FBO Notice Date 12/13/18
BIDS Reference Number 191
Document Type: Sources Sought
Research & Development

Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 20892-9559

A -- Early Markers of Alzheimer's Disease: PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA) SOL HHS-NIH-NIDA(AG)-SBSS-75N95019R00019 DUE 122718 POC Fred Ettehadieh, Contracting Officer, Email fred.ettehadieh@nih.govThis is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Yourresponses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

BACKGROUND:

The National Institute on Aging (NIA) initiated amyloid PET imaging with Pittsburgh compound B (PiB) in the Baltimore Longitudinal Study of Aging (BLSA) in 2005 and tau PET imaging with AV-1451 (T-807) in 2016. Consistent with autopsy data from BLSA and other studies, approximately 30% of cognitively normal individuals have detectable amyloid deposition in the brain on PET-PiB imaging. Individuals with higher levels of β-amyloid are older, more likely to carry the Apolipoprotein E ε4 allele, have greater longitudinal decline in memory and other cognitive functions, and are more likely to accumulate amyloid over time. In addition, through the BLSA autopsy program, NIA has shown the correspondence between in vivo imaging and post-mortem values of amyloid burden (13,18). Workby our group has been central to defining the relationship between amyloid burden and memory change (17,23), to characterizing the magnitude and spatial pattern of progression of amyloid burden (2,4,7,11,16), to highlighting the importanceof individuals with intermediate amyloid levels that would be considered PiB negative in many binary classification schemes (7,16), and to identifying modifiers of amyloid burden (3,7,9,10,12,20,21). The NIA has also developed an approach for estimating age at onset of amyloid accumulation, providing an individualizedindex that can be used as a dependent outcome to assess factors that may modifyage at onset of amyloid accumulation (4). This approach was applied to demonstrate that Apolipoprotein E ε4 genotype is associated with earlier age of onset of amyloid accumulation in the BLSA sample.

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.Since 1994, the NIA has been conducting a longitudinal brain imaging study of selected older adults in the BLSA to characterize individual differences in longitudinal brain changes, to investigate the extent to which these brain changes underlie individual differences in cognitive aging, to identify brain changes thatmay be predictors of cognitive decline and Alzheimer's disease (AD), and to assess the impact of potential modulators of brain and cognitive aging. More recently, the NIA has been collecting in vivo measures of brain amyloid and tau, the hallmark pathologies of AD, using PET scanning.

PURPOSE AND OBJECTIVES:

The objective of this requirement is for a better understanding of "age-related" changes also requires definition of the various neuropathologies that accumulate in conjunction with advancing age. NIA collects detailed neuroimaing, as well as cognitive measures in BLSA study participants. NIA acquires measures of regional brain volume (MPRAGE) and vascular lesion burden (T2, FLAIR), white matter integrity (DTI), and functional networks (resting state functional MRI). In alimited number of BLSA participants, NIA also acquire measures of amyloid and tau through PET molecular imaging. The longitudinal assessment of these differentmodalities will provide insights into the neurobiological underpinnings of bothdiseases and age-related cognitive changes. In particular, this information will answer the question of whether accumulating neuropathologies fully account forage-related cognitive change or if there is some degree of age-related cognitive decline that is intrinsic to the aging process, i.e. "normal aging."

Specifically, the purpose is to acquire services to perform and quantify in vivo brain scans, including amyloid and tau neuropathology and regional cerebralblood flow, using Positron Emission Tomography (PET) in the BLSA. Studies of changes in amyloid deposition will be conducted using PET and 11C- Pittsburgh Compound-B (PiB) and studies of changes in tau pathology will be conducted using PETand 18F-T807 from Avid Pharmaceuticals (Lilly).

The following are two goals to satisfy NIA's objective fully:

1. Investigate changes in brain function and amyloid and tau burden as earlybiomarkers of cognitive decline and impairment including Alzheimer's disease.
2. Identify possible protective factors which prevent or delay the onset of cognitive
impairment in individuals who maintain normal cognition despite substantial amyloid and
tau burden.

PROJECT REQUIREMENTS:

NIA will provide structural MRI scans and the Contractor shall perform PET 11C- PiB, and 18F-AV1451 scans and assist in 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 at the NIA 3T MRI facility and will be provided to the Contractor for image processing and analysis. A minimum of 90 scans and a maximum of 120 scans inthe Base year of performance, and a minimum of 120 scans and a maximum of 150 scans for the following four (4) options years is anticipated.

The Contractor shall:

• Perform and assist in quantification of in vivo brain scans, including amyloid and tau neuropathology and regional cerebral blood flow, using Positron Emission Tomography (PET).
• Assist 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.
• Provide Radioisotope administration.
• Provide Medical monitoring of participants during PET scan procedures.
• Provide parking coupon and lunch to research participants.

REPORTING REQUIREMENTS AND DELIVERABLES

The contractor shall provide monthly Data Transfer and Calibration Factors, and Semi-annual Kinetic Modeling and Parametric Distribution Volume Ratio and Annual progress reports.

ANTICIPATED PERIOD OF PERFORMANCE:

The estimated month of award is September 2019 with an anticipated period ofperformance of one (1) year plus four (4) option years.

OTHER IMPORTANT CONSIDERATIONS:

(1) The Government is expected to use procedures in FAR Part 6.302-1 and (2)The North American Industry Classification System (NAICS) Code 541714 with a size standard of 1,000 employees.

CAPABILITY STATEMENT/INFORMATION SOUGHT:

NIA is interested in soliciting capability statements from all qualified Offerors demonstrating their ability to perform this effort. At a minimum, respondents to this notice must provide, as part of their response, a capability statement to include the following: (1) information regarding the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of a similar nature; (d) corporate experience and management capability; and, (e) examples of prior completed Government contracts, references, and other related information; (2) respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code; and, (3) any other information that may be helpful in developing or finalizing the acquisition requirement.

INFORMATION SUBMISSION INSTRUCTIONS:

Respondents should provide responses accordingly: (1) submit information electronically. No telephone or facsimile responses will be accepted; (2) format capability statements using Microsoft Word or Adobe PDF including attachments, resumes, charts, etc. Use single space, 12 font minimum and 8 ½ x 11 size paper; (3) organize material in such a manner that clearly identifies and address capability requirements and provide an executive summary; (4) capability statement should not exceed ten (10) pages including references; (5) respondents must send via email to fred.ettehadieh@nih.gov; (6) responses should be received no later than December 27, 2018 at 4:00 PM (EST); and (7) include respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

DISCLAIMER AND IMPORTANT NOTES

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. 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 to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt ofthe information received or provide feedback to respondents with respect to anyinformation submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

CONFIDENTIALITY

No proprietary, classified, confidential, or sensitive information should beincluded in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

CITE: https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHS-NIH-NIDA(AG)-SBSS-75N95019R00019/listing.html