Attach 6 STO No. 3 Final.pdf

RFP 75N91021R00007

Attachment 6 – Sample Task Order #3 (11/20/2020)

SAMPLE TASK ORDER #3

STATEMENT OF WORK

NOTE: THIS IS ONLY AN SAMPLE TASK ORDER REQUEST FOR PROPOSAL. WHILE A RESPONSE IS REQUIRED AS PART OF YOUR SUBMISSION AS REFERENCED IN SECTION L OF THE RFP, NO ACTUAL

TASK ORDER AWARD WILL BE MADE IN RESPONSE TO THIS SAMPLE TASK ORDER.

TORFP No: _#3__

Order Title: Analytical Support for Pharmacology Evaluations of Selected Anticancer Agents_

Type of Order: Fixed-price type task order Period of Performance: One year from date of award

A. Statement of Work/Protocol/Project Description:

For the Base Task:

The contractor shall provide analytical support for the quantification of one small-molecule anticancer agent in plasma and tumor samples to be provided by NCI. These samples may be derived from efficacy or pharmacodynamic evaluations in mice or other pharmacology/toxicology evaluations to be specified. The in-life portion of all evaluations will be conducted at another NCI-designated facility.

Assume for costing purposes that a total 100 samples will be provided for quantification of a single analyte and that there will be no more than two matrices (e.g., plasma, tumor fragments).

The following specific efforts shall be carried out for the set of samples:

• Implement LC-MS/MS methodology for the quantification of the compound in plasma and tumor samples and perform limited validation as required. Assume a drug-like small molecule of ~300-700 MW. Full validation to GLP standard is not required.

• Determine levels of the compound in a total of 100 unknown samples to be provided to you by NCI. Run appropriate blanks, standards, and QC samples. Control matrix will be provided to the extent available.

• Non-compartmental PK parameters (Cmax, Tmax, AUC, t1/2) shall be calculated for plasma and tissues in each dose group (where allowed by the data available).

For Options 1 through 5:

For each Option exercised during the Period of Performance, the contractor shall analyze 100 additional plasma and/or tumor samples in the manner outlined above. The compounds to be determined may be different for the base period and each option. For each set of samples there will be no more than two matrices. Options are considered additional quantities, are not directly related to predetermined dates, and may be exercised at any time within the Task Order period of performance.

B. Deliverables:

Separately for the Base task and each Option exercised:

RFP 75N91021R00007

Attachment 6 – Sample Task Order #3 (11/20/2020)

• Preliminary Data File: Results of each study and data analysis performed (c vs. t data and derived PK parameters, with plots as appropriate) shall be provided to the COR in a tabular format (Excel) within two weeks of receipt of the samples to be analyzed.

• Final Data File: The Preliminary Data File shall be updated to include an outline of methods used (analytical conditions and validation, etc.), results of any sample or PK re-analysis, and any changes requested by the COR. All information should be formatted on separate tabs in Excel.

The Final Data File shall be due two weeks after receipt of comments on the Preliminary Data File.

• Monthly Reports: Monthly Technical Progress Reports are required for this task order. These reports shall include: 1) a summary of progress on the study during the past month, 2) whether or not the project is on schedule, and (3) whether any problems were encountered in the collection, handling or processing of data, including resolution of the problems.

The reporting period shall consist of each calendar month. The first report shall cover the period consisting of the first full calendar month following the effective date of the task order and any fractional part of the initial month. Reports shall be due on or before the 15th of each month following the end of each reporting period. A Monthly Study Progress Report shall not be submitted when the Final Report is due.

• A narrative final report (e.g., Word document) will NOT be required for this Task Order.

C. Evaluation Factors:

The evaluation criteria found in Section M of the ID/IQ RFP will govern the evaluation of responses received to this Sample Task Order Request for Proposals or TORFP (see Section M). In an actual TORFP competed under any resultant IDIQ contract, study-specific evaluation criteria will be provided in this section. Per the RFP, any options will be evaluated in accordance with FAR 52.217- 5.

D. Order Response Due Date: Responses to this Task Order shall be included in your technical and business proposals for this RFP.