Notice of Issuance of Final Determination Concerning Wound Therapy System, 38718-38721 [2015-16553]
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Federal Register / Vol. 80, No. 129 / Tuesday, July 7, 2015 / Notices
Selection of Interventions for Review
SAMHSA will select interventions for
review from among submissions
meeting the minimum requirements. In
selecting interventions for review,
SAMHSA may give special
consideration to interventions that meet
one or more of the following conditions:
• More than one research study or
evaluation has been conducted on the
same or a similar target population that
meets the minimum requirements.
• The intervention targets
underserved populations (e.g., minority
populations, tribal communities or
American Indian/Alaska Native
populations, elderly individuals, young
adults, individuals who are
incarcerated, etc.).
• Dissemination and implementation
materials (e.g., program or practice
manuals, training guides, measurement
instruments, implementation fidelity
tools) are available. Lower costs and nocost materials may be prioritized.
• The intervention contributes to a
content area in which few evidencebased interventions have been
previously identified.
Interventions that are not selected for
review may be resubmitted by the
applicant in a future open submission
period.
tkelley on DSK3SPTVN1PROD with NOTICES
The Review Process
The review process has been revised
to improve the quality of the reviews
and utility of information that NREPP
can provide its users. In addition to
articles and reports submitted by NREPP
applicants, additional studies, articles,
and evaluation reports regarding the
interventions will be identified through
literature searches. Studies and
outcomes to be reviewed will be
determined through the systematic
application of standardized screening
criteria, and the number of studies and
outcomes to be reviewed will be
expanded to more comprehensively
represent the evidence base for the
program or practice. Inclusion of studies
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studies and outcomes that meet the
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and non-significant effects. Programs
and practices will be assessed on the
basis of evaluation studies of program or
practice impact, information related to
conceptual framework (that is, program
or practice goals, theory of change, and
program or practice components), and
information about implementation
fidelity (that is, whether a study
employs quality assurance measures to
declare that the program or practice is
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delivered as intended to the program’s
or practice’s target population).
The methodological rigor (that is,
internal validity, statistical validity, and
measurement validity) of the research
for each program or practice will be
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examined, along with the magnitude
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rigor of the research examining the
program or practice, and the ratings will
be displayed on the NREPP Web site.
In general, each NREPP evidence
review will be conducted by two trained
and certified reviewers. However, based
on funding and available resources,
SAMHSA use one reviewer for programs
and practices being re-reviewed. When
necessary, NREPP may conduct author
queries to confirm or gather additional
information needed for the review.
Program and practice profiles will be
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Dissemination and implementation
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or practice, highlighting information
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users, will be included in the program
or practice profile, along with
information documenting the extent to
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Programs and practices currently
posted on NREPP will be re-reviewed as
time and resources permit but the rereviews of currently posted programs
and practices will take place over the
next few years.
Detailed information about the
revised review process will be available
at https://www.nrepp.samhsa.gov after
the re-launch of the new NREPP Web
site.
Enhancing the Learning Center
NREPP’s Learning Center is a
developing and underutilized
component of the NREPP Web site. With
the evolution and enhancement of the
registry, SAMHSA seeks to bring greater
recognition to both rigorously evaluated
behavioral health interventions and
those interventions that have been
implemented, demonstrate promise, but
have not necessarily been evaluated in
a rigorous manner. To that end, the
Learning Center is being significantly
revamped to support stakeholder
engagement and to become a shared
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learning environment for all
stakeholders. SAMHSA recognizes that
the successful promotion and
dissemination of evidence-based
programs and practices requires an
environment that promotes community
assessment, program and practice
planning and evaluation, as well as
guidance on the selection and
implementation of programs and
practices listed on NREPP. There are
useful types of evaluation research,
often conducted among underserved
populations, which provide valuable
insights for practitioners, but do not
meet the minimum criteria required for
experimental or quasi-experimental
design. SAMHSA intends the Learning
Center to be a forum for presenting
research on emerging programs and
practices, and exploring ways that preexperimental and qualitative research
can complement and enrich findings
from experimental and quasiexperimental research designs. An
inventory of such programs and
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of reviewed programs and practices
with experimental and quasiexperimental designs. In this way,
SAMHSA intends to support programs
and practices researched with the most
rigorous approaches while also
supporting the development of practicebased evidence, especially for certain
populations and emerging practices that
are critical to learning and improving
behavioral health outcomes for persons
with or at risk of developing behavioral
health issues.
Summer King,
Statistician.
[FR Doc. 2015–16573 Filed 7–6–15; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Notice of Issuance of Final
Determination Concerning Wound
Therapy System
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 the PICO single use negative
pressure wound therapy system
manufactured and distributed by Smith
SUMMARY:
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Federal Register / Vol. 80, No. 129 / Tuesday, July 7, 2015 / Notices
& Nephew. Based upon the facts
presented, CBP has concluded that the
United Kingdom will be the country of
origin of the PICO single use negative
pressure wound therapy system (‘‘PICO
NPWT System’’) for purposes of U.S.
Government procurement.
The final determination was
issued on June 30, 2015. 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
6, 2015.
DATES:
FOR FURTHER INFORMATION CONTACT:
Antonio J. Rivera, Valuation and Special
Programs Branch, Regulations and
Rulings, Office of International Trade
(202) 325–0226.
Notice is
hereby given that on June 30, 2015
pursuant to subpart B of part 177, U.S.
Customs and Border Protection
Regulations (19 CFR part 177, subpart
B), CBP has issued a final determination
concerning the country of origin of the
PICO NPWT System manufactured and
distributed by Smith & Nephew, which
may be offered to the U.S. Government
under an undesignated government
procurement contract. This final
determination, HQ H259473, was issued
under procedures set forth at 19 CFR
part 177, subpart B, which implements
Title III of the Trade Agreement Act of
1979, as amended (19 U.S.C. 2511–18).
In the final determination, under the
totality of the circumstances,
considering the PICO NPWT System’s
use as a single medical instrument, the
origin of the dressings, and the flash
programming and final assembly of the
pump, which will be performed in the
U.K., and will change the pump into a
specialized pump that can only be used
with its respective dressings, CBP
concluded that the country of origin of
the PICO NPWT System will be the
United Kingdom 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.
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SUPPLEMENTARY INFORMATION:
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Dated: June 30, 2015.
Harold Singer,
Acting Executive Director, Regulations and
Rulings, Office of International Trade.
HQ H259473
June 30, 2015
OT:RR:CTF:VS H259473 AJR
CATEGORY: Origin
Daniel S. Char, Esq.
Associate General Counsel (Commercial)
Smith and Nephew, PLC
150 Minuteman Road
Andover, MA 01810
RE: Trade Agreements Act; Government
Procurement; Country of Origin of the
PICO Single Use Negative Pressure
Wound Therapy System
Dear Mr. Char:
This is in response to your letter, dated
November 19, 2014, requesting a final
determination on behalf of Smith & Nephew,
PLC (‘‘Smith & Nephew’’), 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.
This final determination concerns the
country of origin of Smith & Nephew’s PICO
Single Use Negative Pressure Wound
Therapy System (‘‘PICO NPWT System’’). As
the manufacturer and U.S. importer, Smith &
Nephew is a party-at-interest within the
meaning of 19 CFR 177.22(d)(1) and is
entitled to request this final determination. In
addition, we have reviewed and grant the
request for confidentiality pursuant to 19
CFR 177.2(b)(7), with respect to certain
information submitted.
FACTS:
The PICO NPWT System is a sterile, singleuse, complete negative pressure wound
therapy system consisting of a pump, two
dressings with attached long tube assemblies,
and retention strips. It is marketed for use in
a sterile operating room environment. Each
dressing is applied to the wound and held in
place with the retention strips. The long tube
assembly is attached to the dressing on one
end, and to the PICO pump on the other end,
connecting them together. The suction pump
pulls air out of the dressing via the long tube
assembly, creating negative pressure and
drawing excess fluid from the wound into the
dressing. The pump is battery powered and
delivers 80 mmHg of continuous negative
pressure for up to seven days, after which it
is programmed to permanently stop working.
Consistent with the lifespan of the pump, the
dressings provide a total of seven days wear
time. The pump in the PICO NPWT System
can only be used with the dressings included
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in the system, and will only be used once by
a patient for a specific wound type as the
therapy prescribes. The dressings are only
sold with the pump and not separately
available. Unlike conventional negative
pressure systems that use canisters for the
collection of wound fluid, the PICO NPWT
System is canister-less, which according to
your submission means that the components
of the PICO NPWT System can only be used
together as a system.
The pump in the PICO NPWT System
consists of: a printed circuit board (‘‘PCB’’)
assembly that provides pressure
measurement and feedback control for the
pump; a diaphragm pump and motor that
provide airflow to maintain pressure;
components such as an internal air path and
check valve; a plastic housing; and, batteries.
Most of the pump’s components are made in
China, except for a lightweight pipe, valve
and connector made in the U.S., and the
batteries. The pump components and
subassemblies will be shipped from China to
the United Kingdom (‘‘U.K.’’) for the
remainder of the pump manufacturing
process. In the U.K., U.S.-origin firmware,
written and validated in the U.S. according
to medical device and Food and Drug
Administration standards, will be loaded
onto the pump at flash programming stations.
The flash programming stations are equipped
with ‘‘bed of nails’’ interfaces, which have
discrete electrical conductors that extend and
make contact with discrete pads on the PCB
assembly. You state that the erasable
programmable read-only memory (‘‘EPROM’’)
on the PCB assembly is actively programmed
by sending electric charges through the ‘‘bed
of nails’’ to the PCB assembly in order to
drive the EPROM into receptive mode, and
then sending byte by byte to program the
EPROM with the unique calibrations and
specific parameters required to operate the
pump.1 You state that this process requires
moderate, semi-skilled technicians trained in
‘‘clean-room’’ techniques and operating
programming fixtures. The pump is then
fully assembled by assembling the
subassemblies with the case pieces and
attaching the battery cover and label, which
you state requires low, basic ‘‘box build’’
assembly techniques. After assembly, the
pump goes through a series of tests to verify
calibrated performance of the device, which
you state requires moderate, semi-skilled
technicians operating test fixtures.
You state that the firmware is essential to
the function of the pump because the
firmware ensures that the pump dispenses
the accurate amount of negative pressure.
You state that while the components used to
manufacture the PICO NPWT System are
largely generic (e.g. micro-controllers, small
battery powered motors and generic PCB
assemblies), it is only when the pump is
calibrated and then flashed with specific
firmware that it becomes a true medical
device, as the flashing enables the pump to
deliver calibrated, therapeutic negative
pressure levels to the wound.
1 You state that, though EPROM is not
irreversible, re-programming EPROM requires
working through different levels of encryption and
the use of specific equipment, which is not readily
available.
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You state that the material, labor, and
overhead costs of the PICO NPWT System are
broken down per country as follows:
[XXXX]% from the pump and battery
production in China, [XXXX]% from flashing
and final assembly in the U.K., and the
remaining [XXXX]% 2 mainly from the U.K.
The dressings are manufactured in the
U.K., with materials of U.K. and Canadian
origin,3 to produce a four-layer dressing that
consists of: (1) a high moisture vapor transfer
rate (‘‘MTVR’’) film to allow for transpiration
of the wound fluid; (2) a superabsorbent layer
to hold the fluid; (3) an airlock layer to
ensure consistent delivery of negative
pressure from the pump to the wound bed;
and, (4) an adhesive layer to maintain an
effective seal around the dressing and
prevent trauma. The manufacturing
operations to produce the dressings involve
extruding medical grade film, perforating the
adhesive layer to ensure breathability of the
dressing, and then shaping, cutting and
laminating together the layers of the dressing.
The four-layer dressing is then connected to
a long tube assembly, which is also
manufactured in the U.K. from U.K.-origin
materials. The dressings and pumps are then
sterilized, separately sealed, packed, and
then re-sterilized. Once the PICO NPWT
System is received by its user, the user will
connect the pump to the dressing by the
attached long tube assembly.
You state that a majority of the essential
therapeutic elements for wound healing are
delivered via the unique dressing. You state
that the dressing is the fundamental
‘‘enabling technology,’’ as the combination of
layers work together to: manage the wound
fluid; ensure consistent delivery of negative
pressure from the pump to the wound bed
(stimulating blood vessel and cell growth);
and, maintain an optimal environment for
wound healing by protecting the wound from
outside contaminants and limiting disruption
of the wound bed, which allows for the
formation of granulation tissue.
The PICO NPWT System is imported into
the United States packaged for retail sale. Its
main components, the pump and the
dressings, are not assembled together and
must be connected to each other by the user
after the dressing is secured to the patient
with the retention strips. You state that, as
imported, the PICO NPWT System is
classified in subheading 9018.90.80,
Harmonized Tariff Schedule of the United
States (‘‘HTSUS’’), as a medical instrument.
You also state that it is described by two of
the American Medical Association Current
Procedural Terminology (‘‘CPT’’) codes,
G0456 and G0457, which provide for:
‘‘negative pressure wound therapy (e.g.
vacuum assisted drainage collection) using a
[. . .] device, not durable medical
equipment, including provision of [. . .]
dressing(s), topical application(s), wound
assessment, and instructions for ongoing
care, per session.’’ According to your
2 [XXXX]% derives from the production of the
dressing in the U.K. Aside from [XXXX]% for
primary sterile barrier costs from both the U.K. and
[XXXX], the remaining costs will be incurred in the
U.K.
3 All of the layers, except for the super-absorbent
layer that is from Canada, are from the U.K.
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submission, the difference in the codes is
based on the description of the size of the
wound to be treated.
ISSUE:
What is the country of origin of the PICO
NPWT System for purposes of U.S.
Government procurement?
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 determining whether the combining of
parts or materials constitutes a substantial
transformation, the determinative 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. If the
manufacturing or combining process is a
minor one which leaves the identity of the
article intact, a substantial transformation has
not occurred. Uniroyal, Inc. v. United States,
3 CIT 220, 542 F. Supp. 1026 (1982), aff’d
702 F. 2d 1022 (Fed. Cir. 1983).
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. Additionally, factors such as
the resources expended on product design
and development, the extent and nature of
post-assembly inspection and testing
procedures, and worker skill required during
the actual manufacturing process will be
considered when determining whether a
substantial transformation has occurred. No
one factor is determinative.
In this case, the PICO NPWT System is
comprised of the pump and the dressings.
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These two components are attached to each
other by the user and together, these two
components are used as one product to
extract fluid from the wound. The four-layer
dressing is manufactured in the U.K. by
combining MTVR film from the U.K. to allow
for transpiration of the wound fluid, a
superabsorbent layer from Canada to hold the
fluid, an airlock layer from the U.K. to ensure
consistent delivery of negative pressure from
the pump to the wound bed, and an adhesive
layer from the U.K. to effectively seal the
dressing. The long tube assembly, which is
produced in the U.K. from U.K. materials, is
adhered to the dressing in the U.K. and is
later connected by the user to the pump to
create a one-way vacuum via a unique taperlock connector that ensures the pump and
dressing can only connect to each other and
not to other medical connectors. The pump
is as important as the dressing in allowing
negative pressure to be created and to enable
fluid to be drawn from the wound. Therefore,
the additional processes performed on the
pump component are necessary in order to
find that the PICO NPWT System is a product
of the U.K.
You argue that the PICO NPWT System
should be considered a product of the U.K.
because the U.K is the country of origin of
the dressings, and that although the pump
components and subassemblies will be made
in China, the pump will be flash programmed
with firmware and the final assembly of the
pump will take place in the U.K. You state
that the pump will be programmed with U.S.origin firmware at flash programming
stations equipped with ‘‘bed of nails’’
interfaces, which have discrete electrical
conductors that extend from the ‘‘bed of
nails’’ and make contact with discrete pads
on the PCB assembly.4 You state that the
EPROM is actively programmed because this
process sends electric charges through the
‘‘bed of nails’’ to the PCB assembly in order
to drive the EPROM into receptive mode, and
then sends byte by byte to program the
EPROM with the unique calibrations and
specific parameters required to operate the
pump.5 You state that, though the EPROM is
not irreversible, re-programming the EPROM
requires working through different levels of
4 ‘‘Bed of nails’’ refers to a traditional electronic
fixture with numerous pins extending from the
fixture to make contact with points on a PCB.
Pressing a PCB against a ‘‘bed of nails’’ interface
allows the PCB to be directly accessed for
programming. See Michael J. Smith, Why Program
Devices at In-Circuit Test?, Evaluation Engineering,
at https://www4.evaluationengineering.com/articles/
201110/why-program-devices-at-in-circuit-test.php
(specifically the ‘‘bed of nails’’ explanation); see
also ‘‘In-Circuit Test,’’ Wikipedia, at https://
en.wikipedia.org/wiki/In-circuit_test (only with
reference to ‘‘Bed of Nails tester’’ section).
5 EPROM refers to a non-volatile memory that
retains its contents until it is exposed to ultraviolet
light, and it is programmed by using a specialized
machine to force an electric charge that sends bits
of the EPROM onto a PCB. See G. Groeseneken, et
al., Basics of Nonvolatile Semiconductor Memory
Devices, 25–28, at https://citeseerx.ist.psu.edu/
viewdoc/download?doi=10.1.1.111.9431&rep=rep1
&type=pdf; see also Integrated Circuit Engineering
Corporation, ROM, EPROM, and EEPROM
Technology, 4–9, at https://web.eecs.umich.edu/
∼prabal/teaching/eecs373-f10/readings/rom-epromeeprom-technology.pdf.
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encryption and the use of specific
equipment, which is not readily available.6
Accordingly, you state that only when the
pump is calibrated and flashed with specific
firmware, it becomes a true medical device,
as the flashing enables the pump to deliver
calibrated, therapeutic negative pressure
levels to the wound. In support of your
positions you cite Headquarters Ruling
(‘‘HQ’’) H034843, dated May 5, 2009; and HQ
968000, dated February 14, 2006.
HQ H034843 concerned the country of
origin of USB flash drives that used software
and firmware developed in Israel and an
assembly process that began in China and
ended in Israel or the United States. CBP
noted that the assembly in Israel or the
United States, mainly the installation and
customization of the firmware and software,
made the USB flash drives functional,
permitted them to execute their security
features, and increased their value.
Therefore, the USB flash drives were
substantially transformed in the countries
where these operations took place, making
the country of origin for the USB flash drives
either Israel or the United States.
In HQ 968000, CBP ruled that the country
of origin for marking purposes of a fabric
switch for storage area networks was the
United States. The assembly of the hardware
for the switch occurred in China. Then, the
resulting electromechanical assembly was
shipped to the United States, where U.S.origin software was installed, configured, and
tested. See also Data General v. United
States, 4 Ct. Int’l Trade 182 (1982).
As in HQ H034843 and HQ 968000, the
firmware will be installed in a different
country from where the majority of the
product is assembled, thereby imparting the
product (here, the pump) with an essential
and required feature (here, enabling the
pump to operate as a unique medical device).
However, despite these similarities, HQ
H034843 and HQ 968000 concerned a USB
flash drive and a switch for network storage,
which are instruments primarily associated
with computer-related products, while in this
case the product is primarily a medical
instrument and serves separate functions
apart from the programmed capabilities. For
instance, in HQ H215657, dated April 29,
2013, CBP held that a flashlight originated
from China despite the fact that it was
programmed in the U.S. with U.S. software.
HQ H215657 explained that the programming
was not essential to the basic operation of the
flashlight, as it only enhanced how the
flashlight operated, without changing its
fundamental nature. Though such
programming provided the flashlight with
some additional features, CBP held that the
programming was not sufficiently complex to
change the identity or characterize the
device.
Nonetheless, to the extent that the
programming process in the U.K. is
integrated with the U.K.-origin dressing to
produce a specific-use medical device, we
find that the last substantial transformation
of the PICO NPWT System occurs in the U.K.
The unique dressing is the ‘‘enabling
technology’’ that provides the essential
therapeutic elements for wound healing (e.g.
fluid management, protecting against
contaminants, and limiting wound bed
disruption) to the instrument. Furthermore,
the programmed pressure calibrations are
critical to the pump’s function as a medical
device, and can only tolerate a small margin
for error since any programming error would
devalue the pump for medical purposes and
require correction via a difficult
reprogramming technique.
Based on the information in your request,
under the totality of the circumstances,
considering the PICO NPWT System’s use as
a single medical instrument, the origin of the
dressings, and the flash programming and
final assembly of the pump, which will be
performed in the U.K, and will change the
pump into a specialized pump that can only
be used with its respective dressings, we find
that the country of origin of the PICO NPWT
System will be the United Kingdom for
purposes of U.S. Government procurement.
HOLDING:
Based on the facts in this case, we find that
the country of origin of the PICO NPWT
System will be the United Kingdom for
purposes of U.S. Government procurement.
Notice of this final determination will be
given in the Federal Register, as required by
19 CFR 177.29. Any party-at-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 party-atinterest 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.
6 EPROM is not easily reprogrammed because,
even when the reprogramming change is minimal,
the process requires erasing the memory by
exposing the EPROM to ultraviolet light, and then
reprogramming it byte by byte. See id.
SUMMARY:
VerDate Sep<11>2014
20:31 Jul 06, 2015
Jkt 235001
Sincerely,
Harold Singer, Acting Executive
Director
Regulations and Rulings
Office of International Trade
[FR Doc. 2015–16553 Filed 7–6–15; 8:45 am]
BILLING CODE 9111–14–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2015–0001; Internal
Agency Docket No. FEMA–B–1515]
Proposed Flood Hazard
Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Elevation (BFE), base flood depth,
Special Flood Hazard Area (SFHA)
boundary or zone designation, or
regulatory floodway on the Flood
Insurance Rate Maps (FIRMs), and
where applicable, in the supporting
Flood Insurance Study (FIS) reports for
the communities listed in the table
below. The purpose of this notice is to
seek general information and comment
regarding the preliminary FIRM, and
where applicable, the FIS report that the
Federal Emergency Management Agency
(FEMA) has provided to the affected
communities. The FIRM and FIS report
are the basis of the floodplain
management measures that the
community is required either to adopt
or to show evidence of having in effect
in order to qualify or remain qualified
for participation in the National Flood
Insurance Program (NFIP). In addition,
the FIRM and FIS report, once effective,
will be used by insurance agents and
others to calculate appropriate flood
insurance premium rates for new
buildings and the contents of those
buildings.
Comments are to be submitted
on or before October 5, 2015
ADDRESSES: The Preliminary FIRM, and
where applicable, the FIS report for
each community are available for
inspection at both the online location
and the respective Community Map
Repository address listed in the tables
below. Additionally, the current
effective FIRM and FIS report for each
community are accessible online
through the FEMA Map Service Center
at www.msc.fema.gov for comparison.
You may submit comments, identified
by Docket No. FEMA–B–1515, to Luis
Rodriguez, Chief, Engineering
Management Branch, Federal Insurance
and Mitigation Administration, FEMA,
500 C Street SW., Washington, DC
20472, (202) 646–4064, or (email)
Luis.Rodriguez3@fema.dhs.gov.
FOR FURTHER INFORMATION CONTACT: Luis
Rodriguez, Chief, Engineering
Management Branch, Federal Insurance
and Mitigation Administration, FEMA,
500 C Street SW., Washington, DC
20472, (202) 646–4064, or (email)
Luis.Rodriguez3@fema.dhs.gov; or visit
the FEMA Map Information eXchange
(FMIX) online at
www.floodmaps.fema.gov/fhm/fmx_
main.html.
DATES:
FEMA
proposes to make flood hazard
determinations for each community
listed below, in accordance with section
110 of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4104, and 44 CFR
67.4(a).
SUPPLEMENTARY INFORMATION:
Comments are requested on
proposed flood hazard determinations,
which may include additions or
modifications of any Base Flood
38721
E:\FR\FM\07JYN1.SGM
07JYN1
Agencies
[Federal Register Volume 80, Number 129 (Tuesday, July 7, 2015)]
[Notices]
[Pages 38718-38721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16553]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
U.S. Customs and Border Protection
Notice of Issuance of Final Determination Concerning Wound
Therapy System
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 the PICO single use negative pressure wound
therapy system manufactured and distributed by Smith
[[Page 38719]]
& Nephew. Based upon the facts presented, CBP has concluded that the
United Kingdom will be the country of origin of the PICO single use
negative pressure wound therapy system (``PICO NPWT System'') for
purposes of U.S. Government procurement.
DATES: The final determination was issued on June 30, 2015. 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 6, 2015.
FOR FURTHER INFORMATION CONTACT: Antonio J. Rivera, Valuation and
Special Programs Branch, Regulations and Rulings, Office of
International Trade (202) 325-0226.
SUPPLEMENTARY INFORMATION: Notice is hereby given that on June 30, 2015
pursuant to subpart B of part 177, U.S. Customs and Border Protection
Regulations (19 CFR part 177, subpart B), CBP has issued a final
determination concerning the country of origin of the PICO NPWT System
manufactured and distributed by Smith & Nephew, which may be offered to
the U.S. Government under an undesignated government procurement
contract. This final determination, HQ H259473, was issued under
procedures set forth at 19 CFR part 177, subpart B, which implements
Title III of the Trade Agreement Act of 1979, as amended (19 U.S.C.
2511-18). In the final determination, under the totality of the
circumstances, considering the PICO NPWT System's use as a single
medical instrument, the origin of the dressings, and the flash
programming and final assembly of the pump, which will be performed in
the U.K., and will change the pump into a specialized pump that can
only be used with its respective dressings, CBP concluded that the
country of origin of the PICO NPWT System will be the United Kingdom
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: June 30, 2015.
Harold Singer,
Acting Executive Director, Regulations and Rulings, Office of
International Trade.
HQ H259473
June 30, 2015
OT:RR:CTF:VS H259473 AJR
CATEGORY: Origin
Daniel S. Char, Esq.
Associate General Counsel (Commercial)
Smith and Nephew, PLC
150 Minuteman Road
Andover, MA 01810
RE: Trade Agreements Act; Government Procurement; Country of Origin
of the PICO Single Use Negative Pressure Wound Therapy System
Dear Mr. Char:
This is in response to your letter, dated November 19, 2014,
requesting a final determination on behalf of Smith & Nephew, PLC
(``Smith & Nephew''), 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.
This final determination concerns the country of origin of Smith
& Nephew's PICO Single Use Negative Pressure Wound Therapy System
(``PICO NPWT System''). As the manufacturer and U.S. importer, Smith
& Nephew is a party-at-interest within the meaning of 19 CFR
177.22(d)(1) and is entitled to request this final determination. In
addition, we have reviewed and grant the request for confidentiality
pursuant to 19 CFR 177.2(b)(7), with respect to certain information
submitted.
FACTS:
The PICO NPWT System is a sterile, single-use, complete negative
pressure wound therapy system consisting of a pump, two dressings
with attached long tube assemblies, and retention strips. It is
marketed for use in a sterile operating room environment. Each
dressing is applied to the wound and held in place with the
retention strips. The long tube assembly is attached to the dressing
on one end, and to the PICO pump on the other end, connecting them
together. The suction pump pulls air out of the dressing via the
long tube assembly, creating negative pressure and drawing excess
fluid from the wound into the dressing. The pump is battery powered
and delivers 80 mmHg of continuous negative pressure for up to seven
days, after which it is programmed to permanently stop working.
Consistent with the lifespan of the pump, the dressings provide a
total of seven days wear time. The pump in the PICO NPWT System can
only be used with the dressings included in the system, and will
only be used once by a patient for a specific wound type as the
therapy prescribes. The dressings are only sold with the pump and
not separately available. Unlike conventional negative pressure
systems that use canisters for the collection of wound fluid, the
PICO NPWT System is canister-less, which according to your
submission means that the components of the PICO NPWT System can
only be used together as a system.
The pump in the PICO NPWT System consists of: a printed circuit
board (``PCB'') assembly that provides pressure measurement and
feedback control for the pump; a diaphragm pump and motor that
provide airflow to maintain pressure; components such as an internal
air path and check valve; a plastic housing; and, batteries. Most of
the pump's components are made in China, except for a lightweight
pipe, valve and connector made in the U.S., and the batteries. The
pump components and subassemblies will be shipped from China to the
United Kingdom (``U.K.'') for the remainder of the pump
manufacturing process. In the U.K., U.S.-origin firmware, written
and validated in the U.S. according to medical device and Food and
Drug Administration standards, will be loaded onto the pump at flash
programming stations. The flash programming stations are equipped
with ``bed of nails'' interfaces, which have discrete electrical
conductors that extend and make contact with discrete pads on the
PCB assembly. You state that the erasable programmable read-only
memory (``EPROM'') on the PCB assembly is actively programmed by
sending electric charges through the ``bed of nails'' to the PCB
assembly in order to drive the EPROM into receptive mode, and then
sending byte by byte to program the EPROM with the unique
calibrations and specific parameters required to operate the
pump.\1\ You state that this process requires moderate, semi-skilled
technicians trained in ``clean-room'' techniques and operating
programming fixtures. The pump is then fully assembled by assembling
the subassemblies with the case pieces and attaching the battery
cover and label, which you state requires low, basic ``box build''
assembly techniques. After assembly, the pump goes through a series
of tests to verify calibrated performance of the device, which you
state requires moderate, semi-skilled technicians operating test
fixtures.
---------------------------------------------------------------------------
\1\ You state that, though EPROM is not irreversible, re-
programming EPROM requires working through different levels of
encryption and the use of specific equipment, which is not readily
available.
---------------------------------------------------------------------------
You state that the firmware is essential to the function of the
pump because the firmware ensures that the pump dispenses the
accurate amount of negative pressure. You state that while the
components used to manufacture the PICO NPWT System are largely
generic (e.g. micro-controllers, small battery powered motors and
generic PCB assemblies), it is only when the pump is calibrated and
then flashed with specific firmware that it becomes a true medical
device, as the flashing enables the pump to deliver calibrated,
therapeutic negative pressure levels to the wound.
[[Page 38720]]
You state that the material, labor, and overhead costs of the
PICO NPWT System are broken down per country as follows: [XXXX]%
from the pump and battery production in China, [XXXX]% from flashing
and final assembly in the U.K., and the remaining [XXXX]% \2\ mainly
from the U.K.
---------------------------------------------------------------------------
\2\ [XXXX]% derives from the production of the dressing in the
U.K. Aside from [XXXX]% for primary sterile barrier costs from both
the U.K. and [XXXX], the remaining costs will be incurred in the
U.K.
---------------------------------------------------------------------------
The dressings are manufactured in the U.K., with materials of
U.K. and Canadian origin,\3\ to produce a four-layer dressing that
consists of: (1) a high moisture vapor transfer rate (``MTVR'') film
to allow for transpiration of the wound fluid; (2) a superabsorbent
layer to hold the fluid; (3) an airlock layer to ensure consistent
delivery of negative pressure from the pump to the wound bed; and,
(4) an adhesive layer to maintain an effective seal around the
dressing and prevent trauma. The manufacturing operations to produce
the dressings involve extruding medical grade film, perforating the
adhesive layer to ensure breathability of the dressing, and then
shaping, cutting and laminating together the layers of the dressing.
The four-layer dressing is then connected to a long tube assembly,
which is also manufactured in the U.K. from U.K.-origin materials.
The dressings and pumps are then sterilized, separately sealed,
packed, and then re-sterilized. Once the PICO NPWT System is
received by its user, the user will connect the pump to the dressing
by the attached long tube assembly.
---------------------------------------------------------------------------
\3\ All of the layers, except for the super-absorbent layer that
is from Canada, are from the U.K.
---------------------------------------------------------------------------
You state that a majority of the essential therapeutic elements
for wound healing are delivered via the unique dressing. You state
that the dressing is the fundamental ``enabling technology,'' as the
combination of layers work together to: manage the wound fluid;
ensure consistent delivery of negative pressure from the pump to the
wound bed (stimulating blood vessel and cell growth); and, maintain
an optimal environment for wound healing by protecting the wound
from outside contaminants and limiting disruption of the wound bed,
which allows for the formation of granulation tissue.
The PICO NPWT System is imported into the United States packaged
for retail sale. Its main components, the pump and the dressings,
are not assembled together and must be connected to each other by
the user after the dressing is secured to the patient with the
retention strips. You state that, as imported, the PICO NPWT System
is classified in subheading 9018.90.80, Harmonized Tariff Schedule
of the United States (``HTSUS''), as a medical instrument. You also
state that it is described by two of the American Medical
Association Current Procedural Terminology (``CPT'') codes, G0456
and G0457, which provide for: ``negative pressure wound therapy
(e.g. vacuum assisted drainage collection) using a [. . .] device,
not durable medical equipment, including provision of [. . .]
dressing(s), topical application(s), wound assessment, and
instructions for ongoing care, per session.'' According to your
submission, the difference in the codes is based on the description
of the size of the wound to be treated.
ISSUE:
What is the country of origin of the PICO NPWT System for
purposes of U.S. Government procurement?
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 determining whether the combining of parts or materials
constitutes a substantial transformation, the determinative 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. If the manufacturing or combining process is a minor
one which leaves the identity of the article intact, a substantial
transformation has not occurred. Uniroyal, Inc. v. United States, 3
CIT 220, 542 F. Supp. 1026 (1982), aff'd 702 F. 2d 1022 (Fed. Cir.
1983).
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. Additionally, factors such as the
resources expended on product design and development, the extent and
nature of post-assembly inspection and testing procedures, and
worker skill required during the actual manufacturing process will
be considered when determining whether a substantial transformation
has occurred. No one factor is determinative.
In this case, the PICO NPWT System is comprised of the pump and
the dressings. These two components are attached to each other by
the user and together, these two components are used as one product
to extract fluid from the wound. The four-layer dressing is
manufactured in the U.K. by combining MTVR film from the U.K. to
allow for transpiration of the wound fluid, a superabsorbent layer
from Canada to hold the fluid, an airlock layer from the U.K. to
ensure consistent delivery of negative pressure from the pump to the
wound bed, and an adhesive layer from the U.K. to effectively seal
the dressing. The long tube assembly, which is produced in the U.K.
from U.K. materials, is adhered to the dressing in the U.K. and is
later connected by the user to the pump to create a one-way vacuum
via a unique taper-lock connector that ensures the pump and dressing
can only connect to each other and not to other medical connectors.
The pump is as important as the dressing in allowing negative
pressure to be created and to enable fluid to be drawn from the
wound. Therefore, the additional processes performed on the pump
component are necessary in order to find that the PICO NPWT System
is a product of the U.K.
You argue that the PICO NPWT System should be considered a
product of the U.K. because the U.K is the country of origin of the
dressings, and that although the pump components and subassemblies
will be made in China, the pump will be flash programmed with
firmware and the final assembly of the pump will take place in the
U.K. You state that the pump will be programmed with U.S.-origin
firmware at flash programming stations equipped with ``bed of
nails'' interfaces, which have discrete electrical conductors that
extend from the ``bed of nails'' and make contact with discrete pads
on the PCB assembly.\4\ You state that the EPROM is actively
programmed because this process sends electric charges through the
``bed of nails'' to the PCB assembly in order to drive the EPROM
into receptive mode, and then sends byte by byte to program the
EPROM with the unique calibrations and specific parameters required
to operate the pump.\5\ You state that, though the EPROM is not
irreversible, re-programming the EPROM requires working through
different levels of
[[Page 38721]]
encryption and the use of specific equipment, which is not readily
available.\6\ Accordingly, you state that only when the pump is
calibrated and flashed with specific firmware, it becomes a true
medical device, as the flashing enables the pump to deliver
calibrated, therapeutic negative pressure levels to the wound. In
support of your positions you cite Headquarters Ruling (``HQ'')
H034843, dated May 5, 2009; and HQ 968000, dated February 14, 2006.
---------------------------------------------------------------------------
\4\ ``Bed of nails'' refers to a traditional electronic fixture
with numerous pins extending from the fixture to make contact with
points on a PCB. Pressing a PCB against a ``bed of nails'' interface
allows the PCB to be directly accessed for programming. See Michael
J. Smith, Why Program Devices at In-Circuit Test?, Evaluation
Engineering, at https://www4.evaluationengineering.com/articles/201110/why-program-devices-at-in-circuit-test.php (specifically the
``bed of nails'' explanation); see also ``In-Circuit Test,''
Wikipedia, at https://en.wikipedia.org/wiki/In-circuit_test (only
with reference to ``Bed of Nails tester'' section).
\5\ EPROM refers to a non-volatile memory that retains its
contents until it is exposed to ultraviolet light, and it is
programmed by using a specialized machine to force an electric
charge that sends bits of the EPROM onto a PCB. See G. Groeseneken,
et al., Basics of Nonvolatile Semiconductor Memory Devices, 25-28,
at https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.111.9431&rep=rep1&type=pdf; see also Integrated
Circuit Engineering Corporation, ROM, EPROM, and EEPROM Technology,
4-9, at https://web.eecs.umich.edu/~prabal/teaching/eecs373-f10/
readings/rom-eprom-eeprom-technology.pdf.
\6\ EPROM is not easily reprogrammed because, even when the
reprogramming change is minimal, the process requires erasing the
memory by exposing the EPROM to ultraviolet light, and then
reprogramming it byte by byte. See id.
---------------------------------------------------------------------------
HQ H034843 concerned the country of origin of USB flash drives
that used software and firmware developed in Israel and an assembly
process that began in China and ended in Israel or the United
States. CBP noted that the assembly in Israel or the United States,
mainly the installation and customization of the firmware and
software, made the USB flash drives functional, permitted them to
execute their security features, and increased their value.
Therefore, the USB flash drives were substantially transformed in
the countries where these operations took place, making the country
of origin for the USB flash drives either Israel or the United
States.
In HQ 968000, CBP ruled that the country of origin for marking
purposes of a fabric switch for storage area networks was the United
States. The assembly of the hardware for the switch occurred in
China. Then, the resulting electromechanical assembly was shipped to
the United States, where U.S.-origin software was installed,
configured, and tested. See also Data General v. United States, 4
Ct. Int'l Trade 182 (1982).
As in HQ H034843 and HQ 968000, the firmware will be installed
in a different country from where the majority of the product is
assembled, thereby imparting the product (here, the pump) with an
essential and required feature (here, enabling the pump to operate
as a unique medical device). However, despite these similarities, HQ
H034843 and HQ 968000 concerned a USB flash drive and a switch for
network storage, which are instruments primarily associated with
computer-related products, while in this case the product is
primarily a medical instrument and serves separate functions apart
from the programmed capabilities. For instance, in HQ H215657, dated
April 29, 2013, CBP held that a flashlight originated from China
despite the fact that it was programmed in the U.S. with U.S.
software. HQ H215657 explained that the programming was not
essential to the basic operation of the flashlight, as it only
enhanced how the flashlight operated, without changing its
fundamental nature. Though such programming provided the flashlight
with some additional features, CBP held that the programming was not
sufficiently complex to change the identity or characterize the
device.
Nonetheless, to the extent that the programming process in the
U.K. is integrated with the U.K.-origin dressing to produce a
specific-use medical device, we find that the last substantial
transformation of the PICO NPWT System occurs in the U.K. The unique
dressing is the ``enabling technology'' that provides the essential
therapeutic elements for wound healing (e.g. fluid management,
protecting against contaminants, and limiting wound bed disruption)
to the instrument. Furthermore, the programmed pressure calibrations
are critical to the pump's function as a medical device, and can
only tolerate a small margin for error since any programming error
would devalue the pump for medical purposes and require correction
via a difficult reprogramming technique.
Based on the information in your request, under the totality of
the circumstances, considering the PICO NPWT System's use as a
single medical instrument, the origin of the dressings, and the
flash programming and final assembly of the pump, which will be
performed in the U.K, and will change the pump into a specialized
pump that can only be used with its respective dressings, we find
that the country of origin of the PICO NPWT System will be the
United Kingdom for purposes of U.S. Government procurement.
HOLDING:
Based on the facts in this case, we find that the country of
origin of the PICO NPWT System will be the United Kingdom for
purposes of U.S. Government procurement.
Notice of this final determination will be given in the Federal
Register, as required by 19 CFR 177.29. Any party-at-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
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,
Harold Singer, Acting Executive Director
Regulations and Rulings
Office of International Trade
[FR Doc. 2015-16553 Filed 7-6-15; 8:45 am]
BILLING CODE 9111-14-P