Amendment_1_NIAID-DAIDS-NIHAI2016060.pdf

AMENDMENT #1, BAA NIAID-DAIDS-NIHAI2016060

Amendment No. 1

NIAID-DAIDS-NIHAI2016060

“Nonhuman Primate Core Cellular Immunology Laboratory for AIDS Vaccine Research and Development”

Solicitation Number:

Amendment Number:

Amendment Issue Date:

NIAID-DAIDS-NIHAI2016060

One (1)

July 8, 2016

Proposal Due Date/Time:

Monday, July 25, 2016, at 3:00 PM, Local Time (CHANGED)

Issued By: Michelle L. Scala Contracting Officer

OA/DEA/NIAID/NIH/DHHS

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

Points of Contact: PRIMARY:

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

SECONDARY:

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

Please note that the due date for submission of proposals is CHANGED as a result of this amendment.

The purpose of this amendment is to: 1) answer questions from Offerors regarding the solicitation; 2) extend the due date for submission of proposals.

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.

Question 1:

Attachment 4, Additional Technical Proposal Instructions, page 3 Section 4: Scientific and Technical Personnel states: “Provide CVs for the PI and scientific staff. Limit CVs to 2-3 pages and provide selected references for publications relevant to the scope of the RFP. Include experience with projects of similar scope, size and complexity carried out by the Offeror and any proposed subcontractors over the past 5 years.” Should the CVs be in a NIH Biosketch format?

Are CVs required for the technical staff?

Response 1:

mailto:durandca@niaid.nih.gov mailto:anhughes@niaid.nih.gov

The CVs may be in any format that captures the experience and expertise of the investigators. CVs are not required for the technical staff, but a paragraph describing their technical capabilities and experience and indicating their role in the contract activities should be included in the proposal.

Question 2:

The following text: “Include experience with projects of similar scope, size and complexity carried out by the Offeror and any proposed subcontractors over the past 5 years” from the above section, seems out of place and is covered by what is in the business proposal. Do we duplicate the section from the business proposal and give it its own header? It seems odd to include this information in section 4 which is about personnel?

Response 2:

The Business Proposal is not reviewed by the Peer Review Panel. They only see the Technical Proposal. As stated in the solicitation, the information about your experience related to the current RFP’s requirements can be used by reviewers to evaluate your capability to successfully conduct the work of the Cellular Immunology Lab contract. It would be to your advantage to include a description of this experience in the Technical Proposal. (And in the Business Proposal, as appropriate.)

Question 3:

Attachment 5: Additional Business Proposal Instructions and Uniform Cost Assumptions, Page 1, SECTION 2 – Cost or Price Support states: “Section L of the RFP specifies the minimum documentation requirements for cost data and all cost related support. All related documentation should be included in a clearly marked section of the proposal.” What is the documentation needed to support costs?

Response3:

Please refer to the RFP under Section L – Instruction, Conditions, and Notices to Offerors, Paragraph 1, Instructions to Offerors, paragraph c, Business Proposal Instructions (starting on page 70 of the solicitation) details what documentation should be included in the business proposal to support proposed costs

Question 4:

Attachment 5: Additional Business Proposal Instructions and Uniform Cost Assumptions, Page 2, Section 3 – Uniform Cost Assumptions, paragraph 2) Technical Cost Assumptions, subparagraph

a) states: “Offerors should assume that they will be requested to perform up to 2000 peptide stimulated cytokine ELISPOT assays on approximately 400 nonhuman primate samples per year.” Please clarify number of time points/animal, number of replicates/sample, number of tissues/animal and numbers of peptides to evaluate per ELISPOT assay. As an example is unclear whether this is 400 animals X 50 peptides = 2000 ELISPOT assays or 400 animals X 2000 ELISPOT assays = 800,000 ELISPOTS

Response 4:

We apologize for the lack of clarity. The request is for the cost to conduct T cell ELISPOT assays on approximately 400 samples per year. Each sample may be stimulated by different peptide pools (or individual peptides) or there may be several different cytokine readouts from stimulation of a sample with one set of peptides, or duplicate assays may be needed. So please estimate the cost of running 2000 T cell ELISPOT assays.

Question 5:

Please clarify whether budget should be only for interferon-gamma ELISPOT assays or should they also include other relevant ELISPOT assays such as IL-2 ELISPOTs and perforin

ELISPOT?

Response 5:

It is anticipated that there will be requests to evaluate other readouts, but (for simplicity) for the purpose of estimating proposed costs, please estimate the cost based on interferon-gamma readouts.

Question 6:

Section 3 – Uniform Cost Assumptions, paragraph 2) Technical Cost Assumptions, subparagraph

b) states: “Offerors should assume that approximately 10% of the samples will require further characterization (i.e., identification and of number of peptide epitopes recognized)” How deeply should such an analysis be taken from a budgeting perspective? Should this cover the entire viral proteome or only selected proteins? Should the peptide epitope mapping be done to the level of the optimal epitope, i.e. 9-mer for a CD8 epitope?

Response 6:

For the purpose of this budget preparation, please propose to use overlapping sets of peptides to determine the number of epitopes in SIV Gag and SIV gp140 that elicit cellular immune responses. For purposes of this proposal, use interferon-gamma as the indicator read-out cytokine (although in practice, other readouts will be more informative.) For purposes of this budget proposal, it is not expected that the optimal 9-mer epitope will be identified.

Question 7:

Section 3 – Uniform Cost Assumptions, paragraph 2) Technical Cost Assumptions, subparagraph

c) states: “Offerors should assume that they will be requested to perform up to 2000 flow cytometric-based intracellular cytokine assays/ phenotypic characterizations on nonhuman primate samples per year.” Please clarify number of time points/animal, number of replicates/sample, number of tissues/animal and numbers of peptides to evaluate per ICS analysis.

Response 7:

We agree that this is a difficult item to cost, since the actual set of fluorescent-labeled monoclonal antibodies could vary with the cell type being evaluated. However, to simplify the estimation of costs, please assume that the flow cytometric assays will focus on the characterization of T cells. The request is for the performance of 2000 flow cytometric assays, independent of the number of time points, animals, and the antibody panels used. Please base proposed costs on your experience with the average cost of your multi-color flow cytometric assay. Your standard replicate practice should be included in the 2000 assays.

Question 8:

Should the phenotyping be considered only in the context of an ICS panel or should this be separate?

Response 8:

Please see the previous response, which attempts to narrow down the large number of potential flow cytometric assays for the purposes of estimating costs.

Question 9:

Section 3 – Uniform Cost Assumptions, paragraph 2) Technical Cost Assumptions, subparagraph

d) states: “Offerors should include the cost of ordering peptides for the ELISPOT and intracellular cytokine assays. Assume that a minimum of 10 mg each of peptides covering three HIV or SIV envelope glycoproteins, one p55 Gag, and one each of Tat, Nef, Rev, and Vif will be required per year. Also include the cost of the appropriate antibodies to be used as reagents for flow cytometric assays (ICS and T cell phenotyping).” 10mg of peptide suggests enough peptide to do 10,000 tubes for ICS but this will depend on the concentration of stock peptides and how peptides are pooled. More detailed information would be useful to determine the workload requested and the cost of conducting that work.

Response 9:

Please use the examples provided in the Uniform Cost Assumptions since this is only an estimate for budgeting purposes.

Question 10:

The number of peptides spanning individual HIV/SIV proteins will depend on the length of individual peptides and the number of amino acids (aa) overlap of adjacent peptides. Please clarify whether budget should be for 15aa long peptides overlapping by 11aa?

Response 10:

Please propose a budget for 15 aa long peptides overlapping by 11aa.

Question 11:

The request to include the cost of antibodies here seems redundant with the request for the cost of phenotypic studies in “2. Technical Cost Assumptions section “c” above. Should “c” include everything but antibodies and “d” include the antibodies separately? Please clarify.

Response 11:

The cost of antibodies for flow cytometric assays should be based on the 2000 assays as discussed above in response to Question 7.

Question 12:

Section 3 – Uniform Cost Assumptions, paragraph 2) Technical Cost Assumptions, subparagraph

e) states: “Offerors should include the cost of conducting up to 400 B cell ELISPOT assays per year.” How many peptides/ELISPOT assay? What cytokine(s) should be evaluated in the ELISPOTs?

Response 12:

While previous cost assumptions in (a) and (b) were for T cell ELISPOT assays, the request for (e) is to estimate the cost of conducting B cell ELISPOT assays to quantitate the number of SIVenv-specific or HIVenv-specific antibody-secreting cells in a lymphocyte sample.

Question 13:

Section 3 – Uniform Cost Assumptions, paragraph 2) Technical Cost Assumptions, subparagraph

g) states: “For purposes of preparing a cost proposal related to improving existing and adapting new immunological assays, Offerors may propose budgetary commitments of personnel and materials to these aspects of the Statement of Work, but no additional budgetary provisions are required.” Can any additional guidance be provided? Regardless of what would be entered no such work could start without a discussion with the COR and a negotiation with respect to the specific course of work to be done and the costs involved.

Response 13:

You are correct. Any developmental work would be well-defined and approved before initiation, and it is difficult to estimate personnel and materials in advance. Therefore, the estimate of effort included in the solicitation takes into consideration the need for the development, improvement, and acquisitions of assays, in addition to the conduct of assays, assuming that both types of functions could be conducted by the contract scientific and technical staff.

Question 14:

Section 3 – Uniform Cost Assumptions, paragraph 3) Travel states: “Contract Meetings: For purposes of preparing a cost proposal, Offerors should assume one trip per year for the Principal Investigator (or designee) and a co-investigator to attend meetings with the Contracting Officer’s Representative in the Washington, D.C. metropolitan area.” How many days should we budget for the travel mentioned above?

Response 14:

For purposes of this cost proposal, assume travel on the morning of Day 1, an overnight hotel accommodation on Day 1, and return travel on the afternoon or evening of Day 2.

Questions 15:

This question is regarding Section K of the Business Proposal (Reps & Certs). Does Attachment 7 of the RFP need to be complete. Or will a copy of the Reps & Certs downloaded from SAM.gov be acceptable? The downloaded version has a different look than the documents in the

RFP.

Response 15:

As stated in Section K on page 43 of the solicitation, Representations and Certifications needs to be completed for both the System for Award Management (SAM.gov) and Attachment 7: SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS of the RFP.

END OF AMENDMENT # 1, BAA No. NIAID-DAIDS-NIHAI2016060