Amendment_5_Questions_and_Answers.pdf

RFP Number : N02CM47001-42 Amendment 5

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OFFICE OF ACQUISITIONS

NATIONAL CANCER INSTITUTE

REQUEST FOR PROPOSAL NUMBER: N02CM47001-42

Amendment No.: 5

Date of Issuance: 11/10/2014

The above numbered Request For Proposal (RFP) is amended as set forth below. The hour and date specified for receipt of Offerors remains unchanged

Offerors MUST acknowledge receipt of the amendment prior to the hour and the date specified in the solicitation or as amended, by separate letter, telegram, or Electronic Mail which includes a reference to the RFP and Amendment number(s). For your convenience, the Proposal Intent Response Form is provided in SECTION J - List of Attachments of this RFP, for this purpose.

FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERORS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.

This Amendment lists addtional questions and answers:

1. Task order 1 is for contractor attendance at a video-/Tele-conference during which the COR and CO will provide information on the IDIQ contract and the Contractor will be presenting the Project plan and their facility information.

The Project Plan and Slide deck appear to be deliverables for this task order. Therefore, it appears the costing should include labor efforts for preparation of slide deck, and project plan and attending a 2.5hr meeting via video-/Tele-conference; however, the evaluation factor for the proposal seems to indicate the project plan should be provided at the proposal stage. Please Clarify.

Answer: TO 1 is to be a kick off meeting for the contract. The contractor will need to provide the Contracting Officer with a slide deck consisting of pictures of the facilities. The plan should include: Animal facilities; various labs and operation suites and Primary rooms where studies will be conducted. The plan may track one example project from start to finish. Please assume you will be compensated for your hours of attendance. Please prepare a proposal covering this cost.

2. It seems that each sample task or task order 1 need to have a standalone section, each with its own technical cost summary. Does NCI also need an overall technical cost summary that includes the cost for all sample Tasks and Task Order 1?

Answer: Please provide an overall technical cost summary that includes all task orders except TO 1.

3. In Amendment 4, Question 9, asked if GLP studies method development and validation should be included as separate items. The answer was not clear with respect to separation of the cost. Can you please clarify if Analytical and Bioanalytical method development and validation can be included as part of the overall cost of the study or would NCI like to see these costs as line items for each study.

Answer: Analytical and Bioanalytical method development and validation can be included as line items for each study.

4. In Sample Tasks 3 and 4 it is stated that the studies will be conducted in accordance with FDA GLP regulations, but dose range-finding studies are not required by FDA to be conducted GLP. This adds a significant cost to the project as it will then requires an audit of the study, as well as validation of all methods used for plasma drug analysis and dose formulation verification. Please clarify if NCI requires the dose range-finding studies to be GLP compliant.

Answer: Dose range-finding studies do not need to be GLP compliant.

RFP Number : N02CM47001-42 Amendment 5

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5. On page 49 of the RFP, it states that a Business proposal must be submitted with EACH task order. Does the Government want the business proposal for each sample/task order to include such items as Total Compensation, Annual Financial Report, Small Business Plan, SDB Participation, etc? Due to the size of each task order volume and duplicative information, would the Government consider only including such documents at the Contract business proposal level?

Answer: Deliverables stated in Article F.1. of the solicitation as an annual or semi-annual report are at the contract level and not the Task Order Level. Accordingly, these reports can be omitted from the Task Order Business Proposal. All deliverables mentioned in Article F.1 that are Task Order specific as well as all information listed in the Business Proposal Instructions (Page 49) that are not omitted per the statement above must be submitted with each Task Order/Sample Task Order.

6. Page 78 of the RFP #7 Sustainability Acquisition Plan. Based on our research- a Sustainability Acquisition Plan was required under HHSAR 352.223-17. HHSAR 352.223-71 required offerors to submit a Sustainable Acquisition Plan in their technical proposal that addressed the environmental products and services to be delivered under the resulting contract. However, 352.223-71 in not a current citation. Please clarify - is a Sustainability Acquisition Plan required under the current solicitation?

Answer: Yes, a Sustainability Acquisition Plan is required per FAR 23.1. (https://acquisition.gov/far/current/html/ Subpart%2023_1.html) The authorities to allow the Government to ask for the Sustainability Acquisition Plan are specified in subparts 23.2, 23.4, 23.7, 23.8, 23.9, and 23.10.