Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 63955

provide all available expertise and

information to date giving the company

full access to existing data and data

developed pursuant to the CRADA.

The successful company will provide

the necessary scientific, financial and

organizational support to characterize

and test the animals.

Background information is available

from the above-referenced address.

Patent applications and pertinent

information not yet publicly described

can be obtained under a Confidential

Disclosure Agreement.

The CRADA aims include the rapid

publication of research results and the

timely exploitation of commercial

opportunities. The CRADA partner will

enjoy rights of first negotiation for

licensing Government rights to any

inventions arising within the scope of

the agreement. The license option and

commercialization of inventions shall

not conflict with NIH Guidelines for the

availability of transgenic/knockout

animals (http://www1.od.nih.gov/wals/

transgen.html).

The expected duration of the CRADA

will be 2 years.

The role of the Laboratory of

Metabolism in this CRADA will be as

follows:

1. Isolate and characterize genomic

clones of human CYP2D6 and CYP3A4.

2. Generate mice by standard

injections of oocyte pronuclei and

screen founders.

3. Characterize tissue specificity of

expression.

4. Jointly publish research results.

The role of the Collaborator will be:

1. Characterize in vitro metabolism

using hepatic microsomal fractions.

2. Evaluate in vivo pharmacokinetics

with probe substrates and proprietary

compounds.

3. Analyze the role of CYP2D6 and

CYP3A4 on bioavailability and efficacy

of test compounds.

4. Jointly publish research results.

Selection criteria for choosing the

CRADA partner will include but not be

limited to:

1. Ability to collaborate with NCI on

further research and development of

this technology. Demonstration of

experience and expertise in this or

related areas of technology and the

ability to provide intellectual

contribution to the ongoing research and

development. Ability to accomplish

objectives according to an appropriate

timetable to be outlined in the

Collaborator’s proposal.

2. Willingness to comply with NIH

IRP Guidelines for the Availability of

Transgenic/Knockout Animals (http://

www1.od.nih.gov/wals/transgen.html).

The proposal should specifically

address the methods by which the

animals will be made available.

3. Demonstration of the resources

(facilities, personnel and expertise)

necessary to perform research,

development and commercialization of

this technology.

4. Commitment of reasonable effort

and resources on research, development

and commercialization of this

technology.

5. Expertise in the commercial

development, production, marketing

and sales of products related to this area

of technology.

6. The level of financial support the

Collaborator will supply for CRADArelated Government activities.

7. A willingness to cooperate with the

National Cancer Institute in the

publication of research results.

8. An agreement to be bound by the

DHHS rules involving human subjects,

patent rights and ethical treatment of

animals.

9. A willingness to accept the legal

provisions and language of the NIH

model CRADA with modifications to

address selection criteria #2 and other

minor modifications.

10. Provisions for distribution of

patent rights to any inventions.

Generally, the rights of ownership are

retained by the organization which is

the employer of the inventor, with (1) an

irrevocable, nonexclusive, royalty-free

license to the Government (when a

company employee is the sole inventor)

or (2) an option to negotiate an

exclusive or nonexclusive license to the

company on terms that are appropriate

(when the Government employee is the

sole inventor).

Dated: November 21, 1997.

Kathleen Sybert,

Acting Director, Technology Development

and Commercialization Branch, National

Cancer Institute, NIH.

[FR Doc. 97–31638 Filed 12–2–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; 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

National Cancer Institute Special

Emphasis Panel (SEP) meeting:

Name of SEP: Cancer Genetics Network—

Informatics and Information Technology

Group.

Date: December 9–10, 1997.

Time: December 9–7:30 p.m. to Recess.

December 10—8:00 a.m. to Adjournment.

Place: Ramada Inn—Rockville, 1775

Rockville Pike, Rockville, MD 20852.

Contact Person: Gerald Lovinger, Ph.D.,

Scientific Review Administrator, National

Cancer Institute, NIH, Executive Plaza North,

Room 630C, 6130 Executive Boulevard, MSC

7405, Bethesda, MD 20892–7405, Telephone:

301/496–7987.

Purpose/Agenda: To review, discuss and

evaluate grant applications.

This notice is being published less

than 15 days prior to the meeting due

to the urgent need to meet timing

limitations imposed by the review and

funding cycle.

The meeting will be closed in

accordance with the provisions set forth

in secs. 552b(c)(4) and 552b(c)(6), Title

5, U.S.C. Applications and the

discussions could reveal confidential

trade secrets or commercial property

such as patentable material and

personal information concerning

individuals associated with the

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program Numbers: 93.393, Cancer Cause and

Prevention Research; 93.394, Cancer

Detection and Diagnosis Research; 93.395,

Cancer Treatment Research; 93.396, Cancer

Biology Research; 93.397, Cancer Centers

Support; 93.398, Cancer Research Manpower;

93.399, Cancer Control)

Dated: November 25, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–31636 Filed 12–02–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; 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

of the National Cancer Institute Special

Emphasis Panel (SEP):

Name of SEP: Informatics Support for

Breast and Colon Cancer Cooperative Family

Registries.

Date: December 8, 1997.

Time: 9:00 a.m. to Adjournment.

Place: Executive Plaza North, Conference

Room C, 6130 Executive Boulevard,

Bethesda, MD 20892.

Contact Person: Courtney M. Kerwin,

Ph.D., M.P.H., Scientific Review

Administrator, National Cancer Institute,

NIH, Executive Plaza North, Room 630I, 6130