Q_and_A_Sentinel_2019__2.docx

SENTINEL PRE-BID SOLICITATION FORUM Part II of II

POST EVENT QUESTION/ANSWER BY INDUSTRY TO FDA

As of: 17 April 2019

Key:

Question1:

Reference RFP Section H4.3.C (Database), which reads, in part, as follows: “The contractor shall retain the above information, where applicable, for any subcontractors or consultants performing work under the contract. The COI Plan shall require that new work received by the company during the contracting period be promptly added to the database and evaluated for COI”.

Can you please confirm that it is acceptable for the Contractor to require its subcontractors and consultants to maintain their own databases and, as needed, to periodically certify to the Contractor their compliance with FDA’s OCI/COI requirements?

Response:

The prime contractor may require its subcontractors and consultants to maintain their own databases and periodically certify to the prime contractor their compliance with FDA’s conflict of interest requirements. However, it is the responsibility of the prime contractor to manage and oversee its subcontractors and consultants.

Question 2:

Reference RFP Section H4.3.B (Searching and Identifying COI) and C (Database), which sets forth the parameters for the database and related COI searches.

Like many companies, our firm bids on and performs a wide range of services for various Government and commercial clients. A significant portion of our past, current, and future work has or will have no relevance to the work that will be performed under the Sentinel contract.

Can you please confirm that it is acceptable to limit our database searches to only the work that is related to the work performed under the Sentinel contract?

Response:

It is acceptable to limit your search to only the work that is related to the work performed under the Sentinel contract. FDA defines Sentinel-related work as pertaining to epidemiology, real-world evidence, real-world data, and all activities pertaining to the pharmaceutical industry (paid or voluntary) or FDA-regulated medical products.

Question 3:

Can a company be included as a subcontractor on multiple proposals with different organizations bidding as prime?

Response:

Yes, the same company can be a subcontractor for different prime contractor proposals.

Question 4:

Can a company be included as a subcontractor on a later task order if not the company was not originally listed on a prime contractor’s IDIQ team?

Response:

Yes, a company can be included as a subcontractor on a later task even if the company was not initially listed on a prime contractor’s IDIQ team. However, any such change shall be reviewed and approved by FDA.

Question 5:

Section_C_Sentinel_Base_IDIQ C7. Task Area 3, page 7 Is the written Accessibility Conformance Report (ACR) required as part of this proposal submission?

Response:

Yes. Completing the ACR is a required part of the proposal submission.

Question 6:

Section_C_Sentinel_Base_IDIQ C7. Task Area 3, page 7 Is the Accessibility Conformance Report (ACR) excluded from page count?

Response:

Yes, the ACR can be excluded from the page count.

Question 7:

Section_C_Sentinel_Base_IDIQ C4. IDIQ Scope of Work, page 5 Contractors who are awarded any individual IDIQ shall collaborate, as necessary, to achieve the overall scientific, training, outreach and communication objectives described in the task orders."

Response:

See Q8 response.

Question 8:

Can the government confirm that all of the parties that the contractor will be required to share information with will have signed the required FDA NDAs that are included in this proposal?"

Response:

Yes, all contractors working on the Sentinel contract will sign FDA non-disclosure agreements.

Question 9:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ H2.1 Section 508 Compliance, page 16 This section references a DME Technical Scenario.

Can the Government clarify what the DME technical scenario is?

Response:

The Offeror shall submit a written Accessibility Conformance Report (ACR) which is complete and includes a detailed explanation of the Offeror’s capabilities and understanding of accessibility testing and customization to conform with the above Section 508 standards. FDA will revise the text to remove reference to the DME Technical Scenario.

Question 10:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ H4.3.C Database, page 29 Must Offerors include the project history for all subcontractors and consultants in the database submitted as part of their proposal?

Response:

Yes, this project history is not included in the page count.

Question 11:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ H4.3.C Database, page 29 Is the database excluded from the page count?

Response:

Appendix and it will not be towards page count.

Question 12:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ H4.3.C Database, page 30 Can the Government confirm that the database should include contracts or in progress proposals with the FDA?

Response:

Yes

Question 13:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ H4.3 Submittal of Conflict of Interest Plan and Answer to Question 79 In order to address all of the areas required for the OCI Mitigation Plan, the plan could be fifteen (15) or more pages not including the required database. The Technical Volume has a page limit of 30 pages. Will the government reconsider allowing the OCI Mitigation Plan as an attachment to the Technical Volume?

Response:

Appendix just like the COI.

Question 14:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ Attachment 3 - FDA Non-Disclosure Forms Is Attachment 3 excluded from the page count?

Response:

Attachments can be provided as an appendix and not included in the page count.

Question 15:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ L2. Proposal Preparation Instructions, page 49 Are the following items excluded from page count: Table of Contents, cover page, transmittal letter?

Response:

No.

Question 16:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ L2. Proposal Preparation Instructions, page 49 Will the Government allow a font size of no smaller than 10 for matrices, charts, and other graphics?

Response:

The Offeror is required to a proposal that are clear and legible. If something is unreadable to the government, this could negatively impact the offeror’s evaluation.

Question 17:

Attachment_6_Revised_TO__1 What is the anticipated contract type for Task Order 1?

Response:

To be determined. It could be firm fixed price, time and materials, labor hour or a hybrid of contract types.

Question 18:

Attachment_7_TO__2 What is the anticipated contract type for Task Order 2?

Response:

To be determined. It could be firm fixed price, time and materials, labor hour or a hybrid of contract types.

Question 19:

Attachment_8_TO__3 What is the anticipated contract type for Task Order 3?

Response:

To be determined. It could be firm fixed price, time and materials, labor hour or a hybrid of contract types.

Question 20:

Attachment_9_Revised_Sentinel_Pricing_Matrix Tabs are protected and unable to copy formulas in "Total Price" column when inserting new rows for additional LCATs. Can the Government provide an unprotected pricing file?

Response:

The Government will provide an unprotected pricing matrix.

Question 21:

Attachment_9_Revised_Sentinel_Pricing_Matrix Can the Government confirm that Offerors may propose additional key personnel per task order?

Response:

Yes, Offerors may propose additional key personnel.

Question 22:

sf33_Sentinel_2019 Will the Government send an updated SF33 to include the correct due date?

Response:

Question 23:

Section G7, Pages 12 & 13, versus Attachment 9 (Revised Sentinel Pricing Matrix) - TO#2 Labor-ODC Section G7 lists 5 key personnel as required for the IDIQ submittal. Attachment 9 lists those 5 key personnel only for TO#1, and seemingly requires only a Project Manager for TO#2. We assume that for Task Order 2, key personnel beyond the minimum required, a Project Manager, will be defined by the bidder.

Section L, Page 49, Instructions, Conditions, and Notices to Offerors or Respondents (Section 2, Page 52, Past Performance Information)

Response:

The key personnel are listed in Section B-M Base Contract IDIQ, Section G7. This section lists 5 key personnel for all activities within the IDIQ.

Question 24:

Based on the instructions in Section L, offers will only submit Past Performance Questionnaires. This form does not address, in any depth, the scope of work for the submitted contracts. How does the government intend to determine if the proposed past performance is of similar scope to Sentinel?

Response:

See Section M Factor 4. PPQ should reflect the size, scope and complexity of the effort that is being evaluated (see statement of work). Therefore, if you are submitting PPQ for the overarching IDIQ, the PPQ should reflect all aspects of that SOW.

Question 25:

The government has not provided information in the solicitation on the dollar value of Task Order #2. What dollar amount should bidders consider when selecting past performance references?

Response:

FDA doesn’t provide that information in the solicitation; there is no dollar amount bidders should consider when selecting past performance. The Offerors should refer to the SOW for size and scope.

Question 26:

Section L2, Page 49, Proposal Preparation Instructions versus Question 29 Section L2 states “The use of matrices, charts or other graphic, on non-standard size sheet of paper, are accepted and encouraged and are not included in the page count.” But Question 29 states that matrices, charts or other graphics “can be included as an appendix, however, they will count toward the total page count”. These statements are conflicting How does the Government define a non-standard size sheet of paper?

Response:

The offeror must submit the technical proposal on standard 8 x 11.5 size paper. Only charts and graphs may be included on non-standards size paper.

Question 27:

Does a non-standard size sheet of paper count as only one page?

Response:

Yes. All pages count as one page and equal.

Question 28:

Section L3, Page 50, VOLUME I - IDIQ Contract Technical Proposal 1. The Offeror shall submit a written, comprehensive and executable narrative demonstrating that it possesses a full understanding of the Sentinel Initiative scientific program requirements detailed in the IDIQ Statement of Work (SOW) and the ability to execute all tasks and sub-tasks as identified. The offeror must clearly demonstrate the ability to meet the required areas of the Statement of Work

a. Executive Leadership Team (Functional Area C5.1.1)

b. Operation Center (OC) (Functional Area C5.1)

c. Innovation Center (IC) (Functional Area C6)

d. Community Building and Outreach Center (CBOC) (Functional Area C7)

e. 508 compliance

f. Conflict of Interest Plan Please clarify that in addressing these requirements in the SOW bidder must address the Task (Functional area) and all subtasks. For example, Item ( c ) identifies Innovation Center (IC) C6. Are bidders required to address C6 and all subtasks in C6?

Response:

Yes, the Contractor shall address all subtasks in C6 including C6.1, C6.2, C6.3, C6.4, and C6.5.

Question 29:

Please clarify the distinction between item (b), C.5.1, and item (a) C.5.1.1. Does the response to item (b) require bidders to address C.5.1.1 and C.5.1.2?

Response:

The contractor shall submit a response to ALL requirements detailed in the IDIQ Statement of Work (SOW), including all tasks and sub-tasks. FDA will amend the instructions in Section L3 to restate that contractors shall respond to ALL tasks and subtasks in the Operations Center Section C (not just Sections C5.1 and C5.1.1). However, as stated at the bottom of Section L3, “Offerors do not need to meet the minimum mandatory requirements for Task Order 1 to be eligible for an IDIQ award.”

Question 30:

Section L12, Page 55, Subcontracting Plan, versus Section L2, Page 49, Proposal Preparation Instructions Section L12 states that The Offeror shall complete attached subcontracting plan (Attachment 4). However in L2, the Subcontracting Plan has been crossed out.

Response:

Corrected in Amendment 1

Question 31:

Would the Government clarify if the Subcontracting Plan is excluded from page count in Volumes I – IX and can be provided as an Appendix to the Offerors IDIQ Technical Proposal?

Response:

Yes

Question 32:

Section M.1, Page 57, Basis for Award This section states that “Technical, past performance and key personnel are significantly more important than the price in determining the successful Offeror. However, among equally rated technical, past performance and key personnel, price may become the determining factor”.

Would the Government please provide a relative weighting among non-cost factors.

Response:

All non-priced factors are equal. Refer to Section M.

Question 33:

M.3, Page 58, Evaluation Criteria, VOLUME I. IDIQ Contract Technical Proposal, Item (1) IDIQ Evaluation Criteria states:

“The Government will evaluate the extent to which the Offeror’s proposal:

1. Demonstrates its understanding of the requirements and its overall technical approach to satisfying the requirements for each functional area in the SOW. ………..”

Would the government please clarify what is meant by the term “functional area” in Section M.3? This term is not found in the IDIQ SOW, Section C.

Response:

Also see related response to Q29. Reference is also made to “L.2 Proposal Preparation Instructions” and to the slides presented on March 11, 2019 at the public Pre-Proposal Conference.

This question pertains to the sentence in Section M3, Volume I, IDIQ Contract Technical Proposal that states, “Demonstrates its understanding of the requirements and its overall technical approach to satisfying the requirements for each functional area in the SOW.” The “functional areas” described in this sentence are Task Area 1 (OC), Task Area 2 (IC) and Task Area 3 (CBOC) that are described in Section C, IDIQ Base Contract Statement of Work. As stated in the response to Q29, the contractor shall submit a response to ALL requirements detailed in the IDIQ Statement of Work (SOW), including all tasks and sub-tasks.

Recall that the RFP is divided into two distinct stages. Phase 1 is the IDIQ evaluation stage and Phase 2 is the Task Order evaluation stage. Contractors must be awarded an IDIQ in order to be considered for a task order. In the table below, Volumes I and II are related to the IDIQ evaluation stage. Volumes III – IX are related to the task order evaluation stage.

Question 34:

Section M3, Page 59, Evaluation Criteria, VOLUME II. IDIQ Contract Price Proposal versus Attachment 9, Revised Sentinel Pricing Matrix The price evaluation for Vol II IDIQ Contract Price Proposal includes the statement “The price evaluation consists of the combination of all proposed pricing over the contract’s performance period including the sample pricing matrix.” However, Attachment 9 only contains a Labor Category Pricing tab with labor rates, and no hours, without a defined sample pricing matrix.

Would the government please clarify that the IDIQ price proposal evaluation consists of a labor rate analysis only? If so, would the government clarify that there will be a price realism component and a risk evaluation to discredit unreasonably low proposed rates?

Response:

The Labor Category Pricing tab is just that – the labor rate that is being charged by the contractor. The other tabs for TO#1 Labor, TO#2 Labor and TO#3 Labor all have the rates and hours required to complete that task. The price evaluation consists of the combination of all proposed pricing over the contract’s performance period including the sample pricing matrix. The labor rates are determined to be fair and reasonable.

Question 35:

Section M4, Page 63, Subcontracting Plan, versus Section M3, Pages 58-63, Evaluation Criteria Section M4 includes details for the Subcontracting Plan, but it is not specifically part of M3 Evaluation Criteria Would the Government clarify if the Subcontracting Plan is evaluated as pass/fail, and where it falls in order relative to technical, past performance, key personnel, and price?

Response:

Subcontracting plan is a separate evaluation factor from the other factors

Question 36:

Attachment_9_Revised_Sentinel_Pricing_Matrix.xlsx Update worksheet When trying to insert rows we are unable to adjust the sum columns because everything in the spreadsheet is unprotected. Errors were found that we need to adjust. For example on the TO #1 tab: Cells E43-45 are not calculating properly and the totals are pointing to the wrong cells. Also, when inserting rows the total columns are not capturing the additional rows.

Recommend unprotecting the worksheet so that we can fix/revise errors and add in rows as necessary.

Response:

The Government will provide an updated and unprotected pricing matrix.

Question 37:

Attachment _9_Revised Sentinel Pricing Matrix, Tab TO#2 Labor -ODC The referenced pricing template provides bidders an input for entering labor hours and labor rates for Task 4.1 Natural Language Processing (NLP) of unstructured data Attachment 7 TO 2, Section 4 Master Plan for Integration of innovative Technologies, defines a deliverable Master Plan. This section and sub-sections that follow define the content of the Master Plan and timeframe (12-18 months) for delivery. It is our understanding that projects defined in the plan will be funded via work orders after the plan is approved by the FDA.

Why does the pricing matrix provide cells to input pricing for sub-section 4.1, but does not provide for pricing the development of the Master Plan?

Response:

The intent was only to remove sections from the Pricing Matrix that were related to future projects that would be funded using Work Orders, not for the development of the Master Plan itself. Costs related to development of the Master Plan should be included in the pricing matrix.

Question 38:

See also the response provided in the Q&A for Question 4 (blue) “Offerors shall submit pricing for only the specific deliverables in the scope of work. For example, Section 4.1 to 4.7 describe potential areas of innovation but do not have a specific deliverable and therefore do not require a price proposal.”

Please amend the TO 2 tab of the pricing matrix to allow for bidder’s to provide a price for developing the Master Plan.

Response:

The intent was only to remove sections from the Pricing Matrix that were related to future projects that would be funded using Work Orders, not for the development of the Master Plan itself. Costs related to development of the Master Plan should be included in the pricing matrix.

Question 39:

Attachment 12, HHS FAR Class Deviation 18-01 Whistleblower Protection for Contractor Employees Attachment 12 is referenced in the Section B_M document but is not provided.

Please provide Attachment 12 for Offeror’s review.

Response:

Deviation will be posted in FBO.gov with Q and A.

Question 40:

(Section M, Past Performance, Page 59) Section M states: “Past Performance information regarding predecessor companies, key personnel who have relevant experience, and subcontractors that will perform major or critical aspects of the requirement may be provided as past performance submissions, key personnel who have relevant experience, and subcontractors that will perform major or critical aspects of the requirement may be provided as past performance submissions.”

Will the government allow for the prime to submit a past performance reference submission from a subcontractor partner where the subcontractor performed referenceable work as a prime contractor?

Response:

Yes.

Question 41:

(Attachment 8, Page 4) Is there a community outreach Master Plan, or similar document, for the Sentinel Program? If yes, will the government please provide the document or documents?

Response:

There is no current community outreach Master Plan. This is one of the deliverables for Task Order 3. However, the overarching goals are expressed in the Sentinel 5 Year Strategy document available here:

https://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM629243.pdf

Question 42:

Does the government plan to continue, under separate contract, the existing Sentinel program and associated functionality current supported by Harvard Pilgrim?

Response:

The current 5-year Sentinel IDIQ base contract with Harvard Pilgrim expires at the end of this fiscal year. The current RFP under open competition is for the next 5-year Sentinel contract.

Question 43:

Is the current Sentinel Contractor precluded from competing for the subject IDIQ and associated Tasks? If no, can the government please articulate how evaluations will be conducted to ensure fair evaluation for factors such as price and technical approach given the significant economies and established infrastructure already in place since the inception of the Sentinel program?

Response:

This is a full and open competitive award. As a result, no vendor, including the incumbent, is precluded from competing to the work. FDA intends to evaluate all proposal responses according to the evaluation criteria expressed in Section M. Additionally, FDA carefully selected and included background material as well as communicated and collaborated with industry vendors on multiple occasions to ensure that all potential vendors are on a level playing field in regard to the requirement, the objectives and the background of Sentinel.

Question 44:

Can the government please clarify the names and labor category descriptions for the IDIQ and each specific Task Order?

Response:

The pricing matrix contains a list of labor categories that shall be used throughout the IDIQ and all task orders. Offerors may add new labor categories to this list according to the needs of their proposal.

Question 45:

Page 10, Section_C_Sentinel_Base_IDIQ, Subsection C17. Data Rights This RFP file states “The Offeror shall provide as required by FAR clause 52.227-14 Data in Rights – General, Alternative IV a descriptive list of the data that is considered proprietary, confidential, of commercial value and/or trade secret information.

Is this list to be provided after contract award or with the offeror’s proposal? If the latter, can this list be provided as an appendix to Volume 1 IDIQ Contract Technical Proposal?

Response:

After contract award.

Question 46:

Page 49, Amendment_1_Section_B-M_Sentinel_Base_IDIQ, Subsection L.2 Proposal Preparation Instructions This RFP file states “The use of matrices, charts or other graphic, on non-standard size sheet of paper, are accepted and encouraged and are not included in the page count.”

If an offeror includes, within the body of a proposal volume, a page sized 11x17, would that page be included in the volume’s page count?

Response:

See previous answer considering page size and count.

Question 47:

Page 51, Amendment_1_Section_B-M_Sentinel_Base_IDIQ, Subsection 3. Key Personnel This RFP file states “The offeror shall include resumes (not more than two pages) for everyone identified as key personnel along with letters of commitment.

Are Letters of Commitment required only for key personnel who are not currently full-time employees of the offeror, or are they required for every key personnel regardless of employment status?

Response:

Letters of Commitment are required for all key personnel regardless of employment status.

Question 48:

Pages 13, 30, and 45, Q_and_A_Sentinel_2019_26_March_2019 The government’s response to Question 92 appears to contradict the government’s responses to Question 36 and Question 41, which state that “attachment 2 can be provided as an appendix and not included in the page count.”

Please confirm that attachment 2 can be provided as an appendix and will not be included in the page count.

Response:

Yes.

Question 49:

Please confirm that attachment 2 can be provided as an appendix and will not be included in the page count.

Response:

Question 50:

Does the acronym “OC” stand for Operations Center, Operation Center, or Operating Center? It is spelled out differently in various places.

Response:

OC stands for Operating Center

Question 51:

The VPAT, as stated in the VPAT2.2 template is “used to document a PRODUCT’S conformance with accessibility standards and guidelines.”

Please confirm that an ACR is ONLY required if products are being offered as part of this solicitation and if a plan is required, please confirm it will not be part of the page count for Volume I.

Response:

Answer pending at a later time.

Question 52:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ (page 2, 43, and 78) Attachment 12- HHS FAR Class Deviation 18-01 Whistleblower Protection for Contractor Employees The government has made several references to Attachment 12 throughout the SOW though it was missing from the files already provided. Please provide Attachment 12.

Response:

Deviation will be posted in FBO.gov with Q and A

Question 53:

Amendment_1_Sentinel_Base_IDIQ_Attachment 2 Resource Data Table (page 73) Attachment 2 Resource Data Table Please confirm that the completion of Attachment 2 is ONLY related to Task Order 1.

Response:

Attachment 2 is only related to TO#1.

Question 54:

Attachment_9_Sentinel_Pricing_Matrix (Labor Category Pricing Tab) Education/Years of Experience column referencing “M.A., Ph.D.

Please confirm that the education requirements are referring to either a Master of Arts (M.A.) OR a Ph.D. as a minimum educational requirement for the listed labor category.

Also, please confirm that an equivalent degree to an MA, such as MS or MBA, meet the governments intended requirement.

Response:

When two degrees are specified, such as “MA, PhD”, either degree will suffice for this labor category. However, many labor categories have multiple tiers denoted as I, II, III. Higher compensated categories are associated with more educational credentials or relevant experience. The Government will accept equivalent degrees such as MS or MBA.

Question 55:

Amendment_1_Sentinel_Base_IDIQ F.1 Period of Performance (page 8) The period of performance shall be five years, starting from the actual date of award.

Question: For pricing purposes, please provide an anticipated begin date for the IDIQ and Task Orders.

Response:

The begin date for the IDIQ and Task Orders will be sometime in September 2019.

Question 56:

Amendment_1_Sentinel_Base_IDIQ Volume VII Evaluation Criteria (page 62) The price proposal shall represent the Offeror’s response to the requirements of Task Order #1. Please confirm the evaluation criteria for Volume VII pertains to Task Order 2, not Task Order 1.

Response:

Volume VII is for Task Order 2 Innovation Center Task Order Price Proposal.

Question 57:

L12 SUBCONTRACTING PLAN (page 55) Attachment 4 - HHS SUBCONTRACTING PLAN TEMPLATE (page 2) L4 VOLUME II. IDIQ Contract Price Proposal (page 51) Given that Attachment requests dollar amounts related to goals, please confirm (and revise the RFP instructions accordingly) that Attachment 4 should be included in the Offeror’s IDIQ Contract Price Proposal, Answer: Subcontracting Plan is a separate document and is not apart of the Price Proposal.

Response:

Subcontracting Plan is a separate document and is not apart of the Price Proposal.

Question 58:

All documents and Q and A 2019 26 March 2019 In the recent Q and A responses dated 26 March, there were a number of answers to questions that require a change to the language that are not reflected in the final solicitation. For those instances, should offerors assume that the Q and A responses take precedence or will the government be updating the solicitation through an amendment? For example, program question 43 states that pricing should not be provided as part of Task Order 2 Section 6; however, there has been no amendment to this Task Order's SOW to remove the request for pricing estimates.

Response:

An amendment will be posted for Section B-M Sentinel Base IDIQ and an Amendment for Attachment 7, Task Order #2.

Question 59:

Can the government clarify that this attachment is not required as part of the proposal submission?

Response:

Correct. The NDA shall be submitted to the CO and/or COR prior to performing any work.

Question 60:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ (Page 13 Section G7) The contractor shall provide the names and qualifications of the key personnel assigned to this contract. The individuals cited below are key personnel.

Can the government clarify the list of key personnel that are referenced in this section and how they relate to offerors that may not be pursuing all three task orders (e.g., offerors only pursuing the Innovation Center)?

Response:

Per the instructions in the solicitation, the government is requiring key personnel at the IDIQ level as well as key personnel at the task order level.

Question 61:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ (Page 49 Section L2) Can the government confirm that cover page and table of contents are not included in the page count restrictions?

Response:

Cover page and table of contents are included in the page count.

Question 62:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ (Page 51 Section L3 Section 3) The offeror shall provide a narrative for all the key personnel working on this contract.

Can the government clarify the evaluation of key personnel for the IDIQ given that there are no resources specific to the IDIQ and the offeror may not be responding to all Task Orders?

Response:

See above answer.

Question 63:

Attachment 9 Revised Sentinel Pricing Matrix (TO#2 Labor-ODC) For the Innovation Center pricing, can the government clarify that the pricing associated with Task 2: Master Plan for Integration of Innovative Technologies should be allocated under SOW 4 (row 25) as opposed to SOW 4.1 (row 26) and that 4.1 is an unfunded requirement?

Response:

Section 4 represents the Master Plan and is a funded deliverable. In contrast, Sections 4.1 – 4.7 are descriptions of the types of potential projects that are within scope. For this reason, Sections 4.1 – 4.7 are not funded.

Question 64:

Attachment 9 Revised Sentinel Pricing Matrix (TO#2 Labor-ODC) In order to ensure a consistent set of requirements for offerors to price, can the government provide additional specificity for SOW 5 Task 3: Innovation Projects and IC Collaboration Activities given that there is a not a fixed deliverable, but rather a range of deliverables (1 to 3 per year) for which the scope of each project has not yet been determined?

Response:

In Section 6, Task Order #2, FDA has provided 2 sample innovation projects to illustrate the type of work that would be conducted under this Innovation Center task order. On average, FDA anticipates issuing 1-3 of these types of activities using Work Orders in a given year. However, FDA reserves the right to issue fewer or more projects to meet its needs.

Question 65:

Attachment 9 Revised Sentinel Pricing Matrix (TO#2 Labor-ODC) In Attachment 9 Revised pricing for TO 2, can the government clarify if the Program Manager is the only Key Personnel required for this task order?

Response:

The key personnel are listed in Section B-M Base Contract IDIQ, Section G7. This section lists 5 key personnel for all activities within the IDIQ.

Question 66:

Attachment 9 Revised Sentinel Pricing Matrix (TO#2 Labor-ODC) If the Program Manager is not the only Key Personnel required, can the government modify and repost a revised Attachment 9 Pricing Matrix with any additional key personnel?

Response:

The price matrix will be amended.

Question 67:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ (Page 16,17 Section H2.1 Section 508 Compliance) The Offeror shall submit a written Accessibility Conformance Report (ACR) for this DME Technical Scenario which is complete and includes a detailed explanation of the Offeror’s capabilities and understanding of accessibility testing and customization to conform with the above Section 508 standards. The ACR shall be based on the Voluntary Product Accessibility Template Version 2.1 (VPAT link: http://www.itic.org/policy/accessibility/vpat) (MS Word) provided by the Industry Technology Industry Council (ITIC).

Is the Accessibility Conformance Report (ACR) required to be submitted with the IDIQ? If so, can the ACR be included outside of page count?

Response:

The Accessibility Conformance Report (ACR) is to be submitted with the IDIQ and it is a separate document outside of the page count.

Question 68:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ (Page 45 Section K.1 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998)) In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): www.acquisition.gov/far/index.html Based on the revised solicitation dated on March 26th, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation of offer. In which volume should this be provided, what format and is it included in the page count?

Response:

The information should be provided as part of the cost proposal (look at the volume, only IDIQ cite that volume). Please complete the information in section K and it doesn’t count toward the page count.

Question 69:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ (Page 43 Section J - List of Attachments) "Can the government clarify which volume these attachments should be included in and also if they are part of the required Page count within that volume? Attachment 2 – Resource Data Characteristics Table Attachment 3 – FDA Non-Disclosure Agreement – 3398 FORM Attachment 4 – Subcontracting Plan Template

Response:

Attachments can be provided as an appendix and not included in the page count.

Question 70:

Attachment 9 Revised Sentinel Pricing Matrix (TO#2 Labor-ODC) Is it required to reflect any supporting subcontractor pricing (specifically labor hours) within the ODC?

Response:

Yes, please list the supporting estimated subcontracting labor hours within the ODC category to provide more granular information regarding the costs of the subcontractors.

Question 71:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ (Page 51 Section 3: Past Performance) A listing of at least two corporate past performance references to whom the FDA may contact. The listing shall include the references Company Name, Dun & Bradstreet number (DUNS), Contract type, Contract Value, Period of Performance, Current Company point of contact (POC) who may be reached, Phone Number and email.

Can the offeror provide a Past Performance Narrative associated with each corporate past performance reference that would highlight relevancy to this solicitation?

Response:

In addition to the required Past Performance Questionnaire, the offeror can submit a brief past performance narrative. However, the past performance questionnaire shall be used for evaluation purposes.

Question 72:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ (Page 51 Section 3: Past Performance) The Offeror shall provide the Past Performance Questionnaire (See Section J, Attachment 5 - Past Performance Questionnaire (PPQ)), per the instructions on the form.

In lieu of submitting a Past Performance Questionnaire, can the offeror submit actual CPAR's issued by the Contracting officer?

Response:

No.

Question 73:

Can the Prime (offeror) submit one past performance reference and subcontractor A submit a past performance reference to meet the needs of the RFP? Both past performance references would be when they were a Prime Contractor.

Response:

Yes.

Question 74:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ (Page 51 Section 3: Past Performance) Can the government clarify which volume the Past Performance information should be included?

Response:

Volume I for Sentinel Base IDIQ, Volume IV for Task Order #1 (OC); Volume VI for Task Order #2 (IV) and Volume VII for Task Order #3)

Question 75:

Attachment_7_TO__ (Page 26 5. Innovation Projects and IC Collaboration Activities) Such healthcare data could also include data from the Sentinel System network, in collaboration with the OC. For each of its proposed data resources, the offeror shall provide a detailed written narrative description and a Data Characteristics Table (See Attachment 2 – Data Characteristics Table).

Since innovation project 4.1 thru 4.7 are currently unfunded efforts, can offerors provide only proposed data sources that would be used in reference to sample innovation projects 1 and 2?

Response:

The offeror shall propose data sources for the sample innovation projects that the contractor has a realistic ability to obtain and use to complete the project scope of work. In other words, the proposals should be ready-to-execute in the scenario where FDA awards the sample innovation projects as part of the overall contract award.

Question 76:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ (Page 51 L3 Volume 1, Section 4) The Offeror is expected to provide at least but not to exceed two (2) references relating to past performance work on contracts of the same size, dollar value and complexity.

Can the Government clarify if the offeror is to include two past performances/PPQs for the IDIQ as well as two past performances/PPQs for each Task Order the offeror responds to?

Response:

Yes.

Question 77:

Q_and_A_Sentinel_2019_26_March_2019 (Page 21 Question 57 (Red)) References in the form of the past performance questionnaire won’t count toward the page limit. All other references will count toward the page limit.

Can the Government clarify what is meant by "all other references will count towards the page limit." Please elaborate on what all other references include?

Response:

Past Performance Questionnaires will not count toward the page count limit. However, any additional past performance information provide shall count against the page count limit.

Question 78:

Attachment_7_TO__ (Page 27 Section 6.1) The proposal should address the assessment of scientific validity of Targeted Learning methods compared with current approaches for evaluating medical product safety and efficacy in the Sentinel System, as well as practical aspects of the feasibility of how such approaches might be implemented in a distributed environment.

What is the time-frame for "might be implemented in a distributed environment"?

Response:

Within the 5-year base contract period.

Question 79:

Attachment_7_TO (Page 25 Section 4.3) New clinical data sources are being introduced to the healthcare ecosystem quickly with the diffusion of once costly technologies, such as genome sequencing, and novel collection media such as wearables that capture huge amounts of data outside traditional healthcare settings.

To what extent does the analysis address factors that affect adherence to medical regiments, including medical adherence, and factors that affect outcomes, exercise, sleep, social support, etc.?

Response:

Any scientific proposals to use novel data sources in the Innovation Center Master Plan needs to consider factors such as adherence. Not all novel data sources may provide useful information to evaluate medical product performance. The Master Plan must factor in these limitations and prioritize projects and data sources that are realistic and achievable. As stated in the introduction section, “The Innovation Center’s charge includes the following: clearly define the use cases where adoption of advanced analytics increases value, prioritize a set of demonstration projects along key dimensions such as cost, time horizon, feasibility and impact, and convert the analytics into scalable solutions within a multi-site distributed database environment. The work of the Innovation Center shall include, but not be limited to, strategic planning, proof-of-concept investigations, and demonstration projects that will help the Sentinel System improve over the long term.”

Question 80:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ (Page 52, 53, 54 Section L6, L8, L10) The Offeror is expected to provide two (2) references relating to past performance work on contracts of the same size, dollar value and complexity.

Can the same past performance instance be submitted for the IDIQ and a Task Order or for multiple Task Orders? Or does each past performance instance need to be unique?

Response:

Yes, if they also apply to the task orders.

Question 81:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ (Page 28 Section H4.3.A) The plan shall describe any parent company relationship and list all affiliates and subsidiaries whose work may present a COI. Generally, this listing need not exceed three corporate tiers.

Please clarify if the requirement is to list ALL company affiliates at least three tiers down or to list only those affliate companies that have a relationship that may create a COI in the Corporate Structure section of the COI Plan.

Response:

If the industry standard is three tiers down, that is the policy the FDA will follow. The main point is to ensure that the offerors are aware of potential conflicts of interest and we want to ensure this issue is addressed.

Question 82:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ (Page 29 Section H4.3.C) The COI Plan shall include a database with sufficient information to review a contractor's past work [the previous three (3) years, at a minimum], work-in-progress, and work that the company may be pursuing under any on-going marketing proposals.

Our interpretation of the requirement to include a database (or spreadsheet, as provided in previous Q&As) is that ALL of the contractor's work in at least the past three years, work-in-progress and work that the company may be pursuing is to be included in the database, rather than only those contracts that present a potential conflict and require a conflict mitigation plan. Is our interpretation correct?

Response:

The contractor only needs to address the items that relate to the scope of work for this contract. The conflict of interest wants to ensure that existing efforts don’t create a conflict of interest if you were to be awarded this contract.

Question 83:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ (Page 29 Section H4.3.C) The COI Plan shall include a database with sufficient information to review a contractor's past work [the previous three (3) years, at a minimum], work-in-progress, and work that the company may be pursuing under any on-going marketing proposals.

Please clarify if the contractor is required to include only the contractor's work in at least the past three years, work-in-progress and work that the company may be pursuing is to be included in the database or is the contractor required to also include parent and affiliate past work for at least the past three years, work-in-progress and work that the is being pursued.

Response:

The contractor is only required to include work that relates to the scope of work for this contract. That should include all past, present and work-in-progress efforts.

Question 84:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ (Page 29 Section H4.3.C) The COI Plan shall include a database with sufficient information to review a contractor's past work [the previous three (3) years, at a minimum], work-in-progress, and work that the company may be pursuing under any on-going marketing proposals.

Our interpretation of "work that the company may be pursuing under any on-going marketing proposals" is that the company is only required to include work for which the company currently has an active proposal award pending. Is our interpretation correct? Does this also include the parent company and any affiliate?

Response:

The offeror is required to provide sufficient information to ensure that no current or potentially future conflicts of interest will exist over the life the of the contract. If you are doing a teaming arrangement (parent and affiliate) then the proposal must demonstrate no conflicts of interest exist in that relationship.

Question 85:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ (Page 29 Section H4.3.C) The contractor shall retain the above information, where applicable, for any subcontractors or consultants performing work under this contract.

Our interpretation of this requirement to retain a database (or spreadsheet, as provided in previous Q&As) for any subcontractors or consulstants performing work under this contract is that the same requirements expected of the contractor is expected of the subcontractors or consultants. Is our interpretation correct?

Response:

See response to Question 1. The prime contractor may require its subcontractors and consultants to maintain their own databases and periodically certify to the prime contractor their compliance with FDA’s conflict of interest requirements. However, it is the responsibility of the prime contractor to manage and oversee its subcontractors and consultants.

Question 86:

Amendment_1_Section_B-M_Sentinel_Base_IDIQ (Page 29 Section H4.3.C) The contractor shall retain the above information, where applicable, for any subcontractors or consultants performing work under this contract.

There is a potential for a named subcontractor in support of this program to have information that would be considered competitively sensitive. To comply with the requirements of this RFP the COI that would be required to be put in place may have confidential implications.

How should the prime contractor treat this sensitive information ie: Sealed response between the subcontractor and the Contracting officer, separate discussions between the contracting officer and the subs ... etc?

Response:

Printing

Only print documents when necessary.

Retrieve printed documents from the printer immediately.

When available, use secure print features, which may require the use of a PIV card and/or PIN number for authentication.

Mail

Use opaque packaging and clearly label it with recipient’s name and address.

Ensure the package is fully sealed.

Include only the minimum amount of sensitive information necessary.

When mailing storage media, follow policies for securing and tracking the package.

Use a tracking service with confirmed receipt.

Confirm the intended recipient received the mailing when using interoffice mail.

Physical Transfer (e.g., hand delivery and courier)

Use opaque packaging and clearly label it with the recipient’s name and address.

Ensure the package is fully sealed.

Include only the minimum amount of sensitive information necessary.

Use a reputable carrier.

Confirm the intended…