Amendment_3_NIHAI2015040.pdf

AMENDMENT #3, BAA NIAID-DAIDS-NIHAI2015040

Amendment No. 3 Pre-Solicitation Notice

BAA-NIAID-DAIDS-NIHAI2015040

“Staged Vaccine Development”

Solicitation Number:

Amendment Number:

Amendment Issue Date:

BAA-NIAID-DAIDS-NIHAI2015040

Three (3)

July 22, 2015

Response Date:

Thursday, August 20, 2015 at 3:00 PM, Local Time (Unchanged)

Issued By: Michelle L. Scala Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3D10 Bethesda, Maryland 20892-9821

Points of Contact: PRIMARY:

Callie Durand, Contract Specialist durandca@niaid.nih.gov Phone: 240-669-5155

SECONDARY:

Michelle L. Scala, Contracting Officer mscala@niaid.nih.gov Phone: 240-669-5156

The purpose of this amendment is to answer a question from potential offeror regarding the solicitation.

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.

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.

Questions from Potential Offerors:

Question 3:

While the BAA clearly states the maximum performance period for Stage I (two years), no required or expected minimum performance period is listed. Does DAIDS have any requirements mailto:durandca@niaid.nih.gov mailto:anhughes@niaid.nih.gov

AMENDMENT #3, BAA NIAID-DAIDS-NIHAI2015040

or expectations for a minimum performance period for Stage I? For example, would a 3-month or 6-month period be sufficient for Stage 1?

Response to Question 3:

The BAA states that the maximum performance period for Stage I is two years as it is anticipated that by the end of this time period the Process Development Plan (PDP) would be refined and finalized; selection of the contractors/subcontractors completed after performing audits and due diligence; and limited initial activities initiated to prepare for Stage II. In addition, DAIDS would also complete due diligence audits of the proposed facilities during this time. However if the Offeror anticipates achieving these activities in less than 2 years, they may propose a minimum of one year performance period for Stage I. Each year costs should not exceed approximately $100,000 for a maximum cost of $200,000 for Stage I.

Question 4:

We are seeking clarification of language in Attachment 5 to the BAA. Page 2 of this attachment states that "Vaccine concepts involving more than one platform" will not be supported by contract awards under this BAA. We interpret this to mean that applications requesting financial support for more than one platform are ineligible for funding. Could DAIDS provide clarification as to whether a project including manufacture of a single vaccine candidate (single platform) that will be used in heterologous prime-boost regimens in clinical trials would be appropriate and eligible for funding under the Staged Vaccine Development mechanism?

Response to Question 4:

The statement "Vaccine concepts involving more than one platform will not be supported by contract awards under this BAA” implies that the applicants can apply for only one platform per BAA. If there are more platforms involved in the heterologous vaccination strategy then for each platform a separate application needs to be submitted to request funding. The applicants requesting financial support for more than one platform in one application are ineligible for funding.