This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made because of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.

Background / Purpose / Objective: The National Institute on Aging (NIA) is conducting research on Alzheimer's disease there is currently a pressing need to identify biomarkers of Alzheimer's disease (AD) and understand mechanisms of AD pathogenesis. Recent studies on human brain tissue samples in the Baltimore Longitudinal Study of Aging (BLSA) reveal several metabolic abnormalities in brain regions vulnerable to AD pathology. Some of these abnormalities may present novel targets for effective disease-modifying AD treatments. NIA now wish to extend these findings by confirming them in a larger set of samples in the BLSA as well as in an independent cohort i.e. Religious Orders Study (ROS). Using capillary electrophoresis time-of-flight mass spectrometry (CE-TOFMS) on human brain tissue samples, NIA have identified several metabolic abnormalities in AD including in polyamine biosynthesis and transmethylation reactions. Prior to testing whether correcting these abnormalities in experimental models may be of utility as novel treatments, it is essential to confirm these novel findings in a larger sample size and in independent cohorts. In the proposed acquisition, the objective is to apply the same techniques as in the original study to confirm index results in BLSA and ROS-derived brain tissue samples.

Project 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.

The main objective of the requirement is but not limited to the following: (1) Measure the concentration of polar and hydrophilic small metabolites in three hundred and ninety-four (394) human brain tissue samples using capillary electrophoresis time-of-flight mass spectrometry (CE-TOFMS). The measurement shall be through advanced scan reporting and absolute quantitation. The list of metabolites to be assayed is attached separately; (2) For each of the above services, the contractor shall also perform statistical analyses of the utility of the metabolites as markers of resilience to Alzheimer's Disease (AD) pathology. The contractor shall provide its interpretation, including annotation of relevant biological pathways, of the likely role(s) of the assayed metabolites in AD; and (3) Return all unused specimens to their place of origin.

Level of Effort: The level of effort is for a Senior Research for 960-labor hours for the 12-month period of performance.

Government Responsibilities: Provide adequate quantities of archived brain tissue samples to the contractor to enable the performance of the metabolomics assays detailed above.

Delivery or Deliverables: Electronic copy of excel spreadsheet including absolute concentrations of all assayed metabolites to be delivered within 364 calendar says of receipt of samples by the contractor. The timely submission of this deliverable is essential to successful completing this requirement.

Reporting Requirements: The contractor is required to provide written progress reports every 2 months for the contract period 9/30/19 through 9/29/20. The progress report shall cover all work completed during the specified period and shall present the work to be accomplished during the subsequent period. This report shall also identify any problems that arose and a statement explaining how the problem was resolved. This report shall also identify any problems that have arisen but have not been completely resolved and provide an explanation.
Reports should be as follows: (1) Excel spreadsheet with absolute brain tissue concentrations for metabolites listed above on all brain samples provided to the contractor; (2) WORD document detailing all the technical aspects of the experimental methodology used including coefficients of variation (CV) of the assays, specimen usage, and success/failure rate of the assay; and (3) WORD document summarizing the clinical utility measures of the best serum and brain metabolite markers associated with AD.

Data Rights: The National Institute on Aging shall have unlimited rights to 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.

Technical Criteria: Factor 1: Technical Approach. The Contractor's proposal shall address each area of the statement of work requirements in sufficient detail to demonstrate a clear understanding of the efforts to be performed and the skill level required to perform them. Approach shall be evaluated for expertise in mass spectrometry-based quantitative assay methodology outlining capability to assay the specific metabolites/metabolite classes specified in the SOW. Capability in these areas shall be viewed favorably. Factor 2: Past Performance: The Contractor shall provide details of at least one prior project on frozen human brain tissue samples that assayed the specific metabolites/metabolite classes specified in the SOW. Past Performance shall be evaluated for relevance to the current requirement.

Anticipated period of performance / delivery date: The Government anticipates the month of award is September 2019 for a 1-year period of performance.

Other important considerations: The response may cite any other information that is necessary for potential respondents to understand the nature of the potential requirement or proposed acquisition.

Capability statement /information sought. The government 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) DUNS number; (6) respondents must send via email to Debra C. Hawkins Contractor, Acquisition Policy Analyst II, at [email protected]; (7) responses should be received no later than August 16, 2019, 12:00 Noon Eastern Time; and (8) 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 provide the product or perform the services specified herein. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation 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 be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).