20140731_QVOA_NIHAI2013184_Amend_4_FINAL.pdf

AMENDMENT #4, RFP NIAID-DAIDS-NIHAI2013184

Amendment No. 4

NIAID-DAIDS-NIHAI2013184

“Quantitative Viral Outgrowth Assay Service Resource”

Solicitation Number:

Amendment Number:

Amendment Issue Date:

NIAID-DAIDS-NIHAI2013184

Four (4)

July 31, 2014

Proposal Due Date/Time:

Thursday, August 14, 2014 at 3:00 PM, Local Time (Unchanged)

Issued By: Michelle L. Scala Contracting Officer

OA/DEA/NIAID/NIH/DHHS

6700-B Rockledge Drive, Room 3214 Bethesda, Maryland 20892-7612

Points of Contact: PRIMARY:

george.keane@nih.gov George Keane, Contract Specialist Phone: 301-451-3690

SECONDARY:

mscala@niaid.nih.gov Michelle L. Scala, Contracting Officer Phone: 301-451-3693

Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals remains unchanged.

The purpose of this amendment is to answer questions from potential offerors regarding the solicitation.

Offerors must acknowledge receipt of this amendment by identifying this amendment number and date of the amendment on each copy of the proposal submitted. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

mailto:george.keane@nih.gov mailto:anhughes@niaid.nih.gov

AMENDMENT #4, RFP NIAID-DAIDS-NIHAI2013184

Questions from Potential Offerors:

Question 1:

Will positive control human patient samples for assay optimization be provided?

Response to Question 1:

No, the Government will not provide materials for the optimization of the assay. Note under the Statement of Work, the following: “Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work as specified herein.”

Question 2:

In addition to training external PIs at the contractor site, will there be a requirement to perform a tech transfer of the existing or newly developed/optimized/qualified/validated assay to external sites?

Response to Question 2:

This is not a requirement. See Statement of Work. There is a training component but the SOW does not mention tech transfer of assays performed/optimized/developed under the contract.

Question 3:

The Statement of Work indicates plans should be made based on receiving 200 mL of blood for testing with the QVOA assay. Previous work (Siliciano and Siliciano 2005) used 120 mL of blood. For a resultant contract, is it contemplated that all 200 mL should be tested by the QVOA assay, which would be a large experiment, or will some of the blood be banked at the contractor for potential future use if the assay is sensitive enough to use a smaller blood volume?

Response to Question 3:

The SOW states that the “assay shall be able to detect, at a minimum, one latently infected cell per one million resting CD4+ T cells, starting with 200 ml of blood from a well suppressed subject on HAART.” This is a statement regarding the minimal sensitivity level that the Contractor’s assay will be required to meet. It does not indicate the volume of sample that will be received by the Contractor for assay. With regard to storage of samples, a number is given (100) that should be costed out (see ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS

ATTACHMENT 5).