56848 Federal Register / Vol. 73, No. 190 / Tuesday, September 30, 2008 / Notices 

133 2000 Nursing Facility CPG, supra note 2, at 

14289. 

134OIG, ‘‘HHS—OIG—Fraud Prevention & 

Detection—Corporate Integrity Agreements,’’ 

available on our Web site at http://oig.hhs.gov/ 

fraud/cias.html. 

135Appropriate Federal and State authorities 

include OIG, CMS, the Criminal and Civil Divisions 

of the Department of Justice, the U.S. Attorney in 

relevant districts, the Food and Drug 

Administration, the Department’s Office for Civil 

Rights, the Federal Trade Commission, the Drug 

Enforcement Administration, the Federal Bureau of 

Investigation, and the other investigative arms for 

the agencies administering the affected Federal or 

State health care programs, such as the State 

Medicaid Fraud Control Unit, the Defense Criminal 

Investigative Service, the Department of Veterans 

Affairs, the Health Resources and Services 

Administration, and the Office of Personnel 

Management (which administers the Federal 

Employee Health Benefits Program). 

136To qualify for the ‘‘not less than double 

damages’’ provision of the False Claims Act, the 

provider must provide the report to the Government 

within 30 days after the date when the provider first 

obtained the information. 31 U.S.C. 3729(a). 

137Some violations may be so serious that they 

warrant immediate notification to governmental 

authorities prior to, or simultaneous with, 

commencing an internal investigation. By way of 

example, OIG believes a provider should 

immediately report misconduct that: (i) Is a clear 

violation of administrative, civil, or criminal laws; 

(ii) poses an imminent danger to a patient’s safety; 

(iii) has a significant adverse effect on the quality 

of care provided to Federal health care program 

beneficiaries; or (iv) indicates evidence of a 

systemic failure to comply with applicable laws or 

an existing corporate integrity agreement, regardless 

of the financial impact on Federal health care 

programs. 

138OIG has published criteria setting forth those 

factors that OIG takes into consideration in 

determining whether it is appropriate to exclude an 

individual or entity from program participation 

pursuant to section 1128(b)(7) of the Act (42 U.S.C. 

1320a–7(b)(7)) for violations of various fraud and 

abuse laws. See 62 FR 67392 (December 24, 1997), 

‘‘Criteria for Implementing Permissive Exclusion 

Authority Under Section 1128(b)(7) of the Social 

Security Act.’’ 

139For details regarding the Provider SelfDisclosure Protocol, including timeframes and 

required information, see 63 FR 58399 (October 30, 

1998), ‘‘Publication of the OIG’s Provider SelfDisclosure Protocol,’’ available on our Web site at 

http://oig.hhs.gov/authorities/docs/ 

selfdisclosure.pdf. See also OIG’s April 15, 2008, 

Open Letter to Health Care Providers, available on 

our Web site at http://oig.hhs.gov/fraud/docs/ 

openletters/OpenLetter4–15–08.pdf; OIG’s April 24, 

2006, Open Letter to Health Care Providers, 

available on our Web site at http://oig.hhs.gov/ 

fraud/docs/openletters/ 

Open%20Letter%20to%20Providers%202006.pdf. 

B. Regular Review of Compliance 

Program Effectiveness 

Nursing facilities should regularly 

review the implementation and 

execution of their compliance program 

systems and structures. This review 

should be conducted periodically, 

typically on annual basis. The 

assessment should include an 

evaluation of the overall success of the 

program, as well as each of the basic 

elements of a compliance program 

individually, which include: 

• Designation of a compliance officer 

and compliance committee; 

• Development of compliance 

policies and procedures, including 

standards of conduct; 

• Developing open lines of 

communication; 

• Appropriate training and teaching; 

• Internal monitoring and auditing; 

• Response to detected deficiencies; 

and 

• Enforcement of disciplinary 

standards. 

Nursing facilities seeking guidance for 

establishing and evaluating their 

compliance operations should review 

OIG’s 2000 Nursing Facility CPG, which 

explains in detail the fundamental 

elements of a compliance program.133

Nursing facilities may also wish to 

consult quality of care corporate 

integrity agreements (CIA) entered into 

between OIG and parties settling 

specific matters.134 Other issues a 

nursing facility may want to evaluate 

are whether there has been an allocation 

of adequate resources to compliance 

initiatives; whether there is a reasonable 

timetable for implementation of the 

compliance measures; whether the 

compliance officer and compliance 

committee have been vested with 

sufficient autonomy, authority, and 

accountability to implement and enforce 

appropriate compliance measures; and 

whether compensation structures create 

undue pressure to pursue profit over 

compliance. 

V. Self-Reporting 

If the compliance officer, compliance 

committee, or a member of senior 

management discovers credible 

evidence of misconduct from any source 

and, after a reasonable inquiry, believes 

that the misconduct may violate 

criminal, civil, or administrative law, 

the nursing facility should promptly 

report the existence of the misconduct 

to the appropriate Federal and State 

authorities.135 The reporting should 

occur within a reasonable period, but 

not longer than 60 days,136 after 

determining that there is credible 

evidence of a violation.137 Prompt 

voluntary reporting will demonstrate 

the nursing facility’s good faith and 

willingness to work with governmental 

authorities to correct and remedy the 

problem. In addition, prompt reporting 

of misconduct will be considered a 

mitigating factor by OIG in determining 

administrative sanctions (e.g., penalties, 

assessments, and exclusion) if the 

reporting nursing facility becomes the 

subject of an OIG investigation.138

To encourage providers to make 

voluntary disclosures to OIG, OIG 

published the Provider Self-Disclosure 

Protocol.139 When reporting to the 

Government, a nursing facility should 

provide all relevant information 

regarding the alleged violation of 

applicable Federal or State law(s) and 

the potential financial or other impact of 

the alleged violation. The compliance 

officer, under advice of counsel and 

with guidance from governmental 

authorities, may be requested to 

continue to investigate the reported 

violation. Once the investigation is 

completed, and especially if the 

investigation ultimately reveals that 

criminal, civil, or administrative 

violations have occurred, the 

compliance officer should notify the 

appropriate governmental authority of 

the outcome of the investigation. This 

notification should include a 

description of the impact of the alleged 

violation on the applicable Federal 

health care programs or their 

beneficiaries. 

VI. Conclusion 

In today’s environment of increased 

scrutiny of corporate conduct and 

increasingly large expenditures for 

health care, it is imperative for nursing 

facilities to establish and maintain 

effective compliance programs. These 

programs should foster a culture of 

compliance and a commitment to 

delivery of quality health care that 

begins at the highest levels and extends 

throughout the organization. This 

supplemental CPG is intended as a 

resource for nursing facilities to help 

them operate effective compliance 

programs that decrease errors, fraud, 

and abuse and increase quality of care 

and compliance with Federal health 

care program requirements for the 

benefit of the nursing facilities and their 

residents. 

Dated: September 24, 2008. 

Daniel R. Levinson, 

Inspector General. 

[FR Doc. E8–22796 Filed 9–29–08; 8:45 am] 

BILLING CODE 4152–01–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. 


ebenthall on PROD1PC60 with NOTICES
Federal Register / Vol. 73, No. 190 / Tuesday, September 30, 2008 / Notices 56849 

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. 

Transgenic Mice With ConditionallyEnhanced Bone Morphogen Protein 

(BMP) Signaling: A Model for Human 

Bone Diseases 

Description of Technology: This 

technology relates to novel animal 

models of several human bone diseases 

that have been linked to enhanced BMP 

signaling. More specifically, this mouse 

model expresses a mutant receptor for 

BMP, known as Alk2 that is always 

actively signaling. This receptor is 

under the control of the Cre-loxP 

system, which allows control of 

expression of the mutant Alk2 in both 

a developmental and tissue-specific 

manner. As a result, the enhanced 

signaling conditions exhibited in 

multiple human bone-related diseases 

can be studied with the same animals. 

Applications: The mouse model can 

be applied to the study of BMP 

signaling-related human diseases such 

as fibrodysplasia ossificans progressiva, 

which involves the postnatal 

transformation of connective tissue into 

bone. Another example of BMP 

signaling-related disease is 

Craniosynostosis, which involves the 

premature closing of the sutures in 

childhood so that normal brain and 

skull growth are inhibited. This mouse 

model can potentially be used in other 

human diseases where BMP signaling 

might play a pivotal role, for example 

cleft lip and cleft palate, breast cancer, 

osteoarthritis, lung fibrosis, multiple 

myeloma, juvenile polyposis, cephalic 

neural tube closure defects, diabetes and 

other types of blood glucose control 

problems, and pulmonary hypertension. 

Development Status: Early-stage 

development. 

Inventors: Yuji Mishina, Manas Ray, 

Greg Scott (NIEHS). 

Relevant Publications: 

1. T Fukada et al. Generation of a 

mouse with conditionally activated 

signaling through the BMP receptor, 

ALK2. Genesis. 2006;44:159–167. 

2. L Kan et al. Transgenic mice 

overexpressing BMP4 develop a 

fibrodysplasia ossificans progressiva 

(FOP)-like phenotype. Am J Path. 2004 

Oct;165(4):1107–1115. 

3. EM Shore et al. A recurrent 

mutation in the BMP type I receptor 

ACVR1 causes inherited and sporadic 

fibrodysplasia ossificans progressive. 

Nat Genet. 2006 May;38(5):525–527. 

Patent Status: HHS Reference No. E– 

328–2008/0—Research Material. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for nonexclusive licensing. 

Licensing Contact: Steve Standley, 

Ph.D.; 301–435–4074; 

sstand@mail.nih.gov. 

Production of Endotoxin Free TEV 

Protease 

Description of Technology: This 

technology relates to an efficient 

method of purifying proteins. More 

specifically, this technology relates to a 

method of obtaining an endotoxin-free 

‘TEV protease,’ a common name for a 27 

kDa catalytic domain of the Nuclear 

Inclusion a (NIa) protein from Tobacco 

Etch Virus. TEV protease is a sitespecific protease that can be used to 

cleave purified fusion proteins that have 

been engineered to contain a TEV 

protease cleavage site. This is typically 

done to enable stable expression and 

purification of a protein of interest. The 

technology consists of (a) the DNA 

construct (created by Dom Esposito) to 

allow expression of the protein in insect 

cells, (b) the insect cell line, and (c) the 

purification protocol. TEV protease 

itself is expressed as a fusion to MBP 

(Maltose Binding Protein) to enhance 

solubility. 

Advantages: TEV protease expressed 

and produced in E. coli contains 

substantial amounts of endotoxin, 

which presents a barrier to use where 

the final purified product is required to 

be endotoxin-free. It is important to note 

that all proteins which are used for 

therapeutic purposes must have little or 

no endotoxin for safety reasons. The 

method of obtaining an endotoxin-free 

TEV protease is to express and purify 

TEV protease using a baculovirus/insect 

cell expression system, instead of E. coli 

which results in an endotoxin-free TEV 

protease. 

Development Status: Early stage 

development. 

Inventors: William K. Gillette, 

Dominic Esposito, and Ralph Hopkins 

(SAIC/NCI). 

Relevant Publication: RB Kapust and 

DS Waugh. Controlled intracellular 

processing of fusion proteins by TEV 

protease. Protein Expr Purif. 2000 

Jul;19(2):312–318. 

Patent Status: HHS Reference No. E– 

139–2008/0—Research Material. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for nonexclusive licensing. 

Licensing Contact: Steve Standley, 

PhD; 301–435–4074; 

sstand@mail.nih.gov. 

Association of the ECHDCI/RNF146 

Gene Region on Human Chromosome 

6q With Breast Cancer Risk and 

Protection 

Description of Technology: The 

technology describes a genetic locus 

(ECHDC l/RNF146 gene region on 

human chromosome 6q) that may be 

predictive for risk of breast cancer in 

relatives of individuals diagnosed with 

breast cancer. Furthermore, the 

invention provides evidence that one or 

more polymorphism alleles in 

chromosome 6q22.33 indicates a lower 

risk or increased risk of developing 

breast cancer in individuals. 

Applications: 

• The invention has the potential of 

being developed into a predictive 

diagnostic test, for people at a risk of 

breast cancer, together with other risk 

factors for the disease, such as age, 

parity, and other genetic contributions 

especially for predicting risk of breast 

cancer in individuals free of BRCA1 and 

BRCA2 polymorphism. 

• The invention may help to develop 

pharmaceuticals through elucidation of 

the contributing biochemical, etiologic 

pathway. 

Advantages: This study was a clinical 

study in a cohort of individuals. Thus 

the relevance of the data is of 

considerable significance. 

Development Status: Validation of the 

correlation between the polymorphisms 

and risk of breast cancer is ongoing 

using different cohorts. 

Inventors: Bert Gold et al. (NCI). 

Patent Status: U.S. Provisional 

Application No. 61/023,936 filed 28 Jan 

2008 (HHS Ref. No. E–065–2008/0–US– 

01). 

Licensing Contact: Surekha Vathyam, 

PhD; 301–435–4076; 

vathyams@mail.nih.gov. 

Novel Chemoattractant-Based Toxins to 

Improve Vaccine Immune Responses 

for Cancer and Infectious Diseases 

Description of Technology: Cancer is 

one of the leading causes of death in the 

United States and it is estimated that 

there will be more than half a million 


ebenthall on PROD1PC60 with NOTICES
56850 Federal Register / Vol. 73, No. 190 / Tuesday, September 30, 2008 / Notices 

deaths caused by cancer in 2008. A 

major drawback of the current 

chemotherapy-based therapeutics is the 

cytotoxic side-effects associated with 

them. Thus there is a dire need to 

develop new therapeutic strategies with 

fewer side-effects. Immuno-therapy has 

taken a lead among the new therapeutic 

approaches. Enhancing the innate 

immune response of an individual has 

been a key approach for the treatment 

against different diseases such as cancer 

and infectious diseases. 

This technology involves the 

generation of novel chemoattractant 

toxins that deplete the T regulatory cells 

(Treg) or other immunosuppressive or 

hyperactivated cells locally. Treg 

controls activation of immune responses 

by suppressing the induction of 

adaptive immune responses, 

particularly T cell responses. 

Immunosuppressive cells such as tumor 

infiltrating macrophages or NKT and 

other cells down regulate antitumor 

immune responses. The chemoattractant 

toxins consist of a toxin moiety fused 

with a chemokine receptor ligand, 

chemokines and other chemoattractants 

that enables specific targeting and 

delivery to the Treg cells. This 

technology is advantageous over the 

more harmful antibodies and chemicals 

that are currently used for the systemic 

depletion of Treg cells. The current 

technology can be used therapeutically 

in a variety of ways. They can be used 

together with vaccines to increase 

efficacy of the vaccine for the treatment 

of cancer, and can be used to locally 

deplete Treg cells or other immuno 

suppressive cells to induce cytolytic cell 

responses at the tumor site or to 

eliminate chronic infectious diseases 

such as HIV and tuberculosis. 

Applications: 

• New chemoattractant based toxins 

targeted towards Treg cells. 

• New chemoattractant based toxins 

targeted towards immunosuppressive 

NKT, and macrophages. 

• New chemoattractant based toxins 

targeted towards local depletion of 

hyperactivated CD4 T cells to treat 

autoimmune diseases. 

• Chemoattractant based toxins 

depleting Treg cells or other 

immunosuppressive cells causing 

enhanced vaccine immune responses. 

• Novel immunotherapy by 

increasing vaccine efficacy against 

cancer and infectious diseases. 

Market: 

• 565,650 deaths from cancer related 

diseases estimated in 2008. 

• The technology platform involving 

novel chemo-attractant based toxins can 

be used to improve vaccine immune 

responses. The cancer vaccine market is 

expected to increase from $135 million 

in 2007 to more than $8 billion in 2012. 

• The technology platform has 

additional market in treating several 

other clinical problems such as 

autoimmune diseases. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development. 

Inventors: Arya Biragyn (NIA), Dolgor 

Bataar (NIA), et al. 

Related Publications: 

1. Copy of manuscript from this 

technology can be provided once 

accepted for publication. 

2. M Coscia, A Biragyn. Cancer 

immunotherapy with chemoattractant 

peptides. Semin Cancer Biol 2004 

Jun;14(3):209–218. 

3. R Schiavo et al. Chemokine 

receptor targeting efficiently directs 

antigens to MHC class I pathways and 

elicits antigen-specific CD8+ T-cell 

responses. Blood 2006 Jun 15;107 

(12):4597–4605. 

Patent Status: U.S. Patent Application 

filed 28 Mar 2008, claiming priority to 

30 Sep 2005 (HHS Reference No. 

E–027–2005/0–US–06). 

Licensing Status: Available for nonexclusive or exclusive licensing. 

Licensing Contact: Jennifer Wong; 

301–435–4633; wongje@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIA Laboratory of Immunology is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize 

novel chemoattractant-based toxins. 

Please contact John D. Hewes, Ph.D. at 

301–435–3121 or hewesj@mail.nih.gov 

for more information. 

Dated: September 18, 2008. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E8–22889 Filed 9–29–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; 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: National Cancer 

Institute Special Emphasis Panel; Review of 

Education and Career Development Award 

Applications. 

Date: October 24, 2008. 

Time: 10 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Sheraton Sand Key Resort, 1160 

Gulf Boulevard, Clearwater, FL 33767. 

Contact Person: Robert Bird, PhD, 

Scientific Review Officer, Resources and 

Training Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, 6116 Executive Boulevard, Room 

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7978, birdr@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Cancer 

Prevention Research Small Grant Program 

(R03). 

Date: October 30–31, 2008. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Renaissance M Street Hotel, Marriot, 

1143 New Hampshire Avenue NW., 

Washington, DC 20037. 

Contact Person: Irina Gordienko, PhD, 

Scientific Review Officer, Scientific Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

6116 Executive Blvd., Rm. 7073, Bethesda, 

MD 20892, 301–594–1566, 

gordienkoiv@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; 

Community Clinical Oncology Program 

(CCOP). 

Date: November 5, 2008. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott, 5151 Pooks Hill 

Road, Bethesda, MD 20814. 

Contact Person: Gerald G. Lovinger, PhD, 

Scientific Review Administrator, Special 

Review and Logistics Branch, Division of 

Extramural Activities, National Cancer 

Institute, 6116 Executive Blvd., Room 8101, 

Bethesda, MD 20892–8329, 301–496–7987, 

lovingeg@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 


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