Sample_Task_Order__3_REV_12-21-15.pdf
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- Preclinical Pharmacokinetic and Pharmacology Evaluations of Agents Being Developed for Cancer Patients
- Solicitation number
- N02CM67000-11
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Attachment Sample Task Order 19-3
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SAMPLE TASK ORDER REQUEST FOR PROPOSAL #3
NOTE: THIS IS ONLY A SAMPLE - NO TASK ORDER AWARD WILL BE MADE IN RESPONSE TO THIS
REQUEST
Contractor: _______TBD_______________
Contract No: ____TBD_________________
Pending Order No: __3___ Modification No: _____
Order Title: Analytical Support for Pharmacology Evaluations of Selected Anticancer Agents_
Task Order Type: Fixed Price (FP)
Order Originator: ____ _________________ Date Prepared: __________________________
Part I. INITIATOR’S REQUEST
A. Period of Performance: TO BE DETERMINED
B. Statement of Work/Protocol/Project Description:
For the Base Period:
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). For the base period, the compound for analysis will be NSC xxxxxx.
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 each tissue and dose group (where allowed by the data available).
Selected plasma and tumor samples shall also be analyzed by full-scan LC/MS for qualitative identification of possible metabolites, m/z for major non-parental ions present in samples from treated mice but not in control plasma shall be reported.
For Options 1 through 9:
For each Option, 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 and are not directly related to specific dates. Options may be exercised anytime hudakad Typewritten Text RFP Number: N02CM67000-11 hudakad Typewritten Text Attachment 19-3 during the Task Order Period of Performance.
C. Deliverables:
Interim c vs. t data in spreadsheet format for each compound sent to the COR within 14 working days after receipt of samples.
Draft analysis report for the base period and separate draft analysis reports for all options exercised. Each report will cover the results for a single compound/sample set, and include sections on the methods used, data obtained (including charts/graphs and tables as appropriate), and analysis/discussion of the results Draft reports will be due 14 working days after provision of interim data for the base period and any options
Final analysis reports will be due 7 working days after return of a draft report for revision.
D. Additional Instructions:
As Task Orders may be competed among the contractors if multiple awards are made pursuant to this RFP, please consider and provide information in your response to address Items E and F.
E. Evaluation Factors:
Proposals will be evaluated on the following factors, in order of importance:
1) Cost (Weight 40%): Realistic per sample cost based on number of samples/compounds specified;
costs shall not be based solely on the total period of performance of the Task Order.
2) Schedule (Weight 30%): Documented ability to rapidly initiate method development once notified that samples will be available; timely delivery of initial results and analyses within two weeks from time of sample receipt. Evidence of previous achievement of similar timeline goals.
3) Technical (Weight 30%): Demonstrated ability to expeditiously implement LC/MS-MS methods for small drug-like molecules and apply them to analysis of plasma and tumor samples.
F. Order Response: Technical Proposal shall be 3-4 pages in length and consist of a brief summary of your approach to analytical method implementation, the schedule for sample analysis as batches are received, and the relevant experience with similar tasks and timelines.
The Business Response shall at least include a Coversheet and a Budget (provided substantially as indicated in Part II of this form). The Coversheet shall at least consist of:
• RFP number
• Task Order RFP Number
• Name, address, email and telephone number of point of contact
• Name, address, email and telephone number of contract Administration Office (if applicable)
• Date of submission
• Name, title, address, email, telephone and signature of authorized Business Representative
(person authorized to sign contracts on behalf of the organization)
Budgets for the base period and each Option shall be provided separately. Note this Order will initially be awarded only for the base period and associated costs for one compound (100 samples). The Government may decide to unilaterally exercise and fund one or more Options for additional analyses as listed above in a sequential manner. A notice of intent to exercise each option will be sent 7 days prior to unilateral exercise.
G. Order Response Due Date: Responses to this Task Order shall be included in your technical and business proposals for this RFP.
TASK ORDER REQUEST FOR PROPOSAL (TORP)
Contractor: _____________[fill in]____________________ Contract No: ___ __________________
TORFP No: __ 3___ Modification No: __ 0____ Date Prepared: ______________________
Part II. CONTRACTOR’s RESPONSE TO ORDER REQUEST (*The Contractor shall attach a detailed budget to this form to identify all proposed fixed-price costs.)
A. Estimated Cost and Effort:
1. Labor hours – list order leader, specific individuals to be assigned, labor category, and estimated hours for each.
2. Labor costs – list by labor category and total.
3. Employee benefits.
4. Direct materials.
5. Travel.
6. Subcontracts.
7. Other direct costs.
8. Indirect costs.
9. Total estimated costs for this Order: ______________* 10.
B. Detailed description of the approach to be used and of the deliverable(s). (Be specific):
APPROVAL TO PROCEED: The Contractor shall not exceed the estimated labor hours, estimated Order amount, or change the Order leader without the prior written approval of the Contracting Officer’s Representative and the Contracting Officer.
1. For the Contractor: _____________________________ Date: ______________
(Signature)
Typed Name: __________________________________
2. For the Government: ____________________________ Date: ______________ Contracting Officer’s Representative (COR)
____________________________ Date: ______________ Contracting Officer
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