SOURCES SOUGHT
A -- Clinical Laboratory Diagnostics for Invasive Aspergillosis
- Notice Date
- 11/17/2005
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Program 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- Reference-Number-SS-RFP-NIAID-DMID-07-13
- Response Due
- 12/1/2005
- Archive Date
- 12/16/2005
- Description
- THIS NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT A REQUEST FOR PROPOSALS AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON CAPABILITY STATEMENTS RECEIVED FROM THIS SOURCES SOUGHT THIS ACQUISITION MAY BE SOLICITED AS AN 8(a) SET-ASIDE; 100% SMALL BUSINESS SET-ASIDE OR AS FULL AND OPEN. ALL SIZE ORGANIZATIONS ARE ENCOURAGED TO RESPOND. THE NAICS CODE IS 541710 WITH A SIZE STANDARD OF 500 EMPLOYEES. The Division of Microbiology and Infectious Diseases (DMID), of the National Institutes of Allergy and Infectious Diseases (NIAID), of the National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS), is seeking contractors interested in providing the effort to advance the field of contemporary clinical laboratory diagnostics for Invasive Aspergillosis (IA). Diagnosis and treatment of serious fungal infections are high priorities of the NIAID. Systemic fungal infections are a significant health problem in immunocompetent hosts (the endemic mycoses) and immunocompromised hosts (the opportunistic mycoses in addition to the endemic mycoses). The burden of invasive fungal disease in the U.S. has shifted from the community to the hospital base. These are recognized as important emerging infectious diseases, especially in nosocomial settings involving the management of bone marrow and solid organ transplant recipients, neutropenic cancer patients, and surgical, trauma and critical care patients. Fungi cause approximately ten percent of nosocomial bloodstream infections. This contract will link the appropriate clinical specimens (blood, urine, etc.) from patients at risk for IA and potentially interfering medical conditions to currently available and experimental laboratory tests for the purposes of diagnostic proof of principle, test comparison and evaluation. Respondants are required to demonstrate relevant experience in establishing and operating a clinical sample repository in accordance with the Office for Human Research Protections (OHRP) guidelines, access to human subjects at high risk for developing Invasive Aspergillosis that must include subjects receiving hematopoietic stem cell transplantation therapy and subjects at high risk for IA with potentially interfering medical conditions that must also include subjects receiving hematopoietic stem cell transplantation therapy, personnel with experience in Good Clinical Practices and collection of samples from human subjects, personnel with experience in Good Laboratory Practices and diagnostic test development, and adequate facilities. The contractor will be expected to achieve these goals through the establishment and maintenance of a repository of clinical samples from patients at risk for IA and by performing evaluation and comparison studies between FDA-licensed tests for IA and experimental IA diagnostic tests. Organizations that submit capability statements in response to this notice will be evaluated against the adequacy of their training, experience, expertise and availability of the proposed PI, including technical and management skills, knowledge of applicable regulations to manage a GCP and GLP compliant clinical sample repository and ability to direct GLP compliant test studies along with personnel that have appropriate GCP and GLP training. The organization should have access to patient populations at risk for Invasive Aspergillosis (IA) such that it is highly probable that serial clinical samples will be collected from at least 30 subjects diagnosed with proven IA during the first three years of the contract. A potential offerer would be asked to provide a cost-effective plan for obtaining and storing samples from subjects at risk for developing IA and provide documented evidence of all collaborations/consortiums that will be formed to collect and/or store specimens. Patient populations must include bone marrow transplant patients and may also include neutropenic cancer patients, and solid organ transplant recipients. You should address staff expertise in the collection of clinical research samples and medical information in a GCP compliant manner along with an understanding of the OHRP guidelines for the operation of a repository. You should have experience in the storage, retrieval and distribution of samples and would be expected to provide personnel, facilities (clean rooms, laboratories, storage area, etc.), and equipment (freezers, refrigerators, etc.) available for preparing the samples and the repository, along with a system that will be used to track samples in the repository. Potential offerors should have an understanding of state, federal and international shipping regulations, validation testing for cold chain shipping containers, preparing SOPs based on the results of validation testing, preparation of all shipping documents and preparing SOPs for recipient to properly store the samples. You would be expected to have experience in the techniques used in published laboratory tests available to detect Aspergillus fumigatus to include PCR and other technologies that could potentially be used to develop IA diagnostic tests, expertise in performing and interpreting the results from the Bio-Rad PlateliaTM Aspergillus EIA test, and access to samples required for replication studies (IA animal model or samples from previous IA clinical studies. It is estimated that approximately 6 FTEs will be required for the performance of this project over a 7-year period of performance. Interested small business organizations that believe they possess the capabilities necessary to undertake this project should submit two (2) copies of their capability statement, addressing the areas above. Capability statements must identify the business status of the organization (i.e. educational institution, non-profit, large business, small business, 8 (a), or other corporate or non-corporate entity). NO COLLECT CALL WILL BE ACCEPTED. RESPONDENTS MAY SUBMIT THEIR CAPABILITY STATEMENTS VIA E-MAIL OR FAX. See NUMBER NOTE 25.
- Record
- SN00933559-W 20051119/051117211758 (fbodaily.com)
- Source
-
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