Federal Register / Vol. 60, No. 79 / Tuesday, April 25, 1995 / Notices 20279

The role of Merck & Co. under the

CRADA will include the following:

1. Participate in the selection of the

CRADA collaborator and in the

development of the CRADA Research

Plan.

2. Provide for the licensing of Merck

intellectual property rights to the

selected Collaborator as necessary for

the clinical development and

commercialization of CAI as an anticancer agent.

The role of the successful

pharmaceutical company under the

CRADA will include the following:

1. Provide plans to independently

secure future continuing supplies of

GMP produced and formulated material

to assure continued collaborative

clinical development of CAI.

2. Provide funds to supplement the

clinical trials support contracts and

offer any other necessary support to the

NCI for continued collaborative clinical

development of this compound. This

includes both financial support as well

as personnel for data management and

clinical care.

3. Provide planning and support for

clinical development leading to FDA

approval for marketing.

Criteria for choosing the

pharmaceutical company include its

demonstrated experience and

commitment to the following:

1. Experience in preclinical and

clinical drug development.

2. Experience and ability to produce,

package, market and distribute

pharmaceutical products.

3. Experience in the monitoring,

evaluation and interpretation of the data

from investigational agent clinical

studies under an IND.

4. A willingness to cooperate with the

NCI in the collection, evaluation,

publication and maintaining of data

from clinical trials of investigational

agents.

5. The provision of adequate

quantities of GMP produced and

formulated CAI as needed for clinical

development of this agent for the

specified field of use to be determined

upon mutual agreement of the parties.

6. Provide defined financial and

personnel support for the clinical trials

to be mutually agreed upon.

7. An agreement to be bound by the

DHHS rules involving human and

animal subjects.

8. The aggressiveness of the

development plan, including the

appropriateness of milestones and

deadlines for preclinical and clinical

development.

9. Provisions for equitable

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(s) is (are) the sole inventor(s))

or (2) an option to negotiate an

exclusive or nonexclusive license to the

company on terms that are appropriate

(when the Government employee(s) is

(are) the sole inventor(s) or where a joint

invention arises).

Dated: April 13, 1995.

Thomas D. Mays,

Director, Office of Technology Development,

OD, NCI.

[FR Doc. 95–10109 Filed 4–24–95; 8:45 am]

BILLING CODE 4140–01–P

National Cancer Institute: Opportunity

for a Cooperative Research and

Development Agreement (‘‘CRADA’’)

for the Scientific and Commercial

Development of Certain Signal

Transduction Inhibitors as Anticancer

Agents

AGENCY: National Institutes of Health,

PHS, DHHS.

ACTION: Notice.

SUMMARY: The Department of Health and

Human Services (DHHS) seeks a

pharmaceutical company which can

effectively pursue the preclinical

development and possible eventual

clinical development of a family of

agents which inhibit the signal

transduction pathways required for the

growth and metastasis of cancer cells.

The National Cancer Institute has

preclinical data suggesting that these

agents may have potential for the

treatment and/or prevention of cancer.

The selected sponsor will be awarded a

CRADA for the co-development of these

agents in a specified field of use to be

determined upon mutual agreement of

the parties.

ADDRESSES: Questions about this

opportunity may be addressed to Mark

W. Noel, Office of Technology

Development, NCI, Building 31/Room

4A51, 9000 Rockville Pike, Bethesda,

Maryland 20892, (301) 496–0477,

facsimile (301) 402–2117, from whom

further information including a

summary copy of the preclinical data

may be obtained.

DATES: In view of the important priority

of developing new drugs for the

treatment or prevention of cancer,

interested parties should notify this

office in writing no later than June 26,

1995. Respondents will then be

provided an additional 60 days for the

filing of formal proposals.

SUPPLEMENTARY INFORMATION:

‘‘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

October 10, 1987 to collaborate on the

specific research project described

below.

The Government is seeking a

pharmaceutical company which, in

accordance with the requirements of the

regulations governing the transfer of

Government-developed agents (37 CFR

404.8), can develop the subject agents to

a marketable status to meet the needs of

the public and with the best terms for

the Government. These agents are a

novel, chemically-defined family of

agents being investigated in the

Laboratory of Pathology of the Division

of Cancer Biology, Diagnosis and

Centers, National Cancer Institute.

These agents have been demonstrated to

inhibit the signal transduction pathways

required for the growth and metastasis

of cancer cells and have shown

promising antitumor activity in

preclinical investigations. The majority

of the agents which are the subject of

the CRADA opportunity are the subject

of patent U.S. Patent 5,359,078 which is

assigned to the Dept. of Health and

Human Services. A method for the

detection and quantitation of the levels

of these agents in blood is claimed in

U.S. Patent 5,405,782 which is also

assigned to the Dept. of Health and

Human Services. The Cooperative

Research and Development Agreement

(‘‘CRADA’’) will allow a pharmaceutical

company to provide resources, in

collaboration with the NCI, for the

continuing preclinical development and

possibly the clinical development for

this group of agents.

The government will provide all

relevant available expertise and

information to date and will, jointly

pursue further preclinical development

of these agents with the chosen

Collaborator. Relevant background

patent rights are available for licensing

to the Collaborator.

The successful pharmaceutical

company will provide the necessary

quantities of the agents plus the

necessary technical expertise, financial

and organizational support to complete

further development of these agents to

establish their efficacy and possible

commercial status.

The expected duration of the CRADA

will be three (3) to five (5) years.

The role of the National Cancer

Institute, includes the following:

1. The government will continue

preclinical development of the agents as
20280 Federal Register / Vol. 60, No. 79 / Tuesday, April 25, 1995 / Notices

signal transduction inhibitors in vitro

and in vivo. Data from these studies will

be provided to the Collaborator and

evaluated jointly.

2. The government will provide data

for the production of the subject agents.

The successful pharmaceutical company

will be allowed exclusive access to this

resource.

3. As appropriate, agents showing

promise in preclinical studies may

proceed to collaborative clinical

development under NCI’s clinical trials

network, as mutually agreed upon by

both parties and subject to appropriate

amendment of this CRADA or

alternatively by negotiation and

execution of a Clinical Trials CRADA.

The Clinical Trial CRADA is a

modification of the standard NIH Model

Agreement wherein additional language

has been drafted to enable the

Collaborator to access and utilize

clinical trial data.

4. Relevant Government patent rights

are available for licensing through the

Office of Technology Transfer, National

Institutes of Health. For further

information contact Jack Spiegel, Office

of Technology Transfer, National

Institutes of Health, Box OTT, Bethesda,

MD 20892; (301) 496–7735; Facsimile

(301) 402–0220.

The role of the successful

pharmaceutical company under the

CRADA will include the following:

1. Provide plans to independently

secure future continuing supplies of the

selected agents for their continued

preclinical development. The

collaborator will also supply sufficient

quantities of GMP produced and

formulated material for the selected

agents which, upon mutual consent of

the parties, proceed to collaborative

clinical development.

2. Provide scientific development

strategy and financial and other support

for the collaborative preclinical

development of the selected agents.

Criteria for choosing the

pharmaceutical company include its

demonstrated experience and

commitment to the following:

1. Experience in preclinical and

clinical drug development.

2. Experience and ability to produce,

package, market and distribute

pharmaceutical products.

3. Experience in the monitoring,

evaluation and interpretation of the data

from preclinical studies and

investigational agent clinical studies

under an Investigational New Drug

Application (IND).

4. A willingness to cooperate with the

NCI in the collection, evaluation,

publication and maintaining of data

from preclinical investigations and

clinical trials, as appropriate, of

investigational agent(s).

5. The ability to provide adequate

quantities of the subject agents for their

continued preclinical investigation and

ability, as appropriate to provide

adequate quantities of GMP produced

and formulated material as needed for

clinical development of one or more of

these agents, as mutually agreed by the

parties.

6. Provide defined financial and

personnel support for the preclinical

studies and clinical trials (as

appropriate) to be mutually agreed

upon.

7. An agreement to be bound by the

DHHS rules involving human and

animal subjects.

8. The aggressiveness of the

development plan, including the

appropriateness of milestones and

deadlines for preclinical and clinical

development.

9. Provisions for equitable

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(s) is (are) the sole inventor(s))

or (2) an option to negotiate an

exclusive or nonexclusive license to the

company on terms that are appropriate

(when the Government employee(s) is

(are) the sole inventor(s) or where a joint

invention arises).

Dated: April 13, 1995.

Thomas D. Mays,

Director, Office of Technology Development,

OD, NCI.

[FR Doc. 95–10108 Filed 4–24–95; 8:45 am]

BILLING CODE 4140–01–P

Division of Research Grants; Amended

Notice of Meeting

Notice is hereby given of a change in

the meeting May 8–9, 1995, starting at

8:30 a.m., Building 31C, Conference

Room 6, of the Division of Research

Grants Advisory Committee, which was

published in the Federal Register on

April 3 (60 FR 16880).

This committee was to have convened

at 8:30 a.m. on May 8 to adjournment

on May 9, but has been changed to May

10–11, 1995, Building 31C, Conference

Room 6, National Institutes of Health,

9000 Rockville Pike, Bethesda,

Maryland 20892.

The meeting will be open to the

public from 8:30 a.m. on May 10 to

adjournment on May 11.

Dated: April 18, 1995.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 95–10107 Filed 4–24–95; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Issuance of Permit for Incidental Take

of Threatened Species

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice.

On February 9, 1995, a notice was

published in the Federal Register (60

FR 7785) that an application had been

filed with the U.S. Fish and Wildlife

Service (Service) by Heritage Arts

Foundation, Inc., St. George, Utah, for a

permit to incidentally take, pursuant to

section 10(a)(1)(B) of the Endangered

Species Act (Act) of 1973, as amended

(16 U.S.C. 1531 et seq.), threatened

desert tortoises (Gopherus agassizii) in

conjunction with operation of an access

road to the Tuacahn School and

Performing Arts Center in Padre

Canyon, town of Ivins, Washington

County, Utah, pursuant to an

implementation agreement which

implements the Heritage Arts

Foundation’s Habitat Conservation Plan.

Thirty-seven comments were received.

Thirty-six commenters expressed

support for issuance of the incidental

take permit, and one commenter

opposed issuance of any incidental take

permits in this area and questioned the

evaluation of alternatives to, and

impacts of, the proposal. These

comments have been addressed and are

incorporated into the final

environmental assessment.

Notice is hereby given that on March

31, 1995, as authorized by the

provisions of the Act, the Service issued

an incidental take permit (PRT–798634)

to the above-named party subject to

certain conditions set forth therein. The

permit was granted only after it was

determined that it was applied for in

good faith, that by granting the permit

it will not be to the disadvantage of the

threatened species, and that it will be

consistent with the purposes and policy

set forth in the Act, as amended.

Additional information on this permit

action may be obtained by contacting

the Assistant Field Supervisor, U.S. Fish

and Wildlife Service, 145 East 1300

South, Suite 404, Salt Lake City, Utah

84114, telephone (801) 524–5001,

between the hours of 7:30 a.m. to 4:30

p.m. weekdays.