75N91021Q00070_RFQ Oncology SME.pdf

Combined Synopsis / Solicitation Notice

75N91021Q00070

TITLE: Professional Scientific and Medical Guidance on NCI/CTEP Extramural Clinical Trials, Network Programs, and Treatment Trials.

GENERAL INFORMATION

Document Type: Combined Synopsis / Solicitation Notice Solicitation Number: 75N91021Q00070 Posted Date: 6/23/2021 Proposed Response Date: 7/2/2021

Product & Service Code: R499 – Support – Professional: Other NAICS Code: 541990 – All Other Professional, Scientific, and Technical

Services Business Size Standard: $16.5 million

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E136, Rockville, MD 20850, United States.

DESCRIPTION

The Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP) requires services from one (1) Subject Matter Expert (SME) for professional scientific and medical guidance on CTEP extramural clinical trials, network programs, and treatment trials.

This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice, and shall be processed in accordance with FAR Part 13.5 – Simplified Procedures for Certain Commercial Items. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation, 75N91021Q00070, is issued as a request for quote (RFQ) and includes all applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2021-05 (03-10-2021) Simplified Acquisition Procedures for commercial items.

The North American Industry Classification System code is 541990 and the business size standard is $16.5 million.

Only one (1) award will be made as a result of this solicitation. This requirement will be awarded as a firm fixed price purchase order.

1.0 BACKGROUND

The National Cancer Institute (NCI) is an Institute within the National Institutes of Health (NIH), whose mission is to plan, conduct, and coordinate the National Cancer Program and involves, (a) research on the causes, detections, diagnosis, preventions, treatment, and palliative care of cancers and on rehabilitation of the cancer patient and (b) demonstration of the effectiveness of cancer control methods and techniques.

The NCI Division of Cancer Treatment and Diagnosis (DCTD) takes prospective detection and treatment leads, facilitates their paths to clinical application, and expedites the initial and subsequent large-scale testing of new agents, biomarkers, imaging tests, and other therapeutic interventions (radiation, surgery, immunotherapy) in patients.

As such, the DCTD funds and conducts large scale studies on precision medicine that involve evaluation of pre-clinical studies and clinical research methods to predict response to systemic cancer treatment as well as treatment trials under collaborative agreements with pharmaceutical and biotechnology companies. DCTD supports extramural clinical trial network programs through the Cancer Therapy Evaluation Program (CTEP). CTEP’s two largest clinical trials network programs involve the NCI Experimental Therapeutics Clinical Trials Network (ETCTN) focused on early phase 1 and phase 2 trials (overseen by CTEP’s Investigational Drug Branch) and the NCI National Clinical Trials Network (NCTN) focused on phase 2 and phase 3 late phase clinical trials (overseen by CTEP’s Clinical Investigations Branch). These two clinical trials programs enroll between 20,000 and 25,000 patients annually at over 2,000 participating sites. Approximately 70% of the clinical trials supported under these network programs are conducted with NCI DCTD/CTEP as the legal Investigational New Drug (IND) sponsor of the trials. All of the trials supported by CTEP include collaborations with a wide variety of centers and institutions worldwide. In addition, CTEP IND trials often include two or more pharmaceutical companies, diagnostic companies and other participants, requiring extensive and complex negotiations on the design and management needed to support and conduct these federally funded clinical trials to address the needs of all partners.

Oncology drug development has traditionally focused on toxicity, dosing, and schedule of therapy, but with the advent of personalized medicine, it must now also encompass qualification of biomarkers to select patients, define toxicity, and monitor outcomes. These growing demands require effective integration of the CTEP with other key DCTD programs, including the Cancer Diagnosis Program (CDP), the Radiation Research Program (RRP), the Cancer Imaging Program (CIP), the Developmental Therapeutics Program (DTP), and the Biometrics Research Program (BRP).

NCI DCTC/CTEP supports cancer treatment trials across the spectrum of both hematologic and solid tumor malignancies, include both IND and non-IND trials. NCI DCTD/CTEP is also in the process of developing several new Precision Medicine Initiatives that will encompass biomarker-driven, precision medicine and immunotherapy trials in oncology testing combinations of targeted drugs supported by preclinical in vivo evidence (NCI ComboMATCH), targeted combinations in acute myeloid leukemia (MYELOMATCH), and new immunotherapy approaches in, a variety of cancer types (iMATCH). These initiatives all require expertise in the design and conduct of a new type of clinical trial (involving both umbrella and basket designs) that specifically address the unique characteristics of these initiatives.

Physician oncologic consulting expertise is needed to support development, implementation, and monitoring both selected NCI/CTEP treatment trials in hematologic and solid tumors as well as the new Precision Medicine Initiatives (PMIs) described above and existing NCI DCTD/CTEP PMIs, including Adult MATCH trial, the DART trial, and the ALCHEMIST project in early-stage lung cancer.

In performance of these clinical trials, the NCI is in need of a senior physician consultant to work as a Subject Matter Expert (SME) with NCI/CTEP within DCTD to provide guidance that shall be used by NCI leadership to inform their decision-making process. The consulting SME shall provide guidance on the background justification for the scientific objectives and medical safety of the trials supported by CTEP, the interaction between the regulatory aspects of clinical trial agreements and terms for trials with pharmaceutical collaborators and extramural investigators, and comment on the content and provide feedback on specific concerns by the extramural investigators as well as the extramural sites subject to the medical/scientific and policy requirements of the specific CTEP-supported clinical trials that they participate in. In addition, this physician consultant shall offer guidance on other DCTD initiatives that affect its clinical trials network programs as requested by NCI leadership. The physician consultant will also provide guidance on the clinical trials being supported by CTEP, especially biomarker-driven, precision medicine trials in both tissue agnostic and disease-specific indications as requested by the CTEP Associate Director, the Developmental Therapeutics Program (DTP) Associate Director, the Cancer

Diagnosis Program (CDP) Associate Director, and the DCTD Director in support of their decision-making process.

The Contractor shall not perform personal services under this contract. Contractor personnel are employees of the Contractor or its subcontractors and are under the administrative control and supervision of the Contractor. A Contractor supervisor must give all individual Contractor employee assignments and daily work direction. The Government will not supervise or direct Contractor employees in the performance of their assignments. If at any time the Contractor believes that any Government action or communication has been given that would create a personal service relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action. The Contractor shall not perform any inherently governmental functions under this contract. No Contractor employee shall represent or give the appearance that he/she is a Government employee, agent or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. The Contractor is responsible for ensuring that all employees assigned to this order understand and are committed to following these requirements.

2.0 SCOPE

DCTD requires services from one (1) Subject Matter Expert (SME) for professional scientific and medical guidance on CTEP extramural clinical trials, network programs, and treatment trials. NCI-sponsored clinical trials contain many complex components. The SME shall provide in-depth expert evaluation and review of the interactions between various NCI programs, the extramural clinical investigators conducting the trials, the NCI contractors supporting the clinical development program, and pharmaceutical collaborator providing agents or diagnostic tests for CTEP Investigational New Drug (IND) or Investigational Device Exemption (IDE) trials. The contractor shall work with the relevant DCTD/CTEP project managers and NCI DCTD/CTEP staff in the Clinical Investigations Branch and the Investigational Drug Branch as well as with the NCI NCTN Groups and the NCI ETCTN organizations to accomplish this goal. All work by the contractor shall be for informational purposes only to be used by NCI leadership to inform their decision-making process.

It is anticipated currently that the contractor shall provide input/advice on the development of 4 new trial/study proposals on average per month (2 select heme/solid tumor trials, 1 PMI sub-study trial, and 1 correlative ancillary study). In addition, the contractor shall monitor accrual and conduct issues requiring amendments related to approximately 25 active trials per year. Evaluation of new study proposals and monitoring of active studies are performed through regular meetings as outlined in the Contract Requirements. It is estimated that the contractor shall attend the following regular meetings for the entire period and that preparatory time and follow-time will be equivalent to the call/meeting time (i.e., 1 call of 2 hours would require an additional 2 hours in associated preparatory time and 2 hours in follow-up time for a total of 6 hours):

• Disease-Specific Steering Committee Calls: 1 call of 2 hours in length each month

• Disease-Specific Task Force Calls: 4 calls of 1 hour in length each month

• CTEP Protocol Review Committee Call: 4 calls of 3 hours in length each month

• CTEP Concept/Correlative/Accrual Call: 4 calls of 1 hour in length each month

It is anticipated that an additional 8 to 10 hours per week would be needed to provide additional guidance on the selected trials and PMI trials. The scientific and medical input/advice provided by the contractor shall allow DCTD to complete Consensus Evaluations for extramural investigators; address questions/concerns raised by the FDA on IND or IDE issues; and develop amendments and modifications for active trials and PMI sub-studies.

3.0 TYPE OF ORDER

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

4.0 PURCHASE ORDER REQUIREMENTS AND PERSONNEL QUALIFICATIONS

In support of DCTD/CTEP staff, the Subject Matter Expert shall:

4.1 Report status of work on a monthly basis, detailing activities with allocation of labor hours and identification of work products for the period. A final report shall be provided at the end of the Period of Performance summarizing all work completed.

4.2 Complete work products/documents related to compiling pertinent data, including assessment of the supporting pre-clinical and clinical data, patient safety issues, agent side effects, appropriate patient monitoring, and other aspects of patient care, to ensure DCTD/CTEP staff can complete final Consensus Evaluations for extramural investigators.

4.3 Complete work products and documents related to compiling pertinent data in order to provide written scientific input and advice on select hematologic and solid tumor malignancies and PMI sub-studies to address questions/concerns raised by the FDA on IND or IDE issues.

4.4 Complete work products and documents related to compiling pertinent data to provide written scientific input and advice on amendments for active select hematologic and solid tumor malignancy trials and PMI sub-studies so DCTD/CTEP can make final decisions on the need for amendments and any required modifications to the amendments before final approval is provided by NCI.

4.5 Provide scientific and medical guidance to extramural DCTD/CTEP staff on selected hematologic and solid tumor malignancy clinical treatment trials and PMI trials being proposed and developed for conduct in the NCI National Clinical Trials Network (NCTN) and the NCI Experimental Therapeutics Clinical Trials Network (ETCTN), including sharing expert interpretation of various viewpoints from the extramural research community on the trials to help aid in DCTD/CTEP staff and senior DCTD leadership decision-making.

4.6 Review clinical treatment trials, including Clinical Trials collaborations with pharmaceutical partners for trials involving cooperative research and development agreements (CRADAs) for which NCI/DCTD is the legal IND sponsor, in concordance with general CTEP policies and with policies specific for trials involving CTEP IND agents.

4.7 Participate in appropriate meetings, in person or via phone/webinar and provide scientific and medical guidance related to selected hematologic and solid tumor trials and PMI trials. These meetings include, but are not limited to:

4.7.1 Disease-Specific Steering Committee Calls

4.7.2 Disease-Specific Task Force Calls

4.7.3 CTEP Protocol Review Committee Call

4.7.4 CTEP Concept/Correlative/Accrual Call

4.8 Edit appropriate review assessments for both tissue agnostic and disease-specific trials, especially trials involving gastrointestinal malignancies. DCTD shall make all final decisions regarding assessments generated by the SME.

4.9 Provide scientific and medical guidance to pharmaceutical collaborators regarding appropriate scientific and medical rationale for language in the clinical agreements on selected hematologic and solid tumor malignancy treatment trials and PMI trials

4.10 Review administrative policies and procedures supporting NCI DCTD/CTEP PMIs and provide scientific and medical guidance to DCTD/CTEP to assist in their decision-making process.

4.11 Provide scientific and medical insight related to the development of novel collaborations and treatment approaches for PMI trials as well as on other selected hematologic and solid tumor treatment trials with extramural investigators and pharmaceutical partners

4.12 Provide professional scientific and medical opinion on future initiatives associated with special projects and precision medicine trials planning, as directed by DCTD. DCTD Leadership shall have final decision-making authority on all future initiatives.

4.13 Contractor personnel shall possess an active US License to practice medicine and board-certification in Medical Oncology

4.14 Contractor personnel shall demonstrate extensive experience (minimum 10 years) in FDA regulatory requirements related to conduct of clinical treatment trials in oncology

4.15 Contractor personnel shall demonstrate extensive experience (minimum 10 years) in clinical trial design and conduct, especially with respect to multi-center, biomarker-driven, precision medicine oncology treatment trials

4.16 Contractor personnel shall have strong, written communication skills

4.17 Contractor personnel shall have excellent analytical, and time management skills

4.18 Contractor personnel shall demonstrate Senior-Level/Managerial leadership experience in academia, such as Chair of an academic or clinical department, or senior level position in the government.

4.19 Contractor personnel shall demonstrate past participation in scientific advisory boards or committees, at least two (2).

5.0 PERIOD OF PERFORMANCE

The period of performance shall consist of one (1) 12-month base period, plus two (2) 12-month option periods, as follows:

Base Period: September 1, 2021 to August 31, 2022 Option Period 1: September 1, 2022 to August 31, 2023 Option Period 2: September 1, 2023 to August 31, 2024

6.0 PLACE OF PERFORMANCE

National Cancer Institute 9609 Medical Center Drive Rockville, MD 20850 *This work may also be performed remotely.

7.0 REPORT(S)/DELIVERABLES

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 Contracting Officer’s Representative (COR), 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/making-files-accessible/create-accessible-pdfs/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 COR. Final copies of approved drafts shall be delivered to the COR within five (5) business days after receipt of the Government’s comments.

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 COR.

All deliverables shall be sent electronically (Microsoft Word, PDF, or Excel 2013, unless approved by the COR) 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 Contracting Officer’s Representative (COR). A monthly report shall be submitted to the COR, 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 COR 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 COR 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 COR are provided to the contractor, the contractor will have 30 days to respond to comments an and/or provide revisions.

https://www.hhs.gov/web/section-508/making-files-accessible/create-accessible-pdfs/index.html https://www.section508.gov/

DELIVERABLE/TASK DELIVERABLE DESCRIPTION DUE DATE

BASE PERIOD

Base Period – Monthly Reports (Task 4.1)

Monthly Report detailing activities with allocation of labor hours and identification of work products for the period.

All activities specifically related to Tasks 4.5, 4.6, 4.7, 4.8, 4.9, 4.10, & 4.11 shall be addressed in the Monthly Report.

The Monthly Report shall be an electronic document. Acceptable formats include Microsoft Word, Excel, or PowerPoint; or Adobe PDF.

5 business days after the end of the month

Base Period – Consensus Evaluation Support (Task 4.2)

Work products/documents related to compiling pertinent data (including assessment of the supporting pre-clinical and clinical data, patient safety issues, agent side effects, appropriate patient monitoring, and other aspects of patient care) in order to provide written scientific input and advice on selected trial proposals and/or associated correlative ancillary studies. The trial proposals (and/or associated correlative ancillary studies) will be for select hematologic and solid tumor malignancies and PMI sub-studies.

Scientific input and advice on the trial proposals shall be provided to DCTD/CTEP staff per established timelines for the NCTN and ETCTN programs to ensure DCTD/CTEP staff can determine the final decision for a proposal and submit that decision and an associated Consensus Evaluation to the appropriate extramural investigators in a timely manner.

4-weeks after initial request from COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Base Period – FDA Question Support (Task 4.3)

Work products and documents related to compiling pertinent data in order to provide written scientific input and advice on select hematologic and solid tumor malignancies and PMI sub-studies to DCTD/CTEP staff with respect to questions/concerns raised by the FDA on IND or IDE issues. Scientific input and advice on these FDA issues shall be provided to DCTD/CTEP staff per established timelines to ensure DCTD/CTEP staff can determine a final decision on how to respond to the FDA by established regulatory timelines.

4-weeks after initial request from COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Base Period – Amendment Support (Task 4.4)

Work products and documents related to compiling pertinent data to provide written scientific input and advice to DCTD/CTEP staff on amendments for active select hematologic and solid tumor malignancy trials and PMI sub-studies so DCTD/CTEP can make final decisions on the need for amendments and any required modifications to the amendments before final approval is provided by NCI.

4-weeks after initial request from COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Base Period – Commentary on New Initiatives and Special Projects (Task 4.12)

As a Subject Matter Expert, the contractor shall provide advice and guidance to CTEP leadership to support their decision making around new initiatives and special projects.

4-weeks after initial request from COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Base Period – Final Report (Task 4.1)

Report Summarizing activities conducted during the period.

The Final Report shall be an electronic document.

Acceptable formats include Microsoft Word, Excel, or PowerPoint; or Adobe PDF.

4-weeks prior to end of Period of Performance.

Subsequent comments on the draft must be addressed within 1-week of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

OPTION PERIOD 1

Option Period 1 - Monthly Reports (Task 4.1)

Monthly Report detailing activities with allocation of labor hours and identification of work products for the period.

All activities specifically related to Tasks 4.5, 4.6, 4.7, 4.8, 4.9, 4.10, & 4.11 shall be addressed in the Monthly Report.

The Monthly Report shall be an electronic

Option Period 1 - Consensus Evaluation Support (Task 4.2)

Work products/documents related to compiling pertinent data (including assessment of the supporting pre-clinical and clinical data, patient safety issues, agent side effects, appropriate patient monitoring, and other aspects of patient care) in order to provide written scientific input and advice on selected trial proposals and/or associated correlative ancillary studies. The trial proposals (and/or associated correlative ancillary studies) will be for select hematologic and solid tumor malignancies and PMI sub-studies.

Scientific input and advice on the trial proposals shall be provided to DCTD/CTEP staff per established timelines for the NCTN and ETCTN programs to ensure DCTD/CTEP staff can determine the final decision for a proposal and submit that decision and an associated Consensus Evaluation to the appropriate extramural investigators in a timely manner.

4-weeks after initial request from COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Option Period 1 - FDA Question Support (Task 4.3)

Work products and documents related to compiling pertinent data in order to provide written scientific input and advice on select hematologic and solid tumor malignancies and PMI sub-studies to DCTD/CTEP staff with respect to questions/concerns raised by the FDA on IND or IDE issues. Scientific input and advice on these FDA issues shall be provided to DCTD/CTEP staff per established timelines to ensure DCTD/CTEP staff can determine a final decision on how to respond to the FDA by established regulatory timelines.

4-weeks after initial request from COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Option Period 1 - Amendment Support (Task 4.4)

Work products and documents related to compiling pertinent data to provide written scientific input and advice to DCTD/CTEP staff on amendments for active select hematologic and solid tumor malignancy trials and PMI sub-studies so DCTD/CTEP can make final decisions on the need for amendments and any required modifications to the amendments before final approval is provided by NCI.

4-weeks after initial request from COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Option Period 1 - Commentary on New Initiatives and Special Projects (Task 4.12)

As a Subject Matter Expert, the contractor shall provide advice and guidance to CTEP leadership to support their decision making around new initiatives and special projects.

4-weeks after initial request from COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Option Period 1 - Final Report (Task 4.1)

Report Summarizing activities conducted during the period.

The Final Report shall be an electronic document.

3-weeks prior to end

Performance.

Subsequent comments on the draft must be addressed within 1-week of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

OPTION PERIOD 2

Option Period 2 - Monthly Reports (Task 4.1)

Monthly Report detailing activities with allocation of labor hours and identification of work products for the period.

All activities specifically related to Tasks 4.5, 4.6, 4.7, 4.8, 4.9, 4.10, & 4.11 shall be addressed in the Monthly Report.

The Monthly Report shall be an electronic

Option Period 2 - Consensus Evaluation Support (Task 4.2)

Work products/documents related to compiling pertinent data (including assessment of the supporting pre-clinical and clinical data, patient safety issues, agent side effects, appropriate patient monitoring, and other aspects of patient care) in order to provide written scientific input and advice on selected trial proposals and/or associated correlative ancillary studies. The trial proposals (and/or associated correlative ancillary studies) will be for select hematologic and solid tumor malignancies and PMI sub-studies.

Scientific input and advice on the trial proposals shall be provided to DCTD/CTEP staff per established timelines for the NCTN and ETCTN programs to ensure DCTD/CTEP staff can determine the final decision for a proposal and submit that decision and an associated Consensus Evaluation to the appropriate extramural investigators in a timely manner.

4-weeks after initial request from COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Option Period 2 - FDA Question Support (Task 4.3)

Work products and documents related to compiling pertinent data in order to provide written scientific input and advice on select hematologic and solid tumor malignancies and PMI sub-studies to DCTD/CTEP staff with respect to questions/concerns raised by the FDA on IND or IDE issues. Scientific input and advice on these FDA issues shall be provided to DCTD/CTEP staff per established timelines to ensure DCTD/CTEP staff can determine a final decision on how to respond to the FDA by established regulatory timelines.

4-weeks after initial request from COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Option Period 2 - Amendment Support (Task 4.4)

Work products and documents related to compiling pertinent data to provide written scientific input and advice to DCTD/CTEP staff on amendments for active select hematologic and solid tumor malignancy trials and PMI sub-studies so DCTD/CTEP can make final decisions on the need for amendments and any required modifications to the amendments before final approval is provided by NCI.

4-weeks after initial request from COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days

Option Period 2 - Commentary on New Initiatives and Special Projects (Task 4.12)

As a Subject Matter Expert, the contractor shall provide advice and guidance to CTEP leadership to support their decision making around new initiatives and special projects.

4-weeks after initial request from COR.

Subsequent comments on the draft must be addressed within 4-weeks of receipt from COR

Final versions due 5-business days after COR approval of finalized draft

Option Period 2 - Final Report (Task 4.1)

Report Summarizing activities conducted during the period.

The Final Report shall be an electronic document.

4-weeks prior to end

Performance.

Subsequent comments on the draft must be addressed within 1-week of receipt from COR

Final versions due 5-business days

7.1 APPROVALS BY THE CONTRACTING OFFICER’S REPRESENTATIVE (COR)

All services delivered to the COR will be deemed to have been accepted 30 calendar days after date of delivery, except as otherwise specified in this purchase order, if written approval or disapproval has not been given within such period. The COR’s approval or revision to the services delivered shall be within the general scope of work stated in this purchase order.

COR: TBD

Cancer Therapy Evaluation Program Division of Cancer Treatment and Diagnosis National Cancer Institute

8.0 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:

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 System for Award Management (SAM.gov).

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. The Contractor shall submit invoice to the National Institutes of Health (NIH)/Office of Financial Management (OFM) via email at invoicing@nih.gov with a copy to the approving https://ofm.od.nih.gov/Pages/Home.aspx https://ofm.od.nih.gov/Pages/Home.aspx mailto:invoicing@nih.gov 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 Technical Point of Contact.

The Contractor shall submit a copy of the electronic invoice to the following Approving Official (Contracting Officer’s Representative):

Approving Official: Contracting Officer’s Representative Name: TBD Email Address: TBD

For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@incontactemail.com 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.

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://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files mailto:OFM%20Customer%20Service mailto:ofm_customer_service@incontactemail.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS,

FAR 52.232-40 (December 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.

c) 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.

9.0 PURCHASE ORDER CLAUSES

FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS - COMMERCIAL ITEMS (JAN 2021)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (JUL 2018) (Section 1634 of Pub. L.

115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

_X__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (OCT 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

https://www.acquisition.gov/content/52212-5-contract-terms-and-conditions-required-implement-statutes-or-executive-orders-commercial-items https://www.acquisition.gov/content/52203-19-prohibition-requiring-certain-internal-confidentiality-agreements-or-statements#i52_203-19 https://www.acquisition.gov/content/52204-23-prohibition-contracting-hardware-software-and-services-developed-or-provided-kaspersky-lab-and-other-covered-entities#id189A70O0P1N https://www.acquisition.gov/content/52204-25-prohibition-contracting-certain-telecommunications-and-video-surveillance-services-or-equipment#id1989I600I4C https://www.acquisition.gov/content/52209-10-prohibition-contracting-inverted-domestic-corporations#i1062680 https://www.acquisition.gov/content/52233-3-protest-after-award#i1048661 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52233-4-applicable-law-breach-contract-claim#i1048698 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52203-6-restrictions-subcontractor-sales-government#i1063319 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509)).

___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) (31 U.S.C. 6101 note).

___ (5) [Reserved].

___ (6) 52.204-14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).

_X__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters

(OCT 2018) (41 U.S.C. 2313).

___ (10) [Reserved].

___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR 2020) (15 U.S.C.657a).

___ (ii) Alternate I (MAR 2020) of 52.219-3.

_X_ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (MAR 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

___ (ii) Alternate I (MAR 2020) of 52.219-4.

___ (13) [Reserved]

___ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) (15 U.S.C.644).

___ (ii) Alternate I (MAR 2020) of 52.219-6

___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

___ (ii) Alternate I (MAR 2020) of 52.219-7.

_X__ (16) 52.219-8, Utilization of Small Business Concerns (OCT 2018) (15 U.S.C. 637(d)(2) and (3)).

https://www.acquisition.gov/content/52203-13-contractor-code-business-ethics-and-conduct#i1063504 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52203-15-whistleblower-protections-under-american-recovery-and-reinvestment-act-2009#i1063607 https://www.acquisition.gov/content/52204-10-reporting-executive-compensation-and-first-tier-subcontract-awards#i1064087 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/content/52204-14-service-contract-reporting-requirements#i1064214 https://www.acquisition.gov/content/52204-15-service-contract-reporting-requirements-indefinite-delivery-contracts#i1064243 https://www.acquisition.gov/content/52209-6-protecting-government%E2%80%99s-interest-when-subcontracting-contractors-debarred-suspended-or-proposed-debarment#i1062590 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/content/52209-9-updates-publicly-available-information-regarding-responsibility-matters#i1062651 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim https://www.acquisition.gov/content/52219-3-notice-hubzone-set-aside-or-sole-source-award#i1057314 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637a&num=0&edition=prelim https://www.acquisition.gov/content/52219-3-notice-hubzone-set-aside-or-sole-source-award#i1057314 https://www.acquisition.gov/content/52219-4-notice-price-evaluation-preference-hubzone-small-business-concerns#i1057352 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52219-4-notice-price-evaluation-preference-hubzone-small-business-concerns#i1057352 https://www.acquisition.gov/content/52219-6-notice-total-small-business-set-aside#i1057393 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52219-7-notice-partial-small-business-set-aside#i1057419 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52219-7-notice-partial-small-business-set-aside#i1057419 https://www.acquisition.gov/content/52219-8-utilization-small-business-concerns#i52_219-8

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (JUN 2020) (15 U.S.C. 637(d)(4)).

___ (ii) Alternate I (NOV 2016) of 52.219-9.

___ (iii) Alternate II (NOV 2016) of 52.219-9.

___ (iv) Alternate III (JUN 2020) of 52.219-9.

___ (v) Alternate IV (JUN 2020) of 52.219-9

___ (18) (i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).

___ (ii) Alternate I (MAR 2020) of 52.219-13

___ (19) 52.219-14, Limitations on Subcontracting (MAR 2020) (15 U.S.C.637(a)(14)).

___ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (JAN 1999) (15 U.S.C. 637(d)(4)(F)(i)).

___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (MAR 2020) (15 U.S.C. 657f).

_X_ (22)(i) 52.219-28, Post Award Small Business Program Rerepresentation (NOV 2020) (15 U.S.C. 632(a)(2)).

___ (ii) Alternate I (MAR 2020) of 52.219-28.

___ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (MAR 2020) (15 U.S.C. 637(m)).

___ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (MAR 2020) (15 U.S.C. 637(m)).

___ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C. 644(r)).

___ (26) 52.219-33, Nonmanufacturer Rule (MAR 2020) (15 U.S.C. 637(a)(17)).

_X_ (27) 52.222-3, Convict Labor (JUN 2003) (E.O.11755).

____ (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (JAN 2020) (E.O.13126).

_X_ (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

_X_ (30) (i) 52.222-26, Equal Opportunity (SEP 2016) (E.O.11246).

___ (ii) Alternate I (Feb 1999) of 52.222-26.

https://www.acquisition.gov/content/52219-9-small-business-subcontracting-plan#i52_219-9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52219-9-small-business-subcontracting-plan#i52_219-9 https://www.acquisition.gov/content/52219-9-small-business-subcontracting-plan#i52_219-9 https://www.acquisition.gov/content/52219-9-small-business-subcontracting-plan#i52_219-9 https://www.acquisition.gov/content/52219-9-small-business-subcontracting-plan#i52_219-9 https://www.acquisition.gov/content/52219-13-notice-set-aside-orders#i1057715 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52219-14-limitations-subcontracting#i1057730 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52219-16-liquidated-damages-subcontracting-plan#i1057758 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52219-27-notice-service-disabled-veteran-owned-small-business-set-aside#i1057823 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52219-28-post-award-small-business-program-rerepresentation#i1057874 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3…