32168 Federal Register / Vol. 74, No. 128 / Tuesday, July 7, 2009 / Notices 

1Hutchings, A., Wu, J., Asiedu, C., Hubbard, W., 

Eckhoff, D., Contreras, J., Thomas, F.T., Neville, D., 

& Thomas, J.M. ‘‘The immune decision toward 

allograft tolerance in non-human primates requires 

early inhibition of innate immunity and induction 

of immune regulation.’’ Transpl Immunol. 11(3– 

4):335–344, July–September 2003. (Retraction 

required by UAB.) 

Thomas, J.M., Eckhoff, D.E., Contreras, J.L., 

Lobashevsky, A.L., Hubbard, W.J., Moore, J.K., 

Cook, W.J., Thomas, F.T., & Neville, D.M. Jr. 

‘‘Durable donor-specific T and B cell tolerance in 

rhesus macaques induced with peritransplantation 

anti-CD3 immunotoxin and deoxyspergualin: 

Absence of chronic allograft nephropathy.’’ 

Transplantation 69(12):2497–2503, June 27, 2000. 

(Retracted.) 

Thomas, J.M., Contreras, J.L., Jiang, X.L., Eckhoff, 

D.E., Wang, P.X., Hubbard, W.J., Lobashevsky, A.L., 

Wang, W., Asiedu, C., Stavrou, S., Cook, W.J., 

Robbin, M.L., Thomas, F.T., & Neville, D.M. Jr. 

‘‘Peritransplant tolerance induction in macaques: 

Early events reflecting the unique synergy between 

immunotoxin and deoxyspergualin.’’ 

Transplantation 68(11):1660–1673, December 15, 

1999. (Retracted.) 

Contreras, J.L., Eckhoff, D.E., Cartner, S., Frenette, 

L., Thomas, F.T., Robbin, M.L., Neville, D.M. Jr., & 

Thomas, J.M. ‘‘Tolerability and side effects of antiCD3-immunotoxin in preclinical testing in kidney 

and pancreatic islet transplant recipients.’’ 

Transplantation 68(2):215–219, July 27, 1999. 

(Retracted.) 

Contreras, J.L., Wang, P.X., Eckhoff, D.E., 

Lobashevsky, A.L., Asiedu, C., Frenette, L., Robbin, 

M.L., Hubbard, W.J., Cartner, S., Nadler, S., Cook, 

W.J., Sharff, J., Shiloach, J., Thomas, F.T., Neville, 

D.M. Jr., & Thomas, J.M. ‘‘Peritransplant tolerance 

induction with anti-CD3-immunotoxin: A matter of 

proinflammatory cytokine control.’’ 

Transplantation 65(9):1159–1169, May 15, 1998. 

(Retracted.) 

2Hubbard, W.J., Eckhoff, D., Contreras, J.L., 

Thomas, F.T., Hutchings, A., & Thomas, J.M. 

‘‘STEALTH on the preclinical path to tolerance.’’ 

Graft 5(6):322–330, 2002. (Retraction required by 

UAB—Journal has ceased publication.) 

Hubbard, W.J., Contreras, J.V., Eckhoff, D.E., 

Thomas, F.T., Neville, D.M., & Thomas, J.M. 

‘‘Immunotoxins and tolerance induction in 

primates.’’ Current Opinion in Organ 

Transplantation 5:29–34, 2000. (Partially retracted.) 

U19 AI056542, National Institute of 

Diabetes and Digestive and Kidney 

Diseases (NIDDK), NIH, grant U19 

DK57958, and NIH/Novartis 

Cooperative Research and Development 

Agreement 96–MH–01/NIHITC–0697. 

PHS found that Respondent engaged 

in scientific misconduct by falsifying in 

seven publications reports of research 

results in NIH-supported experiments 

with non-human primate (NHP) renal 

allograft recipients. 

Specifically, PHS found that 

Respondent engaged in scientific 

misconduct by falsely reporting in five 

publications 1 that at least 32 specific 

non-human primates in a renal allotransplantation study had received 

bilateral nephrectomies, while in fact an 

intrinsic kidney was left in place in 

each animal, and generally, in two 

additional publications 2 by reporting 

that all long term surviving non-human 

primate renal allograft recipients had 

received bilateral nephrectomies of their 

native kidneys. 

The objective of the research was to 

test the effectiveness of different 

immunomodulating agents, 

administered around the time of renal 

transplantation in non-human primates, 

in preventing rejection of the 

transplanted kidney. To determine 

whether or not the transplanted kidney 

was functioning (able to sustain life) 

after the immunomodulating therapy, 

the animals were to have both of their 

native kidneys removed at or shortly 

after the time of transplant, so that their 

survival would depend solely on the 

viability of the transplanted kidney. 

Failure to remove both native kidneys 

rendered it impossible to assess the 

effectiveness of the immunomodulating 

treatment. 

Both Dr. Contreras and PHS are 

desirous of concluding this matter 

without further expense of time and 

other resources, and the parties have 

entered into a Voluntary Exclusion 

Agreement to settle the matter. Dr. 

Contreras accepted responsibility for the 

reporting described above, but denied 

that he intentionally committed 

scientific misconduct. The settlement is 

not an admission of liability on the part 

of the Respondent. 

Dr. Contreras has entered into a 

Voluntary Exclusion Agreement in 

which he has voluntarily agreed, for a 

period of three (3) years, beginning on 

June 17, 2009: 

(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’’ and defined by 2 CFR 

Parts 180 and 376; and 

(2) 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 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. E9–15909 Filed 7–6–09; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Developmental Disabilities 

Program Independent Evaluation 

Project. 

OMB No.: New Collection. 

Description: The Developmental 

Disabilities Program Independent 

Evaluation (DDPIE) Project is an 

independent (non-biased) evaluation to 

examine through rigorous and 

comprehensive performance-based 

research procedures the targeted impact 

on the lives of people with 

developmental disabilities and their 

families of three programs funded under 

the Developmental Disabilities 

Assistance and Bill of Rights Act of 

2000 (DD Act): (1) State Councils on 

Developmental Disabilities (SCDDs); (2) 

State Protection and Advocacy Systems 

for Individuals with developmental 

disabilities (P&As); and (3) University 

Centers for Excellence in Developmental 

Disabilities (UCEDDs). The intent of this 

evaluation is to understand and report 

on the accomplishments of these 

programs, including collaborative efforts 

among the DD Network programs. The 

results of this evaluation will provide a 

report to the Administration on 

Developmental Disabilities (ADD) (the 

agency that administers these programs) 

with information on the effectiveness of 

its programs and policies and serve as 

a way for ADD to promote 

accountability to the public. 

The independent evaluation is a 

response to accountability requirements 

for ADD as identified in the 

Developmental Disabilities Assistance 

and Bill of Rights Act of 2000 (DD Act), 

the Government Performance and 

Results Act (GPRA) of 1993, and the 

Program Assessment Rating Tool 

(PART), administered by the Office of 

Management and Budget (OMB). This 

project meets the requirements of PART 

by providing a non-biased method of 

evaluating the effectiveness and impact 

of DD Network programs on the lives of 

people with developmental disabilities 

and their families. 

ADD is seeking OMB approval for the 

evaluation tools (e.g., data collection 

instruments). The evaluation tools are 

designed to collect data for two 

purposes: (1) To measure the programs 

according to indicators (structural, 

process, output, and outcome) in key 

function areas; and (2) to establish 

performance standards for measuring 

Federal Register / Vol. 74, No. 128 / Tuesday, July 7, 2009 / Notices 32169 

the impact of each of the programs. The 

evaluation tools are primarily protocols 

for conducting interviews with various 

staff of the three programs and 

stakeholders associated with the 

programs. The interview protocols were 

tested during a pilot study in 2008. 

There is also a self-administered form 

for each of the programs to be 

completed by Executive Directors or 

his/her designee. The self-administered 

form was developed as a result of the 

pilot study and, therefore, has not been 

tested for reliability and validity. It is 

intended that the clearance process will 

be a mechanism for determining the 

reliability, validity, and feasibility of 

using this instrument. 

Respondents: Staff of State Councils 

on Developmental Disabilities, State 

Protection and Advocacy Systems for 

Individuals with developmental 

disabilities, and University Centers for 

Excellence in Developmental 

Disabilities, Education, Research, and 

Service; individuals with 

developmental disabilities; parents of 

individuals with developmental 

disabilities; siblings of individuals with 

developmental disabilities; guardians; 

advocates; policymakers; service 

providers; university faculty; and others 

(e.g., DDC chairs, members of Protection 

and Advocacy boards of directors or 

commissioners; Consumer Advisory 

Committee members) 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

DD Council: Executive Director Interview ...................................................... 20 1 4 80 

DD Council: Interview with Council Chair/Council Members ........................ 60 1 0 .75 45 

DD Council: Group Interview with Policymakers, Collaborators, and Grantees .............................................................................................................. 160 1 2 320 

UCEDD: Telephone Interview with Current and Graduated Students .......... 100 1 0 .75 75 

UCEDD: Interview with the Consumer Advisory Committee ......................... 60 1 0 .75 45 

UCEDD: Interview with Peer Researchers and Colleagues ......................... 100 1 0 .75 75 

UCEDD: Interview with Recipients of Community Services or Members of 

Organizations/Agencies that Are Trained To Provide Community Services ............................................................................................................. 100 1 0 .75 75 

UCEDD: Self-administered Form ................................................................... 20 1 8 160 

P&A: Executive Director Interview ................................................................. 20 1 4 80 

P&A: Staff Interview ....................................................................................... 60 1 0 .75 45 

P&A: Board of Directors (Commissioners)—Chair and Members ................ 60 1 0 .75 45 

P&A: Group Interview with Policymakers and Collaborators ........................ 160 1 2 320 

P&A: Interview with Recipient of Community Education ............................... 100 1 0 .75 75 

P&A: Interview with Clients ........................................................................... 100 1 0 .75 75 

P&A: Self-administered Form ........................................................................ 20 1 8 160 

UCEDD: Interview with Director .................................................................... 20 1 4 80 

DD Council: Group Interview with Recipients of Self-Advocacy and Leadership Education and Training ................................................................... 100 1 0 .75 75 

DD Council: Group Interview with Recipients of Education and Training to 

Improve Community Capacity .................................................................... 100 1 0 .75 75 

DD Council: Self-administered Form ............................................................. 20 1 8 160 

DD Council Estimate of Total Burden Hours for Activities to Support Administration of Proposed Information Collection Instruments .................... 20 1 33 .50 670 

P&A Estimate of Total Burden Hours for Activities to Support Administration of Proposed Information Collection Instruments ................................. 20 1 33 .50 670 

UCEDD Estimate of Total Burden Hours for Activities to Support Administration of Proposed Information Collection Instruments ............................. 20 1 33 .50 670 

Estimated Total Annual Burden 

Hours: 4,075. 

Additional Information: 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project, Fax: 202– 

395–7245, Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: June 30, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–15841 Filed 7–6–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material,