Federal Register / Vol. 71, No. 156 / Monday, August 14, 2006 / Notices 46495 

Environmental Health Hazards; 93.114, 

Applied Toxicological Research and Testing, 

National Institutes of Health, HHS) 

Dated: August 7, 2006. 

Anna Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 06–6877 Filed 8–11–06; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Statement of Organization, Functions, 

and Delegations of Authority 

Part N, National Institutes of Health, 

of the Statement of Organization, 

Functions, and Delegations of Authority 

for the Department of Health and 

Human Services (HHS) (40 FR 22859, 

May 27, 1975, as amended most recently 

at 70 FR 61146, October 20, 2005, and 

redesignated from Part HN as Part N at 

60 FR 56606, November 9, 1995), is 

amended as set forth below to reflect the 

reorganization of the NIH Ethics Office. 

Section N–B, Organization and 

Functions, is amended by replacing the 

current section NAT (formerly HNAT) 

with the following: 

NIH Ethics Office (NAT, formerly 

HNAT). (1) Provides oversight and 

strategic direction of NIH activities 

relating to ethics policy, oversight, and 

operational activities; (2) develops and 

administers the NIH policies and 

procedures for implementing the 

Government-wide conflict of interest 

statutes and regulations, the HHS 

supplemental conflict of interest 

regulations, and HHS policies; (3) 

implements a program for trans-NIH 

ethics oversight that includes 

information technology (IT) support 

systems, periodic reviews, audits, 

delegations of authority, training, and 

records management; and (4) determines 

real or potential conflicts of interest and 

assesses ethical considerations in 

scientific reporting, clinical trials, and 

scientific conferences and workshops. 

Division of IC Operations and Liaison 

(NAT2, formerly HNAT2). (1) Provides 

centralized operational services to ICs in 

the review and processing of: (a) 

Individual ethics actions and (b) ethics 

actions having IC-wide impact such as 

preapproval of awards, and blanket 

approval of widely attended gatherings 

(WAGs); (2) provides advisory services 

in the management of IC ethics reviews; 

and (3) provides ethics services for the 

Office of the Director, NIH. 

Division of Policy and Management 

Review (NAT3, formerly HNAT3). (1) 

Provides technical review of NIH and IC 

Ethics Programs and conducts risk 

assessment; (2) develops NIH-wide 

policies and procedures to ensure a 

rigorous NIH Ethics Program; (3) 

manages ethics delegations of authority; 

(4) develops and manages content for 

the NIH Ethics Web site; and (5) 

provides NIH-wide ethics training to 

staff. 

Delegations of Authority: All delegations 

and redelegations of authority to officers and 

employees of NIH that were in effect 

immediately prior to the effective date of this 

amendment and are consistent with this 

amendment shall continue in effect, pending 

further redelegation. 

Dated: August 4, 2006. 

Elias A. Zerhouni, 

Director, National Institutes of Health. 

[FR Doc. E6–13305 Filed 8–11–06; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Recombinant Antibodies and 

Immunoconjugates Targeted to CD–22 

Bearing Cells and Tumors 

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 of an exclusive 

patent license to practice the inventions 

embodied in U.S. Patent Application 

No. 09/381,497, filed September 20, 

1999, entitled ‘‘Recombinant Antibodies 

and Immunoconjugates Targeted to CD–

22 Bearing Cells and Tumors’’ [E–059–

1997/0–US–07]; European Patent 

Application No. 98912977.0, filed 

October 13, 1999, entitled 

‘‘Recombinant Antibodies and 

Immunoconjugates Targeted to CD–22 

Bearing Cells and Tumors’’ [E–059–

1997/0–EP–05]; Japanese Patent 

Application No. 10–540812, filed March 

19, 1998, entitled ‘‘Recombinant 

Antibodies and Immunoconjugates 

Targeted to CD–22 Bearing Cells and 

Tumors’’ [E–059–1997/0–JP–06]; 

Australian Patent No. 740904, issued on 

February 28, 2002, entitled 

‘‘Recombinant Antibodies and 

Immunoconjugates Targeted to CD–22 

Bearing Cells and Tumors’’ [E–059–

1997/0–AU–03]; and Canadian Patent 

Application No. 2284665, filed March 

19, 1998, entitled ‘‘Recombinant 

Antibodies and Immunoconjugates 

Targeted to CD–22 Bearing Cells and 

Tumors’’ [E–059–1997/0–CA–04]; to 

Cambridge Antibody Technology, Ltd., 

which has offices in Cambridge, United 

Kingdom. 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 limited to the use 

of the BL22 and HA22 and variants 

thereof as claimed in the licensed patent 

rights for the treatment of hematologic 

malignancies. 

DATES: Only written comments and/or 

applications for a license which are 

received by the NIH Office of 

Technology Transfer on or before 

October 13, 2006 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: Jesse S. Kindra, J.D., 

M.S., Technology Licensing Specialist, 

Office of Technology Transfer, National 

Institutes of health, 6011 Executive 

Boulevard, Suite 325, Rockville, MD 

20852–3804; Telephone (301) 435–5559; 

Facsimile: (301) 402–0220; E-mail: 

kindraj@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: This 

technology is a family of two (2) 

immunoconjugates, each consisting of 

an anti-CD–22 antibody coupled to a 

killing moiety, specifically 

pseudomonas exotoxin (PE38). The 

immunotoxins are both targeted towards 

CD–22, and may be useful as 

therapeutic agents for the treatment of 

leukemias, lymphomas and 

autoimmune diseases. Further, BL22 has 

shown success in early clinical trials. 

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 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 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. 


jlentini on PROD1PC65 with NOTICES
46496 Federal Register / Vol. 71, No. 156 / Monday, August 14, 2006 / Notices 

Dated: July 28, 2006. 

Steven Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 06–6871 Filed 8–11–06; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Treatment of Cardiovascular 

Conditions With Nitrite Therapy 

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 

§ (a)(1)(I), that the National Institutes of 

Health (NIH), Department of Health and 

Human Services (HHS), is 

contemplating the grant of an exclusive 

license to practice the invention 

embodied in: PCT patent application 

PCT/US2004/041256 filed December 9, 

2004, entitled: ‘‘Methods for 

Suppressing an Immune Response or 

Treating a Proliferative Disorder’’ [HHS 

Reference Number: E–259–2003/0–PCT–

02], to Sahajanand Medical 

Technologies Pvt. Ltd., registered as a 

private limited company in accordance 

with the Companies Act of India, having 

a principle place of business in Surat, 

India and U.S. headquarters in 

Gaithersburg, Maryland. The field of use 

may be limited to the use of 2-(4- 

piperazinyl)-8-phenyl-4H-1-benzopyran4-one (LY303511), for the treatment and 

prevention of stenosis and restenois 

and/or other proliferative disorders. The 

United States of America is an assignee 

of the patent rights in these inventions. 

DATES: Only written comments and/or 

application for a license, which are 

received by the NIH Office of 

Technology Transfer on or before 

October 13, 2006 will be considered. 

ADDRESSES: Requests for a copy of the 

patent application, inquiries, comments 

and other materials relating to the 

contemplated license should be directed 

to: Susan Carson, D. Phil, Office of 

Technology Transfer, National Institutes 

of Health, 6011 Executive Boulevard, 

Suite 325, Rockville, MD 20852–3804; 

E-mail: carsonsu@od.nih.gov; 

Telephone: (301) 435–5020; Facsimile: 

(301) 402–0220. 

SUPPLEMENTARY INFORMATION: The 

search for specific kinase inhibitors is 

an active area of drug development as 

there is a continued need for effective 

anti-proliferative therapeutics with 

acceptable toxicities. The core invention 

is a novel method of use of one of the 

4H-1-benzopyran-4-one derivatives 

(LY303511) which has been shown to 

target mTOR and casein kinase 2 (CK2) 

without affecting P13K activity (JPET, 

May 26, 2005, doi: 10.1124/ 

jpet.105.083550). Proof of concept data 

is available in an in vivo human 

zenograft PC-3 prostate tumor model, 

without observed toxicity. In vitro data 

suggests that (2-(4-piperazinyl)-8- 

pheynl-4H-1 benzopyran-4-one and 

derivatives may be effective in treating 

inflammatory, autoimmune and other 

proliferative disorders including 

restenosis and a variety of cancers. 

Method of use claims are directed to 

derivatives of 2-(4-piperazinyl)- 

substituted 4H-1-benzopyran-4-one 

compounds as anti-proliferative, 

immunosuppressive, anti-inflammatory, 

anti-restenosis and anti-neoplastic 

agents. 

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 60 days from the date of this 

published Notice, 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. 

Properly filed competing applications 

for a license filed in response to this 

notice will be treated as objections to 

the contemplated license. Comments 

and objections submitted in response 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: July 24, 2006 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 06–6880 Filed 8–11–06; 8:45am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Privacy Act of 1974; Proposed Altered 

System of Records 

AGENCY: National Institutes of Health 

(NIH), Department of Health and Human 

Services (DHHS). 

ACTION: Notification of Proposed Altered 

System of Records. 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

as amended (Privacy Act), the National 

Institutes of Health (NIH) hereby 

publishes a notice of a proposal to alter 

System of Records, No. 09–25–0168, 

‘‘Invention, Patent, and Licensing 

Documents Submitted to the Public 

Health Service by its Employees, 

Grantees, Fellowship Recipients, and 

Contractors, HHS/NIH/OD.’’ NIH 

proposes a new legal authority for the 

maintenance of the System to read: 15 

U.S.C. 3710, 3710a, 3710c & 3710d and 

35 U.S.C. 200 et seq. provide authority 

to maintain the records; 37 CFR part 401 

‘‘Rights to Inventions Made by 

Nonprofit Organizations and Small 

Business Firms under Government 

Grants, Contracts, and Cooperative 

Agreements;’’ 37 CFR part 404 

‘‘Licensing of Government Owned 

Inventions;’’ and 45 CFR part 7 

‘‘Employee Inventions.’’ NIH is also 

proposing new routine uses for this 

System. 

These records will be maintained by 

the Office of Technology Transfer 

(OTT), OIR/OD; Office of Financial 

Management (OFM), OD; Office of 

Reports and Analysis (ORA), OER/OD; 

Health and Human Services Technology 

Development Coordinators and HHS 

Contract Attorneys who retain files 

supplemental to the records maintained 

by the Office of Technology Transfer; 

and the Extramural Inventions and 

Technology Resources Branch, OPERA/ 

OER/OD. 

DATES: The NIH invites interested 

parties to submit comments on or before 

September 13, 2006. The NIH will send 

a Report of the Proposed Altered System 

to the Congress and to the Office of 

Management and Budget (OMB). The 

proposed altered System of Records will 

be effective 40 days from the date 

submitted to the OMB, unless NIH 

receives comments that would result in 

a contrary determination. 

ADDRESSES: You may submit comments, 

identified by the Privacy Act System of 

Records Number 09–25–0168, by any of 

the following methods: 

• Federal eRulemaking Portal: http:// 

regulations.gov. Follow the instructions 

for submitting comments. 

• E-mail: 

nihprivacyactofficer@mail.nih.gov and 

include PA SOR number 09–25–0168 in 

the subject line of the message. 

• Phone: (301) 496–2832 (not a tollfree number). 

• Fax: (301) 402–0169. 

• Mail: NIH Privacy Act Officer, 

Office of Management Assessment, 

National Institutes of Health, 6011 

Executive Boulevard, Suite 601, MSC 

7669, Rockville, Maryland 20892. 


jlentini on PROD1PC65 with NOTICES