9252 Federal Register / Vol. 74, No. 40 / Tuesday, March 3, 2009 / Notices 

status, the reasons they seek care at 

health centers, their diagnoses, the 

services they utilize at health centers 

and elsewhere, the quality of those 

services, and their satisfaction with the 

care they receive, through personal 

interviews of a stratified random sample 

of health center patients. Interviews are 

planned to take approximately 1 hour 

and six minutes each. 

The Patient Survey builds on previous 

periodic User-Visit Surveys which were 

conducted to learn about the process 

and outcomes of care in CHCs and HCH 

projects. The original survey questions 

were derived from the National Health 

Interview Survey (NHIS) and the 

National Hospital Ambulatory Medical 

Care Survey (NHAMCS) conducted by 

the National Center for Health Statistics 

(NCHS). Conformance with the NHIS 

and NHAMCS allowed comparisons 

between these NCHS surveys and the 

previous CHC and HCH User-Visit 

Surveys. The new Patient Survey was 

developed using a questionnaire 

methodology similar to that used in the 

past, and will also allow some 

longitudinal comparisons for CHCs and 

HCH projects with the previous UserVisit survey data, including monitoring 

of process outcomes over time. In 

addition, this survey will include 

interviews of patients drawn from 

migrant populations and from residents 

of public housing; these populations 

were not included in the previous 

surveys. 

The annual estimate of burden is as 

follows: 

The estimated response burden for the 

survey is as follows: 

SURVEY

Type of respondent; activity involved Number of 

respondents 

Responses 

per 

respondent 

Total 

number of 

responses 

Burden per 

response 

(hours) 

Total hour 

burden 

Grantee/Site Recruitment and Site Training .......................................... 115 3 345 3 .75 1,294 

Patient Recruitment ............................................................................... 5,658 1 5,658 .167 945 

Patient Survey ....................................................................................... 4,526 1 4,526 1 .1 4,979 

Total ................................................................................................ 5,773 .................... 10,529 ...................... 7,218 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to 

the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov 

or by fax to 202–395–6974. Please direct 

all correspondence to the ‘‘attention of 

the desk officer for HRSA.’’ 

Dated: February 24, 2009. 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E9–4460 Filed 3–2–09; 8:45 am] 

BILLING CODE 4165–15–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. 

Prevention of Head and Neck Cancer 

Using Rapamycin and Its Analogs 

Description of Technology: It is 

frequently observed in head and neck 

squamous cell carcinoma (HNSCC), a 

cancer occurring mostly in the mouth, 

that the Akt/mTOR pathway is 

abnormally activated. Therefore, 

inhibiting this signaling pathway may 

help in treating this disease. Rapamycin 

and its analogs are known to inhibit the 

activity of mTOR so in principle they 

could serve as therapeutics for treating 

HNSCC. 

Researchers at the NIH have 

developed a method of potentially 

preventing or treating HNSCC through 

the inhibition of mTOR activity. The 

proof of this principle was 

demonstrated by rapid regression of 

mouth tumors in mice afflicted with 

Cowden syndrome with the 

administration of rapamycin. Like 

HNSCC, development of this disease is 

linked to over activation of the Akt/ 

mTOR pathway. Furthermore, the 

therapeutic potential of rapamycin was 

demonstrated using mice in 

experiments that model chronic 

exposure to tobacco, which promotes 

the development of HNSCC. Therefore, 

inhibitors of mTOR have considerable 

potential in the prevention and 

treatment of HNSCC. 

Applications: Preventing the 

development of oral cancer using mTOR 

inhibitors to halt progression of precancerous lesions. 

Market: Approximately 500,000 new 

cases of squamous cell carcinomas of 

the head and neck arise every year 

making it the 6th most common cancer 

in the world. 

Frequently, prognosis is poor due to 

late detection of cancer. 

Development Status: Pre-clinical 

proof of principle. 

Inventors: J. Silvio Gutkind et al. 

(NIDCR). 

Publications: 1. CH Squarize, RM 

Castilho, JS Gutkind. Chemoprevention 

and treatment of experimental Cowden’s 

disease by mTOR inhibition with 

rapamycin. Cancer Res. 2008 Sep 

1;68(17):7066–7072. 

2. R Czerninski, P Amornphimoltham, 

V Patel, AA Molinolo, JS Gutkind. 

Targeting mTOR by rapamycin prevents 

tumor progression in an oral-specific 

chemical carcinogenesis model. Cancer 

Prevention Res. 2009 Jan;2(1):27–36. 

Patent Status: U.S. Patent Application 

No. 61/090/414 filed 20 Aug 2008 (HHS 

Reference No. E–302–2008/0-US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Whitney Hastings; 

301–451–7337; hastingw@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Dental and 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 74, No. 40 / Tuesday, March 3, 2009 / Notices 9253 

Craniofacial Research, Oral and 

Pharyngeal Cancer Branch, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize this technology. Please 

contact David W. Bradley, PhD at 

bradleyda@nidcr.nih.gov for more 

information. 

Use of Tetracyclines as Anti-Cancer 

Agents 

Description of Technology: The 

invention describes compositions of 

tetracycline compounds and their 

derivatives as having anti-cancer 

activity, as well as methods of treating 

cancer. Tetracyclines are commonly 

used as antibiotics; however, testing of 

these compounds in a high throughput 

screening system revealed certain 

derivatives to be potent inhibitors of 

tyrosyl-DNA-phosphodiesterase (Tdp1). 

Camptothecins are effective 

Topoisomerase I (Top1) inhibitors, and 

two derivatives (Topotecan® and 

Camptosar®) are currently approved for 

treatment of ovarian and colorectal 

cancer. Camptothecins damage DNA by 

trapping covalent complexes between 

the Top1 catalytic tyrosine and the 3=- 

end of the broken DNA. Tdp1 repairs 

Top1-DNA covalent complexes by 

hydrolyzing the tyrosyl-DNA bond. This 

can reduce the effectiveness of 

camptothecins as anti-cancer agents. In 

addition, Tdp1 repairs free-radicalmediated DNA breaks. 

As disclosed in the instant 

technology, tetracyclines have the 

potential to enhance the anti-neoplastic 

activity of Top1 inhibitors by reducing 

repair of Top1-DNA lesions through 

inhibition of Tdp1. Inhibition of Tdp1 

may also reduce repair of DNA breaks 

and increase the rate of apoptosis in 

cancer cells, making them potential 

anti-cancer agents on their own. 

Development Status: Pre-clinical 

stage. 

Inventors: Yves Pommier, Christophe 

Marchand, Laurent Thibaut (NCI). 

Publications: 1. Z Liao et al. 

Inhibition of human tyrosyl-DNA 

phosphodiesterase (Tdp1) by 

aminoglycoside antibiotics and 

ribosome inhibitors. Mol Pharmacol. 

2006 Jul;70(1):366–372. 

2. Y Pommier. Camptothecins and 

topoisomerase I: A foot in the door. 

Targeting the genome beyond 

topoisomerase I with camptothecins and 

novel anticancer drugs: Importance of 

DNA replication, repair and cell cycle 

checkpoints. Curr Med Chem 

Anticancer Agents. 2004 Sep;4(5):429– 

434. Review. 

3. Y Pommier et al. Repair of and 

checkpoint response to topoisomerase I 

mediated DNA damage. Mutat Res. 2003 

Nov 27;532(1–2):173–203. Review. 

Patent Status: U.S. Provisional 

Application No. 60/786,746 filed 27 Mar 

2006 (HHS Reference No. E–097–2006/ 

0–US–01). 

International Application No. PCT/ 

US2007/007724 filed 27 Mar 2007 (HHS 

Reference No. E–097–2006/0–PCT–02). 

U.S. Patent Application No. 12/ 

241,011 filed 29 Sep 2008 (HHS 

Reference No. E–097–2006/1–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Betty Tong, PhD; 

301–594–6565; tongb@mail.nih.gov. 

Collaborative Research Opportunity: 

The Laboratory of Molecular 

Pharmacology at the National Cancer 

Institute is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize tetracycline derivatives, 

particularly optimizing them for 

therapeutic use. Please contact John D. 

Hewes, PhD at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

Glutathione S-transferase Clones for 

Members of the Ubiquitin-Dependent 

Protein Degradation Pathway 

Description of Technology: Scientists 

at the National Institutes of Health have 

developed cDNA for glutathione Stransferase (GST) clones for the 

following factors: Nedd4, XIAP, 

UBCH5B, and CBL–B. These proteins 

are involved in the ubiquitin-dependent 

pathway of protein degradation in cells, 

the major cellular system for protein 

degradation. The ubiquitin-proteosome 

pathway regulates several cancer 

regulated proteins. Defects in this 

pathway can lead to cancer 

development. The GST clones can be 

used to produce corresponding GST 

fusion proteins in order to isolate each 

protein from the pathway for further 

analysis. These constructs can also be 

incorporated into assays/kits to detect 

proteins in the ubiquitin-dependent 

pathway. 

Applications: Research tools for 

detection and isolation of ubiquitindependent pathway members in order to 

understand the pathway defects that 

lead to cancer and develop preventions 

and treatments to overcome these 

defects. 

Research tools for generating fusion 

proteins of Nedd4, XIAP, UBCH5B, and 

CBL–B to further analyze their functions 

in vivo and in vitro. 

Controls for screening inhibitors of 

the ubiquitin-dependent pathway in 

order to better understand the different 

mechanisms of ubiquitin-dependent 

protein degradation. 

Inventors: Allan M. Weissman et al. 

(NCI). 

Patent Status: HHS Reference No. E– 

245–2003/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for 

licensing under a Biological Materials 

License Agreement. 

Licensing Contact: Samuel E. Bish, 

Ph.D.; 301–435–5282; 

bishse@mail.nih.gov. 

Dated: February 24, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–4477 Filed 3–2–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings 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, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Microbiology, 

Infectious Diseases and AIDS Initial Review 

Group; Acquired Immunodeficiency 

Syndrome Research Review Committee. 

Date: March 30–31, 2009. 

Time: 8 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Washington/Rockville, 1750 

Rockville Pike, Rockville, MD 20852. 

Contact Person: Erica L. Brown, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health/NIAID, 6700B 

Rockledge Drive, MSC 7616, Bethesda, MD 

20892–7616, 301–451–2639, 

ebrown@niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Pandemic Flu. 

Date: April 1, 2009. 

mstockstill on PROD1PC66 with NOTICES