Notice of Issuance of Final Determination Concerning Certain Carbon Dioxide Sampling Line Products, 40772-40774 [2014-16424]
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Federal Register / Vol. 79, No. 134 / Monday, July 14, 2014 / Notices
State and county
Guadalupe .....
Guadalupe .....
Harris .............
Harris .............
Harris .............
Harris .............
Montgomery ...
Terrell .............
Location and
case No.
Chief executive officer of
community
City of Cibolo
The Honorable Lisa M.
(13–06–4035P).
Jackson, Mayor, City of
Cibolo, 200 South Main
Street, Cibolo, TX
78108.
Unincorporated
The Honorable Larry
Areas of GuaJones, Guadalupe
dalupe County
County Judge, 211
(13–06–4035P).
West Court Street,
Seguin, TX 78155.
City of Houston
The Honorable Annise D.
(13–06–2759P).
Parker, Mayor, City of
Houston, P.O. Box
1562, Houston, TX
77251.
Unincorporated
The Honorable Ed M. EmAreas of Harris
mett Harris, County
County (13–
Judge, 1001 Preston
06–2759P).
Street, Suite 911, Houston, TX 77002.
Unincorporated
The Honorable Ed M. EmAreas of Harris
mett Harris, County
County (13–
Judge, 1001 Preston
06–4636P).
Street, Suite 911, Houston, TX 77002.
Unincorporated
The Honorable Ed M. EmAreas of Harris
mett Harris, County
County (14–
Judge, 1001 Preston
06–1079P).
Street, Suite 911, Houston, TX 77002.
City of Conroe
The Honorable Webb K.
(13–06–3145P).
Melder, Mayor, City of
Conroe, P.O. Box 3066,
Conroe, TX 77305.
Unincorporated
The Honorable Santiago
Areas of
Flores, Terrell County
Terrell County
Judge, 105 East
(13–06–3003P).
Hackberry Street,
Sanderson, TX 79848.
(Catalog of Federal Domestic Assistance No.
97.022, ‘‘Flood Insurance.’’)
Dated: June 17, 2014.
Roy E. Wright,
Deputy Associate Administrator for
Mitigation, Department of Homeland
Security, Federal Emergency Management
Agency.
[FR Doc. 2014–16319 Filed 7–11–14; 8:45 am]
BILLING CODE 9110–12–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Internal Agency Docket No. FEMA–4175–
DR; Docket ID FEMA–2014–0003]
Mississippi; Amendment No. 4 to
Notice of a Major Disaster Declaration
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
mstockstill on DSK4VPTVN1PROD with NOTICES
AGENCY:
This notice amends the notice
of a major disaster declaration for State
of Mississippi (FEMA–4175–DR), dated
May 12, 2014, and related
determinations.
DATES: Effective Date: June 27, 2014.
SUMMARY:
VerDate Mar<15>2010
19:25 Jul 11, 2014
Jkt 232001
Community map
repository
Online location of letter of map
revision
Effective date of
modification
200 South Main Street,
Cibolo, TX 78108.
https://www.msc.fema.gov/lomc
September 3,
2014.
480267
Guadalupe County, 2605
North Guadalupe
Street, Seguin, TX
78155.
https://www.msc.fema.gov/lomc
September 3,
2014.
480266
Public Works and Engineering Department,
611 Walker Street,
Houston, TX 77002.
https://www.msc.fema.gov/lomc
September 15,
2014.
480296
Harris County, 10555
Northwest Freeway,
Houston, TX 77092.
https://www.msc.fema.gov/lomc
September 15,
2014.
480287
Harris County, 10555
Northwest Freeway,
Houston, TX 77092.
https://www.msc.fema.gov/lomc
August 21, 2014
480287
Harris County, 10555
Northwest Freeway,
Houston, TX 77092.
https://www.msc.fema.gov/lomc
September 15,
2014.
480287
City Hall, 505 West Davis
Street, Conroe, TX
77301.
https://www.msc.fema.gov/lomc
August 21, 2014
480484
Terrell County Courthouse, County Clerk’s
Office, 105 East
Hackberry Street,
Sanderson, TX 79848.
https://www.msc.fema.gov/lomc
September 26,
2014.
480619
FOR FURTHER INFORMATION CONTACT:
Dean Webster, Office of Response and
Recovery, Federal Emergency
Management Agency, 500 C Street SW.,
Washington, DC 20472, (202) 646–2833.
SUPPLEMENTARY INFORMATION: The
Federal Emergency Management Agency
(FEMA) hereby gives notice that
pursuant to the authority vested in the
Administrator, under Executive Order
12148, as amended, Terry L. Quarles, of
FEMA is appointed to act as the Federal
Coordinating Officer for this disaster.
This action terminates the
appointment of Mark H. Landry as
Federal Coordinating Officer for this
disaster.
The following Catalog of Federal Domestic
Assistance Numbers (CFDA) are to be used
for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora
Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034,
Disaster Unemployment Assistance (DUA);
97.046, Fire Management Assistance Grant;
97.048, Disaster Housing Assistance to
Individuals and Households In Presidentially
Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance—
Disaster Housing Operations for Individuals
and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals
and Households—Other Needs; 97.036,
Disaster Grants—Public Assistance
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
Community
No.
(Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.
W. Craig Fugate,
Administrator, Federal Emergency
Management Agency.
[FR Doc. 2014–16321 Filed 7–11–14; 8:45 am]
BILLING CODE 9111–23–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Notice of Issuance of Final
Determination Concerning Certain
Carbon Dioxide Sampling Line
Products
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: Notice of final determination.
AGENCY:
This document provides
notice that U.S. Customs and Border
Protection (‘‘CBP’’) has issued a final
determination concerning the country of
origin of certain carbon dioxide
sampling line products known as
‘‘FilterLine’’ and ‘‘CapnoLine.’’ Based
upon the facts presented, CBP has
concluded that Israel is the country of
SUMMARY:
E:\FR\FM\14JYN1.SGM
14JYN1
Federal Register / Vol. 79, No. 134 / Monday, July 14, 2014 / Notices
origin for purposes of U.S. Government
procurement.
DATES: The final determination was
issued on July 8, 2014. A copy of the
final determination is attached. Any
party-at-interest, as defined in 19 CFR
177.22(d), may seek judicial review of
this final determination within August
13, 2014.
FOR FURTHER INFORMATION CONTACT:
Grace A. Kim, Valuation and Special
Programs Branch, Regulations and
Rulings, Office of International Trade
(202) 325–7941.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that on July 8, 2014
pursuant to subpart B of Part 177, U.S.
Customs and Border Protection
Regulations (19 CFR part 177, subpart
B), CBP issued a final determination
concerning the country of origin of
certain carbon dioxide sampling line
products known as ‘‘FilterLine’’ and
‘‘CapnoLine,’’ which may be offered to
the U.S. Government under an
undesignated government procurement
contract. This final determination, HQ
H248851, was issued under procedures
set forth at 19 CFR part 177, subpart B,
which implements Title III of the Trade
Agreements Act of 1979, as amended
(19 U.S.C. 2511–18). In the final
determination, CBP concluded that,
based upon the facts presented, the
assembly operations performed in
China, using Israeli components, do not
substantially transform the sampling
line components. Therefore, the country
of origin is Israel for purposes of U.S.
Government procurement.
Section 177.29, CBP Regulations (19
CFR 177.29), provides that a notice of
final determination shall be published
in the Federal Register within 60 days
of the date the final determination is
issued. Section 177.30, CBP Regulations
(19 CFR 177.30), provides that any
party-at-interest, as defined in 19 CFR
177.22(d), may seek judicial review of a
final determination within 30 days of
publication of such determination in the
Federal Register.
Dated: July 8, 2014.
Sandra L. Bell,
Executive Director, Regulations and Rulings,
Office of International Trade.
Attachment
mstockstill on DSK4VPTVN1PROD with NOTICES
HQ H248851
July 8, 2014
OT:RR:CTF:VS H248851 GaK
CATEGORY: Origin
Michelle L. Butler
Hyman, Phelps & McNamara, P.C.
700 13th Street NW., Suite 1200
Washington, DC 20005.
VerDate Mar<15>2010
19:25 Jul 11, 2014
Jkt 232001
RE: U.S. Government Procurement;
Country of Origin of FilterLine Set
and CapnoLine; Substantial
Transformation
Dear Ms. Butler:
This is in response to your letter,
dated November 6, 2013, requesting a
final determination on behalf of Oridion
Medical 1987 Ltd. (‘‘Oridion’’), pursuant
to subpart B of part 177 of the U.S.
Customs and Border Protection (‘‘CBP’’)
Regulations (19 CFR part 177). Under
these regulations, which implement
Title III of the Trade Agreements Act of
1979 (‘‘TAA’’), as amended (19 U.S.C.
§ 2511 et seq.), CBP issues country of
origin advisory rulings and final
determinations as to whether an article
is or would be a product of a designated
country or instrumentality for the
purposes of granting waivers of certain
‘‘Buy American’’ restrictions in U.S. law
or practice for products offered for sale
to the U.S. Government. Your letter was
forwarded to this office by the National
Commodity Specialist Division on
December 12, 2013. By letters dated
February 19, May 15, and May 28, 2014,
additional explanation was provided for
our consideration in connection with
the request for a final determination.
This final determination concerns the
country of origin of Oridion’s carbon
dioxide sampling lines, specifically the
FilterLine Set Adult/Pediatric
(‘‘FilterLine’’) and the Smart CapnoLine
H Plus O2 (‘‘CapnoLine’’). We note that
as a foreign manufacturer of the
products at issue, Oridion is a party-atinterest within the meaning of 19 CFR
§ 177.22(d)(1) and is entitled to request
this final determination. Photographs
were submitted with your request.
FACTS
The products at issue are referred to
as carbon dioxide (‘‘CO2’’) sampling
lines: medical devices designed to carry
a patient’s breath to a monitor. Each
sampling line includes tubing, a means
of connecting to the patient, referred to
as the patient interface, and a means of
connection to a monitor.
These sampling lines are classified
into two product families: (1) The
Filterline set sampling lines for
intubated patients, designed to connect
to ventilator tubing carrying oxygenated
air from a ventilator to a patient through
an airway adaptor, and (2) the
Capnoline sets for non-intubated
patients, which provide a nasal or oral/
nasal ‘‘interface’’ for the patient.
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
40773
FilterLine
The components of the FilterLine
include:
(1) CO2 tube (manufactured in Israel
and cut to length in China),
(2) Universal Airway Adapter
(manufactured in China), and
(3) Quick Seal Connector (itself
assembled in China using an Israeli
origin Quick Seal Filter Housing,
Chinese origin Hollofiber and an end
connector called the Quick Seal LD
Orange Golden).
The Hollofiber is a fiber membrane
filter that prevents liquids, particles, or
bacteria from reaching the monitor
which can contaminate the breath
sample. The Hollofiber is placed inside
the Quick Seal Filter Housing, which is
connected to the Quick Seal LD Orange
Golden. The Universal Airway Adapter
is connected to the CO2 tube and the
Quick Seal Connector is adhered to the
other end of the CO2 tube.
The CO2 tube delivers the patient’s
breath to the monitor, which you claim
is the essential function of the finished
product. The tube is of a patented
design. In order to prevent blockage
from mucus and blood, the tube must be
able to handle moisture in a very precise
manner. In addition, the tube’s diameter
cannot be too narrow, which would
increase the likelihood of blockage, or
too wide, which would create a delay in
measurements. The FilterLine is
assembled in China. It is then sent to
Israel for quality control, final
inspections, and packaging.
CapnoLine
The Components of the CapnoLine
Include
(1) CO2 tube (manufactured in Israel
and cut to length in China),
(2) Cannula, which is connected to
the patient (manufactured in Israel),
(3) Quick Seal Connector (itself
assembled in China using an Israeli
origin Quick Seal Filter Housing,
Chinese origin Hollofiber and an end
connector called the Quick Seal LD
Yellow Golden),
(4) O2 tube (manufactured in Israel
and cut to length in Israel),
(5) Miscellaneous tubing
(manufactured in Israel),
(6) Nafion dryer, used to reduce the
humidity of the breath (manufactured in
the U.S.),
(9) connector/slides to hold the O2
and CO2 tubing in place (manufactured
in China).
In China, the cannula is connected to
the Nafion dryer on the right side and
to the tubing on the left side. The other
end of the Nafion dryer is attached to
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40774
Federal Register / Vol. 79, No. 134 / Monday, July 14, 2014 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
the CO2 tube. The CO2 tube and the
miscellaneous tubing from the Cannula
are held together with a connector/slide
and connected to the O2 tube. Then, the
Quick Seal Connector, is attached to the
end of the CO2 tube.
As with the FilterLine, the CO2 tube
and in this case the O2 tube deliver the
patient’s breath to the monitor, which
you claim is the essential function of the
finished product. The finished
CapnoLine is sent to Israel for quality
control and packaging.
LAW AND ANALYSIS:
Pursuant to Subpart B of Part 177, 19
CFR § 177.21 et seq., which implements
Title III of the Trade Agreements Act of
1979, as amended (19 U.S.C. § 2511 et
seq.), CBP issues country of origin
advisory rulings and final
determinations as to whether an article
is or would be a product of a designated
country or instrumentality for the
purposes of granting waivers of certain
‘‘Buy American’’ restrictions in U.S. law
or practice for products offered for sale
to the U.S. Government.
Under the rule of origin set forth
under 19 U.S.C. § 2518(4)(B):
An article is a product of a country or
instrumentality only if (i) it is wholly
the growth, product, or manufacture of
that country or instrumentality, or (ii) in
the case of an article which consists in
whole or in part of materials from
another country or instrumentality, it
has been substantially transformed into
a new and different article of commerce
with a name, character, or use distinct
from that of the article or articles from
which it was so transformed.
See also 19 CFR § 177.22(a).
In order to determine whether a
substantial transformation occurs when
components of various origins are
assembled into completed products,
CBP considers the totality of the
circumstances and makes such
determinations on a case-by-case basis.
The country of origin of the item’s
components, extent of the processing
that occurs within a country, and
whether such processing renders a
product with a new name, character,
and use are primary considerations in
such cases. No one factor is decisive, the
key issue is the extent of operations
performed and whether the parts lose
their identity and become an integral
part of the new article. Belcrest Linens
v. United States, 573 F.Supp. 1149 (Ct.
Int’l Trade 1983), aff’d, 741 F.2d 1368
(Fed. Cir. 1984). Assembly operations
that are minimal or simple, as opposed
to complex or meaningful, will
generally not result in a substantial
transformation. See C.S.D. 80–111,
C.S.D. 85–25, C.S.D. 89–110, C.S.D. 89–
VerDate Mar<15>2010
19:25 Jul 11, 2014
Jkt 232001
118, C.S.D. 90–51, and C.S.D. 90–97.
Additionally factors such as the
resources expended on product design
and development, extent and nature of
post-assembly inspection and testing
procedures, and the degree of skill
required during the actual
manufacturing process may be relevant
when determining whether a substantial
transformation has occurred.
In HQ 560613, dated October 28,
1997, CBP held that U.S.-origin
components were not substantially
transformed in Ireland when made into
a pregnancy test kit. The test kit was
made from the following U.S.
components: top and bottom housing,
paper, antibody, wick, laminate, and
nitrocellulose. In addition, a splash
guard from Ireland and rayon from
Germany was used. The critical
components of the pregnancy test kit
were found to be the three U.S.-origin
antibodies. CBP recognized that the
U.S.-origin components imparted the
essential character of the pregnancy test
kit and that the simple assembly of
placing the antibodies onto the rayon
membrane, and subsequent assembly of
the strips into a plastic housing did not
result in a substantial transformation.
FilterLine
You believe that the country of origin
of the FilterLine is Israel because it is
the country in which the CO2 tube was
manufactured. We agree that the CO2
tube performs the essential function of
the finished product, which is the
delivery of breath for monitoring the
CO2 level in a patient’s breath. The
assembly process in China consists of
cutting to length and attaching the CO2
tube with four other components from
Israel and China. Under the described
assembly process, the CO2 tube is
attached to other components that
facilitate its function and it does not
lose its individual identity. Consistent
with HQ 560613, we find that the Israelorigin CO2 tube is not substantially
transformed by the cutting to length and
assembly operations performed in China
to produce the FilterLine. We conclude,
based upon these specific facts, that the
country of origin of the FilterLine for
purposes of U.S. Government
procurement is Israel.
CapnoLine
You believe that the country of origin
of the CapnoLine is Israel because it is
the country in which the CO2 tube and
O2 tube were manufactured. As with the
FilterLine, the CO2 tube and O2 tubes in
the CapnoLine perform the essential
function, which is the delivery of breath
for monitoring the CO2 level in a
patient’s breath while delivering O2 to
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
the patient. The assembly process in
China consists of cutting to length and
connecting the CO2 tube to several
different components from Israel, U.S.
and China by inserting components and
adhering them with a solvent. The CO2
tube is not physically altered, aside
from being cut to length. Based on the
information before us, and consistent
with HQ 560613, we find that the Israelorigin CO2 tube and the O2 tube impart
the essential character of the CapnoLine
and is not substantially transformed by
the assembly operations performed in
China. We note that the Cannula and
Quick Seal Filter Housing are also of
Israeli origin. Therefore, based upon
these specific facts, the country of origin
of the CapnoLine for purposes of U.S.
Government procurement is Israel.
HOLDING
The FilterLine and the CapnoLine are
not substantially transformed when they
are assembled in China with Israeli and
U.S. components. As a result, the
country of origin of Oridion’s sampling
lines, specifically the FilterLine and the
CapnoLine, for purposes of U.S.
Government procurement is Israel.
Notice of this final determination will
be given in the Federal Register, as
required by 19 CFR § 177.29. Any partyat-interest other than the party which
requested this final determination may
request, pursuant to 19 CFR § 177.31,
that CBP reexamine the matter anew
and issue a new final determination.
Pursuant to 19 CFR § 177.30, any partyat-interest may, within 30 days of
publication of the Federal Register
Notice referenced above, seek judicial
review of this final determination before
the Court of International Trade.
Sincerely,
Sandra L. Bell,
Executive Director,
Regulations and Rulings, Office of
International Trade.
[FR Doc. 2014–16424 Filed 7–11–14; 8:45 am]
BILLING CODE 9111–14–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–5752–N–56]
30-Day Notice of Proposed Information
Collection: Record of Employee
Interview
Office of the Chief Information
Officer, HUD.
ACTION: Notice.
AGENCY:
HUD has submitted the
proposed information collection
requirement described below to the
SUMMARY:
E:\FR\FM\14JYN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 134 (Monday, July 14, 2014)]
[Notices]
[Pages 40772-40774]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16424]
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
U.S. Customs and Border Protection
Notice of Issuance of Final Determination Concerning Certain
Carbon Dioxide Sampling Line Products
AGENCY: U.S. Customs and Border Protection, Department of Homeland
Security.
ACTION: Notice of final determination.
-----------------------------------------------------------------------
SUMMARY: This document provides notice that U.S. Customs and Border
Protection (``CBP'') has issued a final determination concerning the
country of origin of certain carbon dioxide sampling line products
known as ``FilterLine'' and ``CapnoLine.'' Based upon the facts
presented, CBP has concluded that Israel is the country of
[[Page 40773]]
origin for purposes of U.S. Government procurement.
DATES: The final determination was issued on July 8, 2014. A copy of
the final determination is attached. Any party-at-interest, as defined
in 19 CFR 177.22(d), may seek judicial review of this final
determination within August 13, 2014.
FOR FURTHER INFORMATION CONTACT: Grace A. Kim, Valuation and Special
Programs Branch, Regulations and Rulings, Office of International Trade
(202) 325-7941.
SUPPLEMENTARY INFORMATION: Notice is hereby given that on July 8, 2014
pursuant to subpart B of Part 177, U.S. Customs and Border Protection
Regulations (19 CFR part 177, subpart B), CBP issued a final
determination concerning the country of origin of certain carbon
dioxide sampling line products known as ``FilterLine'' and
``CapnoLine,'' which may be offered to the U.S. Government under an
undesignated government procurement contract. This final determination,
HQ H248851, was issued under procedures set forth at 19 CFR part 177,
subpart B, which implements Title III of the Trade Agreements Act of
1979, as amended (19 U.S.C. 2511-18). In the final determination, CBP
concluded that, based upon the facts presented, the assembly operations
performed in China, using Israeli components, do not substantially
transform the sampling line components. Therefore, the country of
origin is Israel for purposes of U.S. Government procurement.
Section 177.29, CBP Regulations (19 CFR 177.29), provides that a
notice of final determination shall be published in the Federal
Register within 60 days of the date the final determination is issued.
Section 177.30, CBP Regulations (19 CFR 177.30), provides that any
party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial
review of a final determination within 30 days of publication of such
determination in the Federal Register.
Dated: July 8, 2014.
Sandra L. Bell,
Executive Director, Regulations and Rulings, Office of International
Trade.
Attachment
HQ H248851
July 8, 2014
OT:RR:CTF:VS H248851 GaK
CATEGORY: Origin
Michelle L. Butler
Hyman, Phelps & McNamara, P.C.
700 13th Street NW., Suite 1200
Washington, DC 20005.
RE: U.S. Government Procurement; Country of Origin of FilterLine Set
and CapnoLine; Substantial Transformation
Dear Ms. Butler:
This is in response to your letter, dated November 6, 2013,
requesting a final determination on behalf of Oridion Medical 1987 Ltd.
(``Oridion''), pursuant to subpart B of part 177 of the U.S. Customs
and Border Protection (``CBP'') Regulations (19 CFR part 177). Under
these regulations, which implement Title III of the Trade Agreements
Act of 1979 (``TAA''), as amended (19 U.S.C. Sec. 2511 et seq.), CBP
issues country of origin advisory rulings and final determinations as
to whether an article is or would be a product of a designated country
or instrumentality for the purposes of granting waivers of certain
``Buy American'' restrictions in U.S. law or practice for products
offered for sale to the U.S. Government. Your letter was forwarded to
this office by the National Commodity Specialist Division on December
12, 2013. By letters dated February 19, May 15, and May 28, 2014,
additional explanation was provided for our consideration in connection
with the request for a final determination.
This final determination concerns the country of origin of
Oridion's carbon dioxide sampling lines, specifically the FilterLine
Set Adult/Pediatric (``FilterLine'') and the Smart CapnoLine H Plus
O2 (``CapnoLine''). We note that as a foreign manufacturer
of the products at issue, Oridion is a party-at-interest within the
meaning of 19 CFR Sec. 177.22(d)(1) and is entitled to request this
final determination. Photographs were submitted with your request.
FACTS
The products at issue are referred to as carbon dioxide
(``CO2'') sampling lines: medical devices designed to carry
a patient's breath to a monitor. Each sampling line includes tubing, a
means of connecting to the patient, referred to as the patient
interface, and a means of connection to a monitor.
These sampling lines are classified into two product families: (1)
The Filterline set sampling lines for intubated patients, designed to
connect to ventilator tubing carrying oxygenated air from a ventilator
to a patient through an airway adaptor, and (2) the Capnoline sets for
non-intubated patients, which provide a nasal or oral/nasal
``interface'' for the patient.
FilterLine
The components of the FilterLine include:
(1) CO2 tube (manufactured in Israel and cut to length
in China),
(2) Universal Airway Adapter (manufactured in China), and
(3) Quick Seal Connector (itself assembled in China using an
Israeli origin Quick Seal Filter Housing, Chinese origin Hollofiber and
an end connector called the Quick Seal LD Orange Golden).
The Hollofiber is a fiber membrane filter that prevents liquids,
particles, or bacteria from reaching the monitor which can contaminate
the breath sample. The Hollofiber is placed inside the Quick Seal
Filter Housing, which is connected to the Quick Seal LD Orange Golden.
The Universal Airway Adapter is connected to the CO2 tube
and the Quick Seal Connector is adhered to the other end of the
CO2 tube.
The CO2 tube delivers the patient's breath to the
monitor, which you claim is the essential function of the finished
product. The tube is of a patented design. In order to prevent blockage
from mucus and blood, the tube must be able to handle moisture in a
very precise manner. In addition, the tube's diameter cannot be too
narrow, which would increase the likelihood of blockage, or too wide,
which would create a delay in measurements. The FilterLine is assembled
in China. It is then sent to Israel for quality control, final
inspections, and packaging.
CapnoLine
The Components of the CapnoLine Include
(1) CO2 tube (manufactured in Israel and cut to length
in China),
(2) Cannula, which is connected to the patient (manufactured in
Israel),
(3) Quick Seal Connector (itself assembled in China using an
Israeli origin Quick Seal Filter Housing, Chinese origin Hollofiber and
an end connector called the Quick Seal LD Yellow Golden),
(4) O2 tube (manufactured in Israel and cut to length in
Israel),
(5) Miscellaneous tubing (manufactured in Israel),
(6) Nafion dryer, used to reduce the humidity of the breath
(manufactured in the U.S.),
(9) connector/slides to hold the O2 and CO2
tubing in place (manufactured in China).
In China, the cannula is connected to the Nafion dryer on the right
side and to the tubing on the left side. The other end of the Nafion
dryer is attached to
[[Page 40774]]
the CO2 tube. The CO2 tube and the miscellaneous
tubing from the Cannula are held together with a connector/slide and
connected to the O2 tube. Then, the Quick Seal Connector, is
attached to the end of the CO2 tube.
As with the FilterLine, the CO2 tube and in this case
the O2 tube deliver the patient's breath to the monitor,
which you claim is the essential function of the finished product. The
finished CapnoLine is sent to Israel for quality control and packaging.
LAW AND ANALYSIS:
Pursuant to Subpart B of Part 177, 19 CFR Sec. 177.21 et seq.,
which implements Title III of the Trade Agreements Act of 1979, as
amended (19 U.S.C. Sec. 2511 et seq.), CBP issues country of origin
advisory rulings and final determinations as to whether an article is
or would be a product of a designated country or instrumentality for
the purposes of granting waivers of certain ``Buy American''
restrictions in U.S. law or practice for products offered for sale to
the U.S. Government.
Under the rule of origin set forth under 19 U.S.C. Sec.
2518(4)(B):
An article is a product of a country or instrumentality only if (i)
it is wholly the growth, product, or manufacture of that country or
instrumentality, or (ii) in the case of an article which consists in
whole or in part of materials from another country or instrumentality,
it has been substantially transformed into a new and different article
of commerce with a name, character, or use distinct from that of the
article or articles from which it was so transformed.
See also 19 CFR Sec. 177.22(a).
In order to determine whether a substantial transformation occurs
when components of various origins are assembled into completed
products, CBP considers the totality of the circumstances and makes
such determinations on a case-by-case basis. The country of origin of
the item's components, extent of the processing that occurs within a
country, and whether such processing renders a product with a new name,
character, and use are primary considerations in such cases. No one
factor is decisive, the key issue is the extent of operations performed
and whether the parts lose their identity and become an integral part
of the new article. Belcrest Linens v. United States, 573 F.Supp. 1149
(Ct. Int'l Trade 1983), aff'd, 741 F.2d 1368 (Fed. Cir. 1984). Assembly
operations that are minimal or simple, as opposed to complex or
meaningful, will generally not result in a substantial transformation.
See C.S.D. 80-111, C.S.D. 85-25, C.S.D. 89-110, C.S.D. 89-118, C.S.D.
90-51, and C.S.D. 90-97. Additionally factors such as the resources
expended on product design and development, extent and nature of post-
assembly inspection and testing procedures, and the degree of skill
required during the actual manufacturing process may be relevant when
determining whether a substantial transformation has occurred.
In HQ 560613, dated October 28, 1997, CBP held that U.S.-origin
components were not substantially transformed in Ireland when made into
a pregnancy test kit. The test kit was made from the following U.S.
components: top and bottom housing, paper, antibody, wick, laminate,
and nitrocellulose. In addition, a splash guard from Ireland and rayon
from Germany was used. The critical components of the pregnancy test
kit were found to be the three U.S.-origin antibodies. CBP recognized
that the U.S.-origin components imparted the essential character of the
pregnancy test kit and that the simple assembly of placing the
antibodies onto the rayon membrane, and subsequent assembly of the
strips into a plastic housing did not result in a substantial
transformation.
FilterLine
You believe that the country of origin of the FilterLine is Israel
because it is the country in which the CO2 tube was
manufactured. We agree that the CO2 tube performs the
essential function of the finished product, which is the delivery of
breath for monitoring the CO2 level in a patient's breath.
The assembly process in China consists of cutting to length and
attaching the CO2 tube with four other components from
Israel and China. Under the described assembly process, the
CO2 tube is attached to other components that facilitate its
function and it does not lose its individual identity. Consistent with
HQ 560613, we find that the Israel-origin CO2 tube is not
substantially transformed by the cutting to length and assembly
operations performed in China to produce the FilterLine. We conclude,
based upon these specific facts, that the country of origin of the
FilterLine for purposes of U.S. Government procurement is Israel.
CapnoLine
You believe that the country of origin of the CapnoLine is Israel
because it is the country in which the CO2 tube and
O2 tube were manufactured. As with the FilterLine, the
CO2 tube and O2 tubes in the CapnoLine perform
the essential function, which is the delivery of breath for monitoring
the CO2 level in a patient's breath while delivering
O2 to the patient. The assembly process in China consists of
cutting to length and connecting the CO2 tube to several
different components from Israel, U.S. and China by inserting
components and adhering them with a solvent. The CO2 tube is
not physically altered, aside from being cut to length. Based on the
information before us, and consistent with HQ 560613, we find that the
Israel-origin CO2 tube and the O2 tube impart the
essential character of the CapnoLine and is not substantially
transformed by the assembly operations performed in China. We note that
the Cannula and Quick Seal Filter Housing are also of Israeli origin.
Therefore, based upon these specific facts, the country of origin of
the CapnoLine for purposes of U.S. Government procurement is Israel.
HOLDING
The FilterLine and the CapnoLine are not substantially transformed
when they are assembled in China with Israeli and U.S. components. As a
result, the country of origin of Oridion's sampling lines, specifically
the FilterLine and the CapnoLine, for purposes of U.S. Government
procurement is Israel.
Notice of this final determination will be given in the Federal
Register, as required by 19 CFR Sec. 177.29. Any party-at-interest
other than the party which requested this final determination may
request, pursuant to 19 CFR Sec. 177.31, that CBP reexamine the matter
anew and issue a new final determination. Pursuant to 19 CFR Sec.
177.30, any party-at-interest may, within 30 days of publication of the
Federal Register Notice referenced above, seek judicial review of this
final determination before the Court of International Trade.
Sincerely,
Sandra L. Bell,
Executive Director,
Regulations and Rulings, Office of International Trade.
[FR Doc. 2014-16424 Filed 7-11-14; 8:45 am]
BILLING CODE 9111-14-P
