[Federal Register Volume 66, Number 152 (Tuesday, August 7, 2001)]
[Notices]
[Pages 41252-41253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19640]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


The National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK): Opportunity for Cooperative Research and Development 
Agreements (CRADAs) to Implement a Multicenter, Clinical Trial to Study 
Viral Resistance to Pegylated Interferon Therapy in Combination with 
Ribavirin in Patients Who Have Chronic Hepatitis C, Genotype 1, 
Specifically Focusing Upon African Americans

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 companies for a 
Cooperative Research and Development Agreement (CRADA) to provide 
active agent(s) to study important issues surrounding viral resistance 
to interferon in hepatitis C, particularly in African Americans.
    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 provide active agent(s) to 
study important issues surrounding viral resistance to interferon in 
hepatitis C. The potential Collaborator(s) capability statement should 
provide proof of expertise in the design and implementation of 
pegylated interferon and ribavirin therapies for hepatitis C and should 
include the scientific rationale for the study proposed, proposed 
dosing regimes, possible strategies for assessing compliance, proposed 
methods for assessing interferon levels, pharmacokinetics, and drug 
distribution methodology.

DATES: Only written CRADA capability statements received by the NIDDK 
on or before August 24, 2001 will be considered. Applicants meeting the 
criteria as set forth in this announcement will be invited to discuss 
their plans, capabilities, and research findings pertinent to pegylated 
interferon and ribavirin with the study's Steering Committee on 
September 23-24, 2001. This will be at the Collaborator's expense. The 
Institute may issue an additional notice of CRADA opportunity. This 
notice is directed toward companies with resources to support 
collaborations.

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

[[Page 41253]]

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 Goal: The goal of this study is to plan and implement a 
multicenter clinical investigation into combination antiviral therapy 
of patients with chronic hepatitis C infected with HCV genotype 1.
    Applicants must include a description of investigators and staff 
with experience and expertise to collaborate in multicenter clinical 
studies to assess combination antiviral therapy of patients with 
chronic hepatitis C infected with HCV genotype 1. Applicants must give 
evidence of their ability and experience to conduct multicenter 
clinical trials, with patients with chronic hepatitis C. 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 
pharmacokinetics of the proposed drugs to be used including how and 
when the drugs should be taken. The process for biologic sample 
collection, storage and handling needs must be included. A description 
of the laboratory tests that are needed including assays to determine 
interferon levels along 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. How the drug will be sent to each 
participating center as well as packaging, storing, and accountability 
issues must be presented.
    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 methods to 
be utilized in the investigation of combination antiviral therapy of 
patients with chronic hepatitis C infected with HCV genotype 1 and 
clearly describe important issues surrounding viral resistance to 
interferon in hepatitis C.
    2. The statement should include a detailed plan demonstrating the 
ability to provide sufficient quantities of the therapeutic medication 
agents in a timely manner for the duration of the study.
    3. The statement should 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 viral 
resistance to interferon in hepatitis C, 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: July 27, 2001.
Jack Spiegel,
Director, Division of Technology Development and Transfer Office of 
Technology Transfer.
[FR Doc. 01-19640 Filed 8-6-01; 8:45 am]
BILLING CODE 4140-01-P