Solicitation Number: RFQ-1071390
Office: Food and Drug Administration
Location: Office of Acquisitions and Grants Services
- Original SynopsisAug 18, 20107:23 pm
The assessment of molecular diagnostic assays as alternative reference methods for premarket evaluation of rapid molecular diagnostic devices for the detection of H5N1 influenza virus, using a small animal model
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Part 12.6 and Part 13. This announcement constitutes the only solicitation and a written solicitation will not be issued. This combined synopsis/solicitation; NAICS code 541380, Testing Laboratories identified as RFQ #1071390, is to notify contractors that the government intends to issue a Firm Fixed-Price Purchase Order in accordance with FAR Part 13.106 for the following scope of work (SOW), under the simplified acquisition procedures. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation.
A. Background & Objective
The office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at the Center for Device Evaluation and Radiological Health (CDRH) of the Food and Drug Administration (FDA) regulates diagnostic devices for Influenza and the Center for Biologics Evaluation and Research (CBER) regulates the in vitro diagnostic devices used for blood donor screening. Rapid diagnosis and accurate detection of influenza is critical for appropriate patient management in the setting of acute respiratory illness and the potential use in the blood donor setting is emerging. Rapid molecular diagnostic methods for the detection of influenza are more sensitive and robust than conventional virus isolation methods and are increasingly replacing these conventional methods in the diagnosis of influenza in clinical practice.
This poses a regulatory challenge to FDA as currently, in order to assess the sensitivity and specificity of investigational influenza devices, it is required that manufacturers compare their devices' performance to virus culture. This study will help assess the use of alternative molecular diagnostic methods as more rapid and accurate reference methods for the premarket evaluation of H5N1 in- vitro diagnostic devices and the potential transmission of H5N1 by blood transfusion from asymptomatic donors.
Unlike other influenza viruses H5N1 exhibits a wide range of pathologic features which suggest that the modes of transmission of this virus may be different. These studies will determine the longevity of presence of infectious H5N1 virus in nasal samples and in blood after primary infection using virus isolation and RT-PCR methods and determine the ability to use sensitive nucleic acid detection methods as a reference method for detection of H5N1 in respiratory specimens. The transfusion of blood from asymptomatic ferrets to naive ferrets will address the knowledge gap in transfusion safety of this virus.
B. Scope of Work
At this time we are seeking a contractor to perform a longitudinal challenge study, by infecting ferrets via a respiratory route and collecting serial nasal wash samples and peripheral blood samples, from H5N1 infected ferrets. Samples are to be collected 12 hours post-infection and then daily until day 10, and at days 15 and 30. All samples must be transported fresh to the FDA to perform be tested for the presence of: (1) influenza virus particles by a conventional virus isolation method (culture); (2) influenza RNA by RT-PCR; (3) Peripheral blood samples from the animal model will also be used to assess the pathogenesis and serological response to help confirm the diagnosis.
The contractor is also expected to collect blood from animals which are PCR positive for H5N1 and negative for virus isolation by culture. This blood will be transfused into naïve ferrets, and the animals will be followed up collecting serial samples for assessment of the presence of Influenza infection following the same protocol described above, to determine potential transmission via this route.
C. Tasks:
The Contractor shall:
1. Infect ferrets with H5N1 virus in their BSL3 facility.
2. Follow up the animals closely collecting respiratory, blood and other tissue samples (as applicable) periodically following the pre-defined protocol and recording any symptoms.
3. Transfuse blood from infected ferrets into naïve ferrets in their BSl3 facility, collecting samples and observing symptoms as per the pre-defined protocol.
4. Record symptoms, collect, and send samples and observational data to the FDA as it becomes available at pre-defined milestones.
Period of Performance:
The contract performance period shall not exceed 2 years.
Animal infection and sample collection: 8 months
Detection of Influenza virus in blood and other samples: 8 months
Transfusion and transmission and detection of Influenza virus: 8 months
Technical Evaluation Factors
The offerors shall demonstrate a thorough understanding of the objectives stated in the Scope of Work and offer a logical program for its achievement. All submitted proposals shall not exceed 10 pages. The contractor will be evaluated based on the following criteria.
1. Possess a facility and appropriate Licensing from the DHHS and all the necessary bio-safety clearance for performing studies with BSL3 agents (particularly Influenza strains) using ferrets. In combination with well documented technical expertise and recent records of experience in performing Influenza virus (H5N1) challenge and viral shedding studies using ferrets as animal model in BSL3 facility. (50%)
2. Having the appropriate infrastructure for collection and transport of samples, and prior experience in performing research for the FDA or other agencies within HHS (40%).
3. Experienced in record keeping and ability to communicate feasibly via phone, FAX, E-mail, and in person. Technical expertise in maintaining and working with electronic records. (10%)
The Government is more concerned with obtaining performance capability superiority rather than lowest overall cost. However, the Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance. Overall cost to the Government may become the ultimate determining factor for award of a contract as quotations become more equal based on the other factors.
CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Duns & Bradstreet number and banking information.
QUESTIONS DEADLINE: All questions are to be submitted via email to: Christopher.Cunningham@fda.hhs.gov no later than 12:00 pm EST Tuesday August 24, 2010.
QUOTATIONS DUE: All quotations are due, via email to: Christopher.Cunningham@fda.hhs.gov , no later than 12:00 pm, EST Tuesday August 31, 2010.
ANTICIPATED AWARD DATE: The anticipated award date is on or about September 2, 2010; however, all dates in this announcement are subject to change.
PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition.
Responses to this notice must be sent via email to Christopher.Cunningham@fda.hhs.gov No phone calls will be accepted.
Rockville, Maryland 20857-0001
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