This Small Business Sources Sought Notice (SBSS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI).

The purpose of this Small Business Sources Sought Notice is to identify qualified small business concerns, including 8(a), HUBZone or Service-Disabled Veteran-owned business concerns, that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract based on responses received nor otherwise pay for the preparation of any information submitted. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned North American Industry Classification System (NAICS) code 541990 with a size standard of $15 million is being considered.

NCI may issue a request for quotation (RFQ) as a result of this Small Business Sources Sought Notice. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Small Business Sources Sought Notice or the NCI’s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement.

BACKGROUND

The National Cancer Institute (NCI), Surgery Branch (SB) is developing immune-based therapies to treat patients with metastatic cancer. One of the branch’s current major therapeutic strategies is to use tumor mutation-reactive T cells to treat patients with cancer. This is based on data from the SB clinical trials demonstrating that the curative responses seen in patients with melanoma treated with T cells are likely mediated by mutation-reactive T cells. Moreover, the NCI treated a patient with metastatic bile duct cancer with a highly pure population of mutation-reactive T cells and are observing ongoing tumor regression at 16+ months after therapy. The SB is thus attempting to treat more patients with mutation-reactive T cells. In order to do this, the SB first has to identify mutation- reactive T cells from patients. The reagents that the branch requires to identify mutation-reactive T cells are custom genes and custom peptides that encode for tumor mutations. Since the SB is using these reagents in “real time” to develop therapies to treat patients with late stage cancer, the branch requires that these reagents be synthesized quickly, be error-free and that the product sequences are of high quality.

OBJECTIVE

The patients being treated at the SB are late-stage patients with no other therapeutic options, thus the NCI requires that all these reagents be synthesized in an expeditious manner as time is of the essence. This process is required for every single patient on the SB protocol (i.e., this is highly personalized medicine/therapy).

SCOPE

Independently, and not as an agent of the Government, the Contractor shall furnish all necessary supplies, equipment, labor, and services to perform gene synthesis/cloning, peptide synthesis, and QC analysis of peptides and mammalian expression constructs for the Government's use in the conduct of cancer-related clinical research/trials.

CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS

Contractor shall conduct gene synthesis/cloning, peptide synthesis, and QC analysis of peptides and mammalian expression constructs for 125 cases. Detailed requirements for each of these services are as follows:

4.1 - Gene Synthesis/Cloning and Peptide Synthesis:

The contractor shall produce crude or HPLC purified peptides or peptide pools that encode normal endogenous protein sequences and those with tumor mutations embedded. They will use the sequence file that researchers provide to them from the NGS sequencing done on clinical trial patient tumor samples associated with one of many trials under The National Cancer Institute (NCI), Surgery Branch (SB). Additionally, the contractor shall provide tandem minigene fragments that encode normal endogenous gene sequences and those with tumor mutations embedded in tandem. Gene fragments will be cloned into mammalian expression vectors provided by the researcher. The contractor shall provide purified TMG constructs at varying concentrations dependent upon what the researcher requestors. The contractor shall provide retroviral mammalian expression vectors containing antigen specific T-cell receptor (TCR) inserts for the TCR-alpha/beta chains (TCRa/b). Constructs shall be purified at varying concentrations dependent upon what the researcher requestors. Importantly, the contractor shall provide advice on the codon optimization of mammalian expression inserts to ensure that all constructs will have a good chance of working in vitro and in vivo.

4.2 - QC Analysis of peptides and mammalian expression constructs:

The contractor shall perform QC analysis of crude or HPLC purified peptides or peptide pools that encode normal endogenous protein sequences and those with tumor mutations embedded using Mass Spectrometry (MS) to determine the amino acid composition of said peptides. Documentation shall be sent with the peptides or via email to the specific researcher. Additionally, the contractor shall Sanger sequence every construct that the researchers request to determine that either the TMG insert is correct in sequence or that the TCRa/b molecule is correct in sequence. The sequencing file for all constructs shall be made available via mail or email.

TYPE OF ORDER

This will be issued as a firm fixed price purchase order.

PERIOD OF PERFORMANCE

The period of performance is for twelve (12) months with two (2) twelve (12) month option periods.

PLACE OF PERFORMANCE

All work shall be performed at the Contractor’s facility.

REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

The Contractor shall provide the following:

1. Sequence data of the constructs. The constructs shall be DNA sequenced for verification, and electronic files that describe the generated product shall contain electropherograms showing the DNA sequence of the constructs. These shall show the cloning site as well as the full length insert.
2. Lyophilized crude peptides containing the specific amino acid sequence. Peptides shall be delivered within 2-4 weeks of order. (Delivery address to be provided by the NCI Technical Point of Contact (TPC)). Lead times exceeding 4 weeks may be authorized by the NCI TPC depending on complexity of sequence and length of peptide.
3. Genetic constructs encoding the mutations cloned into an expression plasmid. Genetic constructs shall be made and delivered within 3 weeks of order. (Delivery address to be provided by the TPC).

The aforementioned deliverables and any ancillary reports containing relevant data items, per above, will be scrutinized and subsequently accepted within thirty (30) calendar days of receipt,

The Government’s Technical Point of Contact (TPC), who will be named upon award, will be responsible for reviewing the work done by the Contractor, making sure that it is consistent with the terms of the Contract, and approving the reports/deliverables provided by the contractor.

The TPC is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Government may unilaterally change its TPC designation.

All reports required herein shall be submitted in electronic format. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

PAYMENT

Payment shall be made in full upon delivery and acceptance by the Government. Payment authorization requires submission and approval of invoices to the COR and NIH OFM, in accordance with the attached payment provisions listed below:

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls:  Prompt Payment (Jan 2017) FAR 52.232-25.  Highlights of this clause and NIH implementation requirements follow:

1. Invoice Requirements
   1. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed.  A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9.  If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats or oils) with a statement of the reasons why it is not a proper invoice.  (See exceptions under II., below.)  Untimely notification will be taken into account in the computation of any interest penalty owed the Contractor.

1. 1. 1. Vendor/Contractor:  Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).
      2. Remit-to address (Name and complete mailing address to send payment).
      3. Remittance name must match exactly with name on original order/contract.  If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice.
      4. Invoice date.
      5. Unique invoice #s for all invoices per vendor regardless of site.
      6. NBS document number formats must be included for awards created in the NBS:  Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.
      7. Data Universal Numbering System (DUNS) or DUNS + 4 as registered in the Central Contractor Registration (CCR).
      8. Federal Taxpayer Identification Number (TIN).  In those exceptional cases where a contractor does not have a DUNS number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice.  The VIN is the number that appears after the contractor’s name on the face page of the award document.
      9. Identify that payment is to be made using a three-way match.
      10. Description of supplies/services that match the description on the award, by line billed.*
      11. Freight or delivery charge must be billed as shown on the award.  If it is included in the item price do not bill it separately.  If identified in the award as a separate line item, it must be billed separately.
      12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*

NOTE:  If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice.  A modification to the order or contract may be needed before the invoice can be submitted and paid.

1. 1. Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order.  If authorized, shipping costs must be itemized.  Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

1. 1. The Contractor shall submit invoice to the National Institutes of Health (NIH)/Office of Financial Management (OFM) via email at [email protected] with a copy to the approving official, as directed below. The Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment on the website at https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files. The invoice shall be transmitted as an attachment via email to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer.

The Contractor shall submit a copy of the electronic invoice to the following Technical Point of Contact (TPOC):

Technical Point of Contact (TPOC)

Name- ___________________Email Address-

For inquiries regarding the status of invoices, contact OFM Customer Service via email at [email protected] or via phone at 301-496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx.

Note: The OFM Customer Service is open Eastern Standard Time Monday – Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

1. Invoice Payment

1. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.
2. The 30th day after Government acceptance of supplies delivered or services performed.
    

1. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

1. Interest Penalties

1. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.
2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition.

1.   In the case of a final invoice for any balance of funds due the contractor for             supplies delivered or services performed, the amount was not subject to further           settlement actions between the Government and the Contractor.

1. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

1. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (December 2013)

1. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor. 
2. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.
3. Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items. 

SUBMISSION INFORMATION

Capability statements shall be submitted via email to Contracting Officer, Miguel Diaz, at [email protected] no later than 12:00 P.M. EST on August 2, 2021 (08/02/2021). All information furnished must be in writing and must contain enough detail to allow the NCI to determine if it can meet the unique specifications described herein. Please reference number 75N91021Q00179 on all correspondence.

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 capability. 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, an RFQ may be published. However, responses to this notice will not be considered adequate responses to a solicitation(s).