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###### Department of Health and Human Services

###### National Institutes of Health

# 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.

      ( print 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: mels@nih.gov.

# 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