MODIFICATION
Q -- Measurement of p16 in T cells/CD3+ cells from the Baltimore Longitudinal Study on Aging (BLSA) participant samples.
- Notice Date
- 2/24/2021 8:00:12 AM
- Notice Type
- Solicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95021Q00060
- Response Due
- 3/3/2021 12:00:00 AM
- Archive Date
- 03/18/2021
- Point of Contact
- Jeanette Russll, Phone: (301) 827-5140
- E-Mail Address
-
Jeanette.Russell@nih.gov
(Jeanette.Russell@nih.gov)
- Description
- NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: Measurement of p16 in T cells/CD3+ cells from the Baltimore Longitudinal Study on Aging (BLSA) participant samples. (i)�������� This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii)������� The solicitation number is 75N95021Q00060� and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13�Simplified Acquisition Procedures; FAR Subpart 13.5�Simplified Procedures for Certain Commercial Items; and FAR Part 12�Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).� The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National Institute on Aging (NIA), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Sapere Bio, Inc. at 400 Park Offices Dr Ste 113 Durham, NC 27709 for the measurement of p16 in T cells/CD3+ cells from the Baltimore Longitudinal Study on Aging (BLSA) participant samples. This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). Pursuant to FAR Subpart 13.501(a)(1)(iii) the justification (excluding brand name) will be made available within 14 days after contract award or in the case of unusual and compelling urgency within 30 days after contract award. (iii)������ The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2021-03, with effective date� February 16, 2021. (iv)�������� The associated NAICS code 621511 and the small business size standard is $35 million.� No set-aside restriction is applicable. (v)������� Background: �The National Institute on Aging (NIA), Laboratory of Clinical Investigation (LCI) is evaluating medical conditions related to a rise in age-related diseases and the urgent need to understand, prevent, and treat these medical conditions. One method of evaluation is evaluating samples taken from the Baltimore Longitudinal Study on Aging (BLSA) participants. Fresh blood samples will be obtained from the BLSA participants admitted at the NIA at Harbor Hospital, in Baltimore MD and the LCI wet lab team will isolate and sort cells.The Contractor shall measure and evaluate the samples, and the Contractor will provide the NIA with the sample results. Purpose and Objectives: P16 is an important biomarker cellular senescense. In several publications it has been demonstrated that the measurement of p16 Tcells/CD3+ cells has clinical utility in identifying individuals at risk for age-related complications. The NIA, LCI will evaluate the cellular senescence from theBaltimore Longitudinal Study on Aging (BLSA) participants. Fresh blood samples will be obtained from the BLSA participants admitted at the NIA at Harbor Hospital, in Baltimore MD. The LCI wet lab team will perform an isolation of the peripheral blood mononuclear cells (PBMCs), and consequentially sort CD3+ cells using magnetic bead bound to specific antibodies. Frozen aliquots of CD3+ cells will be sent from the NIA to the Contractor 4 times a week in a batch of 40 samples each at a total of 160 samples. It is crucial for the Contractor to isolate the T cells/CD3+ as it has been demonstrated that the level of p16 expression in other PBMC populations (e.g. in monocytes) is too low. It is also crucial to sort the T cells/CD3+ from fresh blood vs frozen because it has been demonstrated that PBMCs can be thawed and intact T cells isolated using traditional cell sorting methods. Unfortunately, the levels of p16 expression measured in T cells isolated from frozen PBMCs correlates poorly with levels obtained from T cells isolated from fresh blood, with R2 of only 0.59. The measurement of p16 in T cells/CD3+ from the BLSA participant samples is needed to continue ongoing research. 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 attached to this solicitation. Project Requirements: The Contractor shall provide a measurement of p16 in T cells/CD3+ cells using BLSA participant samples. The p16 cells will be measured as p16 mRNA transcripts abundance using quantitative real-time PCR assay. The Contractor shall develop the p16 measurement assay in a CLIA-compliant laboratory test using quality control systems and optimization of analytical performance of the assay; based on clinical performance standards and clinical workflow considerations. The Contractor shall provide everything necessary for the project set-up, tools and reagent (including blood stabilization solution) for T cells/CD3+ isolation, and completion of a p16 qPCR assay by measuring p16 in 160 BLSA participant samples. The contractor shall provide a data report for each sample received and batch run. The data report must include a study rationale and objective, methods used to generate the data, data analysis of the data, rationale used in the data analysis, and provide the study context. The Contractor must provide information on whether the p16 expression T cells/CD3+ cells from the BLSA participants is in correlation of other studies with participants similar in age. Government Responsibilities: The Government will provide 4 batches of 40 BLSA participant samples of frozen T cells. The Contractor will not require access to government facilities. Delivery or Deliverables: The Contractor shall provide a virtual training for the T cells/CD3+ cells isolation from whole blood to the LCI wet lab team within 15 business days from contract award. The Contractor shall provide 2 T cells isolation magnets, 80 blood collection kits and 10 T cells isolation kits within 15 business days from contract award. The Contractor shall provide results of the p16 qPCR assays in T cells/CD3+ cells within 30 days from the shipping of individual batches. The Contractor must provide electronic copies of the results. Reporting Requirements: The Contractor shall provide a data reports for each completed batch. The NIA LCI wet lab will send frozen aliquots of T cells/CD3+ cells to the Contractor 4 times in a batch of 40 BLSA participant samples for a total of 160 samples. The completion timeline will depend on the accessibility to the BLSA participants at the NIA Harbor Hospital Clinic in Baltimore, MD. Before the COVID-19 pandemic the LCI wet lab was receiving an average of 10 BLSA participant samples per week. Due the pandemic, the limitation on the number of occupants in the Harbor Hospital Clinic, changes of COVID-19 and other hospital and medical regulations, the NIA LCI wet lab receives 2 or 3 samples. Data Rights: As listed above, reports for each batch are required within 30 days from the shipping of individual batch over the contract period performance of a year. The Contractor will not have any rights to the data. Confidentiality of Information: The Contractor will treat all data and information acquired as part of services provided as confidential. The Government will not share any personal identifying information of the participants with the Contactor. (vii)����� The Government anticipates award of a firm fixed-price purchase order for this acquisition with an anticipated period of performance of one (1) year. (viii)���� The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses:� https://www.acquisition.gov/browse/index/far�� https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html�� (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) FAR 52.212-1, Instructions to Offerors-Commercial Items (Jun 2020) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Aug 2020) HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far���� https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html� (End of clause) The following clauses apply to this acquisition and are incorporated by reference: FAR 52.204-13, System for Award Management Maintenance (Oct 2018) FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020) FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Oct 2018). Addendum to this FAR clause applies to this acquisition and is attached. FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020). HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text: FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jan 2021) Standard NIH Invoice and Payment Provisions (Aug 2014) Interim NIH Invoice and Payment Provisions (Oct 2020) (ix)������ The provision at FAR clause 52.212-2, Evaluation-Commerical Items, applies to this acquisition. (a) 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 following factors shall be used to evaluate offers: (i.) technical capability, (ii.) past performance and (iii.) price. Technical capability and past performance, when combined, are significantly more important than price. (b) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer�s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (x)������� The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer. (xi)������ The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. (xii)����� The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition and is attached in full text. (xiii)���� There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiv)���� The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xv)����� Responses to this solicitation must include sufficient information to establish the interested parties� bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s), product description, and any other information or factors that may be considered in the award decision. Such factors may include: past performance, special features required for effective program performance, trade-in considerations, probable life of the item selected as compared with that of a comparable item, warranty considerations, maintenance availability, and environmental and energy efficiency considerations. The Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), 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. All quotations must be received by 3:00 p.m., Eastern Daylight/Standard Time, on Wednesday, March 3, 2021 and reference Solicitation Number 75N95021Q00060. Responses must be submitted electronically to Jeanette Russell, Contract Specialist, at jeanette.russell@nih.gov. Fax responses will not be accepted. (xvi)���� The name and telephone number of the individual to contact for information regarding the solicitation: Jeanette Russell, Contract Specialist 301-827-5140 Jeanette.Russell@nih.gov
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/9a36c624738d4be6b05d6f90874d2e80/view)
- Place of Performance
- Address: Baltimore, MD 21224, USA
- Zip Code: 21224
- Country: USA
- Zip Code: 21224
- Record
- SN05925139-F 20210226/210224230111 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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