22108 Federal Register / Vol. 76, No. 76 / Wednesday, April 20, 2011 / Notices 

Management and Budget, at 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact Eddie 

Billingslea, PhD, Division of 

Neuroscience, National Institute on 

Aging, NIH, DHHS, 7201 Wisconsin 

Avenue, Suite 350, Bethesda, Maryland 

20892–9205 or call non-toll-free number 

301–496–9350 or e-mail your request, 

including your address to: 

billingsleae@nia.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: April 11, 2011. 

Taryn Ayoub, 

Project Clearance Liaison, National Institute 

on Aging, National Institutes of Health. 

[FR Doc. 2011–9511 Filed 4–19–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Prostate, Lung, Colorectal 

and Ovarian Cancer Screening Trial 

(PLCO) (NCI) 

SUMMARY: In compliance with the 

requirement of section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Cancer Institute (NCI), the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: Prostate, 

Lung, Colorectal and Ovarian Cancer 

Screening Trial (PLCO) (NCI). Type of 

Information Collection Request: 

Revision (OMB #: 0925–0407, current 

expiry date 10/31/2011). Need and Use 

of Information Collection: This trial is 

designed to determine if screening for 

prostate, lung, colorectal and ovarian 

cancer can reduce mortality from these 

cancers which currently cause an 

estimated 254,570 deaths annually in 

the U.S. The design is a two-armed 

randomized trial of men and women 

aged 55 to 74 at entry. OMB first 

approved this study in 1993 and has 

approved it every 3 years since then 

through 2011. During the first approval 

period a pilot study was conducted to 

evaluate recruitment methods and data 

collection procedures. Recruitment was 

completed in 2001 and data collection 

continues through 2014. When 

participants enrolled in the trial they 

agreed to be followed for at least 13 

years from the time of enrollment. The 

current number of respondents in the 

study is 122,655; this is down from the 

initial total due to deaths. The primary 

endpoint of the trial is cancer specific 

mortality for each of the four cancer 

sites (prostate, lung, colorectal, and 

ovary). In addition, cancer incidence, 

stage shift, and case survival are to be 

monitored to help understand and 

explain results. Biologic prognostic 

characteristics of the cancers will be 

measured and correlated with mortality 

to determine the mortality predictive 

value of these intermediate endpoints. 

Basic demographic data, risk factor data 

for the four cancer sites and screening 

history data, as collected from all 

subjects at baseline, will be used to 

assure comparability between the 

screening and control groups and make 

appropriate adjustments in analysis. 

Further, demographic and risk factor 

information may be used to analyze the 

differential effectiveness of screening in 

high versus low risk individuals. 

Frequency of Response: Annually. 

Affected Public: Individuals. 

Type of Respondents: Adult men and 

women. The annual reporting burden is 

provided for each study component as 

shown in the Table 1 below. There are 

no Capital Costs, Operating Costs, and/ 

or Maintenance Costs to report. 

TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS

Type of respondents Survey 

instrument 

Number of 

respondents 

Frequency of 

response 

Average time per 

response 

(minutes/hour) 

Annual burden 

hours 

Male and Female Participants ......................... ASU 92,941 1.00 5/60 

(0.08) 

7,745 

HSQ 2,000 1.00 5/60 

(0.08) 

167 

SQX 92,941 1.00 30/60 

(0.50) 

46,471 

Total .......................................................... ............................ ............................ ............................ ............................ 54,383 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Minimize the burden 

of the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Dr. Christine D. 

Berg, Chief, Early Detection Research 

Group, National Cancer Institute, NIH, 

EPN Building, Room 3100, 6130 

Executive Boulevard, Bethesda, MD 

20892, or call non-toll-free number 301– 

496–8544 or e-mail your request, 

including your address to: 

bergc@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 76 / Wednesday, April 20, 2011 / Notices 22109 

Dated: April 13, 2011. 

Vivian Horovitch-Kelley, 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2011–9509 Filed 4–19–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

NAG–1 Transgenic Mouse Model 

Description of Technology: The 

nonsteroidal anti-inflammatory drugactivated gene-1 (NAG–1) encodes a 

protein that has anti-inflammatory, 

proapoptotic, and antitumor properties. 

It plays a pivotal role in 

antitumorigenesis induced by 

chemopreventive compounds. 

Transgenic mice expressing human 

NAG–1 have been developed by the NIH 

investigator and collaborator. 

The NAG–1 transgenic mice are 

shown to develop few tumors in 

response to carcinogenic stimuli than 

wild type mice. They are also leaner 

with less fat than their wild type 

counterparts. As such, these mice can be 

used to investigate the development of 

cancers, and they could be of value in 

studying obesity and the relationship to 

cancer risk, and inflammation. 

Inventors: Thomas E. Eling (NIEHS), 

et al. 

Publications: 

1. Baek SJ, Okazaki R, Lee SH, Martinez J, 

Kim JS, Yamaguchi K, Mishina Y, Martin 

DW, Shoieb A, McEntee MF, Eling TE. 

Nonsteroidal anti-inflammatory drug 

activated gene-1 overexpression in 

transgenic mice suppresses intestinal 

neoplasia. Gastroenterology. 2006 

Nov;131(5):1553–1560. [PubMed: 

17101328] 

2. Cekanova M, Lee SH, Donnell RL, 

Sukhthankar M, Eling TE, Fischer SM, 

Baek SJ. Nonsteroidal anti-inflammatory 

drug-activated gene-1 expression inhibits 

urethane-induced pulmonary 

tumorigenesis in transgenic mice. Cancer 

Prev Res (Phila). 2009 May;2(5):450–458. 

[PubMed: 19401523] 

Patent Status: HHS Reference No. E– 

093–2011/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for 

licensing under a Biological Materials 

License Agreement. 

Licensing Contact: Betty B. Tong, 

PhD; 301–594–6565; 

tongb@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIEHS is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize this technology. Please 

contact Elizabeth M. Denholm, NIEHS 

Office of Technology Transfer, 

denholme@niehs.nih.gov, 919–541– 

0981, for more information. 

Altered miRNA Expression as 

Diagnostics and Therapeutics for 

Adrenocortical Carcinomas 

Description of Technology: This 

technology describes that altered human 

miRNA expression such as miRNA–483 

and miRNA 100 can accurately predict 

if a patient’s adrenal cortex tumor is 

benign or malignant. Adrenocortical 

carcinomas (ACC) are rare but 

aggressive cancers and typically have a 

poor prognosis. Currently, there are 

limited options for molecular diagnosis 

to distinguish malignant tumors from 

benign tumors of this type. As a result 

there are few treatment strategies for 

ACC. 

Additionally, preliminary results 

suggest that altering the expression of 

this miRNA in ACC cells can effect 

cancer cell growth. Therefore, inhibiting 

a miRNA may serve as a therapeutic 

option for ACC. 

Applications: 

• Technology can be developed into a 

diagnostic and prognostic marker for 

ACC. 

• Inhibiting miRNA can serve as a 

potential therapeutics for ACC. 

Advantages: 

• Distinguishes malignant Adrenal 

cortex tumor from a benign tumor, 

options for such distinction are limited 

at this time. 

• Technology can help in increased 

and improved diagnosis and therapeutic 

options for ACC. 

Development Status: 

• Pre-clinical. 

• Clinical study to test the markers in 

biopsy and serum samples being 

planned. 

Inventors: Electron Kebebew (CCR, 

NCI) and Erin E. Patterson (CCR, NCI) 

Publication: Patterson E. E. et al. 

(Cancer, 2010). [PubMed: 21061324] 

Patent Status: U.S. Provisional 

Application No. 12/961,298 filed 

December 6, 2010 (HHS Reference No. 

E–026–2011/0–US–01) 

Licensing Status: Available for 

licensing. 

Licensing Contact: Sabarni Chatterjee, 

PhD, M.B.A.; 301–435–5587; 

chatterjeesa@mail.nih.gov 

Collaborative Research Opportunity: 

The Center for Cancer Research, Surgery 

Branch, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize the use of diagnostic 

miRNAs and to target these miRNAs for 

treatment. Please contact John Hewes, 

PhD at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

Novel Inhibitors of Thymic Stromal 

Lymphopoietin (TSLP) for Cancer 

Therapy 

Description of Technology: With 

estimated overall costs in the U.S. in 

2006 at $206.3 billion and WHO 

predictions of 15 million new cases 

globally by 2020, the overall economic 

cost of cancer is staggering. There 

remains a significant unmet need for 

therapies to control the spread 

(metastasis) of cancers to other organs in 

the body. Available for licensing are 

compositions and methods of using 

antagonists of thymic stromal 

lymphopoietin (TSLP) to prevent cancer 

progression and metastasis. 

TSLP, an IL–7-like type 1 

inflammatory cytokine that is often 

associated with the induction of Th2- 

type allergic responses in the lungs, is 

also expressed in cancers regulating 

their escape (1–3). The cancerpromoting activity of TSLP primarily 

required signaling through the TSLP 

receptor on CD4+ T cells, promoting 

Th2-skewed immune responses and 

production of immunosuppressive 

factors such as IL–10 and IL–13. 

Expression of TSLP therefore may be a 

useful prognostic marker and its 


srobinson on DSKHWCL6B1PROD with NOTICES