Federal Register / Vol. 70, No. 178 / Thursday, September 15, 2005 / Notices 54563 

20850, 240–276–0106. 

For biologics issues: Carol Rehkopf, 

Center for Biologics Evaluation and 

Research (HFM–650), Food and 

Drug Administration, 1401 

Rockville Pike, Rockville, MD 

20852, 301–827–6202. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On October 26, 2002, the Medical 

Device User Fee and Modernization Act 

of 2002 (MDUFMA) (Public Law 107–

250) was signed into law. Section 201 of 

MDUFMA amends the Federal Food, 

Drug, and Cosmetic Act (the act) by 

adding new provisions authorizing FDA 

to establish a voluntary inspection 

program under which eligible 

manufacturers of class II or class III 

devices can elect to have FDAaccredited third parties conduct some of 

their establishment inspections instead 

of FDA. Certain technical corrections 

were subsequently made to these 

provisions by the Medical Devices 

Technical Corrections Act (MDTCA) 

(Public Law 108–214), which was 

enacted on April 1, 2004. FDA 

announced in the Federal Register of 

June 3, 2004 (69 FR 31397), the 

availability of a draft guidance 

document entitled ‘‘Requests for 

Inspection by an Accredited Person 

under the Inspections by Accredited 

Persons Program Authorized by Section 

201 of the Medical Device User Fee and 

Modernization Act of 2002,’’ and 

invited interested persons to comment 

by September 1, 2004. 

One person submitted a comment in 

response to the draft guidance. The 

comment suggested, among other things, 

that partial inspections during a 2-year 

period should be permitted without the 

need for establishments to have to 

reapply to participate in the AP Program 

after each partial inspection. The 

comment further suggested that the 

guidance be revised to explicitly state 

that complete inspections conducted by 

APs under the new program which 

result in either a ‘‘No Action Indicated’’

or ‘‘Voluntary Action Indicated’’

classification can satisfy FDA’s biennial 

establishment inspection requirement 

under section 510(h) of the act (21 

U.S.C. 360(h)). The agency carefully 

considered the comment while 

finalizing the guidance and has revised 

the document accordingly. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on implementation of a 

new program that allows third-party 

inspections of eligible device 

establishments as authorized by section 

201 of MDUFMA (as amended by 

MDTCA). It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

To receive ‘‘Requests for Inspection 

by an Accredited Person under the 

Inspection by Accredited Persons 

Program Authorized by Section 201 of 

the Medical Device User Fee and 

Modernization Act of 2002’’ by fax, call 

the CDRH Facts-On-Demand system at 

800–899–0381 or 301–827–0111 from a 

touch-tone telephone. Press 1 to enter 

the system. At the second voice prompt, 

press 1 to order a document. Enter the 

document number 1532 followed by the 

pound sign (#). Follow the remaining 

voice prompts to complete your request. 

Persons interested in obtaining a copy 

of the guidance may also do so by using 

the Internet. The Center for Devices and 

Radiological Health (CDRH) maintains 

an entry on the Internet for easy access 

to information including text, graphics, 

and files that may be downloaded to a 

personal computer with Internet access. 

Updated on a regular basis, the CDRH 

home page includes device safety alerts, 

Federal Register reprints, information 

on premarket submissions (including 

lists of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

IV. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (the PRA) (44 

U.S.C. 3501–3520). The collections of 

information addressed in the guidance 

document have been approved by OMB 

in accordance with the PRA under the 

regulations governing the agency 

request or requirement that members of 

the public submit reports, keep records, 

or provide information to a third party. 

The provisions addressed in the 

guidance have been approved by OMB 

under OMB control number 0910–0569. 

This approval expires on August 31, 

2008. An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: September 9, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18364 Filed 9–14–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Bureau of U.S. Customs and Border 

Protection 

Notice of Issuance of Final 

Determination Concerning Desktop 

Scanners 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Notice of final determination. 

SUMMARY: This document provides 

notice that the Bureau of Customs and 

Border Protection (CBP) has issued a 

final determination concerning the 

country of origin of certain desktop 

scanners to be offered to the United 

States Government under an 

undesignated government procurement 

contract. The final determination found 

that, based upon the facts presented, the 

United States is the country of origin of 

the Kodak i600 line of desktop scanners 

for purposes of U.S. Government 

procurement. The Kodak i600 series 

includes the i620, i640, and i660 

models. 

DATES: The final determination was 

issued on September 9, 2005. 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 30 days 

of September 15, 2005. 

54564 Federal Register / Vol. 70, No. 178 / Thursday, September 15, 2005 / Notices 

FOR FURTHER INFORMATION CONTACT: Ed 

Caldwell, Valuation and Special 

Programs Branch, Office of Regulations 

and Rulings (202–572–8872). 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that on September 9, 2005, 

pursuant to subpart B of part 177, 

Customs Regulations (19 CFR part 177, 

subpart B), CBP issued a final 

determination concerning the country of 

origin of certain desktop scanners to be 

offered to the United States Government 

under an undesignated government 

procurement contract. The CBP ruling 

number is HQ 563294. This final 

determination was issued at the request 

of Eastman Kodak Company 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). 

The final determination concluded 

that, based upon the facts presented, the 

assembly in the United States of parts of 

various origins to create the Kodak i600 

scanners substantially transformed the 

imported parts used in production. 

Section 177.29, Customs Regulations 

(19 CFR 177.29), provides that notice of 

final determinations shall be published 

in the Federal Register within 60 days 

of the date the final determination is 

issued. Section 177.30, Customs 

Regulations (19 CFR 177.30), states 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: September 9, 2005. 

Michael T. Schmitz, 

Assistant Commissioner, Office of 

Regulations and Rulings. 

Attachment 

HQ 563294 

September 9, 2005. 

MAR–2–05 RR:CR:SM 563294 EAC 

Category: Marking. 

Mr. Alan W.H. Gourley, Crowell & Moring 

LLP, 1001 Pennsylvania Avenue, NW., 

Washington, DC 20004–2595 

RE: U.S. Government Procurement; Final 

Determination; country of origin of 

desktop scanners; substantial 

transformation; 19 CFR part 177 

Dear Mr. Gourley: 

This is in response to your letter dated 

June 3, 2005, requesting a final determination 

on behalf of Eastman Kodak Company 

(‘‘Kodak’’), pursuant to subpart B of part 177, 

Customs Regulations (19 CFR 177.21 et seq.). 

Under these regulations, which implement 

Title III of the Trade Agreements Act of 1979, 

as amended (19 U.S.C. 2411 et seq.), U.S. 

Customs and Border Protection (‘‘CBP’’) 

issues country of origin advisory rulings and 

final determinations on whether an article is 

or would be a product of a designated foreign 

country or instrumentality for the purpose 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 certain desktop scanners 

that Kodak is considering selling to the U.S. 

Government. We note that Kodak is a partyat-interest within the meaning of 19 CFR 

177.22(d)(2) and is entitled to request this 

final determination. 

Facts: 

I. Background 

We are advised that the scanners under 

consideration consist of the three models 

within Kodak’s i600 line of scanners, the 

i620, i640, and i660. The Kodak i600 Series 

Scanners are desktop scanners that have the 

primary function of creating electronic 

images from paper documents. Paper 

documents of various sizes, dimensions, and 

types may be fed into the scanners, viewed 

through cameras, and converted into 

electronic images. The scanners can process 

these images at a rate of up to 480 per 

minute. In addition, the scanners have a 

number of features to enhance their 

performance and improve the quality of the 

images they produce, such as skew angle 

determination, which detects and corrects 

images fed at an angle, and electronic color 

dropout, which removes irrelevant 

background color from images. 

The primary difference between these 

models is the speed at which they are able 

to process images, with the i660 able to 

process images most quickly. The mechanical 

components and manufacturing processes 

used to build the different models are nearly 

identical. The differences in processing 

speed are attributable to differences between 

the programming solutions that are installed 

on the scanners. Kodak developed the 

programming for the i600 line of scanners in 

the United States. 

II. Component Parts and Subassemblies 

Kodak has manufactured its i600 series 

scanners both in its Rochester, New York 

facility and in a facility located in Shanghai, 

China. Many, but not all, of the parts used 

in the manufacture of the scanners are 

obtained from Chinese sources. The i600 

scanners are comprised of 13 major 

subassemblies. Regardless of whether the 

scanners are manufactured to completion in 

the United States or China, the Shanghai 

facility also assembles three of the thirteen 

major subassemblies for the scanners from 

parts of U.S., Chinese, and other origins. 

The present ruling request pertains only to 

Kodak i600 scanners to be manufactured in 

the United States from parts shipped from 

China, but sourced from various countries 

abroad. 

Each subassembly performs a specific 

function and together, with miscellaneous 

other components and hardware, constitute a 

finished product capable of electronically 

scanning a variety of paper images. The 

finished scanners consist of approximately 

600 individual parts. The major 

subassemblies are identified and described as 

follows. 

Operator Control Panel (‘‘OCP’’) Assembly: 

This assembly provides the interface between 

the user and scanner, including wiring and 

the power switch used to turn the machine 

on and off. 

Elevator Assembly: This assembly lifts the 

paper to the proper height to be fed into the 

machine for scanning without jamming the 

feed. 

Carriage Assembly: This assembly is 

located at the front of the machine where 

paper is fed, and includes a metal tray upon 

which paper rests as it is fed into the 

scanner. The carriage assembly also includes 

the lead edge of the paper transport system 

which has a separation roller that ensures the 

top sheet of paper is separated from those 

below. 

Feed Module Assembly: This assembly is 

set above the carriage assembly where it 

grabs the top sheet of paper and feeds it into 

the scanner. 

Image Baffle Assembly: Each scanner 

includes two image baffle assemblies. Each 

assembly has a glass plate through which a 

camera module views paper for scanning. 

There are two such assemblies because 

separate cameras view the front and back of 

each document as it moves through the 

scanner. 

Backup Baffle Assembly: Each scanner 

includes two backup baffle assemblies. Each 

assembly is adjacent to the paper path where 

it guides the paper through the scanner and 

helps assure the paper feeds cleanly through 

the machine and does not jam. Each 

assembly also includes a backup strip, which 

provides a background for documents as they 

are viewed by a camera. There is one backup 

baffle assembly for each of the image baffle 

assemblies. 

Camera Modules (Upper and Lower): Each 

scanner includes two camera modules. The 

camera modules include mirrors and lenses 

used to view documents as they are fed 

through the scanner. Each camera module 

views and electronically captures a different 

side of the document. The upper camera 

module is part of the pod assembly. The 

lower camera module is located below the 

paper path. As the camera modules view a 

document, the light images they detect are 

converted into raw electronic data using a 

charge couple device. That raw data is 

amplified and forwarded to the ‘‘E-box’’, 

where the data is converted into an electronic 

image. 

Pod Assembly: The pod assembly is the top 

portion of the machine, which can be opened 

to provide access to the paper path. The 

components in this assembly operate together 

to feed a document through the machine and 

to view one side of the document during 

scanning. This assembly includes numerous 

parts, as well as the following major 

subassemblies: (a) The upper camera module; 

(b) an image baffle assembly; and (c) a 

backup baffle assembly. 

E-Box Assembly: This assembly contains 

the central ‘‘brain’’ of the machine, and it 

converts raw electronic data from the camera 

assembly into high quality electronic images. 

The E-box Assembly incorporates two circuit 

boards, the machine control board (‘‘MCB’’) 

and the image processing board (‘‘IPB’’). 

Shroud Assembly and Cabinetry: These 

pieces are the cosmetic cabinetry that 

Federal Register / Vol. 70, No. 178 / Thursday, September 15, 2005 / Notices 54565 

encompass and form the outside of the 

machine. 

Under the proposed production scenario, 

Kodak will purchase the two ‘‘camera 

modules’’ and the ‘‘feed module’’ as 

assembled units from its Shanghai facility. 

The Shanghai facility will assemble these 

modules using various parts, including a 

charge couple device for each camera 

module, which is purchased from the United 

States. The other major subassemblies will be 

manufactured in Rochester, New York, using 

component parts purchased from inventory 

at the Shanghai facility. It is envisioned that 

the Rochester facility will purchase the 

necessary number of parts, but that they 

would not be packaged or inventoried as kits. 

The parts inventoried at the Shanghai facility 

are sourced primarily from China, but 

include components from such designated 

countries as the United States, Canada, Japan, 

and Korea. 

III. The Assembly Process 

We are informed that assembly of the 

scanners at the Rochester facility requires 

approximately four to six hours of work 

encompassing essentially five stages: (a) 

Manufacturing most of the major 

subassemblies; (b) building the pod 

assembly; (c) performing the ‘‘main build’; 

(d) performing ‘‘end of line’’ procedures; and 

(e) packaging. During these stages, the 

machine is built, the firmware that allows the 

machine to work as a scanner is loaded, the 

major subassemblies and the integrated 

circuit are tested, and the scanner’s 

parameters are set to enable proper operation. 

1. Manufacture of Major Subassemblies 

The first step of production involves 

assemblage of most of the scanner’s major 

subassemblies. In order to demonstrate the 

complexity of these operations, a description 

of the operations undertaken to assemble the 

E-box assembly has been provided. As noted 

above, the E-box Assembly contains the 

central brain of the machine and is a key 

component for ensuring the proper function 

and quality of the scanning operation. It 

contains approximately 50 individual parts 

that technicians in the United States must 

assemble. The building process includes, 

among other things, mounting a CPU board 

to a base and adding to that CPU board a 

programmed chip that enables and controls 

processing speed. Other operations 

performed include mounting gaskets and a 

card cage, installing electromagnetic 

interference (‘‘EMI’’) gaskets, installing the 

machine control board (‘‘MCB’’) and image 

processing board (‘‘IPB’’) circuit boards, 

attaching a power supply to the CPU board, 

mounting a fan and installing an air duct, 

and attaching a cover to the base. 

During this stage of production, 

technicians also build the OCP, elevator, 

carriage, image baffle, backup baffle, and 

shroud assemblies. At the end of this 

production stage, these subassemblies are 

complete and ready to undergo further 

processing. 

2. Building the Pod Assembly 

After completing the major subassemblies 

set forth above, the technicians begin 

assembling the pod assembly, which is the 

top of the scanner. The technicians use the 

upper camera module, image baffle assembly, 

backup baffle assembly, and approximately 

180 additional parts to build the pod 

assembly. Additional parts that must be 

integrated during this manufacturing stage 

include lamp inverters, air ducts, dust seals, 

video cables, blowers, air filters, rollers, 

support baffles, lamps, clutches, gears, and 

shafts. Special fixtures and tooling are used 

to build the pod assembly. 

3. Main Build 

After building the pod assembly, the 

technicians manufacture the bottom of the 

scanner, integrate the pod assembly, make 

fine adjustments to the unit, and perform 

certain testing operations. This stage of 

production is referred to as the ‘‘main build.’’

During the main build, technicians 

integrate the elevator, carriage, image baffle, 

backup baffle, E-box, shroud, OCP, and lower 

camera subassemblies, along with literally 

hundreds of additional parts. The additional 

parts include components such as camera 

mounts, lamp invertors, latch handles, 

bumpers, stops, slide blocks, bushings, 

brackets, gaskets, wires, air ducts, UDDS 

emitter boards (a circuit board for the 

ultrasonic double document sensor, which is 

used to detect misfeeds), electronic 

grounding jacks, elevator position sensors, 

carriage plates, motors, lamps, shafts, belts, 

blowers, air filters, foam seals, bearings, 

cables, switch actuators, and exterior 

cabinetry. The technicians also attach the 

pod assembly with a special fixture during 

this stage. 

Technicians perform quality assurance 

checks throughout the main build and also 

use special fixtures designed to test electrical 

grounding. 

4. End of Line Procedures 

During this phase of production, additional 

quality control checks are conducted to 

ensure, for example, that the OCP cover is 

correctly installed, that all wires are dressed 

correctly, that the pod latches operate 

properly, and that glass and roller 

components are clean and ready for 

operation. The feeder module is then 

installed along with a separation roller and 

a separation pad. It is stated that the core 

elements of this stage of production, 

however, are operations such as 

programming, testing, and calibration of the 

machine. 

The technicians program the equipment by 

inputting Kodak’s proprietary firmware 

designed for the i600 line of scanners. This 

firmware was developed by Kodak’s Software 

Engineering Group within the United States 

and is considered the ‘‘intelligence’’ of the 

scanner. The firmware provides the 

programming that will control machine 

function and the algorithms to process 

images. 

The technicians load the firmware using 

Kodak’s Scanner Validation Tool (‘‘SVT’’), 

which is a software package also developed 

and provided by Kodak’s Software 

Engineering Group. In order to perform this 

task, technicians connect the scanner to a 

computer with the SVT and firmware already 

loaded. They then use the SVT to transfer the 

firmware onto the scanner. This process 

installs the firmware onto the IPB circuit 

board and CPU circuit board, which the 

technicians previously installed during 

manufacture of the E-box subassembly. 

Once the firmware is loaded onto the 

scanner, the technicians use the SVT and the 

firmware to calibrate and test the responses 

of the machine for specific inputs. These 

testing and calibration operations include 

procedures such as calibration of the UDDS 

system, calibration of the scanner for 

brightness, calibration of the scanner’s speed, 

and measurement of image quality. 

5. Packaging 

Once the end of line procedures are 

completed, the assembled scanners are 

visually inspected and packaged for 

shipment. 

Issue: Whether the assembled Kodak i600 

line of scanners are considered to be 

products of the United States 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 on 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 

(CIT 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. In 

C.S.D. 85–25, 19 Cust. Bull. 844 (1985), CBP 

held that for purposes of the Generalized 

System of Preferences (‘‘GSP’’), the assembly 

of a large number of fabricated components 

onto a printed circuit board in a process 

involving a considerable amount of time and 

skill resulted in a substantial transformation. 

In that case, in excess of 50 discrete 

fabricated components (such as resistors, 

capacitors, diodes, integrated circuits, 

sockets, and connectors) were assembled. 

CBP has held in a number of cases 

involving similar type equipment that 

54566 Federal Register / Vol. 70, No. 178 / Thursday, September 15, 2005 / Notices 

complex and meaningful assembly 

operations involving a large number of 

components will generally result in a 

substantial transformation. For example, in 

Headquarters Ruling Letter (‘‘HRL’’) 562495 

dated November 13, 2002, color ink jet 

printers were assembled in Singapore of 

components imported from a number of other 

countries. CBP determined that the imported 

components were substantially transformed 

during assembly such that the country of 

origin of the assembled ink jet printers was 

Singapore. In support of this position, CBP 

recognized that the processing operations 

that occurred within Singapore were 

complex and extensive, required the 

integration of 13 major subassemblies to the 

chassis, and that the resulting product was a 

new and distinct article of commerce that 

possessed a new name, character, and use. 

In HRL 561734 dated March 22, 2001, 

published in the Federal Register on March 

29, 2001 (66 FR 17222), CBP held that certain 

multi-functional machines (consisting of 

printer, copier, and fax machines) assembled 

in Japan were a product of that country for 

purposes of U.S. Government procurement. 

The multi-functional machines were 

assembled from 227 parts (108 parts obtained 

from Japan, 92 from Thailand, 3 from China, 

and 24 from other countries) and eight 

subassemblies, each of which was assembled 

in Japan. One of the subassemblies produced 

in Japan, referred to as the scanner unit, was 

described as the ‘‘heart of the machine.’’ In 

finding that the imported parts were 

substantially transformed in Japan, CBP 

stated that the individual parts and 

components lost their separate identities 

when they became part of the multifunctional machine. See also, HRL 561568 

dated March 22, 2001, published in the 

Federal Register on March 29, 2001 (66 FR 

17222). 

By contrast, assembly operations that are 

minimal or simple will generally not result 

in a substantial transformation. For example, 

in HRL 734050 dated June 17, 1991, CBP 

held that Japanese-origin components were 

not substantially transformed in China when 

assembled in that country to form finished 

printers. The printers consisted of five main 

components identified as the ‘‘head’’, 

‘‘mechanism’’, ‘‘circuit’’, ‘‘power source’’, 

and ‘‘outer case.’’ The circuit, power source 

and outer case units were entirely assembled 

or molded in Japan. The head and 

mechanical units were made in Japan but 

exported to China in an unassembled state. 

All five units were exported to China where 

the head and mechanical units were 

assembled with screws and screwdrivers. 

Thereafter, the head, mechanism, circuit, and 

power source units were mounted onto the 

outer case with screws and screwdrivers. In 

holding that the country of origin of the 

assembled printers was Japan, CBP 

recognized that the vast majority of the 

printer’s parts were of Japanese origin and 

that the operations performed in China were 

relatively simple assembly operations. 

The programming operations performed in 

the instant case must also be considered. In 

Data General Corporation v. United States, 4 

CIT 182 (1982), the Court of International 

Trade held that a PROM (programmable readonly memory) fabricated in a foreign country 

but programmed in the United States for use 

in a computer circuit board assembled abroad 

was substantially transformed. In Data 

General, the court stated that the electronic 

pattern introduced into the circuit by 

programming gave the PROM the function as 

a read only memory and that the essence of 

the article, its pattern of interconnection or 

stored memory, was established by 

programming. 

As applied, we find that the various 

foreign-origin parts are substantially 

transformed within the United States when 

assembled to form the Kodak i600 line of 

scanners in the manner set forth above. In 

making this determination we note that the 

scanners are comprised of approximately 600 

parts and thirteen subassemblies. Ten of the 

subassemblies are assembled to completion 

within the United States during a complex 

and meaningful process. Illustrative 

examples of two major subassemblies built to 

completion in the United States are the E-Box 

assembly (comprised of approximately 50 

parts) and the pod assembly (comprised of 

more than 180 parts). During the main build 

phase of production, the various 

subassemblies and literally hundreds of 

additional parts are assembled together to 

form the scanners. Specialized fixtures, 

tooling, and other equipment are used 

throughout assembly to align, test, and 

calibrate the scanners as they are built. After 

assembly, the scanners are programmed with 

firmware developed in the United States, 

which constitutes the intelligence of the 

scanners. During such assembly and 

programming operations, the individual 

components and subassemblies of foreignorigin are subsumed into a new and distinct 

article of commerce that has a new name, 

character, and use. Therefore, we find that 

the country of origin of the Kodak i600 

scanners for purposes of U.S. Government 

procurement is the United States. 

Holding: Based upon the specific facts of 

this case, we find that the individual 

components and subassemblies imported 

into the United States are substantially 

transformed when assembled in the manner 

set forth above to form Kodak i600 desktop 

scanners. Therefore, the country of origin of 

the Kodak i600 line of desktop scanners for 

purposes of U.S. Government procurement is 

the United States. 

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. 

Any party-at-interest may, within 30 days 

after publication of the Federal Register 

notice referenced above, seek judicial review 

of this final determination before the Court 

of International Trade. 

Sincerely, 

Michael T. Schmitz, 

Assistant Commissioner, Office of 

Regulations and Rulings. 

[FR Doc. 05–18359 Filed 9–14–05; 8:45 am] 

BILLING CODE 9110–06–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Bureau of Customs and Border 

Protection 

Notice of Cancellation of Customs 

Broker License Due to Death of the 

License Holder 

AGENCY: Bureau of Customs and Border 

Protection, U.S. Department of 

Homeland Security. 

ACTION: General notice. 

SUMMARY: Notice is hereby given that, 

pursuant to Title 19 of the Code of 

Federal Regulations § 111.51(a), the 

following individual Customs broker 

licenses and any and all permits have 

been cancelled due to the death of the 

broker: 

Name License 

No. Port name 

Thomas A. Borgia ... 10419 Miami. 

Karl A. Becnel ......... 09684 New 

Orleans. 

Dated: September 8, 2005. 

Jayson P. Ahern, 

Assistant Commissioner, Office of Field 

Operations. 

[FR Doc. 05–18360 Filed 9–14–05; 8:45 am] 

BILLING CODE 9110–06–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Bureau of Customs and Border 

Protection 

Notice of Cancellation of Customs 

Broker Permit 

AGENCY: Bureau of Customs and Border 

Protection, U.S. Department of 

Homeland Security. 

ACTION: General notice. 

SUMMARY: Pursuant to section 641 of the 

Tariff Act of 1930, as amended, (19 

U.S.C. 1641) and the Customs 

Regulations (19 CFR 111.51), the 

following Customs broker permits are 

cancelled without prejudice. 

Name Permit Issuing port 

General Brokerage Services, Inc. ..................................................................................................................... H34 Miami.