Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices 31803 

inconsistent with the GRAS 

determination; and 

—The basis for concluding, in light of 

the data and information submitted, that 

there is consensus among experts 

qualified by scientific training and 

experience to evaluate the safety of 

substances added to food that there is 

reasonable certainty that the substance 

is not harmful under the intended 

conditions of use. 

Æ For a GRAS determination through 

experience based on common use in 

food, such summary should include: 

—A comprehensive discussion of, and 

citations to, generally available data and 

information that the notifier relies on to 

establish safety, including documented 

evidence of a substantial history of 

consumption of the substance by a 

significant number of animals. Where a 

substance is intended for use in the food 

of an animal used to produce human 

food, this should include a 

comprehensive discussion of, and 

citations to, generally accepted 

scientific data, information, methods, or 

principles about both safety to the target 

animal and human food safety. The 

scientific data, information, methods, or 

principles provided should be sufficient 

to show that the substance is generally 

recognized among qualified experts to 

be safe for animals consuming food 

containing the substance as well as to 

humans consuming food derived from 

such animals (i.e., under its intended 

conditions of use); 

—A comprehensive discussion of any 

reports of investigations or other 

information that may appear to be 

inconsistent with the GRAS 

determination; 

—The basis for concluding, in light of 

the data and information submitted, that 

there is consensus among experts 

qualified by scientific training and 

experience to evaluate the safety of 

substances added to food that there is 

reasonable certainty that the substance 

is not harmful under the intended 

conditions of use. 

IV. How FDA Will Administer Notices 

Under the Pilot Program 

In general, the agency will administer 

the notices under the pilot program as 

described in proposed § 570.36(d) 

through (f) of the 1997 proposed rule, as 

follows: 

1. Within 30 days of receipt of the 

notice, FDA intends to acknowledge 

receipt of the notice by informing the 

notifier in writing. 

2. Under the 1997 proposed rule, FDA 

would respond to the notifier in writing 

within 90 days of receipt of the notice 

either that the notice provides a 

sufficient basis for the GRAS 

determination or that FDA has 

identified questions as to whether the 

intended use of the substance is GRAS. 

Due to resource limitations in the 

animal food program, it is unlikely that 

CVM will be able to evaluate and 

respond to notices within the 90-day 

timeframe contained in the 1997 

proposed rule. CVM will therefore 

respond to notifications of GRAS 

determinations in its pilot program as 

quickly as resources permit. 

• Any GRAS determination claim 

submitted as part of the pilot program 

shall be immediately available for 

public disclosure on the date the notice 

is received. All remaining data and 

information in the notice shall be 

available for public disclosure, in 

accordance with 21 CFR part 20, on the 

date the notice is received. 

• For each notice of GRAS 

determination submitted under the pilot 

program, the following information 

shall be readily accessible for public 

review and copying: 

Æ A copy of the submitted GRAS 

determination claim, 

Æ A copy of any letter issued by the 

agency, as described in paragraph 2 of 

this section. 

Æ A copy of any subsequent letter 

issued by the agency regarding such 

notice. 

V. Paperwork Reduction Act of 1995 

The collections of information in this 

notice are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520), and 

have been previously approved by 

OMB. OMB originally approved 

Paperwork Reduction Act (PRA) 

burdens for GRAS notification under the 

1997 proposed rule under OMB control 

number 0910–0342. The original OMB 

approval covered the collections of 

information in both proposed 21 CFR 

170.36 and 570.36; however, only 

CFSAN operated a GRAS notification 

program for human food under the 

original OMB PRA approval. Extension 

of the original OMB PRA approval for 

GRAS notification was granted by OMB 

on August 24, 2009, under OMB control 

number 0910–0342. 

As with the human food GRAS 

notification program administered by 

CFSAN, which has operated for several 

years, the animal food pilot program, 

which will be administered by CVM, 

will be based on the notification 

procedures announced in the 1997 

proposed rule. The provisions for GRAS 

notification under proposed §§ 170.36 

and 570.36 for human and animal food, 

respectively, are virtually identical and 

therefore the same number of hours per 

response were estimated for reporting 

(150 hours) and recordkeeping (15 hours 

per record) burdens for both proposed 

sections under the original and 

extended OMB PRA approvals. Because 

CFSAN’s GRAS program has 

successfully operated under these PRA 

estimates for several years, FDA believes 

these burden estimates remain accurate 

for CVM’s GRAS pilot program. 

FDA’s estimate of the annual number 

of GRAS determination notices that will 

be received by CVM in the extended 

OMB PRA approval (5) was revised 

downward from the original PRA 

approval (10). This revision was based 

on the actual number of GRAS notices 

received by CFSAN from 1998 to 2008, 

which was lower than anticipated and 

caused CFSAN to also revise downward 

its estimate in the extended PRA 

approval. The revised estimate in the 

extended PRA approval reflects FDA’s 

best judgment at this time as to the 

number of notices CVM will receive 

annually through this pilot program. 

CVM believes that the PRA estimates 

in the extended PRA approval cover 

CVM’s GRAS notice program. 

Dated: May 26, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–13464 Filed 6–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Notice of Issuance of Final 

Determination Concerning a Lift Unit 

for an Overhead Patient Lift 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 a lift unit for an overhead 

patient lift system. Based upon the facts 

presented, CBP has concluded in the 

final determination that Sweden is the 

country of origin of the lift unit for 

purposes of U.S. government 

procurement. 

DATES: The final determination was 

issued on May 28, 2010. 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 July 6, 

2010. 


srobinson on DSKHWCL6B1PROD with NOTICES
31804 Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Heather K. Pinnock, Valuation and 

Special Programs Branch: (202) 325– 

0034. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that on 2010, 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 the 

lift unit which may be offered to the 

U.S. Government under an 

undesignated government procurement 

contract. This final determination, in 

HQ H100055, was issued at the request 

of Hill-Rom Company, Inc., 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 

lift unit, assembled in Sweden from 

parts made in a non-TAA country and 

in Sweden, is substantially transformed 

in Sweden, such that Sweden is the 

country of origin of the finished article 

for purposes of U.S. government 

procurement. 

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, 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: May 28, 2010. 

Harold M. Singer, 

Acting Executive Director, Regulations and 

Rulings, Office of International Trade. 

Attachment 

HQ H100055 

May 28, 2010 

OT:RR:CTF:VS H100055 HkP 

CATEGORY: Marking 

Karen A. McGee, Esq. 

Linda M. Weinberg, Esq. 

Barnes & Thornburg LLP 

750 17th Street, N.W., Suite 900 

Washington, DC 20006–4675 

RE: Government Procurement; Country of 

Origin of a Lift Unit for an Overhead 

Patient Lift System; Substantial 

Transformation 

Dear Mses. McGee and Weinberg: This is 

in response to your letter dated April 1, 2010, 

requesting a final determination on behalf of 

Hill-Rom Company, Inc., pursuant to subpart 

B of part 177 of the U.S. Customs and Border 

Protection Regulations (19 C.F.R. 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 a lift unit for the Likorall 

Overhead Patient Lift System. We note that 

as a U.S. importer Hill-Rom is a party-atinterest within the meaning of 19 C.F.R. 

§ 177.22(d)(1) and is entitled to request this 

final determination. 

FACTS: 

According to the information submitted, 

the Likorall Overhead Patient Lift System is 

a ceiling-mounted or free-standing patient lift 

system. The system is capable of lifting and 

transporting patients with limited mobility, 

weighing up to 550 pounds, from one part of 

a room to another or from one room to 

another. It can also be used for weighing and 

lifting in combination with a stretcher and 

for walking, standing, gait and balance 

training. The system is designed to lift and 

move patients safely while avoiding injuries 

to caregivers. 

The merchandise at issue, the Likorall lift 

unit, is the motorized component of the 

Overhead Patient Lift System that extends 

and retracts the lift belt to which the patientsupporting sling is attached. The unit is 

manufactured in 3 basic models: (1) 242, 

which has a lifting capacity up to 440 

pounds; (2) 243, which has a lifting capacity 

up to 507 pounds; and (3) 250, which has a 

lifting capacity up to 550 pounds. Models 

243 and 250 come in an ‘‘ES’’ version, which 

is equipped with an infrared (IR) receiver for 

optional use with a remote control. Model 

242 comes in the ‘‘S’’ version, which operates 

only with an attached hand control, as well 

as in the ES version. In addition, the 242 

model has ‘‘R2R’’ versions, which feature a 

contact for a transfer motor so that the patient 

can be moved between two independent 

overhead rail systems in separate rooms, 

without the need for openings above 

doorways. The lift unit was designed, 

developed and engineered in Sweden. It 

incorporates approximately 100 components 

imported from non-TAA countries, except for 

the motor, which is imported from a TAA 

country and the IR remote control, which is 

made in Sweden. 

At the manufacturing facility in Sweden, 

teams of employees assemble the lift unit in 

a four segment process and perform a 25-step 

final functional test under specified 

conditions. The segments are: Manufacturing 

the electrical motor, drum and motor package 

in a 17-step process; mounting batteries and 

installing the exterior covers of the drum/ 

motor assembly in a 5-step process; 

connecting a printed circuit board assembly 

(PCBA) to the motor, housed drum and 

batteries in a 3-step process; and, assembling 

the emergency strap, cover and end caps in 

a 14-step process. The PCBA is assembled 

and programmed prior to importation into 

Sweden but is designed in Sweden and its 

software program is written in Sweden. 

During the final functional test the 

electronics of the lift unit are checked and 

the maximum load is attached to check 

performance. At the conclusion of the test, 

the employee performing the test must 

complete a test protocol form, with the 

original being provided to the customer and 

a copy retained by the manufacturer in a test 

log that tracks units by serial number. The 

full manufacturing process takes 

approximately 45 minutes and the testing 

process takes approximately 15 minutes. 

According to the information submitted, 

the employees manufacturing the lift unit 

have mechanical knowledge and skill related 

to their work gained from technical 

secondary education, product specific 

training, and certified final functional test 

training. The lift unit is also tested by an 

accredited testing institute and complies 

with the requirements of directives for 

medical-technical Class 1 products in the 

European Union (MDD 93/42/EEC). 

Packaged for retail sale with the lift unit is 

a hand control, which is attached by cable to 

the overhead unit and is used to control 

power, lifting and lowering of the lift unit’s 

belt, and the moving of the lift unit along the 

rails. The hand control plugs into a contact 

on one of the end plates and is physically 

and electrically connected to the overhead 

lift unit. It is made in a non-TAA country. 

An IR remote hand control (ES versions and 

242 ESR2R), which can be used as an 

alternative to the attached hand control is 

also imported with the unit. The remote 

control and the PCB it incorporates are made 

in Sweden. A battery charger, into which the 

wired hand control is inserted to charge the 

batteries inside the lift unit, is also imported 

with the lift unit. The charger is made in the 

same non-TAA country as the hand control. 

ISSUE: 

What is the country of origin of the lift unit 

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 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices 31805 

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. 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. 

Whether an operation is complex and 

meaningful depends on the nature of the 

operation, including the number of 

components assembled, number of different 

operations, time, skill level required, 

attention to detail, quality control, the value 

added to the article, and the overall 

employment generated by the manufacturing 

process. 

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. 

CBP has held in a number of cases that 

complex and meaningful assembly 

operations involving a large number of 

components result in a substantial 

transformation. In Headquarters Ruling Letter 

(HQ) H047362, dated March 26, 2009, CBP 

found that 61 components manufactured in 

China and assembled into ground fault 

circuit interrupters (GFCIs) in Mexico in a 

two-phase process by skilled workers using 

sophisticated equipment were substantially 

transformed in Mexico. In particular, we took 

into consideration that the first phase 

involved the assembly of a PCB in a 42-step 

technically complex process that took 12 

minutes and that the completed PCB had all 

the major components necessary for the GFCI 

to fulfill its function. We also took into 

consideration that in the second phase the 

PCB would be assembled with 29 other 

components to form the GFCIs in a 43-step 

process taking approximately 10 minutes, 

after which the components would have lost 

their individual identities and become an 

integral part of the interrupters with a new 

name, character and use. 

By contrast, assembly operations that are 

minimal or simple will generally not result 

in a substantial transformation. For example, 

in HQ 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. 

In this case, approximately 100 

components manufactured in non-TAA 

countries will be assembled in Sweden in 

four phases requiring specialized training. 

The manufacturing process has 39 steps and 

takes 45 minutes. After manufacturing, the 

unit is subjected to a 25-step testing process, 

which takes approximately 15 minutes. We 

find these manufacturing and testing 

operations in Sweden to be sufficiently 

complex and meaningful, in that individual 

components’ names, uses and identities are 

lost and are transformed in Sweden into the 

lift unit. Therefore, the country of origin of 

the lift unit is Sweden. 

You argue that of the lift unit, detachable 

hand control and battery charger being 

imported, the lift unit provides the essential 

character of the Likorall System. ‘‘The term 

‘character’ is defined as ‘one of the essentials 

of structure, form, materials, or function that 

together make up and usually distinguish the 

individual.’ ’’ Uniden America Corporation v. 

United States, 120 F. Supp. 2d. 1091, 1096 

(citations omitted) (Ct. Int’l Trade 2000), 

citing National Hand Tool Corp. v. United 

States, 16 Ct. Int’l Trade 308, 311 (1992). In 

Uniden (concerning whether the assembly of 

cordless telephones and the installation of 

their detachable A/C (alternating current) 

adapters constituted instances of substantial 

transformation), the Court of International 

Trade applied the ‘‘essence test’’ and found 

that ‘‘[t]he essence of the telephone is housed 

in the base and the handset. Consumers do 

not buy the article because of the specific 

function of the A/C adapter, but rather 

because of what the completed handset and 

base provide: communication over telephone 

wires.’’ Id. at 1096. 

Further, you argue that the detachable 

hand control and battery charger are 

substantially transformed with the lift unit, 

in that they have a new character, use and 

name because they are attached to and form 

parts of the Likorall System. In support of 

this view, you cite Uniden, supra, in which 

the court also found that the detachable 

A/C adapters underwent a substantial 

transformation pursuant to the Generalized 

System of Preferences (GSP) when installed 

into the cordless telephones. The court noted 

that the substantial transformation test is to 

be applied to the product as a whole and not 

to each of its detachable components. See id. 

Consequently, the court found that the A/C 

adapter, as part of the cordless phone, had a 

new character, use and name. 

Based on the findings of the court in 

Uniden, we agree with your view that the 

detachable hand control and battery charger 

are substantially transformed when attached 

to the lift unit. Consequently, if they are 

imported from Sweden packaged together 

with the lift unit, their country of origin for 

purposes of U.S. government procurement 

will be Sweden. 

HOLDING 

Based on the facts of this case, we find that 

the manufacturing and testing operations 

performed in Sweden substantially 

transforms the non-TAA country 

components. Therefore, the country of origin 

of the lift unit is Sweden for purposes of U.S. 

government procurement. Moreover, because 

the lift unit conveys the essential character 

of the Likorall System and the detachable 

hand control and the battery charger are parts 

of that system, they are substantially 

transformed when attached to the lift unit. 

The country of origin of the hand control and 

battery charger for purposes of U.S. 

government procurement, when imported 

from Sweden packaged with the lift unit, is 

Sweden. 

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 after publication 

in the Federal Register Notice referenced 

above, seek judicial review of this final 

determination before the Court of 

International Trade. 

Sincerely, 

Harold M. Singer 

Acting Executive Director 

Regulations and Rulings 

Office of International Trade 

[FR Doc. 2010–13497 Filed 6–3–10; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–5300–FA–25] 

Announcement of Funding Awards for 

the Resident Opportunity and SelfSufficiency (ROSS)—Service 

Coordinators Program for Fiscal Year 

2009 

AGENCY: Office of Public and Indian 

Housing, HUD. 

ACTION: Announcement of funding 

awards. 


srobinson on DSKHWCL6B1PROD with NOTICES