Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Notices 62845 

a hospital-based environment, where 

the risks to the patient are minimized. 

CDRH and NIH seek feedback on ways 

to overcome obstacles in the 

development of an artificial pancreas 

and what might be considered 

reasonable clinical expectations for 

systems considering the available 

existing technology. 

This public workshop is to seek input 

from a wide range of constituencies 

including but not be limited to industry, 

academia, patient/consumer advocacy 

groups, professional organizations, and 

other State and Federal bodies under 

aligned public health missions, to 

address the issues outlined in this 

notice. During the public workshop, 

there will be an open dialogue between 

Federal Government and experts from 

the private and public sectors regarding 

the topics described in this document. 

Workshop participants will not be 

expected to develop consensus 

recommendations, but rather to provide 

their perspectives on the clinical 

development of these device systems. 

II. Issues for Discussion 

The workshop will focus on three 

topics: (1) Technical considerations 

when developing a clinical study 

design; (2) expectations of the various 

artificial pancreas device systems; and 

(3) a discussion of the various 

development plans for the Artificial 

Pancreas System. The discussion of 

these general topics should not be 

limited by current statutes or 

regulations and will include, but not be 

limited to, discussion of the preceding 

questions. 

III. Where can I find more information 

about this public workshop? 

Background information on the public 

workshop, registration information, the 

agenda, and other relevant information 

will be posted, as it becomes available, 

on the Internet at http://www.fda.gov/ 

MedicalDevices/NewsEvents/ 

WorkshopsConferences/ 

ucm226251.htm. 

IV. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD. A transcript will 

also be available in either hardcopy or 

on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, Rm. 6–30, Rockville, MD 20857. 

Dated: October 5, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–25600 Filed 10–12–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Toxicology Program (NTP) 

Interagency Center for the Evaluation 

of Alternative Toxicological Methods 

(NICEATM): Workshop Series on Best 

Practices for Regulatory Safety 

Testing: Assessing the Potential for 

Chemically Induced Eye Injuries and 

Chemically Induced Allergic Contact 

Dermatitis (ACD) 

AGENCY: National Institute of 

Environmental Health Sciences 

(NIEHS), National Institutes of Health 

(NIH), Department of Health and Human 

Services. 

ACTION: Announcement of a Workshop 

Series. 

SUMMARY: NICEATM and the 

Interagency Coordinating Committee on 

the Validation of Alternative Methods 

(ICCVAM) announce a planned series of 

workshops on ‘‘Best Practices for 

Regulatory Safety Testing.’’ The first two 

workshops in this series, ‘‘Best Practices 

for Assessing the Potential for 

Chemically Induced Eye Injuries’’ and 

‘‘Best Practices for Assessing the 

Potential for Chemically Induced 

Allergic Contact Dermatitis,’’ are 

planned for January 19 and 20, 2011, 

respectively. These one-day workshops 

will help participants gain a practical 

understanding of the theory and 

application of available in vitro and in 

vivo alternative test methods that can be 

used to evaluate the hazard potential of 

chemicals and products while avoiding 

or minimizing animal use and animal 

pain and distress. Participants will learn 

the strengths and weaknesses of 

available alternative test methods, 

become familiar with the types of data 

they provide, and learn how to use these 

data in regulatory safety assessments. 

Workshop topics will be of particular 

interest to those involved in conducting 

safety tests for chemically induced eye 

injuries and/or chemically induced 

ACD, those responsible for reviewing 

and approving study protocols prior to 

testing, and regulators who are expected 

to review data generated by the tests. 

The workshops are free and open to the 

public with attendance limited only by 

the space available. Those interested 

may register for one or both workshops. 

DATES: The workshop on ‘‘Assessing the 

Potential for Chemically Induced Eye 

Injuries’’ will be held on January 19, 

2011. The workshop on ‘‘Assessing the 

Potential for Chemically Induced 

Allergic Contact Dermatitis’’ will be held 

on January 20, 2011. Sessions for both 

workshops will begin at 8:30 a.m. and 

end at approximately 5 p.m. Individuals 

who plan to attend either or both 

workshops are asked to register with 

NICEATM by January 6, 2011. 

ADDRESSES: The workshops will be held 

at the William H. Natcher Conference 

Center, 45 Center Drive, NIH Campus, 

Bethesda, MD 20892. Persons needing 

special assistance in order to attend, 

such as sign language interpretation or 

other reasonable accommodation, 

should contact 919–541–2475 voice, 

919–541–4644 TTY (text telephone), 

through the Federal TTY Relay System 

at 800–877–8339, or e-mail to 

niehsoeeo@niehs.nih.gov. Requests 

should be made at least 14 days before 

the event. 

FOR FURTHER INFORMATION CONTACT: 

Correspondence should be sent by mail, 

fax, or e-mail to Dr. William S. Stokes, 

NICEATM Director, NIEHS, P.O. Box 

12233, MD K2–16, Research Triangle 

Park, NC 27709, (phone) 919–541–2384, 

(fax) 919–541–0947, (e-mail) 

niceatm@niehs.nih.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

To protect workers and consumers, 

regulatory agencies require testing to 

determine if chemicals and products 

may cause illnesses or injuries. Each 

year, approximately 2 million eye 

injuries occur in the U.S., of which 

more than 40,000 result in permanent 

visual impairment. Data on consumer 

product-related eye injuries indicate 

that the most common products causing 

eye injuries in children under the age of 

10 are household cleaning chemicals 

and other chemical products. ACD is 

also a significant concern because skin 

diseases, including ACD, constitute the 

second most common category of 

occupational disease. ACD frequently 

develops in workers and consumers 

exposed to skin sensitizing products 

and chemicals, results in lost workdays, 

and can significantly diminish quality 

of life. 

To address these concerns, regulatory 

authorities require safety testing that 

can identify substances that may present 

these hazards. Tests for ocular and ACD 

hazards are two of the four most 

frequently conducted product safety 

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62846 Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Notices 

1 7 U.S.C. 2131–2159. 

tests. Test results are used to determine 

appropriate labeling to warn consumers 

and workers of potential hazards and to 

communicate precautions that should 

be taken to avoid eye injury or 

development of ACD. 

The U.S. Public Health Service Policy 

on Humane Care and Use of Laboratory 

Animals and the U.S. Department of 

Agriculture’s Animal Welfare Act 

regulations 1 require that alternatives to 

procedures that can cause more than 

slight or momentary pain or distress to 

test animals must be considered and 

used where appropriate. Substantial 

progress has been made in recent years 

in the development, validation, and 

regulatory acceptance of alternative test 

methods that reduce, refine (decrease or 

eliminate pain and distress), or replace 

the use of animals for ocular safety 

assessments and ACD hazard testing. 

Investigators and Institutional Animal 

Care and Use Committee (IACUC) 

members need to be aware of currently 

available alternative methods so that 

they can be considered before animal 

study protocols are approved. 

For ocular safety testing, ICCVAM has 

recommended the bovine corneal 

opacity and permeability, isolated 

chicken eye, and Cytosensor 

microphysiometer test methods for use 

in specific circumstances to identify 

ocular corrosives and severe irritants 

without the use of live animals. 

ICCVAM also recently recommended 

that pain management procedures 

should always be used whenever it is 

necessary to use rabbits for eye safety 

testing required by Federal regulatory 

agencies. The ICCVAM 

recommendations include a test method 

protocol that describes how to use 

topical anesthetics (similar to those 

used in human eye surgeries) and 

systemic analgesics prior to and after 

test substance administration in order to 

avoid or minimize animal pain and 

distress. The report also identifies 

specific clinical signs and lesions that, 

if observed during animal testing, can be 

used as humane endpoints to allow the 

investigator to end a study early in order 

to reduce or avoid potential animal pain 

and distress. Use of the ICCVAMrecommended ocular safety testing 

methods (available at http:// 

iccvam.niehs.nih.gov/methods/ocutox/ 

ocutox.htm) may reduce the number of 

animals required to identify substances 

with the potential to cause chemically 

induced eye injuries, and eliminate pain 

and distress when it is necessary to use 

animals for such testing. 

To identify substances with the 

potential to cause ACD, U.S. Federal 

agencies have accepted ICCVAM 

recommendations on an updated 

murine local lymph node assay (LLNA) 

protocol that uses 20% fewer animals. 

Federal agencies also accepted ICCVAM 

recommendations on the use of a 

modified procedure called the reduced 

LLNA that uses 40% fewer animals than 

the updated 3-dose LLNA protocol. 

ICCVAM also recently recommended 

two modified versions of the LLNA that 

do not require radioactive reagents, 

allowing more institutions to take 

advantage of the reduction and 

refinement benefits afforded by the 

LLNA compared to traditional guinea 

pig methods. These nonradioactive 

methods will also eliminate the expense 

and environmental hazard associated 

with use and disposal of radioactive 

materials used in the traditional LLNA. 

ICCVAM-recommended ACD testing 

methods are available at http:// 

iccvam.niehs.nih.gov/methods/ 

immunotox/immunotox.htm. 

While toxicologists recognize the 

usefulness and strengths of these new 

approaches, many are unfamiliar with 

the specific techniques. Before a new 

test method is implemented, the safety 

community must understand the 

method, as well as the manner in which 

agencies expect the method to be 

conducted and data interpreted. Users 

and regulatory agency staff need to 

become familiar with the technical 

procedures required to conduct a new 

method, and to understand the method’s 

usefulness and limitations. 

Consequently, there is a need for indepth training of individuals in the 

safety and regulatory community on the 

appropriate use of new tools for hazard, 

safety, and risk assessment. 

These workshops provide 

opportunities for such training. They 

will bring together scientific experts 

from relevant stakeholder organizations 

to discuss available alternative test 

methods for assessing chemicals and 

products for their ocular and ACD 

hazard potential. The goal is to raise 

awareness of available alternatives that 

users should consider before using 

traditional animal methods to assess eye 

injury and ACD hazards. The workshops 

will also provide information about the 

usefulness and limitations of these test 

methods. Users can then determine 

whether the methods are appropriate for 

specific testing applications. 

Who Should Attend 

Scientists from industry, government, 

and academia who have an interest in 

learning more about alternative test 

methods that are available for assessing 

potential eye injury or ACD hazards are 

encouraged to participate. Topics 

discussed during these workshops will 

be of particular interest to those 

involved in conducting tests for ocular 

safety and ACD hazards (such as 

toxicologists and study directors), those 

responsible for reviewing study 

protocols prior to testing (such as 

chairpersons and members of IACUCs), 

and regulators who will review data 

generated by such tests. Those 

interested may choose to attend one or 

both workshops. 

Workshop Program 

The workshop on ‘‘Best Practices for 

Assessing the Potential for Chemically 

Induced Eye Injuries’’ will be held on 

January 19, 2011. The workshop on 

‘‘Best Practices for Assessing the 

Potential for Chemically Induced 

Allergic Contact Dermatitis’’ will 

convene on January 20, 2011. Sessions 

are scheduled to run from 8:30 a.m. to 

5 p.m. each day. The programs will 

begin with presentations on U.S. 

requirements for the consideration of 

available alternatives, current regulatory 

requirements for safety testing, and the 

acceptance status of alternative 

methods. The scientific development of 

the test methods will be described, and 

the validation status of the test methods 

will be discussed. Detailed 

presentations will then provide 

practical instruction on application of 

the test methods, including standard 

protocols and data interpretation. 

Workshop participants will also have an 

opportunity to apply knowledge gained 

from the program using case studies in 

breakout group discussion sessions. 

Preliminary Workshop Agenda: Best 

Practices for Assessing the Potential for 

Chemically Induced Eye Injuries 

(January 19, 2011) 

• Welcome, Introduction, and Public 

Health Impact of Chemically Induced 

Eye Injuries. 

• Review of Alternative Test Methods 

and Integrated Strategies for Ocular 

Safety Assessments. 

• Consideration and Use of Available 

Reduction, Refinement, and 

Replacement Alternative Test Methods: 

Study Director and IACUC 

Responsibilities. 

• Current Guidelines for Ocular 

Safety Testing. 

• Regulatory Agency Requirements 

and Acceptable Alternative Test 

Methods for Ocular Safety Assessments. 

• ICCVAM Evaluation and 

Recommendations on Best Practices for 

Incorporating Pain Management and 

Humane Endpoints in Ocular Safety 

Testing. 

• The Bovine Corneal Opacity and 

Permeability Test Method. 

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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