Federal Register / Vol. 77, No. 199 / Monday, October 15, 2012 / Notices 62521 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: The Development of 

Therapeutic Agents for the Treatment 

of Metastatic Breast Cancer and T-cell 

Lymphoma 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: This is notice, in accordance 

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

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

Institutes of Health, Department of 

Health and Human Services, is 

contemplating the grant to Birich 

Technologies, Inc., of an exclusive 

evaluation option license to practice the 

inventions embodied in the following 

U.S. Patent Applications (and all 

continuing applications and foreign 

counterparts): Serial No. 61/045,088 

entitled, ‘‘COMPOSITIONS AND 

METHODS FOR DELIVERING 

INHIBITORY OLIGONUCLEOTIDES’’ 

[HHS Ref. E–051–2008/0–US–01]; Serial 

No. 61/333,512 entitled, ‘‘Peptide 

Inhibitors of Interferon Gamma and 

Interleukin 10 Signaling’’ [HHS Ref. E– 

167–2010/0–US–01]; and Serial No. 60/ 

987,340 entitled, ‘‘Diagnostic and 

Therapeutic Applications of a p53 

Isoform in Regenerative Medicine, 

Aging and Cancer’’ [HHS Ref. E–033– 

2008/0–US–01]. The patent rights in 

these inventions have been assigned or 

exclusively licensed to the Government 

of the United States of America. 

The prospective exclusive evaluation 

option license territory may be 

worldwide, and the field of use may be 

limited to: 

The use in humans of the peptide-based 

antisense delivery technology (ChemoArp) in 

conjunction with either (i) a peptide-based 

interleukin-10 (IL–10) inhibitor as a dualbiologic therapy to treat metastatic breast 

cancer, or ii) incorporating a p53 isoform 

antisense oligonucleotide as a single biologic 

therapy to treat T-cell lymphoma. 

Upon the expiration or termination of 

the exclusive evaluation option license, 

Birich Technologies, Inc. will have the 

exclusive right to execute an exclusive 

commercialization license which will 

supersede and replace the exclusive 

evaluation option license with no 

greater field of use and territory than 

granted in the exclusive evaluation 

option license. 

DATES: Only written comments or 

applications for a license (or both) 

which are received by the NIH Office of 

Technology Transfer on or before 

October 30, 2012 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, comments, 

and other materials relating to the 

contemplated exclusive evaluation 

option license should be directed to: 

Patrick McCue, Ph.D., Licensing and 

Patenting Manager, Office of 

Technology Transfer, National Institutes 

of Health, 6011 Executive Boulevard, 

Suite 325, Rockville, MD 20852–3804; 

Telephone: (301) 435–5560; Facsimile: 

(301) 402–0220; Email: 

mccuepat@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: These 

inventions concern i) compositions and 

methods for targeted delivery of 

inhibitory nucleic acids to cells using a 

cell surface receptor ligand targeting 

domain and an inhibitory 

oligonucleotide-binding domain to 

efficiently deliver the antisense nucleic 

acid to cells that expresses the cell 

surface receptor that binds the ligand, ii) 

compositions that potently and 

selectively interfere with dimerization 

of interleukin-10 and binding of this 

protein to its receptor, and iii) 

compositions that inhibit delta133p53, a 

natural variant nucleic acid of tumor 

suppressor protein 53 (p53) that inhibits 

p53-dependent cell senescence. 

The prospective exclusive evaluation 

option license is being considered under 

the small business initiative launched 

on 1 October 2011, and will comply 

with the terms and conditions of 35 

U.S.C. 209 and 37 CFR Part 404.7. The 

prospective exclusive evaluation option 

license, and a subsequent exclusive 

commercialization license, may be 

granted unless 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 

within fifteen (15) days from the date of 

this published notice. 

Complete 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 

evaluation option 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: October 9, 2012. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

& Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2012–25170 Filed 10–12–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2012–0056] 

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 

Tuesday, October 16, 2012, at the 

United States Access Board, 1331 F 

Street NW., Suite 800, Washington, DC 

20004. The meeting will be open to the 

public. 

DATES: The NIAC will meet Tuesday, 

October 16, 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@hq.dhs.gov. 

ADDRESSES: United States Access Board, 

1331 F Street NW., Suite 800, 

Washington, DC 20004. 

For information on facilities or 

services for individuals with disabilities 

or to request special assistance at the 

meeting, contact the person listed under 

FOR FURTHER INFORMATION CONTACT, 

below as soon as possible. 

To facilitate public participation, we 

are inviting public comment on the 

issues to be considered by the Council 

as listed in the SUMMARY section below. 

Comments must be submitted in writing 

no later than October 11, 2012, and 

must be identified by ‘‘DHS–2012– 

0056’’ and may be submitted by any one 

of the following methods: 

• Federal eRulemaking Portal: 

www.regulations.gov. Follow the 

instructions for submitting written 

comments. 

• Email: NIAC@hq.dhs.gov. Include 

the docket number in the subject line of 

the message. 

• Fax: (703) 603–5098. 

• Mail: Nancy Wong, National 

Protection and Programs Directorate, 

Department of Homeland Security, 245 

Murray Lane SW., Mail Stop 0607, 

Arlington, VA 20598–0607. 

Instructions: All written submissions 

received must include the words 

‘‘Department of Homeland Security’’ 

and the docket number for this action. 

Written comments received will be 

posted without alteration at 

www.regulations.gov, including any 

personal information provided. 


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62522 Federal Register / Vol. 77, No. 199 / Monday, October 15, 2012 / Notices 

Docket: For access to the docket to 

read background documents or 

comments received by the NIAC, go to 

www.regulations.gov. 

Members of the public will have an 

opportunity to provide oral comments 

after the presentation of the report from 

the Regional Resilience Working Group. 

We request that comments be limited to 

the issues listed in the meeting agenda 

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 received by 

Nancy Wong after October 11, 2012, will 

still be accepted and reviewed by the 

members, but not necessarily by the 

time of the meeting. In-person 

presentations will be limited to 3 

minutes per speaker, with no more than 

30 minutes for all speakers. Parties 

interested in making in-person 

comments should register no later than 

15 minutes prior to the beginning of the 

meeting at the meeting location. 

FOR FURTHER INFORMATION CONTACT: 

Nancy Wong, National Infrastructure 

Advisory Council Designated Federal 

Officer, Department of Homeland 

Security, telephone (703) 235–2888. 

SUPPLEMENTARY INFORMATION: Notice of 

this meeting is given under the Federal 

Advisory Committee Act, 5 U.S.C. App. 

(Pub. L. 92–463). The NIAC shall 

provide the President through the 

Secretary of Homeland Security with 

advice on the security of the critical 

infrastructure sectors and their 

information systems. 

The NIAC will meet to discuss issues 

relevant to the protection of critical 

infrastructure as directed by the 

President. At this meeting, the Council 

will receive and discuss a presentation 

from the NIAC Regional Resilience 

Working Group documenting their work 

to date on the Regional Resilience 

Study, which includes the role and 

impact of critical infrastructure on 

regional resiliency, best regional 

practices and models, and the 

contribution of public private 

partnerships. The presentation will be 

posted no later than one week prior to 

the meeting on the Council’s public 

Web page on www.dhs.gov/NIAC. The 

Council will review and discuss the 

findings of the Working Group. Federal 

officials will provide further direction to 

the Council on the scope of the Working 

Group’s study. 

The Federal Advisory Committee Act 

requires that notices of meetings of 

advisory committees be announced in 

the Federal Register 15 days prior to the 

meeting date. 

This notice of the NIAC meeting is 

published in the Federal Register with 

less than 15 days notice due to the 

complexity of the issues within the 

current study. Due to the complexities, 

the NIAC Working Group was not able 

to complete the interim finding of the 

report within this aggressive time line. 

Waiting for the full 15 day notice period 

to conduct the meeting will delay the 

discussion of the report. In order to not 

delay the continuation of this important 

study, this meeting is being announced 

with less than 15 days notice. 

Meeting Agenda 

I. Opening of Meeting 

II. Roll Call of Members 

III. Opening Remarks and Introductions 

IV. Approval of July 17, 2012, minutes 

V. NIAC Presentation on Regional 

Resilience Working Group 

VI. Public Comment: Discussion 

Limited to Meeting Agenda Items 

and Previous NIAC Studies 

VII. Closing Remarks 

Information on Services for Individuals 

With Disabilities 

For information on facilities or 

services for individuals with disabilities 

or to request special assistance at the 

meeting, contact the NIAC Secretariat at 

(703) 235–2888 as soon as possible. 

Dated: October 3, 2012. 

Nancy Wong, 

Designated Federal Officer for the NIAC. 

[FR Doc. 2012–25176 Filed 10–12–12; 8:45 am] 

BILLING CODE 9110–9P–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

[FWS–R4–ES–2012–N236; 

FXES11130400000EA–123–FF04EF1000] 

Endangered and Threatened Wildlife 

and Plants; Receipt of Application for 

Incidental Take Permit; Availability of 

Proposed Low-Effect Habitat 

Conservation Plan; Primax Properties, 

LLC, Lake County, FL 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Notice of availability; request 

for comment/information. 

SUMMARY: We, the Fish and Wildlife 

Service (Service), have received an 

application from Primax Properties, LLC 

(applicant), for an incidental take permit 

(ITP). The applicant requests a 5-year 

ITP under the Endangered Species Act 

of 1973, as amended (Act). We request 

public comment on the permit 

application (#TE83714A–0) and 

accompanying proposed habitat 

conservation plan (HCP), as well as on 

our preliminary determination that the 

plan qualifies as low-effect under the 

National Environmental Policy Act 

(NEPA). To make this determination, we 

used our environmental action 

statement and low-effect screening form, 

which are also available for review. 

DATES: To ensure consideration, please 

send your written comments by 

November 14, 2012. 

ADDRESSES: If you wish to review the 

application and HCP, you may request 

documents by email, U.S. mail, or 

phone (see below). These documents are 

also available for public inspection by 

appointment during normal business 

hours at the office below. Send your 

comments or requests by any one of the 

following methods. 

Email: northflorida@fws.gov. Use 

‘‘Attn: Permit number TE83714A–0’’ as 

your message subject line. 

Fax: David L. Hankla, Field 

Supervisor, (904) 731–3045, Attn.: 

Permit number TE83714A–0. 

U.S. mail: David L. Hankla, Field 

Supervisor, Jacksonville Ecological 

Services Field Office, Attn: Permit 

number TE83714A–0, U.S. Fish and 

Wildlife Service, 7915 Baymeadows 

Way, Suite 200, Jacksonville, FL 32256. 

In-person drop-off: You may drop off 

information during regular business 

hours at the above office address. 

FOR FURTHER INFORMATION CONTACT: Erin 

M. Gawera, telephone: (904) 731–3121; 

email: erin_gawera@fws.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

Section 9 of the Act (16 U.S.C. 1531 

et seq.) and our implementing Federal 

regulations in the Code of Federal 

Regulations (CFR) at 50 CFR part 17 

prohibit the ‘‘take’’ of fish or wildlife 

species listed as endangered or 

threatened. Take of listed fish or 

wildlife is defined under the Act as ‘‘to 

harass, harm, pursue, hunt, shoot, 

wound, kill, trap, capture, or collect, or 

to attempt to engage in any such 

conduct’’ (16 U.S.C. 1532). However, 

under limited circumstances, we issue 

permits to authorize incidental take— 

i.e., take that is incidental to, and not 

the purpose of, the carrying out of an 

otherwise lawful activity. 

Regulations governing incidental take 

permits for threatened and endangered 

species are at 50 CFR 17.32 and 17.22, 

respectively. The Act’s take prohibitions 

do not apply to federally listed plants 

on private lands unless such take would 

violate State law. In addition to meeting 

other criteria, an incidental take 

permit’s proposed actions must not 


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