Federal Register / Vol. 75, No. 62 / Thursday, April 1, 2010 / Notices 16491 

foreign counterparts [HHS Ref. No. E– 

135–2007/0]; 

5. U.S. Patent Application No. 07/ 

205,189 filed June 10, 1988, as well as 

all continuation and divisional 

applications, and issued and pending 

foreign counterparts [HHS Ref No. E– 

136–2007]; 

6. U.S. Patent Application No. 60/ 

625,321 filed November 5, 2004, as well 

as all continuation and divisional 

applications, and issued and pending 

foreign counterparts [HHS Ref. No. E– 

138–2007]; and 

7. U.S. Patent Application No. 07/ 

340,052 filed April 18, 1989, as well as 

all continuation and divisional 

applications, and issued and pending 

foreign counterparts [HHS Ref. No. E– 

147–2007]. 

The patent rights in these inventions 

have been assigned to the United States 

of America. 

The prospective exclusive license 

territory may be worldwide and the 

field of use may be use of Licensed 

Patent Rights for development of 

therapeutics for human cancers. The 

field of use will specifically exclude 

prostate cancer, melanoma and 

colorectal cancer. For the avoidance of 

doubt, delivery formulations shall 

specifically exclude canary poxvirus 

vectors, NYVAC, non-viral eukaryotic 

expression vectors and recombinant 

yeast vectors in all geographic 

territories. 

DATES: Only written comments and/or 

applications for a license which are 

received by the NIH Office of 

Technology Transfer on or before May 3, 

2010 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, comments, 

and other materials relating to the 

contemplated exclusive license should 

be directed to: Sabarni K. Chatterjee, 

Ph.D. Licensing and Patenting 

Associate, Cancer Branch, Office of 

Technology Transfer, National Institutes 

of Health, 6011 Executive Boulevard, 

Suite 325, Rockville, MD 20852–3804; 

Telephone: (301) 435–5587; Facsimile: 

(301) 435–4013; E-mail: 

chatterjeesa@od.nih.gov. 

SUPPLEMENTARY INFORMATION: 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 patents and patent applications 

describe a vaccine technology, TRICOM, 

in conjunction with tumor associated 

antigens (TAAs). The TRICOM 

technology employs avirulent 

poxviruses to present a combination of 

costimulatory signaling molecules with 

tumor-associated antigens (TAAs) to 

activate T-cells and break the immune 

systems tolerance towards cancer cells. 

This is achieved using recombinant 

poxvirus DNA vectors that encode both 

T-cell costimulatory molecules and 

TAAs. The combination of the three (3) 

costimulatory molecules B7.1, ICAM–1 

and LFA–3, hence the name TRICOM, 

has been shown to have more than the 

additive effect of each costimulatory 

molecule when used individually to 

optimally activate both CD4+ and CD8+ 

T cells. When a TRICOM based vaccine 

expressing TAAs is administered it 

greatly enhances the immune response 

against the malignant cells expressing 

those TAAs. By changing the TAAs 

used for immunization with TRICOM 

vaccines, immune responses can be 

generated to diverse types of cancers. 

The versatility of the vector-based 

TRICOM based vaccine is that it allows, 

including several TAAs, to help 

maximize the effectiveness. Transgenes 

reflecting alterations of TAAs can also 

be inserted into TRICOM based vaccines 

to further enhance immunogenicity. The 

addition of the two well-known TAAs, 

carcinoembryonic antigen (CEA) and 

MUC–1 to the TRICOM vector results in 

the PANVAC vaccine, which is used in 

a prime and boost vaccine strategy. It is 

well established that the overexpression 

of these two (2) TAAs are associated 

with the presence of a variety of 

carcinomas; therefore PANVAC can 

potentially be effective against a range 

of tumor types. 

Additionally, new TAAs are being 

continually identified. One such 

example is the antigen Brachyury. 

Although Brachyury has been well 

known for its role in developmental cell 

biology, it has recently been implicated 

in tumor cell invasion and metastasis. 

Pre-clinical data indicates that 

Brachyury is aberrantly expressed on 

tumors of the lung, intestine, stomach, 

kidney, bladder, uterus, ovary, and 

testis, and in chronic lymphocytic 

leukemia. When used in combination 

with costimulatory molecules, it can 

effectively activate T-cells to kill tumors 

cells that originated from above 

mentioned tumors. Therefore, as one 

example, Brachyury combined with 

TRICOM also has potential as a cancer 

immunotherapy for the treatment of 

several tumors. 

The prospective exclusive license will 

be royalty bearing and will comply with 

the terms and conditions of 35 U.S.C. 

209 and 37 CFR 404.7. The prospective 

exclusive license may be granted unless 

within thirty (30) days from the date of 

this published notice, the NIH receives 

written evidence and argument that 

establishes that the grant of the license 

would not be consistent with the 

requirements of 35 U.S.C. 209 and 37 

CFR 404.7. 

Applications for a license in the field 

of use filed in response to this notice 

will be treated as objections to the grant 

of the contemplated exclusive license. 

Comments and objections submitted to 

this notice will not be made available 

for public inspection and, to the extent 

permitted by law, will not be released 

under the Freedom of Information Act, 

5 U.S.C. 552. 

Dated: March 26, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–7341 Filed 3–31–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2010–0026] 

Science and Technology Directorate; 

Submission for Review; Information 

Collection Request for the Department 

of Homeland Security Science and 

Technology Directorate First 

Responders Community of Practice 

AGENCY: Science and Technology 

Directorate, DHS. 

ACTION: 30-day Notice and request for 

comment. 

SUMMARY: The Department of Homeland 

Security (DHS) invites the general 

public to comment on a new data 

collection form for the Science and 

Technology Directorate (S&T) First 

Responders Community of Practice 

(FRCoP): User Registration Page (DHS 

Form 10059 (9/09)). The FRCoP webbased tool will be collecting profile 

information from first responders and 

select authorized non-first responder 

users to facilitate networking and 

formation of online communities. All 

users will be required to authenticate 

prior to entering the site. In addition, 

the tool will provide members the 

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16492 Federal Register / Vol. 75, No. 62 / Thursday, April 1, 2010 / Notices 

capability to create wikis, discussion 

threads, blogs, and documents allowing 

them to enter and upload content in 

accordance with the site’s Rules of 

Behavior. Members will also be able to 

participate in threaded discussions and 

comment on other members’ content. 

The S&T FRCoP program is responsible 

for providing a collaborative 

environment for the first responder 

community to share information, best 

practices, and lessons learned. Section 

313 of the Homeland Security Act of 

2002 (Pub. L. 107–296) established this 

requirement. This notice and request for 

comments is required by the Paperwork 

Reduction Act of 1995 (Pub. L. 104–13, 

44 U.S.C. chapter 35). 

DATES: Comments are encouraged and 

will be accepted until May 3, 2010. 

Comments: Interested persons are 

invited to submit written comments on 

the proposed information collection to 

the Office of Information and Regulatory 

Affairs, Office of Management and 

Budget. Comments should be addressed 

to Desk Officer for the Department of 

Homeland Security, Science and 

Technology Directorate, and sent via 

electronic mail to 

oira_submission@omb.eop.gov or faxed 

to (202) 395–6974. Please include 

docket number DHS–2010–0026 in the 

subject line of the message. 

FOR FURTHER INFORMATION CONTACT: 

Jeffery Harris (202) 254–6015. 

SUPPLEMENTARY INFORMATION: The User 

Registration Form will be available on 

the FRCoP Web site found at (https:// 

communities.firstresponder.gov). The 

user will complete the form online and 

submit it through the Web site. 

Overview of This Information 

Collection 

(1) Type of Information Collection: 

New information collection. 

(2) Title of the Form/Collection: First 

Responders Community of Practice: 

User Registration Form. 

Agency Form Number, if any, and the 

applicable component of the 

Department of Homeland Security 

sponsoring the collection: DHS Science 

and Technology Directorate, DHS Form 

10059 (09/09). 

(3) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Individuals; the data will be 

gathered from individual first 

responders who wish to participate in 

the FRCoP. 

(4) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 

a. Estimate of the total number of 

respondents: 5000. 

b. An estimate of the time for an 

average respondent to respond: 0.25 

burden hours. 

Dated: March 24, 2010. 

Tara O’Toole, 

Under Secretary for Science and Technology. 

[FR Doc. 2010–7275 Filed 3–31–10; 8:45 am] 

BILLING CODE 9110–9F–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Form G–28, and Form G–28I, 

Revision of an Existing Information 

Collection; Comment Request 

ACTION: 60-Day Notice of Information 

Collection under Review: Form G–28, 

Notice of Entry of Appearance as 

Attorney or Accredited Representative, 

and Form G–28I, Notice of Entry of 

Appearance of Foreign Attorney. OMB 

Control No. 1615–0105. 

The Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services (USCIS) has 

submitted the following information 

collection request for review and 

clearance in accordance with the 

Paperwork Reduction Act of 1995. The 

information collection is published to 

obtain comments from the public and 

affected agencies. Comments are 

encouraged and will be accepted for 

sixty days until June 1, 2010. 

Written comments and suggestions 

regarding items contained in this notice, 

and especially with regard to the 

estimated public burden and associated 

response time should be directed to the 

Department of Homeland Security 

(DHS), USCIS, Chief, Regulatory 

Products Division, Clearance Office, 111 

Massachusetts Avenue, NW., 

Washington, DC 20529–2210. 

Comments may also be submitted to 

DHS via facsimile to 202–272–8352, or 

via e-mail at rfs.regs@dhs.gov. When 

submitting comments by e-mail, please 

make sure to add the OMB Control 

Number 1615–0105 in the subject box. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information should address one or more 

of the following four points: 

(1) Evaluate whether the collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information will have practical utility; 

(2) Evaluate the accuracy of the 

agency’s estimate of the burden of the 

collection of information, including the 

validity of the methodology and 

assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques, or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Overview of this Information Collection 

(1) Type of Information Collection: 

Revision of an existing information 

collection. 

(2) Title of the Form/Collection: 

Notice of Entry of Appearance as 

Attorney or Accredited Representative, 

and Notice of Entry of Appearance of 

Foreign Attorney. 

(3) Agency form number, if any, and 

the applicable component of the 

Department of Homeland Security 

sponsoring the collection: Form G–28, 

and Form G–28I. U.S. Citizenship and 

Immigration Services (USCIS). 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Primary: Individuals or 

households. The data collected on 

Forms G–28 and G–28I are used by DHS 

to determine eligibility of the individual 

to appear as a representative. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 2,479,000 responses at 20 

minutes (.333) per response. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: 825,507 annual burden 

hours. 

If you need a copy of the information 

collection instrument, please visit the 

Web site at: http://www.regulations. 

gov/. We may also be contacted at: 

USCIS, Regulatory Products Division, 

111 Massachusetts Avenue, NW., 

Washington, DC 20529–2210, 

Telephone number 202–272–8377. 

Dated: March 26, 2010. 

Stephen Tarragon 

Deputy Chief, Regulatory Products Division, 

U.S. Citizenship and Immigration Services. 

[FR Doc. 2010–7265 Filed 3–31–10; 8:45 am] 

BILLING CODE 9111–97–P 

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