTH AND and maturing, especially with respect to Æ Discuss the solution’s link to the
HUMAN SERVICES its applicability to the health care. stated objectives in the Nationwide
This Ideation Challenge solicits White Interoperability Roadmap, PCOR,
Office of the National Coordinator for Papers on the topic of Blockchain precision medicine and other national
Health Information Technology; Technology and the Potential for Its Use health care delivery priorities.
Announcement of Requirements and in Health IT and/or Healthcare Related
Registration for ‘‘Blockchain and Its How To Enter
Research Data.
Emerging Role in Healthcare and This nationwide call may be Challenge participants will have five
Health-related Research’’ addressed by an individual investigator (5) weeks from the date of the posting
or a investigator team. Interested parties of this Notice. Those submissions must
AGENCY: Office of the National comply with the requirements provided
should submit a White Paper no longer
Coordinator for Health Information above. Up to eight submissions may be
than 10 pages describing the proposed
Technology, HHS. selected as winners. The names of the
Award Approving Official: Karen subject. Investigators or co-investigators
may participate in no more than three winners will be posted on the
DeSalvo, National Coordinator for
submissions. A limited number of these Challenge.gov Web site, as well as the
Health Information Technology.
submissions will be selected. The names of any participants receiving an
ACTION: Notice. honorary mention. Honorary mentions
selection of a White Paper will result in
SUMMARY: The ‘‘Blockchain and Its an invitation to present at an upcoming may be given to highly ranked
Emerging Role in Healthcare and industry-wide workshop on September submissions.
Health-related Research.’’ Ideation 26th–27th at NIST Headquarters in Eligibility Rules for Participating in the
Challenge solicits white papers on the Gaithersburg, MD. Challenge
topic of Blockchain Technology and the Objective
potential use for Healthcare. Winners To be eligible to win a prize under
will be invited to present their The goal of this Ideation Challenge is this Challenge, an individual or entity:
to solicit White Papers that investigate 1. Shall have registered to participate
submission at an upcoming industry-
the relationship between blockchain in the Challenge under the rules
wide workshop co-hosted with the
technology and its use in Health IT and/ promulgated by the Office of the
National Institute of Standards and
or Health Related research. The paper National Coordinator for Health
Technology (NIST). The statutory
should discuss the cryptography and Information Technology.
authority for this Challenge is Section
underlying fundamentals of blockchain 2. Shall have complied with all the
105 of the America COMPETES
technology, examine how the use of stated requirements of the Blockchain
Reauthorization Act of 2010 (Pub. L.
blockchain can advance industry and Its Emerging Role in Healthcare and
111–358).
interoperability needs expressed in the Health-related Research Challenge.
DATES: 3. In the case of a private entity, shall
• Submission period begins: June 20. Nationwide Interoperability Roadmap,
patient centered outcomes research be incorporated in and maintain a
• Submission period ends: July 29.
primary place of business in the United
• Evaluation begins: August 1. (PCOR), precision medicine, and other
• Evaluation ends: August 16. health care delivery needs, as well as States, and in the case of an individual,
• Winners notified: August 17. provide recommendations for whether participating singly or in a
• Winners Announced: August 20. blockchain’s implementation. group, shall be a citizen or permanent
• Winner Presentation: September In lieu of a monetary award, challenge resident of the United States.
26th–27th. winners will be provided the 4. May not be a Federal entity or
FOR FURTHER INFORMATION CONTACT: opportunity to present their White Federal employee acting within the
Debbie Bucci, debbie.bucci@hhs.gov Papers at an industry-wide ‘‘Blockchain scope of their employment.
(preferred), (202) 690–0213. & Healthcare Workshop’’ co-hosted by 5. Shall not be an HHS employee
ONC and NIST. working on their applications or
SUPPLEMENTARY INFORMATION:
Submissions during assigned duty
Subject of Challenge Submission Requirements hours.
A blockchain is a data structure that Include a White Paper, not longer 6. Shall not be an employee of the
can be timed-stamped and signed using than ten (10) pages in length, that: Office of the National Coordinator for
a private key to prevent tampering. • Educates its audience on the Health Information Technology.
There are generally three types of technology; and 7. Federal grantees may not use
blockchain: Public, private and • Can be used to determine whether Federal funds to develop COMPETES
consortium. Potential uses include: there is a place in Health IT and/or Act challenge applications unless
asabaliauskas on DSK3SPTVN1PROD with NOTICES

• Digitally sign information, Healthcare related Research for the consistent with the purpose of their
• Computable enforcement of policies technology. grant award.
and contracts (smart contracts), • The paper should: 8. Federal contractors may not use
• Management of Internet of Things Æ Describe the value of blockchain to Federal funds from a contract to develop
devices, the health-care system; COMPETES Act challenge applications
• Distributed encrypted storage, and Æ Identify potential gaps; or to fund efforts in support of a
• Distributed trust. Æ Discuss the effectiveness of the COMPETES Act challenge Submission.
Proponents of blockchain suggest that solution and the solutions ability to An individual or entity shall not be
it could be used to address concerns function in the ‘‘real world.’’ This deemed ineligible because the

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Document Created: 2016-07-08 00:17:49
Document Modified: 2016-07-08 00:17:49

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 Authorization is effective as of June 17, 2016.
Contact		Carmen Maher, 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 (this is not a toll free number).
FR Citation		81 FR 44629

81 FR 44629 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 131 (July 8, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration