NCI SOW Etiology Lung Cancer--final.pdf

STATEMENT OF WORK (SOW)

1.0 TITLE

Etiology of Lung Cancers from Special Exposure Cohorts and Geographically Diverse Populations

2.0 BACKGROUND

Sherlock-Lung is a research project funded by the National Cancer Institute (NCI) Intramural Research Program at the Division of Cancer Epidemiology and Genetics (DCEG) aiming to investigate the etiology and progression of lung cancer in never-smokers from the general population, as well as from populations with substantial levels of special exposures and geographically diverse regions through: (1) an integrative genomic analysis, and (2) pathology, clinical, radiological and epidemiologic assessment.

Current understanding of the molecular mechanisms of tumorigenesis is primarily based on research in population of European ancestry. However, increasing evidence shows that genomic profiles of cancer, including lung cancer, differ by ancestry. For example, a recent study demonstrated higher genetic instability and homologous recombination deficiency in lung squamous cell carcinoma tumors in African Americans compared to European Americans, it also found African American-specific copy-number-based arm-, focal- and gene-level recurrent features in lung cancer. The evidence highlights the need to understand the molecular landscape of lung cancer in population of African ancestry; such studies are currently under-represented and may have therapeutic implications. Further, besides genomic differences in lung cancer, exposure to risk factors for lung cancer in parts of the developing world where the majority of the population of African ancestry resides also differ substantially from other parts of the world. For example, in sub-Saharan Africa, only 40% of lung cancer deaths are attributable to tobacco smoking, compared to about 60% globally, and >80% in the United States. The evidence further suggests the need to investigate lung cancer etiology in these populations. So far, we are unaware of any studies characterizing the genomic profile and etiology of lung cancer among never-smoking populations of African ancestry. Such efforts are further complicated by the wide geographic spread and the lack of research infrastructure in relevant geographic regions.

Given the paucity of pathology material and other related data particularly among populations of African ancestry, and the logistic challenges to sample collection in relevant geographic areas, NCI needs a coordinating center to assemble existing biospecimens, images, clinical and epidemiologic data for lung cancer among smokers and never-smokers across multiple sites in Nigeria. These activities are essential to ensure the diverse and representative ancestry of the Sherlock-Lung study.

2.1 OBJECTIVE

The purpose of the procurement is to collect and deliver existing biospecimens, images, and associated data from multiple sites in Nigeria as part of NCI’s Sherlock-Lung study.

3.0 SCOPE

In support of the NCI’s Sherlock-Lung study, the Contractor shall assemble and deliver existing biospecimens, images, and associated data from at least 25 lung cancer patients (roughly half of the number of cases from smokers and the other half from never smokers) from multiple centers in Nigeria to the designated NCI Technical Point of Contact (TPOC).

4.0 CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS

The Contractor shall:

4.1 Co-ordinate the assembly of biospecimens, images, and clinical and epidemiologic data of lung cancer cases from multiple sites in Nigeria.

4.2 Shipment of the following biospecimens for at least 25 lung cancer cases (roughly half from smokers and half from nonsmokers) retrieved from sites to the designated laboratory:

a. Fresh frozen tumor tissue (T) >60% tumor cells, <20% necrosis. Multiple samples preferred. If from biopsies, 2 samples of 40 mg each.

b. Paired fresh frozen normal tissue (N), no tumor cells. Multiple samples preferred (4 normal specimens if possible). If biopsies, 2 samples of 40 mg each.

c. Blood (B) 500uL whole blood or buffy coat

d. FFPE blocks at least one from tumor center and one from tumor periphery to be sectioned.

e. Peri-diagnostic plasma (P), optimal ≥ 7ml, minimum ≥ 3 ml

4.3 Deliver the following de-identified data for each lung cancer case retrieved from sites to NCI contact person:

a. Epidemiologic data in spreadsheets: variables shall include but are not limited to demographics, BMI, occupational and environmental exposures, residential history, family history, medical history and history of lung diseases or other infections.

b. Clinical data in spreadsheets: variables shall include but are not limited to clinical stage, histology, grade, survival, recurrence, metastasis and other treatment categories.

c. All available chest CT (in DICOM or equivalent file format), PET, and x-ray images (if CT and/or PET available, x-ray not required) for each case along with de-identified radiology reports or information abstracted from radiology reports.

The images should be transferred via a secure web portal or shipped in CD or DVD.

d. Pathology reports or information abstracted from pathology reports, delivered electronically or via shipment.

4.4 Provide monthly updates on the progress via emails and virtual meetings with the NCI

TPOC.

Test results shall be delivered to the NCI Technical point of contact (TPOC) via encrypted email.

The data files shall be provided as Excel files. No personally identifiable information shall be included.

5.0 TYPE OF ORDER

This is a firm fixed price purchase order.

6.0 PERIOD OF PERFORMANCE

The period of performance shall be for 12 months from the date of award.

7.0 PLACE OF PERFORMANCE

The place of performance shall be at the Contractor’s facility.

8.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

Pursuant to FAR clause 52.212-4, all work described in the SOW to be delivered under this purchase order is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the Technical Point of Contact (TPOC), who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

Regardless of format, all digital content or communications materials produced as a deliverable under this contract, shall conform to applicable Section 508 Standards to allow Federal employees and members of the public with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by Federal employees or by members of the public who are not individuals with disabilities. Remediation of any materials that do not comply with the applicable Section 508 requirements as set forth below, shall be the responsibility of the Contractor.

HHS guidance regarding accessibility of documents can be found at https://www.hhs.gov/web/section-508/additional-resources/index.html.

Federal government-wide guidance regarding accessibility of documents can be found at https://www.section508.gov/, including the documents describing the preferred method of authoring and testing documents produced in Microsoft Word 2013 or later, Microsoft Excel, and files formatted as PDF.

All written deliverable products shall be submitted in draft format for review, comment and approval by the TPOC. Final copies of approved drafts shall be delivered to the TPOC within five (5) business days after receipt of the Government’s comments.

https://www.hhs.gov/web/section-508/additional-resources/index.html https://www.section508.gov/

All written draft and final deliverable products shall be submitted in electronic copy for review and comment. If requested, final deliverable products shall be submitted in an electronic format.

Other quantities and formats may be submitted after prior approval from the TPOC.

All deliverables shall be sent electronically (Microsoft Word, PDF, or Excel 2013, unless approved by the TPOC) per the following deliverable schedule:

Reporting Requirements and Deliverables:

The contractor shall deliver the following items within the applicable Period of Performance/ stated deadlines in the order and as coordinated with the NCI Technical Point of Contact (TPOC). A monthly report shall be submitted to the TPOC, via an appropriate government email address to be provided to the contractor, detailing activities with allocation of labor hours and identification of work products for the period. The NCI TPOC shall review and accept the monthly reports. Any deficiencies identified shall be corrected prior to the final approval, and before the end of the Period of Performance. If no comments or requests for revisions from the NCI TPOC are provided to the contractor within 30 days of receipt of deliverables, the deliverables will be considered acceptable. If comments or requests for revisions from the NCI TPOC are provided to the contractor, the contractor will have 30 days to respond to comments an and/or provide revisions.

DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT

REQUIREMENTS DUE DATE

#1 Shipment of biospecimens (as described in 4.2) and delivery of associated data (as described in 4.3) for at least 13 lung cancer cases retrieved from sites to designated NCI laboratory.

6 months from the award date

#2

Shipment of biospecimens (as described in 4.2) and delivery of associated data (as described in 4.3) for at least additional 12 lung cancer cases retrieved from sites to designated NCI laboratory.

12 months from the award date

#3 Status Report Last day of each month

9.0 PAYMENT

Payment shall be made monthly in arrears. Payment authorization requires submission and approval of invoices to the COR and NIH OFM, in accordance with the payment provisions listed below:

I Invoice Requirements

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:

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 considered 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. Unique Entity Identifier (UEI) which is in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

8. Federal Taxpayer Identification Number (TIN). In those rare cases where a contractor does not have a UEI 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.

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.

B. The Contractor shall submit invoices to the Department of Treasury’s Invoice Processing Platform (IPP) at https://www.ipp.gov with a copy to the approving official, as directed below.

The Contractor shall submit a copy of the electronic invoice to the following TPOC:

Name- Email Address- TBD at time of award

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.

https://www.ipp.gov/

IV PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (Mar 2023)

(a)

(1) In accordance with 31 U.S.C. 3903 and 10 U.S.C. 3801, within 15 days after 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 Contractor agrees to make such payments to its small business subcontractors without any further consideration from or fees charged to the subcontractor.

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

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

(End of clause)

V HHSAR 352.232-71 Electronic Submission of Payment Requests (February 2, 2022)

(a) Definitions. As used in this clause— Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), ‘‘Content of Invoices’’ and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer’s written authorization with each payment request.

(End of Clause) https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/10/3801 http://www.ipp.gov/