Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability, 2369-2378 [2017-00084]

Download as PDF Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. sradovich on DSK3GMQ082PROD with NOTICES SUPPLEMENTARY INFORMATION: Agenda: On February 23, 2017, the committee will discuss and make recommendations on clinical information related to the de novo request for the Sentinel® Cerebral Protection System, a first of a kind embolic protection device to be used with transcatheter aortic valve replacement (TAVR) procedures. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 9, 2017. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 1, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 2, 2017. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 accommodate persons with disabilities. If you require accommodations due to a disability, please contact AnnMarie Williams at AnnMarie.Williams@ fda.hhs.gov or 301–796–5966 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 4, 2017. Janice M. Soreth, Associate Commissioner, Special Medical Programs. [FR Doc. 2017–00143 Filed 1–6–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–4586] 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 ELITechGroup Inc. Molecular Diagnostics. 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 SUMMARY: PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 2369 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 December 9, 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 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 E:\FR\FM\09JAN1.SGM 09JAN1 2370 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices sradovich on DSK3GMQ082PROD with NOTICES 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 VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 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 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. 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 00062 Fmt 4703 Sfmt 4703 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 November 28, 2016, ELITechGroup Inc. Molecular Diagnostics requested, and on December 9, 2016, FDA issued, an EUA for the Zika ELITe MGB® Kit U.S., 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 https://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\09JAN1.SGM 09JAN1 VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4725 E:\FR\FM\09JAN1.SGM 09JAN1 2371 EN09JA17.077</GPH> sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices VerDate Sep<11>2014 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4725 E:\FR\FM\09JAN1.SGM 09JAN1 EN09JA17.078</GPH> sradovich on DSK3GMQ082PROD with NOTICES 2372 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices 2373 .. .. .. VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4725 E:\FR\FM\09JAN1.SGM 09JAN1 EN09JA17.079</GPH> sradovich on DSK3GMQ082PROD with NOTICES .. 2374 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4725 E:\FR\FM\09JAN1.SGM 09JAN1 EN09JA17.080</GPH> sradovich on DSK3GMQ082PROD with NOTICES UI. Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices 2375 Conditions of Authorization B. VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4725 E:\FR\FM\09JAN1.SGM 09JAN1 EN09JA17.081</GPH> sradovich on DSK3GMQ082PROD with NOTICES E. VerDate Sep<11>2014 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4725 E:\FR\FM\09JAN1.SGM 09JAN1 EN09JA17.082</GPH> sradovich on DSK3GMQ082PROD with NOTICES 2376 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices 2377 Mr. R. and MDx CFR Part Authorized Laboratories Kit Kit VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4725 E:\FR\FM\09JAN1.SGM 09JAN1 EN09JA17.083</GPH> sradovich on DSK3GMQ082PROD with NOTICES v. 2378 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices [FR Doc. 2017–00084 Filed 1–6–17; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2016–E–1196 and FDA– 2016–E–1197] BILLING CODE 4164–01–C sradovich on DSK3GMQ082PROD with NOTICES Determination of Regulatory Review Period for Purposes of Patent Extension; ADYNOVATE AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for ADYNOVATE and is publishing this SUMMARY: VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product. Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by March 10, 2017. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for DATES: E:\FR\FM\09JAN1.SGM 09JAN1 EN09JA17.084</GPH> Dated: January 3, 2017. Leslie Kux, Associate Commissioner for Policy.

Agencies

[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)]
[Notices]
[Pages 2369-2378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00084]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-4586]


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 ELITechGroup Inc. Molecular Diagnostics. 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 December 9, 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

[[Page 2370]]

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 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 November 28, 2016, ELITechGroup Inc. 
Molecular Diagnostics requested, and on December 9, 2016, FDA issued, 
an EUA for the Zika ELITe MGB[supreg] Kit U.S., 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 https://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

[[Page 2371]]

[GRAPHIC] [TIFF OMITTED] TN09JA17.077


[[Page 2372]]


[GRAPHIC] [TIFF OMITTED] TN09JA17.078


[[Page 2373]]


[GRAPHIC] [TIFF OMITTED] TN09JA17.079


[[Page 2374]]


[GRAPHIC] [TIFF OMITTED] TN09JA17.080


[[Page 2375]]


[GRAPHIC] [TIFF OMITTED] TN09JA17.081


[[Page 2376]]


[GRAPHIC] [TIFF OMITTED] TN09JA17.082


[[Page 2377]]


[GRAPHIC] [TIFF OMITTED] TN09JA17.083


[[Page 2378]]


[GRAPHIC] [TIFF OMITTED] TN09JA17.084


    Dated: January 3, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00084 Filed 1-6-17; 8:45 am]
 BILLING CODE 4164-01-C

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.