50212 Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Notices 

Notice of this meeting is given under 

the Federal Advisory Committee Act 

(Pub. L. 92–463, 5 U.S.C., App. 2). 

Dated: September 24, 2009. 

Judith Sparrow, 

Office of Programs and Coordination, Office 

of the National Coordinator for Health 

Information Technology. 

[FR Doc. E9–23460 Filed 9–29–09; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Toxicology Program (NTP); 

NTP Interagency Center for the 

Evaluation of Alternative Toxicological 

Methods (NICEATM); Availability of the 

Interagency Coordinating Committee 

on the Validation of Alternative 

Methods (ICCVAM) Test Method 

Evaluation Report: The Reduced 

Murine Local Lymph Node Assay, an 

Alternative Test Method Using Fewer 

Animals To Assess the Allergic 

Contact Dermatitis Potential of 

Chemicals and Products; Availability 

of ICCVAM Recommended Murine 

Local Lymph Node Assay Performance 

Standards; Notice of Transmittal to 

Federal Agencies of ICCVAM Test 

Method Recommendations for the 

Reduced Murine Local Lymph Node 

Assay, Updated Murine Local Lymph 

Node Assay Test Method Protocol, and 

Murine Local Lymph Node Assay Test 

Method Performance Standards 

AGENCY: National Institute of 

Environmental Health Sciences 

(NIEHS), National Institutes of Health 

(NIH) 

ACTION: Availability of ICCVAM Test 

Method Evaluation Report (TMER) and 

Recommended Test Method 

Performance Standards; Notice of 

Transmittal. 

SUMMARY: NICEATM announces 

availability of the ICCVAM Test Method 

Evaluation Report: The Reduced Murine 

Local Lymph Node Assay: An 

Alternative Test Method Using Fewer 

Animals to Assess the Allergic Contact 

Dermatitis Potential of Chemicals and 

Products (NIH Publication 09–6439). 

The TMER provides ICCVAM’s 

evaluation and recommendations for the 

reduced Murine Local Lymph Node 

Assay (rLLNA) test method as a 

reduction alternative that uses fewer 

animals compared to the traditional 

Murine Local Lymph Node Assay 

(LLNA) for assessing the potential of test 

substances to cause allergic contact 

dermatitis (ACD). The report includes 

ICCVAM’s recommendations on (a) the 

usefulness and limitations of the 

rLLNA, (b) an updated ICCVAM LLNA 

test method protocol, which includes 

the procedures for conducting the 

rLLNA, (c) future studies to further 

characterize the usefulness and 

limitations of the rLLNA, and (d) rLLNA 

test method performance standards. The 

TMER includes the report of an 

international independent scientific 

peer review panel (hereafter, Panel) and 

the final rLLNA background review 

document (BRD). The BRD provides the 

data and analyses used to evaluate the 

current validation status of the rLLNA 

test method for assessing the ACD 

potential of chemicals and products. 

ICCVAM concluded that the scientific 

validity of the rLLNA has been 

adequately evaluated and that the 

performance of the rLLNA, when 

conducted in accordance with the 

ICCVAM-recommended LLNA test 

method protocol, is sufficient to 

distinguish between skin sensitizers and 

non-sensitizers. ICCVAM also 

concluded that the rLLNA would reduce 

animal use by 40% for each test 

compared to the traditional, multi-dose 

LLNA. Accordingly, ICCVAM 

recommends that the rLLNA test 

method should be routinely considered 

before conducting the traditional, multidose LLNA, and used where appropriate 

as the initial test to determine the 

potential of chemicals and products to 

produce ACD. For testing situations that 

require dose-response information, 

rLLNA-positive substances will need to 

be tested with the traditional multi-dose 

LLNA. This testing should be done 

using the updated ICCVAMrecommended test method protocol, 

which reduces animal use by 20% 

compared to the original ICCVAMrecommended test method protocol by 

decreasing the minimum number of 

animals per dose group from five to 

four. 

NICEATM also announces availability 

of the ICCVAM Recommended 

Performance Standards: Murine Local 

Lymph Node Assay (NIH Publication 

09–7357). The ICCVAM recommends 

that LLNA test method performance 

standards can be used to efficiently 

evaluate the validity of modified 

versions of the LLNA that are 

mechanistically and functionally similar 

to the traditional LLNA. The traditional 

LLNA test method is the reference test 

method used as the basis for 

establishing the LLNA performance 

standards. The performance standards 

specify the essential test method 

components that must be included in a 

modified LLNA in order to use the 

performance standards to evaluate the 

validity of the modified test method. 

The performance standards also specify 

a minimum list of reference substances 

to evaluate the accuracy and reliability 

of the modified test method, and the 

accuracy and reliability values that must 

be achieved in order for the modified 

test method to be considered equal to or 

better than the traditional LLNA. 

Electronic copies of the ICCVAM 

rLLNA TMER and the report on 

ICCVAM-recommended LLNA 

performance standards are available 

from the NICEATM–ICCVAM Web site 

at http://iccvam.niehs.nih.gov or by 

contacting NICEATM (see FOR FURTHER

INFORMATION CONTACT). The two reports 

have been forwarded to U.S. Federal 

agencies for regulatory and other 

acceptance considerations, where 

applicable. Responses will be posted on 

the NICEATM–ICCVAM website as they 

are received. 

FOR FURTHER INFORMATION CONTACT: Dr. 

William S. Stokes, Director, NICEATM, 

NIEHS, P.O. Box 12233, Mail Stop: K2– 

16, Research Triangle Park, NC 27709, 

(telephone) 919–541–2384, (fax) 919– 

541–0947, (e-mail) 

niceatm@niehs.nih.gov. Courier address: 

NICEATM, NIEHS, Room 2034, 530 

Davis Drive, Morrisville, NC 27560. 

SUPPLEMENTARY INFORMATION: 

Background 

The U.S. Consumer Product Safety 

Commission (CPSC) nominated several 

new versions and applications of the 

LLNA to ICCVAM in 2007 for 

evaluation of their scientific validity 

(http://iccvam.niehs.nih.gov/methods/ 

immunotox/llnadocs/ 

CPSC_LLNA_nom.pdf). The nomination 

requested that ICCVAM assess the 

validation status of: (1) the LLNA limit 

dose procedure (i.e., the rLLNA); (2) 

three modified LLNA test method 

protocols that do not require the use of 

radioactive materials; (3) the use of the 

LLNA to test mixtures, aqueous 

solutions, and metals (applicability 

domain for the LLNA); and (4) the use 

of the LLNA to determine ACD potency 

categories for hazard classification. 

NICEATM published a Federal Register 

notice (72 FR 27815) requesting public 

comments on the appropriateness and 

relative priority of the CPSC-nominated 

LLNA activities, the development of test 

method performance standards for the 

LLNA, the nomination of scientists to 

serve on the Panel, and the submission 

of data from LLNA testing that related 

to the CPSC-nominated LLNA activities, 

as well as corresponding data from 

human and other animal studies. After 

considering public comments and 

comments from the Scientific Advisory 

Committee on Alternative Toxicological 


CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Notices 50213 

Methods (SACATM), ICCVAM 

unanimously endorsed the nomination 

with a high priority. ICCVAM and 

NICEATM began evaluation activities 

and also initiated development of 

proposed test method performance 

standards for the LLNA since these had 

not previously been developed (http:// 

iccvam.niehs.nih.gov/methods/ 

immunotox/immunotox.htm). 

NICEATM and ICCVAM compiled a 

comprehensive draft BRD on the rLLNA 

test method and a draft test method 

performance standards document for the 

LLNA and released them for public 

comment in January 2008 (73 FR 1360). 

NICEATM and ICCVAM convened the 

Panel at a meeting on March 4–6, 2008, 

to review the draft BRDs and evaluate 

the validation status of the proposed test 

methods and applications. The Panel 

also reviewed the extent that the 

information contained in the draft BRDs 

supported draft ICCVAM test method 

recommendations for test method uses 

and limitations, updated standardized 

test method protocols, and proposed 

future studies. The Panel reviewed the 

draft ICCVAM LLNA test method 

performance standards for their 

adequacy for assessing the accuracy and 

reliability of test method protocols that 

are based on similar scientific principles 

and that measure the same biological 

effect as the traditional LLNA. The 

Panel considered public comments 

made at the meeting as well as public 

comments submitted in advance of the 

meeting, before concluding their 

deliberations. The Panel’s report was 

made available in May 2008 (73 FR 

29136) for public comment. The draft 

ICCVAM BRDs, draft ICCVAM test 

method recommendations, draft 

ICCVAM LLNA test method 

performance standards, the Panel’s 

report, and all public comments were 

made available to the SACATM for 

comment on June 18–19, 2008 (73 FR 

25754). 

ICCVAM considered the Panel’s 

report, all public comments, and 

SACATM comments in finalizing its 

recommendations for the rLLNA, the 

updated LLNA test method protocol, 

and LLNA test method performance 

standards. ICCVAM has forwarded its 

test method recommendations to U.S. 

Federal agencies for consideration, in 

accordance with the ICCVAM 

Authorization Act of 2000 (42 U.S.C. 

285l–3(e)(4)). Agency responses to the 

ICCVAM test method recommendations 

will be made available on the 

NICEATM–ICCVAM Web site as they 

are received. 

Background Information on ICCVAM, 

NICEATM, and SACATM 

ICCVAM is an interagency committee 

composed of representatives from 15 

Federal regulatory and research agencies 

that use, generate, or disseminate 

toxicological information. ICCVAM 

conducts technical evaluations of new, 

revised, and alternative methods with 

regulatory applicability and promotes 

the scientific validation and regulatory 

acceptance of toxicological test methods 

that more accurately assess the safety 

and hazards of chemicals and products 

and that refine, reduce, and replace 

animal use. The ICCVAM Authorization 

Act of 2000 established ICCVAM as a 

permanent interagency committee of the 

NIEHS under NICEATM. NICEATM 

administers ICCVAM and provides 

scientific and operational support for 

ICCVAM-related activities. NICEATM 

and ICCVAM work collaboratively to 

evaluate new and improved test 

methods applicable to the needs of U.S. 

Federal agencies. Additional 

information about ICCVAM and 

NICEATM can be found on their Web 

site (http://www.iccvam.niehs.nih.gov). 

SACATM was established January 9, 

2002, and is composed of scientists from 

the public and private sectors (67 FR 

11358). SACATM provides advice to the 

Director of the NIEHS, ICCVAM, and 

NICEATM regarding the statutorilymandated duties of ICCVAM and 

activities of NICEATM. Additional 

information about SACATM, including 

the charter, roster, and records of past 

meetings, can be found at http:// 

ntp.niehs.nih.gov/go/167. 

Dated: September 22, 2009. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. E9–23534 Filed 9–29–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Renewal of Charter for the Secretary’s 

Advisory Committee on National 

Health Promotion and Disease 

Prevention Objectives for 2020 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of Public Health and Science, 

Office of Disease Prevention and Health 

Promotion. 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, as amended (5 

U.S.C. Appendix 2), the U.S. 

Department of Health and Human 

Services is hereby announcing that the 

charter for the Secretary’s Advisory 

Committee on National Health 

Promotion and Disease Prevention 

Objectives for 2020 (Healthy People 

2020 Advisory Committee; HPAC) has 

been renewed. 

FOR FURTHER INFORMATION CONTACT: 

Emmeline Ochiai, Executive Secretary, 

Secretary’s Advisory Committee on 

National Health Promotion and Disease 

Prevention Objectives for 2020, 

Department of Health and Human 

Services, Office of Public Health and 

Science, Office of Disease Prevention 

and Health Promotion, 1101 Wootton 

Parkway, Room LL–100, Rockville, MD 

20852; Telephone: (240) 453–8259; Fax 

(240) 453–8281. Additional information 

is available on the Internet at http:// 

www.healthypeople.gov. 

SUPPLEMENTARY INFORMATION: Every ten 

years, through the Healthy People 

initiative, the U.S. Department of Health 

and Human Services (HHS) leverages 

scientific insights and lessons from the 

past decade, along with the new 

knowledge of current data, trends, and 

innovations to develop the next 

iteration of the national health 

promotion and disease prevention 

objectives. Healthy People provides 

science-based, ten-year national 

objectives for promoting health and 

preventing disease. Since 1980, Healthy 

People has set and monitored national 

health objectives to meet a broad range 

of health needs, encourage 

collaborations across sectors, guide 

individuals toward making informed 

health decisions, and measure the 

impact of our prevention and health 

promotion activities. Healthy People 

2020 will reflect assessment of major 

risks to health and wellness, changing 

public health priorities, and emerging 

technologies related to our nation’s 

health preparedness and prevention. 

The Committee will continue to 

provide advice and consultation to the 

Secretary of Health and Human Services 

for developing and implementing the 

next iteration of the national health 

promotion and disease prevention goals 

and objectives and provide 

recommendations for initiatives to occur 

during the implementation phase of the 

goals and objectives. HHS will use the 

recommendations to form the 

development of the national health 

promotion and disease prevention 

objectives for 2020 and the process for 

implementing the objectives. The intent 

is to develop and launch objectives 

designed to improve the health status 

and reduce health risks for Americans 

by the year 2020. Renewal of the HPAC 

charter provides authorization for the 

Committee to operate until September 4, 


CPrice-Sewell on DSKGBLS3C1PROD with NOTICES