SOLICITATION NOTICE
B -- 541690Longitudinal changes in serum auto antigen signatures as predictive biomarkers of Alzheimer’s disease
- Notice Date
- 7/14/2014
- 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, 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA(SS-SA)-2014-PSOL-366
- Archive Date
- 8/2/2014
- Point of Contact
- Rodney E. Brooks, Phone: 3014020751
- E-Mail Address
-
rodney.brooks@nih.gov
(rodney.brooks@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a pre-solicitation non-competitive (notice of intent) synopsis to award a contract without providing for full or open competition (including brand-name). THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The solicitation number is HHS-NIH-NIDA(SS-SA)-2014-PSOL-366 and the solicitation is issued as a pre-solicitation notice of intent to award a non-competitive order to CDI Nextgen Protecmics, Guanajibo Research & Innovation Park, 4005 St B RD PR, Mayagues, PR 00682. This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-05-73, dated April 29, 2014. A notice regarding any set-aside restrictions, the associated NAICS 333314 code and the small business size standard is 500 employees. This acquisition is being conducted in accordance with the procedures of FAR Part 13-Simplified Acquisition Procedures, FAR Subpart 13.5-Test Program for Certain Commercial Items, and FAR Part 12-Acquisition of Commercial Items. The National Institutes of Health, National Institutes on Aging intends to procure on a sole source basis a service agreement to continue the study for longitudinal changes in serum auto antigen signatures as predictive biomarkers of Alzheimers disease. Purpose and Objectives: 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. We investigate structural and functional brain changes and how they relate to age-associated changes in cognition, and factors that modify cognitive and brain aging. The mission of the LBN is: (1) to conduct basic and clinical research on individual differences inbrain structure, function and cognitive abilities; (2) to investigate the influence of age on these variables, using both cross-sectional and longitudinal designs; and (3) to identify predictors of cognitive decline and Alzheimer's Disease, including both risk and protective factors for cognitive and brain aging. The purpose of this work requirement will be to investigate the diagnostic and prognostic utility of longitudinal changes in serum autoantigen profiles in Alzheimer's disease (AD). The research plan will be conducted as outlined below. Study Design: The proposed study is based on interim analysis of a recently completed longitudinal pilot study performed by CDI Laboratories on serum samples from the Baltimore Longitudinal Study of Aging (BLSA). These results indicate a dynamic and robust auto-antigen response in patients with AD relative to healthy control subjects. Based on analysis of data from this study carried out by CDI on serum samples from the BLSA, it is determined that a larger confirmatory study with additional serum samples will provide definitive information on the utility of longitudinal changes in serum autoantigens as predictive biomarkers of AD. This study will target approximately 75 autoantigens that emerge from the pilot study as the most promising predictive biomarkers of AD. The experiments will be performed on serum samples from 100 AD patients and 100 healthy controls (3 time points each). The contractor shall provide the following: • all resources necessary to accomplish the tasks and deliverables. • Perform targeted autoantigen profiling on 600 serial serum samples collected from the Baltimore Longitudinal Study of Aging (BLSA) using focused HuPROT protein arrays. • Perform hybridization of 86 focused HuPROT arrays containing defined protein targets • Grid alignment on 86 focused HuPROT arrays • Generating Genepix GPR data files from focused HuPROT arrays DELIVERY OR DELIVERABLES 1.Description of Tasks and Associated Deliverables: • Perform serum autoantigen profiling in AD and control samples on CDI's focused HuPROT array platform containing approximately 75 pre-selected protein targets (anticipated completion: 4-weeks from start of project). • Generate a list of ‘positive' antigen hits in AD and control samples (anticipated completion: 6-weeks from start of project). • Generate Genepix GPR data files for all proteins present on CDI's focused HuPROT array on serum samples provided by NIA (anticipated completion: 8-weeks from start of project). 2. Reporting Requirements: The contractor shall provide a written progress reports every 1 month for the contract period 9/30/14 through 9/29/15. 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. Place of Performance: Guanajibo Research and Innovation Park 4005 Street B Road 114 Km 1.3 Mayaguez, P.R. 00682 The provision of FAR clause 52.212-1, Instructions to Offerors - Commercial Items (July 2013), applies to this acquisition. The provision of FAR clause 52.212-2, Evaluation - Commercial Items (January 1999), applies to this acquisition. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The Offeror must include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (August 2013), with its offer. The FAR clause is located at http://www.acquisition.gov/far/. FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (September 2013), applies to this acquisition. There are no additional contract requirement(s) or terms and conditions determined by the contracting officer to be necessary for this acquisition and consistent with customary commercial practices. This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. 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." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. Respondents that believe that they are manufacturers or authorized resellers of the brand-name product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order. All responses must be received by July 18, 2014 at 12:00pm EST and must reference number HHS-NIH-NIDA(SS/SA)-2014-PSOL-366. Responses may be submitted electronically to rodney.brooks@nih.gov "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."
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