22-010186

Submitted by mahonkg on
Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Collection, processing and shipment of convalescent COVID-19 blood samples
Contracting Office
National Institute on Aging (NIA)

Contact Points

Primary Contract Specialist

Randall
Carter
randall.carter@nih.gov
NAICS Code Number
541380
Testing Laboratories
Small Business Size Standard
$16.5M
FPDS Classification Code
Q301
Estimated Period of Performance
September 19, 2022 – September 18, 2023
Competition Status
Non-Competitive
Vendor Name
Research Consortium Luigi Amaducci
Vendor Address
Via Nicolo' Giustiniani 2
Padova, Padova
35100, Italy
Single-Sole Source Determination
Acquisition Authority: This acquisition is conducted under the authority of Federal Authority 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 and at a dollar value less than the simplified acquisition threshold are exempt from the requirements of FAR Part 6- Competition Requirements.

Laboratory of Molecular Biology & Immunology (LMBI), propose to get these services performed by the Research Consortium Luigi Amaducci, a consortium of the CNR, University of Padua-teaching hospital, and other health local units, based in Padua for the following reasons. They have access to young and old COVID-19 survivors and information regarding their medical history. They are also proficient in collecting and processing the blood to serum/plasma and PBMC samples. Furthermore, they are experienced in shipping the cryopreserved samples internationally to the National Institute on Aging.
Background/Description of Requirement

This acquisition is being conducted under 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 2202-07 dated August 10, 2022.

The biopharma race to develop vaccines against SARS-CoV-2 is unlikely to help two demographics that are most susceptible to COVID-19 mortality – the elderly and those with ‘underlying conditions’ (Williamson et al. MedRxiv (2020), CDC Response Report, March (2020)).  It is argued that immune dysfunction is responsible for this pre-disposition, however molecular and cellular mechanisms remain unclear.  In the absence of better understanding of the basis for susceptibility of these populations it is difficult to formulate strategies to protect them.  Studies proposed in this section are based on the premise that virus-neutralizing monoclonal antibodies hold therapeutic promise to ameliorate symptoms during acute infections, especially in the elderly and immune compromised (Kelley, Nat. Biotech. 38, 540 (2020)). Additionally, association of cytokine storms with increased mortality (Hung et al. Lancet 395, 497 (2020), Ruan et al. Intensive Care Med. 46, 846 (2020)) suggests de-regulated inflammation as a contributory factor that could benefit from targeted anti-inflammatory treatments.  

Period of Performance:

Service will be in place from September 19, 2022 – September 18, 2023

Scope of Work: 

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:

 

Specific Requirements:

The contractor will need to have access to young and old individuals that recovered from COVID-19 and their medical history.

The contractor will collect blood samples from young and old COVID-19 survived patients from Padua, Italy.  The blood will then be processed and cryopreserved into serum/plasma and PBMC samples.  The samples will be shipped and delivered internationally to the Laboratory of Molecular Biology and Immunology at the National Institute on Aging. 

Delivery or Deliverables:

The contractor will deliver cryopreseved serum/plasma and PBMC samples.

Government Responsibilities:

The government will receive and store the samples for further analyses to fulfill the project aims.

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), 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.”

Quoter Terms and Conditions (To be completed by the Offeror):

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
5.    SAM UEI No:

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/

1. FAR Provision 52.212-1 Instructions to Offerors-Commercial Items (Sept 2021) is applicable to this solicitation.

2. 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)]

3. FAR Provision 52.212-3, Offeror Representations and Certifications-Commercial Items (Feb 2021), is applicable to this solicitation 

4. 4. FAR Clause 52.212-4, Contract Terms and Conditions-Commercial Items (November 2021), is applicable to this solicitation.

5. FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (May 2022) is applicable to this solicitation. See attachment. 

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 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 12, 2022, at 1 PM EST and must reference announcement / solicitation number 22-010186. Responses may be submitted electronically to Randall Carter (Randall.carter@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.