11136 Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices 

including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to 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. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the 

Attention: NIH Desk Officer, Office of 

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: George 

Chacko, Office of Planning, Analysis, 

and Evaluation, Center for Scientific 

Review, 6701 Rockledge Drive, Suite 

3030, Bethesda, MD 20892 or call nontoll-free at 301–435–1111 or email your 

request, including your address to: 

chackoge@mail.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. 

George Chacko, 

Director, Office of Planning, Analysis, and 

Evaluation, Center for Scientific Review, 

National Institutes of Health. 

[FR Doc. 2012–4271 Filed 2–23–12; 8:45 am] 

BILLING CODE 4104–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; a Multi-Center International 

Hospital-Based Case-Control Study of 

Lymphoma in Asia (AsiaLymph) (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: A MultiCenter International Hospital-Based 

Case-Control Study of Lymphoma in 

Asia (AsiaLymph) (NCI). Type of 

Information Collection Request: 

Emergency. Need and Use of 

Information Collection: Incidence rates 

of certain lymphomas have increased in 

the United States and in many other 

parts of the world. The contribution of 

environmental, occupational, and 

genetic factors to the cause of 

lymphoma has generated a series of 

novel findings from epidemiological 

studies conducted in the United States 

that have attempted to explain this 

increase. However, none of the chemical 

associations have been conclusively 

established and the identification of the 

key, functional alleles in gene regions 

associated with risk of NHL requires 

further elucidation. Further, the ability 

to follow-up, confirm, and extend these 

observations in the United States is 

limited by the low prevalence and 

limited range of several important 

chemical and viral exposures and the 

high to complete linkage disequilibrium 

among key candidate genetic loci in 

Western populations. To optimize the 

ability to build on and clarify these 

findings, it is necessary to investigate 

populations that differ from those in the 

West in both exposure patterns and 

underlying genetic structure. A 

multidisciplinary case-control study of 

lymphoma in Asia, where lymphoma 

rates have also risen, provides an 

opportunity to replicate and extend 

recent and novel observations made in 

studies in the West in a population that 

is distinctly different with regard to 

patterns of key risk factors, including 

range of exposures, prevalence of 

exposures, correlations between 

exposures, and variation in gene regions 

of particular interest. It will also 

improve the ability to understand the 

causes of certain types of rare 

lymphoma tumors in the United States 

that occur at much higher rates in Asia. 

As such, AsiaLymph will confirm and 

extend previous findings and yield 

novel insights into the causes of 

lymphoma in both Asia and in the 

United States. The major postulated risk 

factors for evaluation in this study are 

chemical exposures (i.e., 

organochlorines, trichloroethylene, and 

benzene) and genetic susceptibility. 

Other factors potentially related to 

lymphoma, such as viral infections, 

ultraviolet radiation exposure, medical 

conditions, and other lifestyle factors 

will also be studied. Patients from 19 

participating hospitals will be screened 

and enrolled. There will be a one-time 

computer-administered interview, and 

patients will also be asked to provide a 

one-time blood and buccal cell mouth 

wash sample and lymphoma cases will 

be asked to make available a portion of 

their pathology sample. Frequency of 

Response: Once. Affected Public: 

Individuals. Type of Respondents: 

Newly diagnosed patients with 

lymphoma or patients undergoing 

surgery or other treatment for noncancer related medical issues who live 

in Taiwan and in Hong Kong, Chengdu 

and Tianjin, China will be enrolled at 

treating hospitals. The annual reporting 

burden is estimated at 5,302 hours (see 

Table below). There are $77,000 in 

Capital Costs, Operating Costs, and/or 

Maintenance Costs to report. 

ESTIMATES OF ANNUAL BURDEN HOURS

Category of respondents Types of respondents Number of 

respondents 

Frequency of 

response 

Average time 

per response 

(minutes/hour) 

Annual 

burden hours 

Individuals ......................................... Patients to be Screened .................. 3,100 1 5/60 258 

Patients with Lymphoma .................. 1,100 1 105/60 1,925 

Other Patients .................................. 1,100 1 105/60 1,925 

Study Pathologists ........................... 19 58 5/60 92 

Interviewers ...................................... 19 116 30/60 1,102 

Total ........................................... ........................................................... ........................ ........................ ........................ 5,302 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices 11137 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address 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 Nathaniel 

Rothman, Senior Investigator for the 

Occupational and Environmental 

Epidemiology Branch, Division of 

Epidemiology and Genetics, National 

Cancer Institute, 6120 Executive 

Boulevard, Room 8118, Rockville, MD 

20892 or call non-toll-free number 301– 

496–9093 or email your request, 

including your address to: rothmann 

@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. 

Dated: February 21, 2012. 

Vivian Horovitch-Kelley, 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2012–4347 Filed 2–23–12; 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. 

Polyclonal Antibodies Useful for the 

Detection of Vangl1 and Vangl2 

Proteins Which Play a Role in 

Developmental Processes 

Description of Technology: Vangl1 

(Van Gogh like 1) and Vangl2 (Van Gogh 

like 2) are two core proteins mediating 

establishment of Planar Cell Polarity 

(PCP), which refers to the polarity of 

epithelial cells within a plane 

orthogonal to their apical-basal axis. 

Disruption of core PCP proteins leads to 

many developmental defects, including 

open neural tube, misorientation of 

sensory hair cells in the inner ear, 

polycystic kidney disease and skeletal 

deformations. In humans, mutations in 

Vangl1 and Vangl2 have been identified 

in patients with neural tube defects, 

such as spina bifida, the most common 

permanently disabling birth defect in 

the United States. NHGRI researchers 

have recently generated rabbit 

polyclonal antibodies against Vangl1 

and phosphorylated Vangl2 proteins 

that are suitable for endogenous Vangl1 

and Vangl2 detection. 

Potential Commercial Applications: 

Anti-Vangl1 and Vangl2 antibodies 

could be used in the development of 

diagnostic and therapeutic treatments 

for PCP-related developmental defects. 

Development Stage: 

• Pre-clinical. 

• In vitro data available. 

Inventors: Yingzi Yang and Bo Gao 

(NHGRI); Yingzi Yang and Hai Song 

(NHGRI). 

Publications: 

1. Gao B, et al. Wnt signaling 

gradients establish planar cell polarity 

by inducing Vangl2 phosphorylation 

through Ror2. Dev Cell. 2011 Feb 

15;20(2):163–176. [PMID 21316585] 

2. Song H, et al. Planar cell polarity 

breaks bilateral symmetry by controlling 

ciliary positioning. Nature. 2010 Jul 

15;466(7304):378–382. [PMID 20562861] 

Intellectual Property: HHS Reference 

Nos. E–135–2011/0 and E–136–2011/ 

0—Research Tools. Patent protection is 

not being pursued for these 

technologies. 

Licensing Contact: Suryanarayana 

(Sury) Vepa, Ph.D., J.D.; 301–435–5020; 

vepas@mail.nih.gov. 

Novel Biomarkers for Alcohol-Induced 

Liver Disease (ALD) 

Description of Technology: Alcoholinduced liver disease (ALD) is a leading 

cause of non accident-related deaths 

worldwide. ALD is reversible if 

identified in the early stages, but early 

diagnosis is difficult with existing tools. 

One problem associated with 

developing a new diagnostic tool is the 

genetic background associated 

heterogeneity in physiological responses 

to chronic alcohol consumption. The 

inventors of the present technology have 

solved this problem and have 

discovered background-independent 

novel biomarkers for ALD. In the 

current studies, the inventors generated 

two genetically distinct lines of 

PPARalpha-null mice and evaluated the 

levels of urine metabolites after alcohol 

exposure. The inventors have identified 

indole-3-lactic acid and phenyllactic 

acid as putative biomarkers for ALD. 

Indole-3-lactic acid and phenyllactic 

acid levels were significantly elevated 

in both lines of PPARalpha-null mice 

after two to three months of alcohol 

administration. The inventors had 

identified indole-3-lactic acid and 

phenyllactic acid to be background 

independent markers for ALD. 

Potential Commercial Applications: 

Useful for early non-invasive screening 

of ALD in large numbers of subjects 

irrespective of their genetic background. 

Competitive Advantages: 

• Easily adaptable for the 

development of highly sensitive 

spectroscopy-based assay kits. 

• Amenable for the development of 

high-throughput mass spectrometric 

analysis of urine samples to detect early 

onset of ALD. 

Development Stage: 

• Early-stage. 

• Pre-clinical. 

• In vivo data available (animal). 

Inventors: Soumen Kanti Manna and 

Frank J. Gonzalez (NCI). 

Publications: 

1. Manna SK, et al. UPLC–MS-based 

urine metabolomics reveals indole-3- 

lactic acid and phenyllactic acid as 

conserved biomarkers for alcoholinduced liver disease in the Ppara-null 

mouse model. J Proteome Res. 2011 Sep 

2;10(9):4120–4133. [PMID 21749142] 

2. Manna SK, et al. Identification of 

noninvasive biomarkers for alcoholinduced liver disease using urinary 

metabolomics and the Ppara-null 


srobinson on DSK4SPTVN1PROD with NOTICES