75A50119R00027_Amendment_1_(9.25.2019)_FINAL_(signed).pdf

(x)

75A50119R00027 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.

x

ASPR-BARDA

ASPR-BARDA

Tip O'Neill House Office Building Room 24 F15 Washington DC 20201

09/25/2019

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 75A50119R00027. The RFP close date is extended to October 21, 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 .

jeffrey.brown Typewritten Text 09/25/2019 jeffrey.brown Highlight jeffrey.brown Highlight jeffrey.brown Highlight jeffrey.brown Highlight

RFP 75A50119R00027: 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

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 21, 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) (maximum 60 pages total or up to 90 pages if responding to both Sample RTORs). Appendices may be provided with the technical proposal, with the appropriate tabs (maximum 150 pages total).

L.4.3. Appendicies 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 60 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 (80 pages if responding to both RTORs). 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. 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.

L.6. OTHER ADMINISTRATIVE DATA, is modified as follows (SDCC Only)

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

1 Will BARDA please advise where contractors should include our completed attachment #3?

Attachment 3 should be submitted as part of the Appendix. Where approriate, the Attachment should be referenced within the the body of the RFP. Attachment #3

Will BARDA consider removing the 50 page limit from the appendices?

The limit for appendices is revised to 150 pages. L.4.3. Appendices to Technical Proposal

We request consideration of an extension of the deadline to a timeframe commensurate with that allowed for the CTP&E RFP, which currently provides 2 more weeks for proposal submission. We respectfully assert that preparation of an SDCC proposal response requires a similar level of effort to that of a CTP&E response. In fact, SDCC offerors have to address a robust infrastructure component not required in the CTP&E, and SDCC offerors are required to respond to both task orders, where CTP&E offerors may elect to respond to only one. Further, offerors in both pools have had the same amount of time and level of information available with SDCC and CTP&E draft RFPs released at the same time with the final versions also issued on the same day.

The RFP due date is extended 15 days SF 33 and FBO

4 With reference to the requirement for a centralized archive of clinical study records, please clarify the following:

5 a. Please confirm that all TMF files will be electronic, i.e., no paper files. We expect the TMFs will be primarily electronic, but offerors should include capacity for paper components as well. Section C

b. Please specify what eTMF files the SDCC should expect to receive and approximate timeframes with regard to completed or ongoing studies funded under the current MCM CSN contract.

The SDCC should expect to receive eTMFs for four CSN-funded studies within the first 6 month period following award Section C

c. What is the expected transfer method for the CTP&E to provide TMF to the SDCC?

Under what circumstances would BARDA require access to the TMF archive managed by the SDCC? If so, what type of access? The expected transfer method for the eTMFs will be CDs. BARDA will require access to the

TMF archives primarily for regulatory compliance/audit purposes. Both remote and on-site access would be expected. Section C

8 On page 84 of 98, please confirm that PPQs should be submitted directly to the Contracting Officer at the information listed below. Please have the PPQ submitted to the Contracting Officer as listed in Article G.1. and L.3. G.1. and L.3.

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:

See Answer # 2 Appendicies. L.4.3. Appendices to Technical Proposal

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*

iv. Continuity of Service Plan*

v. Capabilities Matrix

The appendices may not exceed 150 pages. L.4.3. Appendices to Technical Proposal

b. Business Proposal—Please confirm that all business proposal attachments are exempted from the stated business proposal page limits. Attachments are not included in the business proposals 50 page limit; however, attachments may not exceed an additional total of 100 pages (including Sample RTORs). L.5. Business Proposal

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.

Each RTOR may have a buisness proposal up to 15 pages and are in addition to the 50 pages allowed for the main business proposal. L.5. Business Proposal

SDCC 75A50119R00027- Q&As

In Q&A 77 issued pursuant to the draft versions of these RFPs, the Government response indicated that a Past Performance Questionnaire would not be required when a CPARS was available. This response was incorporated into the CTP&E RFP, but the SDCC RFP still states on page 84 of 98 that “the Offeror shall submit a completed questionnaire for each of the contracts listed,” and does not exempt offerors from the PPQ requirement if a CPARS evaluation is available. We ask that you revise the SDCC RFP to also be in accordance with the Draft RFP Q&A response document and require only CPARS when that is available.

If the CPARS Scores are available and the Offeror can provide reference numbers in the CPARS system, or actual copies of CPARS Scores to the CO, the Past Performance Questionnaire would not be required. It is not enough to say that there are CPARS L.5. Business Proposal

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? See Answer #13 L.5. Business Proposal

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 typical for NIH coordinating center RFPs given the typically long duration of such contracts. Past Performance references will stay as planned for three (3) years as currently allowed L.5. Business Proposal

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

The offerors can assume that: 1) the IDIQ base contract will start on the date of award, 2) Routine RTOR0001 will start 6 months following IDIQ award, and 3) Response RTOR0002 will start 12 months following IDIQ award.

The BARDA SDCC RFP requires several examples of various plans expected to be used by the SDCC (Project Management Plan, Transition Plan, Security plan, etc.), each of which can be quite lengthy. The page limit for Attachments is currently set at 50 pages total. Would the government please clarify whether these plans are excluded from the page limit or whether they will accept alternatives to the full sample plans?

No, The appendices has been increased to 150 pages. L.4.3. Appendices to Technical Proposal

The BARDA SDCC RFP requires a 50 page limit for the Technical Proposal. Can the Cover Letter, Cover page, Table of Contents, RFP Matrix and other cover sheets, be excluded from the page count limit?

Yes, however the page limit is extended to 60 pages plus 30 for RTOR responses (15 for each RTOR) for a total of 90 pages. Appendices may not exceed 150 pages.

Page 93 states the Evaluation criteria for the Technical volume includes the responses to the sample RTORs, while page 94 indicates the response to the sample RTORs are in addition to the technical and business proposals. Would the government please clarify whether it is expecting the technical responses to the RTORS to be a separate volume from the Technical and Business proposal volumes? The responses to the RTORs should be included as part of the entire Technical and Business

Volumes. M.4. Technical Evaluation

The requirement to include the crosswalk to mandatory capabilities was included in Sections L and M of the draft RFP but removed for the final RFP. However, the attachment is included as Attachment 3 to the final RFP. Would the government please confirm that the matrix is not required for this solicitation?

While there are no mandatory criteria under SDCC, the offeror is expected to complete attachment 3, capabilities matrix. Attachment 3 may be submitted as part of the Appendix.

Where appropriate, the Attachment should be referenced within the the body of the proposal.

Would the government please clarify the number of DSMB reviews required for Sample RTOR 1 and 2? Both single scheduled meetings and multiple scheduled meetings after the first dose in each group are mentioned.

The offerors should assume 6 DSMB meetings for Sample RTOR001, and 3 DSMB meetings for Sample RTOR002

For Sample RTORs, would the government clarify the basis for estimation of eCTD submission support (e.g., #, type, and size of amendments)? In the absence of this data, is it acceptable to provide assumptions and an estimated cost for each type of submission that is likely to occur? The offerors can make reasonable assumptions based on a similar study.

On page 79 of the RFP, it states the following, “Proposals shall remain valid for one hundred and twenty (120) calendar days after receipt by the Government. Please confirm this on the cover sheet of each, Volume I and Volume II.” However, on page 89, it states “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 270 days from the date of receipt by the Government.”

Would the government please clarify which statement should be added to our Proposals? Proposals will remain valid for 120 days. Section L.6. Other Administrative Data is modified to replace 270 days with 120 days. L.6. Other Administrative Data

Section L.5.2.2, SOO Financial Response, requests that responses shall reflect all cost information per objective and all costs shall clearly crosswalk with the SOO requirements. Please clarify whether these costs are to be for each level of the SOO, i.e., separate and distinct costs for SOO C.3.1.1.a through e, C.3.2.a, C.3.3.a through f, etc.

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. Section C

25 Additionally, please confirm that the level of cost information requested in section L.5.2.2 is applicable to the business proposals for the sample RTORs. Yes, the level of cost information is applicable to the Sample Task Order(s) L.5.2.2

The past performance instructions listed in the Business Proposal Components section L.5.2.6. indicates that the Offeror must provide a list of “the last five (5) contracts completed during the past three years and all contracts currently in process.” Please clarify whether offerors are required to include the information listed in bullets a-g in section L.5.2.6 for all contracts listed to comply with this instruction.

The offerors should provide the information in bullets a-g to the maximum extent possible, failure to provide the information in the list may impact the Government's ability to evaluate the offerors past performance.

The government states in the RFP that the Past Performance evaluation criteria is identical to those used in its CPARS system. Would the government please confirm it is willing to view and accept CPARS results in lieu of the Past Performance Questionnaires? See Answer # 13

Additionally, the past performance instructions require offerors to submit a completed questionnaire for each of the contracts listed (last 5 completed in past 3 three years and all current contracts). Please confirm that the government expects offerors to request questionnaires for their entire current line of business.

The section is modified to read: "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." (L.5.2.6.). L.5.2.6.

The past performance instructions state that “offerors shall submit the following information as part of their business proposal for both the Offeror and proposed major subcontractors (Attachment 8)” and that “… the Offeror shall submit a completed questionnaire (Attachment 9) for each of the contracts listed.”

Attachment 8 is the past performance questionnaire and Attachment 9 is the Summary of Related Activities. Please clarify which attachment(s) are required to comply with the past performance requirement.

Attachment # 8 is the past performance requirement. Attachment # 9 is not a past performance requirement.

Please clarify whether the 50-page limit for the Business Proposal includes the following: a. Summary of Related Activities for each Key Personnel

b. Completed Representations and Certifications

c. Small Business Subcontracting Plan

d. Sample RTOR business proposals 60 pages plus 15 pages per sample RTOR = Total of 90 pages. Attachments may not exceed

100 pages for the business proposal (including sample RTORs). L.5. Business Proposal

With respect specifically to the requirement to provide “… all contracts currently in process”, we assume the Government is only interested in current contracts that are relevant to this solicitation. Large organizations may have hundreds of current contracts (and would likely have no way to address all current contracts and meet the page limitations), so please confirm offerors should only list current contracts that are relevant? [We note the instructions in M.6 at the end of page 96 says: “The Government will only evaluate performance from relevant experience over the past three (3) years.” (emphasis added)] See Answer #28 L.5.2.

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 at the end of page 96 says: “The Government will only evaluate performance from relevant experience over the past three (3) years.” (emphasis added)] Yes, please provide for relevant contracts over the last three (3) years. L.5. Business Proposal

In the previous Q&A, the Government indicated that if CPARS were on file, offerors would not need to submit a PPQ. Can the Government confirm that if there is a CPARS on file, a PPQ is not required?

If the CPARS Scores are available and the Offeror can provide reference numbers in the CPARS system, or CPARS copies to the CO, the Past Performance Questionnaire would not be required. It is not enough to say that there are CPARS L.5.2.

Please clarify the validity period. The instructions on page 77 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 89. Please clarify whether it is 120 days or 270 days? For the SDCC, proposals shall remain valid for 120 days after receipt. L.6. Other Administrative Data

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

For Past Performance Questionaires and/or CPARS requirement remains the last 3 years.

The offeror should provide past performance for the 5 most recent relevant contracts during that period and any relevant on-going contracts. L.5.

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 as the requirement to deliver paper copies effectively reduces the amount of time allowed for this response.

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

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? 1) The response to question 73 of the BARDA Q&A received on April 9, 2019 stated that he Security Plan and the Continuity of Service Plan would be exempted from the appendix 50-page limit.

2) 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.

The limit for appendices is revised to 150 pages.

L.4.3. Appendices to Technical Proposal

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.”

For the purposes of this clause and individuals salary as it relates to the salary limitation is the amount that individual makes in agregate under the contract in a contract year. No individual shall be compensated greater than the Executive Level II pay level in any contract year. HHSAR 352.231-70 Salary Rate Limitation (December 2015) I.1.1, p.58

· 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 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?

This is correct, a employee may earn at a rate higher than the Executive Level II so long as it does not exceed the Executive Level II salary in the aggregate for the contract year.

HHSAR 352.231-70 Salary Rate Limitation (December 2015) I.1.1, p.58

· 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?

Consultants may earn at a rate higher than the Executive Level II, so long as they are not compensated in the agregate above the Executive Level II salary for any contract year.

Unless otherwise approved in the contract, a COA is required for approval of consultants prior to them performing any work under the contract.

HHSAR 352.231-70 Salary Rate Limitation (December 2015) I.1.1, p.58

· If the Government determines that this rule would apply in the situation above, please confirm whether the salary rate limitation rule does not apply to consultants or subcontractors that are paid 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]

The Government must provide consent to any firm-fixed price subcontract that exceeds $250,000. The Executive Level II cap on aggregate annual salary will be used in evaluating subcontracts. However, if a subcontract employee is being compensated at a rate greater than the Executive Level II without reaching the aggregate maximum, the costs would be allowable, pending CO consent.

In terms of pricing information, offerors are asked 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 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 the SOO. Please clarify whether the Government meant this requirement to apply just to the sample RTOR responses or please elaborate if the Government intended other “costs” to be cross-walked?

Fifteen pages are provided per Sample RTOR in the business proposal. The Offeror can provide their labor/ price matrix (NIH Format) as long as a labor/price matric is addressed.

TThe Offeror should cross reference pricing from the WBS. Alternatively the Offeror can choose to add additional categories to the sample template. To clarify, the government intended all associated costs to cross-reference.

L.5. Business Proposal

Will the Government allow Offerors to use their own Labor/Price Matrix (i.e. using the NIH budget template) as long as all detail from the Example Task Order – Labor/Price Matrix is included OR is the Example Task Order – Labor/Price Matrix format required?

Yes, see answer to # 42 for details.

L.5. Business Proposal

On page 101 under Study Design indicates the DSMB will convene after the priming injections (for a total of 3 DSMB Meetings); however, page 102 DSMB Reviews indicates the DSMB will convene following priming and boosting dose for each of the three dosing groups (for a total of 6 DSMB meetings). Please confirm the number and timing of DSMB meetings for Sample Routine RTOR 0001 The offerors should assume 6 DSMB meetings for Sample RTOR001, and 3 DSMB meetings for Sample RTOR002 Attachment 1 Sample Routine RTOR 0001, p.101-102

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 84.

The offeoror 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.

Section L.5.2.7: Section 7: Small Business Subcontracting Plan, p.84

1 )Can Government confirm that BARDA staff will be responsible conducting site visits and independent audits of Contractor and subcontractor facilities? 2) Can the Government confirm expectations for the requirement in C.4 (p. 12) that “The Contractor shall arrange and conduct site visits and independent audits of Contractor and subcontractor facilities as needed” versus the requirement in section E.4 Audits

(p. 15) wherein it states the USG would conduct the audits.

3) Can the Government confirm whether Contractors will be required to perform cGMP audits under this contract?

1) As needed BARDA will conduct site visits and independent audits of contractors and subcontractors

2) The SDCC shall arrange and conduct site visits and independent audits of Contractor and subcontractor facilities as needed

3) No cGMP audits will be required under this contract.

C.4 Meeting E.4 Audits

47 Does the government require integration of data from archival studies?

Yes, it's possible the government may require integration of data from multiple studies including archival studies. C.3.1 5b Data governance, transfer, integration and reporting, Will BARDA require Contractor to maintain, monitor and track licenses within the SDCC (i.e. the cloud environment)?

Yes, BARDA will require the contactor to maintain, monitor, and track licenses within the SDCC. M.4.1. Technical Plan/Approach Factor

Section M.4.2 of the SDCC RFP indicates "Offerors will be able to complete the majority of tasks associated with the statistical and data management support of Phase 1-4 clinical trials with internal resources"; however, on p. 87, the anticipated minimum small business subcontracting goals are 33%. Would the government consider reducing the overall small business participation goals to 10%, understanding that it is optimal to have the majority of SDCC services provided by a single organization. Expectation of 33% small business subcontracting goals require significant outsourcing of activities being provided by external resources.

The Small Business Goals are set in accordance with HHS and SBA and cannot be reduced for this Solicitation.

M.4.2 Organizational Experience and Competency Factor

Can the Government clarify whether attachments to the Business Proposal such as:

Listing of all labor categories/rates, Detailed pricing for Sample RTORs, Accounting System Approval Letters, Indirect Rate Agreements/Letters, Subcontractor Commitment letters, Cost documentation (e.g., pay stubs), etc.) will count against the 50-page limit? 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

Any part of the business proposal that includes a budget or a budget breakdown will be included in the 50 page limit to the Business Proposal. It is recommended that Offeror's submit an Excel version of their budget to the CO listed in G.1. Supporting documentation that includes: Accounting System Approval Letters, Indirect Rate Agreeements/Letter, Subcontract Commitment Letter, Cost documentation will not count against the 50 page limitation. Attachments for the buisness proposal (including Sample RTOR(s) response attachments) shall not exceed 100 pages, and are in addition to the 50 pages for the main Business proposal.

L.3.1.3 Packaging of Proposals/Business Proposal

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?

The maximum 15 pages allotted per sample RTOR response is in addition to the 50 page limit for the Business Proposal.

L.3.1.3 Packaging of Proposals/Business Proposal

52 Can the government confirm that legacy data from previously completed trials will need to be stored?

The government confirms that legacy data from previously completed trials will need to be stored. C.3.1.1.e Study Designs and Data Analyses