Q&A_W81XWH-17-R-0074.pdf

27-Apr-18

Number Reference Question Answer Resulting Amendments

1 W81XWH-17-R-0074-0001_Conformed - Section C - Descriptions and Specifications Performance Work Statement (PWS) (Page 11)

4.1 Period and Place of Performance. The Government states, “For work performed off-site, the Government will provide computers, monitors, printer and/or scanners…. The Contractor shall provide office space, desk, telephone, requisite consumable materials, and conference space.”

Question: Will the Government please clarify if there is a minimum/maximum distance or drive time for the offsite work place?

There is no minimum/maximum distance or drive time for the offsite work place. See PWS Section 4.1.

None

2 W81XWH-17-R-0074-0001_Conformed - Section C - Descriptions and Specifications Performance Work Statement (PWS) (Page 11)

4.1 Period and Place of Performance.

Question: Will the Government please clarify if they are expecting full performance during the transition periods, or a ramp-up during transition in and a ramp-down during transition out?

Full performance is not required during the transition period. Full performance will begin under CLIN 0002. Full performance is required during the transition-out period.

Updated PWS Section 4.1.

3 W81XWH-17-R-0074-0001_

Conformed

- Section C - Descriptions and Specifications Performance Work Statement (PWS) (Page 11) Section I – Contract Clauses and K – Clauses Incorporated by Reference (Page 49)

FAR 52.222-41 (Service Contract Act of 1965, as Amended) has not been incorporated into the solicitation.

Question: Please confirm that the Government considers the contract resulting from the solicitation to be administratively or otherwise exempt from the requirements of the Service Contract Act (SCA).

Question: If the Government believes this solicitation is subject to SCA, please provide the applicable wage determination schedule.

The Government considers this contract exempt from the Service Contract Act / Service Contract Labor Standards.

None

4 W81XWH-17-R-0074-0001_Conformed - Section L – Instructions, Conditions and Notices to Bidders (Page 69)

The instructions require the Prime to submit hard copies of the proposal.

Question: Are subcontractors still required to provide a breakdown of their rates/price in a Sealed Package if they are other than CPFF?

Question: As a follow-up, would the sealed package submission apply to subcontractor partners with less than 20% of the overall effort?

The Government is not requiring any proposed subcontractors to provide sealed packages. It is the prime Offeror's responsibility to provide sufficient information for the Government to determine whether proposed costs are fair, reasonable, and realistic. If prime Offerors are unable to obtain/provide this information because the data is proprietary to the proposed subcontractor, sealed packages will be accepted for cost/price information only.

None

5 W81XWH-17-R-0074-0001_Conformed - Section L – Instructions, Conditions and Notices to Bidders

“SUBMISSION: Each volume shall be submitted (1) in hard copy as a separate file/three-ring binder and (2) on CDs with each proposal volume written to its own CD, and (3) via email with each proposal volume attached as its own file. Each file/binder and disc shall be clearly labeled with its Title and a copy number (e.g., copy 1 of 5).”uestion: Could the Government provide a file size limit/capacity for the email/electronic submission?

See Question 6 See Question 6

6 W81XWH-17-R-0074-0001_Conformed - Section L – Instructions, Conditions and Notices to Bidders (Page 69)

“SUBMISSION: Each volume shall be submitted (1) in hard copy as a separate file/three-ring binder and (2) on CDs with each proposal volume written to its own CD, and (3) via email with each proposal volume attached as its own file. Each file/binder and disc shall be clearly labeled with its Title and a copy number (e.g., copy 1 of 5).”

Question: In the event a proposal volume submission file size exceeds the Government’s email limit, could the Government confirm that it is acceptable for the Offeror to break down the volume into two parts (e.g. pages 1-40 and 41-85) and submit in multiple emails?

Question: Could the Government please provide what the Government’s email size limit is?

Email messages with attachments are limited to 20 MB. If necessary, it is acceptable for Offerors to break down proposal volumes and submit in multiple emails in order to comply with the size limit.

RFP Section L.1 Electronic Submission is revised to include email size limits and instructions.

7 W81XWH-17-R-0074-0001_Conformed - Section L – Instructions, Conditions and Notices to Bidders (Page 70)

The current instructions state to mail the proposal to USAMRAA, Dana Kavitski.

Question: Will the Government allow hand delivery of the proposal?

Yes, hand delivery is acceptable. Proposals shall be delivered to 839 Chandler Street, Fort Detrick, MD 21702. It is the Offeror's responsibility to ensure that proposals are received in all formats prior to the time established for proposal receipt.

Delivery instructions in RFP Section L.1.

SUBMISSION are revised.

8 W81XWH-17-R-0074-0001_Conformed - Section L – Instructions, Conditions and Notices to Bidders (Page 70)

The current instructions state to mail the proposal to USAMRAA, Dana Kavitski.

Question: Will the Government accept deliveries via courier services (e.g. FedEx, UPS, etc.)?

Yes, courier delivery is acceptable. Proposals shall be delivered to 839 Chandler Street, Fort Detrick, MD 21702. It is the Offeror's responsibility to ensure that proposals are received in all formats prior to the time established for proposal receipt.

Delivery instructions in RFP Section L.1.

SUBMISSION are revised.

9 W81XWH-17-R-0074-0001_Conformed - Section C - Descriptions and Specifications, Performance Work Statement (PWS) 15.0 Organizational Conflict of Interest (OCI) (Page 39)

“The comparative analysis must be included in the quote for this contract, and must include a statement certifying whether the Offeror believes that its performance of the proposed contract would create a real or apparent OCI.”

Question: This comparative analysis requirement is not listed under any of the volumes in the proposal submission table of volumes on page 70. Since the OCI certification is listed under the Administrative Volume, should Offerors include the comparative analysis and statement in that volume?

Yes - The comparative analysis is part of the OCI Certification.

The chart in RFP Section L.1. SUBMISSION is revised to include the Comparative Analysis in the Administration Volume.

10 General Question: Due to the uncertainty of the travel and ODC requirements, would the Government please provide ODC/travel plugs that Offerors should use for the base year and all option years, to include Transition Out?

Plug numbers provided in the amended RFP are for travel purposes only. If the offeror determines additional ODCs are necessary beyond travel, it shall propose additional ODCs for the appropriate period in its cost proposal.

ODC line items are revised to include plug numbers.

11 W81XWH-17-R-0074-0001_Conformed - Section C - Descriptions and Specifications Performance Work Statement (PWS)

9.1 OCONUS Travel (Page 29)

Section 9.1 states: “Prior to non-contract related OCONUS travel, such as vacation, Contractor employees that hold security clearances (Secret and above) shall complete training and submit documentation as required in the Foreign Clearance Guide (FCG)…”

Question: Will Secret clearances be required for this contract, and if so, will a DD254 be issued after contract award?

See PWS 13.1, 6.1.6.1, and 6.1.7. No DD254 is required.

None

12 W81XWH-17-R-0074-0001_Conformed - Section L – Instructions, Conditions and Notices to Bidders (Page 73)

“The POCs shall be instructed to electronically complete Part II of the questionnaire and e-mail the entire questionnaire to the Contracting Office no later than the proposal due date, to Ms.

Dana Kavitski at Dana.Kavitski.civ@mail.mil, and Mr. Herbert (Caj) Keen, at herbert.e.keen.civ@mail.mil. The Offeror shall e-mail to the Contracting Officer a list of all the POC’s who were sent a questionnaire. The Government must receive this list no later than the proposal due date. The POC List shall be submitted in Word for Windows Table Format.”

Question: Does the Government want this list provided in a separate email from the proposal email submission, or submitted as a section of a proposal volume? If submitted with the proposal, within which volume should it be placed?

Offerors shall provide this list within Volume III (Past Performance / Small Business Volume) of the proposal.

Volume III in the chart at RFP Section L.1.

SUBMISSION is revised to clarify how the list of POCs should be provided. RFP Section L.3(c) is also revised for clarification.

W81XWH-17-R-0074 Questions

13 3b. VOLUME II – Experience Volume (Page 72) / 3f. VOLUME V – Cost Proposal Volume (Page 76)

Resumes/Letters of Intent for Key Personnel “For those individuals proposed as Key Personnel who are not current employees of the Offeror’s company, include a signed a letter of intent. Offerors do not have to provide a letter of intent for individuals proposed as Key Personnel who are current employees of the prime contractor. Offerors shall include a letter of intent for any other individual proposed as Key Personnel to include subcontractor employees, teaming partner employees, and consultants.”

“Letters of commitment shall clearly identify the prospective employees’ agreed-to salary/hourly rate and other pertinent conditions of employment.”

Question: Is the Government using the terms “letter of intent” and “letter of commitment” interchangeably? Please confirm if only one type of letter is required.

Only one type of letter is required. "Letters of commitment" is revised to state "letters of intent" in RFP Sections L.3(c) and L.3(f).

14 W81XWH-17-R-0074-0001_Conformed - Section L – Instructions, Conditions and Notices to Bidders / 3f. VOLUME V – Cost Proposal Volume (Page 76)

The solicitation states: “The specific direct labor rates utilized to price the proposal must be identified in the cost proposal only. The proposal shall set forth a complete breakdown of the direct and indirect rates by category and the rationale thereof. Provisions for overtime and shift differential charges shall be clearly addressed on a per-hour basis…”

Question: If a subcontractor is other than CPFF, does the Government still want the same supporting breakdown of their rates?

See Question 4 See Question 4

15 W81XWH-17-R-0074-0001_Conformed - Section L – Instructions, Conditions and Notices to Bidders

3f. VOLUME V – Cost Proposal Volume (Page 76)

The solicitation states: “Letters of commitment shall clearly identify the prospective employees’ agreed-to salary/hourly rate and other pertinent conditions of employment.”

Question: Would the Government consider removing the salary/hourly rate requirement from the letter, as this is sensitive candidate information?

Yes, this requirement has been removed. Updated 3f. VOLUME V – Cost Proposal Volume (Page 76)

16 Section I – Contract Clauses FAR 252.219-7004 is currently not listed in the solicitation. Our comprehensive small business subcontracting plan is authorized by and approved under the test program with the Department of Defense to utilize that plan for all new DoD solicitations and contracts.

Question: We respectfully request that FAR 252.219-7004 be added to the solicitation. Please confirm that FAR 252.219-7004 will be added to the solicitation.

DFARS 252.219-7004 is prescribed for use in contracts, not solicitations. If the successful Offeror has an approved comprehensive subcontracting plan, this clause will be incorporated in the contract in lieu of DFARS 252.219-7003, FAR 52.219-9, and FAR 52.219-16 in accordance with DFARS 219.708.

None

17 W81XWH-17-R-0074-0001_Conformed - Section I – Contract Clauses (Page 49) / Section F - Deliveries or Performance / DELIVERY TABLE 8. Deliverable/ Delivery Schedule Deliverable 3 (Page 44)

When utilizing the comprehensive small business subcontracting plan (FAR 252.219-7004), only SSR reports are submitted, not ISRs, as negotiated in the comprehensive subcontracting plan with the Defense Contract Management Agency.

Question: Please confirm that in light of this, we would be exempt from submitting an individual ISR for this specific contract, if awarded (Deliverable 3, page 44 of the solicitation).

If the successful Offeror has an approved comprehensive subcontracting plan, DFARS 252.219-7004 will be incorporated in the contract (See Question 16). If any contractual requirements (e.g., deliverables) are inconsistent with the requirements of this clause, they will be revised upon award.

None

18 W81XWH-17-R-0074-0001_Conformed - Section L – Instructions, Conditions and Notices to Bidders / 3c. Volume III – Small Business Participation Plan and Small Business Subcontracting Plan (Page 74)

The Government provides the Small Business Participation Goal of a minimum of 16% broken down by Small Business categories.

Question: Will the Government’s evaluation be based on an Offeror providing the minimal goal percentage (16% small business participation) overall, or will an Offeror be ranked lower if the specific subcategory percentages identified are not contained in a submitted plan?

The Government's evaluation will be based on the overall percentage, as well as the percentages for each subcategory.

None

19 W81XWH-17-R-0074-0001_Attch_5- Est_Level_of_Effort / W81XWH-17-R- 0074-0001_Conformed - Attachment 5 Level of Effort / Section C - Descriptions and Specifications / Performance Work Statement (PWS) 5.9 Contractor Personnel Performance/ Replacement – Key Personnel (Pages 15-16)

Question: The Government lists three Key Personnel positions. With respect to the Pharmacovigilance Physician and NPH PMO Biostatistics Support positions, are there current incumbent personnel filling these two positions, or are they new positions?

There are no current incumbent personnel filling the Pharmacovigalance Physician and NPH PMO Biostatistics Support positions.

None

20 W81XWH-17-R-0074-0001_Attch_5- Est_Level_of_Effort / W81XWH-17-R- 0074-0001_Conformed / Attachment 5 Level of Effort

Section C - Descriptions and Specifications Performance Work Statement (PWS)

Question: Are all of the positions listed in Attachment 5 currently filled? If all of the positions are not currently filled, please provide a listing of the position title and number of FTEs per position title that are currently vacant.

This information is proprietary to the incumbent contractor.

None

21 W81XWH-17-R-0074-0001_Attch_5- Est_Level_of_Effort / W81XWH-17-R- 0074-0001_Conformed - Section C - Descriptions and Specifications Performance Work Statement (PWS)

5.9 Contractor Personnel Performance/

Replacement

– Key Personnel (Pages 15-16)

Three Key Personnel positions (Contractor Task Manager, Pharmacovigilance Physician, and NPH PMO Biostatistics Support) are referenced throughout the PWS.

Question: Please provide which USAMMDA Position Title, listed in Attachment 5 Level of Effort, is associated with each Key Personnel position.

See updated Attachment #5. Updated Attachment #5

22 W81XWH-17-R-0074-0001_Attch_5- Est_Level_of_Effort / W81XWH-17-R- 0074-0001_Conformed / Section C - Descriptions and Specifications Performance Work Statement (PWS)

Throughout the PWS, the Government references “team lead” positions.

Question: Will the Government please identify which Position Titles, listed in Attachment 5 Level of Effort, are associated with each of these “team lead” positions?

See updated Attachment #5. Updated Attachment #5

23 W81XWH-17-R-0074-0001_Attch_5- Est_Level_of_Effort / W81XWH-17-R- 0074-0001_Conformed / Section C - Descriptions and Specifications Performance Work Statement (PWS)

Question: Will the Government please provide the PWS Task associated with each of the positions listed in Attachment 5, Level of Effort?

See updated Attachment #5. Updated Attachment #5

24 General Is the subject opportunity set aside for Small Business with a threshold of $15M/500 employees?

No. None

25 RFP page 69 The table indicates that for Vol III, "Required Sections and Titles" includes "Past Performance Questionnaire." As the questionnaires are to be mailed directly to the POCs, please clarify what content should be in this section of the proposal.

The Point of Contact List for the past performance questionairres shall be provided in this section.

Reference Question/Answer No. 12.

The chart in RFP Section L.1. SUBMISSION is revised along with RFP Section L.3(c) for clarity.

26 RFP page 72, 3b Resumes/Letters of Intent for Key Personnel: This paragraph requires offerors to "provide an attachment naming the individuals proposed to fill Key Personnel positions..." By attachment, does the Government mean a table or discussion within the proposal, in the section entitled Resumes/Letters of Intent for Key Personnel"? If so, please verify that there is no page limit for this item.

This requirement has been revised. This list of individuals proposed to fill Key Personnel positions shall be included with the resumes and letters of intent, and is not subject to page count limitations.

Updated 3b. VOLUME II - Experience Volume (Resumes/Letters of Intent for Key Personnel)

27 RFP p. 73, 3c, Past Performance References

Required information includes the PCO, Government's technical rep/COR, and ACO. As not every contract has these individual POCs, may offerors provide as many as are available on a given contract?

While we will make every effort to ensure that POCs send the completed questionnaire to the Contracting Office by the proposal due date, please confirm that meeting this deadline is not a proposal requirement, as the POCs actions are not under our control.

Offerors are required to email a list of all POCs who were sent a questionnaire. Please confirm that this is a separate email, and is not part of the actual proposal volume submission.

If all requested items are not applicable to a particular past performance reference, Offerors may include only those items that do apply. // Receipt of past performance questionnaires is not a prerequisite for consideration for award;

however, failure to receive completed questionnaires may affect Offerors' past performance rating if sufficient information is not otherwise available as described in the RFP. // See response above.

RFP Section M.2(c) is revised.

28 RFP page 39 Section C of the RFP, paragraph 15, midway down page 39/84, states the work required under this contract has been determined by USAMRMC to be Category 1: Internal Support. However, in contrast, the USAMRMC OCI Certification Statement, Attachment 1, states (bottom of its first page) the work required under this contract has been determined by USAMRMC to be Category 2: Program and/or Administrative Support. What is the correct category? Please reconcile this difference. And, does the category stated in the OCI Certification affect any of the clauses or language of Attachment 1?

Level 1 is the correct category. This is consistent with the clauses and language of Attachment 1.

Corrected Attachment #1

29 Attachment 5 page 1 Since 9 positions indicate the percent of time contractors work on and off sites, can we assume that the remaining positions are on-site?

Yes, unless otherwise stated contractor place of performance is at the government site.

Updated Attachment #5

30 RFP page 9 In addition to USAMMDA, USAMMA, and other subordinate commands of the US Army Medical Research and Materiel Command (USAMRMC), will this ORA RFP provide support to Joint Project Manager (JPM) Medical Countermeasure Systems (MCS), and other DoD entities responsible for medical product research and development?

Yes, see PWS Section 2.0. None

31 RFP General Will USAMMDA and USAMMA continue to have separate Medical Device sections? The organizational structure of USAMMDA/USAMMA isn't relevent to this requirement as this requirement provides for regulatory support for all products where needed within USAMRMC.

None

32 RFP attachment 5 Page 1 Attachment 5 states that that the LOE is a Government estimate and strongly encourages Offerors to develop solution. Will the government be providing workload data and or projected workload data and/or volume of projected projects to further develop a solution?

This changes based on products being supported.

Specific workload data will be provided after contract award.

None

33 General What would be the volume expected for the scope of activities? Please share the forecasted volume break-up and it’s percentage.

This changes based on products being supported.

Specific workload data will be provided after contract award.

None

34 General Vendor assumes that resources need to undergo USAMMDA project specific trainings. Please let us know the number and duration of the training programs.

There are no project specific trainings. None

35 General Vendor assumes that the transition period will be for only 30 days, and full performance is expected from 01-Oct-2018. Kindly confirm.

See question 2. None

36 3a. Volume I As per 3a. Volume I, the transition in plan also include “Review, evaluation and transition of support services”. Please clarify the support services in scope with a detailed breakdown of activities.

See updated section L, 3a. VOLUME I – Management Approach. Specific activities will be identified during transition.

Updated Section L, 3a. VOLUME I – Management Approach

37 General Do all the resources mentioned in USMMDA Org Chart position title sheet have to be based in US or can some of them be based in other global locations.

These resources must be based in the United State Updated PWS Section 4.1.

38 General Are all the clinical trial sites located only in US or global locations. If global, kindly share the list of countries.

Sites are global and change based on products being supported.

None

39 RFP pages 4-6 of 84 / Section B – Supplies or Services and Prices

Travel/ODCs are listed as separate cost items in CLIN 0003, CLIN 1002, CLIN2002 and CLIN3002. Will the Government provide estimated plug-in amounts for the Travel/ODCs by

CLIN?

See question 10. See question 10.

40 RFP page 10 of 84 / PWS/C.2.0 – Background

Regarding the phrase, “The Medical DD and Regulatory Science Branches provide…” Would the Government please clarify if these are two distinct/separate branches under ORA, or if they are one in the same?

They are separate. See PWS Section 2.0. None

41 RFP page 11 of 84 / PWS/C.4.1 – Period and Place of Performance

Regarding lease space, are there any infrastructure and/or security requirements necessary for the contractor-provided, off-site office space? Will office space be charged directly to the contract?

Government laptops and VPN accounts must be used when working away from Government space.

Offerors must determine how to propose charging for office space, taking into consideration pre-approved accounting practices and any applicable limitation of FAR Part 31.

See updated PWS Section 4.1.

42 RFP page 13 of 84 / PWS/C.5.5 – Transition Support

Will the incoming transition overlap with the outgoing transition of the incumbent’s contract? Yes. See updated PWS Section 4.1.

43 RFP page 19 of 84 / PWS/C.6.1.3 – Safety Pharmacovigilance Support

Regarding the requirement, “The Contractor shall attend and present safety training to clinical sites, as required.” Safety training isn’t described in PWS/C.8 – Training Requirements. Would the Government please provide examples of safety training for clinical sites?

See updated PWS Section 6.1.3. Updated PWS Section 6.1.3

44 RFP page 19 of 84 / PWS/C.6.1.3 – Safety Pharmacovigilance Support

This section references a “safety database” and a “real-time safety database (Argus).” Would the Government please clarify if access to the safety database will be included in the transfer of software licenses during the incoming transition period?

Yes, the Government will be providing the contractor access to the databases through the government computers and network.

None

45 RFP page 29 of 84 / PWS/C.9.0 – Contractor Travel

Is there an estimated number of CONUS and OCONUS trips to be completed by the contractor?

This changes based on products being supported.

Plug numbers have been provided for Travel/ODCs.

ODC line items are revised to include plug numbers.

46 RFP page 39 of 84 / PWS/C.15.0 – OCI & Attachment 1 (OCI Certification)

Is this work considered Category 1 or 2? Section 15.0 of the PWS states that this work has been determined by USAMRMC to be Category 1, which contradicts with Attachment 1, which clearly states that this work has been determined by USAMRMC to be Category 2. Please clarify.

See question 28. See question 28.

47 RFP page 44 of 84 / Section F – Deliveries or Performance/8.

Deliverable/Delivery Schedule

This table states that the initial Outgoing Transition Plan (Deliverable 5) is due NLT 45 business DACA, which implies that the contractor will have to develop the outgoing transition plan, in part, during the incoming transition period. Would the Government please amend this requirement to either a) require the initial Deliverable 5 with proposal submission, or b) move the initial Deliverable 5 closer to the end of the contract term?

No. The due date for this deliverable will not be changed.

None

48 RFP page 49 of 84 / Section I – Contract Clauses

Clause 52.222-41: Service Contract Labor Standards is not included in the list of clauses incorporated by reference. Would the Government confirm that the Service Contract Act is not applicable to this contract?

The Government considers this contract exempt from the Service Contract Act / Service Contract Labor Standards.

None

49 RFP page 70 of 84 / L.1 – General Information/ Submission

The requirement states “The Submission will be mailed to…” Will the Government allow hand-delivery of proposals to Fort Detrick?

Yes, hand delivery is acceptable. Proposals shall be delivered to 839 Chandler Street, Fort Detrick, MD 21702. It is the Offeror's responsibility to ensure that proposals are received in all formats prior to the time established for proposal receipt.

Delivery instructions in RFP Section L.1.

SUBMISSION are revised.

50 RFP page 71 of 84 / L.1 – General Information/ File Packaging

With respect to electronic submission, would the Government please clarify if there is a file size threshold?

Email messages with attachments are limited to 20 MB. If necessary, it is acceptable for Offerors to break down proposal volumes and submit in multiple emails in order to comply with the size limit.

RFP Section L.1 Electronic Submission is revised to include email size limits and instructions.

51 RFP page 71 of 84 / L.3 – Proposal Content and Format Instructions

Will the Government accept/evaluate an introduction to Volume I in the form of an Executive Summary? If yes, would the Government please clarify if an Executive Summary would be subject to any page limitations?

An Executive Summary will not be accepted or evaluated.

None

52 RFP page 73 of 84 / L.3c – Volume III Past Performance and Small Business Volume/Past Performance References

The requirement states, “Offerors shall submit no more than three past performance references from Government and/or commercial contracts…” In addition to Government and commercial contracts, will the Government accept grants, cooperative research and development agreements (CRADA), and other transaction authority (OTA) as relevant past performance references?

No. The Government will consider Government and/or commercial contracts as relevant past performance references.

None

53 RFP page 73 of 84 / L.3c – Volume III Past Performance and Small Business Volume/Past Performance References & Attachment 3 – PPQ Form

The requirement states that past performance references should be “…awarded during the past three (3) years from the issue date of this RFP…” This conflicts with ‘Part II – Evaluation’ instructions on the PPQ Form (Attachment 3), which references “… the contractor’s record of past (within the past three years) and current performance…” In order to promote more competition, would the Government please revise the language in L.3c to align with the instructions provided in Attachment 3? More specifically, clarify that past performance references should be performed during the past three years, and not necessarily “awarded” during that timeframe.

Past performance references shall include performance within the last three (3) years.

RFP Section L - 3c is revised.

54 RFP page 75 of 84 / L.3e – Volume IV Administrative Volume/ Non-Disclosure Agreement with CACI

Per the guidance in the solicitation, we reached out to CACI for the NDA for review and signature. CACI directed us back to the Government. Would the Government please clarify how Offerors should proceed with fulfilling this requirement?

The Government is working with CACI to ensure NDA's will be signed prior to closing of the solicitation.

None

55 RFP page 75 of 84 / L.3f – Volume V Cost Proposal Volume

Will the Government allow subcontractor pricing data to be submitted directly to the Government, or provided as a sealed package? If so, will subcontractor pricing data be subject to the same cost proposal submission requirements for the Prime?

See Question 4 See Question 4

56 RFP page 76 of 84 / L.3f – Volume V Cost Proposal Volume

The RFP states that provisions for overtime and shift differential charges shall be clearly addressed on a per-hour basis. Would the Government provide more information about this?

(1) What positions are required to work overtime? (2) Are there work schedules that require shift differential? (3) What positions are required to work on a different shift?

The tasks requiring performance outside of normal business hours are described in PWS Sections

6.1.3 and 6.1.5.

None

57 RFP page 76 of 84 / L.3f – Volume V Cost Proposal Volume

The RFP states that letters of commitment shall clearly identify the prospective employees’ agreed-to salary/hourly rate and other pertinent conditions of employment. Would the Government clarify if the letters of commitment are only required for key personnel? Would the Government please clarify the difference between these letters of commitment and the letters of intent for Key Personnel referenced in RFP section L.3b (page 72 of 84)?

See Question 13 See Question 13

58 RFP page 76 of 84 / L.3f – Volume V Cost Proposal Volume

The RFP states that for proposal preparation purposes, the expected or approximate date for initiation of contract performance is September 1, 2018 for transition in with full performance beginning October 1, 2018. Would the Government confirm that the period of performance for Item No. 0001(RCT Support Services - Transition In) will cover a period of 30 days: September 1, 2018 to September 30, 2018 for transition in only and the period of performance for Item No.

0002 (RCT Support Service-Base Period) in Section B will cover a period of 11 months, excluding the 30-day transition-in period: October 1, 2018 –August 31, 2019?

See Question 2 See Question 2

59 RFP page 76 of 84 / L.3f – Volume V Cost Proposal Volume / Evidence of Adequate Accounting System

The RFP states that all Offerors are required to have an adequate accounting system to be eligible for award in accordance with FAR 16.3013(3). The adequacy of Offerors’ accounting systems will be determined using the Standard Form (SF) 1408 evaluation checklist. Offerors shall provide evidence of accounting system adequacy in the form of (a) Defense Contract Audit Agency (DCAA) cost accounting system audit report, (b) completed DCAA SF 1408, or

(c) independent third-party audit report of accounting system and methods within the past two

(2) years. Prior to award, a DCAA preaward survey may be requested to confirm accounting system adequacy. In order to meet this requirement, will the Government accept a DCAA Cost Accounting System Approval Letter issued by the USAMRAA as an evidence of Adequate Accounting system?

USAMRAA does not issue DCAA Cost Accounting System Approval Letters.

None

60 RFP page 76 of 84 / L.3f – Volume V Cost Proposal Volume / Evidence of Adequate Accounting System

The RFP states that all Offerors are required to have an adequate accounting system to be eligible for award in accordance with FAR 16.3013(3). Would the Government clarify if major subcontractors are required to have an approved account system, if the prime contractor proposes the major subcontractor at a cost relation (e.g., CPFF, Cost-Reimbursable)?

Yes, major subcontractors are required to have an adequate accounting system if the prime contractor proposes the major subcontractor at a cost relation.

Revised L.3f – Volume V Cost Proposal Volume / Evidence of Adequate Accounting System

61 RFP page 76 of 84 / L.3f – Volume V Cost Proposal Volume / Evidence of Adequate Accounting System

The RFP states the specific direct labor rates utilized to price the proposal must be identified in the cost proposal only. The proposal shall set forth a complete breakdown of the direct and indirect rates by category and the rationale thereof. Provisions for overtime and shift differential charges shall be clearly addressed on a per-hour basis. Letters of commitment shall clearly identify the prospective employees’ agreed-to salary/hourly rate and other pertinent conditions of employment. The same detailed support data shall be furnished for all major subcontractors (subcontractors proposed to perform 20% or more of the overall effort). If the Offeror proposes subcontractors at a non-cost relation (e.g., T&M or FFP), would the subcontractors be required to submit the breakdown of the direct and indirect rates as well?

See Question 4 See Question 4

62 RFP Attachment 5 Estimated Level of Effort

The Government provided the numbers of contractors for each labor category but not the FTEs.

Would the Government clarify if the number of contractors are the same as the number of FTEs?

Number of contractors is the same as number of FTEs.

None

63 RFP Attachment 5 Estimated Level of Effort

The Government provided time effort breakdown for Offsite and Onsite for 9 labor categories but not for all positions in the RFP. Would the Government clarify if those labor categories without offsite and onsite breakdown will work 100% onsite?

See updated Attachment #5. See updated Attachment #5.

64 RFP Attachment 5 Estimated Level of Effort

The Government estimated Manufacturing SME would work 50% of time Offsite but no time effort was provided for the Onsite work. Does the Government mean the Manufacturing SME will work part-time with 50% time effort off-site only?

See updated Attachment #5. See updated Attachment #5.

65 RFP Attachment 5 Estimated Level of Effort

Will the Government provide the labor category descriptions with minimum education and experience requirements?

The Government is not issuing educational or experience requirements for contractor personnel.

Offerors are expected to use their expertise to propose a staffing solution appropriate for the required tasks.

None

66 Solicitation, Section K, (c) (2), Page 62 “The following representations or certifications are applicable as indicated by the Contracting Officer [Contracting Officer check as appropriate.]

(i) 52.204-17, Ownership or Control of Offeror.

(ii) 52.204-20, Predecessor of Offeror.

(iii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products.

(iv) 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Certification.

(v) 52.222-52 Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Certification.

(vi) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered Material Content for EPA-Designated Products (Alternate I only).

(vii) 52.227-6, Royalty Information.

(A) Basic.

(B) Alternate I.

(viii) 52.227-15, Representation of Limited Rights Data and Restricted Computer Software.”

Question: Will the Government please clarify if the above FAR clauses apply to the RFP?

52.204-17 – APPLICABLE

52.204-20 – APPLICABLE

52.222-18 – NOT APPLICABLE

52.222-48 – NOT APPLICABLE

52.222-52 – NOT APPLICABLE

52.223-9 Alt 1 – NOT APPLICABLE 52.227-6 Basic or Alternate– NOT APPLICABLE

52.227-15 – NOT APPLICABLE

Clause 52.204-8 is revised to include check marks for the applicable clauses.

67 Solicitation, Attachment 5 Question: Will the Government please clarify that onsite support indicates the level of effort that contract staff work at the government site located on the Ft. Detrick campus and that offsite support indicates the level of effort contract staff work at the vendor’s office space.

In addition, please clarify what the level of effort is for offsite vs. onsite for position titles listed in the table that do not have a percentage (%) number indicated in the “Offsite” and “Onsite” columns

See updated attachment #5. See updated attachment #5.

68 Solicitation, Section 6.1.6.1 Clinical Monitoring Support

Question: Will the Government please clarify if the 21CFR Part 11compliant EDC system is government or contractor furnished as noted on page 22 of the solicitation (excerpt below). Will the Government please clarify the system names currently being utilized?

The Contractor shall conduct centralized monitoring activities for studies conducted using electronic data capture (EDC) systems by reviewing enrollment, adverse events, deviations, and other data to ensure stopping criteria has not been met, and to identify any safety or regulatory concerns between monitoring visits.

The EDC is a portion of this but is Government owned and is part 11 compliant.

None

69 Solicitation, 6.1.8.3 SAS Programmer Support Section

Question: Will the Government please clarify if the Statistical Analysis System (SAS) is government or contract furnished as noted on page 25 of the solicitation (excerpt below). Will the Government please clarify the system names currently being utilized?

The Contractor shall independently perform SAS programming and provide support for statistical analyses. The Contractor shall create SAS data files for statistical analyses, which may include importing data and converting data to SAS files. Integrate data within studies and across projects. The Contractor shall produce and implement SAS programs for standard and custom data listings, tables, and figures for inclusion in clinical study reports and FDA submissions. The Contractor shall test, document, review and validate all programs according to specified guidelines.

The systems are Government furnished and will be loaded on the Government laptops.

None

70 General The level of effort in the Request for Proposal (RFP) indicates approximately 46 Full Time Equivalents (FTEs). The previous RFP for this effort had approximately 27 FTEs. Will the government please indicate if there is a combination of multiple contracts to account for this increase in level of effort? If so, please identify the contract numbers for the contracts being combined.

This increase in the level of effort is not the result of a combination of multiple contracts.

None

71 General Will the government please clarify why the period of performance only consists of a one year base period, with two 6-month optional periods? This seems like a short period of performance to support such a large effort.

The period of performance reflects the Government's current requirement.

None

72 General For the off-site facility required for a limited number of FTEs, is there a proximity requirement for this facility to USAMMDA/Fort Detrick?

See Question 1 See Question 1

73 General The RFP in Section 15.0 states the work required under this contract has been determined to be an OCI Category 1: Internal Support effort, while the Attachment 1: OCI Certification states this work is under Category 2: Program and/or Administrative Support. Will the government please clarify which is the correct category?

See Question 28 See Question 28

74 General Will the government please consider changing the NAICS Code from 541990 to 541713/541714 since the PWS is inherently tied to research and development projects?

No. 541990 is the appropriate NAICS code for this requirement.

None

75 Section L, Volume V of the RFP 6. Under Section L, Volume V of the RFP it states the Offeror shall submit a complete breakdown of costs for all subcontractors proposed. In order to protect the subcontractor’s proprietary cost data, may each Subcontractor submit their Volume V Supporting Cost information (salary costs, overhead, fringe, profit) under separate cover, via e-mail, directly to the Government POCs identified in Section L?

See Question 4. This information may be submitted under separate cover, via e-mail, directly to the Government POCs identified in Section L.

See Question 4

76 Section 3c. Volume III on page 73 Regarding the instruction in section 3c. Volume III on page 73 related to Past Performance References, please confirm that Government will accept up to 3 past performance references for contracts awarded or performed during the past three (3) years? The current language appears to limit this to contracts “awarded” during the past 3 years. We assume contracts currently in performance or very recently performed will also be eligible for use in the past performance section.

Past performance references shall include performance within the last three (3) years.

RFP Section L - 3c is revised.

77 Section 15.0 Organizational Conflict of Interest, instructions on page 39

Regarding Section 15.0 Organizational Conflict of Interest, the instructions on page 39 require offerors to “perform a comparative analysis of the potential new work against all current and previous work performed in support of USAMRMC in any other category ….” Please confirm whether it is acceptable to limit the analysis of “previous work performed” to contracts that finished during the last 3 years? If not, please confirm what period is required for analyzing previous work (e.g., we assume work performed 10 or 20 years ago would not be relevant).

There is no limit on the timeframe for work that should be analyzed for potential conflicts of interest.

None

78 Section 5.9 Contractor Personnel Performance/Replacement

Regarding Section 5.9 Contractor Personnel Performance/Replacement – The instructions related to Key Personnel indicate that “Any substitution or replacement Key Personnel shall have qualifications equal to or greater than the individuals proposed.” As this is not a personal services contract, we believe the appropriate standard for replacing Key Personnel should be that the proposed replacement personnel are appropriately qualified to perform the job and not that they must have qualifications equal to or greater than the individual originally performing the work. If the standard is based on the qualifications of the proposed (original) individual (rather than the qualifications to perform the job), there may be instances where the initial Key person has, for example, 30+ years’ experience and it is nearly impossible to find a replacement with at least those qualifications; but the contractor will be able to find a replacement who is qualified to perform the job even though they may have fewer years of experience. Please confirm that the replacement of Key Personnel should be tied to the capability to perform the job and not simply to the qualifications of the specific predecessor employee?

PWS Section 5.9 has been revised. Revised PWS Section 5.9

79 Attachment 5 Estimated Level of Effort Is it the Government’s estimate that the total proposed labor (fte’s) required for this opportunity is the # of contractors column of this attachment (46 fte’s) or is it the on-site and off-site total fte’s (8.5)

See updated Attachment #5. See updated Attachment #5.

80 Attachment 5 Estimated Level of Effort If it is the full 46 ftes – is it up to the offeror to determine on-site or off-site status for those positions that are not denoted in the attachment

See updated Attachment #5. See updated Attachment #5.

81 4.1 Period and Place of Performance Will the Government please confirm the period of performance is intended to be a one-year base period and two six-month option periods? Given the scope of work and historical contract duration please confirm the options are six months.

This is correct. None

82 5.9 Contractor Personnel Performance/Replacement

Will the Government please provide Key Personnel requirements for the following positions:

5.1 Contractor Task Manager

6.1.5 Pharmacovigilance Physician (PVP)

6.1.8.2.1 NPH PMO Biostatistics Support

See Section L 3b. Volume II and Section M 2b.

Experience

None

83 6.1.2.3 Submissions Support

6.1.3 Safety Pharmacovigilance Support

Section 6.1.2.3 states the contractor shall monitor a central email inbox (USARMY Ft Detrick MEDCOM USAMMDA Mailbox) and section 6.1.3 indicates the contractor shall assist in monitoring the safety mailbox 7 days a week. Will the Government please confirm the mailbox the contractor will be responsible for monitoring is the referenced central email inbox (USARMY Ft Detrick MEDCOM USAMMDA Mailbox)?

There is a separate mailbox for Safety Reporting and also for submissions that will be provided upon contract award.

None

84 15.0 Organizational Conflict of Interest

(OCI)

6.0 Specific Tasks

6.1.1 Regulatory Science Support

Section 6.0 states the contractor may be required to support and participate in the development of contracting strategies and associated documents in support of specific products and Section

6.1.1 states support includes providing guidance to IPTs for development of contract documents and statement of works for the development of medical devices, drugs, or biologic products. Will the Government please confirm that contractor support classified as OCI Category 1 is limited in nature to contracting materials for development of medical devices, drugs, or biologic products and does not include other procurement activities (e.g., analysis of said products, milestone development review-related activities)?

See updated PWS Section 6.0. Updated PWS Section 6.0

85 15.0 Organizational Conflict of Interest

(OCI)

Will the Government please confirm that the OCI level for the current opportunity should be Category 1 (indicating command-level procurements) rather than Category 2 (indicating directorate and/or subordinate-level procurements)?

See Question 28 See Question 28

86 3b. Volume II – Experience Volume Will the Government please indicate if subcontractors shall submit signed letters of intent for proposed Key Personnel following the same submission guidelines as indicated for Prime vendors (i.e., 2 CDs/ 7 hard copy/ 1 email attachment)?

Signed letters of intent are required for all individuals proposed as Key Personnel who are not current employees of the Offeror’s company.

The Government intends for all letters of intent to be submitted by the Prime contractor with its proposal in accordance with proposal submission instructions.

None

87 3e. Volume IV – Administrative Volume Will the Government please clarify if subcontracts shall sign NDAs with CACI as part of subcontractor sealed, unsanitized packages.

No, this is not required. None

88 3f. Volume V Will the Government please indicate if subcontractors shall submit sealed unsanitized packages following the same submission guidelines as indicated for Prime vendors (i.e., 2 CD/ 2 hard copy/ 1 email attachment)?

See Questions 4 and 75 See Questions 4 and 75

89 Attachment 5 Estimated Level of Effort – for the positions listed without offsite/onsite designation, is this at the contractor’s discretion (with the understanding that ad hoc/intermittent travel onsite at Ft Detrick, WRAIR, etc. for IPTs, training, meetings, etc. may be required for many of the positions)? Can you clarify/confirm what the “Y” represent within the Offsite column cells?

See updated Attachment #5. See updated Attachment #5.

90 5.0 ORGANIZATIONAL CONFLICT OF

INTEREST (OCI) and Attachment 1, OCI Certification / page 39, Att 1 pg 1

Please clarify the OCI Category classification - on page 39 it is listed as OCI Category 1 and on the first page of Attachment 1, it states OCI Category 2.

See Question 28 See Question 28

91 3.0 PROPOSAL CONTENT AND

FORMAT INSTRUCTIONS / page 71

Please confirm that there is no requirement for a Technical Approach section/volume in the response.

This is correct. None

92 4.0 GENERAL INFORMATION

Attachment 5, Estimated Level of Effort / page 11, Att 5 LOE

Can the Gov please clarify the work location (onsite / offsite) of the 19 un-designated positions in Attachment 5?

See updated Attachment #5. See updated Attachment #5.

93 5.0 PERFORMANCE OBJECTIVES AND

STANDARDS / subsection 5.9 Contractor Personnel Performance/Replacement /

Is there a requirement for CRAs or other staff to speak a foreign language due to the location of a clinical site?

No None

94 6.0 SPECIFIC TASKS / 6.1.2.2

Document Control Support / page 17

Is the contractor required to create and maintain the computer archive and database in an existing system or expected to provide their own system for this purpose?

This will be done within the provided Government laptops and network.

None

95 6.0 SPECIFIC TASKS / 6.1.5

Pharmacovigilance Physician (PVP) Support / page 20

Given that the Gov is requiring the PVP to be available 7 days a week in the event of an emergency, is it expected that we staff this position 24/7 and compensate for availability?

Offerors are expected to address staffing requirements for this task within their non-cost proposals.

None

96 6.0 SPECIFIC TASKS / 6.1.6.1 Clinical Monitoring Support / page 21

For cost estimation purposes, please provide assumptions we should use when determining the appropriate number of monitoring visits, e.g., # site locations CONUS vs OCONUS, average number of visits per month/year or will the government consider providing a Plug Number for all contract-related travel?

See Question 10 See Question 10.

97 5.0 PERFORMANCE OBJECTIVES AND

STANDARDS and Attachment 5, Estimated Level of Effort / 5.1 Task Management / page 12, Attachment 5

LOE

The Contract Task Manager is listed…