Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability, 61690-61700 [2016-21353]

Download as PDF 61690 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of disclosures per respondent Number of respondents 21 CFR Section Total annual disclosures Average burden per disclosure Total hours 1271.55(a) ................................................................ 1271.60(c) and (d)(2) ............................................... 1271.290(c) .............................................................. 1271.290(f) ............................................................... 1271.370(b) and (c) ................................................. 1,551 1,375 1,561 1,561 1,561 1,422.88 416 1,324.08 1 1,324.08 2,206,890 572,000 2,066,890 1,561 2,066,890 .5 (30 minutes) .......... .5 (30 minutes) .......... .083 (5 minutes) ........ 1 ................................ .25 (15 minutes) ........ 1,103,445 286,000 171,552 1,561 516,723 Total .................................................................. ........................ ........................ ........................ .................................... 2,079,281 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: August 31, 2016. Leslie Kux, Associate Commissioner for Policy. FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document. [FR Doc. 2016–21351 Filed 9–6–16; 8:45 am] 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 Viracor-IBT Laboratories, 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 mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:30 Sep 06, 2016 The Authorization is effective as of July 19, 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. DATES: BILLING CODE 4164–01–P Jkt 238001 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 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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 E:\FR\FM\07SEN1.SGM 07SEN1 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices 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), FDA1 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 mstockstill on DSK3G9T082PROD with NOTICES 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. VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 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 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 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 61691 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 July 7, 2016, Viracor-IBT Laboratories, Inc. requested, and on July 19, 2016, FDA issued, an EUA for the Zika Virus Real-time RT–PCR test, 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\07SEN1.SGM 07SEN1 61692 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4725 E:\FR\FM\07SEN1.SGM 07SEN1 EN07SE16.020</GPH> mstockstill on DSK3G9T082PROD with NOTICES Dear Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices 61693 I. Criteria for Issuance of Authorization VerDate Sep<11>2014 17:30 Sep 06, 2016 of Authorization Jkt 238001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4725 E:\FR\FM\07SEN1.SGM 07SEN1 EN07SE16.021</GPH> mstockstill on DSK3G9T082PROD with NOTICES U. 61694 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices The Authorized Zika Virus Real-time RT -PCR test VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4725 E:\FR\FM\07SEN1.SGM 07SEN1 EN07SE16.022</GPH> mstockstill on DSK3G9T082PROD with NOTICES the Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices 61695 .. each .. .. VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4725 E:\FR\FM\07SEN1.SGM 07SEN1 EN07SE16.023</GPH> mstockstill on DSK3G9T082PROD with NOTICES .. 61696 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4725 E:\FR\FM\07SEN1.SGM 07SEN1 EN07SE16.024</GPH> mstockstill on DSK3G9T082PROD with NOTICES III. Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices 61697 Conditions of Authorization this D. herein. VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4725 E:\FR\FM\07SEN1.SGM 07SEN1 EN07SE16.025</GPH> mstockstill on DSK3G9T082PROD with NOTICES H. 61698 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices luc. M. VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4725 E:\FR\FM\07SEN1.SGM 07SEN1 EN07SE16.026</GPH> mstockstill on DSK3G9T082PROD with NOTICES 0. Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices 61699 Authorized laboratories T. v. w. and Authorized Laboratories VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4725 E:\FR\FM\07SEN1.SGM 07SEN1 EN07SE16.027</GPH> mstockstill on DSK3G9T082PROD with NOTICES BB. 61700 Dated: August 31, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–21353 Filed 9–6–16; 8:45 am] BILLING CODE 4164–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration mstockstill on DSK3G9T082PROD with NOTICES [Docket No. FDA–2016–N–2523] Request for Comment on the Status of Vinpocetine AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is SUMMARY: VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 requesting comments related to the regulatory status of vinpocetine. Specifically, we request comments on our tentative conclusion that vinpocetine is not a dietary ingredient and is excluded from the definition of dietary supplement in the Federal Food, Drug, and Cosmetic Act (FD&C Act). This action is being taken as part of an administrative proceeding to determine the regulatory status of vinpocetine. All comments submitted by the comment deadline (see DATES) will be accepted as part of the official record for this proceeding. Submit either electronic or written comments on the notice by November 7, 2016. DATES: ADDRESSES: You may submit comments as follows: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that E:\FR\FM\07SEN1.SGM 07SEN1 EN07SE16.028</GPH> Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices

Agencies

[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Notices]
[Pages 61690-61700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21353]


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

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 Viracor-IBT Laboratories, 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 July 19, 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, 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

[[Page 61691]]

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 July 7, 2016, Viracor-IBT Laboratories, 
Inc. requested, and on July 19, 2016, FDA issued, an EUA for the Zika 
Virus Real-time RT-PCR test, 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

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[GRAPHIC] [TIFF OMITTED] TN07SE16.028


    Dated: August 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21353 Filed 9-6-16; 8:45 am]
 BILLING CODE 4164-01-C
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