MODIFICATION
B -- The assessment of molecular diagnostic assays as alternative reference methods for premarket evaluation of rapid molecular diagnostic devices for influenza
- Notice Date
- 8/23/2010
- Notice Type
- Modification/Amendment
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- RFQ-1071222
- Archive Date
- 9/14/2010
- Point of Contact
- Christopher E. Cunningham, Phone: 301-827-7185, Doreen Williams, Phone: 301-827-3366
- E-Mail Address
-
christopher.cunningham@fda.hhs.gov, doreen.williams@fda.hhs.gov
(christopher.cunningham@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Project Title: The assessment of molecular diagnostic assays as alternative reference methods for premarket evaluation of rapid molecular diagnostic devices for influenza 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 #1071222, 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. This is an unrestricted requirement. 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. Objective The office of In Vitro Diagnostics Device Evaluation and Safety (OIVD) at the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) regulates diagnostic devices for Influenza. Rapid diagnosis of influenza is critical for appropriate patient management in the setting of acute respiratory illness. 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 since currently the determination of sensitivity and specificity of an investigational influenza devices are based on the comparison of the manufacturer's new device to virus culture. This study will determine if it is possible to use alternative molecular diagnostic methods as more rapid and accurate reference methods for the premarket evaluation of influenza devices. It will provide information that could support a paradigm shift on the Agency's review of these devices. Understanding the association between infectious virus and the presence of nucleic acid is essential both for FDA review of newer diagnostic technologies and for properly describing how nucleic acid tests should be used in clinical practice. This project addresses the public health needs as it seeks to expedite and improve the regulatory mission of OIVD through accelerating the availability of safe and effective rapid influenza diagnostic devices. Rapid influenza diagnostic devices are of critical importance, since novel strains of influenza virus have quickly emerged and spread (e.g., recent 2009 H1N1 has). B. Scope of Work At this time we are seeking the use of contractors to perform a prospective longitudinal clinical study, collecting respiratory samples e.g., nasal swab samples, from patients clinically diagnosed with influenza during the Influenza season. The basis for confirmation of influenza infection should follow the current standard of care practices including the clinical presentation. Any laboratory tests or testing algorithms used as an aid in the confirmation of active infection should be clearly described as part of the clinical protocol prior to the initiation of the study. It is required that the diagnostic tests used to confirm diagnosis are FDA cleared assays. The contractor shall obtain their own IRB approval for the study and provide us with the clinical specimens de linked and de identified. The date of sample collection, demographic information, clinical symptoms, and days from the onset of symptoms are required. The nature of the required study is such that samples will be collected initially at the onset of infection and follow up samples will be collected at subsequent time points for up to two weeks after the initial infection. The contractor should have the ability to follow up with the patients for up to 30 days after infection. The target number of patients to be included in the study is 60 patients, immunocompetent individuals (not transplant patients), and we do not have an age restriction. We expect to evaluate the different strains of influenza circulating in the season. However, we plan to stratify the results by age groups and patients infected by the 2009 H1N1 and other seasonal influenza strains. The contract should include a detailed description of the parameters the contractor will use to determine the acute phase of the infection. The contractor should be able to collect the initial nasal samples within three days of symptom onset. Patients have to be followed up obtaining longitudinal samples daily for the first three days post infection and then biweekly for the first two weeks. The proposal should propose a detailed sample collection plan, indicating the time points the contractor is able to include and the appropriate justifications or limitations as applicable. Samples should be shipped fresh to the FDA to perform virus isolation by cell culture and RT-PCR analysis and the proposal should provide a description of the sample shipping plan. We recommend that sample collection and shipment protocols follow standardized guidelines. The contractor should be an entity with recognized academic expertise in the field of Influenza diagnostics and molecular epidemiological studies. It is recommended that the contractor has prior experience in performing viral shedding studies. Prior to the initiation of the clinical study the contractor is required to share knowledge and expertise as well as provide proficiency panels, virus strains or well characterized samples for the validation of FDA's virus culture and RT-PCR methods and the contractor shall be available to communicate and share expertise and discuss the progress and findings of the study. The proposal should indicate the expected deliverables, required budget, payment schedules, and timelines as well as the periodic reporting and communication scheme with the FDA. C. Tasks: The Contractor shall: 1. Perform a longitudinal viral shedding collection study during the influenza season, enrolling patients and collecting nasal samples from patients diagnosed with influenza at the onset of symptoms and subsequently for the first two weeks after infection. 2. Provide proficiency panels or material for the validation of virus isolation and PCR tests used at the FDA. 3. Interact, communicate, and share knowledge and expertise as needed throughout the study period. Deliverables: The contractor shall: • Provide the FDA with a detailed study plan • Execute the clinical study; deliver specimens and the required clinical and demographic information to the FDA. • Provide materials and share resources and expertise in developing and validating the diagnostic tests at the FDA. • Share expertise in the data analysis and reporting of results. Assignments and deliverables are at the discretion of the Principal Investigator of the project at OIVD. The principal investigator will coordinate with the Project Officer, serving as the technical representative responsible for validating the quantity and quality of services received, as well as certifying receipt of required deliverables. Period of Performance: The contract performance period shall not exceed two years. Evaluation: Technical Evaluation Factors The offerors shall show thorough understanding of the objectives stated in the Scope of Work and offer a logical program for its achievement. The technical proposals will be evaluated on the following. All submitted proposals shall not exceed 10 pages. The contractor will be evaluated based on the following criteria. 1. The ability to demonstrate a high level of technical expertise and record of recent successful experience in performing longitudinal Influenza virus shedding in clinical studies in immunocompetent individuals along with having the appropriate infrastructure for storage and shipping samples in place. (50%) 2. The ability to demonstrate excellent research expertise and scientific records in the application of and evaluation of FDA cleared in- vitro diagnostic methods for Influenza; including molecular diagnostic tests. (40%) 3. Demonstrated experience in record keeping and ability to communicate feasibly via phone, fax, e-mail, and in person. Technical expertise required 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 Wednesday August 25, 2010, 12:00 pm EST. QUOTATIONS DUE: All quotations are due, via email to: Christopher.Cunningham@fda.hhs.gov, no later than 12:00 pm, EST on Monday August 30, 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/RFQ-1071222/listing.html)
- Record
- SN02250540-W 20100825/100823234709-2b115f88a8d382c8b94449180f41e739 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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