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been retracted: 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 Neurosci. 2009 was retracted 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• J. Neurochem. 2007 was retracted 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
Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices 11539 

Suspension, 2 CFR part 180 (collectively 

the ‘‘Debarment Regulations’’) for a 

period of one (1) year, beginning on 

February 6, 2012; 

(2) To have his research supervised 

for a period of two (2) years 

immediately following the one (1) year 

period of exclusion; Respondent agrees 

that prior to the submission of an 

application for U.S. Public Health 

Service (PHS) support for a research 

project on which the Respondent’s 

participation is proposed and prior to 

the Respondent’s participation in any 

capacity on PHS-supported research, 

Respondent shall ensure that a plan for 

supervision of Respondent’s duties is 

submitted to ORI for approval; the 

supervision plan must be designed to 

ensure the scientific integrity of 

Respondent’s research contribution as 

outlined below; Respondent agrees that 

he shall not participate in any PHSsupported research until such a 

supervision plan is submitted to and 

approved by ORI; Respondent agrees to 

maintain responsibility for compliance 

with the agreed upon supervision plan; 

the requirements for Respondent’s 

supervision plan are as follows: 

i. A committee of 2–3 senior faculty 

members at the institution who are 

familiar with Respondent’s field of 

research, but not including 

Respondent’s supervisor or 

collaborators, will provide oversight and 

guidance for two (2) years immediately 

following the period of exclusion; the 

committee will review primary data 

from Respondent’s laboratory on a 

quarterly basis and submit a report to 

ORI at six (6) month intervals setting 

forth the committee meeting dates, 

Respondent’s compliance with 

appropriate research standards, and 

confirming the integrity of Respondent’s 

research; and 

ii. The committee will conduct an 

advance review of any PHS grant 

applications (including supplements, 

resubmissions, etc.), manuscripts 

reporting PHS-funded research 

submitted for publication, and abstracts; 

the review will include a discussion 

with Respondent of the primary data 

represented in those documents and 

include a certification to ORI that the 

data presented in the proposed 

application/publication is supported by 

the research record; 

(3) That any institution employing 

him during the two (2) years during 

which the supervisory plan is in effect 

shall submit, in conjunction with each 

application for PHS funds, or report, 

manuscript, or abstract involving PHSsupported research in which 

Respondent is involved, a certification 

to ORI that the data provided by 

Respondent are based on actual 

experiments or are otherwise 

legitimately derived and that the data, 

procedures, and methodology are 

accurately reported in the application, 

report, manuscript, or abstract; and 

(4) To exclude himself from serving in 

any advisory capacity to PHS including, 

but not limited to, service on any PHS 

advisory committee, board, and/or peer 

review committee, or as a consultant for 

a period of three (3) years, beginning on 

February 6, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Director, Division of Investigative 

Oversight, Office of Research Integrity, 

1101 Wootton Parkway, Suite 750, 

Rockville, MD 20852, (240) 453–8800. 

John Dahlberg, 

Director, Division of Investigative Oversight, 

Office of Research Integrity. 

[FR Doc. 2012–4366 Filed 2–24–12; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–12–11JD] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–7570 or send an 

email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC 20503 or by fax to (202) 395–5806. 

Written comments should be received 

within 30 days of this notice. 

Proposed Project 

Evaluation of Dating Matters: 

Strategies to Promote Healthy Teen 

RelationshipsTM—New—National 

Center for Injury Prevention and 

Control—Centers for Disease Control 

and Prevention. 

Background and Brief Description 

Dating Matters: Strategies to Promote 

Healthy Teen RelationshipsTM is the 

Centers for Disease Control and 

Prevention’s new teen dating violence 

prevention initiative. 

Recently, efforts to prevent teen 

dating violence (TDV) have grown, 

particularly in schools, among 

policymakers, and among sexual 

violence and domestic violence 

coalitions. Now many states and 

communities also are working to stop 

teen dating violence. However, these 

activities vary greatly in quality and 

effectiveness. To address the gaps, CDC 

has developed Dating Matters, a teen 

dating violence prevention program that 

includes programming for students, 

parents, educators, as well as policy 

development. Dating Matters is based on 

the current evidence about what works 

in prevention and focuses on high-risk, 

urban communities where participants 

include: Middle school students age 11 

to 14 years; middle school parents; 

brand ambassadors; educators; school 

leadership; program implementers; 

community representatives; and local 

health department representatives in the 

following communities: Alameda 

County, California; Baltimore, 

Maryland; Broward County, Florida; 

and Chicago, Illinois. 

The primary goal of the current 

proposal is to conduct an outcome and 

implementation evaluation of Dating 

Matters in the four metropolitan cities to 

determine its feasibility, cost, and 

effectiveness. In the evaluation a 

standard model of TDV prevention (Safe 

Dates administered in 8th grade) will be 

compared to a comprehensive model 

(programs administered in 6th, 7th, and 

8th grade as well as parent, educator, 

policy, and communications 

interventions). 

Burden estimates are based on the 

following information: 

• Number of communities/sites: 4 

• Number of schools across 4 

communities/sites: 44 (12 in 3 

communities, 8 in 1 community) 

• Number of students in each middle 

school: 600 (200 per grade) 

• Number of school staff in each 

school: 40 

• Number of schools implementing 

the standard model of TDV prevention: 

22 (across 4 sites/communities) 

• Number of schools implementing 

the comprehensive model of TDV 

prevention: 22 (across 4 sites/ 

communities) 

Population. The study population 

includes students in 6th, 7th and 8th 

grades at 44 schools in the four 

participating sites. At most, schools are 

expected to have 6 classrooms per 

grade, with an average of 30 students 

per classroom yielding a population of 

23,760 students (44 schools * 3 grades 

* 6 classrooms per grade * 30 students 

per classroom). 

The sampling frame for parents, given 

that we would only include one parent 

per student, is also 23,760 for the three 

years of data collection covered by this 


srobinson on DSK4SPTVN1PROD with NOTICES