[Federal Register: August 7, 2001 (Volume 66, Number 152)]
[Notices]
[Page 41252-41253]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07au01-102]
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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: 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
[[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