Amendment_5_N02CO54417-02.doc

RFQ Number: N02CO54417-02, Total 100% Small Business Set-Aside Amendment No. Five (5) National Institutes of Health (NIH), National Cancer Institute (NCI)

Office of Acquisitions (OA), Treatment and Support Branch (TSB)

Date of Issuance: October 30, 2015 The above numbered Request for Quotation (RFQ) is amended as set forth below. This Amendment also provides responses to questions received on 10/8/15, 10/13/15, 10/15/15 and 10/16/15. The hours and dates specified for receipt of responses remains unchanged.

Therefore, this Amendment #5 revises the subject Request for Quotation (RFQ) as follows:

1. Section 2.2 Payment Schedule for Biospecimens and Data and Other Applicable Information, hereby includes the following HHSAR clause:

Standard for Encryption Language, HHSAR 352.239-71 (January 2010)

a. The Contractor shall use Federal Information processing Standard (FIPS) 140-2-compliant encryption (Security) Requirements for Cryptographic Module, as amended) to protect all instances of HHS sensitive information during storage and transmission. (Note: The Government has determined that HHS information under this contract is considered "sensitive" in accordance with FIPS 199, Standards for Security Categorization of Federal Information and Information Systems, dated February 2004).

b. The Contractor shall verify that the selected encryption product has been validated under the Cryptographic Module Validation Program (see http://csrc.nist.gov/groups/STM/cmvp/ ) to confirm compliance with FIPS 140-2 (as amended). The Contractor shall provide a written copy of the validation documentation to the Contracting Officer and the Contracting Officer's Technical Representative.

c. The Contractor shall use the Key Management Key (see FIPS 201, Chapter 4, as amended) on the HHS personal identification verification (PIV) card; or alternatively, the Contractor shall establish and use a key recovery mechanism to ensure the ability for authorized personnel to decrypt and recover all encrypted information (see http://csrc.nist.gov/drivers/documents/ombencryption-guidance.pdf ). The Contractor shall notify the Contracting Officer and the Contracting Officer's Technical Representative of personnel authorized to decrypt and recover all encrypted information.

d. The Contractor shall securely generate and manage encryption keys to prevent unauthorized decryption of information in accordance with FIPS 140-2 (as amended).

e. The Contractor shall ensure that this standard is incorporated into the Contractor's property management/control system or establish a separate procedure to account for all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive HHS information.

f. The Contractor shall ensure that its subcontractors (all tiers) which perform work under this contract comply with the requirements contained in this clause.

2. Section 7. To be Submitted with Offeror’s Proposal, the page limitation is hereby changed from 10 to 20 as follows:

· A RFQ response page limit of 20 pages, inclusive of all/any attachments.

3. Section 8. Purchase Order Clauses and Terms, Ordering and Ordering Limitations, The following FAR clauses are all hereby changed to allow the Contracting Officer to exercise the option by written notice to the Contractor within one (1) calendar day versus the original thirty (30) calendar days:

FAR 52.217-6 Option for Increased Quantity (Mar 1989)

FAR 52.217-7 Option for Increased Quantity-Separately Priced Line Item (Mar 1989)

FAR 52.217-8 Option to Extend Services (Nov 1999) FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000)

4. Appendix E: DRAFT Data Collection Forms are hereby provided in the below hyperlink zip file. These are draft documents and are subject to change.

CPTAC III CRF drafts v1.0.zip Inquiry 1 Question 1: We are a network of tissue source sites. Can shipments go directly from the TSS to the BCR to minimize sample transportation?

Response 1: Yes, provided that the samples meet the criteria specified in the Statement of Work.

Question 2: Will all 10 tissue types go to one BCR?

Response 2: The plan is for one BCR to process 5 tumor types and the other to process the other 5 tumor types.

Question 3: Will you require an additional subcontract between us and each of our tissue source sites? We have current agreements regarding tissue collection in place with each TSS in our network.

Response 3: No.

Inquiry 2

Question 1: The RFQ states that the response should be no more than 10 pages inclusive; however, some of our appendices makes us exceed this page limit. Is this acceptable? Will we be excluded based on this criteria?

Response 1: The page limit will be changed to 20 pages, including attachments. No, [offerors] will not be excluded because of this.

Inquiry 3 Question 1: Please clarify the time requirements for the blood draw. How many days pre or post-surgery are acceptable?

Response 1: The blood draw for solid tumor cases is intended to measure only germline DNA. Therefore, blood collected from two weeks prior to surgery to two weeks after surgery is acceptable.

Question 2: Will a blood collection kit be provided? Or is the site allowed to use their own tubes and collection procedures?

Response 2: Yes, the blood collect kit will contain a sodium-citrate tube.

Question 3: Will a tumor collection kit be provided? Or is the site allowed to collect tissue according to their own collection tubes and procedures?

Response 3: Yes, a tumor collection kit will be provided.

Inquiry 4 Question 1: Are biosketches from the PI or others required? We have a letter of recommendation. Can these documents be added as appendices or do they constitute part of the 10 page max application?

Response 1: Biosketches are not required. The page limitation includes appendices. As part of this amendment, the page limit has been revised to 20 pages, inclusive of all attachments.

Question 2: I intend to use the TCGA template for fixed cost calculation. Does that work?

Response 2: That should be sufficient. Your fixed price per case must be inclusive of all indirect costs and be supported by documentation (i.e. commercial price list, etc.), per Section 7 of the RFQ.

END OF AMENDMENT #5.