2388 Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Notices 

Elizabeth Doyle, PhD, Chief, Human Health 

Risk Assessment Branch, Health and 

Ecological Criteria Division, Office of Science 

and Technology, Office of Water, U.S. 

Environmental Protection Agency. 

Isabel Garcia, DDS, MPH, Acting Director, 

National Institute of Dental and Craniofacial 

Research, National Institutes of Health, U.S. 

Department of Health and Human Services. 

Barbara Gooch, DMD, MPH, Acting 

Associate Director for Science, Division of 

Oral Health, National Center for Chronic 

Disease Prevention and Health Promotion, 

Centers for Disease Control and Prevention, 

U.S. Department of Health and Human 

Services. 

Jesse Goodman, MD, MPH, Chief Scientist 

and Deputy Commissioner for Science and 

Public Health, Food and Drug 

Administration, U.S. Department of Health 

and Human Services. 

J. Nadine Gracia, MD, MSCE, Chief 

Medical Officer, Office of the Assistant 

Secretary for Health, U.S. Department of 

Health and Human Services. 

Susan O. Griffin, PhD, Health Economist, 

Division of Oral Health, National Center for 

Chronic Disease Prevention and Health 

Promotion, Centers for Disease Control and 

Prevention, U.S. Department of Health and 

Human Services. 

Laurence Grummer-Strawn, PhD, Chief, 

Maternal and Child Nutrition Branch, 

Division of Nutrition, Physical Activity, and 

Obesity, National Center for Chronic Disease 

Prevention and Health Promotion, Centers for 

Disease Control and Prevention, U.S. 

Department of Health and Human Services. 

Jay Hirschman, MPH, CNS, Director, 

Special Nutrition Staff, Office of Research 

and Analysis, Food and Nutrition Service, 

U.S. Department of Agriculture. 

Frederick Hyman, DDS, MPH, Division of 

Dermatology and Dental Products, Center for 

Drug Evaluation and Research, Food and 

Drug Administration, U.S. Department of 

Health and Human Services. 

Timothy Iafolla, DMD, MPH, Office of 

Science and Policy Analysis, National 

Institute of Dental and Craniofacial Research, 

National Institutes of Health, U.S. 

Department of Health and Human Services. 

William Kohn, DDS, Director, Division of 

Oral Health, National Center for Chronic 

Disease Prevention and Health Promotion, 

Centers for Disease Control and Prevention, 

U.S. Department of Health and Human 

Services. 

Richard Manski, DDS, MBA, PhD, Senior 

Scholar, Center for Financing, Access and 

Cost Trends, Agency for Healthcare Research 

and Quality, U.S. Department of Health and 

Human Services. 

Benson Silverman, MD, Staff Director, 

Infant Formula and Medical Foods, Center 

for Food Safety and Applied Nutrition, Food 

and Drug Administration, U.S. Department of 

Health and Human Services. 

Thomas Sinks, PhD, Deputy Director, 

National Center for Environmental Health/ 

Agency for Toxic Substances and Disease 

Registry, Centers for Disease Control and 

Prevention, U.S. Department of Health and 

Human Services. 

[FR Doc. 2011–637 Filed 1–12–11; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the National Biodefense 

Science Board 

AGENCY: Department of Health and 

Human Services, Office of the Secretary. 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the U.S. 

Department of Health and Human 

Services is hereby giving notice that the 

National Biodefense Science Board 

(NBSB) will be holding a public 

meeting. The meeting is open to the 

public. 

DATES: The NBSB will hold a public 

meeting on January 25, 2011 from 1:15 

p.m. to 3 p.m. ET. The agenda is subject 

to change as priorities dictate. 

ADDRESSES: Department of Health and 

Human Services; Hubert H. Humphrey 

Building, Room 800; 200 Independence 

Avenue, SW., Washington, DC 20201. 

To attend by teleconference, call 1–866– 

395–4129, pass-code ‘‘ASPR.’’ Please call 

15 minutes prior to the beginning of the 

conference call to facilitate attendance. 

Pre-registration is required for public 

attendance. Individuals who wish to 

attend the meeting in person should 

send an email to NBSB@HHS.GOV with 

‘‘NBSB Registration’’ in the subject line. 

FOR FURTHER INFORMATION CONTACT: Email: NBSB@HHS.GOV. 

SUPPLEMENTARY INFORMATION: Pursuant 

to section 319M of the Public Health 

Service Act (42 U.S.C. 247d–7f) and 

section 222 of the Public Health Service 

Act (42 U.S.C. 217a), the Department of 

Health and Human Services established 

the National Biodefense Science Board. 

The Board shall provide expert advice 

and guidance to the Secretary on 

scientific, technical, and other matters 

of special interest to the Department of 

Health and Human Services regarding 

current and future chemical, biological, 

nuclear, and radiological agents, 

whether naturally occurring, accidental, 

or deliberate. The Board may also 

provide advice and guidance to the 

Secretary and/or the Assistant Secretary 

for Preparedness and Response on other 

matters related to public health 

emergency preparedness and response. 

Background: A portion of this public 

meeting will be dedicated to swearing in 

the six new voting members who will 

replace the members whose 3-year terms 

expired on December 31, 2010. The 

Board will be asked to consider the 

various components of a science 

response to disasters. Subsequent 

agenda topics will be added as priorities 

dictate. 

Availability of Materials: The meeting 

agenda and materials will be posted on 

the NBSB Web site at http:// 

www.phe.gov/Preparedness/legal/ 

boards/nbsb/Pages/default.aspx prior to 

the meeting. 

Procedures for Providing Public Input: 

Any member of the public providing 

oral comments at the meeting must signin at the registration desk and provide 

his/her name, address, and affiliation. 

All written comments must be received 

prior to January 18, 2011 and should be 

sent by e-mail to NBSB@HHS.GOV with 

‘‘NBSB Public Comment’’ as the subject 

line. Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should email NBSB@HHS.GOV. 

Dated: January 7, 2011. 

Nicole Lurie, 

Assistant Secretary for Preparedness and 

Response. 

[FR Doc. 2011–684 Filed 1–12–11; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Toxicology Program (NTP); 

NTP Interagency Center for the 

Evaluation of Alternative Toxicological 

Methods (NICEATM); Federal Agency 

Responses to Interagency 

Coordinating Committee on the 

Validation of Alternative Methods 

(ICCVAM) Recommendations on Two 

Nonradioactive Versions of the Murine 

Local Lymph Node Assay (LLNA) for 

Assessing Allergic Contact Dermatitis 

(ACD) Hazard Potential of Chemicals 

and Products, and Expanded Uses of 

the LLNA for Pesticide Formulations 

and Other Products; Notice of 

Availability 

AGENCY: National Institute of 

Environmental Health Sciences 

(NIEHS), National Institutes of Health 

(NIH), HHS. 

ACTION: Notice of Availability. 

SUMMARY: U.S. Federal agency responses 

to ICCVAM test method 

recommendations on two 

nonradioactive versions of the LLNA for 

assessing the ACD hazard potential of 

chemicals and products and for 

expanded uses of the LLNA for 

pesticide formulations and other 

products are now available on the 

NICEATM–ICCVAM Web site at http:// 

iccvam.niehs.nih.gov/methods/ 

immunotox/llna.htm. ICCVAM 

recommended the nonradioactive 

LLNA: 5-bromo-2-deoxyuridineenzyme-linked immunosorbent assay 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Notices 2389 

(BrdU-ELISA) and LLNA: Daicel 

Adenosine Triphosphate (DA), and 

expanded uses for the LLNA. In 

accordance with the ICCVAM 

Authorization Act (42 U.S.C. 285l– 

3(e)(4)), ICCVAM forwarded 

recommendations to Federal agencies 

and made these recommendations 

available to the public (75 FR 37443). 

Agencies have now notified ICCVAM in 

writing of their findings and ICCVAM is 

making these responses available to the 

public. 

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 

In 1999, ICCVAM recommended the 

LLNA as a valid safety test for assessing 

the ACD hazard potential of many 

chemicals and products (NIH 

Publication No. 99–4494; available at 

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

immunotox/llna_PeerPanel98.htm). 

ICCVAM also concluded that the LLNA, 

when used as an alternative method to 

the guinea pig maximization test 

(GPMT) or the Buehler test (BT), could 

also significantly reduce animal use and 

improve animal welfare. Based on this 

evaluation, the U.S. Environmental 

Protection Agency (EPA 2003), the U.S. 

Food and Drug Administration, and the 

U.S. Consumer Product Safety 

Commission (CPSC) subsequently 

accepted the method as a valid 

substitute for the GPMT and BT 

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

immunotox/llna_PeerPanel98.htm). The 

Organisation for Economic Co-operation 

and Development (OECD) subsequently 

adopted the LLNA in 2002 as 

international OECD Test Guideline 429 

(OECD, 2002). The International 

Organization for Standardization (ISO) 

adopted the LLNA as ISO standard 

10993–10 in 2002 (ISO, 2002). 

ICCVAM recommended an updated 

LLNA test method protocol in 2009 that 

further reduced animal use for each 

safety test by 20–40% (ICCVAM, 2009). 

Federal agencies endorsed this updated 

protocol (75 FR 25866). OECD Test 

Guideline 429 was subsequently 

updated in 2010 to incorporate the 

updated revisions (OECD, 2010a). The 

ISO standard was also updated in 2010 

(ISO, 2010). 

Compared to the LLNA, the LLNA: 

BrdU-ELISA and LLNA: DA do not use 

radioactive reagents and therefore 

provide additional advantages in terms 

of reduced hazardous waste disposal 

and broader availability for use by 

laboratories that cannot use radioactive 

reagents. ICCVAM concludes that the 

accuracy and reliability of the LLNA: 

BrdU-ELISA and LLNA: DA support 

their use to determine whether 

substances have the potential to cause 

ACD. The protocols also include 

reduced LLNA: BrdU-ELISA and LLNA: 

DA procedures that should always be 

considered and used where determined 

appropriate because they can further 

reduce animal use by 40% compared to 

multi-dose procedures. The ICCVAM 

evaluation and complete 

recommendations for the LLNA: BrdUELISA and LLNA: DA are provided in 

the ICCVAM Test Method Evaluation 

Report on the Murine Local Lymph 

Node Assay: BrdU-ELISA, A 

Nonradioactive Alternative Test Method 

to Assess the Allergic Contact 

Dermatitis Potential of Chemicals and 

Products (NIH Publication No. 10–7552, 

available at http://iccvam.niehs.nih.gov/ 

methods/immunotox/llna-ELISA/ 

TMER.htm) and the ICCVAM Test 

Method Evaluation Report on the 

Murine Local Lymph Node Assay: DA, A 

Nonradioactive Alternative Test Method 

to Assess the Allergic Contact 

Dermatitis Potential of Chemicals and 

Products (NIH Publication No. 10–7551, 

available at http://iccvam.niehs.nih.gov/ 

methods/immunotox/llna-DA/ 

TMER.htm). The OECD subsequently 

adopted the LLNA: BrdU-ELISA and 

LLNA: DA as international test 

guidelines (OECD, 2010b, 2010c). 

ICCVAM also concluded that 

available data support the use of the 

LLNA for safety testing of a broader 

range of chemicals and products, 

including pesticide formulations, metals 

with the exception of nickel, substances 

in aqueous solutions, and other 

chemicals and products, unless there 

are unique physicochemical properties 

associated with these materials that may 

interfere with the accuracy of the LLNA. 

Aqueous solutions should be tested in 

an appropriate vehicle that maintains 

sufficient contact of the test article with 

the skin. The ICCVAM evaluation and 

complete recommendations for 

expanded uses of the LLNA are 

provided in ICCVAM Test Method 

Evaluation Report on Using the Murine 

Local Lymph Node Assay for Testing 

Pesticide Formulations, Metals, 

Substances in Aqueous Solutions, and 

Other Products (NIH Publication No. 

10–7512, available at http:// 

iccvam.niehs.nih.gov/methods/ 

immunotox/LLNA-app/TMER.htm). 

ICCVAM evaluated the new versions 

and applications of the LLNA in 

response to a 2007 nomination from 

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

methods/immunotox/llnadocs/ 

CPSC_LLNA_nom.pdf). The nomination 

requested that ICCVAM assess (1) the 

validation status of the LLNA limit dose 

procedure (i.e., the reduced LLNA); (2) 

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; and (4) the use of the LLNA as 

a stand-alone assay to determine ACD 

potency categories for hazard 

classification. ICCVAM 

recommendations on an updated LLNA 

test method protocol that included the 

reduced LLNA were communicated to 

Federal agencies and each of the 15 

ICCVAM agencies concurred with the 

ICCVAM recommendations for the 

reduced LLNA. ICCVAM has completed 

the evaluation of the LLNA for its 

validity for potency categorization of 

chemicals causing ACD in humans. 

Final ICCVAM recommendations will 

be forwarded to Federal agencies in 

2011. 

Agency Responses to ICCVAM 

Recommendations 

In June 2010, ICCVAM forwarded 

final test method recommendations for 

the LLNA BrdU-ELISA, LLNA: DA and 

the expanded uses of the LLNA to U.S. 

Federal agencies for consideration (74 

FR 50212), in accordance with the 

ICCVAM Authorization Act of 2000 (42 

U.S.C. 285l–3(e)(4)). The Act requires 

agencies to review ICCVAM test method 

recommendations and notify ICCVAM 

in writing of their findings no later than 

180 days after receipt of 

recommendations. The Act also requires 

ICCVAM to make ICCVAM 

recommendations and agency responses 

available to the public. Agency 

responses are to include identification 

of relevant test methods for which the 

ICCVAM test method recommendations 

may be added or substituted, and 

indicate any revisions or planned 

revisions to existing guidelines, 

guidances, or regulations to be made in 

response to these recommendations. 

Federal agency responses include 

acceptance decisions and agreement 

with the test method recommendations 

for the LLNA: BrdU-ELISA, LLNA: DA 

and the expanded uses of the LLNA. 

Several agencies also indicated that they 

would communicate the ICCVAM 

recommendations to stakeholders and 

encourage their appropriate use. Agency 

responses are available at http:// 

iccvam.niehs.nih.gov/methods/ 

immunotox/llna.htm. 


srobinson on DSKHWCL6B1PROD with NOTICES
2390 Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Notices 

Background Information on ICCVAM 

and NICEATM 

ICCVAM is an interagency committee 

composed of representatives from 15 

Federal regulatory and research agencies 

that require, use, generate, or 

disseminate toxicological and safety 

testing information. ICCVAM conducts 

technical evaluations of new, revised, 

and alternative methods with regulatory 

applicability and promotes the scientific 

validation and regulatory acceptance of 

toxicological and safety-testing methods 

that more accurately assess the safety 

and hazards of chemicals and products 

and that reduce, refine (decrease or 

eliminate pain and distress), or replace 

animal use. The ICCVAM Authorization 

Act of 2000 established ICCVAM as a 

permanent interagency committee of the 

NIEHS under NICEATM (42 U.S.C. 

285l–3(a)). NICEATM administers 

ICCVAM, provides scientific and 

operational support for ICCVAM-related 

activities, and conducts independent 

validation studies to assess the 

usefulness and limitation of new, 

revised, and alternative 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 and technical evaluations. 

Additional information about ICCVAM 

and NICEATM can be found on the 

NICEATM–ICCVAM Web site (http:// 

iccvam.niehs.nih.gov). 

References 

EPA. 2003. Health Effects Test 

Guidelines: OPPTS 870.2600—Skin 

Sensitization. EPA 712–C–03–197. 

Washington, DC: U.S. 

Environmental Protection Agency. 

Available: http://www.epa.gov/ 

ocspp/pubs/frs/publications/ 

Test_Guidelines/series870.htm. 

ICCVAM 2010 ICCVAM Test Method 

Evaluation Report. The Murine 

Local Lymph Node Assay: BrdUELISA, a Nonradioactive 

Alternative Test Method to Assess 

the Allergic Contact Dermatitis 

Potential of Chemicals and 

Products. NIH Publication No. 10– 

7552. Research Triangle Park, NC: 

National Institute of Environmental 

Health Sciences. Available at: 

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

methods/immunotox/llna-ELISA/ 

TMER.htm. 

ICCVAM. 2010. ICCVAM Test Method 

Evaluation Report. The Murine 

Local Lymph Node Assay: DA, a 

Nonradioactive Alternative Test 

Method to Assess the Allergic 

Contact Dermatitis Potential of 

Chemicals and Products. NIH 

Publication No. 10–7551. Research 

Triangle Park, NC: National 

Institute of Environmental Health 

Sciences. Available at: http:// 

iccvam.niehs.nih.gov/methods/ 

immunotox/llna-D/TMER.htm. 

ICCVAM. 2010. ICCVAM Test Method 

Evaluation Report on Using the 

LLNA for Testing Pesticide 

Formulations, Metals, Substances in 

Aqueous Solutions, and Other 

Products. NIH Publication No. 10– 

7512. Research Triangle Park, NC: 

National Institute of Environmental 

Health Sciences. Available at: 

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

methods/immunotox/LLNA-app/ 

TMER.htm. 

ICCVAM. 2009. Recommended 

Performance Standards: Murine 

Local Lymph Node Assay. NIH 

Publication No. 09–7357. Research 

Triangle Park, NC: National 

Institute of Environmental Health 

Sciences. Available at: http:// 

iccvam.niehs.nih.gov/methods/ 

immunotox/llna_PerfStds.htm. 

ICCVAM. 1999. The Murine Local 

Lymph Node Assay: A Test Method 

for Assessing the Allergic Contact 

Dermatitis Potential of Chemicals/ 

Compounds. The Results of an 

Independent Peer Review 

Evaluation Coordinated by ICCVAM 

and NICEATM. NIH Publication No. 

99–4494. Research Triangle Park, 

NC: National Institute of 

Environmental Health Sciences. 

Available at: http:// 

iccvam.niehs.nih.gov/methods/ 

immunotox/llna_PeerPanel98.htm. 

ISO. 2002. Biological evaluation of 

medical devices—10993 Part 10: 

Tests for irritation and delayed-type 

hypersensitivity. Available for 

purchase at: http://www.iso.org/iso/ 

home.htm. 

ISO. 2010. Biological evaluation of 

medical devices—10993 Part 10: 

Tests for irritation and skin 

sensitization. Available for 

purchase at: http://www.iso.org/iso/ 

home.htm. 

OECD. 2002. Test Guideline 429. Skin 

Sensitization: Local Lymph Node 

Assay, adopted April 24, 2002. In: 

OECD Guidelines for Testing of 

Chemicals. Paris: OECD. 

OECD. 2010a. Test Guideline 429. Skin 

Sensitization: Local Lymph Node 

Assay, adopted July 22, 2010. In: 

OECD Guidelines for Testing of 

Chemicals. Paris: OECD. Available 

at: http://dx.doi.org/10.1787/ 

9789264071100-en. 

OECD. 2010b. Test Guideline 442B. 

Skin Sensitization: Local Lymph 

Node Assay: BrdU-ELISA, adopted 

July 22, 2010. In: OECD Guidelines 

for Testing of Chemicals. Paris: 

OECD. Available at: http:// 

dx.doi.org/10.1787/9789264090996- 

en. 

OECD. 2010c. Test Guideline 442A. 

Skin Sensitization: Local Lymph 

Node Assay: DA, adopted July 22, 

2010. In: OECD Guidelines for 

Testing of Chemicals. Paris: OECD. 

Available at: http://dx.doi.org/ 

10.1787/9789264090972-en. 

Dated: January 5, 2011. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2011–669 Filed 1–12–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project: 

‘‘Connecting Primary Care Practices with 

Hard-to-Reach Adolescent Populations.’’ 

In accordance with the Paperwork 

Reduction Act, 44 U.S.C. 3501–3520, 

AHRQ invites the public to comment on 

this proposed information collection. 

DATES: Comments on this notice must be 

received by March 14, 2011. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by 

e-mail at 

doris.lefkowitz@AHRQ.hhs.gov. 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

e-mail at 

doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 


srobinson on DSKHWCL6B1PROD with NOTICES