48214 Federal Register / Vol. 73, No. 160 / Monday, August 18, 2008 / Notices 

lead poisoning prevention practices and 

recommends improvements in national 

childhood lead poisoning prevention efforts. 

Matter To Be Discussed: Agenda items are 

subject to change as priorities dictate; 

however, the current agenda includes: 

• Discussion on the potential approaches 

to strengthen existing strategies to achieve 

the Healthy People 2010 goal of eliminating 

elevated blood lead levels as a public health 

problem in the United States by 2010; 

• Update on school performance and 

concurrent blood lead levels (BLLs); 

• Discussion on study designs related to 

adverse effects from BLLs <10 μg/dL; 

• Discussion on the development of a 

prevention-based research agenda. 

Opportunities will be provided during the 

meeting for oral comments. Depending on the 

time available and the number of requests, it 

may be necessary to limit the time for each 

presenter. 

FOR FURTHER INFORMATION CONTACT: 

Claudine Johnson, Program Operations 

Assistant, telephone: 770–488–3629 or 

Barry Brooks, Administrative Team 

Leader, telephone: 770–488–3641, 

Division of Environmental Emergency 

Health Services, National Center for 

Environmental Health, Centers for 

Disease Control and Prevention, 4770 

Buford Hwy, Mailstop F–60, Atlanta, 

Georgia 30341 telephone: 770–488–

3300, fax: 770–488–3635. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both CDC and 

the Agency for Toxic Substances and 

Disease Registry. 

Dated: August 7, 2008. 

Daniel Riedford, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. E8–19044 Filed 8–15–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Prostate, Lung, 

Colorectal and Ovarian Cancer 

Screening Trial (PLCO) (NCI) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Cancer Institute (NCI), the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request to review and approve 

the information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on June 6, 2008, Volume 73, 

Number 110, Page 32338 and allowed 

60 days for public comment. In response 

to the notice, there were no public 

comments received. The purpose of this 

notice is to allow an additional 30 days 

for public comment. The National 

Institutes of Health may not conduct or 

sponsor, and the respondent is not 

required to respond to, an information 

collection that has been extended, 

revised, or implemented on or after 

October 1, 1995, unless it displays a 

currently valid OMB control number. 

Proposed Collection: Title: Prostate, 

Lung, Colorectal and Ovarian Cancer 

Screening Trial (PLCO). Type of 

Information Collection Request: 

REVISION (OMB #: 0925–0407, current 

expiry date 10/31/2008). 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 254,900 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 2008. 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 2008. 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 136, 341; this is down from the 

total initially due to deaths. The 

primary endpoint of the trial is cancerspecific mortality for each of the four 

cancer sites (prostate, lung, colorectum, 

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 estimated total annual burden 

hours requested is 11,401. The 

annualized cost to respondents is 

estimated at $219,919 per year, for a 

total of $659,756 over the proposed 

three year renewal. There are no Capital 

Costs to report. There are no Operating 

or Maintenance Costs to report. 

TABLE A.12–1—ESTIMATES OF ANNUAL BURDEN HOURS

Type of respondents Survey 

instrument 

Number of 

respondents 

Frequency of 

response 

Average time 

per response 

(hours) 

Total annual 

burden hours 

Male and Female Participants ............................................. ASU 133,341.00 1.00 5/60 11,111.75 

HSQ 1,333.33 1.00 5/60 111.08 

Male Participants ................................................................. Prostate 1,066.67 1.00 10/60 177.83 

Total .............................................................................. ........................ ........................ ........................ ........................ 11,400.66 

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 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 73, No. 160 / Monday, August 18, 2008 / Notices 48215 

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: Dr. 

Christine D. Berg, Chief, Early Detection 

Research Group, National Cancer 

Institute, NIH, EPN Building, Room 

3070, 6130 Executive Boulevard, 

Bethesda, MD 20892, or call non-tollfree 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 30 days of the date of 

this publication. 

Dated: August 5, 2008. 

Vivian Horovitch-Kelley, 

NCI Project Clearance Liaison Office, 

National Institutes of Health. 

[FR Doc. E8–18981 Filed 8–19–08; 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. 

Extracellular Matrix Gene Chips To 

Detect Metastatic Tumors 

Description of Technology: Cancer 

mortality is primarily associated with 

metastatic disease and not the primary 

tumor. Recent evidence suggests that 

metastatic disease can be an early event 

and in the majority of patients 

metastasis starts by the time the disease 

is diagnosed. Currently however, 

approximately one third of patients 

without evidence of tumor 

dissemination at the time of surgical 

resection of the primary tumor 

subsequently develop distant metastases 

after the tumor is removed. Therefore 

there is a need for methods of 

characterizing the early metastatic 

process for better treatment of cancer. 

This invention provides arrays which 

can be used for detecting the metastatic 

capacity of a tumor. In particular, these 

gene chips or microarrays detect the 

over-expression of the cancer-related 

extracellular matrix (ECM) modifier 

proteins Anakin and Bromodomain 4 

(Brd4). It has been shown that ECM gene 

dysregulation is predictive of metastasis 

in breast cancer and recently Brd4 and 

Anakin have been identified as 

metastasis modifiers. 

Using the signature profiles of Anakin 

and Brd4, the inventors have 

demonstrated that these genes predict 

survival outcome in affymetrix and glass 

slide based microarray experiments. As 

a result, screening for Brd4 and/or 

Anakin status in tumors could be an 

important prognostic test and may 

enable physicians to better stratify 

patients based on risk of recurrence and 

progression to metastatic disease. 

Applications: 

• Detecting metastatic disease in 

patients diagnosed with cancer. 

• Method of characterizing a tumor or 

cancer by detecting the expression 

levels of Anakin or Brd4. 

• Diagnostic tool to aid clinicians in 

determining appropriate cancer 

treatment. 

Market: 

• Approximately 1,437,180 new 

cancer cases are expected to be 

diagnosed in 2008. 

• Almost 565,650 people in the U.S. 

are expected to die of cancer. This is 

more than 1,500 people a day. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development. 

Inventors: Kent Hunter and Nigel 

Crawford (NCI). 

Patent Status: U.S. Provisional 

Application No. 60/970,400 filed 06 Sep 

2007 (HHS Reference No. E–093–2007/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Whitney A. 

Hastings; 301–451–7337; 

hastingw@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute Metastasis 

Susceptibility Section of the Laboratory 

of Cancer Biology and Genetics is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize 

Brd4 and/or RRP1B (Anakin) prognostic 

tests. Please contact John D. Hewes, 

Ph.D. at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

NUP98-HOXD13 Transgenic Mice 

Description of Technology: 

Myelodysplastic syndrome (MDS) is 

collection of closely related blood 

diseases that arise in the bone marrow 

characterized by anemia, neutropenia, 

and thrombocytopenia resulting from 

hematopoietic stem cell disorders. A 

variety of genetic aberrations have been 

associated with MDS, including 

chromosomal translocations of the 

NUP98 gene. The only current curative 

therapy for MDS is allogeneic bone 

marrow transplant. Without bone 

marrow transplant, patients either die of 

progressive pancytopenia or following 

transformation of MDS to acute myeloid 

leukemia. Progress in understanding 

and treating MDS has been hampered by 

a lack of an animal model that 

accurately recapitulates all of the 

features of human MDS. Utilizing a 

NUP98-HOXD13 (hereafter NHD13) 

fusion gene, a mouse model was 

developed to elucidate the biology of 

MDS. Genetically engineered mice that 

express an NHD13 transgene display all 

of the phenotypic features of MDS 

including peripheral blood cytopenia, 

bone marrow dysplasia, and 

transformation to acute leukemia. These 

mice provide an accurate preclinical 

model for MDS. 

Applications: Model to study MDS 

and evaluate MDS therapy. 

Market: 15,000–20,000 new cases of 

MDS are diagnosed in the U.S.; 80–90% 

of patients are older than 60 years old. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development. 

Inventors: Peter D. Aplan et al. (NCI). 

Publications: 

1. YW Lin et al. Notch1 mutations are 

important for leukemic transformation 

in murine models of precursor-T 

leukemia/lymphoma. Blood. 2006 Mar 

15;107(6):2540–2543. 


sroberts on PROD1PC70 with NOTICES