49686 Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices 

TABLE A—ANNUALIZED BURDEN ESTIMATES FOR CHIS 2009—Continued 

Type of respondent Form type Number of 

respondents 

Frequency 

of response 

Average 

time per 

response 

(hours) 

Annual hour 

burden 

Adolescents .............................................. Adolescent Pilot ........................................ 8 1 2/60 .27 

Adolescent Survey ................................... 2,000.00 1 2/60 66.67 

Total ................................................... ................................................................... 26,083 .................... .................... 3,276.94 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the 

proposed performance of the function of 

the agency, including whether the 

information will have practical utility; 

(2) 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) Ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

Ways to 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 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Nancy Breen, 

Ph.D., Project Officer, National Cancer 

Institute, EPN 4005, 6130 Executive 

Boulevard MSC 7344, Bethesda, 

Maryland 20852–7344, or call non-toll 

free number 301–496–8500 or email 

your request, including your address to: 

breenn@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of this 

publication. 

Dated: August 13, 2008. 

Vivian Horovitch-Kelley, 

NCI Project Clearance Liaison Office, 

National Institutes of Health. 

[FR Doc. E8–19453 Filed 8–21–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Licensing and/or Cooperative 

Research and Development Agreement 

(CRADA) Opportunities—Enhanced Tcell Activation by Costimulation: A 

Potentially Novel Approach for the 

Prevention and/or Therapy of Cancer 

(Excluding Prostate Diseases and 

Melanoma) and for Infectious Diseases 

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. Cooperative Research and 

Development Agreement (CRADA) 

opportunities are also available. 

FOR FURTHER INFORMATION CONTACT: 

Licensing information and copies of the 

U.S. patent applications listed below 

may be obtained by contacting Mojdeh 

Bahar, J.D., Office of Technology 

Transfer, National Institutes of Health, 

6011 Executive Boulevard, Suite 325, 

Rockville MD 20852; telephone: 301/ 

435–2950; e-mail: 

baharm@mail.nih.gov. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. If interested in a 

Cooperative Research and Development 

Agreement (CRADA) Opportunity, 

please submit a statement of interest 

and capability to Kevin Brand, J.D., in 

the NCI Technology Transfer Center, 

6120 Executive Boulevard, Suite 450, 

Rockville MD 20852; telephone: 301/ 

451–4566; e-mail: kb229t@nih.gov. 

SUPPLEMENTARY INFORMATION: 

Description of Technology 

Cancer immunotherapy is a recent 

approach where tumor associated 

antigens (TAAs), which are primarily 

expressed in human tumor cells and not 

expressed or minimally expressed in 

normal tissues, are employed to 

generate a tumor specific immune 

response. Specifically, these antigens 

serve as targets for the host immune 

system and elicit responses that results 

in tumor destruction. The initiation of 

an effective T-cell immune response to 

antigens requires two signals. The first 

one is antigen specific via the peptide/ 

major histocompatibility complex and 

the second or ‘‘costimulatory’’ signal is 

required for cytokine production, 

proliferation, and other aspects of T-cell 

activation. 

The present technology describes 

recombinant poxvirus vectors encoding 

at least three or more costimulatory 

molecules and tumor associated 

antigens (TAAs). The use of three 

costimulatory molecules such as B7.1, 

ICAM–1 and LFA–3 (TRICOM) has 

been shown to act in synergy with 

several tumor antigens and antigen 

epitopes to activate T cells. The effects 

with TRICOM were significantly 

greater than with one or two 

costimulatory molecules. Laboratory 

results support the greater effect of 

TRICOM to activate both CD4∂ and 

CD8∂ T cells. The invention also 

describes the use of at least one target 

antigen or immunological epitope as an 

immunogen or vaccine in conjunction 

with TRICOM. The antigens include 

but are not limited to carcinoembryonic 

antigen (CEA) and MUC–1. The 

combination of CEA, MUC–1, and 

TRICOM is referred to as PANVAC. 

Availability 

The technology is available for 

exclusive and non-exclusive license in 

combinations and fields of use. Some 

potential licensing opportunities 

involving recombinant poxviral vectors 

containing transgenes are as follows: 

(1) TRICOM (alone or with a 

transgene for a tumor antigen and/or an 

immunostimulatory molecule); 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices 49687 

(2) The antigens only, including but 

not limited to CEA and MUC–1; 

PANVAC; and 

(3) Recombinant fowlpox–GM–CSF. 

Applications and Modality 

Vector-based TRICOM (alone or with 

a transgene(s) for a tumor antigen and/ 

or an immunostimulatory molecule(s)), 

PANVAC and combinations thereof 

can be a potential novel approach for 

the prevention or treatment of cancer 

(with the exclusion of prostate cancer, 

prostatic diseases, and melanoma) and 

infectious diseases. 

Advantages 

• The technology is beyond proof-ofconcept, supported by laboratory results 

and publications. 

• Phase I and Phase II clinical data 

available (to qualified licensees). 

• Fewer validation studies are 

required compared to other 

immunotherapy related technologies. 

Development Status 

Phase I and Phase II results available 

(to qualified licensees) for poxvirus 

recombinants containing transgenes for 

TRICOM, CEA–TRICOM, and 

PANVAC. Further clinical studies are 

ongoing. 

Inventors 

Jeffrey Schlom (NCI) et al. (Inventor 

Web page: http://ccr.cancer.gov/Staff/ 

staff.asp?profileid=5444). 

Publications 

1. Kudo-Saito C, Wansley EK, Gruys 

ME, Wiltrout R, Schlom J and Hodge 

JW. Combination therapy of an 

orthotopic renal cell carcinoma model 

employing intratumoral vector-mediated 

costimulation and systemic IL–2. Clin 

Cancer Res. 13:1936–1946, 2007. 

2. Chakraborty M, Schlom J, and 

Hodge JW. The combined activation of 

positive costimulatory signals with 

modulation of a negative costimulatory 

signal for the enhancement of vaccine 

mediated T-cell responses. Cancer 

Immunol Immunother. 56:1471–1484, 

2007. 

3. Kudo-Saito C, Garnett CT, Wansley 

EK, Schlom J, and Hodge JW. 

Intratumoral delivery of vector mediated 

IL–2 in combination with vaccine 

results in enhanced T-cell avidity and 

anti-tumor activity. Cancer Immunol 

Immunother. 56:1897–1910, 2007. 

4. Garnett CT, Schlom J, and Hodge 

JW. Combination of docetaxel and 

recombinant vaccine enhances T-cell 

responses and antitumor activity: Effects 

of docetaxel on immune enhancement. 

Clin Cancer Res. (in press). 

5. Chakraborty M, Gelbard A, 

Carrasquillo JA, Yu S, Mamede M, Park 

CH, Camphuasen K, Schlom J, and 

Hodge JW. Use of radiolabeled 

monoclonal antibody to enhance 

vaccine-mediated antitumor effects. 

Cancer Immunol Immunother. 56:1471–

1484, 2007. 

6. Litzinger MT, Fernando R, Curiel 

TJ, Grosenbach DW, Schlom J, and 

Palena C. The IL–2 immunotoxin 

denileukin diftitox reduces regulatory 

T-cells and enhances vaccine-mediated 

T-cell immunity. Blood 110:3192–3201, 

2007. 

7. Gelbard A, Garnett CT, Abrams SI, 

Patel V, Gutkind JS, Palena C, Tsang KY, 

Schlom J, and Hodge JW. Combination 

chemotherapy and radiation of human 

squamous cell carcinoma of the head 

and neck augments CTL-mediated lysis. 

Clin Cancer Res. 12:1897–1905, 2006. 

8. Kaufman HL, Cohen S, Cheung K, 

DeRaffele, Mitcham J, Moroziewicz D, 

Schlom J, and Hesdorffer C. Local 

delivery of vaccinia virus expressing 

multiple costimulatory molecules for 

the treatment of established tumors. 

Human Gene Ther. 17:239–244, 2006. 

9. Marshall J, Gulley JL, Arlen PM, 

Beetham PK, Tsang KY, Slack R, Hodge 

JW, Doren S, Grosenbach DW, Hwang J, 

Fox E, Odogwa L, Park S, Panicali D, 

Schlom J. A phase I study of sequential 

vaccinations with fowlpox-CEA(6D)- 

TRICOM (B7–1/ICAM–1/LFA–3) alone 

and sequentially with vacciniaCEA(6D)-TRICOM, with and without 

GM-CSF, in patients with CEAexpressing carcinomas. J Clin Oncol. 

23:720–731, 2005. 

10. Palena C, Foon KA, Panicali D, 

Yafal AG, Chinsangaram J, Hodge JW, 

Schlom J, and Tsang KY. A potential 

approach to immunotherapy of chronic 

lymphocytic leukemia (CLL): enhanced 

immunogenicity of CLL cells via 

infection with vectors encoding for 

multiple costimulatory molecules. 

Blood 106:3515–3523, 2005. 

11. Yang S, Hodge JW, Grosenbach 

DW, and Schlom J. Vaccines with 

enhanced costimulation maintain high 

avidity memory CTL. J. Immunol. 

175:3715–3723, 2005. 

12. Yang S, Tsang KY, and Schlom J. 

Induction of higher avidity human CTL 

by vector-mediated enhanced 

costimulation of antigen-presenting 

cells. Clin Cancer Res. 11:5603–5615, 

2005. 

13. Hodge JW, Chakraborty M, KudoSaito C, Garnett CT, Schlom J. Multiple 

costimulatory modalities enhance CTL 

avidity. J Immunol 174:5994–6004, 

2005. 

14. Tsang K-Y, Palena C, Yokokawa J, 

Arlen PM, Gulley JL, Mazzara GP, Gritz 

L, Go ́mez Yafal A, Ogueta S, Greenhalgh 

P, Manson K, Panicali D, and Schlom J. 

Analyses of recombinant vaccinia and 

fowlpox vaccine vectors expressing 

transgenes for two human tumor 

antigens and three human costimulatory 

molecules. Clin Cancer Res. 11:1597–

1607, 2005. 

15. Chakraborty M, Abrams SI, 

Coleman CN, Camphausen K, Schlom J, 

Hodge JW. External beam radiation of 

tumors alters phenotype of tumor cells 

to render them susceptible to vaccinemediated T-cell killing. Cancer Res. 

64:4328–4337, 2004. 

16. Zeytin HE, Patel AC, Rogers CJ, et 

al. Combination of a poxvirus-based 

vaccine with a cyclooxygenase-2 

inhibitor (celecoxib) elicits antitumor 

immunity and long-term survival in 

CEA.Tg/MIN mice. Cancer Res. 

64:3668–3678, 2004. 

17. Palena C, Zhu M-Z, Schlom J, and 

Tsang K-Y. Human B cells that 

hyperexpress a triad of costimulatory 

molecules via avipoxvector infection: 

An alternative source of efficient 

antigen-presenting cells. Blood 104:192–

199, 2004. 

18. Kudo-Saito C, Schlom J, and 

Hodge JW. Intratumoral vaccination and 

diversified subcutaneous/intratumoral 

vaccination with recombinant 

poxviruses encoding a tumor antigen 

and multiple costimulatory molecules. 

Clin Cancer Res. 10:1090–1099, 2004. 

19. Hodge JW, Poole DJ, Aarts WM, 

Go ́mez Yafal A, Gritz L, and Schlom J. 

Modified vaccinia virus ankara 

recombinants are as potent as vaccinia 

recombinants in diversified prime and 

boost vaccine regimens to elicit 

therapeutic antitumor responses. Cancer 

Res. 63:7942–7949, 2003. 

20. Hodge JW, Grosenbach DW, Aarts 

WM, Poole DJ, and Schlom J. Vaccine 

therapy of established tumors in the 

absence of autoimmunity. Clin Cancer 

Res. 9:1837–1849, 2003. 

21. Aarts WM, Schlom J, and Hodge 

JW. Vector-based vaccine/cytokine 

combination therapy to enhance 

induction of immune responses to a 

self-antigen and anti-tumor activity. 

Cancer Res. 62:5770–5777, 2002. 

22. Hodge JW, Sabzevari H, Yafal AG, 

Gritz L, Lorenz MG, Schlom J. A triad 

of costimulatory molecules synergize to 

amplify T-cell activation. Cancer Res. 

59: 5800–5807, 1999. 

Patent Status 

1. U.S. Patent No. 6,969,609 issued 

November 29, 2005 as well as issued 

and pending foreign counterparts [HHS 

Ref. No. E–256–1998/0]; 

2. U.S. Patent Application No. 11/ 

321,868 filed December 30, 2005 [HHS 

Ref. No. E–256–1998/1]; and 

3. U.S. Patent No. 6,756,038 issued 

June 29, 2004 as well as issued and 


jlentini on PROD1PC65 with NOTICES
49688 Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices 

pending foreign counterparts [HHS Ref. 

No. E–099–1996/0]; 

4. U.S. Patent No. 6,001,349 issued 

December 14, 1999 as well as issued and 

pending foreign counterparts [HHS Ref. 

No E–200–1990/3–US–01]; 

5. U.S. Patent No.6,165,460 issued 

December 26, 2000; as well as issued 

and pending foreign counterparts [HHS 

Ref. No E–200–1990/4–US–01]; 

6. U.S. Patent No. 7,118,738 issued 

October 10, 2006 as well as issued and 

pending foreign counterparts [HHS Ref. 

No E–154–1998/0–US–07]; 

7. PCT Application No. PCT/US97/ 

12203 filed July 15, 1997 [HHS Ref. No 

E–259–1994/3–PCT–02]; 

8. U.S. Patent Application Nos. 10/ 

197,127. and 08/686,280 filed July 17, 

2002 and July 25, 1996 [HHS Ref. No E–

259–1994/3–US–08 and /4–US–01]; 

9. U.S. Patent No. 6,946,133 issued 

September 20, 2005 as well as issued 

and pending foreign counterparts [HHS 

Ref. No E–062–1996/0–US–01]; 

10. U.S. Patent Application No. 11/ 

606,929 filed December 1, 2006 [E–062–

1996/0–US–11]; 

11. U.S. Patent Nos. 6,893,869, 

6,548,068 and 6,045,802 issued May 17, 

2005, April 15, 2003 and April 4, 2000 

respectively, as well as issued and 

pending foreign counterparts [HHS Ref. 

Nos. E–260–1994/1–US–03, US–02, US–

01]; and 

12. U.S. Patent. Application No. 11/ 

090,686 filed March 8, 2005 [HHS Ref. 

No E–260–1994/1–US–04]. 

Cooperative Research and Development 

Agreement (CRADA) Opportunities 

A CRADA partner for the further codevelopment of this technology is 

currently being sought by the Laboratory 

of Tumor Immunology and Biology, 

Center for Cancer Research, NCI. The 

CRADA partner will (a) generate and 

characterize recombinant poxviruses 

expressing specific tumor-associated 

antigens, cytokines, and/or T-cell 

costimulatory factors, (b) analyze the 

recombinant poxviruses containing 

these genes with respect to appropriate 

expression of the encoded gene 

product(s), (c) supply adequate amounts 

of recombinant virus stocks for 

preclinical testing, (d) manufacture and 

test selected recombinant viruses for use 

in human clinical trials (with the 

exception of trials for prostatic diseases 

and melanoma), (e) submit Drug Master 

Files detailing the development, 

manufacture, and testing of live 

recombinant vaccines to support the 

NCI-sponsored IND and/or companysponsored IND, (f) supply adequate 

amounts of clinical grade recombinant 

poxvirus vaccines for clinical trials 

conducted at the NCI Center for Cancer 

Research (CCR), and (g) provide 

adequate amounts of vaccines for 

extramural clinical trials, if agreed upon 

by the parties, and conduct clinical 

trials under company-sponsored or NCIsponsored INDs. NCI will (a) provide 

genes of tumor-associated antigens, 

cytokines and other immunostimulatory 

molecules for incorporation into 

poxvirus vectors, (b) evaluate 

recombinant vectors in preclinical 

models alone and in combination 

therapies, and (c) conduct clinical trials 

(with the exception of trials for prostatic 

diseases and melanoma) of recombinant 

vaccines alone and in combination 

therapies. 

Dated: August 14, 2008 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E8–19462 Filed 8–21–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

is hereby given of a meeting of the 

National Advisory Neurological 

Disorders and Stroke Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting 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 Advisory 

Neurological Disorders and Stroke Council; 

Clinical Trials Subcommittee. 

Date: September 18, 2008. 

Closed: 8 a.m. to 9 a.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, C Wing, 

Conference Room 10, Bethesda, MD 20892. 

Open: 9 a.m. to 10 a.m. 

Agenda: To discuss clinical trials policy. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, C Wing, 

Conference Room 10, Bethesda, MD 20892. 

Contact Person: Deborah G Hirtz, MD, 

Acting Director, Clinical Trials Cluster, 

National Institute of Neurological, Disorders 

and Stroke, National Institute of Health, 6001 

Executive Blvd., Suite 2212, Bethesda, MD 

20892, (301) 496–5821, hirtz@ninds.nih.gov. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: 

www.ninds.nih.gov, where an agenda and 

any additional information for the meeting 

will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to NeurologicalDisorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: August 15, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–19442 Filed 8–21–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of 

Meetings 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

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

is hereby given of meetings of the 

National Advisory Neurological 

Disorders and Stroke Council. 

The meetings will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: National Advisory 

Neurological Disorders and Stroke Council, 

Training, Career Development, and Special 

Programs Subcommittees. 

Date: September 17, 2008. 

Time: 8 p.m. to 10 p.m. 


jlentini on PROD1PC65 with NOTICES