SOLICITATION NOTICE
R -- Early Markers of Alzheimer Disease: PET Tau Imaging in BLSA participants
- Notice Date
- 8/14/2014
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-PSOL-14-410
- Archive Date
- 9/10/2014
- Point of Contact
- Hunter A. Tjugum, Phone: 301 435 8780, ,
- E-Mail Address
-
hunter.tjugum@nih.gov, NIDASSSAPurchaseRequ@mail.nih.gov
(hunter.tjugum@nih.gov, NIDASSSAPurchaseRequ@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION. The National Institute on Drug Abuse (NIDA), Station Support Contracts and Simplified Acquisitions Branch (SS/SA) on behalf of the National Institute of Aging (NIA) intends to negotiate and award a contract for Early Markers of Alzheimer's Disease: PET Tau Imaging in Baltimore Longitudinal Study of Aging (BLSA) participants. EXTENT OF COMPETITION This acquisition is being released on a full and open basis with no set aside restrictions. The intended procurement is classified under NAICS code 541690 Other technical and scientific consulting services with a Size Standard of $14.0 million. The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-76 dated July 25, 2014. This acquisition is conducted under the procedures as prescribed in FAR subpart 15-contracting by Negotiations at an amount exceeding the simplified acquisition threshold ($150,000). DESCRIPTION OF REQUIREMENT Background The National Institute on Aging (NIA), one of the 27 Institutes and Centers of NIH, leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life. The Intramural Research Program (IRP) of the National Institute on Aging (NIA) provides a stimulating setting for a comprehensive effort to understand aging through multidisciplinary investigator-initiated research, in this regard. Since 1994, the NIA have investigated changes in brain structure and function as predictors of cognitive decline and Alzheimer Disease (AD) through longitudinal neuroimaging assessments of selected participants from the Baltimore Longitudinal Study of Aging (BLSA). Magnetic Resonance Imaging, Positron Emission Tomography (PET), and neuropsychological testing have been performed annually or biennially for the neuroimaging substudy participants, aged 55 and older. Since 2005 the NIA have performed amyloid imaging studies with PET and 11C-PiB for approximately 125 individuals to date with more than 300 scans and up to 7 repeated assessments. With the recent development of radiotracers to image tau/neurofibrillary tangle pathology in vivo with PET, the current procurement aims to acquire PET Tau imaging in participants who will receive amyloid imaging, approximately 50 BLSA studies per year. The addition of PET Tau imaging will allow us to measure both pathological hallmarks of AD in well-characterized BLSA participants and will allow prospective investigation of the temporal trajectories of these pathologies in relation to longitudinal memory change. Evaluation criteria will include demonstrated experience in high resolution brain PET imaging and kinetic modeling for image quantitation, including quantitation of new radiotracers not yet approved for clinical use. Prospective Offerors will also be evaluated on evidence of publication of relevant work in scientific journals. Purpose and Objectives The purpose of this project is to acquire services to perform and quantify in vivo PET scans using a radiotracer that binds the Tau pathology characteristic of Alzheimer's disease. This study will include approximately 50 PET Tau scans per year of participants from the BLSA, who are also undergoing PET amyloid imaging studies. The Scientific Aims are to (1) investigate changes in both amyloid and tau pathology in relation to memory change and the development of cognitive impairment; and (2) identify possible protective factors which prevent or delay the onset of cognitive impairment in individuals who maintain normal cognition despite substantial Alzheimer's type neuropathology measured by in vivo PET imaging. Period of Performance The period of performance will be one base year beginning on or around September 30, 2014 with the option to exercise four (4) additional one year periods of performance. Project Description Scope of Work: The purpose of this project is to acquire services to perform and quantify in vivo brain PET scans of Tau pathology, using a radiotracer that binds Alzheimer's type tau pathology. Initial studies of changes in tau pathology will be conducted using PET and 18F-T807 from Avid Pharmaceuticals (Lilly). The Contractor shall acquire the PET Tau neuroimaging scans and shall provide sophisticated quantitative analysis of imaging data, using kinetic modeling techniques. Quantitative results shall include data with and without MRI-based partial volume correction. Structural magnetic resonance (MR) imaging brain scans necessary for any image analysis will be acquired by the NIA-IRP at the NIA 3T MRI facility and will be provided to the Contractor for image processing and analysis. The Contractor also shall be responsible for: • Assistance with scheduling the PET scan studies • Assistance with preparation and review of regulatory documents, including materials to meet Institutional Review Board, FDA, and radiation safety regulatory requirements • Manufacture of a customized thermoplastic mask for each participant for use with a compatible head-holder to reduce participant motion • Capability of producing PET radiotracers approved for human administration • Radioisotope administration • Medical monitoring of participants during PET scan procedures • Provide parking coupon to research participants where necessary The Contractor must be located in close proximity to the NIA Intramural Research Program in Baltimore Maryland to allow PET neuroimaging studies to be conducted in conjunction with regular BLSA visits. Moreover, close proximity is also necessitated by the need for frequent visits to the imaging facility by the Project Officer or his designate to monitor the PET scan acquisitions. Deliverables will include monthly Electronic transfer of raw and reconstructed PET Tau images, and Calibration factors and any other information necessary for quantification of PET images. Deliverables will include semi-annual Results of kinetic modeling with and without partial volume correction in the form of an excel spreadsheet, and Parametric PET Tau images. Contractor will also be required to provide an annual progress report. The progress report shall provide the numbers of PET scans completed during the specified period. The report shall identify any problems that arose and a statement explaining how the problem was resolved. CLOSING STATEMENT The solicitation will be issued on or about August 26, 2014 and proposals will be tentatively due about 30 days after the solicitation release date. Potential offerors may request a copy of the solicitation from the Contract Specialist for this solicitation electronically at hunter.tjugum@nih.gov or by fax on 301-480-1358. Please reference the solicitation number HHS-NIH-NIDA-SSSA-2014-410 on your electronic and fax request.
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