[Federal Register Volume 80, Number 166 (Thursday, August 27, 2015)]
[Notices]
[Pages 52051-52055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21266]


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DEPARTMENT OF HOMELAND SECURITY

U.S. Customs and Border Protection


Modification of National Customs Automation Program (NCAP) Test 
Concerning the Submission of Certain Data Required by the Food and Drug 
Administration (FDA) Using the Partner Government Agency (PGA) Message 
Set Through the Automated Commercial Environment (ACE)

AGENCY: U.S. Customs and Border Protection, Department of Homeland 
Security.

ACTION: General notice.

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SUMMARY: This document announces U.S. Customs and Border Protection's 
(CBP's) plan to conduct a National Customs Automation Program (NCAP) 
test concerning the electronic transmission of certain import data for 
all Food and Drug Administration (FDA)-regulated commodities. Under the 
pilot, this data will be transmitted electronically through the 
Automated Broker Interface (ABI) for processing in CBP's Automated 
Commercial Environment (ACE) system utilizing the Partnering Government 
Agency (PGA) Message Set.

DATES: The FDA PGA Message Set test will begin no earlier than August 
27, 2015. This test will continue until concluded by way of 
announcement in the Federal Register. Public comments are invited and 
will be accepted through the duration of the test pilot.

ADDRESSES: Comments concerning this notice and any aspect of this test 
may be submitted at any time during the test via email to Josephine 
Baiamonte, ACE Business Office (ABO), Office of International Trade, at 
[email protected]. In the subject line of your email, 
please indicate, ``Comment on FDA PGA Message Set Test FRN''.

FOR FURTHER INFORMATION CONTACT:  For PGA-related questions, contact 
Elizabeth McQueen at [email protected]. For technical 
questions related to the Automated Commercial Environment (ACE) or 
Automated Broker Interface (ABI) transmissions, contact your assigned 
client representative. Interested parties without an assigned client 
representative should direct their questions to Steven Zaccaro at 
[email protected] with the subject heading ``PGA Message Set 
FDA Test FRN-Request to Participate.'' For FDA-related questions, 
contact Sandra Abbott at [email protected] or Max Castillo at 
[email protected].
    Any party seeking to participate in this test must provide CBP, in 
its request to participate, its filer code and the port(s) at which it 
is interested in filing the appropriate PGA Message Set information. At 
this time, PGA Message Set data may be submitted only for entries filed 
at certain ports. A current listing of those ports may be found at the 
following link: http://www.cbp.gov/document/guidance/list-aceitds-pga-message-set-pilot-ports.

SUPPLEMENTARY INFORMATION:

I. Background

    The National Customs Automation Program (NCAP) was established in 
Subtitle B of Title VI--Customs Modernization (Customs Modernization 
Act), in the North American Free Trade Agreement Implementation Act, 
Public Law 103-182, 107 Stat. 2057 (19 U.S.C. 1411). Through NCAP, the 
initial thrust of customs modernization was on trade compliance and the 
development of the Automated Commercial Environment (ACE), the planned 
successor to the Automated Commercial System (ACS). ACE is an automated 
and electronic system for processing commercial trade data which is 
intended to streamline business processes, facilitate growth in trade, 
ensure cargo security, and foster participation in global commerce, 
while

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ensuring compliance with U.S. laws and regulations and reducing costs 
for U.S. Customs and Border Protection (CBP) and all of its communities 
of interest. The ability to meet these objectives depends on 
successfully modernizing CBP's business functions and the information 
technology that supports those functions. The Automated Broker 
Interface (ABI) is the electronic data interchange (EDI) that enables 
members of the trade community to file electronically required import 
data with CBP and transfers that data to ACE.
    CBP's modernization efforts are accomplished through phased 
releases of ACE component functionality designed to replace specific 
legacy ACS functions. Each release will begin with a test and will end 
with mandatory use of the new ACE feature, thus retiring the legacy ACS 
function. Each release builds on previous releases and sets the 
foundation for subsequent releases.
    For the convenience of the public, a chronological listing of 
Federal Register publications detailing ACE test developments is set 
forth below in Section XV, entitled, ``Development of ACE Prototypes.'' 
The procedures and criteria related to participation in the prior ACE 
test pilots remain in effect unless otherwise explicitly changed by 
this or subsequent notices published in the Federal Register.

II. Authorization for the Test

    The Customs Modernization Act provisions provide the Commissioner 
of CBP with authority to conduct limited test programs or procedures 
designed to evaluate planned components of the NCAP. The test described 
in this notice is authorized pursuant to Sec.  101.9(b) of title 19 of 
the Code of Federal Regulations (19 CFR 101.9(b)) which provides for 
the testing of NCAP programs or procedures. See Treasury Decision 
(T.D.) 95-21.

III. International Trade Data System (ITDS)

    This test is also in furtherance of the International Trade Data 
System (ITDS) key initiatives, set forth in section 405 of the Security 
and Accountability for Every Port Act of 2006 (``SAFE Port Act''), Sec. 
405, Public Law 109-347, 120 Stat. 1884 (19 U.S.C. 1411(d)) and in 
Executive Order 13659 of February 19, 2014, Streamlining the Export/
Import Process for America's Businesses, 79 FR 10657 (February 25, 
2014). The purpose of ITDS, as stated in section 405 of the SAFE Port 
Act, is to eliminate redundant information requirements, efficiently 
regulate the flow of commerce, and effectively enforce laws and 
regulations relating to international trade, by establishing a single 
portal system, operated by CBP, for the collection and distribution of 
standard electronic import and export data required by all 
participating Federal agencies. CBP is developing ACE as the ``single 
window'' for the trade community to comply with the ITDS requirement 
established by the SAFE Port Act.
    Executive Order 13659 requires that by December 31, 2016, ACE, as 
the ITDS single window, have the operational capabilities to serve as 
the primary means of receiving from users the standard set of data and 
other relevant documentation (exclusive of applications for permits, 
licenses, or certifications) required for the release of imported cargo 
and clearance of cargo for export, and to transition from paper-based 
requirements and procedures to faster and more cost-effective 
electronic submissions to, and communications with, U.S. government 
agencies.

IV. Partner Government Agency (PGA) Message Set

    The PGA Message Set is the data needed to satisfy the PGA reporting 
requirements. ACE enables the message set by acting as the ``single 
window'' for the submission of trade-related data required by the PGAs 
only once to CBP. Once validated, the data will be made available to 
the relevant PGAs involved in import, export, and transportation-
related decision making. The data will be used to fulfill merchandise 
entry requirements and may allow for earlier release decisions and more 
certainty for the importer in determining the logistics of cargo 
delivery. Also, by virtue of being electronic, the PGA Message Set will 
eliminate the necessity for the submission and subsequent handling of 
paper documents.
    At this time, a limited number of ports of entry will be accepting 
FDA PGA Message Set data. A list of those ports is provided at the 
following link: http://www.cbp.gov/document/guidance/list-aceitds-pga-message-set-pilot-ports. CBP may expand the list of ports accepting FDA 
PGA Message Set data in the future. Any expansion to include additional 
ports will be published on the aforementioned link.

V. The Food and Drug Administration PGA Message Set Test

    Section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 381) authorizes the Secretary of Health and Human Services 
(HHS), through the FDA, to make admissibility decisions for FDA-
regulated commodities (foods, drugs, cosmetics, medical devices, and 
tobacco products), and prior notice risk and threat assessment 
decisions for imported food products. Moreover, section 536 of the FD&C 
Act (21 U.S.C. 360mm) and 42 U.S.C. 264 provide similar authority for 
radiation emitting products and human cell, tissue, and cellular and 
tissue-based products (HCT/Ps). Carrying out these responsibilities 
involves close coordination and cooperation between the FDA and CBP.
    Until October 1998, importers were required to file manual entries 
on Office of Management and Budget (OMB)-approved forms which were 
accompanied by related documents. Thereafter, the FDA implemented an 
automated nationwide entry processing system known as the ``Operational 
and Administrative System for Import Support (OASIS)'' that enabled the 
FDA to more efficiently obtain and process the information it requires 
to fulfill its regulatory responsibilities. Most of the data that the 
FDA requires to make admissibility and prior notice-related decisions 
regarding imported products is already provided electronically by 
importers and entry filers to CBP. Since CBP relays the entry data to 
the FDA using an electronic interface as discussed below, most of the 
data submitted by an importer or entry filer need be completed only 
once.
    Information for commercial entries for shipments of FDA-regulated 
products that are imported or offered for import into the United States 
is submitted by the importer (or his or her agent) or entry filer 
through CBP's Automated Broker Interface of the Automated Commercial 
System (ABI/ACS) into OASIS. For imported foods and feeds, this process 
includes the submission of prior notice information, which is reviewed 
for targeting higher-risk shipments for examination by the FDA or CBP 
upon arrival at the port of entry. With respect to the transmission of 
entry information, the FDA reviews relevant data as part of its 
admissibility review. The FDA sends a message back to the importer or 
entry filer with its decision as to whether (1) the product is 
admissible; (2) additional information is required; (3) an examination 
of the shipment is required; or (4) the shipment is subject to refusal 
of admission.
    In December of 2011, the FDA fully implemented its new 
admissibility targeting application called ``Predictive Risk-based 
Evaluation for Dynamic Import Compliance Targeting,'' commonly known as 
``PREDICT.'' PREDICT screens all entries, identifies shipments based on 
risk, and facilitates FDA's ability to determine whether products 
should be examined or

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allowed into the commerce of the United States. After this screening is 
completed, if PREDICT recommends the product be admitted into the 
United States, real time notification is provided to the importer or 
entry filer through OASIS.
    In addition to the entry information collected by CBP, the FDA uses 
additional data elements in order to make an admissibility decision. 
This information includes the following data elements:
    (1) FDA product code;
    (2) FDA country of production;
    (3) FDA-required information on the manufacturer and shipper; and
    (4) Ultimate consignee.
    Additionally, the FDA has identified data elements or Affirmation 
of Compliance (``A of C'') codes that an importer or entry filer may 
submit upon entry to help expedite the review process. For example, 
providing the registration number of the manufacture as an A of C may 
result in an immediate release of the product. Alternatively, an entry 
filed without the A of C code would be flagged for review and release 
may be delayed.
    If the FDA did not collect this data the agency could not 
adequately meet its statutory responsibilities to regulate imported 
products, nor control potentially dangerous products from entering the 
U.S. marketplace.
    This document announces CBP's plan to conduct a new test pilot 
concerning the submission of electronic FDA data elements required by 
the FDA's cargo admissibility process under the auspices of ACE for 
those commodities regulated by the FDA that are being imported or 
offered for import into the United States. This new FDA PGA Message Set 
capability will satisfy the FDA data requirements for formal and 
informal consumption entries through electronic filing in ACE and via 
the FDA PGA Message Set. This will enable the trade community to have a 
CBP-managed ``single window'' for the submission of data required by 
the FDA during the cargo importation and review process. For FDA-
regulated food products requiring prior notice, the necessary PGA data 
elements must be submitted prior to the time of arrival of the 
merchandise. The technical requirements for submitting FDA data 
elements are set forth in the supplemental Customs and Trade Automated 
Interface Requirements (CATAIR) guidelines for the FDA. These technical 
requirements, including the ACE CATAIR chapters, can be found at the 
following link: http://www.cbp.gov/trade/ace/catair#field-content-tab-group-tab-4.
    Upon successful completion of the FDA PGA Message Set test, it is 
anticipated that CBP will decommission the legacy ACS/OASIS interface 
for the new ACE/OASIS interface.

VI. Test Participant Responsibilities

    PGA Message Set test participants will be required to:
    (1) Transmit the appropriate ACE PGA Message Set data, including 
the additional data elements listed in Section V of this notice, for 
the commodities and the ports of entry based upon the implementation 
schedule found at the following link: http://www.cbp.gov/document/guidance/list-aceitds-pga-message-set-pilot-ports;
    (2) Transmit the PGA Message Set electronically to ACE using ACE 
Entry or ACE Entry Summary at any time prior to the arrival of the 
merchandise on the conveyance transporting the cargo to the United 
States;
    (3) Transmit PGA Message Set import filings only as part of an ACE 
Entry or ACE Entry Summary certified for cargo release;
    (4) Transmit import entry filings to CBP via ABI in response to a 
request for documentation or in response to a request for release 
information for certified ACE Entry Summaries;
    (5) Only transmit to CBP information that has been requested by 
either CBP or the FDA;
    (6) Use a software program that has completed ACE certification 
testing for the PGA Message Set; and
    (7) Take part in a CBP-FDA evaluation of this test.

VII. Waiver of Regulation Under the Test

    For purposes of this test, those provisions of 19 CFR part 12 that 
are inconsistent with the terms of this test are waived for test 
participants only. See 19 CFR 101.9(b). This document does not waive 
any recordkeeping requirements found in part 163 of title 19 of the 
Code of Federal Regulations (19 CFR part 163) and the Appendix to part 
163 (commonly known as the ``(a)(1)(A) list'').

VIII. Test Participation and Selection Criteria

    To be eligible to apply for this test, the applicant must:
    (1) Be a self-filing importer who has the ability to file ACE Entry 
Summaries certified for cargo release or a broker who has the ability 
to file ACE Entry Summaries certified for cargo release; and
    (2) File prior notices or entries for FDA-regulated commodities.
    Test participants must meet all the eligibility criteria described 
in this document in order to participate in the test program.

IX. Application Process

    Any party seeking to participate in the FDA PGA Message Set test 
should email their CBP Client Representative, ACE Business Office 
(ABO), Office of International Trade. Interested parties without an 
assigned client representative should submit an email message to Steven 
Zaccaro at [email protected] with the subject heading ``PGA 
Message Set FDA Test FRN--Request to Participate''. All email 
communications should include the subject heading, ``Request to 
Participate in the FDA PGA Message Test.''
    Email messages sent to the CBP client representative or Steven 
Zaccaro must include the applicant's filer code and the port(s) at 
which it is interested in filing the appropriate PGA Message Set 
information. Client representatives will work with test participants to 
provide information regarding the transmission of this data.
    CBP will begin to accept applications upon the date of publication 
of this notice and will continue to accept applications throughout the 
duration of the test. CBP will notify the selected applicants by an 
email message of their selection and the starting date of their 
participation. Selected participants may have different starting dates. 
Anyone providing incomplete information, or otherwise not meeting 
participation requirements, will be notified by an email message and 
given the opportunity to resubmit its application.

X. Test Duration

    The initial phase of the pilot test will begin no earlier than 
August 27, 2015. At the conclusion of the test pilot, an evaluation 
will be conducted to assess the effect that the FDA PGA Message Set has 
on expediting the submission of FDA importation-related data elements 
and the processing of FDA entries. The final results of the evaluation 
will be published in the Federal Register and the Customs Bulletin as 
required by Sec.  101.9(b)(2) of the CBP regulations (19 CFR 
101.9(b)(2)). Any future expansion in ACE including but not limited to 
any additional PGA commodities and eligible environments (i.e., truck, 
ocean, rail, air) will be announced via a separate Federal Register 
notice.

XI. Comments

    All interested parties are invited to comment on any aspect of this 
test at any time. CBP requests comments and

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feedback on all aspects of this test, including the design, conduct and 
implementation of the test, in order to determine whether to modify, 
alter, expand, limit, continue, end, or fully implement this program.

XII. Paperwork Reduction Act

    The collection of information contained in this FDA PGA Message Set 
test has been approved by the Office of Management and Budget (OMB) in 
accordance with the requirements of the Paperwork Reduction Act (44 
U.S.C. 3507) and assigned OMB control number 0910-0046. An agency may 
not conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a valid control number 
assigned by OMB.

XIII. Confidentiality

    Data submitted and entered into the ACE Portal includes information 
that is exempt or restricted from disclosure by law, such as by the 
Trade Secrets Act (18 U.S.C. 1905). As stated in previous notices, 
participation in this or any of the previous ACE tests is not 
confidential and upon a written Freedom of Information Act (FOIA) 
request, a name(s) of an approved participant(s) will be disclosed by 
CBP in accordance with 5 U.S.C. 552.

XIV. Misconduct Under the Test

    A test participant may be subject to civil and criminal penalties, 
administrative sanctions, liquidated damages, or discontinuance from 
participation in this test for any of the following:
    (1) Failure to follow the terms and conditions of this test;
    (2) Failure to exercise reasonable care in the execution of 
participant obligations;
    (3) Failure to abide by applicable laws and regulations that have 
not been waived; or
    (4) Failure to deposit duties or fees in a timely manner.
    If the Director, Business Transformation, ACE Business Office 
(ABO), Office of International Trade, finds that there is a basis for 
discontinuance of test participation privileges, the test participant 
will be provided a written notice proposing the discontinuance with a 
description of the facts or conduct warranting the action. The test 
participant will be offered the opportunity to appeal the Director's 
decision in writing within 10 calendar days of receipt of the written 
notice. The appeal must be submitted to Acting Executive Director, ABO, 
Office of International Trade, by emailing 
[email protected].
    The Acting Executive Director will issue a decision in writing on 
the proposed action within 30 working days after receiving a timely 
filed appeal from the test participant. If no timely appeal is 
received, the proposed notice becomes the final decision of the Agency 
as of the date that the appeal period expires. A proposed 
discontinuance of a test participant's privileges will not take effect 
unless the appeal process under this paragraph has been concluded with 
a written decision adverse to the test participant.
    In the case of willfulness or those in which public health, 
interest, or safety so requires, the Director, Business Transformation, 
ABO, Office of International Trade, may immediately discontinue the 
test participant's privileges upon written notice to the test 
participant. The notice will contain a description of the facts or 
conduct warranting the immediate action. The test participant will be 
offered the opportunity to appeal the Director's decision within 10 
calendar days of receipt of the written notice providing for immediate 
discontinuance. The appeal must be submitted to Acting Executive 
Director, ABO, Office of International Trade, by emailing 
[email protected]. The immediate discontinuance will remain 
in effect during the appeal period. The Executive Director will issue a 
decision in writing on the discontinuance within 15 working days after 
receiving a timely filed appeal from the test participant. If no timely 
appeal is received, the notice becomes the final decision of the Agency 
as of the date that the appeal period expires.

XV. Developments of ACE Prototypes

    A chronological listing of Federal Register publications detailing 
ACE test developments is set forth below:
     ACE Portal Accounts and Subsequent Revision Notices: 67 FR 
21800 (May 1, 2002); 69 FR 5360 and 69 FR 5362 (February 4, 2004); 69 
FR 54302 (September 8, 2004); 70 FR 5199 (February 1, 2005).
     ACE System of Records Notice: 71 FR 3109 (January 19, 
2006).
     Terms/Conditions for Access to the ACE Portal and 
Subsequent Revisions: 72 FR 27632 (May 16, 2007); 73 FR 38464 (July 7, 
2008).
     ACE Non-Portal Accounts and Related Notice: 70 FR 61466 
(October 24, 2005); 71 FR 15756 (March 29, 2006).
     ACE Entry Summary, Accounts and Revenue (ESAR I) 
Capabilities: 72 FR 59105 (October 18, 2007).
     ACE Entry Summary, Accounts and Revenue (ESAR II) 
Capabilities: 73 FR 50337 (August 26, 2008); 74 FR 9826 (March 6, 
2009).
     ACE Entry Summary, Accounts and Revenue (ESAR III) 
Capabilities: 74 FR 69129 (December 30, 2009).
     ACE Entry Summary, Accounts and Revenue (ESAR IV) 
Capabilities: 76 FR 37136 (June 24, 2011).
     Post-Entry Amendment (PEA) Processing Test: 76 FR 37136 
(June 24, 2011).
     ACE Announcement of a New Start Date for the National 
Customs Automation Program Test of Automated Manifest Capabilities for 
Ocean and Rail Carriers: 76 FR 42721 (July 19, 2011).
     ACE Simplified Entry: 76 FR 69755 (November 9, 2011).
     National Customs Automation Program (NCAP) Tests 
Concerning Automated Commercial Environment (ACE) Document Image System 
(DIS): 77 FR 20835 (April 6, 2012).
     National Customs Automation Program (NCAP) Tests 
Concerning Automated Commercial Environment (ACE) Simplified Entry: 
Modification of Participant Selection Criteria and Application Process: 
77 FR 48527 (August 14, 2012).
     Modification of NCAP Test Regarding Reconciliation for 
Filing Certain Post-Importation Preferential Tariff Treatment Claims 
under Certain FTAs: 78 FR 27984 (May 13, 2013).
     Modification of Two National Customs Automation Program 
(NCAP) Tests Concerning Automated Commercial Environment (ACE) Document 
Image System (DIS) and Simplified Entry (SE): 78 FR 44142 (July 23, 
2013).
     Modification of Two National Customs Automation Program 
(NCAP) Tests Concerning Automated Commercial Environment (ACE) Document 
Image System (DIS) and Simplified Entry (SE); Correction: 78 FR 53466 
(August 29, 2013).
     Modification of NCAP Test Concerning Automated Commercial 
Environment (ACE) Cargo Release (formerly known as Simplified Entry): 
78 FR 66039 (November 4, 2013).
     Post-Summary Corrections to Entry Summaries Filed in ACE 
Pursuant to the ESAR IV Test: Modifications and Clarifications: 78 FR 
69434 (November 19, 2013).
     National Customs Automation Program (NCAP) Test Concerning 
the Submission of Certain Data Required by the Environmental Protection 
Agency and the Food Safety and Inspection Service Using the Partner 
Government Agency Message Set Through the Automated Commercial 
Environment (ACE): 78 FR 75931 (December 13, 2013).

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     Modification of National Customs Automation Program (NCAP) 
Test Concerning Automated Commercial Environment (ACE) Cargo Release 
for Ocean and Rail Carriers: 79 FR 6210 (February 3, 2014).
     Modification of National Customs Automation Program (NCAP) 
Test Concerning Automated Commercial Environment (ACE) Cargo Release to 
Allow Importers and Brokers to Certify From ACE Entry Summary: 79 FR 
24744 (May 1, 2014).
     Modification of National Customs Automation Program (NCAP) 
Test Concerning Automated Commercial Environment (ACE) Cargo Release 
for Truck Carriers: 79 FR 25142 (May 2, 2014).
     Modification of National Customs Automation Program (NCAP) 
Test Concerning Automated Commercial Environment (ACE) Document Image 
System: 79 FR 36083 (June 25, 2014).
     Announcement of eBond Test: 79 FR 70881 (November 28, 
2014).
     eBond Test Modifications and Clarifications: Continuous 
Bond Executed Prior to or Outside the eBond Test May Be Converted to an 
eBond by the Surety and Principal, Termination of an eBond by Filing 
Identification Number, and Email Address Correction: 80 FR 899 (January 
7, 2015).
     Modification of National Customs Automation Program (NCAP) 
Test Concerning Automated Commercial Environment (ACE) Document Image 
System Relating to Animal and Plant Health Inspection Service (APHIS) 
Document Submissions: 80 FR 5126 (January 30, 2015).
     Modification of National Customs Automation Program (NCAP) 
Test Concerning the use of Partner Government Agency Message Set 
through the Automated Commercial Environment (ACE) for the Submission 
of Certain Data Required by the Environmental Protection Agency (EPA): 
80 FR 6098 (February 4, 2015).
     Announcement of Modification of ACE Cargo Release Test to 
Permit the Combined Filing of Cargo Release and Importer Security 
Filing (ISF) Data: 80 FR 7487 (February 10, 2015).
     Modification of NCAP Test Concerning ACE Cargo Release for 
Type 03 Entries and Advanced Capabilities for Truck Carriers: 80 FR 
16414 (March 27, 2015).
     Automated Commercial Environment (ACE) Export Manifest for 
Air Cargo Test: 80 FR 39790 (July 10, 2015).
     National Customs Automation Program (NCAP) Concerning 
Remote Location Filing Entry Procedures in the Automated Commercial 
Environment (ACE) and the Use of the Document Image System for the 
Submission of Invoices and the Use of eBonds for the Transmission of 
Single Transaction Bonds: 80 FR 40079 (July 13, 2015).

    Dated: August 24, 2015.
Brenda Smith,
Assistant Commissioner, Office of International Trade.
[FR Doc. 2015-21266 Filed 8-26-15; 8:45 am]
 BILLING CODE 9111-14-P