Authorization of Emergency Use of an In Vitro Diagnostic Device for Diagnosis of Zika Virus Infection; Availability, 17170-17180 [2016-06888]

Download as PDF 17170 Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices FOR FURTHER INFORMATION CONTACT: 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. 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. SUMMARY: 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. Lhorne on DSK5TPTVN1PROD with NOTICES DATES: VerDate Sep<11>2014 14:52 Mar 25, 2016 Jkt 238001 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 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, 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. PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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 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 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. E:\FR\FM\28MRN1.SGM 28MRN1 Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices 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. Lhorne on DSK5TPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 14:52 Mar 25, 2016 Jkt 238001 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. PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 17171 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: BILLING CODE 4164–01–P E:\FR\FM\28MRN1.SGM 28MRN1 VerDate Sep<11>2014 Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices 14:52 Mar 25, 2016 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4725 E:\FR\FM\28MRN1.SGM 28MRN1 EN28MR16.021</GPH> Lhorne on DSK5TPTVN1PROD with NOTICES 17172 Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices 17173 I. Criteria for Issuance of Authorization L to VerDate Sep<11>2014 14:52 Mar 25, 2016 of Authorization Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4725 E:\FR\FM\28MRN1.SGM 28MRN1 EN28MR16.022</GPH> Lhorne on DSK5TPTVN1PROD with NOTICES H. 17174 Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices 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 EN28MR16.023</GPH> Lhorne on DSK5TPTVN1PROD with NOTICES The Authorized Zika MAC·ELISA Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices 17175 Dr. Frieden . • ELISA. The Zika in .. .. • . 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 EN28MR16.024</GPH> Lhorne on DSK5TPTVN1PROD with NOTICES .. VerDate Sep<11>2014 Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices 14:52 Mar 25, 2016 Jkt 238001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4725 E:\FR\FM\28MRN1.SGM 28MRN1 EN28MR16.025</GPH> Lhorne on DSK5TPTVN1PROD with NOTICES 17176 Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices 17177 IV. Conditions of Authorization Centers for Disease Control and Prevention VerDate Sep<11>2014 14:52 Mar 25, 2016 Jkt 238001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4725 E:\FR\FM\28MRN1.SGM 28MRN1 EN28MR16.026</GPH> Lhorne on DSK5TPTVN1PROD with NOTICES B. 17178 Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices G. H. M. 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 EN28MR16.027</GPH> Lhorne on DSK5TPTVN1PROD with NOTICES Authorized Laboratories Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices 17179 8 Dr. CDC and Authorized Laboratories 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 EN28MR16.028</GPH> Lhorne on DSK5TPTVN1PROD with NOTICES T. 17180 Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Lhorne on DSK5TPTVN1PROD with NOTICES Statement of Organization, Functions and Delegations of Authority This notice amends Part R of the Statement of Organization, Functions and Delegations of Authority of the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) (60 FR 56605, as amended November 6, 1995; as last amended at 81 FR 10874–10875 dated March 2, 2016). This notice reflects organizational changes in the Health Resources and Services Administration (HRSA), Office of Operations (RB), Office of Information Technology (RB5). Specifically, this notice: (1) Updates the functional statement for the Office of the Director, Office of Information Technology (RB5); and (2) updates the functional statement for the Division of Enterprise Solutions and Applications Management (RB56) within the Office of Information Technology (RB5). Chapter RB5—Office of Information Technology Section RQ–20, Function Delete the functional statement for the Office of the Director (RB5) and for the Division of Enterprise Solutions and VerDate Sep<11>2014 14:52 Mar 25, 2016 Jkt 238001 Applications Management (RB56) and replace in their entirety. This notice reflects organizational changes in the Health Resources and Services Administration (HRSA), Office of Operations (RB), Office of Information Technology (RB5). Specifically, this notice: (1) Updates the functional statement for the Office of the Director (RB5); and (2) updates the functional statement for the Division of Enterprise Solutions and Applications Management (RB56) within the Office of Information Technology (RB5). Office of the Director and Chief Information Officer (RB5) The Office of Information Technology is responsible for the organization, management, and administrative functions necessary to carry out responsibilities including: (1) Architects, deploys, and supports IT infrastructure; (2) provides IT end user support; (3) develops enterprise and custom applications; (4) provides investment control, budget formulation and execution, policy development, strategic and tactical planning, and performance monitoring; (5) provides leadership in the development, review, and implementation of policies and procedures to promote improved information technology (IT) management capabilities and best practices throughout HRSA; (6) coordinates IT workforce issues and works closely with the Office of Administrative Services on IT recruitment and training issues; and (7) oversees HRSA security operations and management program. The Office of the Director is also responsible for the IT business function including: (1) Provides oversight and PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 management of IT budget formulation and execution; (2) serves as the focal point to OIT’s contracts; (3) provides centralized procurement services for the Office of Information Technology; and (4) serves as the coordinator for OIT’s Inter-agency and Service Level Agreements. Chief Information Security Officer The Chief Information Security Officer, reporting to the Chief Information Officer, provides leadership for and collaborates with Agency staff to oversee the implementation of security and privacy policy in the management of their IT systems, and plans all activities associated with the Federal Information Security Management Act or other Agency security and privacy initiatives including: (1) Implements, coordinates, and administers security and privacy programs to protect the information resources of HRSA in compliance with legislation, Executive Orders, directives of the Office of Management and Budget, or other mandated requirements; (2) executes the Agency’s Risk Management Program, and evaluates and assists with the implementation of safeguards to protect major information systems and IT infrastructure; and (3) manages the development, implementation, and evaluation of HRSA’s information technology security and privacy training programs to meet requirements mandated by the Office of Management and Budget. Division of Enterprise Solutions and Applications Management (RB56) The Division of Enterprise Solutions and Applications Management (DESAM) develops the HRSA grants E:\FR\FM\28MRN1.SGM 28MRN1 EN28MR16.029</GPH> BILLING CODE 4164–01–C

Agencies

[Federal Register Volume 81, Number 59 (Monday, March 28, 2016)]
[Notices]
[Pages 17170-17180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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

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.
---------------------------------------------------------------------------

    \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 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:
BILLING CODE 4164-01-P

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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