Questions__Answers_PREVENT_23R00024Amend1_0001.pdf

RFP 75N91023R00024 Amendment 01 (1/26/23) Page 2

This amendment answers questions received regarding RFP Solicitation 75N91023R00024.

Clarification note: “RFP_PREVENT_75N91023R00024.pdf” attachment from SAM.gov is the main RFP document and establishes the instructions and scope of the requirement, while directing potential offerors’ attention to pertinent attachments relevant to specific needs and details referenced in the main RFP (Mandatory Qualification Criteria, Small Business Subcontracting Plan, Statements of Work (SOWs) for each IDIQ pool and Sample Task Order, Technical Proposal Instructions, etc.).

1. Reading through the PREVENT Cancer Preclinical Drug Development Program RFP. It’s a little hard to tell sometimes what is efficacy/ biomarkers and CGMP and Toxicology. The efficacy and biomarker application consists of a 150-page Technical Proposal, 2 samples 12-page Task Order Request for Proposal(s) (TORFPs) (GPC3 vaccine and KRAS inhibitor), a kickoff meeting TORFP and a Business Proposal. Plus, budgets for the 3 TORFPs and the prime contract center. Is my understanding correct?

1. Answer: Clarification: When a contract “Center” is referenced in these questions, the Government assumes this is referring to the Prime contract or contractor that may receive an award in response to this RFP. Note this RFP is not intended to establish a center per se (e.g., coordinating center).

A vendor/ potential offeror may submit proposals for consideration under 1, 2, or all 3 of the IDIQ PREVENT pools. Each proposal for a specific IDIQ Pool could have up to 150 pages, excluding the CVs and corresponding Business Proposals. In addition to providing a response to the base IDIQ Statement of Work, each Pool has either 1 or 2 Sample Task Orders to which the potential offeror must respond.

Review and consider the information in Section L, Instructions to Offerors, the Statements of Work (SOWs) attachments 3thru9 and Attachments 10thru14 for technical proposal instructions. All offerors, regardless of pool, must submit a response to the initial task order proposal (kickoff meeting) in addition to any required sample task orders. The three Pools and required number of sample tasks orders for each pool are as follows:

a. Preclinical Efficacy and Intermediate Endpoint Biomarkers (Efficacy)-- There are 2 Sample Task Orders for Efficacy and offerors must complete both if proposing under the Efficacy pool.

b. CGMP Preclinical Services Biopharmaceutical Product Development & Manufacturing (cGMP)-

- There is 1 Sample Task Order for cGMP.

c. Toxicology and Pharmacology Testing (Pharmacology/Toxicology)-- There is 1 Sample Task Order for Pharmacology/Toxicology.

Note: The number of pages allowed for a sample task order proposal is 15 pages, not 12 pages as stated in the question above. Also, as stated above, no single, overall budget is due for the base IDIQ contract;

refer to instructions to offerors under Section L . See attachment 1&2 for page and formatting, for example from Attachment 1:

“B. Page limitations:

1. The total page count of the Technical Proposal shall not exceed 150 pages. The page limits for Technical Proposal excludes any response to the Sample Protocols. The total page count for the Technical Proposals for Sample Protocols shall not exceed 15 pages (per Sample Protocol). Pages in excess of this limitation will be removed from the proposal and will not be provided to the reviewers to read or evaluate. Proposal pages shall be numbered “Page 1 of 150, “Page 2 of 150”, etc. The page limits for the Technical Proposals excludes any sample task order proposals.

2. Total page count does not include: Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section.

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3. Each Curriculum Vitae (CV) shall not exceed 5 pages. Not part of 150 page total count.

4. Pages exceeding limitations will be removed from the proposal and will not be considered.”

2. What attachment has the instructions on the business proposal?

2. Answer: Section L, Instructions to Offerors, contains business proposal instructions. The Statements of Work attachments 3 through 9 detail the tasks and scope of each IDIQ Pool, along with the corresponding Sample Task Orders.

Attachment 18 is a sample offeror price/cost worksheet. The potential offeror should complete either Attachment 18 or use a similar formatted template for their business proposals. The offeror shall provide a complete business proposal for each of the corresponding Sample Task Order(s) which matches their intended IDIQ Pool as well as the initial task order proposal (kickoff meeting) The business proposal should also address offeror pertinent details that will impact future proposal submissions such as salary documentation, Fringe, Overhead, Fees, G&A, etc. Refer to Section L, Instructions to Offerors, for additional details.

3. There is no budget for the Center per se, but only for the 3 TORFPs?

3. Answer: Offerors do not need to propose a budget for the entire IDIQ, only for the required Sample Task Order(s) for their pool(s) and for the Kick-off Task Order.

4. [We] would like to confirm if this will be unrestricted or set aside?

4. Answer. This is unrestricted competition. A set-aside may be used at the individual task order level at the Government’s discretion.

5. Is there any room in the envisioned work for companies that do only fill and finish?

5. Answer: Offerors must propose a solution to perform the entire Statement of Work. Fill and finish may be a subcontracting opportunity (where one company which specializes in one aspect of the Statement of Work may partner with another business who is able to provide other aspects of the Statement of Work.) Offerors should respond to the entire Statement of Work indicating which subcontractor are anticipated for aspects of the SOW. Refer to Section L, Instructions to Offerors, for additional details.

6. A PREVENT IDIQ can have a subcontract at another institution.

6. Answer: Yes. Subcontracting is encouraged. A small business subcontracting plan is required if the potential offeror is other than a small business as established by their NAICS code. Limitations on subcontracting will be established by terms and conditions of the resultant contract (e.g., regulatory limitation on pass-through charges for cost type contracts, limitations on subcontracting related to small businesses).

7. If a PREVENT IDIQ is awarded, and subsequently a Task Order is funded, funds to support PREVENT IDIQ, for example the PI effort and administrator effort, can be requested in the Task Order budget.

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7. Answer: Yes. Any resultant IDIQ base contract is technically “Unfunded”. All funds will be obligated at the Task Order level. Each offeror would provide a task order proposal covering their anticipated costs/ prices, which would include the PI, administrative efforts (not covered under indirect costs), and all labor categories and anticipated hours to complete performance of the task order.

8. Can the PI effort and/or administrator effort be subcontracted to the PREVENT IDIQ subcontract, or not?

8. Answer: A potential offeror can conduct their business arrangements as they each determine appropriate; however, the Prime contractor will be responsible for performance and oversight of the contract and task order(s). The Contact PI must be employed at the prime contractor's organization. The Prime contract PI and administrative effort cannot be billed under a subcontract. If there is an approved multiple PI leadership plan (see pg. 94 of the RFP), there can be multiple PIs involved in the contract and/or task order. Note that some requirements or contract types may be subject to additional restrictions, for example, FAR 52.215-23- Limitation on Pass-Through Charges, or subject to subcontract limitations referenced in Question #6.

9. How many PREVENT Efficacy IDIQ Centers are there now currently?

9. Answer: There are currently seven IDIQ contracts in the Efficacy pool (subject to change).

a. IIT Research Institute

b. SRI International

c. Toxicology Research Laboratory, University of Illinois at Chicago

d. The Research Institute of Fox Chase Cancer Center

e. University of Oklahoma Health Sciences Center

f. University of Alabama at Birmingham

g. University of Texas MD Anderson Cancer Center

10. Confirming that given the short timeline before the deadline, that for Efficacy IDIQ Center RFP, BOTH Task Order drafts are required and not either/or.

10. Answer: Yes, if a potential offeror chooses to propose on the Efficacy Pool, there are two (2) Sample Task Orders which must accompany the proposal as stated on page 85 of the Main RFP document, and in “Additional Technical Proposal Instructions” for the Efficacy Pool, on pg. 6 of 21 of Attachment 10thru14. The other IDIQ Pools, cGMP and Toxicology/ Pharmacology, each only have one (1) Sample Task Order to complete and submit with proposal.

11. For PREVENT IVIQ Task Order Title – “Contract Orientation and Kickoff Meeting” One option discussed in the RFP is hold a virtual meeting for this Task Order. If a virtual kickoff meeting is held, is a budget still required since there will be no travel?

11. Answer: Yes, a budget is required to account for labor hours and labor categories involved; however, travel costs are not anticipated as it is planned for a virtual meeting.

12. (We) don’t have the capabilities for some of the animal testing requirements. Can we No Bid areas?

12. Answer: The base IDIQ proposals must address the entire Statement of Work for each pool for which the offeror would like to be considered. Once the base IDIQ awards are made, each task order is

RFP 75N91023R00024 Amendment 01 (1/26/23) Page 5 solicited separately and prime contract holders are not required to submit a proposal for every task order request for proposal; however, when submitting a task order proposal, the contractor would propose on the task order requirement as a whole (with or without subcontractors or consultants).

For example, each Statement of Work for each pool specifies any allowable deviations to the requirement. Note under the animal testing requirements (pgs. 114 of RFP), the requirements may allow a vendor to have documented participation of a qualified vet and/or propose a vet established by the company or as a consultant for one to be available.

13. Question about the biosketches/CVs.: In Attachment 1, Section II.B., it says the page limitation for CVs is 3 pages. In Attachment 10, Section 3.A., the page limitation for bios/CVs is 5 pages. Please clarify.

13. Answer: Attachment 1, Section II.B and all other references to CV length should be changed from 3 pages to 5 pages across all pools.

14. The Proposal Intent Response Sheet (Attachment 2) indicates that it is due on the same day as the proposal, February 21, 2023. Is this correct or would it be helpful for NCI to know of the intended submissions by an earlier date?

14. Answer: The Proposal Intent Response Sheet can be submitted not later than the RFP closing date.

Earlier submission is preferable for the Government’s planning purposes, but not mandatory.

15. Can you provide guidance as to what is included in the “Government Notice for Handling Proposals” section? (From Attachment 10thru14)

15. Answer: All proposals mut be submitted to the Electronic Contract Proposal System website, or eCPS, as stated in Attachment 1. Once received, the proposals are handled in a manner to keep them safeguarded from unauthorized disclosure throughout the source selection process. However, the question above about “Government Notice for Handling Proposals” refers to any instructions the offerors will provide the Government regarding handling of their proposal related to confidentiality, restrictions on disclosure and use of data from the Contractor’s perspective. The Government recognizes that proposals submitted in response to this RFP may contain data (trade secrets; business data, commercial information, financial information, cost and pricing data; and technical data) which the offeror, including its prospective subcontractor(s), does not want used or disclosed for any purpose other than for evaluation of the proposal. The use and disclosure of any data may be so restricted;

provided, that the Government determines that the data is not required to be disclosed under the Freedom of Information Act, 5 U.S.C. 552, as amended, and the offeror marks the cover sheet of the proposal with the following legend, specifying the particular portions of the proposal which are to be restricted in accordance with the conditions of the legend. For example, the offeror may mark the proposal “The data subject to this restriction are contained in pages (insert page numbers, paragraph designations, etc. or other identification to indicate restriction.)” . In addition, the offeror may mark each page of data it wishes to restrict with the following type of statement: "Use or disclosure of data contained on this page is subject to the restriction on the cover sheet of this proposal."

The Government's determination to withhold or disclose a record will be based upon the particular circumstances involving the record in question and whether the record may be exempted from disclosure under the Freedom of Information Act.

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16. Given the number of TORFPs released simultaneously with the current RFP, would NCI consider extending the deadline for this submission to reduce the burden on current Prime Contractors?

16. Answer: As stated on the SF-30, the closing due date and time is extended to 02/27/2023 at 2:00 PM Eastern Time.

17. There are several references to web links on pages 77 and 78 of the Subject RFP. All of the weblinks appear to be broken and do not lead to the required forms, including the form to be submitted . Please issue an Amendment or response to questions that provides valid weblinks.

17. Answer: The Page 77 / 78 are referring to the RFP document “RFP_PREVENT_75N91023R00024”, which in turn points to Section J “Attachments” and all the referenced attachments are uploaded in SAM.gov under the RFP 75N91023R00024 for potential offerors to download.