11536 Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices 

FRTIB–10 

SYSTEM NAME: 

Identity Management System (IDMS). 

SYSTEM LOCATION: 

[CHANGE TO READ] 

Federal Retirement Thrift Investment 

Board, 77 K Street NE., Suite 1000, 

Washington, DC 20002. Some data 

covered by this system may be at 

Federal buildings and Federally-leased 

space where staffed guard-stations have 

been established in facilities that have 

installed the Personal Identity 

Verification (PIV) system, as well as the 

physical security offices or computer 

security offices of those locations. 

SYSTEM MANAGER(S) AND ADDRESS: 

[CHANGE TO READ] 

The Chief Financial Officer maintains 

the Agency’s electronic identity data 

and all other records in FRTIB–10. The 

Chief Financial Officer may be 

contacted in writing at 77 K Street NE., 

Suite 1000, Washington, DC 20002. 

NOTIFICATION PROCEDURE: 

[CHANGE TO READ] 

Individuals seeking to determine 

whether this system of records contains 

information about themselves should 

send inquiries to the Chief Financial 

Officer at Federal Retirement Thrift 

Investment Board, 77 K Street NE., Suite 

1000, Washington, DC 20002. When 

requesting notification of or access to 

records covered by FRTIB–10, an 

individual should provide his/her full 

name, date of birth, social security 

number, and home address in order to 

establish identity. 

* * * * * 

FRTIB–11 

SYSTEM NAME: 

Financial Disclosure Reports and 

Outside Business Interest Records. 

SYSTEM LOCATION: 

[CHANGE TO READ] 

Federal Retirement Thrift Investment 

Board, 77 K Street NE., Suite 1000, 

Washington, DC 20002. 

SYSTEM MANAGER(S) AND ADDRESS: 

[CHANGE TO READ] 

Ethics Officer, Federal Retirement 

Thrift Investment Board, 77 K Street 

NE., Suite 1000, Washington, DC 20002. 

* * * * * 

FRTIB–12 

SYSTEM NAME: 

Collection Records. 

SYSTEM LOCATION: 

[CHANGE TO READ] 

Federal Retirement Thrift Investment 

Board, 77 K Street NE., Suite 1000, 

Washington, DC 20002. 

SYSTEM MANAGER(S) AND ADDRESS: 

[CHANGE TO READ] 

Associate General Counsel, Federal 

Retirement Thrift Investment Board, 77 

K Street NE., Suite 1000, Washington, 

DC 20002. 

NOTIFICATION PROCEDURE: 

[CHANGE TO READ] 

Inquiries under the Privacy Act of 

1974 should be addressed to the Privacy 

Act Officer, Federal Retirement Thrift 

Investment Board, 77 K Street NE., Suite 

1000, Washington, DC 20002. All 

individuals making inquiries should 

provide with their requests as much 

descriptive matter as is possible to 

identify the particular record desired. 

The System Manager will advise as to 

whether the Board or FMS will process 

the record request. 

* * * * * 

FRTIB–13 

SYSTEM NAME: 

Fraud and Forgery Records. 

SYSTEM LOCATION: 

[CHANGE TO READ] 

These records are located at the 

Federal Retirement Thrift Investment 

Board, 77 K Street NE., Suite 1000, 

Washington, DC 20002 and at the office 

of the entity engaged by the Agency to 

perform record keeping services for the 

TSP. The current address for the 

Agency’s record keeper is listed at 

http://www.tsp.gov. 

SYSTEM MANAGER(S) AND ADDRESS: 

[CHANGE TO READ] 

Director, Office of Participant 

Services, Federal Retirement Thrift 

Investment Board, 77 K Street NE., Suite 

1000, Washington, DC 20002. 

NOTIFICATION PROCEDURE: 

Inquiries under the Privacy Act of 

1974 should be addressed to the Privacy 

Act Officer, Federal Retirement Thrift 

Investment Board, 77 K Street NE., Suite 

1000, Washington, DC 20002. All 

individuals making inquiries should 

provide with their requests as much 

descriptive matter as is possible to 

identify the particular record desired. 

[FR Doc. 2012–4489 Filed 2–24–12; 8:45 am] 

BILLING CODE 6760–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Interagency Coordinating Committee 

on the Validation of Alternative 

Methods (ICCVAM) Recommendations 

on the Use of the Murine Local Lymph 

Node Assay for Potency 

Categorization of Chemicals Causing 

Allergic Contact Dermatitis: 

Availability of Federal Agency 

Responses 

AGENCY: Division of the National 

Toxicology Program (DNTP), National 

Institute of Environmental Health 

Sciences (NIEHS), National Institutes of 

Health (NIH). 

ACTION: Availability of Agency 

Responses. 

SUMMARY: The NTP Interagency Center 

for the Evaluation of Alternative 

Toxicological Methods (NICEATM) 

announces availability of U.S. Federal 

agency responses to ICCVAM test 

method recommendations on the use of 

the murine local lymph node assay 

(LLNA) for potency categorization of 

chemicals causing allergic contact 

dermatitis (ACD). ICCVAM forwarded 

the recommendations to Federal 

agencies and made these 

recommendations available to the 

public (76 FR 45254). In accordance 

with the ICCVAM Authorization Act of 

2000 (42 U.S.C. 285l–3), agencies have 

notified ICCVAM in writing of their 

findings, and ICCVAM is making these 

responses available to the public. 

Federal agency responses are available 

on the NICEATM–ICCVAM Web site at 

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

immunotox/LLNApotency.htm. The 

ICCVAM recommendations are 

provided in the ICCVAM test method 

evaluation report (ICCVAM, 2011). 

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, (email) 

niceatm@niehs.nih.gov. Courier address: 

NICEATM, NIEHS, Room 2034, 530 

Davis Drive, Morrisville, NC 27560. 

SUPPLEMENTARY INFORMATION: 

Background 

The LLNA is accepted worldwide as 

a valid alternative to traditionally 

accepted guinea pig test methods for 

assessing ACD hazard potential for most 

testing applications. In January 2007, 

the U.S. Consumer Product Safety 

Commission (CPSC) requested that 

NICEATM and ICCVAM evaluate the 

LLNA for its usefulness for determining 

skin sensitization potency categories. 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices 11537 

The CPSC, under the Federal Hazardous 

Substances Act, requires hazard labeling 

of products considered to be strong skin 

sensitizers. Results from tests that could 

be used to identify potential strong 

human skin sensitizers would support 

the CPSC and other agencies with an 

interest in identifying strong skin 

sensitizers. While guinea pig tests have 

traditionally been used to categorize the 

potency of skin sensitizers, the LLNA 

uses fewer animals, requires less time to 

perform, provides dose-response 

information, and eliminates the pain 

and distress produced by positive 

reactions. 

Accordingly, NICEATM and ICCVAM 

evaluated the extent that the LLNA 

could be used to correctly predict 

‘‘strong’’ versus ‘‘other than strong’’ 

human skin sensitizers. NICEATM, 

working in collaboration with the 

ICCVAM Interagency Immunotoxicity 

Working Group (IWG), prepared a draft 

background review document (BRD) and 

draft recommendations for use of the 

LLNA for potency categorization of 

chemicals that cause ACD in humans. 

The draft BRD and draft ICCVAM 

recommendations were reviewed in a 

public meeting of an international 

independent scientific peer review 

panel in March 2008; the peer review 

panel report was made available to the 

public for comment in May 2008 (73 FR 

29136). The Scientific Advisory 

Committee on Alternative Toxicological 

Methods (SACATM) discussed and 

commented on the report, draft BRD, 

and draft ICCVAM recommendations at 

its June 2008 meeting (73 FR 25754). 

ICCVAM considered the panel’s report, 

comments from SACATM, and public 

comments, and finalized its 

recommendations. 

The final ICCVAM recommendations 

are provided in the ICCVAM Test 

Method Evaluation Report: Usefulness 

and Limitations of the Murine Local 

Lymph Node Assay for Potency 

Categorization of Chemicals Causing 

Allergic Contact Dermatitis in Humans 

(NIH Publication No. 11–7709, available 

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

immunotox/LLNA-pot/TMER.htm). The 

test method evaluation report also 

includes an updated ICCVAMrecommended LLNA protocol and 

recommended future studies that may 

further characterize the usefulness and 

limitations of the LLNA for potency 

determinations. The final BRD, 

including additional analyses performed 

by NICEATM as recommended by the 

peer review panel, is included as an 

appendix to the test method evaluation 

report. ICCVAM recommended that 

positive results from ACD safety testing 

using the murine LLNA could be used 

to categorize some chemicals and 

products as strong skin sensitizers. 

However, since the current LLNA 

decision criterion only identified 52% 

of the strong human skin sensitizers, 

ICCVAM recommended that this 

criterion should not be used as the basis 

for determining that a substance is not 

a strong skin sensitizer. Therefore, the 

potency criterion should only be used in 

a screening approach, where chemicals 

that meet the criterion could be 

categorized as strong skin sensitizers, 

but chemicals that do not meet the 

criterion would require additional 

testing or information to determine that 

they are not strong skin sensitizers. In 

accordance with the Public Health 

Service Policy on Humane Care and Use 

of Laboratory Animals and Animal 

Welfare Act regulations, the LLNA 

should be routinely considered when 

planning animal studies to evaluate 

whether chemicals and products are 

strong sensitizers in order to minimize 

animal use and to avoid unrelieved pain 

and distress, and should be used when 

determined appropriate. 

Agency Responses to ICCVAM 

Recommendations 

In June 2011, ICCVAM forwarded 

final test method recommendations on 

using the LLNA for potency 

categorization of chemicals to U.S. 

Federal agencies for consideration (76 

FR 45254), in accordance with the 

ICCVAM Authorization Act of 2000 (42 

U.S.C. 285l–3). The ICCVAM 

Authorization Act requires member 

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. 

Complete agency responses are available 

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

immunotox/LLNApotency.htm. 

Background Information on NICEATM, 

ICCVAM, and SACATM 

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 safety testing 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 while 

reducing animal use, refining animal 

use by enhancing animal welfare and 

lessening or avoiding unrelieved pain 

and distress, or replacing animals used 

for testing. The ICCVAM Authorization 

Act of 2000 (42 U.S.C. 285l–3) 

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 

conducts independent validation 

studies to assess the usefulness and 

limitations of new, revised, and 

alternative test methods and strategies. 

NICEATM and ICCVAM work 

collaboratively to evaluate new and 

improved test methods and strategies 

applicable to the needs of U.S. Federal 

agencies. NICEATM and ICCVAM 

welcome the public nomination of new, 

revised, and alternative test methods 

and strategies 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). 

SACATM was established in response 

to the ICCVAM Authorization Act 

[Section 285l–3(d)] and is composed of 

scientists from the public and private 

sectors (67 FR 11358). SACATM advises 

ICCVAM, NICEATM, and the Director of 

the NIEHS and NTP regarding 

statutorily mandated duties of ICCVAM 

and activities of NICEATM. SACATM 

provides advice on priorities and 

activities related to the development, 

validation, scientific review, regulatory 

acceptance, implementation, and 

national and international 

harmonization of new, revised, and 

alternative toxicological test methods. 

Additional information about SACATM, 

including the charter, roster, and 

records of past meetings, can be found 

at http://ntp.niehs.nih.gov/go/167. 

Reference 

ICCVAM. 2011. ICCVAM Test Method 

Evaluation Report: Usefulness and 

Limitations of the Murine Local Lymph 

Node Assay for Potency Categorization of 

Chemicals Causing Allergic Contact 

Dermatitis in Humans. NIH Publication No. 

11–7709. Research Triangle Park, NC: 

National Institute of Environmental Health 

Sciences. Available: http:// 

iccvam.niehs.nih.gov/methods/ 

immunotox/LLNA-pot/TMER.htm. 


srobinson on DSK4SPTVN1PROD with NOTICES
11538 Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices 

Dated: February 15, 2012. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2012–4541 Filed 2–24–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Findings of Research Misconduct 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: Notice is hereby given that 

the Office of Research Integrity (ORI) 

has taken final action in the following 

case: 

Michael W. Miller, Ph.D., State 

University of New York, Upstate 

Medical University: Based on the report 

of an investigation conducted by the 

State University of New York, Upstate 

Medical University (SUNY UMU) and 

additional analysis conducted by ORI in 

its oversight review, ORI found that Dr. 

Michael W. Miller, former Professor and 

Chair, Department of Neuroscience and 

Physiology, SUNY UMU, engaged in 

research misconduct in research 

supported by National Institute of 

Alcohol Abuse and Alcoholism 

(NIAAA), National Institutes of Health 

(NIH), grants R01 AA07568–18A1, R01 

AA06916, and P50 AA017823–01. 

ORI finds that the Respondent 

engaged in research misconduct by 

falsifying and/or fabricating data that 

were included in grant applications R01 

AA07568–18, R01 AA07568–18A1, R01 

AA006916–25, and P50 AA017823–01 

and in the following: 

• Miller, M.W., Hu, H. ‘‘Lability of 

neuronal lineage decisions is revealed 

by acute exposures to ethanol.’’ Dev. 

Neurosci. 31(1–2):50–7, 2009 (‘‘Dev. 

Neurosci. 2009’’) 

• Bruns, M.B., Miller, M.W. 

‘‘Functional nerve growth factor and 

trkA autocrine/paracrine circuits in 

adult rat cortex are revealed by episodic 

ethanol exposure and withdrawal.’’ J. 

Neurochem. 100(5):1115–68, 2007 (‘‘J. 

Neurochem. 2007’’) 

• A prepared manuscript submitted 

to PNAS for publication. 

As a result of its investigation, SUNY 

UMU recommended that Dev. Neurosci. 

2009 and J. Neurochem. 2007 be 

retracted. Both publications have now 

been retracted: 

• Dev. Neurosci. 2009 was retracted 

online on January 19, 2012, at: http:// 

content.karger.com/ProdukteDB/ 

produkte.asp?Aktion=

ShowPDF&ArtikelNr=

323471&Ausgabe=0&ProduktNr=

224107&filename=323471.pdf. 

• J. Neurochem. 2007 was retracted 

online on January 23, 2012, at: http:// 

onlinelibrary.wiley.com/doi/10.1111/ 

j.1471-4159.2012.07662.x/full. 

Specifically, ORI finds that the 

Respondent: 

• Falsified Figure 5 in NIH grant 

application R01 AA07568–18A1 by 

altering the bar graphs to make the 

experimental results appear valid and 

consistent with his hypothesis that 

ethanol exposure in-utero alters the 

transition of cells from Pax 6 expression 

to Tbr2 expression, which is critical to 

normal brain development. Specifically: 

a. In the VZ/SZ panel (upper row, 

right), Dr. Miller decreased the values 

by 50% for the bar graphs representing 

control and treated mice for ‘‘Tbr2,’’ 

‘‘both,’’ and ‘‘both/Ki-67,’’ to falsely 

report an equivalent frequency of Tbr2 

expressing cells in the right and left 

panels; this result was required for the 

experiment to appear valid; 

b. In the MGE panel (lower row, 

right), Dr. Miller altered the bar graphs 

representing control and treated mice 

for ‘‘Ki-67,’’ ‘‘Pax6,’’ and ‘‘both’’ to 

falsely report that ethanol increased the 

frequency of K–67+ cells and to report 

an equivalent frequency of Pax 

expressing cells in the right and left 

panels. 

• Fabricated bar graphs in 

Supplemental Figure 2 in a manuscript 

submitted to PNAS and text in the 

manuscript also appearing in the grant 

application AA00616–25 to support the 

hypothesis that ethanol exposure during 

postnatal weeks 1 and 2 causes specific 

neuronal cell death in layers II/III and 

V of the cortex. Specifically, Dr. Miller: 

a. Fabricated bar graphs in 

Supplemental Figure 2 and related text 

in the PNAS manuscript to show that in 

select layers of the cortex, ethanol 

induced neuronal death occurred in 

post-natal day 10 (P10) mice; 

b. Included fabricated text in the 

PNAS manuscript and the grant 

application citing results of experiments 

using 15–25-day-old mice treated with 

ethanol during the second postnatal 

week, when these mice were never 

generated. 

• Falsified Figure 6 in a manuscript 

submitted to PNAS by altering data 

points for the labeling index of caspase3 

and TUNEL in cortex layers II/III and V 

after exposure to ethanol in postnatal 

day 7 (P7) mice, such that the two 

assays confirmed each other. The same 

data were also included as Figure 4 in 

NIH grant application R01 AA06916 and 

as Figure 7 in a poster presentation at 

the 2009 Research Society on 

Alcoholism. 

• Falsified the figure legends and/or 

text in a published paper and multiple 

grant applications to support the 

primary hypothesis of the published 

paper that gestational alcohol exposure 

had an effect on brain development by 

affecting the way neurons differentiate 

and migrate into the cortex, rather than 

by changes to cell growth or death. 

Specifically, Dr. Miller falsely reported 

the number of animals (n) that were 

used in figure legends and/or text in the 

following: 

Æ Figures 2 and 5, Dev. Neurosci. 

2009, also included as Figures 3 and 4, 

respectively, in R01 AA07568–18; 

Æ Figure 4 and Table 2 in P50 

AA017823–01. 

• Falsified Figures 4 and 6 in J. 

Neurochem. 2007 by altering bar graphs 

to increase the significance of the effect 

of ethanol exposure and/or withdrawal 

on NGF or trkA protein expression, 

thereby conforming with the paper’s 

hypothesis that ethanol exposure and 

withdrawal affect the normal NGF/trkA 

circuits in cortical layer V. Specifically, 

Dr. Miller: 

a. Increased the value of the ethanol 

treated NGF expression in Figure 4 and 

decreased the value of withdrawal NFG 

to alter the difference between the two 

from approximately 2.2% to 11.6%, 

thereby falsely reporting significance 

where there was none; 

b. In Figure 6: 

(a) Increased the value of withdrawal 

trkA data by approximately 70% to 

falsely report significance with relation 

to the ethanol treated value and increase 

significance with relation to the control; 

(b) Increased the value of the ethanol 

treated phospho-trkA data by 

approximately 100% to increase the 

significance with relation to the control; 

(c) Falsely reported the results for 

Figure 6 as showing a nearly doubled 

ratio of p-trkA to total trkA after ethanol 

exposure when there was no increase at 

all. 

Dr. Miller has entered into a 

Voluntary Exclusion Agreement 

(Agreement). Dr. Miller neither admits 

nor denies committing research 

misconduct but accepts ORI has found 

evidence of research misconduct as set 

forth above. 

Dr. Miller has voluntarily agreed: 

(1) To exclude himself voluntarily 

from any contracting or subcontracting 

with any agency of the United States 

Government and from eligibility or 

involvement in nonprocurement 

programs of the United States 

Government referred to as ‘‘covered 

transactions’’ pursuant to HHS’ 

Implementation (2 CFR part 376 et seq) 

of OMB Guidelines to Agencies on 

Governmentwide Debarment and 


srobinson on DSK4SPTVN1PROD with NOTICES