22588 Federal Register / Vol. 66, No. 87 / Friday, May 4, 2001 / Notices

FOR ADDITIONAL INFORMATION AND

QUESTIONS: Capability statements should

be submitted to Dr. Michael W.

Edwards, Office of Technology

Development, National Institute of

Diabetes and Digestive and Kidney

Diseases, National Institutes of Health,

BSA Building, Suite 350 MSC 2690,

9190 Rockville Pike, Bethesda, MD

20814–3800; Tel: 301/496–7778, Fax:

301/402–0535; Email: mels@nih.gov.

SUPPLEMENTARY INFORMATION: A CRADA

is an agreement designed to enable

certain collaborations between

Government laboratories and nonGovernment laboratories. It is not a

grant, and is not a contract for the

procurement of goods/services. The

NIDDK is prohibited from transferring

funds to a CRADA collaborator. Under

a CRADA, NIDDK can contribute

facilities, staff, materials, and expertise

to the effort. The collaborator typically

contributes facilities, staff, materials,

expertise, and funding to the

collaboration. The CRADA collaborator

receives an exclusive option to negotiate

an exclusive or non-exclusive license to

Government intellectual property rights

arising under the CRADA in a predetermined field of use and may qualify

as a co-inventor of new technology

developed under the CRADA.

Study Organization: The Type 1

Diabetes TrialNet, or TrialNet, will be a

national network of cooperative clinical

research groups, consisting of a

consortia of clinical centers and core

support facilities, whose aim is to

recruit patients and to support studies

that may eventually result in an

improved understanding of type 1

diabetes and the prevention of the

disease.

Applicants must include a description

of investigators and staff with

experience and expertise to collaborate

in multicenter clinical trials and Phase

II and Phase III studies to assess

interventions for preventing or

ameliorating type 1 diabetes. Applicants

should describe their ability to lead

clinical trials that could be performed

using Type 1 Diabetes TrialNet

resources. Applicants must give

evidence of their ability and experience

to conduct multicenter clinical trials,

with prediabetic or diabetic subjects. If

applicants have particular expertise and

accomplishments in recruiting

individuals from minority groups, these

should be described.

Applicants should provide a detailed

description of the design of the

proposed study, including what

eligibility, baseline, and follow-up tests

are to be done, what surrogate markers

and endpoints will be examined, and

the duration of follow-up. Examples of

data forms and questionnaires proposed

should be given. The process for

biologic sample collection, storage and

handling needs must be included. A

description of the laboratory tests that

are needed with appropriate methods

for performing them should be

provided, as well as other core facilities

and interactions with core facilities that

are needed. Also included should be the

methods that would be used to assure

privacy and maintain confidentiality of

data. Sample size needs and the criteria

and calculations used to estimate

sample sizes should be detailed.

Capability Statements: A Selection

Committee will utilize the information

provided in the ‘‘Collaborator Capability

Statements’’ received in response to this

announcement to help in its

deliberations. It is the intention of the

NIDDK that all qualified Collaborators

have the opportunity to provide

information to the Selection Committee

through their capability statements. The

Capability Statement should not exceed

10 pages and should address the

following selection criteria:

(1) The statement should provide

specific details of the method to be

utilized in the investigation of

promising new approaches to prevent or

ameliorate type 1 diabetes.

(2) The statement should include a

detailed plan demonstrating the ability

to provide sufficient quantities of the

agent in a timely manner for the

duration of the study.

(3) The statement may include

outcome measures of interest to the

Collaborator. The specifics of the

proposed outcome measures and the

proposed support should include but

not be limited to the following:

Promising new approaches to prevent or

ameliorate type 1 diabetes, specific

funding commitment to support the

advancement of scientific research,

Personnel, services, facilities,

equipment, or other resources that

would contribute to the conduct of the

commercial development.

(4) The statement must address

willingness to promptly publish

research results and ability to be bound

by PHS intellectual property policies

(see CRADA: http://ott.od.nih.gov/

newpages/crada.pdf).

Dated: April 26, 2001.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer.

[FR Doc. 01–11189 Filed 5–3–01; 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 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: Clinical Trials Review

Committee.

Date: June 17–19, 2001.

Time: 7 p.m. to 5 p.m.

Agenda: To review and evaluate grant

applications.

Place: Holiday Inn, 5520 Wisconsin

Avenue, Chevy Chase, MD 20815.

Contact Person: Joyce A. Hunter, Ph.D,

Review Branch, Room 7192, Division of

Extramural Affairs, National Heart, Lung, and

Blood Institute, National Institutes of Health,

Bethesda, MD 20892–7924, 301/435–0277.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.233, National Center for

Sleep Disorders Research; 93.837, Heart and

Vascular Diseases Research; 93.838, Lung

Diseases Research; 93.839, Blood Diseases

and Resources Research, National Institutes

of Health, HHS)

Dated: April 27, 2001.

Anna P. Snouffer,

Acting Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–11182 Filed 5–3–01; 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 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.,