Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Notices 62847 

• The Isolated Chicken Eye Test 

Method. 

• The Cytosensor Microphysiometer 

Test Method. 

• Case Studies in Breakout Groups. 

• New Models and Strategies in the 

Validation Pipeline for Ocular Safety 

Testing. 

• Roundtable Discussion and 

Summary Question-and-Answer 

Session. 

• Closing Comments. 

Preliminary Workshop Agenda: Best 

Practices for Assessing the Potential for 

Chemically Induced Allergic Contact 

Dermatitis (January 20, 2011) 

• Welcome, Introduction, and Public 

Health Impact of Chemically Induced 

ACD. 

• Review of Alternative Test Methods 

and Integrated Strategies for ACD 

Hazard Assessments. 

• Consideration and Use of Available 

Reduction, Refinement, and 

Replacement Alternative Test Methods: 

Study Director and IACUC 

Responsibilities. 

• Current Guidelines for ACD Hazard 

Testing. 

• Regulatory Agency Requirements 

and Acceptable Alternative Test 

Methods for ACD Hazard Assessments. 

• The Reduced LLNA. 

• The LLNA: Bromodeoxyuridine 

Enzyme-linked Immunosorbent Assay 

(BrdU–ELISA). 

• The LLNA: Daicel Adenosine 

Triphosphate (DA). 

• Application of Peptide Reactivity 

for Screening ACD Hazard Potential. 

• Case Studies in Breakout Groups. 

• New Models and Strategies in the 

Validation Pipeline for ACD Hazard 

Testing. 

• Roundtable Discussion and 

Summary Question-and-Answer 

Session. 

• Closing Comments. 

Registration 

Registration information, a tentative 

agenda for each workshop, and 

additional information for both 

workshops are available on the 

NICEATM–ICCVAM Web site (http:// 

iccvam.niehs.nih.gov/meetings/ 

Implement-2011/ImplmtnWksp.htm) 

and upon request from NICEATM (see 

FOR FURTHER INFORMATION CONTACT). 

Background Information on ICCVAM 

and NICEATM 

ICCVAM is an interagency committee 

composed of representatives from 15 

U.S. Federal regulatory and research 

agencies that require, use, or generate 

toxicological and safety testing 

information for chemicals, products, 

and other substances. ICCVAM 

conducts technical evaluations of new, 

revised, and alternative methods with 

regulatory applicability, and promotes 

the scientific validation, regulatory 

acceptance, and national and 

international harmonization of 

toxicological and safety testing methods 

that more accurately assess the safety 

and health hazards of chemicals and 

products while reducing, refining 

(decreasing or eliminating pain and 

distress), or replacing animal use. The 

ICCVAM Authorization Act of 2000 (42 

U.S.C. 285l-2, 285l-5 [2000], available at 

http://iccvam.niehs.nih.gov/docs/ 

about_docs/PL106545.pdf) established 

ICCVAM as a permanent interagency 

committee of the NIEHS under 

NICEATM. 

NICEATM administers ICCVAM, 

provides scientific and operational 

support for ICCVAM-related activities, 

and coordinates international validation 

studies of new and improved test 

methods. NICEATM and ICCVAM work 

collaboratively to evaluate new and 

improved test methods applicable to the 

needs of U.S. Federal agencies. 

NICEATM and ICCVAM welcome the 

public nomination of new, revised, and 

alternative test methods for validation 

studies as well as technical evaluations. 

Additional information about NICEATM 

and ICCVAM can be found on the 

NICEATM–ICCVAM Web site (http:// 

www.iccvam.niehs.nih.gov). 

Dated: October 1, 2010. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2010–25676 Filed 10–12–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Notice of Issuance of Final 

Determination Concerning an 

ADFLOTM Respiration 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 an AdfloTM Respiration System 

used in a welding environment. Based 

upon the facts presented, CBP has 

concluded in the final determination 

that Sweden is the country of origin of 

the AdfloTM Respiration System for 

purposes of U.S. government 

procurement. 

DATES: The final determination was 

issued on October 6, 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 on or before 

November 12, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Robert Dinerstein, Valuation and 

Special Programs Branch: (202) 325– 

0132. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that on October 6, 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 AdfloTM Respiration 

System which may be offered to the U.S. 

Government under an undesignated 

government procurement contract. This 

final determination, in HQ H112725, 

was issued at the request of 3M 

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 has concluded that, 

based upon the facts presented and 

precedent from the Court of 

International Trade in Uniden America 

Corporation v. United States, 120. Supp. 

2d. 1091, (Ct. Int’l Trade 2000), that a 

battery charger included with the 

AdfloTM System, lost its separate 

identity and became part of the system 

rendering Sweden the country of origin 

of the AdfloTM Respiration System for 

purposes of U.S. government 

procurement. With respect to a cloth bag 

enclosed with the AdfloTM respiration 

system, because it is a textile product, 

we indicated that its country of origin 

is to be determined in accordance with 

rules for the country of origin of textile 

products set forth in 19 U.S.C. 3592 and 

CBP Regulations at 19 CFR 102.21. 

Since we did not have enough 

information, we could not rule on the 

country of origin of the bag. 

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. 

mstockstill on DSKH9S0YB1PROD with NOTICES

62848 Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Notices 

Dated: October 6, 2010. 

Sandra L. Bell, 

Executive Director, Regulations and Rulings, 

Office of International Trade. 

Attachment 

HQ H112725 

October 6, 2010 

MAR–02 OT:RR:CTF:VS H112725 RSD 

CATEGORY: Marking 

Mr. Matthew Fuller 

Trade Compliance Department 

3M Company 

3M Center 

Building 225–4S–18 

St. Paul, Minnesota 55144–1000 

RE: Final Determination U.S. Government 

Procurement, Title III, Trade Agreements 

Act of 1979 (19 U.S.C. § 2511); Subpart 

B Part 177, CBP 

Regulations; Country of Origin; AdfloTM

Respiration System 

Dear Mr. Fuller: 

This is in response to a letter dated June 

24, 2010, submitted by the law firm K&L 

Gates on behalf of the 3M Company 

requesting a final determination pursuant to 

subpart B Part 177, Customs and Border 

Protection (‘‘CBP’’) Regulations (19 CFR 

§ 177.21 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 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. A telephone conference was 

conducted on August 12, 2010, with you and 

your counsel to discuss this matter. We have 

also received a supplemental submission via 

email on September 7, 2010. 

This final determination concerns the 

country of origin of the AdfloTM respirator 

system. We note that 3M Company is a partyat-interest within the meaning of 19 C.F.R. 

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

final determination. 

FACTS: 

The product at issue is the 3M Adflo TM

respiration system. It is a powered air 

purifying respirator used for respiratory 

protection in a welding environment. The 

Adflo TM respiration system utilizes a 

‘‘stackable’’ configuration, meaning that the 

Adflo TM cartridge can be stacked onto a highefficiency particle filter for additional 

protection against organic, sulfur dioxide, 

chlorine, and hydrogen chloride vapors. The 

system’s main components consist of a 

helmet and a powered blower unit. The 

powered blower unit delivers purified air 

into the helmet for protection of the user 

against contaminants encountered by the 

user in a welding environment. The helmet 

provides the primary protection for the user’s 

head and eyes via the inclusion of an auto 

darkening lens which is sold separately. 

You state that the 3M Adflo TM respiration 

system is comprised of the following 

components: 1) HWR 9000 FV Helmet SW 

Assembly Complete, 2) ADFLO TM Turbo 

Subassembly with its particle filter indicator, 

3) AF Battery, 4) ADFLO TM Leather Belt, 5) 

ADFLO TM Rubber Breath tube, 6) AF Air 

flow indicator. All these components are 

stated to be manufactured in Sweden. 

Sometimes the helmet is equipped with a 

lens. There are two other minor components 

included in the system, an AF Battery 

Charger and a Gas Filter, which are made in 

Germany. It is our understanding that the gas 

filter is installed into the Adflo TM respiration 

system in Sweden. In addition, a cloth 

carrying bag stated to be made in the United 

States will be included with the respiration 

system as a courtesy item. The cloth bag 

serves no function to the use of the product 

other than to store and carry the product 

when it is not in use. During the telephone 

conference, it was indicated that the cloth 

bag may be eventually sourced from other 

countries, such as China. 

All components are packaged at 3M’s 

Valley, Nebraska facility. The system is not 

fully assembled when it is shipped to the 

United States. Rather, all the components are 

packaged together and the final minor 

assembly is performed by the customer (e.g., 

the customer in the United States attaches 

the Adflo TM Rubber Breath tube to the 

helmet and the powered Adflo TM Turbo 

(blower) unit). You indicate that the Swedish 

components account for 86.2 percent of the 

value of the Adflo TM respiration system 

when it sold without the lens and 87.8–88.1 

percent of its value when it is sold with a 

lens. The German origin battery charger 

accounts for 12.9 percent (without a lens) or 

11.2–11.4 percent (with a lens) of the value 

of the Adflo TM respiration system. The 

remaining 0.87 percent (without a lens) or 

0.75–0.77 percent (with a lens) of the value 

of the Adflo TM respiration system is 

attributable to the U.S. component, which is 

the cloth bag. 

ISSUE: 

What is the country of origin of the 

Adflo TM Respiration System for purposes of 

government procurement? 

LAW AND ANALYSIS: 

Pursuant to Subpart B of Part 177, 19 

C.F.R. § 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. 

In rendering advisory rulings and final 

determinations for purposes of U.S. 

Government procurement, CBP applies the 

provisions of subpart B of Part 177 consistent 

with the Federal Procurement Regulations. 

See 19 CFR § 177.21. In this regard, CBP 

recognizes that the Federal Procurement 

Regulations restrict the U.S. Government’s 

purchase of products to U.S.-made or 

designated country end products for 

acquisitions subject to the TAA. See 48 CFR 

§ 25.403(c)(1). 

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 C.F.R. § 177.22(a). 

A substantial transformation occurs when 

an article emerges from a process with a new 

name, character, or use different from that 

possessed by the article prior to processing. 

See Texas Instruments, Inc. v. United States, 

69 CCPA 152, 681 F.2d 778 (1982). 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, 6 Ct. Int’l Trade 204, 

573 F. Supp. 1149 (1983), aff’d, 741 F.2d 

1368 (Fed. Cir. 1984). 

Initially, we note that only three of the 

components of the Adflo TM respiration 

system are not made in Sweden, a battery 

charger and a gas filter which are made in 

Germany, and a cloth carrying bag made in 

the United States. Because the gas filter will 

be permanently installed in Sweden to 

become a part of the Adflo TM respiration 

system, we find that the gas filter will lose 

its separate identity and be substantially 

transformed in Sweden. 

In contrast, we note that no processing is 

performed on the battery charger and the 

cloth bag other than packaging them together 

with the other components of the Adflo TM

respiration system. CBP will not usually 

consider a simple packaging operation to 

result in a substantial transformation of an 

article. See Headquarters Ruling (HQ) 559287 

dated December 16, 1995. Nonetheless in 

Uniden America Corporation v. United 

States, 120. Supp. 2d. 1091, (Ct. Int’l Trade 

2000), the Court of International of Trade 

(CIT) considered the assembly of a cordless 

telephone and the installation of their 

detachable A/C (alternating current) adapters. 

The CIT applied an ‘‘essence test’’ and found 

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

housed in the base and the handset. The 

court noted that 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. The 

court in Uniden found that the detachable A/ 

C adapter was substantially transformed 

pursuant to the Generalized System of 

Preference (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. 

Consequently, the court found that the A/C 

adapter was a part of the cordless phone and 

that it had a new character, use, and name. 

CBP has applied the CIT’s analysis in 

Uniden to determine whether minor 

components when combined with a larger 

and a complex system would lose their 

separate identities to become part of that 

larger system. For example, in HQ H100055 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Notices 62849 

dated May 28, 2010, we ruled on the country 

of origin of a lift unit for an overhead patient 

lift system. Among the issues that we 

considered was whether a battery charger, 

when inserted into the hand control unit 

inside the lift unit, was substantially 

transformed. Relying on the Uniden decision, 

we noted that the substantial transformation 

test should be applied to the product as a 

whole and not to each of the parts. We 

determined that the lift unit conveyed the 

essential character to the system and because 

the detachable hand control and the battery 

charger were parts of that system, they were 

substantially transformed when attached to 

the lift unit. Thus, we held that the country 

of origin of the hand control unit and battery 

charger when packaged with the lift unit was 

Sweden. 

In H089762 dated June 2, 2010, CBP 

determined that component parts and 

subassemblies that were used to produce a 

hand-held mobile computer were 

substantially transformed for government 

procurement purposes in Canada as a result 

of a complex assembly and installation of 

Canadian software programming in Canada. 

Included in the hand-held computer was a 

stylus and stylus holder from China. 

Although the stylus was merely included 

with the hand held computer and not 

permanently attached to it, our analysis did 

not find that the stylus and stylus holder kept 

their separate identities. Instead, the ruling 

only addressed the question of what was the 

country of origin of the whole hand-held 

computer system. We determined that 

Canada was the country of origin of the handheld computer system, and thus those minor 

components such as the stylus and stylus 

holder were accepted as parts of that whole 

system. Thus, for country of origin purposes 

in a government procurement context, they 

lost their separate identity. 

In this instance, we believe that inclusion 

of the battery charger does not alter the 

essential character of the Adflo TM respiration 

system which is designed to provide 

respiratory protection in a welding 

environment. The battery charger is a very 

minor component when compared to the 

complexity of the Adflo TM respiration 

system. Consistent with the CIT’s decision in 

Uniden and our decisions in HQ H100055 

and HQ H089762, we find that the battery 

charger will lose its separate identity and 

become a part of the larger and more complex 

Adflo TM respiration system, when it is 

included with the system to be sold in the 

United States. Consequently, the country of 

origin of the Adflo TM respiration system is 

Sweden, which will be unaffected by the 

inclusion of the battery charger. 

However, the situation is different with 

respect to the cloth bag because it is a textile 

product, and there are special rules for 

determining the country of origin of textile 

products. The rules of origin for textile 

products for purposes of the customs laws 

and the administration of quantitative 

restrictions are set forth in 19 U.S.C. § 3592. 

These provisions are implemented in CBP 

Regulations at 19 C.F.R. § 102.21. At this 

point, we do not have enough information to 

rule on the country of origin of the cloth bag 

when it is included with the Adflo TM system. 

In this instance, however, you state that the 

bag is of U.S. origin. In the event that the 

country of origin of the bag changes to a 

country other than the U.S., we will require 

further description of the bag, including its 

classification and a sample in order for us to 

provide a decision. 

HOLDING: 

Based on the information provided, the 

German filter is substantially transformed 

when it is installed in Sweden into the 

Adflo TM respiration system. The battery 

charger loses its separate identity when it is 

included with the Adflo TM respiration 

system and since it is a minor component it 

also becomes a part of the Adflo TM

respiration system. Therefore, the imported 

country of origin of Adflo TM respiration 

system for purposes of U.S. government 

procurement is Sweden. The country of 

origin of the cloth bag will be governed by 

the rules of origin for textiles set forth in 19 

C.F.R. § 102.21. 

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 

of the Federal Register Notice referenced 

above, seek judicial review of this final 

determination before the Court of 

International Trade. 

Sincerely, 

Sandra L. Bell 

Executive Director 

Office of Regulations and Rulings 

Office of International Trade 

[FR Doc. 2010–25666 Filed 10–12–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–5300–FA–13] 

Announcement of Funding Awards for 

the Self-Help Homeownership 

Opportunity Program (SHOP) for Fiscal 

Year 2009 

AGENCY: Office of Community Planning 

and Development, HUD. 

ACTION: Announcement of funding 

awards. 

SUMMARY: In accordance with Section 

102(a)(4)(C) of the Department of 

Housing and Urban Development 

Reform Act of 1989, this announcement 

notifies the public of funding decisions 

made by the Department in a 

competition for funding under the 

Fiscal Year 2009 (FY 2009) Notice of 

Funding Availability (NOFA) for the 

Self-Help Homeownership Opportunity 

Program (SHOP). This announcement 

contains the consolidated names and 

addresses of this year’s award recipients 

under SHOP. 

FOR FURTHER INFORMATION CONTACT: For 

questions concerning SHOP Program 

awards, contact Ginger Macomber, 

SHOP Program Manager, Office of 

Affordable Housing Programs, U.S. 

Department of Housing and Urban 

Development, 451 Seventh Street, SW., 

Washington, DC 20410–4500, telephone 

(202) 402–4605. Hearing or speechimpaired individuals may access this 

number via TTY by calling the toll-free 

Federal Information Relay Service at 

(800) 877–8339. 

SUPPLEMENTARY INFORMATION: The SHOP 

program provides grants to national and 

regional nonprofit organizations and 

consortia that have experience in 

providing self-help housing. Grant 

funds are used to purchase land and 

install or improve infrastructure, which 

together may not exceed an average 

investment of $15,000 per dwelling 

unit. Low-income homebuyers 

contribute a minimum of 100 hours of 

sweat equity on the construction of their 

homes and/or the homes of other 

homebuyers participating in the local 

self-help housing program. Sweat equity 

can include, but is not limited to, 

assisting in the painting, carpentry, trim 

work, drywall, roofing and siding for the 

housing. Persons with disabilities can 

substitute administrative tasks. Donated 

volunteer labor is also required. 

The SHOP funds together with the 

sweat equity and volunteer labor 

contributions significantly reduce the 

cost of the housing for the low-income 

homebuyers. The FY 2009 awards 

announced in this Notice were selected 

for funding in the competition posted 

on HUD’s Web site on http:// 

www.hud.gov/offices/adm/grants/

nofa09/gensec.pdf. Applications were 

scored and selected for funding based 

on the selection criteria in the General 

Section and the SHOP program section 

which can be found at http:// 

www.hud.gov/library/bookshelf12/

supernofa/nofa09/grpshop.cfm. 

The amount appropriated in FY 2009 

to fund the SHOP grants was 

$26,500,000. The allocations for SHOP 

grantees are as follows: 

Tierra del Sol Housing Corporation, 880 Anthony Drive, Anthony, NM 88021 .................................................................................. $983,089 

Community Frameworks, 409 Pacific Avenue, Bremerton, WA 98337 .............................................................................................. 5,146,258 

Housing Assistance Council, 1025 Vermont Avenue, Washington, DC 20005 .................................................................................. 9,130,912 

mstockstill on DSKH9S0YB1PROD with NOTICES