Amendment_2_N02CO57019-02.pdf

RFP Number : N02CO57019-02 Amendment 2

- 1 -

OFFICE OF ACQUISITIONS

NATIONAL CANCER INSTITUTE

REQUEST FOR PROPOSAL NUMBER: N02CO57019-02

Amendment No.: 2

Date of Issuance: 07/09/2015

The above numbered Request For Proposal (RFP) is amended as set forth below. The hour and date specified for receipt of Offerors remains unchanged: 2:00PM EPT 8/03/2015.

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 #2 provides responses to questions received on 7/6/15, 7/7/15 and 7/8/15, as stated below.

This Amendment also includes a Monthly CPTAC Tissue Collection Team Meeting under Article C.2.b. Reporting Requirements, Other Reports/Deliverables as well as reiterates that all questions regarding this solicitation are to be directed to the Contracting Officers listed under Section L.

Inquiry 1-

Question 1: Is it possible to apply for CPTAC member from the non-US countries as a researcher or as an institution?

Answer 1: There is nothing restricting a foreign company to propose under the subject solicitation.

Inquiry 2-

Question 1: Does the CPTAC program wish that the BCR in this solicitation work closely and mirror processes with the Washington University BCR?

Answer 1: No, while many processes will likely resemble current CPTAC processes, this contract will be independent of previous CPTAC contracts.

Question 2: Just as one example, I know that current CPTAC TSSs are used to clinical data submission to ClinPortal, which is more of an in-house program at Wash U. TCGA TSSs were used to OpenClinica.

Answer 2: This solicitation does not specify a particular clinical data submission program.

Inquiry 3-

Question 1: Time line of the projected proposal, such as exact window (time) of transferring specimen after award announcement, because some of our specimen will be retrospect and some will be newly collected.

Answer 1: Please note, this solicitation is for the biospecimen core resource (BCR) only and collecting biospecimens is outside the scope of work. Biospecimen collection for this project will be covered under a separate solicitation. The BCR shall be ready to receive and process biospecimens within 3 months of receiving the award.

Question 2: In terms of IRB, do you have specific inclusion sentence needs to be there.

Answer 2: Please see pp. 40-45 of the Statement of Work. The IRB approval should indicate approval for each section of those pages.

RFP Number : N02CO57019-02 Amendment 2

- 2 -

Question 3: ten type of tumors, we do have NSCLC, PDA, GBM, SQCC, ccRCC, we had proposed the first 4 tumor types in our previous proposal, can we include part of our original proposal for this.

Answer 3: Please note, this solicitation is for the BCR only and collecting biospecimens is outside the scope of work.

Biospecimen collection will be covered under a separate solicitation.

Inquiry 4 -

Question: How many Tissue Source Sites will the BCR interface with?

Answer: NCI estimates around 50 Tissue Source Sites will be involved in this project.

Inquiry 5 -

Question: Please clarify this statement on pg. 14, E.2.c.1. of the SOW: "The Contractor shall not use the biospecimens or data to support its own research."

Answer: This is a service contract. The NCI is facilitating biospecimen collection to support grants associated with the CPTAC program. This contract may not be used to supply biospecimens or privileged data to support non- CPTAC research at the BCR's institution. All biospecimens and their derived data collected under Tissue Source Site contracts and delivered to the BCR data belong to the NCI.

Article C.2.b. Reporting Requirements, Other Reports/Deliverables, is hereby modified to include:

Monthly CPTAC Tissue Collection Team Meeting

A monthly teleconference will be held amongst the Tissue Source Sites, the NCI COR, and the CPTAC BCRs.

The NCI COR will oversee the meeting. The purpose of the meeting is to review the progress on the biospecimen collection, update the Contractor on the latest program status, disseminate any protocol updates, and ensure open and ongoing communication amongst all the stakeholders and participants in the tissue procurement activities.

Section L - Instructions, Conditions, and Notices to Offerors -

Offerors may submit WRITTEN questions requesting clarification of the Request for Proposal (RFP) contents.Information provided with each question must include the document name, specific page, paragraph, clause or otherdefinitive citation requiring clarification. All questions must be submitted ELECTRONICALLY to Mandie White atwhitems@mail.nih.gov and Tim Crilley at tcrilley@mail.nih.gov . FACSIMILE, TELEPONE OR MAILED

QUESTIONSWILL NOT BE ACCEPTED.

Note: It is respectfully requested that all questions be received by July 13, 2015 at 2:00 PM Eastern Prevailing Time(EPT) to allow NCI adequate time to prepare and issue an amendment prior to receipt of proposals. NCI will continueto accept questions up to the closing date and time for the RFP. HOWEVER, time may not permit responses toquestions received after July 13, 2015 at 2:00 PM EPT to be prepared and issued prior to receipt of proposals.

END OF AMENDMENT #2.

mailto:atwhitems@mail.nih.gov mailto:tcrilley@mail.nih.gov