Amendment_1_(75A50119R00026)_(10.4.2019)_FINAL.pdf

(x)

75A50119R00026 x x

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

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ASPR-BARDA

ASPR-BARDA

Tip O'Neill House Office Building Room 24F-15 Washington DC 20201

10/04/2019

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

09/06/2019

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Amendment 1 to RFP 75A50119R00026. The RFP close date is extended to October 28, 2019 at 12 pm Eastern Time. Attachments to the Amendment include 1) Amendment modification body and 2)

Question and Answer.

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

JEFFREY E. BROWN

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

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RFP 75A50119R00026: Amendment 1

G.10. Negotiated Indirect Rates and Ceiling, is modified as follows:

3. In the absence of an indirect rate agreement the Government may negotiate Rate Ceilings for each applicable indirect cost element. If established, any costs over and above the established cost ceiling shall not be reimbursed under this contract or any other Government contract, grant, or cooperative agreement.

4. If Rate Ceilings are established, the Government is not obligated to pay any additional amount, should the final indirect cost rates exceed the established ceiling rates of the contract. In the event that the final indirect cost rates are less than the negotiated ceiling rates, the Government's obligation shall be reduced to conform to the lower rate.

Indirect Cost Rate Ceiling NTE

Fringe TBD Overhead TBD

G&A TBD

J. Attachment 3: Capabilities Matrix is removed in its entirety.

L.3. Delivery and Packaging of Proposals, is modified as follows:

Proposals shall be delivered no later than 12:00 Noon ET on Monday October 28, 2019.

L.3.1.2 Technical Proposal, is modified as follows:

It is recommended that the technical proposal consist of a cover page, a table of contents, responses to the technical evaluation criteria and the information requested in the SOO in the form of a Statement of Work (SOW). There is a 50 page limit for the technical proposal. An additional 10 pages (for a total of 60 pages) are allotted for the technical proposal if the Offeror is responding to both the routine and response services. In addition to the technical proposal page limits, 15 pages are allotted for each sample RTOR. Appendices may be provided with the technical proposal, with the appropriate tabs (maximum 150 pages total).

L.4.3. Appendices to Technical Proposal, is modified as follows:

Items below can be revised during negotiations with the successful Offeror and will be incorporated into the contract. The Appendices are in addition to the 50 page limit in the Technical Proposal (up to 90 page limit if responding to both Sample RTORs). The Appendices shall not exceed 150 pages.

L.5.1. Business Proposal Instructions, is modified as follows:

The business proposal shall not exceed 50 pages (not inclusive of sample RTOR responses). The proposal must be signed by an official authorized to bind the Offeror(s) organization and must stipulate that it is predicated upon all the terms and conditions of this RFP. The 50 page limit does not include the RTOR responses, which would allow another 15 pages per each RTOR response. In addition to the main proposal and RTOR proposals the offeror can provide attachments. Attachments shall not exceed 100 pages.

L.5.2.6. Section 6: Past Performance, is modified as follows:

Offerors shall submit the following information as part of their business proposal for both the Offeror and proposed major subcontractors (Attachment #8).

The Offeror shall provide a list of the last five (5) relevant contracts completed during the past three years and all relevant contracts currently in process. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial customers. Any previous activities with BARDA must all be included in the submitted past performance list. Offeror’s that are newly formed entities without prior contracts should list contracts and subcontracts as required above for all key personnel. 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 such record.

L.6. OTHER ADMINISTRATIVE DATA, is modified as follows:

1. The proposal must stipulate that it be predicated upon all the terms and conditions of this RFP.

In addition, it must contain a statement to the effect that it is firm for a period of at least 120 days from the date of receipt by the Government.

ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED.

# Contractor Questions BARDA Answers Location in RFP

With respect specifically to the requirement to provide “all contracts currently in process”…would the Government accept a summary of all the offeror’s current relevant experience (without the full details required of past performance, e.g. items a-g), as this list can be quite long? We note that contracts with commercial clients are confidential and commercial clients will not likely respond to PPQ or inquiries regarding their studies. In addition, commercial CROs may have hundreds of current relevant contracts and providing this complete information would likely far exceed page limitations of the proposal. Alternatively, does the Government want a list of only those relevant, current contracts currently in process for which complete past performance details are available?

Modify from "all contracts" to "relevant contracts" Attachment 8: List relevant contracts (past 3 years) for which you can provide past performance details or access to CPARS evaluation scores. This change does not alter Attachment 9: For key personnel identified in the BARDA Proposal, the Offeror needs to cite all presently active federal contracts, cooperative agreements, grants, and/or commercial agreements, and provide the percent levels of effort for their commitment to those projects. L.5.2, item 6, Past Performance, p.88

Please confirm this requirement to provide a list of the last 5 contracts completed during the past three years relates to providing completed contracts that are relevant to this solicitation? [We note the instructions in M.6 on page 100 says: “The Government will only evaluate performance from relevant experience over the past three (3) years.” (emphasis added)]

We are amending the requirement to provide a list of the last five (5) contracts completed during the past three (3) years that are relevant to this solicitation. L.5.2., item 6, Past Performance, p. 88

Please clarify the validity period. The instructions on page 81 immediately above L.3.1 indicate “Proposals shall remain valid for one hundred and twenty (120) calendar days after receipt …” which contradicts the instructions on page 92. Please clarify whether it is 120 days or 270 days? The validity period for proposals is 120 days after receipt Coverage

Please clarify if the Government intended for offerors to provide their relevant organizational experience over the past 5 years, but their Past Performance over the last 3 years.

Yes, this assumption is correct. Relevant organizational experience is a technical sub-factor that is evaluated over the last five years. The evaluation past performance references go back in CPARS (or questionnaires) over the last three (3) years. M.4.2.b, p.97 and M.6, p.100

We respectfully request that technical and business proposals be submitted electronically via encrypted USB or email only – eliminating the requirement for hard copy submissions. Or alternatively, please provide an extension of at least 3 days to deliver the paper copies subsequent to the electronic submission.

The Offeror may submit their proposal via email to the CO listed in G.1. and satisfy the timeliness requirement, even if the hardcopies have not arrived by that time, so long as the hardcopies arrive by 2 business days later. The offeror must submit the required hardcopies to the address listed in L.3. L.3 Delivery and Packaging of Proposals, p.80

Given the length of the required Plans (PMP, Security Plan and Continuity of Service Plan), we respectfully request the Government exempt them from the Appendix page limit? • The response to question 73 of the BARDA Q&A received on April 9, 2019 stated that the Security Plan and the Continuity of Service Plan would be exempted from the appendix 50-page limit. • We are respectfully requesting that the Security Plan, Continuity of Service Plan AND the Project Management Plan be exempted from the Appendix 50-page limit. There are no exemptions. The limit for appendices is revised to 150 pages. L.3.1.2 Packaging of Proposals, p.81

L.4.3.1.a-d of this section requires 2-3-page CVs for Chief Scientific Officer, Principal Investigator or Lead Scientist, Project Manager, Other Key Scientific and Technical Personnel, and additional personnel who will be required for full-time employment, or on a subcontractor or consultant basis. • Can the Government clarify whether CVs are required ONLY for Key Personnel as defined in M.4.4.b.i-ix OR Key Personnel plus Other Key Scientific and Technical Personnel, and additional personnel who will be required for full-time employment, or on a subcontractor or consultant basis • Due to the number of CVs required, we respectfully request that resumes be removed from the Appendix 50-page limit

CVs are required for Key Personnel as defined in M.4.4.b.i-ix and any other personnel Offeror considers Key Personnel required for the success of the contract. L.4.2.3.c, p.84, L.4.3.1.a-d, p.85, M.4.4.b.i-ix, p.98-99

Can the Government confirm that “Head of Statistics” should be included as Key personnel for CTPE proposal submission. If the Government requires this position to be included, can the Government clarify what tasks are envisioned on the CTPE contract that the Head of Statistics would have oversight for?

Statistical key personnel will be fully covered by SDCC and BARDA so there is no need for the CTPE Offeror to propose any key personnel for statistics. M.4.4.b.v, p.99

Can the Government clarify expectations for Contractor support for statistics and data management for the CTPE response?

Statistical and data management support will be fully covered by SDCC and BARDA, so no need to include it in the CTPE response. M.4.4, p.98

Can the Government confirm whether Contractors should include costs for statistical and data management support services in Sample Routine RTOR 0001 and Sample Response RTOR 0002? The Contractors should not include costs for statistical and data management support services in responses to Sample Routine RTOR 0001 and Sample RTOR 0002. p.115-116

CTPE 75A50119R00026- Q&As

HHSAR Clause 352.231-70 is included in the RFP. It indicates that “an individual’s direct salary is the annual compensation that the Contractor pays for an individual’s direct effort (costs) under the contract.” • If a prime contractor or subcontractor employee has a normal gross annual salary of $200,000 (which would exceed Executive Level II if the employee worked full-time for a year under the contract) and only works 100 hours on the contract during a given year, their compensation for the direct effort under the contract will equal approximately $9,615 ($200,000/2080 = $96.15 * 100 = $9,615). Please confirm that this situation would not violate 352.231- 70, because the compensation paid for the direct effort under the contract is far below the Executive Level II threshold? • Consultants are not paid a “salary” and typically are just reimbursed by a company based on actual work performed. If a prime contractor uses a consultant with an hourly rate of $200 (which would appear to be in excess of the current Executive Level II salary divided by 2,080 hours) and the consultant only works 100 hours on the contract during a given year, their compensation for the direct effort under the contract will equal only $20,000. If the only direct effort this consultant performs under the contract in an annual period results in annual compensation of only $20,000, please confirm that in this situation there would be no violation of 352.231-70, because the compensation paid for the direct effort under the contract is far below the Executive Level II threshold? • If the Government determines that this rule would apply in either of the situations above, please confirm whether the salary rate limitation rule does not apply when the services are provided on a fixed price basis (per project or per deliverable) rather than on an hourly basis? [We note that the enabling clause at HHSAR 331.101-70(b) indicates that 352.231-70 should be used for cost-reimbursement; fixed-price level-of-effort, time-and-materials, or labor-hour contracts, but does not mention fixed-price contracts]

For the purposes of this clause and individuals salary as it relates to the salary limitation is the amount that individual makes in aggregate under the contract in a contract year. No individual shall be compensated greater than the Executive Level II. I.3.1, p.62

In terms of pricing information, offerors are asked in Section 3 of the Business Proposal instructions to provide a set of labor rates for each labor category it may use under the prime contract and provide cost proposals for the two sample RTORs.

When pricing the two sample RTORS the requirement to crosswalk costs to the SOO requirements makes sense, but these instructions related to Section 2 on page 87 do not specifically refer to the sample RTOR responses. The individual labor categories are the only items being priced at the prime contract level. We don’t understand the requirement to “crosswalk” the costs to the SOO requirements when the only thing being priced at the prime contract level are labor categories. There is no overall pricing aimed at specific elements in the SOO. Please clarify whether the Government meant this requirement for a cross-walk to apply just to the sample RTOR responses, or please elaborate if the Government intended other “costs” to be cross-walked?

For the purposes of this clause and individuals salary as it relates to the salary limitation is the amount that individual makes in aggregate under the contract in a contract year. No individual shall be compensated greater than the Executive Level II pay level in any contract year. Section L.5.2.7: Section 7: Small Business Subcontracting Plan, p.89

RFP Attachment 10 is the Government’s template small business subcontracting plan. • Would the Government clarify if Offerors are required to submit a Small Business Subcontracting Plan using the template in RFP Attachment 10 as well as another Small Business Subcontracting Plan? We are confused by what appears to be a duplicative reference in numbers 1) and 2) on page 89 and want to make sure we understand the requirements.

The offeror is required to submit a Small Business Subcontracting either using or based on the template in RFP Attachment 10. The reference to Small Business Subcontracting Plan in 2) is an accidental duplication.

Will the Government provide the number of site visits that Contractors and BARDA shall participate in for budget purposes for Sample Routine RTOR 0001 and Sample Response RTOR 0002 and what Contractor attendees should attend? The offeror should propose the number of site visits based on technical approach. C.4 Meetings, p.17

Can the Government confirm responsibilities for performance of audits between the USG and Contractors as stated in C.3.1.5.3 and E.4 that states, “The Contractor shall allow for and provide requested information to support security, quality, regulatory, and cGCP and/or cGLP audits conducted by USG on an ad hoc basis.”

Contractors should be prepared and facilitate USG audits as required upon notification from USG. C.3.1.5.3, p.15; E.4 Audits, p.20

• Can the Government clarify whether attachments to the Business Proposal such as the following count against the 50-page limit? Listing of all labor categories/rates, Detailed pricing for Sample RTORs, Accounting System Approval Letter, Indirect Rate Agreements/Letters, Subcontractor Commitment letters, Cost documentation (e.g., subcontractor budgets, etc.). • We respectfully ask that these appendices be exempt from the 50-page limit of the Business Proposal due to the potential size of these documents

The Business Proposal body is 50 pages plus 15 pages for response to one sample RTOR for a total of 65 pages. The Business Proposal is a total of 80 pages for response to both RTORs. The Business Proposal Appendices are limited to a total of 100 pages. L.3.1.3 Packaging of Proposals/Business Proposal, p.81

Can the Government clarify whether the maximum 15 pages total per sample RTOR response is included as part of the 50-page limit for the Business Proposal or if an additional 15 pages are allotted for each sample RTOR? Cross reference Question # 16 L.3.1.3 Packaging of Proposals/Business Proposal, p.81

• Can the Government clarify expectations for Attachment #3 Capabilities Matrix?

The only references in the RFP are included in J. List of Attachments (p.74) and Attachment #3 (p.130). • If completion of this form is a requirement of the offeror’s proposal, would the Government consider excluding this from the page limit? Attachment 3 is no longer required as part of the CTPE response. Where appropriate, the Offeror capabilities should be discussed within the body of the RFP. Attachment #3, p.130

The frequency defined on page 115 of the RFP states, “There will be 3 IMVs for the unblinded monitor by site. One visit prior to study start (IP receipt), one visit after first dose and one after second dose.” o For Sample RTOR 0001 and 0002, can the Government confirm whether 3 IMVs are by site for the first cohort only OR 3 IMVs by site for each cohort?

Estimated 3 IMVs for unblinded monitor for RTOR 0001 only is by site. Contractor can suggest an alternate technical approach. RTOR 0002 will not require unblinded IMVs. Clinical Monitoring and Site Management Activities, p.115

Does the Government have a required QA/QC Plan template and SOP that Contractors are to use and/or comply with? o If so, will the Government provide the relevant template and SOPs? o If not, please confirm that Contractors can use their own templates

The USG does not have a templates for either the QA/QC plan or SOPs. Contractors should use their own template. F. 5. Deliverable Schedule, p.27

Will CTPE awardees be expected to follow their own SOPs or BARDA’s on a Task Order Basis?

The CTPE awardees should follow their own SOPs. SOPs will be evaluated by the USG prior to Task Order start to ensure they are acceptable. If SOPs are found unacceptable, BARDA may either request a SOP revision or a study specific SOP to address any gaps. M.4.1. Technical Plan/Approach Sub-Factor, p.97

• Does the Government require the Head of Quality Assurance (QA) and Head of Quality Control (QC) Key Personnel positions be held by two separate individuals or is it acceptable for the Offeror to present one qualified individual?

• Can the Government clarify expectations, responsibilities, and the Government’s estimated level of effort for each of the following Key Personnel positions at the Prime IDIQ level as well as for Sample RTOR 0001 and Sample RTOR 0002: Head of Quality Assurance (QA), Head of Quality Control (QC), Clinical Operations, Regulatory, Pharmacovigilance. • Would the Government consider limiting Key Personnel at the Prime Contract level to Principal Investigator/Program Director (PI/PD) and Program Manager (essentially the two positions directly responsible for overall performance under the contract)? Senior positions within a CRO such as Head of QA, QC, Clinical Operations, or Regulatory services have significant responsibilities across many contracts, and it is not appropriate to have so many senior positions within a company identified as “key” on a single contract such that it could interfere with an organization’s ability control its staffing decisions.

The USG doesn't require the Head of Quality Assurance (QA) and Head of Quality Control (QC) Key Personnel positions be held by two separate individuals. Contractors should determine appropriate expectations, responsibilities, and level of effort for each of the Key Personnel positions at the Prime IDIQ level as well as for Sample RTOR 0001 and Sample RTOR 0002. The USG will not considered limiting roles at the Prime Contract level. Each of these roles need to be identified for each RTOR. M.4.4. Key Personnel Qualifications Sub-Factor, p.99

Can the Government confirm that the Cross-Reference is excluded from the page limit of the Technical Proposal? Cross-Reference is excluded from the page limit of the Technical Proposal L.4.1. Technical Proposal Instructions, p.82

Is there a requirement for bidder to propose both for routine and response CPET services? If no, will bidders who propose for both services be given a preference?

(NOTE: In B1 and C2 it appears responding to both is optional, but in B2 the RFP it suggests responding to both is mandatory given the requirement to respond to 100% of the RTORs for response purposes. Please clarify).

There is no requirement for an Offeror to propose for both routine and response clinical services. There is no preference if an Offeror proposes for both routine and response clinical services. The two services will be scored independently. References in RFP: Page 5: Offerors may respond to one or to both capabilities.

C.2. page 11:BARDA acknowledges that some Offerors may have strengths providing services in the conduct of routine studies, while others may have strengths operating in response scenarios. Therefore, BARDA intends to make independent evaluations and separate awards for these two capabilities; in responding to this RFP, Offerors may respond to one or to both. B.2. page 6: After IDIQ award Contractor is required to submit a proposal for at least: 1) 80% of the Requests for Task Order Response (RTORs) if submitting a proposal for Routine Services

2) 100% of the RTORs if submitting a proposal for Response Services

Is there an editable format for the required attachments that need to be completed?

If submitting an electronic version of the propsoal all documents should be in a searchable PDF format.

Is it correct that the CRO is responsible for the logistics of transport/management of IP from the depot?

Yes, CRO will be responsible for IP depot management and logistics. References: C.3.1, 2. Project Management, 2.12.2, page 12: 2.12.2. Investigational product (IP) or device management.

2.12.2.1. Develop and implement a study supplies procurement and management plan as well as Investigational Product or Device Accountability Plan. Page 16: 6.20. Coordinate and manage investigational product/device shipment, delivery, proper storage, and inventory at clinical sites. Conduct accountability procedures and coordinate and manage end of study disposition.

Confirm there are defined locations where BARDA will stockpile IP for response studies. No, there are no defined locations.

For security related requirements, what has to be described as “to be implemented” versus detailed as currently implemented at this point? The offeror should base its response on how it meets or will meet the security requirements of the RFP.

We noted that BARDA expects providers to use COTS software. We wanted to reconfirm this is a requirement and we cannot use a proprietary bespoke CTMS system?

The offeror can use either a proprietary CTMS or a COTS. However the proposed CTMS must be validated and 21CFR Part 11 compliant, and considered sufficient for stated requirements and interact with SDCC and BSIP.

Relative time commitment for planning for rapid response/routine teams before any task order request is issued or award given (i.e., once CROs are under contract as part of this IDIQ effort). Can you comment on the time/efforts that should be assumed and the stakeholders that will take part in these planning efforts?

Offerors should use their assessment of the time/efforts needed and stakeholders that will take part in the planning efforts. The USG doesn't have an estimate on time/efforts. Contractors should anticipate other USG agencies and IP manufacturers will be involved in this process.

For the Sample Routine RTOR0001 and Sample Response RTOR0002- can you confirm if you would like us to include costing for IND/regulatory services or just speak to our capabilities? Costing for IND/Regulatory services should be included in both RTORs.

32 In B2, the RFP suggests the IDIQ contract may be used to support BARDA product development performers, in addition to the clinical services required by BARDA itself. Please clarify.

BARDA can envision a situation where one of BARDA's MCM development partners may not have the capability to conduct clinical trials and may wish to have BARDA conduct clinical studies they need for further development of their MCMs. In this scenario, BARDA will use the CTPE to conduct the clinical study on behalf of the development partner.

Section M.4 lists a “Head of Statistics” as key personnel. Although biostatistics will fall under the SDCC scope, does BARDA intend for the CTPE to have an assigned biostatistics head for every task as well? Cross reference Question # 8

Is it BARDA’s intent that the development and maintenance of Responsible, Accountable, Copied, Informed (RACI)/Study Responsibility Matrix fall completely within the scope of the selected CRO under the CTPE and not within the SDCC responsibility?

Yes, the RACI/ study responsibility matrix is totally within the scope of the selected CRO under the CTPE and not within the SDCC responsibility.

Will BARDA please advise where contractors should include our completed attachment #3? No, Cross reference Question # 18

36 Will BARDA consider removing the 50 page limit from the appendices? Cross reference Question # 6

Taking the page count into consideration, are offerors required to provide vendor quotes/proposals in their RTOR responses. (i.e. The Site Network, the Central Laboratory, Packaging and Kitting, Immunogenicity Lab)?

Contractors should identify key vendors and summarize capabilities and role on RTOR. It is not necessary to include proposals. Business proposals should provide appropriate details to ensure that the USG can evaluate costs and scope of work for each key vendor

Can you please confirm the SOW is the technical approach and that the Government is not expecting a technical proposal and a separate SOW document in this response?

A separate statement of work (SOW) is not required. The SOW is a subset or section of the technical proposal. Section 3 of the Technical Proposal is the SOW, specifying the technical approach, assumptions, and scope-caveats.

May offerors propose one person to fulfill more than one key positions. For example, can one person be proposed as Principal Investigator and Program Director?

Yes, offerors can suggest multiple roles for key positions. Please be sure to fill out Attachment # 9. Cross reference Question #22

Please confirm that offerors are only required to complete the fields that are applicable to the RFP we are responding to. Please confirm this attachment can be provided as part of the Business Volume.

Attachment 3 is no longer required as part of the CTPE response. Where appropriate, the Offeror capabilities should be discussed within the body of the RFP.

1) Are these rates for evaluation purposes only, or, is it the Government’s intent to treat these rates as ceiling rates that will be incorporated into the ID/IQ?

2) If incorporated into the ID/IQ, will they serve as the basis for labor costs when responding to FFP Task Orders? If so, can discounts be offered at the Task Order Level?

The rates are for evaluation purposes; however, if the offeror does not possess a current Rate Agreement with the Government then rate ceilings may be negotiated. The labor rates will be incorporated into the base contract and would serve as the basis for labor costs when responding to any Task Orders. The Sample RTORs attached should be proposed on a Cost Reimbursement or CPFF basis.

Please confirm that this cross walk is only required for the sample task order proposals responses.

The cross-walk is applicable to the budget in the offeror's entire proposal. While the construction of the business proposal is in the business judgement of each offeror, it should be clear based on the proposal what costs are associated with each objectives.

Given the page limitations of the proposal, please confirm the Section 508 compliance templates do not need to be provided as part of the offerors’ submission. If They are required, can they be excluded for the page limitations?

The Section 508 templates may be included as part of the offeror's technical proposal appendix, and will apply to those page limits.

Please confirm if the proposal is due Monday, October 21 or Thursday, October 24. The due date for the soliciation has been extended to Monday October 28, 2019 at 12 pm ET.

For proposal purposes, please provide the start and end dates for the performance periods of the ID/IQ contract and the Sample RTORs.

The IDIQ award date (start) can be assumbed to be April 1, 2020. The start date for RTOR0001 is 6 months after award. For RTOR0002 , the start date is 12 months after award.

46 What regions and countries in-country regulatory representation will be needed for?

USG does not have suggested regions or countries for this RFP response. The USG is open to suggestions on utilizing countries other than US based on CRO's technical approach and capabilities in submitted proposal.

Taking the page count into consideration, please confirm that offerors do not have to submit the actual CPAR document and that only the contract identifier information cited in a-g (Page 89) is required for projects that have CPARS.

If the CPARS Scores are available and the Offeror can provide reference numbers in the CPARS system, or actual copies of the CPARS scores to the CO, the Past Performance Questionnaire would not be required.

It is not enough to say that there are CPARS.

Please confirm that offerors are only required to provide Gantt Charts for the two sample task orders and that a Gantt Chart is not required for the ID/IQ proposal response.

A Gantt Chart and Work Breakdown Structure (WBS) is required only for Sample RTORs and not for ID/IQ proposal response. Section L.4.2. Technical Approach Page 79. L.4.3. Appendices Page 81.

C.3.1 5b Data governance, transfer, integration and reporting, p.11 49 Please clarify the requirement for DSMB reviews. Offerors should plan for 6 planned reviews and 1 adhoc meeting.

Section H.26 (page 44 of 102) specifies offerors must submit Section 508 Product Assessment Templates; however, Sections J (List of Attachments), L (Instructions, Conditions and Notices to Offerors), and M (Evaluation Factors for Award) neglect to expand upon this requirement. Please clarify whether offerors are required to submit Section 508 VPATs as attachments to their Technical Proposal.

The Offeror is expected to submit this documentation as part of the appendix to the technical propsoal.

BARDA posted a Special Notice on 4/9/2019 [solicitation number 19-BARDA-DRAFT- CSN- (CTPE-SDCC-BSIP)] entitled “BARDA CSN Q&As - 2019 DRAFT RFPs - CTPE, SDCC, BSIP,” which stated the following for Q&A 74: “Attachments are exempted from the page limit. This will be clarified in the final RFP.” However, we do not see any such exemption specified in the RFP. Please clarify the following:

a. Technical Proposal—please confirm what documents should be provided within the technical proposal appendices and what documents shall be considered attachments. Then please specify that attachment documents are exempted from page limitations. Please note that, at a minimum, we request that the following are exempted from the page limitations due to their length and/or the number of items required by the RFP: i. Curricula vitae for key personnel; ii. Risk Mitigation Plans/Matrices; iii. Security Plan*; v. Capabilities Matrix; vi. Section 508 VPATs, if required. b. Business Proposal—Please confirm that all business proposal attachments are exempted from the stated business proposal page limits.

The Appendix for the technical proposal is 150 pages; the Appendix for the business proposal is 100 pages.

There are no exemptions.

L.3.1.3 Packaging of Proposals/Business Proposal, p.77

Please confirm that the business proposal page limits for the responses to the 2 sample RTORs (15 pages for each) are in addition to the 50 pages allowed for the main business response.

Cross reference Question # 16

L.3.1.3 Packaging of Proposals/Business Proposal, p.77

With regard to BARDA MCM CSN past performance, will BARDA obtain this information internally or are offerors responsible for requesting this from their BARDA Contracting Officer?

If the CPARS Scores are available and the Offeror can provide reference numbers in the CPARS system, or actual copies of the CPARS scores to the CO, the Past Performance Questionnaire would not be required.

It is not enough to say that there are CPARS. If no CPARS has been created, the Contractor may request a Past Performance review by submitting a PPQ to the cognizant BARDA CO.

C.3.1.1.e Study Designs and Data Analyses

We request that you consider allowing past performance references from the previous five

(5) years versus the three (3) years currently allowed. The five (5) year timeframe is mentioned multiple times within Section M (Evaluation Factors for Award – M.4.2) and the Capabilities Matrix (Attachment 3) where BARDA asks for specific experience metrics within the past five (5) years.

Cross reference Question #4.

For proposal purposes, please confirm the start dates offerors should assume for the CTP&E IDIQ base contract, Sample Routine RTOR 0001, and Sample Response RTOR 0002.

Cross Reference Question #45

Please confirm that Head of Statistics was included in the list of CTP&E Key Personnel in error. Head of Statistics included in CTP&E Key Personnel is an error. Cross reference Question #8

Please confirm proposals are due Monday, October 21, as page 80 of 102 specifies Thursday, October 21.

Cross reference Question # 44

We ask that BARDA reconsider the inclusion of the provision on page 33 of 102, Article G.10. Negotiated Indirect Rates and Ceiling.

The Section is modified to read: "In the absence of an indirect rate agreement the Government may negotiate Rate Ceilings for each applicable indirect cost element. If established, any costs over and above the established cost ceiling shall not be reimbursed under this contract or any other Government contract, grant, or cooperative agreement."

10. For RTOR 0001 please clarify the number of scheduled DSMB reviews. Page 105 and 106 suggest a total of 6 planned DSMB reviews. However, Page 115 presents the following assumptions for Safety Data TLFs compiled for DSMB: 1 regularly scheduled meeting and 1 ad hoc meeting of the DSMB.

Page 115 is incorrect. Cross reference Question # 49

In section M.4.2.2, the government states, ""Most of the tasks should be performed with internal resources, but external resources may perform some tasks. Explicit identification of both internal/external resources is required."" Would the government confirm that an ""external"" resource is a resource external to the team of the prime contractor? In other words, teammates/subcontractors are considered internal."

External resource is considered a "subcontractor".

Would the government clarify that the following technical proposal sections are outside of the 50-page limit? Cover page, Table of contents, Cross reference matrix, All appendices.

The Cover page, Table of Contents, Cross Reference Matrix are outside of the 50 page limit. If the Offeror is responding for clinical services to both RTORs, the limit for the body of the technical proposal is 60 pages, plus 15 pages for each RTOR response. The total page limit of the Technical Proposal is 90 pages. If the Offeror is responding to 1 RTOR (either routine or response clinical services), the page limit is 65 pages (50 pages technical body and 15 pages for RTOR0001 or RTOR0002). The Technical Appendix is limited to 150 pages.

Could the government clarify which sections are not part of the count for the business proposal page limitation, such as required business forms, past performance, small business subcontracting plan.

These forms are not included in the 50 page business proposal limitation (up to 80 if responding to both task order. However, these form count towards the appendix to the business proposal, which is limited to 100 pages.

Are any portions of the business proposal permitted to be submitted in Excel format?

The business proposal should be submitted as one cohesive document in pdf format. It is recommended that the offeror submit an excel budget with their proposal to assist in the evaluation process.

Is it permissible to submit a list of acronyms with the technical and business proposals? Can the list of acronyms be outside of the 50-page limit of the business proposal?

The offeror may submit a list of acronyms with the technical and business proposal; however, if these are not included in the main proposal body they must become part of the appendicies to the respective proposal and are subject to those page limitations.

Will evaluators be given the entire technical approach or will it be pieced out by reviewer? Having this information helps team know how to approach cross referencing.

Each evaluator on the technical evaluation panel (TEP) will be responsible for review and scoring of the entire technical proposal.

The requirement for submitting CPARs and past performance questionnaires (PPQs) has contradictory statements within it. One sentence states, "A Past Performance Questionnaires is not required for U.S. Government projects listed in the proposal, when a finalized CPARS record is available." However, the requirement goes on to state, "... the Offeror shall submit a completed questionnaire (Attachment #8) for each of the contracts listed." Please confirm under what circumstance a PPQ is/is not required.

Cross reference Question #47

Would the government confirm the information requested in section L.6 should be submitted in the business proposal?

Yes, this correct.

The RFP includes an Attachment 3, Capabilities Matrix, but does not specify anything about it in sections L or M. Are offerors supposed to include the matrix with their proposals? Where? Is the matrix evaluated? Does the prime complete the matrix based on data for the entire team? Or does each teammate (prime and each subcontractor) submit an individual capabilities matrix?

The Capabilities Matrix is no longer required. Cross reference Question # 18

With regard to the required content of the Project Management Plan, the RFP states "Provide a Staffing Plan that describes roles, responsibilities, and level of effort for all scientific and technical personnel, including all proposed subcontractors and consultants." Because there is no actual task to be performed at the IDIQ level, how does the government suggest bidders propose level of effort? Are offerors expected to estimate the number of hours a labor category might be used in a given year based on the government's pipeline of RTORs, both planned (routine) and unexpected (response)?"

The Offerors are expected to estimate the number of hours a year for administrative functions, labor categories, response to RTORs, contract kick off, and general contract deliverables. Since the CTPE establishes a new CSN infrastructure, with the statistical and data coordinating center (SDCC) and biological specimen and investigational product storage facility (BSIP), there will be annual meetings with BARDA for governance planning and coordination of services.

Will the cost/price evaluation result in 3 ratings (one rating each for IDIQ, RTOR 1, and RTOR 2) or a single rolled-up rating?

Two or three ratings depending on whether the Offeror responds to one or two RTORs

Is it the intention of the government that each awarded CTPE IDIQ contract will have different labor categories and rates?

Each contract will have different labor categories and rates

Has the government considered providing offerors with a list of labor categories to price rather than having every offeror bid its own list of labor categories?

Every Offeror should bid their own labor categories

Section L.3 states proposals shall remain valid for 120 calendar days. Section L.6 states proposals shall remain "firm" for a period of at least 270 days from the date of receipt by the government. Please advise as to the correct timeframe.

Cross reference Question # 3

Item 6 of section L.6 states that "Any previous activities with BARDA must all be included in the submitted past performance list." Do subcontracted activities (in which the prime CTPE offeror was a subcontractor on a BARDA contract) need to be included in this list?

Yes, please include if the CTPE offeror was a subcontractor on a BARDA contract.

Sample TO 0001 states that a “DSMB will review 7 days of safety data following the priming dose.” It also states later that there is only 1 planned DSMB meeting. Will the one meeting take place after 1st patient, or 1st dose? Would no safety review take place prior to subsequent dose escalations?

Cross reference Question #49

Could the please government clarify the tasks associated with TMF during active study in the cases of Sample Task 0001 and 0002? Does this only include collection of regulatory documents and ensuring sites maintain appropriate investigator files?

CTPE Offerors will be responsible for management of the entire TMF during both RTORs.

The CTP&E RFP under Task Order 0002 states that “subjects discharged during study treatment will receive study drug for at-home use.” Should the offeror provide cost estimates for home health care for the one-hour infusions of study drug while the subjects is receiving that at their home?

CTPE Offerors should suggest appropriate follow-up for visits post hospitalization based on their experience with similar studies.

Will it be acceptable for us to present in the following order our material for the Technical Plan / Approach, as described on RFP pp. 83 - 84? (1) Response to Sample Task Order 0001; (2) Response to Sample Task Order 0002; (3) Statement of Work

No please use the following order for L.4.2. Section 3- Technical criteria (1) SOW; (2) response to Sample RTOR0001; and/ or (3) Response to Sample RTOR0002 followed by L.4.3. Appendices

Our understanding is that, if we respond to both sample task orders, the Technical Proposal can be up to 90 pages long. Is that correct? Also we understand that there is no restriction on how we allocate those 90 pages among the various parts of the Technical Proposal. Is that correct?

Cross reference Question # 61

Will BARDA please confirm the required offer validity period? Pages 1 and 81 of the RFP indicate 120 calendar days whereas page 92, Section L.6.1. indicates 270 days.

Cross reference Question # 3

L.6.1

Can BARDA please clarify whether the Maximum Ordering Amount of $250,000,000 is the maximum amount for the entire IDIQ performance across awarded contractors or is this the maximum amount available for each individual IDIQ award?

This is the maximum amount for each IDIQ holder and is not an aggregate of all potential awardees.

B.6.3

Other than DSMB member identification, what DSMB activities will the CTPE contractor be responsible for?

CTPE Offerors will be responsible for the management of the entire DSMB process.

C.3.1.3.2

Does BARDA require regulatory strategic support or only operational support for specific trials at the task order level?

BARDA does not require regulatory strategic support. BARDA requires only operational support.

In section C.3.1.6.18 BARDA requests that CRO "develop and maintain a system to monitor all clinical site items..." For efficiency and cost effectiveness, would it be acceptable for CRO to use an existing system that has proven successful in clinical trial planning and execution (i.e. CTMS)?

Cross reference Question #29

C.3.1.6.18

With respect to Baseline Security Requirements outlined on page 46, would BARDA kindly consider increasing the notification requirement from one (1) hour or less to within 24 hours which is consistent with the terms outlined on page 26 for Security Reporting and page 50 for Incident Reporting?

This policy is set by HHS ASPR and cannot be modified.

H.27.A.2

Please confirm that FAR 52.222-41 and 52.222-49 (Service Contract Act) are inapplicable if the majority of the services for a task order are for professional services.

These clauses may be applicable if any work on the contract is being conducted by an SCA covered employee.

I

Can the government clarify where the completed Attachment #3 Capabilities Matrix should be included in the submitted proposal? Cross reference Question # 18 J and L

Would BARDA kindly consider eliminating the page limit on the Business Proposal to ensure CRO has adequate space for the requested compliance documentation and supporting cost documents?

Cross reference Question # 16

L.3.1.3

Would the government kindly consider either eliminating or increasing the page limit on the Technical Proposal Appendices to accommodate the amount of required material? Cross reference Question # 6 L.3.1.2

For Past Performance information, BARDA requests, "...a list of the last five (5) contracts completed during the past three years and all contracts currently in process." Would BARDA consider limiting current contracts to those that are directly relevant to the requested RFP services?

We are amending the requirement to provide a list of the last 5 - contracts completed during the past three years that are relevant to this solicitation. L.5.2.6

For the Business Proposal, can BARDA please clarify the difference in Section 2: SOO Financial Response and Section 4: Sample Request for Task Order Response (RTOR)?

The information requested appears to be similar in nature.

Section 3 is General ; Section 4 is Sample RTOR response

L.5.2.2 and L.5.2.4

Please clarify expectations around Key Personnel for IDIQ. Does BARDA expect these teams to support all concurrent task orders activities? Or will there be Key team members plus additional TO teams supporting a specific protocol?

BARDA does not expect the Key Personnel for the IDIQ to necessarily be the same Key Personnel for task order activities. Key personnel for task order activities will need to be proposed by the Offeror in their responses to future RTOR M.4.4.b

For TO0001, would BARDA be willing to consider a proposal with fewer than 6 sites for efficiency and cost effectiveness purposes?

BARDA is willing to accept alternative technical approaches.

TO0001

For TO0001, would CRO be responsible for paper diaries or will that information be captured via eDiary (under the SDCC databases)? Page 115 indicates paper CRFs are not required.

CRO is responsible for diaries for the RTOR0001 and should propose a…