49690 Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: August 15, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–19450 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 Mental Health; 

Notice of Workgroup Meeting; Notice 

Is Hereby Given of a Meeting of the 

Strategic Planning Implementation 

Workgroup (SPIWG) Organized by the 

Interagency Autism Coordinating 

Committee (IACC) 

The purpose of the workgroup 

meeting is to discuss future budgetary 

requirements for the IACC Strategic Plan 

for Autism Spectrum Disorder (ASD) 

Research. The workgroup findings will 

be forwarded to the IACC for 

consideration and discussion at the next 

committee meeting on November 21, 

2008. 

Audio of this workgroup meeting will 

be accessible to the public via a 

teleconference phone link, and there 

will be Web-based access to information 

displayed at the meeting via computer/ 

projector. Attendance at the meeting 

will be limited due to space available. 

Name of Committee: Interagency Autism 

Coordinating Committee (IACC). 

Type of Meeting: Strategic Planning 

Implementation Working Group. 

Date: September 10, 2008. 

Time: 11 a.m. to 3 p.m. EDT. 

Agenda: To discuss future budgetary 

requirements for the IACC Strategic Plan for 

Autism Spectrum Disorder (ASD) Research. 

Place: National Institutes of Health, 

Building 1, Wilson Hall, Bethesda, MD 

20892. 

Access Information: Conference Call and 

Webinar, Webinar Registration and Access 

Information: https://www1.gotomeeting.com/ 

register/550445924. To Access the 

Conference Call: Dial: Number: 888–455–

2920. Access Code: 3857872. 

Contact Person: Azik Schwechter, Ph.D., 

Office of Autism Research Coordination, 

Office of the Director, National Institute of 

Mental Health, NIH, 6001 Executive 

Boulevard, NSC Room 8203a, Bethesda, MD 

20892–9669, 301–443–7163, 

IACCPublicInquiries@mail.nih.gov. 

Please Note: The workgroup meeting will 

be open to the public through a conference 

call phone number and a web presentation 

tool on the Internet. Individuals who 

participate using these electronic services 

and who need special assistance, such as 

captioning of the conference call or other 

reasonable accommodations, should submit a 

request at least 2 weeks prior to the meeting. 

Members of the public who participate 

using the conference call phone number will 

be able to listen to the meeting but will not 

be heard. There may be an opportunity for 

members of the public to submit written 

comments during the workgroup meeting 

through the web presentation tool. Submitted 

comments will be reviewed after the meeting. 

If you experience any technical problems 

with the web presentation tool, please 

contact GoToWebinar at (800) 263–6317. To 

access the web presentation tool on the 

Internet the following computer capabilities 

are required: 

A. Internet Explorer 5.0 or later, Netscape 

Navigator 6.0 or later or Mozilla Firefox 1.0 

or later; 

B. Windows 2000, XP Home, XP Pro, 

2003 Server or Vista; 

C. Stable 56k, cable modem, ISDN, DSL or 

better Internet connection; 

D. Minimum of Pentium 400 with 256 MB 

of RAM (Recommended); 

E. Java Virtual Machine enabled 

(Recommended). 

Information about the IACC is available on 

the Web site: http://www.nimh.nih.gov/ 

research-funding/scientific-meetings/

recurring-meetings/iacc/index.shtml. 

Dated: August 15, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–19455 Filed 8–21–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of an Exclusive 

License: Diagnostics Based on 

Immune Reactions to Brother of the 

Regulator of Imprinted Sites (BORIS) 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: This notice, in accordance 

with 35 U.S.C. 209(c)(1) and 37 CFR 

Part 404.7(a)(1)(i), announces that the 

Department of Health and Human 

Services is contemplating the grant of an 

exclusive license to practice the 

inventions embodied in PCT 

Application No. PCT/US2007/77281, 

entitled ‘‘BORIS Isoforms and Methods 

of Detecting and Treating Disease’’ filed 

August 30, 2007 (E–117–2006/0–PCT–

02); EP Application No. 05799643.1, 

entitled ‘‘Method of Detecting Cancer 

Based On Immune Reaction To BORIS’’

filed September 21, 2005 (E–241–2004/ 

0–EP–03); U.S. Application Serial No. 

11/575,732, entitled ‘‘Method of 

Detecting Cancer Based On Immune 

Reaction To BORIS’’ filed March 21, 

2007 (E–241–2004/0–US–04); U.S. 

Patent No. 7,375,206, entitled ‘‘Brother 

of The Regulator of Imprinted Sites 

(BORIS)’’ issued May 28, 2008 (E–227–

2001/0–US–03); and EP Patent 

Application No. 03743179.8, entitled 

‘‘Brother of The Regulator of Imprinted 

Sites (BORIS)’’ filed September 17, 2004 

(E–227–2001/0–EP–04) to Wellstat 

Diagnostics, Inc. 

The prospective exclusive territory 

may be worldwide, and the field of use 

may be limited to manufacture and sale 

of diagnostics for cancer and cancer 

predisposition. 

DATES: Only written comments and/or 

license applications which are received 

by the National Institutes of Health on 

or before October 21, 2008 will be 

considered. 

ADDRESSES: Requests for copies of the 

patent and/or patent applications, 

inquiries, comments and other materials 

relating to the contemplated exclusive 

license should be directed to: Mojdeh 

Bahar, J.D., Technology Licensing 

Specialist, Office of Technology 

Transfer, National Institutes of Health, 

6011 Executive Boulevard, Suite 325, 

Rockville, MD 20852–3804. Telephone: 

(301) 435–2950; Facsimile: (301) 402–

0220; E-mail: baharm@od.nih.gov. 

SUPPLEMENTARY INFORMATION: The 

above-mentioned patent applications 

describe the human protein Brother of 

Regulator of Imprinted Sites (‘‘BORIS’’), 

and a method of detecting cancer by 

monitoring BORIS expression or by 

detecting anti-BORIS antibodies. Dr. 

Victor V. Lobanenkov and colleagues at 

the National Institute of Allergy and 

Infectious Diseases discovered BORIS 

and its potential application as a cancer 

diagnostic. BORIS is a paralog of 

CCCTC-binding factor (‘‘CTCF’’), a 

transcription factor that also functions 

in chromatin insulation. The amino acid 

sequences of BORIS and CTCF contain 

eleven conserved zinc fingers each of 

which binds to DNA. BORIS protein can 

be detected in cancer cells, and 

importantly, it is one of a few cancertestis antigens that are immunogenic in 

humans. 

BORIS resides in 20q13.2, a region 

that is commonly amplified in many 

human cancers. Normally, BORIS 

mRNA can be detected in testis, but not 

in other human tissues. However, 

BORIS mRNA is detectable in over one 

hundred cancer cell lines representing 

most of the major forms of human 

tumors and is also detectable in primary 

breast cancer tumor samples, but not in 

controls. BORIS protein is misexpressed in cancer cell lines, and 

antibodies against BORIS have been 

detected in serum from patients with 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices 49691 

gliomas, lung, breast or prostate cancers 

but not in serum from controls. 

The correlation between cancer and 

BORIS expression indicates that 

detection of aberrantly expressed BORIS 

and/or anti-BORIS antibodies could 

serve as a method of screening or 

diagnosing cancer. In patients already 

known to have cancer, expression of 

BORIS could be monitored to measure 

a patient’s response to a particular 

therapeutic regimen. 

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 Part 404.7. The 

prospective exclusive license may be 

granted unless within sixty (60) days 

from the date of this published notice, 

the NIH receives written evidence and 

argument that establish that the grant of 

the license would not be consistent with 

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

37 CFR Part 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: August 14, 2008. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E8–19454 Filed 8–21–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: The Development of 

Inmunotoxins as Therapeutics for 

Focal Muscle Spasms 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: This is notice, in accordance 

with 35 U.S.C. 209(c)(l) and 37 CFR part 

404.7(a)(l)(i), that the National Institutes 

of Health, Department of Health and 

Human Services, is contemplating the 

grant of an exclusive patent license to 

practice the invention embodied in 

issued U.S. Patent 6,780,413 entitled 

‘‘Immunotoxin (MAB–Ricin) for the 

Treatment of Focal Movement 

Disorders’’ [HHS Ref. E–132–1996/0–

US–04] to Aphrodite Therapeutics, Inc., 

which has offices in Vancouver, Canada. 

This patent has been assigned to the 

Government of the United States of 

America. There are no foreign patents or 

patent applications associated with this 

technology. There are no other U.S. 

Patents or Patent Applications 

associated with this technology. 

The prospective exclusive license 

territory may be worldwide, and the 

field of use maybe limited to the 

development and sale of antibody 

conjugated toxins targeting the nicotinic 

acetylcholine receptors for therapeutic 

treatment of focal muscle spasms, as 

claimed in the Licensed Patent Rights. 

DATES: Only written comments and/or 

applications for a license which are 

received by the NIH Office of 

Technology Transfer on or before 

October 21, 2008 will be considered. 

ADDRESSES: Requests for copy of the 

patent, inquiries, comments, and other 

materials relating to the contemplated 

exclusive license should be directed to: 

Betty B. Tong, PhD, Technology 

Licensing Specialist, Office of 

Technology Transfer, National Institutes 

of Health, 6011 Executive Boulevard, 

Suite 325, Rockville, MD 20852–3804; 

Telephone: (301) 594–6565; Facsimile: 

(301) 402–0220; E-mail: 

tongb@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: The 

invention describes immunotoxins and 

methods of using the immunotoxins for 

the treatment of focal muscle spasms. A 

specific immunotoxin covered by this 

technology is MAB–Ricin. The 

immunotoxins are targeted via an 

antibody that is specific to acetylcholine 

receptors present in large numbers on 

the muscle side of the neuromuscular 

junction, allowing the specific 

destruction of muscle cells. 

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 part 404.7. The 

prospective exclusive license may be 

granted unless within sixty (60) 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 part 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: August 14, 2008. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E8–19463 Filed 8–21–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 concerning 

opportunity for public comment on 

proposed collections of information, the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

will publish periodic summaries of 

proposed projects. To request more 

information on the proposed projects or 

to obtain a copy of the information 

collection plans, call the SAMHSA 

Reports Clearance Officer on (240) 276–

1243. 

Comments are invited on: (a) Whether 

the proposed collections of information 

are necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Proposed Project: Strategic Prevention 

Framework State Incentive Grant (SPF 

SIG) Program (OMB No. 0930–0279) 

Revision 

SAMHSA’s Center for Substance 

Abuse Prevention (CSAP) is responsible 

for the evaluation instruments of the 

Strategic Prevention Framework State 

Incentive Grant (SPF SIG) Program. The 

program is a major national initiative 

designed to: (1) Prevent the onset and 

reduce the progression of substance 

abuse, including childhood and 

underage drinking; (2) reduce substance 

abuse related problems in communities; 

and, (3) build prevention capacity and 

infrastructure at the State/territory/Tribe 

and community levels. 

Five steps comprise the SPF: 


jlentini on PROD1PC65 with NOTICES