[Federal Register Volume 66, Number 87 (Friday, May 4, 2001)]
[Notices]
[Pages 22587-22588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11189]


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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.

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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.

[[Page 22588]]


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: [email protected].

SUPPLEMENTARY INFORMATION: A CRADA is an agreement designed to enable 
certain collaborations between Government laboratories and non-
Government 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 pre-determined 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