Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability, 44629-44639 [2016-16177]

Download as PDF asabaliauskas on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices by industry and regulators alike to enable a harmonized and smooth implementation of Q3D on a global basis. The U.S. regional workshop is intended to clarify key aspects of ICH Q3D: Guideline on Elemental Impurities by elaborating on those key topics. It will include: (1) A discussion of how to apply Q3D concepts to routes of administration, not addressed in Q3D, (2) justification for elemental impurity levels higher than an established permissible daily exposure (PDE) (3) application of Q3D concepts to determine safe levels of elements not included in Q3D, (4) discussion of the rationale for limits on large volume parenterals, (5) elaboration of the concepts outlined in the Q3D Sections on Risk Assessment and Control of Elemental Impurities and (6) options for converting between PDEs and concentrations. In addition, case studies may be presented to illustrate the concepts described previously, and frequently asked questions will be discussed. The presentation of the material will follow the modules that are available on the ICH Web site, www.ich.org, and will include time for questions and discussion. Breakout sessions will be provided to discuss key topics and provide feedback to participants. Material will be presented by members of the ICH Q3D Implementation Working Group. The agenda for the workshop will be made available on the internet at http://www.fda.gov/Drugs/ NewsEvents/ucm498553.htm. Registration: If you wish to attend this meeting, visit the following Web site to register: https://www.eventbrite.com/e/ regional-public-workshop-on-ich-q3dimplementation-of-guideline-forelemental-impurities-tickets25492458630. Please register by August 15, 2016. If you are unable to attend the meeting in person, you can register to view a live Webcast on the meeting. You will be asked to indicate in your registration if you plan to attend in person or via the Webcast. Your registration must also contain your complete contact information, including name, title, affiliation, address, email address, and phone number. Registrations may be limited, so early registration is recommended. Registration is free and will be on a firstcome, first-served basis. However, the number of participants from each organization may be limited based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the meeting will be based on space availability. If you need special VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 accommodations because of a disability, please contact Amanda Roache (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting. Dated: July 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–16152 Filed 7–7–16; 8:45 am] BILLING CODE 4164–01–P 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. 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– SUMMARY: PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 44629 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 AllHazards 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, E:\FR\FM\08JYN1.SGM 08JYN1 44630 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices asabaliauskas on DSK3SPTVN1PROD with NOTICES 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), VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 FDA 1 concludes: (1) That an agent referred to in a declaration of emergency or threat can cause a serious or lifethreatening 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 lifethreatening 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. 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 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. PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 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® 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 E:\FR\FM\08JYN1.SGM 08JYN1 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices 44631 17, VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4725 E:\FR\FM\08JYN1.SGM 08JYN1 EN08JY16.008</GPH> asabaliauskas on DSK3SPTVN1PROD with NOTICES Dear 44632 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices I. Criteria for Issuance of Authorization for ISSURilCC that: II. of Authorization VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4725 E:\FR\FM\08JYN1.SGM 08JYN1 EN08JY16.009</GPH> asabaliauskas on DSK3SPTVN1PROD with NOTICES The Authorized Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices 44633 VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4725 E:\FR\FM\08JYN1.SGM 08JYN1 EN08JY16.010</GPH> asabaliauskas on DSK3SPTVN1PROD with NOTICES the 44634 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices • VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4725 E:\FR\FM\08JYN1.SGM 08JYN1 EN08JY16.011</GPH> asabaliauskas on DSK3SPTVN1PROD with NOTICES IV. Conditions of Authorization Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices 44635 B. Inc. VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4725 E:\FR\FM\08JYN1.SGM 08JYN1 EN08JY16.012</GPH> asabaliauskas on DSK3SPTVN1PROD with NOTICES J. 44636 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices K. M. 0. P, Authorized Laboratories VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4725 E:\FR\FM\08JYN1.SGM 08JYN1 EN08JY16.013</GPH> asabaliauskas on DSK3SPTVN1PROD with NOTICES R. Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices 44637 T. Laboratories Conditions Related to • • use VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4725 E:\FR\FM\08JYN1.SGM 08JYN1 EN08JY16.014</GPH> asabaliauskas on DSK3SPTVN1PROD with NOTICES • 44638 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices the use of the authorized the or effective may represent or "'u~;!ScM of Zika virus intection. The emergency use of the authorized Zika Virus authorization must with the conditions and a!l other letter of of this authorization. V. Duration of Authorization This EUA will be cflective until the declaration that circumstances the authorization of the emergency use of in vitm tests liJr detection of Zika of Zika virus infection is tenninatcd under section ofthe revoked under section of the Act. VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4725 E:\FR\FM\08JYN1.SGM 08JYN1 EN08JY16.015</GPH> asabaliauskas on DSK3SPTVN1PROD with NOTICES Enclosures Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the National Coordinator for Health Information Technology; Announcement of Requirements and Registration for ‘‘Blockchain and Its Emerging Role in Healthcare and Health-related Research’’ Office of the National Coordinator for Health Information Technology, HHS. Award Approving Official: Karen DeSalvo, National Coordinator for Health Information Technology. ACTION: Notice. AGENCY: The ‘‘Blockchain and Its Emerging Role in Healthcare and Health-related Research.’’ Ideation Challenge solicits white papers on the topic of Blockchain Technology and the potential use for Healthcare. Winners will be invited to present their submission at an upcoming industrywide workshop co-hosted with the National Institute of Standards and Technology (NIST). The statutory authority for this Challenge is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111–358). DATES: • Submission period begins: June 20. • Submission period ends: July 29. • Evaluation begins: August 1. • Evaluation ends: August 16. • Winners notified: August 17. • Winners Announced: August 20. • Winner Presentation: September 26th–27th. FOR FURTHER INFORMATION CONTACT: Debbie Bucci, debbie.bucci@hhs.gov (preferred), (202) 690–0213. SUPPLEMENTARY INFORMATION: asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: Subject of Challenge A blockchain is a data structure that can be timed-stamped and signed using a private key to prevent tampering. There are generally three types of blockchain: Public, private and consortium. Potential uses include: • Digitally sign information, • Computable enforcement of policies and contracts (smart contracts), • Management of Internet of Things devices, • Distributed encrypted storage, and • Distributed trust. Proponents of blockchain suggest that it could be used to address concerns VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 regarding the privacy, security and the scalability of health records. Critics ascertain that it would take enormous processing power and specialized equipment that far exceeds the benefits. Although most would acknowledge blockchain’s potential it is still evolving and maturing, especially with respect to its applicability to the health care. This Ideation Challenge solicits White Papers on the topic of Blockchain Technology and the Potential for Its Use in Health IT and/or Healthcare Related Research Data. This nationwide call may be addressed by an individual investigator or a investigator team. Interested parties should submit a White Paper no longer than 10 pages describing the proposed subject. Investigators or co-investigators may participate in no more than three submissions. A limited number of these submissions will be selected. The selection of a White Paper will result in an invitation to present at an upcoming industry-wide workshop on September 26th–27th at NIST Headquarters in Gaithersburg, MD. Objective The goal of this Ideation Challenge is to solicit White Papers that investigate the relationship between blockchain technology and its use in Health IT and/ or Health Related research. The paper should discuss the cryptography and underlying fundamentals of blockchain technology, examine how the use of blockchain can advance industry interoperability needs expressed in the Nationwide Interoperability Roadmap, patient centered outcomes research (PCOR), precision medicine, and other health care delivery needs, as well as provide recommendations for blockchain’s implementation. In lieu of a monetary award, challenge winners will be provided the opportunity to present their White Papers at an industry-wide ‘‘Blockchain & Healthcare Workshop’’ co-hosted by ONC and NIST. Submission Requirements Include a White Paper, not longer than ten (10) pages in length, that: • Educates its audience on the technology; and • Can be used to determine whether there is a place in Health IT and/or Healthcare related Research for the technology. • The paper should: Æ Describe the value of blockchain to the health-care system; Æ Identify potential gaps; Æ Discuss the effectiveness of the solution and the solutions ability to function in the ‘‘real world.’’ This PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 44639 discussion may include information regarding meeting privacy and security standards, implementation and potential performance issues, and cost implications. Risk analysis and mitigation would be appropriate to include here as well. Æ Discuss the solution’s link to the stated objectives in the Nationwide Interoperability Roadmap, PCOR, precision medicine and other national health care delivery priorities. How To Enter Challenge participants will have five (5) weeks from the date of the posting of this Notice. Those submissions must comply with the requirements provided above. Up to eight submissions may be selected as winners. The names of the winners will be posted on the Challenge.gov Web site, as well as the names of any participants receiving an honorary mention. Honorary mentions may be given to highly ranked submissions. Eligibility Rules for Participating in the Challenge To be eligible to win a prize under this Challenge, an individual or entity: 1. Shall have registered to participate in the Challenge under the rules promulgated by the Office of the National Coordinator for Health Information Technology. 2. Shall have complied with all the stated requirements of the Blockchain and Its Emerging Role in Healthcare and Health-related Research Challenge. 3. In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States. 4. May not be a Federal entity or Federal employee acting within the scope of their employment. 5. Shall not be an HHS employee working on their applications or Submissions during assigned duty hours. 6. Shall not be an employee of the Office of the National Coordinator for Health Information Technology. 7. Federal grantees may not use Federal funds to develop COMPETES Act challenge applications unless consistent with the purpose of their grant award. 8. Federal contractors may not use Federal funds from a contract to develop COMPETES Act challenge applications or to fund efforts in support of a COMPETES Act challenge Submission. An individual or entity shall not be deemed ineligible because the E:\FR\FM\08JYN1.SGM 08JYN1

Agencies

[Federal Register Volume 81, Number 131 (Friday, July 8, 2016)]
[Notices]
[Pages 44629-44639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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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    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