Federal Register / Vol. 77, No. 62 / Friday, March 30, 2012 / Notices 19299 

resolve the disagreement with reporting 

entity but was unsuccessful. The 

Department can only determine whether 

the report was legally required to be 

filed and whether the report accurately 

depicts the action taken and the 

reporter’s basis for action. Additional 

detail on the process of dispute 

resolution and Secretarial Review 

process can be found at 45 CFR 60.14 

of the NPDB regulations. 

RECORD SOURCE CATEGORIES: 

The records contained in the system 

are submitted by the following entities: 

(1) Insurance companies and others who 

have made payment as a result of a 

malpractice action or claim, (2) State 

Boards of Medical and Dental 

Examiners; (3) State Licensing Boards; 

(4) hospitals and other health care 

entities; (5) DEA; and (6) Federal 

entities which employ health 

practitioners or who have authority to 

sanction such practitioners covered by a 

Federal program. Section 1921 of the 

Social Security Act expands reporting of 

actions submitted by State health care 

practitioner licensing and certification 

authorities (including medical and 

dental boards), State entity licensing 

and certification authorities, peer 

review organizations and private 

accreditation organizations. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

The Secretary has exempted this 

system from certain provisions of the 

Act. In accordance with 5 U.S.C. 

552(k)(2) and 45 CFR 5b.11(b)(ii)(L), this 

system is exempt from subsections 5 

U.S.C. 552a(c)(3), (d)(1)–(4), (e)(4)(G) 

and (H), and (f). 

[FR Doc. 2012–7612 Filed 3–29–12; 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. 

MUC–1 Tumor Antigen Agonist 

Epitopes for Enhancing T-cell 

Responses to Human Tumors 

Description of Technology: The MUC– 

1 tumor associated antigen has been 

shown to be overexpressed and/or 

underglycosylated in a wide range of 

human cancers. The C-terminus region 

of MUC–1 (MUC–1C) has been shown to 

be an oncogene and has been associated 

with a more aggressive phenotype in 

several different cancers. 

Scientists at NIH have identified 7 

new agonist epitopes of the MUC–1 

tumor associated antigen. Compared to 

their native epitope counterparts, 

peptides reflecting these agonist 

epitopes have been shown to enhance 

the generation of human tumor cells, 

which in turn have a greater ability to 

kill human tumor cells endogenously 

expressing the native MUC–1 epitope. 

The agonist epitopes span both the 

VNTR region of MUC–1 and the Cterminus region. The epitopes 

encompass 2 major MHC alleles 

reflecting the majority of the population. 

Along with the method of use, the 

technology encompasses the use of 

these agonist epitopes in peptide- and 

protein-based vaccines, with dendritic 

cells or other antigen presenting cells, or 

encoding sequences in DNA, viral, 

bacterial, yeast, or other types of 

vectors, or to stimulate T-cells in vitro 

for adoptive immunotherapy protocols. 

Potential Commercial Applications: 

• As a therapeutic vaccine to enhance 

patient’s immune responses to a range 

of human cancers 

• As a preventive vaccine for patients 

with preneoplastic conditions or a high 

risk of developing cancer 

• As a preventive vaccine for cancers 

• For in vitro stimulation of 

lymphocytes for adoptive transfer 

protocols for cancer 

Competitive Advantages: 

• The agonist epitopes have been 

shown to be much more potent than 

their natural counterparts in activating 

human T-cells to MUC–1. 

• Compared to T-cells activated with 

the corresponding native epitopes, the 

T-cells activated by the agonist epitopes 

lyse tumor cells to a greater extent. 

• The technology can be used in a 

wide range of cancer vaccine platforms 

and in adoptive immunotherapy 

protocols. 

• The technology can be combined 

with existing vaccine platforms 

including those currently showing 

patient benefit, as well as with other 

therapeutic modalities. 

Development Stage: 

• Pre-clinical 

• In vitro data available 

Inventors: Jeffrey Schlom and KwongYok Tsang (NCI). 

Intellectual Property: HHS Reference 

No. E–001–2012/0—U.S. Patent 

Application No. 61/582,723 filed 03 Jan 

2012. 

Related Technologies: 

• HHS Reference No. E–154–1998/0 

—PCT Application No. PCT/US98/ 

03693 

• HHS Reference No. E–321–2003/0 

—PCT Application No. PCT/US2004/ 

41921 

Licensing Contact: Sabarni Chatterjee, 

Ph.D., MBA; 301–435–5587; 

chatterjeesa@mail.nih.gov. 

Collaborative Research Opportunity: 

The Laboratory of Tumor Immunology 

and Biology, National Cancer Institute, 

is seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate or commercialize the 

use of MUC–1 tumor antigen agonist 

epitopes for the treatment or prevention 

of cancer. For collaboration 

opportunities, please contact John 

Hewes, Ph.D. at hewesj@mail.nih.gov. 

Novel Diagnostic, Prognostic and 

Therapeutic Biomarker for 

Hepatocellular Carcinoma 

Description of Technology: Scientists 

at the National Cancer Institute have 

discovered that Stearol-CoA desaturase1 (SCD–1) is associated with 

hepatocellular carcinoma (HCC). 

Utilizing a microarray to analyze HCC 

patient samples, the investigators found 

SCD–1 is elevated in liver tumor tissues 

and it is a marker for a highly aggressive 

form of HCC, hepatic stem cell-like HCC 

subtype (HpSC HCC), which retains 

stem-cell features capable of cellular 

plasticity and cell motility. The 

investigators found SCD–1 is 

significantly elevated in HpSC tumors 

in comparison to less aggressive HCC 

tumors and it is associated with poor 

patient survival. In vitro studies 

demonstrate SCD–1 inhibition and/or 

addition of saturated palmitic acid 

reduces HpSC HCC characteristics. In 

addition to diagnostic, prognostic, and 

treatment applications, this technology 

mstockstill on DSK4VPTVN1PROD with NOTICES

19300 Federal Register / Vol. 77, No. 62 / Friday, March 30, 2012 / Notices 

may enable clinicians to effectively 

stratify patients for more aggressive 

cancer treatment and prioritize 

candidates for liver transplantation. 

Potential Commercial Applications: 

• Method to diagnose HCC 

• Method to prognose patient survival 

• Method to stratify HCC for 

appropriate treatment 

• Method to treat HCC 

Competitive Advantages: 

• Retrospective studies performed on 

human samples 

• Modulation of SCD–1 reduces 

HpSC HCC characteristics 

Development Stage: 

• Early-stage 

• In vitro data available 

• In vivo data available (human) 

Inventors: Anuradha Budhu and Xin 

W. Wang (NCI). 

Intellectual Property: HHS Reference 

No. E–205–2011/0—U.S. Provisional 

Application No. 61/533,392 filed 12 Sep 

2011. 

Related Technology: HHS Reference 

No. E–139–2010/0—PCT Application 

No. PCT/US2011/032285 filed 13 Apr 

2011. 

Licensing Contact: Jennifer Wong; 

301–435–4633; wongje@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate or 

commercialize biomarkers for liver 

cancer. For collaboration opportunities, 

please contact John Hewes, Ph.D. at 

hewesj@mail.nih.gov. 

Potential Use of Anti-IgE in the 

Treatment of Lupus Nephritis 

Description of Technology: Systemic 

lupus erythematosus (SLE) is a multiorgan inflammatory disease 

characterized by a significant morbidity 

and mortality related to both disease 

evolution as well as therapeutic side 

effects. At least half of SLE patients 

develop lupus nephritis. 

The inventors have used a Lyn -/- 

mouse model that develops an 

autoimmune disease exhibiting some 

features of human SLE. Using this 

model the inventors identified basophils 

and self-reactive IgEs as important 

components in the development of 

autoantibody-mediated kidney disease. 

The inventors found that depletion of 

basophils or the absence of IgE causes 

a considerable reduction in 

autoantibody production and preserves 

kidney function in the Lyn -/- mice. The 

inventors’ work demonstrates that IgE 

immune complexes can activate 

basophils and that removal of selfreactive IgEs that form functional 

circulating immune complexes prevents 

kidney disease. Further, the inventors 

have shown that basophils are 

contributors to the production of the 

self-reactive antibodies that cause 

lupus-like nephritis in the Lyn -/- mice. 

Accordingly, reducing circulating IgE 

levels or reducing basophil activation 

may be of therapeutic benefit. 

Potential Commercial Applications: 

Further research and development of 

therapeutic approach to treat lupus 

nephritis. 

Competitive Advantages: Current 

treatment of lupus has not advanced for 

many years. This finding is of 

importance for its potential in 

advancing treatment of the disease. 

Development Stage: 

• Early-stage 

• Pre-clinical 

Inventors: Juan Rivera and Nicolas 

Charles (NIAMS). 

Publications: 

1. Charles N, et al. Basophils and the 

T helper 2 environment can promote the 

development of lupus nephritis. Nat 

Med. 2010 Jun;16(6):701–707. [PMID 

20512127]. 

2. Brightbill HD, et al. Antibodies 

specific for a segment of human 

membrane IgE deplete IgE-producing B 

cells in humanized mice. J Clin Invest. 

2010 Jun;120(6):2218–2229. [PMID 

20458139]. 

3. Mack M, et al. Basophils and mast 

cells in renal injury. Kidney Int. 2009 

Dec;76(11):1142–1147. [PMID 

19692999]. 

4. Busse W, et al. Omalizumab, antiIgE recombinant humanized monoclonal 

antibody for the treatment of severe 

allergic asthma. J Allergy Clin Immunol. 

2001 Aug;108(2):184–90. [PMID: 

11496232]. 

Intellectual Property: HHS Reference 

No. E–216–2010/0—PCT Application 

No. PCT/US2010/058077 filed 24 Nov 

2010. 

Licensing Contact: Jaime M. Greene; 

301–435–5559; 

greenejaime@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Arthritis and 

Musculoskeletal and Skin Diseases is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate or commercialize the 

technology for the use of anti-IgE in the 

treatment of Lupus Nephritis. For 

collaboration opportunities, please 

contact Cecilia Pazman at 

pazmance@mail.nih.gov. 

Dated: March 27, 2012. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2012–7709 Filed 3–29–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2012–0012] 

National Infrastructure Advisory 

Council 

AGENCY: National Protection and 

Programs Directorate, DHS. 

ACTION: Committee Management; Notice 

of an open Federal Advisory Committee 

meeting. 

SUMMARY: The National Infrastructure 

Advisory Council (NIAC) will meet on 

Tuesday, April 17, 2012, 1310 N. 

Courthouse Road, Suite 300, Virginia 

Room, Arlington, VA 22201. The 

meeting will be open to the public. 

DATES: The NIAC will meet Tuesday, 

April 17, 2012, from 1:30 p.m. to 4:30 

p.m. The meeting may close early if the 

committee has completed its business. 

For additional information, please 

consult the NIAC Web site, 

www.dhs.gov/NIAC, or contact the NIAC 

Secretariat by phone at (703) 235–2888 

or by email at NIAC@dhs.gov. 

ADDRESSES: 1310 N. Courthouse Road, 

Suite 300, Virginia Room, Arlington, VA 

22201. 

While this meeting is open to the 

public, participation in the NIAC 

deliberations is limited to committee 

members and appropriate Federal 

Government officials. Discussions may 

include committee members, 

appropriate Federal Government 

officials, and other invited persons 

attending the meeting to provide 

information that may be of interest to 

the Council. 

Immediately following the committee 

member deliberation and discussion 

period, there will be a limited time 

period for public comment. Comments 

should be limited to meeting agenda 

items and previous NIAC studies. All 

previous NIAC studies can be located at 

www.dhs.gov/NIAC. Relevant public 

comments may be submitted in writing 

or presented in person for the Council 

to consider. Comments should be 

limited to the issues and topics 

addressed by the Council. In-person 

presentations will be limited to three 

minutes per speaker, with no more than 

30 minutes for all speakers. Parties 

interested in making in-person 

mstockstill on DSK4VPTVN1PROD with NOTICES