SOLICITATION NOTICE
R -- Positron Emission Tomography (PET) imaging in Baltimore Longitudinal Study of Aging (BLSA) participants
- Notice Date
- 9/30/2014
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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-15-003
- Archive Date
- 11/17/2014
- 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 on Aging (NIA) intends to negotiate and award a contract for conducting Positron Emission Tomography (PET) imaging in participants involved in the Baltimore Longitudinal Study of Aging (BLSA) in the Intramural Research Program (IRP) at the NIA. EXTENT OF COMPETITION This acquisition is being released on a full and open basis with no set-aside restriction. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541990, All Other Professional, Scientific, and Technical Services with a Size Standard of $15.0 million. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-76 thru August 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. The BLSA was initiated in 1958 and is a multi-disciplinary study of physiologic and psychologic aspects of normal aging in community-dwelling men and women. Active BLSA participants are volunteers who visit the Clinical Unit of the NIA-IRP in Baltimore, MD for testing every 1 to 4 years. 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 we 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. As of September 2012, more than 300 PET-PiB scans have been performed for more than 100 individuals with repeat testing ongoing. This potential requirement allows longitudinal continuation of these PET scan studies to allow the IRP to follow individuals during the period of accelerated risk for cognitive impairment and Alzheimer's disease. 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. This experience shall be demonstrated by publications in scientific journals. Purpose and Objectives - The purpose of this procurement is to acquire services to perform and quantify in vivo brain scans, including amyloid neuropathology and regional cerebral blood flow, using Positron Emission Tomography (PET). Initial studies of changes in amyloid deposition will be conducted using PET and 11C- Pittsburgh Compound-B (PiB). PET will also be used to measure regional cerebral blood flow (rCBF) with 15O-water to allow comparison with prior measures of rCBF in BLSA participants and to provide complementary data for the 11C- PiB studies. In combination with the existing physical and psychological data for BLSA participants, information on changes in rCBF and amyloid deposition in vivo will provide important information on preclinical biomarkers of cognitive impairment and Alzheimer's disease. In addition, this project will provide critical information on accelerated brain and cognitive changes associated with cognitive impairment and the predictors of cognitive decline and cognitive resilience. Studies of individuals who maintain cognitive health in the presence of substantial amyloid burden will provide unique insights into our understanding of predictors of individual differences in age-related cognitive change and possible protective factors that prevent or delay the onset of cognitive impairment. The Contractor shall acquire the PET 15O-water and 11C- PiB neuroimaging scans and shall provide sophisticated quantitative analysis of imaging data, using kinetic modeling techniques. 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 should have the ability to be in close proximation to this facility in Baltimore, MD to allow PET neuroimaging studies to be conducted in conjunction with regular BLSA visits and to the imaging facility to monitor PET scan acquisitions. In addition, this project will provide critical information on accelerated brain and cognitive changes associated with cognitive impairment and the predictors of cognitive decline and cognitive resilience. Studies of individuals who maintain cognitive health in the presence of substantial amyloid burden will provide unique insights into our understanding of predictors of individual differences in age-related cognitive change and possible protective factors that prevent or delay the onset of cognitive impairment. The goals and objectives of any contract for this requirement will include investigating changes in brain function and amyloid burden as early biomarkers of cognitive decline and impairment including Alzheimer's disease. In addition, contractor shall assist in identifing possible protective factors which prevent or delay the onset of cognitive impairment in individuals who maintain normal cognition despite substantial amyloid burden. Period of Performance - The period of performance for any contract resulting from this solicitation is anticipated for one base year and four (4) option years beginning on or around November 1, 2014. A cost reimbursement, cost type of contract is anticipated for any contract resulting from this solicitation. Project Description - The Scope of Work that the Contractor shall achieve includes acquiring PET 50-water and 11C- PiB neuroimaging scans from NIA and providing sophisticated quantitative analysis of imaging data, using kinetic modeling techniques. Structural magnetic resonance (MR) imaging brain scans that are 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 providing: 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. Radioisotope administration. Medical monitoring of participants during PET scan procedures. Provide parking coupon to research participants where necessary. Deliverables will include monthly electronic transfer of raw and reconstructed PET scan images, including rCBF and PET-PiB. As well, calibration factors and any other information necessary for quantification of PET Images will be required on a monthly basis. Semi-annually, contractor will be required to delivery results of kinetic modeling in the form of an excel spreadsheet, and the Parametric Distribution Volume Ratio and R1 images in executing the statement of work. The minimum qualification criteria that the Contractor shall possess includes the following: Ability to assist with scheduling the PET scan studies. Ability to assist with preparation and review of regulatory documents, including materials to meet Institutional Review Board, FDA, and radiation safety regulatory requirements. Ability to manufacture a customized thermoplastic mask for each participant for use with compatible head-holder to reduce participant motion. Ability of producing PET C-PIB radiotracers approved for human administration. Ability to perform radioisotope administration. Ability for medical monitoring of participants during PET scan procedures. Ability to provide sophisticated quantitative analysis of imaging data, using kinetic modeling techniques in the form of an excel spreadsheet. Ability to electronically transfer raw and reconstructed PET Amyloid images. Ability to provide calibration factors and any other information necessary for quantification of PET images. CLOSING STATEMENT The solicitation will be issued on or about October 15, 2014 and bids or 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, Hunter A. Tjugum, electronically at hunter.tjugum@nih.gov. Please reference the solicitation number HHS-NIH-NIDA-SSSA-PSOL-15-003, on your electronic request.
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