43002 Federal Register / Vol. 62, No. 154 / Monday, August 11, 1997 / Notices

targeting even though the adduct is

systemically administered and nitric

oxide release is spontaneous.

Selective Prevention of Organ Injury in

Sepsis and Shock Using Selective

Release of Nitric Oxide in Vulnerable

Organs

JF Saavedra, TR Billiar, LK Keefer (NCI)

Serial No. 08/509,558 filed 31 Jul 95

The invention provides a method of

treating mammalian tissue which is

injured or is at risk of injury during

sepsis or shock, including septic shock,

hemorrhagic stock, and cardiogenic

shock. In the suggested method, nitric

oxide is delivered to target tissue or

cells in a controlled and predictable

manner through the administration of a

nitric oxide containing compound

(diazeniumdiolate) which is protected

from the systemic release of nitric oxide

under physiological conditions, and/or

that is concentrated in at risk organs

before releasing its nitric oxide. The

diazeniumdiolate is capable of releasing

at the targeted tissue a therapeutically

effective amount of nitric oxide,

sufficient to protect tissue from sepsis or

shock-induced injury.

O2-aryl Substituted Diazeniumdiolates

JE Saavedra, A Srinivasan, LK Keefer

(NCI)

Serial No. 60/026,816 filed 27 Sep 96

Diazeniumdiolates, wherein the N1

position is substituted by an organic

moiety and the O2-oxygen is bound to

a substituted or unsubstituted aromatic

group, are provided. The O2-aryl

diazeniumdiolates are stable with

respect to the hydrolytic generation of

nitric oxide in neutral to acidic

solutions. These novel compounds

generate nitric oxide in basic or

nucleophilic environments or

microenvironments. Also provided are

compositions, including pharmaceutical

compositions, comprising such

compounds and methods of using such

compounds.

Encapsulated and Non-Encapsulated

Nitric Oxide Generators Used as

Antimicrobial Agents

SJ Green, LK Keefer (NCI)

Serial No. 08/428,632 filed 24 Apr 95

This invention relates to compositions

capable of releasing nitric oxide and

therapeutic methods of use thereof for

the treatment of microorganism-related

disease states. The composition

comprises one or more nitric oxide

generators, preferably encapsulated in

vesicles, such as liposomes. The

compositions are used therapeutically

by administration to humans and

animals via different routes for the

treatment of infectious diseases caused

by pathogenic microbes.

Dated: August 4, 1997.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

[FR Doc. 97–21149 Filed 8–8–97; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Prospective Grant of Exclusive

License: New Brefeldin a Derivatives

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: This is notice in accordance

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

404.7(a)(1)(i) that the National Institutes

of Health (NIH), Department of Health

and Human Services, is contemplating

the grant of an exclusive world-wide

license to practice the inventions

embodied in U.S. Patent Application

Serial Number 08/267,525, entitled

‘‘New Brefeldin A Derivatives And

Their Utility In The Treatment Of

Cancer,’’ and corresponding U.S. and

foreign patent applications to Allelix

Biopharmaceuticals, Inc. of Mississauga,

Ontario, Canada. The patent rights of

the NIH inventors in these inventions

have been assigned to the United States

of America.

DATES: Only written comments and/or

applications for a license which are

received by NIH on or before October

10, 1997, will be considered.

ADDRESSES: Requests for copies of the

patent applications, inquiries,

comments and other materials relating

to the contemplated licenses should be

directed to: Raphe Kantor, Ph.D.,

Technology Licensing Specialist, Office

of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804; Telephone: (301)

496–7056 ext. 247; Facsimile: (301)

402–0220. A signed Confidentiality

Agreement will be required to receive

copies of the patent applications.

SUPPLEMENTARY INFORMATION: This

invention relates to a new class of

compounds which can be characterized

as breveldin A derivatives, e.g., 4-O-

(N,N-dimethylglycyl) breveldin A; 7-O-

(N-N-dimethylglycyl) breveldin A.

These breveldin A analogs are more

water soluble than the parent

compound. These analogs appear to

have reduced toxicities which limited

the clinical utility of the parent

compound. These compounds exhibit

activity against a wide variety of

cancers, including colon cancer,

melanoma, leukemia, ovarian, prostate,

breast and renal tumors. However,

recently performed toxicity studies on

one breveldin A analog (breflate) found

that it still retained an unacceptable

toxicity profile.

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, 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 filed in

response to this notice will be treated as

objections to the grant of the

contemplated licenses. 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 1, 1997.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

[FR Doc. 97–21093 Filed 8–8–97; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Prospective Grant of Exclusive

License: Diagnostic Methods Derived

From the Human Metastasis

Suppressor Gene KAI1

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: This notice in accordance

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

404.7(a)(1)(i) that the National Institutes

of Health, Department of Health and

Human Services, is contemplating the

grant of an exclusive world-wide license

to practice the inventions embodied in

U.S. Patent Applications SN 08/430,225

and corresponding foreign patent

applications entitled, ‘‘Diagnostic

Methods and Gene Therapy Using

Reagents Derived From the Human

Metastasis Suppressor Gene KAI1’’ to

Centocor, Inc. of Malvern, PA. The

patent rights in these inventions have

been assigned to the United States of
Federal Register / Vol. 62, No. 154 / Monday, August 11, 1997 / Notices 43003

America and Johns Hopkins University.

The prospective exclusive license field

of use may be limited to: The use of

KAI1 monoclonal antibodies in the

diagnostic/prognostic fields of use for

prostate cancer.

DATES: Only written comments and/or

applications for a license which are

received by NIH on or before October

10, 1997.

ADDRESSES: Requests for copies of the

patent applications, inquiries,

comments and other materials relating

to the contemplated licenses should be

directed to: Joseph K. Hemby, Jr., J.D.,

Technology Licensing Specialist, Office

of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852-3804; Telephone: (301)

496-7735 ext. 265; Facsimile: (301) 402-

0220. A signed Confidentiality

Agreement will be required to receive

copies of the patent applications.

SUPPLEMENTARY INFORMATION: 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, 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.

The invention relates to the KAI1

gene which has been shown to suppress

metastasis of prostate cancer and is

down regulated in human malignant

prostate cancers. The invention further

provides methods of detection of

alterations in the wild-type KAI1 gene

sequence, KAI1 mRNA, and KAI1

protein useful in determining the

presence of malignant cancer in a

subject or genetic predisposition to

malignancy in a subject. Other uses of

the KAI1 gene include the possible

treatment of patients who are diagnosed

with early stage prostate cancer.

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 licenses. 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: July 18, 1997.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

[FR Doc. 97–21094 Filed 8–8–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Availability of Draft Recovery Plan for

the Inyo California Towhee of the

Southern Argus Range, Inyo County,

California, for Review and Comment

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of document availability.

SUMMARY: The U.S. Fish and Wildlife

Service announces the availability for

public review of a draft recovery plan

for the threatened Inyo California

towhee. The Service solicits review and

comment from the public on this draft

recovery plan.

DATES: Comments on the draft recovery

plan must be received on or before

October 10, 1997.

ADDRESSES: A copy of the draft recovery

plan can be obtained from the Fish and

Wildlife Service’s Ventura Fish and

Wildlife Office, 2493 Portola Road,

Suite B, Ventura, California, 93003,

phone 805/644–1766. Written

comments and materials regarding the

plan should be addressed to the Field

Supervisor at the Ventura Fish and

Wildlife Office. Comments and

materials received are available on

request for public inspection by

appointment at the Ventura Fish and

Wildlife Office.

FOR FURTHER INFORMATION CONTACT:

Robert Mesta in the Ventura Fish and

Wildlife Office (see ADDRESSES section).

SUPPLEMENTARY INFORMATION:

Background

Restoring an endangered or

threatened animal or plant to the point

where it is again a secure, selfsustaining member of its ecosystem is a

primary goal of the U.S. Fish and

Wildlife Service’s endangered species

program. To help guide recovery efforts,

the Service prepares recovery plans for

most of the listed species native to the

United States. Recovery plans describe

actions considered necessary for

conservation of listed species, establish

criteria for the recovery levels for

reclassification from endangered to

threatened or removal from the list, and

estimate the time and cost for

implementing the needed recovery

measures.

The Endangered Species Act of 1973

(Act), as amended (16 U.S.C. 1531 et

seq.) requires the development of

recovery plans for listed species unless

such a plan would not promote the

conservation of a particular species.

Section 4(f) of the Act, as amended in

1988, requires that public notice and an

opportunity for public review and

comment be provided during recovery

plan development. The Service will

consider all information presented

during a public comment period prior to

approval of each new or revised

recovery plan. The Service and other

Federal agencies will take these

comments into account in the course of

implementing approved recovery plans.

Inyo California towhees are restricted

in range and number and therefore, are

susceptible to habitat destruction and

degradation. The recovery strategy for

this subspecies will focus on the

elimination of threats to all known

habitats and the rehabilitation of those

that have been degraded or destroyed.

The draft recovery plan describes tasks

that, when accomplished, should ensure

the continued existence of the Inyo

California towhee, and thereby justify

its removal from the endangered and

threatened species list. The draft

recovery plan was developed in

cooperation with the principle affected

agencies: California Department of Fish

and Game, Bureau of Land Management,

and the Navy.

Public Comments Solicited

The Service solicits written comments

on the draft recovery plan described

herein. All comments received by the

date specified above will be considered

prior to approval of the plan.

Authority: The authority for this action is

section 4(f) of the Endangered Species Act,

16 U.S.C. 1533(f).

Dated: June 17, 1997.

Thomas J. Dwyer,

Acting Regional Director.

[FR Doc. 97–21095 Filed 8–8–97; 8:45 am]

BILLING CODE 4310–55–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Availability of an Environmental

Assessment and Receipt of an

Application for an Incidental Take

Permit for the Cantara Residential

Project in the City of Colton, San

Bernardino County, California

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of availability.

SUMMARY: The Fish and Wildlife Service

has under consideration a proposal to

issue an 8-year permit pursuant to the

Endangered Species Act of 1973, as

amended (Act), that would authorize

incidental taking of the endangered

Delhi Sands flower-loving fly

(Rhaphiomidas terminatus