Parent_SOW.pdf

STATEMENT OF WORK (SOW)

1.0 TITLE

Testing Samples using Inflammation and Cardiometabolic Panels

2.0 BACKGROUND

Two major risk factors for hepatocellular cancer (HCC) are hepatitis B virus (HBV) and hepatitis C virus (HCV). Although HBV and HCV are well-known causes of HCC, most people with HBV or HCV infection do not develop HCC. Immune response to these infections is a critical determinant of who will develop HCC and who will not. Although great strides have been made in understanding immune responses to HBV and HCV, this knowledge is based largely on experimental or clinical studies in a small number of patients. For example, studies in chimpanzees have shown that innate interferon responses are activated early in HCV infection, while adaptive immune responses are delayed, weak, and ineffective. In contrast, HBV infection does not elicit a strong innate response but does induce a strong adaptive immune response. Studies evaluating immune-related markers and their relation to HCC in HBV and HCV infected individuals have not been conducted on a population level, however. Investigating how markers of immune response are associated with the development of HCC in human populations will increase our comprehension of the inflammatory mechanisms involved in hepatocellular carcinogenesis.

Two cohorts in Taiwan, the Risk Evaluation of Viral Load Elevation and Associated Liver Disease/Cancer (REVEAL)-HBV and REVEAL-HCV cohorts offer an excellent opportunity to evaluate how inflammation related to HBV and HCV is associated with the development of HCC and how the inflammatory patterns of HBV-related HCC to HCV-related HCC are similar or different.

Study Objectives: The NCI hypothesizes distinct immune-related markers will be associated with HCC and that the inflammatory profile will differ between HBV- and HCV-related HCC.

The NCI will conduct a case-control analysis including all individuals who developed HCC and an equal number of controls who either developed cirrhosis but not HCC or neither cirrhosis nor HCC, as summarized in Table 1, along with 32 QC samples (~3%). Participants who developed cirrhosis and chronically infected controls will be frequency matched to HCC cases on age (5-year age groups), sex, follow-up time +/-2 years, previously and high HCV-RNA-positive rate for REVEAL-HCV). All samples (N=1178 samples) have already been aliquoted on 96-well plates and are currently at the NCI repository used or unused sample, and viral load (HBV copies/mL <104 or ≥104 for REVEAL-HBV and low, medium, and high HCV-RNA-positive rate for REVEAL-HCV).

2.1 OBJECTIVE

NCI proposes to test up to 1178 samples using inflammation and cardiometabolic panels (N=184 markers).

3.0 SCOPE

The NCI proposes to test up to 1178 samples using inflammation and cardiometabolic panels (N=184 markers). The potential Contractor must complete the testing in 4-7 week timeframe for each task order issued. The Contractor shall have the capability to test for approximately 1000 proteins with sample volume of 1μL per panel.

4.0 CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS

The Contractor shall perform the following tasks:

Task 1. Cardiometabolic analysis (N=184 markers) and delivery of test results: minimum number of samples 882 - maximum number of samples 1178.

Task 2. Inflammation analysis (N=184 markers) and delivery of test results: minimum number of samples 882 - maximum number of samples 1178.

Residual samples will be returned to NCI. NCI will arrange shipment of these samples to and from the Contractor. Delivery of test results will be in an electronic encrypted file sent to the Contractor Officer Representative (COR).

5.0 TYPE OF ORDER

This is an Indefinite Delivery/Indefinite Quantity order with firm fixed priced task orders.

6.0 PERIOD OF PERFORMANCE

The period of performance shall be for 24 months from date of award.

7.0 PLACE OF PERFORMANCE

At the Contractor’s facility.

8.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

The Contractor shall deliver result reports to the NCI COR within 4-8 weeks of sample receipt identified in Section TBD and shall be marked as follows:

1. Name and address of the Contractor;

2. Contract Number;

3. Description of item contained therein; and

4. Consignee's name and address.

DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT

REQUIREMENTS DUE DATE

Task 1

Cardiometabolic analysis (N=184 markers): minimum number of samples 882 - maximum number of samples

To be determined at the task order level

Task 2

Inflammation analysis (N=184 markers): minimum number of samples 882 - maximum number of samples

To be determined at the task order level

9.0 PAYMENT

Payment shall be made in full upon receipt of deliverables. 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:

I INVOICE REQUIREMENTS

A. 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. 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.

B. 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.

C. Mail an original and 1 copy of the itemized invoice to:

National Institutes of Health Office of Financial Management, Commercial Accounts

2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

For inquiries regarding payment call: (301) 496-6088

In order to facilitate the prompt payment of invoices, it is recommended that the vendor submit a photocopy of the invoice to the “Consignee” designated for the acquisition in blocks 6A – 6E of the face page of the Order/Award document.

II. INVOICE PAYMENT

A. 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.

B. 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.

III. INTEREST PENALTIES

A. 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.

3. 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.

B. 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.

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (DEC 2013)

a) 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.

b) The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

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.