RFP_75N93024R00019-Amendment_1-Q_A_0001.pdf

EVALUATION AND TESTING SERVICES (ETS) FOR VACCINES AND OTHER BIOLOGICS FOR INFECTIOUS DISEASES RFP 75N93024R00019 Questions and Responses

Amendment 1

Issued by NIAID: 7/25/2024

Number Question Government Response 1 Please confirm that the representative responsible for negotiating provisional and/or final indirect cost rates for a Contractor can include other cognizant government agencies, for example DCAA or DCMA in lieu of the Director, Division of Financial Advisory Services for National Institutes of Health.

Yes, representatives responsible for negotiating provisional and final indirect cost rates may include those from other government agencies.

2 The list of items is in apparent chronological order. Item 7 describes preparation and provision of assay qualification protocols and Item 8 describes preparation and provision of draft validation protocols. There are no items in between or anywhere else within the list that describe performance of assay qualification or preparation and provision of a qualification report. Should the Contractor include costs and technical description of assay qualification performance and reporting, which would be in line with the separate items for assay development and validation?

Please provide for both the performance of assay qualification and the preparation of the assay qualification report, under item 7.

3 Attachment 7, Section 3 instructs the Offeror to describe all capabilities provided by external sources and identify the specific subcontractor, external vendor or consortia partner if currently known. When task orders are released and the scope of work is known, may additional subcontractors be added as appropriate, or must they be preapproved within the response to this solicitation?

Proposals responsive to a task order can contain any appropriate subcontractor and the evaluation will include the proposed subcontractor. Preapproval of subcontractors is not required to respond to this solicitation. Additional subcontractors and external vendors and consultants may be introduced at the time of Task Order proposals, subject to evaluation.

4 Will the required technical volume attachments (i.e., technical proposal cost summary, summary of related activities, completed 508 VPAT assessment) count toward the maximum page counts (Task Area A 20 pages and Task Areas B and C 40 pages)?

The 508 VPAT is excluded from the page count. All other attachments are included in the existing page count.

5 Within the solicitation, Section M Evaluation Factors for Award, the following must be addressed for the proposal to be “acceptable”: Live Vertebrate Animals (VAS), Authentication of Key Biological and/or Chemical Resources, and Plan for Sharing Model Organism for Biomedical Research. Should these

Yes, Live Vertebrate Animals (VAS), Authentication of Key Biological and/or Chemical Resources, and Plan for Sharing Model Organism for Biomedical Research shall be listed as be included in the technical proposal template as they are not currently in Attachment 7, section 9?

part of the technical proposal template under item 9, attachment 7.

The criteria listed will be evaluated independently for acceptability/unacceptability, as described in the RFP, after an acceptability determination has been made with regards to the overall proposal.

6 On page 29 of the solicitation, Contractors shall adhere to the NIH policy of enhancing reproducibility through rigor and transparency by addressing each of the four areas of the policy in performance of the Statement of Work and in publications, as applicable: 1) Scientific Premise; 2) Scientific Rigor; 3) Consideration of Relevant Biological Variables, including Sex; and 4) Authentication of Key Biological and/or Chemical Resources. Should these be included in the technical proposal template as they are not currently in Attachment 7, section 9?

This item has been added to Attachment 7, Section 9 of the RFP.

7 On page 134 of the solicitation, the Offeror shall demonstrate compliance with the U.S. Government for Institutional Oversight of Live Sciences Dual Use Research of Concern. Should this be included in the technical proposal template as it is not currently in Attachment 7, section 9?

Dual Use Research of Concern has been added to Attachment 7, Section 9 of the RFP.

8 On pages 9, 11, 46, and 162 of the solicitation, EIT Accessibility Standards/Section 508 Compliance is required of the Contractor for both report submission and for an annual Section 508 report. Should this be included in the technical proposal template as it is not currently in Attachment 7, section 9?

EIT accessibility should be addressed through the voluntary product assessment template (VPAT).

9 Attachment 7, Section 6, number 2 lists other key scientific and technical personnel (Leads in Project Management, Quality Assurance, Quality Control, Safety, Assay Development, Animal Model Studies, Safety and Toxicology, and Sample Testing. Is it acceptable in the personnel section to identify a position as “N/A” if that position does not apply to the task area?

Yes, only those key personnel required to carry out the work should be listed.

10 Does the Government expect the Quality Agreement and access to audits to flow down to second tier subcontractors with whom the Prime Contractor will not have privity of contract?

Yes, quality agreement and access to audits shall flow down to subcontractors, as it will be the responsibility of the Prime contractor to ensure compliance with all contract terms, conditions and requirements, including those of subcontractors and external vendors at all tiers.

11 For Task Area A, how many site visits for critical stages and how many audits would the Government anticipate per task order?

Audits will be carried out as part of the individual task orders and will depend upon the GLP status of the task order. Site visits to subcontractor sites (if used) should be budgeted in Task Area A.

12 For Task Area A, what frequency of teleconferences is anticipated by the Government?

For Task Area A there will be a kickoff meeting and annual meetings for years in which there are active Task orders.

13 For Task Area A, does the Government anticipate submission of a final task area report covering the entire period of performance?

There is no requirement for a final task area report for Task Area A

14 For Task Area A, if a final task area report is submitted, what is the anticipated submission dates for the draft and final reports?

There is no requirement for a final task area report for Task Area A

15 For Task Area B, it does not specify assay qualification and qualification statistical analysis reports are to be approved by the COR. Is it expected that the COR will approve these reports?

Yes. All reports will be reviewed and approved by the COR.

16 For Task Area B, are qualification and validation required for the cell mediated immune assays?

The level of qualification and validation will be dependent upon the intended use of the assays. If the assays are intended as primary clinical end-points then the assays for a Phase 2 must be qualified and for phase 3 must be validated. Phase 1 assays will need to be optimized. Task order requests for proposals will clearly delineate the intended use of the assays.

17 For Task Area B, cell mediated immune assays, is it expected that there will be animal work by the CROs to perform assay development and testing?

This will be dependent upon the requirements for the individual Task Orders. Please state the assumptions when proposing for Task Area B i.e. assume that the assay will be against human samples.

18 For Task Area B, sample testing, after validation will the assay monitoring/assay life cycle management go beyond the 24-month task order period of performance (e.g., for up to 5 years)?

The length of time for the assay monitoring will be for the period of performance of the task order.

19 For Task Area B, sample testing, will the COR/NIAID provide a specimen tracking and data management web site?

NIAID will not provide a specimen tracking and data management web site. Data generated as part of the task order may be submitted to external web- based data management sites as directed by the COR.

20 For Task Area B, in addition to the assay statistical analysis for qualification, validation and assay trending, is it expected that the CROs will perform statistical analysis of gene/protein expression data (e.g., clustering analysis of cytokine staining data to determine correlations between a specific antibody and T cell response)?

This will be dependent upon the requirements for the individual Task Orders. Please state the assumptions when proposing for Task Area B i.e. assume that there will be a plan to correlate cytokine staining to T cell response.

21 For Task Areas B and C, what are the expected duration for the site visits? Site visits are anticipated to be conducted either at the site or virtually for 2 days.

22 For Task Area C requirements in Attachment 3, (g)(iv) “all samples generated in the course of performance of the contract, as specified by the COR” please specify if “all samples” includes the residual samples, back-up samples, or replicates if not used.

“All samples” refers to residual samples not used during the completion of the activities in the task order.

23 Attachment 5 for Task Order C, under Quality Management states strict compliance to 21 CFR 58, GLP is not a requirement; however, the Quality Management Plan (QMP) must meet pharmaceutical industry standards for critical phase monitoring of studies. Critical phase study monitoring is done for GLP studies; is it anticipated that the studies completed under Task Area C are to be GLP compliant?

Only studies to be used under the “animal rule” will be required to be GLP compliant.

24 Solicitation Section J hyperlink for Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet link opens up a “page not found.” Can NIAID provide the updated link?

Hyperlinks have been updated.

25 The solicitation contains FAR clauses 52.222-55 (Minimum Wages for Contractor Workers Under Executive Order 14026) and 52.222-62 (Paid Sick Leave Under Executive Order 13706), both of which are associated with the Service Contract Labor Standards clause at 52.222-41; however, the solicitation does not contain FAR clause 52.222-41. Would NIAID confirm whether Service Contract Labor Standards Act applies to this solicitation? If yes, please add the SCLS FAR clause. If not, please amend the solicitation to remove FAR 52.222-55 and 52.222-62 which would not be applicable.

FAR 52.222-55 and 52.222-62 have been removed since SCLSA is not applicable to this solicitation.

26 If SCLS FAR Clause 52.222-41 applies, can NIAID please provide Wage Determination schedules?

The government does not intend on providing the schedule since the SCLSA is not applicable to this solicitation.

27 If SCLS FAR Clause 52.222-41 applies, are offerors able to add a separate CLIN for SCLS covered labor to the pricing?

SCLS is not applicable for this solicitation and therefore, Clause 52.222-41 does not apply.

28 Regarding Attachment_5_-_Sample_Task_Orders, Sample Task Area B contains references to both humoral and cellular assays. Does NIAID anticipate TORFPs will require both humoral and cellular assays?

Task order requirements will be subject to the needs of the programs. In some cases only humoral assays or cellular assays will be required. In some cases, a combination of both assay types may be required.

29 Related to the previous question, must an Offeror possess the capability (itself or through subcontractors) to conduct both humoral and cellular assays?

The offeror can possess only humoral, only cellular or both. Please respond to the relevant portion of the sample task order.

30 Regarding the Small Business Subcontracting Plan, at what level should we submit the plan – at the IDIQ Parent Contract level or at the Task Area/Task Order level?

The plan shall be submitted at the IDIQ parent contract level.

31 For the Small Business Subcontracting Plan, should we assume for a total contract value the ceiling of the ETS IDIQ of $136,588,000? Then for each year of the ETS, use this value divided by 10 (for the base + 9 options) or $13,659,000 for our Plan?

Yes, it anticipated that the total contract value for this contract will be $136,588,000. The value for each individual Task Order created from the parent IDIQ contract will have a different total. Sample Task Orders have been provided to offerors to help determine costs for the out years.

32 Hyperlink Attachments, Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet – when we click on the hyperlink we go to a site that says “Page Not Found.” Please provide the attachment via a new link or in sam.gov or via another method.

Hyperlinks have been updated.

33 The RFP and attachments require discussions of and inclusion in the Technical Volume of the following: BSAT (pg 132 of 169 of RFP, Key Biological and Chemical Resources (pg 135 of 169 of RFP); DURC policy (pg 136 of 169 of RFP); Data Sharing Plan (pg 137 of 169 of RFP); Sharing of Model Organisms (pg 137-138 of 169 of RFP), Section 508 Product Assessment Template (pg 163 of 169 of RFP—this is almost 12 pages long for our organization); IT Systems security (Attachment 7, pg. 7); Care of Live Vertebrate Animals (Attachment 7, pg. 7 for C and D); Vertebrate Animal Section, VAS (pg 132 of RFP); Two page CV’s/biosketches of personnel (Attachment 1).

Also required in the Technical Volume are the required seven sections as described in Attachment 7 (Overview through to Other Considerations). A comprehensive description for our technical approach, description of key personnel, program management plan, quality management, facilities and equipment along with the items above is not possible with the page limitations included in Attachment 1 for Task Areas B, C and D. Would the Government consider allowing the discussions and information in the underlined items above be included in Appendices exclusive of the page counts in Attachment 1, or alternatively, double the page limitations for Task Areas B, C and D?

Listed sections shall remain a part of the body of the technical proposal and included in the page count. This shall include all attachments and appendices. As stated in the response to Question #4, the VPAT will be excluded from the published page count limitations.

34 Will NIAID provide the peptide/viral coat proteins or must we synthesize those needed for immunoassays to quantitate antigen-specific serum IgG and mucosal IgA humoral responses in NHPs. Depending upon the decision, this will impact the assay design and costs considerably.

In responding to the sample task order, state the assumptions used to generate the costs i.e. viral coat proteins are available from a commercial source.

35 For the cellular-based assays to evaluate cellular immune responses in NHPs and/or humans against the viral protein antigen evaluating T cell and B cell responses to the antigen – will NIAID provide the blood from exposed or

In responding to the sample task order, state the assumptions used i.e the government will provide the blood from exposed or vaccinated subjects.

vaccinated or unexposed individuals. Depending upon the decision, the assay design.

36 What will the mode of delivery be for assay samples – cryopreserved blood and/or saliva – or other mode?

In responding to the sample task order, state the assumptions used i.e cryopreserved PBMCs.

37 For Sample Tasks B and C (efficacy) - Is it acceptable to assume BSL2, and non-Select Agent?

There will be BSL2 through BSL4 agents that will be tested.

It is anticipated that offerors may only have capabilities to apply for task orders for BSL2 and non-select agents.

38 With regards to the pathogen in question, is NIAID looking for us to concentrate on a specific model related to a specific pathogen, or would NIAID prefer a comprehensive overview of the capabilities and expertise within our organization across a list of pathogens?

Offerors should concentrate on a single pathogen for the purpose of this sample task order.

39 Is it possible to submit offers as both prime and subcontractor? If so, are there special requirements in doing so?

For the purpose of the solicitation, offerors may submit offers only as the prime contractor. This does not preclude your organization from operating in the capacity as a subcontractor to another prime contractor that is chosen for this solicitation.

40 Are multiple-PI allowed for this contract? Multiple-PI’s will not be allowed on this contract.

41 The business proposal instructions specify that for Area B, the duration is no more than 24 months, and we should budget for testing 90 non-human primate samples and 300 human serum and mucosal samples.

a. Does this mean that the proposed budget for both areas should be for 2-years? We are asking because the contract is a ten-year contract.

b. Are the number of samples for each year or total for two years?

Each Task Order will have a duration that is based upon the expected time to complete the task. The proposed budget should reflect the time and effort required to perform the tasks. The number of samples are the total number of samples to be tested over the period of performance.

42 We have the capacity to develop assays for new pathogens as we did quickly for SARS-COV-2. Multiple teams are now working on pan-coronavirus vaccines which will require testing of additional coronaviruses. Is it reasonable to budget in assay development for new viruses with this application or is it better to leave such efforts out of the budget?

Offerors should budget for a single virus.

43 1. If submitting bids on multiple Task Orders, should a single Small Business Subcontracting Plan be submitted to include all Task Orders bid upon, or does each Task Order require submission of a separate Small Business Subcontracting Plan?

2. Is a biosafety level 4 (BSL-4) facility required to apply? If so, can BSL-4 work be outsourced to accommodate the BSL-4 requirement?

Each Task Order proposal shall be complete in its entirety.

Each Task Order shall include the submission of the Small Business Subcontracting Plan.

BSL-4 capability is not required to apply. Should a task order for a BSL-4 pathogen be issued, that portion of work may be subcontracted to external vendors.

44 1. Attachment 5: Sample Task Order indicates that for Site Visits/Audits, “travel associated with the site visit” should be considered. Is the Contractor responsible for travel costs (airfare, lodging, meals) for NIAID representatives? If so, how many NIAID representatives should be expected for each Site Visit/Audit?

The contractor is not responsible for the travel of NIAID representatives, however, if the contractor subcontracts work it is anticipated that they will participate in an audit of the subcontracting site.

45 1. If electing to subcontract GLP studies related to tumorigenicity and genetic or reproductive toxicology for Task Area D, are there any special issues anticipated relating to the subcontracting of fertility, teratogenicity or pre and postnatal development testing of live viral vaccines under appropriate biosafety containment levels (BSL-2/3/4)?

Live viral vectors should be considered to be BSL-2 or below.

46 Attachment 15 is missing in section J, but there is a hyperlink for the small business subcontracting plan. Is attachment 15 the small business subcontracting plan?

Yes, the subcontracting plan is Attachment 15.

47 One PDF file is required to submit the technical proposals, but one technical proposal is required for each task area. Should the 2-4 technical proposals be combined into one PDF for submission? If so, are section dividers required?

Each Task Area proposal should be submitted as a separate PDF file.

48 Can graphics/tables be a font size less than 10? Graphs and tables should be at a font size between 10 and 12.

49 The proposal for task area A is limited to 20 pages. However, the instructions state the page limit for section 6, personnel, is 20 pages. Should personnel be described in task area A?

For each Task Area, all Key Personnel should be listed that are necessary for the successful completion of that specific Task Area. For Task Area A, PI and PM should be listed as Key Personnel. For Task Areas B, C or D, PI and Other Key Scientific and Technical Personnel should be listed as Key Personnel.

50 ATCH 8 calls for GFE offered for the acquisition. Please specify what the GFE is, or where the list is located.

There is not a specific list of GFE. Depending upon the Task Order, the government may supply the appropriate cells or specific reagents though our Biorepository.

51 What time on August 30 are the proposals due? The solicitation does not specify a time.

Proposals will be due by 3pm Eastern Standard Time (EST).

52 The solicitation describes task area A in ATCH 3, SOW, and also in ATCH 5, sample task orders. However, the descriptions are almost identical. Should the task area A technical response include both a base IDIQ response (ATCH

3) and a sample task order response (ATCH 5), as described in ATCH 7, technical proposal instructions, or should they be combined?

Task Area A should contain both the management of the ID/IQ parent contract and the management of the task order.

53 Are all “other key scientific and technical personnel” positions denoted in ATCH 7 required for ALL task areas? For example, a lead in safety and toxicology seems more relevant for task area D than the others.

Yes, only those key personnel required to carry out the work should be listed. Same as question 9.

54 For costing purposes, please identify what biosafety level the sample task order B studies will require.

Please state your assumptions in determining the costs i.e.

BSL level X.

55 For costing purposes, please identify what biosafety level the sample task order C studies will require.

Please state your assumptions in determining the costs i.e.

BSL level X.

56 For costing purposes, which NHP species will be used during testing for sample task order C?

Please state your assumptions in determining the costs.

For sample task order B, please confirm mucosal sample type (nasal wash or BALF or other)

Please state your assumptions in your response.