Federal Register / Vol. 74, No. 174 / Thursday, September 10, 2009 / Notices 46603 

existing measures to fill critical gaps in 

measures of health care performance. 

National Quality Forum, 601 

Thirteenth Street, NW., Suite 500 North, 

Washington, DC 20005, Fax 202–783– 

3434, http://www.qualityforum.org. 

III. Secretarial Comments on the 

Annual Report to Congress 

The Secretary is pleased with the 

scope and vision of NQF’s March 2009 

annual report. The contract with this 

consensus-based entity, NQF, provides a 

unique opportunity to further enhance 

HHS’ efforts to foster a collaborative, 

multi-stakeholder approach to increase 

the availability of national voluntary 

consensus standards for quality and 

efficiency measures to ensure broad 

transparency in achieving value in 

health care delivery. An internal 

multidisciplinary cross-component HHS 

team is working collaboratively with 

NQF to ensure a clear multi-year vision 

to ensure the most efficient and effective 

utilization of the HHS contract. HHS 

looks forward to the ongoing 

opportunity to collaborate with the 

broader health care community as part 

of this NQF contract to ensure a 

consensus-based national strategy and 

priority setting process for health care 

measurement focusing on high-quality, 

patient-centered, efficient health care 

delivery. 

IV. Future Steps 

The consensus based contract with 

NQF is a four year contract. During the 

first year of the contract, NQF shall 

complete deliverables for each task. 

HHS will task NQF with single year and 

multi-year projects. 

Formulation of National Strategy and 

Priorities for Health Care Performance 

Measurement 

During the first year of the HHS 

contract, NQF will create a framework 

for measurement prioritization by 

conducting an environmental scan of at 

a minimum, the 20 patient conditions 

that account for over 95% of costs to the 

Medicare program. NQF is establishing 

a steering committee to oversee the 

prioritization process. 

Maintenance of Consensus Endorsed 

Measures 

During the first year of the HHS 

contract, NQF is maintaining endorsed 

measures relevant to HHS-wide 

programs and will be maintaining 

consensus-based endorsed measures as 

developed under the priority process. 

Promotion of Electronic Health Records 

During the first year of the HHS 

contract, NQF is supporting the 

promotion of electronic health records 

and quality measurement incorporation 

as part of HHS-wide efforts. 

Focused Measure Development, 

Harmonization, and Endorsement 

Efforts to Fill Critical Gaps in 

Performance Measurement 

During the first year of the HHS 

contract NQF is supporting a variety of 

performance measurement efforts 

including, but not limited to, the areas 

of efficiency, harmonization, outcomes, 

patient safety, care coordination, ICD– 

10, palliative care, and nursing home 

quality metrics. 

The public is encouraged to give 

input through the NQF process and will 

be able to track the progress on work 

related to this contract on the NQF Web 

site located at: http:// 

www.qualityforum.org/projects/ 

ongoing/hhs/. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

Dated: September 3, 2009. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. E9–21783 Filed 9–4–09; 4:15 pm] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Head Start Program 

Administrative Practice and Procedure; 

Appeal Procedures, 45 CFR Part 1303. 

OMB No.: 0980–0242. 

Description: Section 646 of the Head 

Start Act requires the Secretary of 

Health and Human Services to prescribe 

a timeline for conducting administrative 

hearings when adverse actions are taken 

or proposed against Head Start and 

Early Head Start grantees and delegate 

agencies. The Office of Head Start is 

proposing to renew, without changes, 

this rule, which implements these 

requirements and which prescribes 

when a grantee must submit certain 

information and what that information 

shall include. 

Respondents: Head Start and Early 

Head Start grantees and Delegate 

Agencies. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Rule .................................................................................................................. 20 1 26 520 

Estimated Total Annual Burden 

Hours: 520. 

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. 


erowe on DSK5CLS3C1PROD with NOTICES
46604 Federal Register / Vol. 74, No. 174 / Thursday, September 10, 2009 / Notices 

Dated: September 3, 2009. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. E9–21718 Filed 9–9–09; 8:45 am] 

BILLING CODE 4184–01–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. 

Use of a Modified Adaptor Molecule 

LAT to Improve Immunotherapy for 

Cancer and Other Diseases 

Description of Technology: One 

problem with the development of 

immunotherapy for cancer or other 

diseases is the inability to stimulate a 

sufficient immune response in patients 

to tumor associated antigens. The Linker 

Adapted for T Cell Signaling molecule 

(LAT) has been shown to be an 

important molecule in T cell signaling. 

The inventions described and claimed 

in this patent application illustrate a 

new supportive role for LAT which may 

be harnessed to improve a patient’s 

immune response to tumor-associated 

antigens. 

A number of approaches to improving 

the immune response in cancer 

immunotherapy have been investigated. 

One such approach is to be able to 

influence the potency of T Cell 

Signaling. This invention exploits the 

role of LAT in T Cell signaling and 

provides a means to create a more 

intense and effective T Cell response. 

This would have the end result of 

improving the overall response of a 

patient’s immune system to the 

presence of tumor-associated antigens. 

With T Cell signaling being important 

in the body’s immune response to 

bacterial and viral antigens it may also 

be possible to harness the modified LAT 

molecules to improve the immune 

response in developing immunotherapy 

for infectious disease. 

Applications 

• As an adjuvant with 

immunotherapeutic agents to improve 

the overall response of a patient’s 

immune system to tumor associated 

antigens. 

• As an adjuvant with 

immunotherapeutic agents to improve 

the overall response of a patient’s 

immune system to bacterial associated 

antigens. 

• As an adjuvant with 

immunotherapeutic agents to improve 

the overall response of a patient’s 

immune system to viral associated 

antigens. 

Advantages: Enhanced T Cell 

Signaling should improve the overall 

effectiveness of immunotherapy 

producing a more robust patient 

response. 

Development Status: Early stage, 

significant development efforts required 

to reach proof of principle. 

Inventors: Lawrence E. Samelson et 

al. (NCI). 

Publication: This work has not yet 

been published. 

Patent Status 

• U.S. Provisional Application No. 

61/176,231 filed May 7, 2009 (HHS 

Reference No. E–159–2009/0–US–01). 

• Interested parties wishing to review 

the U.S. Patent Application will need to 

sign a CDA. 

Related Technologies: The NIH also 

has three patents related to the basic 

LAT molecule (HHS Reference No. E– 

010–1998)—US 7,118,889, AU 750543, 

and AU 776495—and several pending 

applications in the US published as 

20060073562 A1 and 20070134749 A1 

and corresponding applications in 

Canada (2316769) and Europe (1 141 

281 A1). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Susan S. Rucker; 

301–435–4478; ruckersu@mail.nih.gov. 

Immunogenic Tumor-Associated 

Antigen SPANX–B for Selective Cancer 

Immunotherapy 

Description of Technology: 

Researchers at the National Institutes of 

Health (NIH) have characterized a novel 

tumor-associated antigen, SPANX–B, 

that is naturally immunogenic and is 

expressed in a variety of human 

malignancies, including melanoma and 

lung, colon, renal, ovarian and breast 

carcinomas. In melanoma specifically, 

SPANX–B expression is associated with 

advanced and metastatic disease. 

Moreover, the researchers have found 

several agonist epitope peptides from 

SPANX–B which can be used to activate 

the immune system to eradicate tumors 

utilizing T cells. SPANX–B peptides 

have significant clinical and 

immunotherapeutic potential for the 

development of cancer diagnostic assays 

and potent protective and/or therapeutic 

vaccines to combat a wide-range of 

cancers. 

Applications 

• In vitro diagnostic assays for highlymetastatic melanomas or other cancers. 

• Therapeutic monoclonal antibodies. 

• Cancer vaccine development. 

Advantages 

• Immunogenic: SPANX–B peptides 

are naturally able to elicit immune 

response. 

• Expressed in a wide-range of 

cancers. 

• Use of epitope peptides facilitates 

the activation of cells of the more 

therapeutically effective branch of the 

immune system. 

• Small epitope peptides: Can be 

more easily manufactured in contrast to 

recombinant proteins. 

Development Status: Pre-clinical. 

Market: Cancer; Cancer, Therapy; 

Cancer, Diagnostics/Prognostics. 

Inventors: Arya Biragyn (NIA) and 

Vladimir Larionov (NCI). 

Publication: G Almanzar et al. Spermderived SPANX–B is a clinically 

relevant tumor antigen that is expressed 

in human tumors and readily 

recognized by human CD4+ and CD8+ T 

cells. Clin Cancer Res. 2009 Mar 

15;15(6):1954–1963. 

Patent Status: U.S. Provisional 

Application No. 61/156,435 filed 

February 27, 2009 (HHS Reference No. 

E–089–2009/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Patrick P. McCue, 

Ph.D.; 301–435–5560; 

mccuepat@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute on Aging, 

Laboratory of Immunology, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize the use of SPANX–Bbased therapeutic approaches to combat 


erowe on DSK5CLS3C1PROD with NOTICES