33940 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 / Notices

QOD × 3 (0.25 mg/kilo) produced

complete tumor regressions without

death or toxicity. Since the antibody

does not react with mouse mesothelin,

possible toxicities in mice are due to

non-specific (liver) toxicity. NIH/NCI

scientists have also administered this

aforementioned single chain form to

monkeys. SS(Fv)-PE38 reacts just as

strongly with monkey mesothelin as it

does with human mesothelin, and

therefore, one would expect the monkey

to be a good predictor of toxicity in

humans. At a 0.05 mg/kilo dose level,

no toxicity was experienced. A second

monkey received 0.5 mg/kilo and

showed a transient elevation in liver

enzymes and non-specific physical

signs (inactivity), but fully recovered.

In the United States, an estimated

15,000 patients die of ovarian cancer

each year despite therapy. Although less

common, mesotheliomas are known to

be resistant to all chemotherapeutic

agents. Development of new therapeutic

modalities to treat these malignancies is

needed.

A Cooperative Research and

Development Agreement or CRADA

means the anticipated joint agreement to

be entered into by NCI pursuant to the

Federal Technology Transfer Act of

1986 and Executive Order 12591 of

April 10, 1987 as amended by the

National Technology Transfer

Advancement Act of 1995 to collaborate

to improve the properties of the

SS(dsFv)-PE38 immunotoxin.

The rule of the NCI in the CRADA

may include, but are not be limited to:

1. Providing intellectual, scientific,

and technical expertise and experience

to the research project.

2. Providing the Collaborator with

samples of the subject compounds to

create, optimize, test and develop

targeted drugs for clinical studies.

3. Planning research studies and

interpreting research results.

4. Carrying out research to improve

the properties of the SS(dsFv)-PE38

which include, but are not restricted to,

increased production yield, decreased

side effects, increased cytotoxic activity

and better tissue penetration.

5. Publishing research results.

The role of the CRADA Collaborator

may include, but not be limited to:

1. Providing significant intellectual,

scientific, and technical expertise or

experience to the research project.

2. Planning research studies and

interpreting research results.

3. Providing samples of the subject

compounds to create, optimize, test and

develop targeted drugs for clinical

studies.

4. Providing technical and/or

financial support to facilitate scientific

goals and for further design of

applications of the technology outlined

in the agreement.

5. Incorporating the immunotoxin

into liposomes or producing other

formulations in order to increase the

therapeutic efficacy.

6. Providing immunotoxin for

laboratory and animal studies.

7. Publishing research results.

Selection criteria for choosing the

CRADA Collaborator may include, but

not be limited to:

1. The ability to collaborate with NCI

on further research and development of

this technology. This ability can be

demonstrated through experience and

expertise in this or related areas of

technology indicating the ability to

contribute intellectually to ongoing

research and development.

2. The demonstration of adequate

resources to perform the research and

development of this technology (e.g.

facilities, personnel and expertise) and

accomplish objectives according to an

appropriate timetable to be outlined in

the CRADA Collaborator’s proposal.

3. The willingness to commit best

effort and demonstrated resources to the

research and development of this

technology, as outlined in the CRADA

Collaborator’s proposal.

4. The demonstration of expertise in

the commercial development and

production of products related to this

area of technology.

5. The level of financial support the

CRADA Collaborator will provide for

CRADA-related Government activities.

6. The demonstration of expertise

pertinent to the development of models

to evaluate and improve the efficacy of

the SS (dsFv)-PE38 immunotoxin for the

treatment of ovarian cancer and

mesotheliomas.

7. The demonstration of expertise in

the formulation of drugs into liposomes

or other delivery vehicles.

8. The willingness to cooperate with

the NCI in the timely publication of

research results.

9. The agreement to be bound by the

appropriate DHHS regulations relating

to human subjects, and all PHS policies

relating to the use and care of laboratory

animals.

10. The willingness to accept the legal

provisions and language of the CRADA

with only minor modifications, if any.

These provisions govern the distribution

of patent rights to CRADA inventions.

Generally, the rights of ownership are

retained by the organization that is the

employer of the inventor, with (1) the

grant of a license for research and other

Government purposes to the

Government when the CRADA

Collaborator’s employee is the sole

inventor, or (2) the grant of an option to

elect an exclusive or nonexclusive

license to the CRADA Collaborator

when the Government employee is the

sole inventor.

Dated: May 18, 1998.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer,

National Institutes of Health.

Dated: May 26, 1998.

Kathleen Sybert,

Acting Director, Technology Development

and Commercialization Branch, National

Cancer Institute, National Institutes of Health.

[FR Doc. 98–16426 Filed 6–19–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing: Novel

Antitumor Macrocyclic Lactones,

Compositions and Methods of Use

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The National Institutes of

Health is seeking licensees for the

further development, evaluation and

commercialization of materials and

methods for novel cancer treatment

agents. The invention claimed in DHHS

Reference No. E–244–97/0, ‘‘Novel

Antitumor Macrocyclic Lactones,

Compositions and Methods of Use,’’

(Boyd, M. et al.) filed on 29 June 1997

as USSN 60/053,784, is available for

licensing (in accordance with 35 USC

207 and 37 CFR Part 404).

ADDRESSES: Questions about the

licensing opportunity should be

addressed to Girish C. Barua, Ph.D.,

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804; Telephone: 301/

496–7056 ext. 263; Fax: 301/402–0220.

SUPPLEMENTARY INFORMATION: The

invention relates to a series of

macrocyclic lactones based on

compounds isolated from certain marine

sponges and tunicates. These

compounds have in vitro activity against

certain human solid tumors, including

non-small cell lung cancer, renal cancer

and melanoma, all important killers

which are resistant to currently used

drugs.

Of particular interest is the cell-line

activity profile of these lactones, which

indicates a novel mechanism of action.

Such compounds hold the promise of in
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 / Notices 33941

vivo activities unlike those seen with

current drugs. These lactones thus have

the potential for use as therapeutics

alone or in combination with existing

drugs.

Information about the patent

application and pertinent information

not yet publicly described can be

obtained under a Confidential

Disclosure Agreement. Respondees

interested in licensing the invention

will be required to submit an

Application for License to Public Health

Service Inventions.

Dated: June 16, 1998.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer.

[FR Doc. 98–16425 Filed 6–19–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Diabetes and

Digestive and Kidney Diseases; Notice

of Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute of

Diabetes and Digestive and Kidney Diseases

Special Emphasis Panel, ZDKI GRB–4(02).

Date: July 15–16, 1998.

Time: July 15, 1998, 7:30 pm to

Adjournment.

Agenda: To review and evaluate grant

applications.

Place: Holiday Inn, 5 Boston, MA 02114.

Contact Person: William Elzinga, PhD,

Scientific Review Administrator, Review

Branch, DEA, NIDDK, Natcher Building,

Room 6AS–37, National Institutes of Health,

Bethesda, MD 20892–6600, (301) 594–8895.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.847, Diabetes,

Endocrinology and Metabolic Research;

93.848, Digestive Diseases and Nutrition

Research; 93.849, Kidney Diseases, Urology

and Hematology Research, National Institutes

of Health, HHS)

Dated: June 12, 1998.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 98–16430 Filed 6–19–98; 8:45 am]

BILLING CODE 1410–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Diabetes and

Digestive and Kidney Diseases; Notice

of Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of person privacy.

Name of Committee: National Institute of

Diabetes and Digestive and Kidney Diseases

Special Emphasis Panel, ZDK1 GRB–4(03).

Date: June 30, 1998.

Time: 3:00 pm to Adjournment.

Agenda: To review and evaluate grant

applications.

Place: Natcher Building, 45 Center Drive,

Room 6AS.25S, MD 20892 (Telephone

Conference Call).

Contact Person: William Elzinga, PhD,

Scientific Review Administrator, Review

Branch, DEA, NIDDK, Natcher Building,

Room 6AS–37, National Institutes of Health,

Bethesda, MD 20892–6600, (301) 594–8895.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalog of Federal Domestic Assistance

Program Nos. 93.847, Diabetes,

Endocrinology and Metabolic Research;

93.848, Digestive Diseases and Nutrition

Research; 93.849, Kidney Diseases, Urology

and Hematology Research, National Institutes

of Health, HHS)

Dated: June 12, 1998.

Laverne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 98–16431 Filed 6–9–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Center for Scientific Review; Notice of

Closed Meetings

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meetings.

The meetings will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: Multidisciplinary

Sciences Special Emphasis Panel, ZRG7

SSS–7(67).

Date: June 22–23, 1998.

Time: 8:00 am to 5:00 pm.

Agenda: To review and evaluate grant

applications.

Place: Double Tree Hotel, 1750 Rockville

Pike, Rockville, MD 20852.

Contact Person: Houston Baker, PhD,

Scientific Review Administrator, Center for

Scientific Review, National Institutes of

Health, 6701 Rockledge Drive, Room 5128,

MSC 7854, Bethesda, MD 20892–7854, (301)

435–1175.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

Name of Committee: Multidisciplinary

Sciences Special Emphasis Panel, sss–x(6).

Date: June 22, 1998.

Time: 2:00 pm to 3:30 pm.

Agenda: To review and evaluate grant

applications.

Place: NIH, Rockledge 2, Bethesda, MD

20892 (Telephone Conference Call).

Contact Person: Lee Rosen, PhD, Scientific

Review Administrator, Center for Scientific

Review, National Institutes of Health, 6701

Rockledge Drive, Room 5116, MSC 7854,

Bethesda, MD 20892, (301) 435–1171.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

Name of Committee: Multidisciplinary

Sciences Special Emphasis Panel, ZRG7

SSS–7 (68).

Date: June 25–26, 1998.

Time: 8:00 am to 5:00 pm.

Agenda: To review and evaluate grant

applications.

Place: Woodfin Suite Hotel, 1380 Piccard

Drive, Rockville, MD 20850.

Contact Person: Houston Baker, PhD,

Scientific Review Administrator, Center for