Q&As_CSN_2019-BARDA_Draft_RFPs_CTPE_SDCC_BSIP_2019-04-09.pdf

April 9, 2019

# Potential Offeror Questions BARDA Answers

Please clarify the apparent discrepancy between sections C.3.3.2.2 and C.3.1.4. Is the contractor required to provide their own COTS software for tracking and inventory, or use BARDA provided software? If the latter, what is the software?

BARDA will not provide software. Commercial off the shelf systems (COTS) are required. As long as the BSIP is using a COTS specimen inventory system, then the expectation is that the BSIP and SDCC will collaborate.

BSIP and SDCC will collaborate to ensure the efficient and accurate transfer of data.

19‐BARDA‐DRAFT‐CSN‐BSIP Section C.3.3.2.2 and C.3.1.4f BARDA is providing software for tracking and inventory, is it capable of storing all required information (such as found in section C.3.2.6) or does BARDA anticipate supplemental software being needed?

Commercial off the shelf systems (COTS) are required. As long as the BSIP is using a COTS specimen inventory system, then the expectation is that the BSIP and SDCC will collaborate. BSIP and SDCC will collaborate to ensure the efficient and accurate transfer of data.

BARDA‐DRAFT‐CSN‐BSIP Section C.3.1.1 What biological sample types besides serum are anticipated? Currently, BARDA has serum samples in storage. Depending on the protocol, we may need to collect PBMCs, whole blood, plasma, or blood spotted on filter paper.

We are not excluding possibilities for a more extensive list. It is possible that a protocol may specify granulocytes, serum, DNA\RNA, urine in tube aliquots, saliva in tube aliquots, tissue slides, biopsy specimens, or other surgical specimens.

What are the anticipated numbers of biological specimens and investigational products requiring receipt, storage, aliquoting and distribution each year

BARDA expects to conduct 2 new clinical trials per year. Historically, each clinical trial enrolls several hundred or more participants and collects approximately 20,000 1 ml cryotubes.

The number of investigational product retains are specific per study, but are estimated to be a relatively small amount (approximately 1‐5% of overall clinical trial IP inventory).

What is the anticipated volume of Select Agents requiring receipt, storage, aliquoting and distribution each year?

BARDA's CSN is not currently providing this capability, but wishes to ensure that this need can be fulfilled if it becomes necessary. In such an event, BARDA would discuss specifics around anticipated volume, etc. with the Offeror as early as possible.

19‐BARDA‐DRAFT‐CSN‐BSIP Section C.3.1Please confirm that no protected health information (PHI) or personally identifiable information (PII) will be housed by or provided to the contractor‐ all samples will be de‐identified.

No specimens with protected health information (PHI) or personally identifiable information (PII) is intended to be housed by or provided to the BSIP contractor‐ all samples will be de‐identified. The BSIP will receive de‐ identified samples for long‐term storage. Protected health information and personally identifiable information is not intended to be provided to or housed by the BSIP contractor

7 What is BARDA’s preferred analytic tool? For example, SAS, Excel, R, SPSS? BARDA's preferred analytical tool is SAS.

Is it acceptable for the responding organization to utilize offshore resources that are not located in the United States?

Yes. Please provide process‐proven solution related to issues such as data security, language barriers, time zones, etc.

9 What is the cloud environment at BARDA? Currently there is no cloud environment provided by BARDA

Could BARDA describe its long‐term goal for requiring commercial off‐the‐shelf software for study data capture, management, and analysis?

BARDA needs to ensure that there is a smooth data flow process in place for the Clinical Studies Network, between the CTPE, SDCC and BSIP IDIQ awardees. Looking ahead, a long‐term goal is to facilitate the transfer and transition of data, resulting from IDIQ contracts and task orders, to new awardees.

Does BARDA have a preference regarding the tool selected for study data capture, management, and analysis, either brands or specific features? Is there a required format for data export format?

BARDA's preference is to have leading commercial EDC vendor and SAS datasets for data export and analysis.

Could BARDA describe the other systems within the CSN and used by BARDA researchers that the data capture, management and analysis tools will need to integrate with for SDCC activities?

SDCC contractor is expected to integrate with CTP&E and BSIP systems. BARDA is looking to the SDCC.

CTP&E, and BSIP awardees to collaborate on the development of the necessary infrastructure.

Part I, Section C.3, Objective 1, Section 1.d:Could BARDA provide more detail on what public databases would be used for this objective, and whether the access would be facilitated by the US Government for state‐run healthcare databases?

Public databases to be determined, depending on the project and task order.

BARDA Clinical Study Network ‐ Q&As from Draft RFPs dated March 5, 2019

19‐BARDA‐DRAFT‐CSN‐CTPE | 19‐BARDA‐DRAFT‐CSN‐SDCC | 19‐BARDA‐DRAFT‐CSN‐BSIP

19‐BARDA‐DRAFT‐CSN‐SDCC Part I, Section C.3, Objective 1, Section 4.b:

Could BARDA describe how responsibility for TMF support is delineated between the SDCC and CTPE?

Please note the requirements below from the RFP

∙ CTPE: Manage electronic Trial Master File (eTMF) which includes the following: create eTMF index; set up and maintain eTMF; conduct periodic eTMF audits; final eTMF quality control, archiving and document return.

∙ SDCC: Plan for centralized clinical study records (i.e., TMF) archive for indefinite long‐term storage that meets regulatory requirements.

SDCC contractor will only responsible for archiving final TMF from completed studies.

19‐BARDA‐DRAFT‐CSN‐SDCC Part I, Section C.3, Objective 2, Section 7: Could BARDA describe how responsibility for regulatory support is delineated between the SDCC and CTPE? Please note the requirements below from the RFP.

∙ CTPE: Perform quality control, publish, and transmit FDA submissions which are compliant with eCTD specifications. Note, list of items includes pre‐IND submissions, IND submissions, and protocol amendments.

∙ SDCC: Providing regulatory operation services that include initial and amendment IND publishing and FDA submission in eCTD format.

Offerors should provide capabilities for regulatory support in their response to the RFP. Specific requirements per RTOR will be delineated in the RTOR statement of objectives.

RFP states Aliquoting must take place in facilities and with equipment consistent with CDC/NIH biosafety guidelines. The Contractor shall aliquot and label biological specimens received as follows:”. Are the next two bullet points intended to be the “as follows” description? If not, please provide the instructions that appear to be missing with regard to aliquoting and labeling biological specimens. Page 7, Section B.5.5

The government states that “the database systems must be commercial off‐the‐shelf systems (COTS), validated–i.e.

CFR, ISO 9001, and able to exchange information electronically with other database systems of the CSN Infrastructure.” Can the government provide detail on the CSN infrastructure architecture? Page 8 Section C.3

Detailed requirements for aliquoting, labeling, etc. will be provided with the Statement of Objectives of each individual task order.

The CSN infrastructure architecture for this requirement does not yet exist. BARDA is looking to the BSIP and SDCC awardees to collaborate on the development of the necessary infrastructure.

The RFP states, “develop and implement communication plans consistent with BARDA SOPs” Can the government share the SOPs being referenced?

Yes, after contract award.

Given the sensitive nature of BARDA’s work, will employees of the selected CROs be required to go through background checks, obtain security clearance, or similar?

Some CRO employees may be required to be cleared through the HHS security, if they will have access to PII or other similar protected information. More details will be provided in the final RFP.

Does BARDA have a standard budget excel template they would like applicants to use? BARDA does not have a standard budget template. The Offeror should submit their budget in excel and will include all applicable costs.

Given that multiple CTP&E CROs will need to work with a single SDCC CRO and a single BSIP CRO, will there be an opportunity for all CTP&E IDIQ awardees to meet with them to understand their systems and processes? This will reduce the lead‐in time for awarded projects

BARDA will plan a CSN kick‐off meeting after award to review systems and processes. Additional opportunities for discussion, collaboration, and refinement of systems and processes will be arranged as needed, working with the BARDA COR and CO.

Can BARDA provide a list of anticipated disease areas that might be included within the awarded work?

This may impact the justifications we provide and our prior relevant experience.

Clinical Trials in the last five years included safety and efficacy studies for Ebola vaccine , H7N9 vaccine, H5N1 vaccine, and Anthrax vaccine in the elderly as well as Zika blood collection for evaluation of a diagnostic device. The key word that you used is ‘anticipated.’ Our mission is to facilitate MCM development as a core service for BARDA Programs. Our mission is to aid in securing our nation from chemical, biological, radiological, and nuclear (CBRN) threats, as well as from pandemic influenza (PI) and emerging diseases.

Select Agent List: Please visit PHE.gov or https://www.ncbi.nlm.nih.gov/books/NBK373572/

Brief Description of Supplies or Services: “The systems that will be used to support clinical study data capture, management and analysis must be commercial off‐the‐shelf (COTS) platforms in order to facilitate integration within the CSN and with BARDA researchers in support of the BARDA mission.”

Commercial off the shelf systems (COTS) are required.

Would a non‐COTS database system be acceptable if it is consistent with current CDISC standards, WHO drug coding and MedDRA coding?

Commercial off the shelf systems (COTS) are required.

B.5.4 Cost Unallowables Unless Authorized by the Contracting Officer. Is there a limit on how much statistical or data management work may be subcontracted out?

BARDA will not provide a limit on subcontracting in the RFPs. However, the Offeror should provide a Risk Mitigation Plan that includes the Offeror's detailed strategy on handling subcontracts, how the Offeror will provide oversight and stay involved with the subcontractor's work product throughout the life of potential Task Orders. Please explain how the Offeror's subcontracting model is advantageous to the Government.

H.1 Protection of Human Subjects, HHSAR 352.270‐4(b) (January 2006). Is there a specific HSP training that is required, or if not, a set of minimum criteria for acceptable HSP training?

HSP training is required; however, BARDA does not require a specific HSP training.

B.5.4 Cost Unallowables Unless Authorized by the Contracting Officer; Are subcontractors restricted to being US groups within US companies given this is for a US government RFP?

No, subcontractors are not restricted to being US groups within US companies. Offerors with non‐US groups are encouraged to provide process‐proven solution related to issues such as data security, language barriers, time zones, etc.

E2 Audits: Would it be correct to assume that contractors could also be subject to cGCP audits in addition to cGMP?

Yes, all CSN contractors may be subject to audits (e.g., cGCP, cGLP, cGMP, etc.). Please refer to final RFP when posted.

28 Attachment #3 (page 120 of 150); Will a specific example be provided for the final RFP? Yes, a sample Capabilities Matrix will be provided with final RFP.

Sections C.3. and C.3.1.4. Please elaborate on requirement(s) for COTS regarding database/inventory system. Would a fully validated bespoke system be considered acceptable if it is 21 CFR Part 11 compliant and can provide traceability, specimen tracking and exchange information with outside systems?

Commercial off the shelf (COTS) systems are required.

Section C.3.1.2. Item #2. Maintaining the necessary clean rooms. Are there specific threshold limits for particulates with the anticipated work required in these clean rooms?

The threshold will depend on the specific processing requirements of the Task Order. However, the Offerors should submit their capabilities for both routine as well as more specialized types of work.

BARDA indicates three contract types are possible.

a. In terms of Fixed Fee, is a Commercial Item contract under FAR Part 12 a possible type of fixed fee contract that could be awarded?

b. In terms of Cost Share, would BARDA consider including as a cost share consideration of expenditures outside of any ensuing contract as partial consideration in lieu of a formal cost share contact that would otherwise restrict the ability to receive a fee?

a. The anticipated base contract awards will be Indefinite Delivery/Indefinite Quantity (IDIQ) contracts. Task orders awarded under the IDIQs will be Firm Fixed Price (FFP), Cost‐plus‐Fixed‐Fee (CPFF) or Cost‐Sharing.

The Government does not anticipate using FAR Part 12 for this requirement.

b. This question is unclear; however, please note that issuance of Cost‐Share RTORs/task orders is unlikely.

In the rare event that the Government decides to issue this type of RTOR, details would be provided at that time.

Is BARDA willing to consider awarding these contracts using its Other Transaction Authority The Government has determined that the IDIQ contract mechanism is best‐suited for the specific requirements of the Clinical Studies Network.

Section C.3.3.2.2. Item #3. Please elaborate on utilizing new software provided by BARDA to barcode and track biorepository specimens. Is this in lieu of a current specimen inventory system? If this is an additional inventory system, will integration efforts be required to manage with our current system?

The draft RFP misstated this requirement and the final RFP will clarify. BARDA will not provide software. As long as the BSIP is using a COTS specimen inventory system, then the expectation is that the BSIP and SDCC will collaborate. BSIP and SDCC will collaborate to ensure the efficient and accurate transfer of data.

Section C.3.1.3. Please elaborate on ‘providing arrangements for testing’. Does this also include establishing downstream testing appropriate for the request, or primarily establishing communications and shipping scheduling with the testing facility?

This involves primarily establishing appropriate communications with BARDA, the SDCC, and the testing facility, as well as providing reliable service. The contractor will need to work with the COR, coordinate activities with the SDCC, inventory specimens, develop a schedule, make arrangements with the testing facility for shipment and delivery.

What does BARDA anticipate the proposal response time to be following issuance of a final RFP(s)? Will consideration be given if a contractor intends to apply to more than one of the three anticipated RFPs to allow for adequate time to prepare three separate proposals?

BARDA has issued an RFI and draft RFP in advance to alert potential Offerors and to help ensure that they can be prepared to submit their proposal(s) within 30 days of the final posting.

Section L.5.3. As hourly rates do vary over time, for the purposes of the two studies (outlined in Attachment #1 and #2) should we assume contract award and start day of Jan. 1, 2020 for each study to appropriately capture the correct annual rates?

Offerors can assume October 1, 2019, which is the start of the U.S. Government's fiscal year. However, this date may change.

Section C: A 2.13.1.6. It is understood that our business proposal is to include all cost information per objective as delineated in the SOO. That said, do you want costing for the central lab testing services for the two studies (outlined in Attachment #1 and #2) to be included in this RFP?

Yes.

What does BARDA anticipate the proposal response time to be following issuance of a final RFP(s)? Will consideration be given if a contractor intends to apply to more than one of the three anticipated RFPs to allow for adequate time to prepare three separate proposals?

BARDA has issued an RFI and draft RFP in advance to alert potential Offerors and to help ensure that they can be prepared to submit their proposal(s) within 30 days of the final posting. Please refer to the final RFPs for proposal due dates.

Attachment 1. Can BARDA provide the # of Unique/Repeat tables; Unique/Repeat figures and listings for us to provide pricing for?

Please refer to final RFP once posted.

19‐BARDA‐DRAFT‐CSN‐CTP&E Section C.7. – Does BARDA expect the IT Security Plan to be submitted following the template provided in Attachment 15, or is our current form acceptable for the purposes of this RFP?

The Offeror's current form is acceptable as long as it complies with all federal IT Security guidelines which will be included in the final RFP.

19‐BARDA‐DRAFT‐CSN‐CPT&E Section L.4.2. Question #2 ‐ Does BARDA expect the Security Plan requested here to be submitted following the template provided in Attachment 14, or is our current form acceptable for the purposes of this RFP?

The Offeror's current form is acceptable as long as it complies with all federal physical security guidelines which will be included in the final RFP.

Attachments #1&2 – Systems preferences – Is there a specific system BARDA prefers we utilize for budgeting purposes? EDC? eTMF? ePRO? CTMS? Others?

Leading commercial vendors are preferred, but there is no preference on software platforms.

19‐BARDA‐DRAFT‐CSN‐CPT&E Section L.4.2. Question #3 – Is Offeror’s form of Project Management Plan acceptable?

Yes, if it covers everything requested in the RFP (i.e.; Draft RFP sections L.4.2.3.; C.3.A.1).

Sample RTORS – Will BARDA consider electronic diaries (electronic patient reported outcomes or ePRO) for collecting clinical trial data from patients?

Yes.

Sample RTORS2. 19‐BARDA‐DRAFT‐CSN‐CTP&E Attachments #1&2 – Given the request for centralized and remote e‐monitoring, should we assume a virtual PI meeting to start the trials instead of in‐person?

The nature of the IM or PI meetings may vary depending on the study. The Offeror is encouraged to suggest and plan the type of meeting they believe is most appropriate for the trial in question

Sample RTORS Attachments #1&2 – Protocols request up to 6 US sites for each sample task order. Should we propose less if we believe less will be needed or propose 6 in order to be in line with other CROs proposals?

BARDA provided the estimate of 6 sites based on previous experience. Offerors may use their judgment regarding the number of sites when writing the proposal, and would be expected to provide a rationale for choosing more or fewer than 6.

Sample RTORS Attachments #1&2 – Protocol details request “up to” 15 interim monitoring visits. Should we budget for all 15 or, if our metrics suggest fewer visits, budget for the number we forecast?

BARDA provided the estimate of up to 15 monitoring visits based on previous experience. Offerors may use their judgment regarding the number of monitoring visits when writing the proposal, and would be expected to provide a rationale for choosing more or fewer than 15.

48 Attachments #1&2 – Vendors – Does BARDA have a central lab they prefer using? BARDA does not have a preference for the central lab used.

9‐BARDA‐DRAFT‐CSN‐CTP&E Attachments #1&2 – Does BARDA anticipate patient narratives for the CSR only be limited to SAEs? AEs of special interest?

Offeror may include SAEs and AEs of Special Interest.

19‐BARDA‐DRAFT‐CSN‐CPT&E Attachments #1&2 – Will a specialty lab be used to conduct immunogenicity assessment? Does BARDA have one they prefer?

Yes, it is expected that a specialty laboratory will be used to conduct immunogenicity assessments. BARDA sometimes has a preferred specialty lab, but not for the scenarios provided in sample RTORs.

19‐BARDA‐DRAFT‐CSN‐CTP&E Section C.6. – Does BARDA expect the Continuity Plan to be submitted following the template provided in Attachment 15, or is our current form acceptable for the purposes of this RFP?

The Offeror’s Continuity Plan template is acceptable. We provided a guideline to develop a Continuity Plan if you do not have one.

19‐BARDA‐DRAFT‐CSN‐CPT&E Section L.4.2. Question #4 ‐ Does BARDA expect the Risk Mitigation Plan requested here to be submitted following the template provided in Attachment 13, or is our current form acceptable for the purposes of this RFP?

The Offeror’s Risk Mitigation Plan template is acceptable. We provided a guideline to develop a Risk Mitigation Plan if you do not have one.

19‐BARDA‐DRAFT‐CSN‐CPT&E Section L.4.2. Question #6 ‐ Does BARDA expect the Continuity of Service Plan requested here to be submitted following the template provided in Attachment 15, or is our current form acceptable for the purposes of this RFP?

The Offeror’s Continuity of Service Plan template is acceptable. We provided a guideline to develop a Continuity of Service Plan if you do not have one.

Section L.5.3 Business Proposal sub‐section 4 requires a Small Business Subcontracting Plan is submitted with the initial offer (Page 75). Due to the nature of the contracting vehicle (IDIQ w/ individual task orders) the planned subcontracting dollars will not be known until an RTOR is issued. Can BARDA confirm what the Subcontracting Plan shall be based off (for example the sample RTORs)?

The Small Business Subcontracting Plan should be based off of planned percentages, at the IDIQ level, since fulfillment of the planned goals will be at the task order level. Task order awards should follow the guidelines established in the IDIQ's Small Business Subcontracting Plan.

Section M.5.2 Organizational Experience and Competency Sub‐Factor number 4: Does BARDA anticipate supporting OCONUS Emergency Response trials via this contract?

As a preparedness organization, BARDA must maintain readiness to respond to emergencies outside the continental U.S. (OCONUS). Over the past 5 years, the CSN responded to one OCONUS emergency (West Africa Ebola outbreak).

Section L.4.2 Appendices to Technical Proposal Project Management Plan sub‐section 3.f. notes a Gantt chart and Work Breakdown Structure is required with the submission. Please confirm if the Gantt chart and WBS shall be developed for each of the RTORs, or if a general IDIQ project level Gantt Chart and WBS is required?

For the Sample RTORs: yes, a Gantt chart and WBS should be submitted. A Gantt chart and WBS are not expected to be submitted at the general overall IDIQ level.

Section L. Instructions, Conditions and Notices to Offerors, L.2.1. Delivery of Proposal – please note ‘May 4, 2015’ requires updating

Please refer to final RFP once posted.

Section B Supplies or Service and Price/Cost, B.2. Specific Requirements, please provide example(s) of non‐clinical specimens as used in RFP text ‐ ‘….biological specimens (possibly non‐clinical specimens)…

Examples of non‐clinical specimens would be derived from BARDA non‐clinical studies and task orders. These studies include but are not limited to: rodents, pigs, mini‐pigs, and non‐human primate specimens. Samples can include whole blood, cryopreserved whole blood, plasma, blood spots on filter paper, peripheral blood mononuclear cells (PBMCs), serum, DNA\RNA, urine, and organ specimens.

Regarding Section B. Supplies or Service and Price/Cost, B.3. Contract Type – should ‘single IDIQ’ be multiple or a set number

‐ The CTP&E RFP is intended for multiple award IDIQs.

‐ The SDCC and BSIP RFPs are each intended for single award IDIQs.

This will be clarified in the final RFPs.

Regarding Section B. Supplies or Service and Price/Cost, B.3.1. Base Period of Performance of 2019 – 2021

– is this period limitation intended to filter out any awardees after the base period?

The Base Period of Performance of 2019 ‐ 2021 is not a period limitation intended to remove awardees after the base period. IDIQ contracts typically are awarded with a base period and option years; however, the Government reserves the right to not exercise an option period, as they are not guaranteed.

Acknowledging BARDA anticipates a selection of large, full service, small and specialty CROs, has BARDA determined the number of planned awards, or a maximum number of awards for the routine and response CSN CTPE Contractors?

BARDA has not determined the number of planned awards or a maximum number of awards for the routine and response CSN CTPE Contractors.

Section C – Statement of Objectives, C.3 Technical Requirements, ii., Section 6.0 Clinical Site Management and Monitoring, 6.4 and 6.12 – ‘….robust risk based monitoring plan with quality metric deliverables on an ongoing basis to evaluate site status’ and ‘utilize a clinical trial management system that includes a robust risk‐based monitoring system integrated with central monitoring system tools using real‐time data shared by the SDCC’ – please include within the CTPE RFP BARDA’s expectations of what the CSN SDCC will be providing to facilitate and inform the CTPE proposal response for these two requirements.

BARDA expects that the CTP&E and SDCC contractors will collaborate to develop a data‐sharing plan that is tailored to meet the requirements of each individual task order. In responding to this RFP, the CTP&E Offeror is advised to specify the data sources needed from the SDCC (e.g., EDC) in order to facilitate risk‐ based monitoring, clinical trial management system, and other standard activities.

Section C – Statement of Objectives, C.3 Technical Requirements, Section 4.0 Regulatory Services, 4.1 – please provide a weblink to BARDA’s StartingPoint CTD templates for reference and assessment to best inform RFP responses.

There is no BARDA StartingPoint template. If the Offeror is unfamiliar with the regulatory templates, there are many resources available online. For additional guidance, see FDA link below:

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmi ssions/ucm153574.htm

Regarding Section C. Statement of Objectives, C.3. Technical Requirements, Objective 1: To establish the SDCC infrastructure, 5.a. – ‘Data transfer, integration and reporting plan for all biospecimens that are stored and tracked by the CRO responsible for biospecimens and IP storage’ – suggest editing to read ‘In collaboration with BARDA, the CSN BSIP CRO responsible for biospecimens and IP storage, the data transfer, integration and reporting plan for all biospecimens that are stored and tracked.

BSIP and SDCC will collaborate to ensure efficient and accurate transfer of data. Please refer to final RFP when posted.

Regarding Section C. Statement of Objectives, C.3. Technical Requirements, Objective 1: To establish the SDCC infrastructure, 1.d. – please provide more detail on ‘Data mining and integration capabilities with ability to access health care utilization databases’ requirements and/or expectations.

More details will be added to the final RFP. In brief, BARDA is interested in obtaining real‐time descriptive and predictive analytics based on social network, eHR, pharmacy, laboratory and healthcare data to monitor/identify epidemics of influenza and emerging infectious diseases, and support implementation of response clinical studies.

Regarding Section C. Statement of Objectives, C.3. Technical Requirements, Objective 1: To establish the SDCC infrastructure, 6. – please define or re‐word “warm base” – is this the in‐house BARDA Staff CSN Support? Rather than contractor support?

"Warm‐base" refers to SDCC contractor support.

Both clause B.3 on page 4 and the entry in L.1 (pg. 56) specify the types of task orders that may be issued under the resultant contract. Please harmonize these references; our assumption is that the two (2) types contemplated are FFP and CPFF.

Currently, it expected that task orders issued under the resultant IDIQ contracts, will be Cost‐plus‐Fixed Fee (CPFF) or Firm Fixed Price (FFP). In rare instances, the Government may consider issuing Cost‐Sharing type RTORs.

We are confused by the difference between the Minimum Ordering Amount of $50,000 in B.4.1 and the $200,000 Minimum Order Guarantee in B.4.3. Can you please clarify if these should be the same or if there is a distinction that we are not recognizing?

The 'Minimum Ordering Amount' is related to the task orders that will be issued under the resultant IDIQ contracts. The government will not issue a task order for an amount less than the 'Minimum Ordering Amount.' The 'Minimum Order Guarantee' is related to the minimum amount guaranteed under each IDIQ contract;

i.e. if a contractor receives no task order awards or task order award(s) totaling less than the 'Minimum Order Guarantee,' during the life of the IDIQ, the contractor will be paid the 'Minimum Order Guarantee' or the difference between the 'Minimum Order Guarantee' and the task order award(s) received, if those awards were less than $200,000 in total.

Note: the amounts listed in the Draft RFP are pending revision. Please refer to the final RFPs for any changes.

Clause B.4.3 references a requirement to take advantage of fair opportunity by proposing on at least one task order. We assume this language is inapplicable in this RFP given that it is a single award IDIQ and the contractor is the only possible awardee.

For single award IDIQs, RTORs will not be competed. References of RTOR competition will be removed from RFPs intended for single award IDIQs.

With regard to the allowability of overtime premiums, please consider allowability (with advance notice) given that emergency response scenarios are predicted and may reasonably require overtime labor by the contractor to meet extremely short deadlines. As clarification, we acknowledge that this would apply only to employees who are rightly designated as non‐exempt from overtime under the appropriate labor classifications

All overtime shall be approved by the Contracting Officer prior to accrual. Overtime is not guaranteed, and may be considered only in extremely rare circumstances. Overtime charged without Contracting Officer consent, may be deemed unallowable.

The solicitation currently requires submission of hard copies in binders, electronic copies on a CD/USB drive, and copies submitted electronically via email. We respectfully request that only copies submitted electronically via email be required

Electronic submissions will be accepted via USB or e‐mail. This will be corrected in the final RFP. Please note that electronic submissions will be due on or prior to the due date and time stated in the final RFP, without exception. Offerors shall follow the detailed instructions provided.

For electronic submissions, please clarify in what instance MS Word format may be required versus PDF.

We understand the references to MS Excel and MS Project, though we request verification that MS Project 2007 is required versus a newer version

BARDA requires electronic submissions in either MS Word or OCR/Searchable PDF format. For MS Project documents, 2007 or newer versions are acceptable.

The technical proposal currently limits the main narrative to 50 pages and the technical proposal appendices to 50 pages. Given the length of the required Security Plan and Continuity of Service Plan, please consider exempting them from the appendix page limit.

The Security Plan and the Continuity of Service Plan will be exempted from the appendix 50 page limit.

Page limitations clarified… CTPE RFP:

‐ Technical Proposal: 50 pages. *If Offeror is responding to both, the Routine and Response Services, an additional 10 pages (60 pages total) are allotted for the Technical Proposal.

‐ Business Proposal: 50 pages ‐ Sample RTORs: 15 pages each

SDCC and BSIP RFPs:

‐ Technical Proposal: 50 pages ‐ Business Proposal: 50 pages ‐ Sample RTORs: 15 pages each

**Attachments are exempted from the page limit. This will be clarified in the final RFP.

We request that the USG allow offerors to include Past Performance information from the previous five

(5) years versus the three (3) years currently allowed

Past Performance information shall be within the last three (3) years, based on best practices. The more current the data, the more relevant.

We request that the USG allow offerors to include Past Performance information for directly relevant projects funded by the USG under a grant or cooperative agreement mechanism, which is utilized often by the NIH for similar awards

The type of past performance referenced is acceptable.

Please consider waiving the need for submission of a Past Performance Questionnaire for contracts where a CPARS evaluation is available. We have found in the past that COs have been reluctant to complete a questionnaire if a CPARS is on file.

A Past Performance Questionnaires is not required for U.S. Government projects listed in the proposal, when a finalized CPARS record is available. For each Past Performance project reference cited, where a CPARS record is confirmed available, the Offeror shall provide the identifier for the such record.

The only reference we see in the text to Attachment #8 is under Clause G.8 regarding Post Award Evaluation of Contractor Performance. Is it provided simply for information or is it related to any solicitation response requirement?

Attachment # 8 "Contract Performance Evaluation Report" is being removed and is not related to any solicitation response requirement.

Please clarify the Chief Scientific Officer key role. Can this key role be fulfilled by a Principal Investigator/Lead Scientist?

Yes, BARDA agrees it can be PI or Lead Scientist

Both the CTP&E and SDCC Draft RFPs speak to a “secure (21 CFR Part 11 compliant validated), study‐ specific internet‐based portal that is password protected with managed user access roles. Please clarify whether the SDCC or CTP&E contractor will provide the portal for each study.

SDCC and CTP&E Offerors should provide capabilities for portals in their response to the RFP. Specific requirements per RTOR will be delineated in the RTOR statement of objectives.

If an offeror is only responding to the Routine Clinical Services portion of the CTP&E MA‐IDIQ, please confirm that offeror only needs to provide a Technical Proposal and Business Proposal in response to Technical Requirement C.3.A (page 9), the Routine Clinical Services‐Mandatory Criteria in Section M.4 (page 85), and only respond to Sample Routine RTOR 0001. In this scenario we assume the offeror would not be required to respond to Sample Response RTOR 0002 – please confirm.

Offerors are not required to respond to both sample task orders unless they are submitting for both routine and response services. If an offeror is submitting a proposal for only one of the sample task orders, Technical and Business Proposals are required only for the sample task order they submit a proposal for.

The only reference we see in the text to Attachment #8 is under Clause G.8 regarding Post Award Evaluation of Contractor Performance. Is it provided simply for information or is it related to any solicitation response requirement?

Attachment # 8 "Contract Performance Evaluation Report" is being removed and is not related to any solicitation response requirement.

We recommend BARDA establish in its process and expectations the ability to collaborate with the SDCC contractor to define requirements for inclusion in CTP&E RTORs. Some requirements will be necessary to impose in order to realize the efficiencies expected to arise from the change in the network’s structure.

BARDA will plan a CSN kick‐off meeting after award to review systems and processes. Additional opportunities for discussion, collaboration, and refinement of systems and processes will be arranged as needed, working with the BARDA COR and CO.

We would like to clarify our understanding of the Statement of Objectives as it relates to the technical and business submissions required from offerors. Based on the Statement of Objectives, we interpret the scope for CLIN0001 to include all activities necessary to meet Objective 1 to “establish the SDCC infrastructure” and to provide resources necessary to maintain the “warm base operations of the CSN.”

We also anticipate CLIN0001 to include meetings (C.4), Reporting Requirements (C.5), and Deliverables (F.4) that are not associated with a TO for a specific study. We then understand objective 2 to detail those activities that will be conducted by the SDCC based on subsequent study‐based TOs. Based on this interpretation, we want to confirm the following:

Our technical response should speak to our ability to meet the requirements of all of Section C including both Objective 1 and Objective 2.

We should provide costs for CLIN0001 to cover the services outlined above during the base period. We should then provide costs to continue these services, as applicable, in the option years labeled as CLINs 0002‐0004.

We should provide separate technical responses and bids for each of the sample RTORs as representative of approaches and costs necessary to deliver the services under Objective 2 for future specific studies.

BARDA can confirm that your understanding of the technical response and cost proposal is correct.

On pg. 9, Objective 1, 4a. please confirm what is meant by “source data.” Final RFP section 4a will be updated to clarify that "Source data" in this reference does not mean subject source document data. "Source data" in this reference includes data (e.g.; SDTM, ADaM datasets, etc.) from BARDA‐funded studies performed by the CSN as well as those not performed by the CSN.

We assume G.4.2 is inapplicable, since there will be no competition for task orders under this single award IDIQ.

For single award IDIQs, RTORs will not be competed as there will only be one IDIQ awardee. References of RTOR competition will be removed from RFPs intended for single award IDIQs.

Assuming this is correct, we would not expect annual review/certification of the SDCC by an IRB to be required. Please confirm if BARDA does expect the SDCC to be certified on an annual basis by an IRB. (See H.1.1)

BARDA in consultation to seek a consensus if annual IRB review and certification is not expected for the SDCC. Please refer to the final RFP.

The instructions for the Continuity of Service Plan on page 63 specifically request “a matrix detailing capabilities with chemical agent exposures and/or radiation injury syndromes.’ Can you provide more explanation as to this specific area of emphasis and request given the expected operations of an SDCC contractor?

Those are examples of major incidents for continuity of service. Such emergencies or disasters might include a fire, hurricaine, flood, cyber attack, or any other case where business is not able to occur under normal conditions up to 30 days post incident.

Does BARDA currently use its existing data for increased trial design efficiency? Yes.

We strongly suggest that BARDA stagger the SDCC, CTP&E, and BSIP RFPs such that the SDCC RFP is released and awarded first; the SDCC will need sufficient time to establish its infrastructure in advance of the need to initiate any specific studies.

All RFPs are expected to be released at the same time. BARDA will plan a CSN kick‐off meeting after award to review systems and processes. Additional opportunities for discussion, collaboration, and refinement of systems and processes will be arranged as needed, working with the BARDA COR and CO.

With regard to the “staff extenders” mentioned in the “warm base operations” on page 10, please clarify if there is any expectation that the SDCC would need to provide staff onsite at BARDA or if all services can be rendered from the contractor’s site.

Staff Extenders are not routinely required to be on‐site, but unlikely scenarios might occasionally arise for the staff extenders to be on‐site at BARDA.

We recommend providing a full Responsibility Matrix similar to what was recently used in the Atropine RTOR to provide clear delineation of roles and responsibilities between BARDA and the SDCC, CTP&E, and BISP providers.

A responsibilities matrix will be provided per task order. For the sample RTORs, sample responsibilities matrices will be provided. Please refer to the final RFP.

There are a number of areas where the distribution of responsibilities is unclear. In particular it is unclear how tasks are to be parsed out between the SDCC and CTP&E in regard to Regulatory, Safety/Pharmacovigilance, DSMB, and Protocol Development and other Medical Writing. For example:

Offerors should provide capabilities for regulatory and safety/pharmacovigilance support in their response to the RFP. Specific requirements per RTOR will be delineated in the RTOR statement of objectives.

Regulatory—The following language is included in the SDCC draft RTOR on pg. 10, Objective 2, bullet 7.

“Providing regulatory operation services that include initial and amendment IND publishing and FDA submission in eCTD format.” However, regulatory services are detailed quite extensively in the CTP&E (Pages 11‐12 Tech Requirement 4.0). Please clarify how responsibilities will be parsed between the SDCC and CTP&E?

Offerors should provide capabilities for regulatory and safety/pharmacovigilance support in their response to the RFP. Specific requirements per RTOR will be delineated in the RTOR statement of objectives.

Safety/Pharmacovigilance—The SDCC RTOR specifies that the SDCC will be responsible for developing and supporting the safety database (pg. 9, Objective 1, bullet 3b and Page 10, Objective 2, bullet 6) and for SAE reporting (pg. 10 Objective 2, bullet 6); however, medical and safety monitoring falls under the scope of the CTP&E and includes “identification, reporting, and tracking systems for AEs, SAEs, study pausing/stopping rules” (pg. 11, Tech Requirement 3.3). Please clarify how responsibilities will be parsed between the SDCC and CTP&E?

Offerors should provide capabilities for regulatory and safety/pharmacovigilance support in their response to the RFP. Specific requirements per RTOR will be delineated in the RTOR statement of objectives.

DSMB—The SDCC RTOR specifies the following on pg. 10, Objective 2, bullet 2: “Providing, managing, and supporting an independent DSMB.” However, the CTP&E RTOR specifies the following on pg. 11 Technical Requirement 3.2: “Identify independent DSMB members and provide qualifications for sponsor approval.” Please clarify how DSMB responsibilities will be parsed between the SDCC and CTP&E?

SDCC and CTP&E Offerors should provide capabilities for DSMB support in their response to the RFP. Specific requirements per RTOR will be delineated in the RTOR statement of objectives.

Protocol Development—The SDCC RTOR specifies the following on pg. 10, Objective 2, bullet 8: “Providing protocol development and other medical writing support.” However the CTP&E RTOR specifies on pg. 10 Tech Requirement 2.2 “Protocol development and writing support services, including the development of protocol‐related documents such as sample informed consents,” and on pg 11

SDCC and CTP&E Offerors should provide capabilities for protocol development and other medical writing support in their response to the RFP. Specific requirements per RTOR will be delineated in the RTOR statement of objectives.

4.1 it refers to the CTP&E authoring protocol amendments. Please clarify how these responsibilities will be parsed between the SDCC and CTP&E?

SDCC and CTP&E Offerors should provide capabilities for protocol amendment development in their response to the RFP. Specific requirements per RTOR will be delineated in the RTOR statement of objectives.

With regard to pg. 10, Objective 2, bullet 5, please clarify if you are looking for dashboards on a portal page after data have been rendered into a display or summary or if BARDA wants access to actual datasets.

Both subject‐level data and summary dashboards are expected.

What are the expected minimum database specifications for the completed clinical studies data repository?

No minimum requirement, Offeror should clearly propose the minimum specifications in the response.

Both the SDCC and CTP&E Draft RFPs speak to a “secure (21 CFR Part 11 compliant validated), study‐ specific internet‐based portal that is password protected with managed user access roles.” Please clarify whether the SDCC or CTP&E contractor will provide the portal for each study.

SDCC and CTP&E Offerors should provide capabilities for portals in their response to the RFP. Specific requirements per RTOR will be delineated in the RTOR statement of objectives.

Referencing the Protection of Human Subjects requirements, it is our understanding that the relevant CTP&E awardee will be responsible for securing IRB review and approval of specific studies. Please confirm.

Yes, the CTP&E awardee is responsible for securing IRB review and approval of specific studies.

Section C – Statement of Objectives (SOO), page 10: Items 2.3 and 2.13 both include identification and establishment of contractual agreements with vendors to provide clinical laboratories and IP services.

Please consider consolidating the 2.3 items into the 2.13 items, for clarity.

This will be clarified in the final RFP.

Section C, page 12: Item 4.18 states “Perform protocol‐specific monitoring, identification, assessments and selection plans.” However, Item 6.0 covers Clinical Site Management and Monitoring. Please clarify what is intended by item 4.18, and whether it should be included as part of Items 6.0?

This will be clarified in the final RFP.

Section I – Contract Clauses, pg. 43: The RFP under 52.21‐19 Order Limitations (Oct 1995), references a Maximum Order of $8,000,000. However, based on experience of actual task order awards under the current CSN IDIQ contract, several tasks were above that amount (e.g. ~ 14M, ~ $12M). Please clarify, and consider increasing the maximum to expand BARDA’s flexibility in placing Orders without the constraints of the Order Limitation clause.

BARDA acknowledges this question. Please refer to the final RFP.

Section L.5.2 – Business Proposal Components, pg. 73: Section 3 references the build‐up of labor rates, including the statement that the rates will be incorporated into any contract awards and be used for billing/reimbursement. While the use of burdened labor rates in that manner is consistent with Time and Material (T&M) and Labor Hour (LH) type contracts/tasks, it is not consistent with cost‐ reimbursement contracts/tasks, which are envisioned under this IDIQ. Please clarify.

This will be revised and clarified in the final RFPs.

Section C, page 12: Item 5.1 under Quality Assurance and Audits: Does the QA/QC and Audit plan specified in 5.1 include only CRO coordinating and document preparation activities to ensure their compliance with federal and local regulations and the protocol (and not all CRO activities)?

Both quality control and quality assurance are components that Offerors within each system‐‐i.e., CTP&E, SDCC, and BSIP‐‐will be responsible for managing for the activities directly related to their CSN participation.

Please refer to final RFP once posted.

Section L.6 – Other Administrative Data, pg. 80: Item 2 states that the proposal must list “current commitments with the Government related to nonclinical work or services being performed…” Please clarify, does BARDA want a list of all offeror nonclinical Government contracts, or will an affirmation/ statement by the offeror that no other commitments exist which would interfere with completion of services, suffice?

The draft RFP incorrectly referred to nonclinical work or services. The final RFP will correct this error and refer to clinical work or services. An affirmation statement by the Offeror indicating no other commitments that would interfere will suffice in lieu of a list. Please refer to final RFP once posted.

Section: L.5.2 Business Proposal – Components; 7. Small Business Subcontracting Plan; Point (a); Page 67;

1. If the responding organization is designated as a small business, is it correct that the responding organization does NOT need to utilize any subcontractors should the total proposed budget exceed

$650,000 USD?

If an offeror is designated as a Small Business, a Small Business Subcontracting Plan will not be required.

Section L.5.3., Business Proposal, Item 4. Section 7 Small Business Subcontracting Plan – Is this intended to be cumulative expectations (33% Small Business, 5% Small Disadvantaged Business, 5% Women‐ Owned Small Business, 3% HUBZone Small Business, 3% Veteran‐Owned Small Business, 3% Service‐ Disabled Veteran‐Owned Small Business: totals 52%)?

The anticipated minimum Small Business Subcontracting goal is 33%. Of the 33%, Small Business set‐asides should be broken down as listed in the Draft RFP (5% SDB; 5% WOB; 3% HUBZone; etc.)

Section M.4., Mandatory Qualification Criteria, Routine Clinical Services – Mandatory Criteria, Item 6 – This criterion states that the contractor agrees to respond in full to at least 80% of RTORs issued under the contract. How many Routine and Response Clinical Services RTORs are expected to be released?

Per the RFP, CTP&E contactors must respond in full to at least 80% of the routine RTORs and 100% of the response RTORs. Based on our past experience, you should assume an average of 2‐4 RTORs per year; 2 new and 2 ongoing. Assume there will be 2 new RTORs a year, one simple (e.g., a straightforward vaccine trial) and 1 complicated (e.g., a therapeutic interventional trial with many challenges) RTOR per year. Over the five‐year contract period, this may include at least one national response study and one international response study.

The SDCC contractor and BSIP contractor are required to respond in full to 100% of the RTORs.

Section C.3., Technical Requirements, Section A. Routine Clinical Trial Planning and Execution, 4.0 Regulatory Services – Is it anticipated that the…