Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Notices 47673

communicated shortly thereafter to all

respondents with whom initial

confidential discussions will have

established sufficient mutual interest.

SUPPLEMENTARY INFORMATION:

Technology Available

DHHS scientists are developing a

variety of novel targeted drugs defined

as a conjugated molecule consisting of

a specific binding moiety, such as a

monoclonal antibody, a receptor ligand

or a similar construct, and a natural

product or synthetic cytotoxic moiety

which may include, but not be limited

to the broad category of toxins and

drugs. The specific binding and

cytotoxic moieties would be joined by

appropriate linker molecules. The NCI

can provide a variety of natural product

cytotoxic drugs either in the unaltered

state or chemically-modified (to

facilitate conjugation) as starting

substances for the creation of new

targeted drug agents. In addition, a

limited number of monoclonal

antibodies which can be used in this

drug development effort are available

from the NCI. The NCI can also provide

the chemical expertise to modify agents,

as well as the resources to test newly

constructed agents in an in vitro cell

line screen. Publications outlining these

developments are available on request,

and descriptions of other (unpublished)

advances can be obtained from Dr.

Stackhouse via a Confidential

Disclosure Agreement.

DHHS now seeks collaborative

arrangements for the creation,

optimization, evaluation and possible

clinical exploitation of these agents. A

Cooperative Research and Development

Agreement (CRADA) will be established

to provide for distribution of intellectual

property rights developed under the

Agreement. The successful CRADA

collaborator will provide expertise and

experience in the preparation of targeted

drugs, and will prepare one or more

targeted drug candidates using starting

substances provided jointly by the NCI

and the CRADA collaborator. For

targeted drug candidates selected for

clinical trials, the Collaborator will also

provide the necessary resources and

expertise to perform tests to determine

the drug candidate’s physicochemical

makeup, biological activity, stability

and other characteristics necessary for

filing an Investigational New Drug (IND)

application with the FDA. The NCI will

provide starting substances as well as

consultation and expertise on drug

preparation and development. Also, the

NCI may elect to provide resources for

preclinical and/or clinical evaluation,

subject to future review and approval.

CRADA aims will include rapid

publication of research results as well as

timely clinical evaluation and

exploitation of any commercial

opportunities.

The role of the National Cancer

Institute in this CRADA will include,

but 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. Additional support for preclinical

and/or clinical development of the

targeted drug candidate(s) derived from

this CRADA. Commitment of substantial

resources would require specific review

and approval by the Decision Network

Committee of the NCI’s Division of

Cancer Treatment, Diagnosis, and

Centers (DCTDC). These resources may

include:

(A) In vitro testing in the DCTDC cell

line screen.

(B) Assistance with design and

conduct of preclinical in vivo efficacy

experiments.

(C) Toxicology experiments.

(D) Provision of additional starting

materials for use by the Collaborator in

preparing final targeted drug product.

(E) IND filing and sponsorship of

clinical trials.

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. Production, by current Good

Manufacturing Practices (cGMP),

purification, vialing, product release,

and post-release testing of targeted drug

candidates for clinical trials.

6. 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 willingness to cooperate with

the National Cancer Institute in the

timely publication of research results.

7. 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.

8. 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: August 25, 1997.

Kathleen Sybert,

Acting Director, Office of Technology

Development, National Cancer Institute,

National Institutes of Health.

[FR Doc. 97–23901 Filed 9–9–97; 8:45 am]

BILLING CODE 4140–01–P

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
47674 Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Notices

National Cancer Institute Special

Emphasis Panel (SEP) meeting:

Name of SEP: Science Enrichment

Program.

Date: September 29–30, 1997.

Time: 8:00 a.m. to 5:00 p.m.

Place: National Cancer Institute, Executive

Plaza North, Conference Room J, 6130

Executive Boulevard, Bethesda, MD 20892.

Contact Person: Wilna Woods, Ph.D.,

Scientific Review Administrator, National

Cancer Institute, NIH, Executive Plaza North,

Room 622B, 6130 Executive Boulevard, MSC

7410, Bethesda, MD 20892–7410, Telephone:

301/496–7903.

Purpose/Agenda: To evaluate and review

responses to Requests for Proposals.

The meeting will be closed in accordance

with the provisions set forth in sections

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

Proposals and the discussions could reveal

confidential trade secrets or commercial

property such as patentable material and

personal information concerning individuals

associated with the proposals, 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, Cnacer Centers

Support; 93.398, Cancer Research Manpower;

93.399, Cancer Control)

Dated: September 4, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–23894 Filed 9–9–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Heart, Lung, and Blood

Institute; 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 Heart,

Lung, and Blood Special Emphasis

Panel (SEP) meetings:

Name of SEP: Cooperative Agreement on

Asthma Clinical Research Network.

Date: October 1, 1997.

Time: 8:00 a.m.

Place: Holiday Inn Chevy Chase, 5520

Wisconsin Avenue, Chevy Chase, Maryland

20815.

Contact Person: Anne P. Clark, Ph.D, Two

Rockledge Center, Room 7186, 6701

Rockledge Drive, Bethesda, MD 20892–7924,

(301) 435–0280.

Purpose/Agenda: To review and evaluate

cooperative agreement applications.

Name of SEP: Review of Institutional

National Research Service Awards (T32s),

Short-term Training Students in Health

Professional Schools Awards (T35s),

Independent Scientist Awards (K02s), and

Mentored Clinical Scientist Development

Awards (K08s).

Date: October 13–14, 1997.

Time: 8:00 a.m.

Place: Hyatt Regency, One Bethesda Metro,

Bethesda, Maryland 20814.

Contact Person: S. Charles Selden, Ph.D.,

Two Rockledge Center, Room 7196, 6701

Rockledge Drive, Bethesda, MD 20892–7924,

(301) 435–0288.

Purpose/Agenda: To review and evaluate

grant applications.

These meetings will be closed in

accordance with the provisions set forth in

sections 552b(c)(4) and 552b(c)(6), Title 5,

U.S.C. Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Programs Nos. 93.837, Heart and Vascular

Diseases Research; 93.838, Lung Diseases

Research; and 93.839, Blood Diseases and

Resources Research, National Institutes of

Health)

Dated: September 4, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–23895 Filed 9–9–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Heart, Lung, and Blood

Institute; Notice of Meeting of the

National Heart, Lung, and Blood

Advisory Council

Pursuant to Public Law 92–463,

notice is hereby given of the meeting of

the National Heart, Lung, and Blood

Advisory Council, October 23–24, 1997,

National Institutes of Health, 9000

Rockville Pike, Building 31, Conference

Room 10, Bethesda, Maryland.

The Council meeting will be open to

the public on October 23 from 8:30 a.m.

to approximately 3:00 p.m. for

discussion of program policies and

issues. Attendance by the public will be

limited to space available.

In accordance with the provisions set

forth in sections 552b(c)(4) and

552b(c)(6), Title 5, U.S.C., section 10(d)

of Public Law 92–463, the meeting will

be closed to the public from

approximately 3:00 p.m. on October 23

to adjournment on October 24, for the

review, discussion, and evaluation of

individual grant applications. These

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.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

contact the Executive Secretary in

advance of the meeting.

Dr. Ronald G. Geller, Executive

Secretary, National Heart, Lung, and

Blood Advisory Council, Rockledge

Building (RKL2), Room 7100, National

Institutes of Health, Bethesda, Maryland

20892, (301) 435–0260, will furnish

substantive program information.

(Catalog of Federal Domestic Assistance

Program Nos. 93.837, Heart and Vascular

Diseases Research; 93.838, Lung Diseases

Research; and 93.839, Blood Diseases and

Resources Research, National Institutes of

Health)

Dated: September 4, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–23897 Filed 9–9–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Mental Health;

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 of the National Institute of

Mental Health Initial Review Group:

Agenda/Purpose: To review and evaluate

grant applications.

Committee Name: Epidemiology and

Genetics Review Committee.

Date: October 6–October 7, 1997.

Time: 8:30 a.m.

Place: Bethesda Marriott Hotel, 5151 Pooks

Hill Road, Bethesda, MD 20814.

Contact Person: Shirley Williams,

Parklawn, Room 9C–18, 5600 Fishers Lane,

Rockville, MD 20857, Telephone: 301, 443–

1367.

Committee Name: Mental Disorders of

Aging Review Committee.

Date: October 9–October 10, 1997.

Time: 8:30 a.m.

Place: Double Tree Hotel, 1750 Rockville

Pike, Rockville, MD 20852.

Contact Person: Richard Johnson,

Parklawn, Room 901–18, 5600 Fishers Lane,

Rockville, MD 20852. Telephone: 301, 443–

1367.

Committee Name: Clinical

Psychopathology Review Committee.

Date: October 9–October 10, 1997.