81_FR_17229 81 FR 17170 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Diagnosis of Zika Virus Infection; Availability

81 FR 17170 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Diagnosis of Zika Virus Infection; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 59 (March 28, 2016)

Page Range17170-17180
FR Document2016-06888

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 diagnosis of Zika virus infection 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 the U.S. Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the February 26, 2016, determination by the Department of Health and Human Services (HHS) Secretary that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the HHS Secretary 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 59 (Monday, March 28, 2016) 
[Federal Register Volume 81, Number 59 (Monday, March 28, 2016)]
[Notices]
[Pages 17170-17180]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06888]



[[Page 17170]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0969]


Authorization of Emergency Use of an In Vitro Diagnostic Device 
for Diagnosis of Zika Virus Infection; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 diagnosis of Zika virus infection 
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 the U.S. Centers for Disease Control and 
Prevention (CDC). The Authorization contains, among other things, 
conditions on the emergency use of the authorized in vitro diagnostic 
device. The Authorization follows the February 26, 2016, determination 
by the Department of Health and Human Services (HHS) Secretary that 
there is a significant potential for a public health emergency that has 
a significant potential to affect national security or the health and 
security of U.S. citizens living abroad and that involves Zika virus. 
On the basis of such determination, the HHS Secretary 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 February 26, 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.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the 
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and 
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) 
allows FDA to strengthen the public health protections against 
biological, chemical, nuclear, and radiological agents. Among other 
things, section 564 of the FD&C Act allows FDA to authorize the use of 
an unapproved medical product or an unapproved use of an approved 
medical product in certain situations. With this EUA authority, FDA can 
help assure that medical countermeasures may be used in emergencies to 
diagnose, treat, or prevent serious or life-threatening diseases or 
conditions caused by biological, chemical, nuclear, or radiological 
agents; when there are no adequate, approved, and available 
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may 
be issued, the Secretary of HHS must declare that circumstances exist 
justifying the authorization based on one of the following grounds: (1) 
A determination by the Secretary of Homeland Security that there is a 
domestic emergency, or a significant potential for a domestic 
emergency, involving a heightened risk of attack with a biological, 
chemical, radiological, or nuclear agent or agents; (2) a determination 
by the Secretary of Defense that there is a military emergency, or a 
significant potential for a military emergency, involving a heightened 
risk to U.S. military forces of attack with a biological, chemical, 
radiological, or nuclear agent or agents; (3) a determination by the 
Secretary of HHS that there is a public health emergency, or a 
significant potential for a public health emergency, that affects, or 
has a significant potential to affect, national security or the health 
and security of U.S. citizens living abroad, and that involves a 
biological, chemical, radiological, or nuclear agent or agents, or a 
disease or condition that may be attributable to such agent or agents; 
or (4) the identification of a material threat by the Secretary of 
Homeland Security under section 319F-2 of the Public Health Service 
(PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or 
the health and security of U.S. citizens living abroad.
    Once the Secretary of HHS has declared that circumstances exist 
justifying an authorization under section 564 of the FD&C Act, FDA may 
authorize the emergency use of a drug, device, or biological product if 
the Agency concludes that the statutory criteria are satisfied. Under 
section 564(h)(1) of the FD&C Act, FDA is required to publish in the 
Federal Register a notice of each authorization, and each termination 
or revocation of an authorization, and an explanation of the reasons 
for the action. Section 564 of the FD&C Act permits FDA to authorize 
the introduction into interstate commerce of a drug, device, or 
biological product intended for use when the Secretary of HHS has 
declared that circumstances exist justifying the authorization of 
emergency use. Products appropriate for emergency use may include 
products and uses that are not approved, cleared, or licensed under 
sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 
and 360e) or section 351 of the PHS Act (42 U.S.C. 262). 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 CDC (to the extent feasible and 
appropriate given the applicable circumstances), FDA \1\ concludes: (1) 
That an agent referred to in a declaration of emergency or threat can 
cause a serious or life-threatening disease or condition; (2) that, 
based on the totality of scientific evidence available to FDA, 
including data from adequate and well-controlled clinical trials, if 
available, it is reasonable to believe that: (A) The product may be 
effective in diagnosing, treating, or preventing (i) such disease or 
condition; or (ii) a serious or life-threatening disease or condition 
caused by a product authorized under section 564, approved or cleared 
under the FD&C Act, or licensed under section 351 of the PHS Act, for 
diagnosing, treating, or preventing such a disease or condition caused 
by such an agent; and (B) the known and potential benefits of the 
product, when used to diagnose, prevent, or treat such disease or 
condition, outweigh the known and potential risks of the product, 
taking into consideration the material threat posed by the agent or 
agents identified in a declaration under section 564(b)(1)(D) of the 
FD&C Act, if

[[Page 17171]]

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.
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    \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.
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    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 Diagnosis of Zika 
Virus Infection

    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 February 22, 2016, CDC requested, and 
on February 26, 2016, FDA issued, an EUA for the CDC Zika 
Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent 
Assay (Zika MAC-ELISA), 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 
diagnosis of Zika virus infection 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:
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BILLING CODE 4164-01-C

    Dated: March 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06888 Filed 3-25-16; 8:45 am]
 BILLING CODE 4164-01-P

17170 Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: 247d–6b) sufficient to affect national HUMAN SERVICES Carmen Maher, Office of security or the health and security of Counterterrorism and Emerging Threats, U.S. citizens living abroad. Food and Drug Administration Food and Drug Administration, 10903 Once the Secretary of HHS has New Hampshire Ave., Bldg. 1, Rm. declared that circumstances exist [Docket No. FDA–2016–N–0969] 4347, Silver Spring, MD 20993–0002, justifying an authorization under 301–796–8510. section 564 of the FD&C Act, FDA may Authorization of Emergency Use of an SUPPLEMENTARY INFORMATION: authorize the emergency use of a drug, In Vitro Diagnostic Device for device, or biological product if the Diagnosis of Zika Virus Infection; I. Background Agency concludes that the statutory Availability Section 564 of the FD&C Act (21 criteria are satisfied. Under section U.S.C. 360bbb–3) as amended by the 564(h)(1) of the FD&C Act, FDA is AGENCY: Food and Drug Administration, required to publish in the Federal HHS. Project BioShield Act of 2004 (Pub. L. 108–276) and the Pandemic and All- Register a notice of each authorization, ACTION: Notice. Hazards Preparedness Reauthorization and each termination or revocation of an Act of 2013 (Pub. L. 113–5) allows FDA authorization, and an explanation of the SUMMARY: The Food and Drug reasons for the action. Section 564 of the Administration (FDA) is announcing the to strengthen the public health protections against biological, chemical, FD&C Act permits FDA to authorize the issuance of an Emergency Use introduction into interstate commerce of Authorization (EUA) (the Authorization) nuclear, and radiological agents. Among other things, section 564 of the FD&C a drug, device, or biological product for an in vitro diagnostic device for intended for use when the Secretary of diagnosis of Zika virus infection in Act allows FDA to authorize the use of HHS has declared that circumstances response to the Zika virus outbreak in an unapproved medical product or an exist justifying the authorization of the Americas. FDA issued this unapproved use of an approved medical emergency use. Products appropriate for Authorization under the Federal Food, product in certain situations. With this emergency use may include products Drug, and Cosmetic Act (the FD&C Act), EUA authority, FDA can help assure and uses that are not approved, cleared, as requested by the U.S. Centers for that medical countermeasures may be or licensed under sections 505, 510(k), Disease Control and Prevention (CDC). used in emergencies to diagnose, treat, or 515 of the FD&C Act (21 U.S.C. 355, The Authorization contains, among or prevent serious or life-threatening 360(k), and 360e) or section 351 of the other things, conditions on the diseases or conditions caused by PHS Act (42 U.S.C. 262). FDA may issue emergency use of the authorized in vitro biological, chemical, nuclear, or an EUA only if, after consultation with diagnostic device. The Authorization radiological agents; when there are no the HHS Assistant Secretary for follows the February 26, 2016, adequate, approved, and available Preparedness and Response, the determination by the Department of alternatives. Director of the National Institutes of Health and Human Services (HHS) Section 564(b)(1) of the FD&C Act Health, and the Director of the CDC (to Secretary that there is a significant provides that, before an EUA may be the extent feasible and appropriate potential for a public health emergency issued, the Secretary of HHS must given the applicable circumstances), that has a significant potential to affect declare that circumstances exist FDA 1 concludes: (1) That an agent national security or the health and justifying the authorization based on referred to in a declaration of emergency security of U.S. citizens living abroad one of the following grounds: (1) A or threat can cause a serious or life- and that involves Zika virus. On the determination by the Secretary of threatening disease or condition; (2) basis of such determination, the HHS Homeland Security that there is a that, based on the totality of scientific Secretary declared on February 26, domestic emergency, or a significant evidence available to FDA, including 2016, that circumstances exist justifying potential for a domestic emergency, data from adequate and well-controlled the authorization of emergency use of in involving a heightened risk of attack clinical trials, if available, it is vitro diagnostic tests for detection of with a biological, chemical, radiological, reasonable to believe that: (A) The Zika virus and/or diagnosis of Zika or nuclear agent or agents; (2) a product may be effective in diagnosing, virus infection subject to the terms of determination by the Secretary of treating, or preventing (i) such disease any authorization issued under the Defense that there is a military or condition; or (ii) a serious or life- FD&C Act. The Authorization, which emergency, or a significant potential for threatening disease or condition caused includes an explanation of the reasons a military emergency, involving a by a product authorized under section for issuance, is reprinted in this heightened risk to U.S. military forces of 564, approved or cleared under the document. attack with a biological, chemical, FD&C Act, or licensed under section 351 radiological, or nuclear agent or agents; DATES: The Authorization is effective as of the PHS Act, for diagnosing, treating, (3) a determination by the Secretary of of February 26, 2016. or preventing such a disease or HHS that there is a public health condition caused by such an agent; and ADDRESSES: Submit written requests for emergency, or a significant potential for (B) the known and potential benefits of single copies of the EUA to the Office a public health emergency, that affects, the product, when used to diagnose, of Counterterrorism and Emerging or has a significant potential to affect, prevent, or treat such disease or Threats, Food and Drug Administration, national security or the health and condition, outweigh the known and 10903 New Hampshire Ave., Bldg. 1, security of U.S. citizens living abroad, potential risks of the product, taking Rm. 4338, Silver Spring, MD 20993– and that involves a biological, chemical, into consideration the material threat Lhorne on DSK5TPTVN1PROD with NOTICES 0002. Send one self-addressed adhesive radiological, or nuclear agent or agents, posed by the agent or agents identified label to assist that office in processing or a disease or condition that may be in a declaration under section your request or include a fax number to attributable to such agent or agents; or 564(b)(1)(D) of the FD&C Act, if which the Authorization may be sent. (4) the identification of a material threat See the SUPPLEMENTARY INFORMATION by the Secretary of Homeland Security 1 The Secretary of HHS has delegated the section for electronic access to the under section 319F–2 of the Public authority to issue an EUA under section 564 of the Authorization. Health Service (PHS) Act (42 U.S.C. FD&C Act to the Commissioner of Food and Drugs. VerDate Sep<11>2014 14:52 Mar 25, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\28MRN1.SGM 28MRN1

Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices 17171 applicable; (3) that there is no adequate, living abroad and that involves Zika III. Electronic Access approved, and available alternative to virus. On February 26, 2016, under the product for diagnosing, preventing, section 564(b)(1) of the FD&C Act, and An electronic version of this or treating such disease or condition; on the basis of such determination, the document and the full text of the and (4) that such other criteria as may Secretary of HHS declared that Authorization are available on the be prescribed by regulation are satisfied. circumstances exist justifying the Internet at http://www.regulations.gov. No other criteria for issuance have authorization of emergency use of in been prescribed by regulation under IV. The Authorization vitro diagnostic tests for detection of section 564(c)(4) of the FD&C Act. Zika virus and/or diagnosis of Zika Having concluded that the criteria for Because the statute is self-executing, virus infection, subject to the terms of issuance of the Authorization under regulations or guidance are not required section 564(c) of the FD&C Act are met, any authorization issued under section for FDA to implement the EUA FDA has authorized the emergency use 564 of the FD&C Act. Notice of the authority. determination and declaration of the of an in vitro diagnostic device for II. EUA Request for an In Vitro Secretary was published in the Federal diagnosis of Zika virus infection subject Diagnostic Device for Diagnosis of Zika Register on March 2, 2016 (81 FR to the terms of the Authorization. The Virus Infection 10878). On February 22, 2016, CDC Authorization in its entirety (not On February 26, 2016, the Secretary of requested, and on February 26, 2016, including the authorized versions of the HHS determined that there is a FDA issued, an EUA for the CDC Zika fact sheets and other written materials) significant potential for a public health Immunoglobulin M (IgM) Antibody follows and provides an explanation of emergency that has a significant Capture Enzyme-Linked Immunosorbent the reasons for its issuance, as required potential to affect national security or Assay (Zika MAC–ELISA), subject to the by section 564(h)(1) of the FD&C Act: the health and security of U.S. citizens terms of the Authorization. BILLING CODE 4164–01–P Lhorne on DSK5TPTVN1PROD with NOTICES VerDate Sep<11>2014 14:52 Mar 25, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\28MRN1.SGM 28MRN1

DEFPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Silver Spring, MD 20993 February 26, 2016 Thomas R. Frieden, M.D., M.P.H. Director Centers for Disease Control and Prevention 1600 Clifion Rd, MS D—14 Atlanta, GA 30333 Dear Dr. Frieden: This letteris in responise to your request that the Food and Drug Administration (FDA) tssue an Emergency Use Authorization (EUA) for emergency use ofthe Centers for Disease Control and Prevention‘s (CDC) Zika Immunoglobutin M (IgM) Antibody Capture Enzyme—Linked imimunosorbent Assay (Zika MAC—ELISA) for the presumptive detection of Zika virus— specific IgM in human sera or cerebrospinal fluid (CSF) that is submitted alongside a patient— matched serum specimen from individuals meeting CDC Zika virus elinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., recent historyof travel to geographic regions during a period ofactive Zika virus transmissions at the time oftravel, or other epidemiolagic criteria for which Zika virus testing may be indicated as part of a public health response), by qualified laboratories designated by CDC and, in the United States, certified under the Climcal Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §2634, to perform high complexity tests,‘ pursuant to section 564 of the Federal Food, Drug, and Cosmetic Aet (the Act) (21 ULS.C. §360bbb—3). Where there are positive or equivocal results from the Zika MAC—ELISA, confirmation ofthe presence of anti—Zika IgM antibodies requires additional testing by CDC, or byauthorized faboratories in consultation with CDC, using the CDC—ssued algorithm. On February 26, 2016, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 360bbb— 3(b)(1)(C), the Secretary of Health and Human Services (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 United States citizens living abroad and that involves Zika virus." Pursuant to section 364(b)(1) of the Act (21 U.S.C. § 360bbb—3(b)(1}). and on the basis of such determination, the Secretary of HHS then declared that circumstances o ut exist justifying the authorization of the emergency use ofin vitro diagnostic tests for detection ‘For ease of reference, this letter will refer to *qualified laboratories designated by CDC and, in the United States, certified under the Clinical Laboratory tmprovement Amendments of 1988 (CLIA), 42 U.S.C, § 2632, to perform high complexity tests" as "authorized laboratories." * As amended by the Pandemic and All Hazards Preparedness Reauthorization Act, Pub. L. No. 113—4, under section 564(b)(1)(C) of the Act, the Secretary may make a determination ofa public health emergency; or of a significant potential for a public health emergency.

Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices 17173 I. Criteria for Issuance of Authorization L to H. of Authorization Lhorne on DSK5TPTVN1PROD with NOTICES EN28MR16.022</GPH> VerDate Sep<11>2014 14:52 Mar 25, 2016 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4725 E:\FR\FM\28MRN1.SGM 28MRN1

17174 Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices The Authorized Zika MAC·ELISA Lhorne on DSK5TPTVN1PROD with NOTICES EN28MR16.023</GPH> VerDate Sep<11>2014 14:52 Mar 25, 2016 Jkt 238001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4725 E:\FR\FM\28MRN1.SGM 28MRN1

Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices 17175 Dr. Frieden . • ELISA. The Zika in .. .. • . .. Lhorne on DSK5TPTVN1PROD with NOTICES EN28MR16.024</GPH> VerDate Sep<11>2014 14:52 Mar 25, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4725 E:\FR\FM\28MRN1.SGM 28MRN1

Page 5 —Dr. Frieden, Centers for Discase Control and Prevention * Fact Sheet for Pregnant Women: Understanding Results fromthe Zika MAC—ELISA a Fact Sheet for Patients: Understanding Results from the Zika MAC—ELISA As described in Section IV below, CDC is also authorized to make available additional information relating to the emergency use of the authorized Zika MAC—ELISA that is consistent with, and does not exceed, the terms of this lettor of authorization. I have concluded, pursuant to section 564(d)(2) ofthe Act, that it is reasonable to believe that the known and potential benefits ofthe authorized Zika MAC—ELISA in the specified population, when used for presumptive detection of Zika virus—specific IgM antibodies and used consistently with the Scope of Authorization ofthis letter (Section H}, outweigh the known and potential risks of such a product. I have concluded, pursuant to section 564(d)(3) ofthe Act, based on the totality of scientific evidence —available to FDA, that it is reasonable to believe that the authorized Zika MAC— ELISA may be effective in the diagnosis of Zika virus infection, when used consistently with the Scope of Authorization of this letter (Section I), pursuant to section 564(¢)(2)(A) ofthe Act. FDA has reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section T above, and concludes that the authorized Zika MAC—ELISA, when used to diagnose Zika virus infection in the specified population (as described in the Scope of Authorization of this letter (Section II}}, meets the criteria set forth in section 564(c) ofthe Act concerning safety and potential effectiveness. The emmergency use ofthe authorized Zika MAC—ELISA under this EUA must be consistent with, and may not exceed, the terms of this letter, including the Scope of Authorization (Section I1) and the Conditions of Authorization (Section IV). Subject to the terms ofthis EUA and under the circumstances set forth in the Secretary of HHS‘s determination described above and the Secretary of HHS‘s corresponding declaration under section 564(b)(1), the Zika MAC— ELISA described above is authorized to diagnose Zika virus infection in individuals meeti ng CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiclogical criteria {e.g., recent history of travel to geographic regions during a period of active Zika virus transmissions at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated as part of a public health response). This EUA will cease to be effective when the HHS declaration that cireumstances exist to justify the EUA is termingted under section 564(b)(2) ofthe Act or when the EUA is revoked under section 564(g) of the Act. IIL Waiver of Certain Requirements I am waiving the following requirements for the Zika MAC—ELISA duriny the duration of this EUA:

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17178 Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices G. H. M. Authorized Laboratories Lhorne on DSK5TPTVN1PROD with NOTICES EN28MR16.027</GPH> VerDate Sep<11>2014 14:52 Mar 25, 2016 Jkt 238001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4725 E:\FR\FM\28MRN1.SGM 28MRN1

Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices 17179 8 Dr. CDC and Authorized Laboratories T. Lhorne on DSK5TPTVN1PROD with NOTICES EN28MR16.028</GPH> VerDate Sep<11>2014 14:52 Mar 25, 2016 Jkt 238001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4725 E:\FR\FM\28MRN1.SGM 28MRN1

17180 Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices BILLING CODE 4164–01–C Applications Management (RB56) and management of IT budget formulation Dated: March 22, 2016. replace in their entirety. and execution; (2) serves as the focal Leslie Kux, This notice reflects organizational point to OIT’s contracts; (3) provides Associate Commissioner for Policy. changes in the Health Resources and centralized procurement services for the [FR Doc. 2016–06888 Filed 3–25–16; 8:45 am] Services Administration (HRSA), Office Office of Information Technology; and BILLING CODE 4164–01–P of Operations (RB), Office of (4) serves as the coordinator for OIT’s Information Technology (RB5). Inter-agency and Service Level Specifically, this notice: (1) Updates the Agreements. DEPARTMENT OF HEALTH AND functional statement for the Office of the Chief Information Security Officer HUMAN SERVICES Director (RB5); and (2) updates the functional statement for the Division of The Chief Information Security Health Resources and Services Enterprise Solutions and Applications Officer, reporting to the Chief Administration Management (RB56) within the Office of Information Officer, provides leadership Information Technology (RB5). for and collaborates with Agency staff to Statement of Organization, Functions oversee the implementation of security and Delegations of Authority Office of the Director and Chief and privacy policy in the management Information Officer (RB5) of their IT systems, and plans all This notice amends Part R of the The Office of Information Technology activities associated with the Federal Statement of Organization, Functions is responsible for the organization, Information Security Management Act and Delegations of Authority of the management, and administrative or other Agency security and privacy Department of Health and Human functions necessary to carry out initiatives including: (1) Implements, Services (HHS), Health Resources and responsibilities including: (1) coordinates, and administers security Services Administration (HRSA) (60 FR Architects, deploys, and supports IT and privacy programs to protect the 56605, as amended November 6, 1995; infrastructure; (2) provides IT end user information resources of HRSA in as last amended at 81 FR 10874–10875 support; (3) develops enterprise and compliance with legislation, Executive dated March 2, 2016). This notice reflects organizational custom applications; (4) provides Orders, directives of the Office of changes in the Health Resources and investment control, budget formulation Management and Budget, or other Services Administration (HRSA), Office and execution, policy development, mandated requirements; (2) executes the of Operations (RB), Office of strategic and tactical planning, and Agency’s Risk Management Program, Information Technology (RB5). performance monitoring; (5) provides and evaluates and assists with the Specifically, this notice: (1) Updates the leadership in the development, review, implementation of safeguards to protect functional statement for the Office of the and implementation of policies and major information systems and IT Director, Office of Information procedures to promote improved infrastructure; and (3) manages the Technology (RB5); and (2) updates the information technology (IT) development, implementation, and functional statement for the Division of management capabilities and best evaluation of HRSA’s information Enterprise Solutions and Applications practices throughout HRSA; (6) technology security and privacy training Management (RB56) within the Office of coordinates IT workforce issues and programs to meet requirements Information Technology (RB5). works closely with the Office of mandated by the Office of Management Lhorne on DSK5TPTVN1PROD with NOTICES Administrative Services on IT and Budget. Chapter RB5—Office of Information recruitment and training issues; and (7) Technology Division of Enterprise Solutions and oversees HRSA security operations and Applications Management (RB56) Section RQ–20, Function management program. Delete the functional statement for the The Office of the Director is also The Division of Enterprise Solutions Office of the Director (RB5) and for the responsible for the IT business function and Applications Management EN28MR16.029</GPH> Division of Enterprise Solutions and including: (1) Provides oversight and (DESAM) develops the HRSA grants VerDate Sep<11>2014 14:52 Mar 25, 2016 Jkt 238001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\28MRN1.SGM 28MRN1


Document Created: 2016-03-26 00:13:35
Document Modified: 2016-03-26 00:13:35
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe Authorization is effective as of February 26, 2016.
ContactCarmen 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.
FR Citation81 FR 17170 
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