Federal Register / Vol. 66, No. 87 / Friday, May 4, 2001 / Notices 22587

request more information on the

proposed project or to obtain a copy of

the data collection plans and draft

instruments, call the HRSA Reports

Clearance Officer at (301) 443–1129.

Comments are invited on (a) whether

the agency needs to collect the proposed

information to properly perform its

functions and whether the information

has any practical utility; (b) whether the

agency’s estimate of the burden of the

proposed collection of information is

accurate; (c) ways to enhance the

quality, utility, and clarity of the

information to be collected; and (d)

ways to minimize the burden of the

collection of information for

respondents (e.g., by using automated

collection techniques or other forms of

information technology).

Proposed Project: Ryan White CARE

Act Dental Reimbursement Program

(OMB No. 0915–0151)—Revision

The Dental Reimbursement Program

(DRP) under Part F of the Ryan White

CARE Act offers grants to accredited

dental schools and programs that

provide non-reimbursed oral health care

to patients with HIV disease. The Ryan

White CARE Act Amendments of 2000

expanded eligibility of this program to

accredited schools of dental hygiene, in

addition to previously funded schools of

dentistry and post-doctoral dental

education programs.

HRSA requests a revision to the DRP

Application that schools and programs

use to apply for funding of nonreimbursed costs incurred in providing

oral health care to patients with HIV.

Awards are authorized under section

776(b) of the Public Health Service Act

(42 U.S.C. 294n). The 2001 DRP

Application is intended to collect data

in three different areas: program

information, patient demographics and

services, and reimbursement and

funding. It also requests applicants to

provide narrative descriptions of their

services and facilities, as well as their

links and collaboration with

community-based providers of oral

health services.

The primary purpose of collecting this

information annually, as part of the DRP

Application, is to verify eligibility and

determine the reimbursement amount

each applicant should receive. This

information also allows HRSA to learn

about (1) the extent of the involvement

of dental schools and programs in

treating patients with HIV, (2) the

number and characteristics of clients

who receive CARE Act-supported oral

health services, (3) the types and

frequency of the provision of these

services, (4) the non-reimbursed costs of

oral health care provided to patients

with HIV, and (5) how applicants intend

to use DRP funds once they are

received. In addition to meeting the goal

of accountability to Congress, clients,

advocacy groups, and the general

public, information collected in the DRP

Application is critical for HRSA, State

and local grantees, and individual

providers, to help assess the status of

existing HIV-related health service

delivery systems.

The reporting burden for reviewing

the DRP Application Instructions and

completing the Application Form is

estimated as:

Collection Number of

responsents

Hours per

application

Total burden hours

Reimbursement Request ......................................................................................................................... 125 20 2500

Send comments to Susan G. Queen,

Ph.D., HRSA Reports Clearance Officer,

Room 14–33, Parklawn Building, 5600

Fishers Lane, Rockville, MD 20857.

Written comments should be received

within 60 days of this notice.

Dated: April 30, 2001.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 01–11236 Filed 5–3–01; 8:45 am]

BILLING CODE 4160–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Diabetes and

Digestive and Kidney Diseases

(NIDDK): Opportunity for Cooperative

Research and Development

Agreements (CRADAs) To Perform

Intervention Studies To Preserve

Pancreatic Beta Cell Function and

Prevent Type 1 Diabetes

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The National Institute of

Diabetes and Digestive and Kidney

Diseases (NIDDK) of the National

Institutes of Health (NIH) is seeking

proposals in the form of capability

statements from potential collaborators

for a Cooperative Research and

Development Agreement (CRADA) to

perform intervention studies to preserve

pancreatic beta cell function and

prevent type 1 diabetes. The clinical

research will execute pilot and

expanded studies of new agents to

prevent or ameliorate type 1 diabetes in

populations screened for or enrolled in

these studies.

Pursuant to the Federal Technology

Transfer Act of 1986 (FTTA, 15 U.S.C.

3710; and Executive Order 12591 of

April 10, 1987, as amended by the

National Technology Transfer and

Advancement Act of 1995), the National

Institute of Diabetes and Digestive and

Kidney Diseases (NIDDK) of the

National Institutes of Health (NIH) of

the Public Health Service (PHS) of the

Department of Health and Human

Services (DHHS) seeks a Cooperative

Research and Development Agreement

(CRADA) with a pharmaceutical or

biotechnology company to perform

intervention studies to preserve

pancreatic beta cell function and

prevent type 1 diabetes.

The potential Collaborator(s)

capability statement should provide

proof of expertise in the design and

implementation of new intervention

studies of Type 1 Diabetes and should

include the scientific rationale for the

study proposed, the population to be

studied, eligibility and exclusion

criteria for the study, possible strategies

for patient recruitment and data

collection methods, primary and

secondary endpoints to be determined,

and a discussion of the sample size

required given associated assumptions.

The scientific rationale should include

a discussion of what is the current

‘‘state-of-the-art’’, future opportunities,

and obstacles in the prevention of type

1 diabetes, and discuss how the field

may best be moved forward.

DATES: Only written CRADA capability

statements received by the NIDDK on or

before July 1, 2001 will be considered;

confidential information must be clearly

labeled. Potential Collaborators may be

invited to meet with the Selection

Committee at the Collaborator’s expense

to provide additional information. The

Institute may issue an additional notice

of CRADA opportunity. This notice is

directed toward companies with

resources to support collaborations.

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.,