Contact Points
Nashville, TN 37232-0011
This notice of proposed acquisition is posted as an intent to award a purchase order on a non-competitive basis to Vanderbilt University Medical Center. The main objective of the requirement is to investigate sex differences in genetic risk scores in the Baltimore Longitudinal Study of Aging (BLSA) in relation to newly acquired plasma biomarkers of AD pathology and neurodegeneration. The required service is analyses of imaging data using specific software, which the proposed Contractor has already employed with prior BLSA plasma biomarker data for amyloid-beta, GFAP and NfL. Familiarity with BLSA cognitive and imaging data are required for continuity of analytic approaches for cognitive and imaging data, as well as expertise with the novel proposed analytic methods. No source other than Timothy Hohman, Ph.D. Assistant Professor of Neurology Vanderbilt Memory & Alzheimer’s Center can meet the requirements of this contract because familiarity with BLSA cognitive and imaging data are required for continuity of analytic approaches for cognitive and imaging data, as well as expertise with the novel proposed analytic methods. Dr. Hohman is uniquely qualified because he has worked extensively with BLSA imaging and cognitive data while a predoctoral fellow in NIA Brain Aging and Behavior Section (BABS), and he is expert in the application of the proposed novel PrediXcan approach.
Background Information and Objective:
This acquisition is being conducted under the Federal Acquisition Regulations (FAR)Part 13 - Simplified Acquisition Procedures, and the resultant contract award will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2022-07 dated August 10, 2022.
The purpose of the overall program of research in the Laboratory of Behavioral Neuroscience (LBN) is to enhance our understanding of age-associated physical and biological changes in health and disease. BABS within LBN/NIA investigates structural and functional brain changes and how they relate to age-associated changes in cognition, including the development of Alzheimer’s disease (AD), and factors that modify cognitive and brain aging. Given that women have a higher prevalence of AD, BABS investigators are particularly interested in potential sex differences in brain and cognitive aging.
Recent work performed by the Vanderbilt Memory & Alzheimer’s Center has identified a sex difference in the association between CSF and pathology-based biomarkers of Alzheimer’s disease neuropathology and longitudinal changes in brain structure and cognitive function (Koran et al., 2016). Moderating effects of the APOE genotype on the observed sex differences were also observed, suggesting that there may be unique molecular drivers of cognitive decline and neurodegeneration in males and females. Recently, they found that men actually had steeper rates of cognitive decline in some cognitive functions and that there were no cognitive functions for which women showed steeper decline. These findings highlight the importance of further investigation of sex differences in associations of biomarkers of preclinical AD during the earliest stages of the disease process with brain and cognitive aging.
This requirement will extend prior work by using newly acquired ptau plasma biomarkers of AD pathology (ABeta, GFAP and NfL) and neurodegeneration in the BLSA to investigate sex differences in genetic predictors of AD and neurodegeneration in relation to brain and cognitive aging. The outcome of this work will highlight sex dimorphic AD and neurodegeneration pathways related to ptau that drive cognitive and brain aging.
SCOPE OF WORK
General Requirements:
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:
This requirement will involve first, replicating sex differences in the association between AD biomarkers and brain aging outcomes using newly acquired plasma biomarker data of ptau from the BLSA. Sex interactions of genetic predictors of plasma ptau on longitudinal cognition and brain volumes will be investigated. Second, analyses will be performed to investigate sex-specific genomic drivers of cognitive impairment in the presence of enhanced biomarkers of AD and neurodegeneration.
Specific Requirements:
Specifically, the Contractor will perform the following services:
- The Contractor will first use plasma ptau to replicate prior findings of sex differences in genetic risk in relation to amyloid and tau pathology based on CSF biomarkers and neuropathology studies.
- The contractor will next perform analyses to investigate sex-specific genomic drivers of cognitive and brain aging in the presence of enhanced AD and neurodegeneration biomarkers. This analysis will require a classic genome-wide association analysis approach in combination with an innovative predicted gene-expression analysis called PrediXcan (Gamzon et al, 2015). The PrediXcan approach will be used to build SNP prediction models for tissue-specific gene expression levels and “impute” gene expression levels based on genotype.
LEVEL OF EFFORT:
Researcher in the field of Neurology will be needed for approximately 188 hours over one year.
GOVERNMENT RESPONSIBILITIES
Provide plasma ptau biomarker data and imaging data, as well as other necessary information, including diagnostic data, for analysis of genetic data in relation to biomarkers, brain volumes, cognition and affect. All data will be de-identified. Data transfer will follow BLSA procedures for data sharing.
DELIVERY OR DELIVERABLES
Planned Deliverables:
1) Tissue-specific predicted gene expression profiles in BLSA.
2) Replication of sex and APOE interactions with plasma biomarkers of ptau and neurodegeneration on longitudinal brain aging outcomes.
3) Preparation of a novel report on sex-specific molecular drivers of the relation between plasma ptau and cognitive decline.
REPORTING REQUIREMENTS
12 months from the start of project:
-
- Reports in manuscript format describing results of each of the deliverables.
- Excel spreadsheet with gene expression profiles.
OTHER CONSIDERATIONS
Key Personnel:
Researcher in the field of Neurology
Data Rights:
The National Institute on Aging shall have unlimited rights , and ownership of all deliverables provided under this contract including reports, recommendations, briefings, work plans and all other deliverables. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General, ” is hereby incorporated by reference and made a part of this contract/order.
Contract Type: A Firm Fixed Price (FFP) Purchase Order award not exceeding the Simplified Acquisition Threshold is anticipated from any contract resulting from this requirement.
Summary Statement:
The Unique Entity Identifier (UEI), the Taxpayer Identification Number (TIN), place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture), certification of country of ownership, and the certification of business size must be included in the response.
All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.”
Quote Terms and Conditions (To be completed by the Offeror):
1. Period of Performance OR Delivery Date After Receipt of Order:
2. Shipping Point (F.O.B. OR Destination):
3. Payment Discount Terms:
4. NIH BPA Number, if applicable:
5. UEI Number
6. Name of Company:
7. Street Address, City, State, Zip code:
8. Name of Person Authorized to Provide Quote:
9. Telephone Number and Email Address of Person Authorized to Provide Quote:
ADDITIONAL TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS
The FAR Clauses are incorporated by reference and are provided in full text at https://www.acquisition.gov/
- FAR Provision 52.212-1 Instructions to Offerors—Commercial Items (Nov 2021) is applicable to this solicitation.
- FAR Provision 52.212.2 Evaluation—Commercial Items (Oct 2014) is applicable to this solicitation. The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: Technical capability of the item offered to meet the Government requirement; Price; and Past performance [see FAR 13.106-2(b)(3)]
- FAR Provision 52.212-3, Offeror Representations and Certifications—Commercial Items (Nov 2021), is applicable to this solicitation
- FAR Clause 52.213-4, Terms and Conditions- Simplified Acquisitions (Other than Commercial Products and Commercial Services). (JAN 2022).
- FAR Clause 52.227-14, Rights in Data-General
In addition, the following FAR provisions and clauses are applicable to this solicitation and incorporated by reference:
52.204-7 System for Award Management (Oct 2018),
52.204-13 System for Award Management Maintenance (Oct 2018),
52.204-16 Commercial and Government Entity Code Reporting (Aug 2020),
52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020),
HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015)
The following provisions and clauses apply to this acquisition and are incorporated as an attachment. Offerors MUST complete the provision at 52.204-24 and 52.204-26 and submit a completed copy as a separate document with their quotation.
1. FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020)
2. FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video surveillance Services or Equipment (Aug 2020)
3. FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020)
4. NIH Invoice and Payment Provisions
All responses must be received by September 5, 2022 at 3PMEST and must reference announcement / solicitation number 22-011260. Responses may be submitted electronically to Jacqueline Newman (Jacqueline.newman@nih.gov). Fax responses will not be accepted.
Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.
All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.
All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.