CHARTER (CNS HIV Anti-Retroviral Therapy Effects Research) as a Resource

This is a Research and Development (R&D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R & D requirement. Background. The CNS HIV Antiretroviral Therapy Effects Research (CHARTER) study was awarded in September 2002, under contract N01MH22005, to the University of California at San Diego (UCSD) to examine the presentation and predictors of neurologic complications of HIV in the era of combination antiretroviral treatment (ART). In addition to this primary objective of the contract, UCSD has established, characterized, and stored samples from the CHARTER patient cohort and made them available to scientists conducting HIV-related central and peripheral nervous system studies. The program has accumulated invaluable clinical and research data on approximately 1,600 participants and longitudinal data has been collected on a subset of 600 participants. Purpose and Objectives. The goal of the new CHARTER Resource contract is to further utilize and expand the data and specimens collected beyond the original contract period, to serve as a resource to the broader NeuroAIDS research community. This collection will be an ongoing and important resource that has been requested by NeuroAIDS research investigators as they continue to study the pathophysiology of HIV-Associated Neurocognitive Disorder (HAND). If a follow-on study to CHARTER is approved by the NIH, new samples and data will be added to the collection over the next 5 years. Project Requirements. The key work to be continued includes: 1) Enhancement of the web-based communication suite, publications tracking system, and imaging utility in place at UCSD under the current contract; 2) Development of a system for collecting data generated from ancillary investigations and a mechanism for "freezing" digital datasets which are used for analyses and publications; 3) Providing scientific investigators access to all stored clinical samples that have been collected under the current contract, and samples that will be accumulated under the follow-on contract, if approved; 4) Establishment and maintenance of a scientific review system to determine whether exhaustible clinical samples should be sent to ancillary research investigators; 5) Providing other specialized services, such as assays or complex data analyses, possibly on a re-charge basis such that the requestor pays actual cost for services rendered; 6) Providing expert advice in the form of interpretation of results, analyses planning, assays, project design, and collaboration with Resource Specialists from each core to assist investigators with complex data and/or sample requests; 7) Reporting on structured feedback and indicators of the CHARTER Resource program success. Other important considerations. In order to perform this work, qualified sources MUST have: 1) Access to the resources collected and developed under Contract N01MH22005, including clinical samples and databases; 2) Access to CHARTER subjects for a follow-on initiative, to continue collection of samples and data; 3) Expertise in neuromedical, neurobehavioral, neuroimaging and virology. Anticipated Period of Performance. The resulting contract has an anticipated period of performance of 5 years. Capability Statement. Any business or organization that believes it has the capability to fulfill this requirement should submit a brief narrative response (5-10 pages, single-spaced), indicating previous experience and capabilities related to the described work. Capability Statements should describe (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; (e) examples of prior completed Government contracts, references, and other related information (f) any other resources available to support this project. Responses to this Sources Sought Notice are due by February 12, 4:30 PM local time. Electronic versions of responses will be accepted. Responses can be sent by mail, fax, or E-mail to: Stephanie Powell Contract Specialist, NIDA Neuroscience COAC NIMH R&D Contracts Management Branch 6001 Executive Blvd., Rm. 8154 (MSC 9661) Bethesda, MD 20892 [For commercial overnight services use: Rockville, MD 20852] Voice: 301-443-2696 Fax: 301-443-0501 E-mail: spowel1@mail.nih.gov *NIMH R&D contracts are awarded and administered by the National Institute on Drug Abuse (NIDA), Neuroscience Consolidated Operations Acquisition Center (COAC) Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).