SPECIAL NOTICE
A -- Request for Information to Solicit Interest Regarding NIAID Resource "Clinical Laboratory Diagnostics for Invasive Aspergillosis"
- Notice Date
- 3/29/2010
- Notice Type
- Special Notice
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- RFI-HHSN266200700023C
- Archive Date
- 5/15/2010
- Point of Contact
- Alec Ritchie, Phone: 301-402-8643
- E-Mail Address
-
aritchie@niaid.nih.gov
(aritchie@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Request for Information (RFI): To Solicit Interest Regarding NIAID Resource "Clinical Laboratory Diagnostics for Invasive Aspergillosis" Issued by: National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) Purpose: This is a Request for Information (RFI) only and does not constitute a commitment, implied or otherwise, that the Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), will take procurement action in this matter. This is NOT a solicitation for proposals, applications, proposal abstracts, or quotations. The purpose of this RFI is to obtain knowledge and information for project planning purposes only. This RFI shall not be construed as an obligation on the part of the government. Further, neither DHHS/NIH/NIAID nor the Government will be responsible for any cost incurred in furnishing this information. Responses will be accepted through April 30, 2010, and may be sent to the following email address: aritchie@niaid.nih.gov. NIAID is seeking interest from microbial diagnostic product developers in utilizing the NIAID-funded Clinical Laboratory Diagnostics for Invasive Aspergillosis contract (AsTeC). This resource was created to facilitate the delivery of contemporary diagnostics for invasive aspergillosis (IA). AsTeC can perform comparison studies between Food and Drug Administration (FDA)-cleared tests for IA and experimental IA diagnostic tests for potential FDA clearance using a tissue repository of prospectively collected and archived clinical samples from patients at high risk for invasive aspergillosis and from subjects at high risk for IA with potentially interfering medical conditions. The repository will include sufficient samples from cases subsequently meeting established criteria for proven and probable aspergillosis. http://www.astecdiagnostics.org/ Background: Aspergillus accounts for the most deaths due to mould pathogens and is among the top 3 fungal killers in the world. The development of accurate diagnostics for Aspergillus is one of the most important needs in clinical mycology today. The primary goal of the AsTeC resource is to facilitate the comparison of new diagnostic tests for IA towards FDA clearance through this resource, as well as advance the field of contemporary clinical laboratory diagnostics for IA and improve the standard of care for patients at high risk of developing IA. The AsTeC (http://www.astecdiagnostics.org/members) has the capacity to replicate experimental IA diagnostic tests using samples from animal models of IA, the repository, or other clinical sample repositories to determine whether the experimental test performs at previously reported levels of specificity, sensitivity, and limit of detection as well as other parameters. The AsTeC will then perform evaluative studies using the clinical samples in GLP compliant AsTeC laboratories to compare the IA diagnostic test that has been replicated with an FDA-cleared IA diagnostic test. The AsTeC is not a commercial entity and strives to arrange intellectual property positions favorable to the third-party developer. Information Requested: Through this RFI, NIAID is inviting the scientific diagnostic product developers to express their level of interest in availing themselves of this NIAID-supported resource for testing third-party candidate diagnostic tests for IA. Responses: RFI responses must include: 1) Name of the primary point of contact for the response; 2) Academic faculty or business title; 3) Institution or organization affiliation; 4) Email address; 5) Phone; and 6) Identification of other key individuals who collaborated on the RFI response The responses obtained to this RFI will aid the NIAID and AsTeC in maximizing the public health potential from this resource. Disclaimer and Important Notes: 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. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. 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. Any solicitation resulting from the analysis of information obtained will be announced to the public in Federal Business Opportunities in accordance with the FAR Part 5. However, responses to this notice will not be considered 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). Inquiries: Questions about this request for information may be directed to: Alec Ritchie, PhD Diagnostics Development Program Officer Division of Microbiology and Infectious Diseases NIAID/NIH/DHHS 301-402-8643 (Phone) 301-402-2508 (Fax) aritchie@niaid.nih.gov
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- Record
- SN02106233-W 20100331/100329235812-e2d0989ff5f384bcd8728c90323b59af (fbodaily.com)
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