Q_and_A_Sentinel_2019_26_March_2019.pdf

SENTINEL PRE-BID SOLICITATION FORUM

POST EVENT QUESTION/ANSWER BY INDUSTRY TO FDA

Key:

Color Question Type

Contractual Questions

Program Questions

Question1:

Section L1, L2 and C4 Section L1 states “The Offeror shall provide proposals via email consisting of Volumes I, II, III, IV, V, VI, VII, VIII, and IX labeled separately.” Section C4 states “The Sentinel

Initiative IDIQ contract supports the three task areas described below. Contractors may compete for any one or more of the task areas in this IDIQ.”

In contrast, Section L2 states:

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)

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

Can you please clarify whether vendors are permitted to bid on individual task orders or if vendors are required to bid/meet ALL the required TO areas of the SOW? If the answer is that a vendor can respond to one task, can the vendor address technical qualifications for that task only in the

IDIQ Technical and Price Proposals?

Response:

The vendors do not have to submit proposals for each task order. However, to be awarded a task order(s), the vendor must address all the requirements at the IDIQ level.

Question2:

Section L2, L5, L7, L9 Will resumes of key personnel and associated Letters of Commitment be counted towards the page limitations or can they be presented as an appendix to the respective volume?

Resumes/Letter of Commitment will not count toward the page limitations; however, resumes should not exceed 2 pages.

Question3:

Section L2, L5, L7, L9 In the IDIQ Proposals (Section L.2), Past Performance is not counted towards the page limitations. Will the Past Performance Information text response for Task

Orders 1-3 be excluded from the page count maximums or can that information be presented in an appendix?

The contractor will be providing the past performance questionnaires. They will not count toward the page limitations.

Question4:

Section L4 Volume III MMR If vendors are not proposing a response to Task Order #1, are they required to respond to these Minimum Mandatory Requirements?

Response:

If the vendor is not proposing for task order 1, they aren’t required to respond. The MMR only relate to task order 1.

Question1:

Section H3 Security and Privacy, Attachment 6 TO1 4.1.4

The Sentinel program approach has been to retain all PHI/PII on the data partner systems, and only provide summary results to the FDA. TO1 and TO2 may involve pilot projects in collaboration with data partners and researchers on vendor or partner networks. The procurement language in

H3 applies Federal Information Processing Standards Publication (FIPS)199 to the solicitation requirements. Please validate that the government’s security requirements approach to allow appropriate Privacy ACT policies on privately owned vendor, provider, payer, or research partner sites vs. FIPS/FISMA policies for tasks with systems that reside on government infrastructure.

Answer to this question will posted at a later date.

Question2:

Section B2, B3 The solicitation uses several terms to describe awards, and task orders: Please clarify the following terms and how they relate to each other

• B2: “single-award hybrid task order”

• B2: Workgroup Opportunities (Work Order)

• B2: Request for Task Order Proposal (RTOP)

• B3.D: “technical area”

Single-award hybrid task order: All task orders will be a single award. Some task orders that have a mixture of firm-fixed price, Time & Materials, or Labor hours are considered a hybrid task order.

Workgroup Opportunities (work order): Once a task order is awarded, for example task order

#1, the FDA will issue a workgroup opportunity to that specific task order for projects within the scope of task order #1. Refer to B3 – F. General Process for Individual Work Group Opportunities

(Work Orders).

Request for Task Order Proposal (RTOP): Issued to the IDIQ awardees for new task order work.

Refer to Section B3- D (Requesting Task Order Proposals) and E (Competitive Ordering Process).

Technical Area: Technical areas refers to the functional areas of the SOW.

Question3:

Section B2

B2 states that “In-Network: Sentinel Data Partners” and “Outside Network Organizations” will be involved in Work Order opportunities.

Please clarify government versus IDIQ vendor roles in creating competing work orders with these entities.

How will the government manage relationships with In-Network: Sentinel Data Partners across

IDIQ contract holders?

Each contractor manages the relationships for the In-Network organizations for their respective coordinating center: Operations Center, Innovations Center, and Community Building and

Outreach Center. Each Sentinel Center may have both Data Partners and scientific collaborators who have signed collaborative agreements with the prime contractor for each coordinating center. Upon FDA’s request, the prime contractor of the Sentinel Center shall issue workgroup opportunities to enable in-network collaborators to compete for a specific project (or work order). Please see Section B3(F) “General Process for Individual Work Group Opportunities

(Work Orders)” for further information.

The government will manage the relationships of the In-Network collaborators across the IDIQ contract holders. However, as stated in Section C4. IDIQ Scope of Work, “Contractors who are awarded any individual IDIQ task order shall collaborate, as necessary, to achieve the overall scientific, training, outreach and communication objectives described in all task orders.”

If FDA determines that the requisite scientific expertise or other need cannot be met with in-network collaborators, then the Sentinel Center contractor shall procure the necessary expertise to accomplish the scope of work and objectives in the work order using out-of-network expertise. The identification of out-of-network expertise will be done jointly by the

Sentinel Center contractor and FDA.

Question4:

Attachment 9, Sentinel Pricing Matrix

Task Order 2, Sections 4 and 7

We recommend that for Attachment 9, that Task Order 2 require pricing only for the scope which has specific deliverables to allow the government to evaluate offeror proposals. For example, Task Order 2, Section 3 requires specific deliverables; an operational Innovation Center and the Master Plan artifact. Also, Section 6 can be priced due to the requirement for "brief proposals" involving projects with deliverables.

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.

Question5:

Section E. Competitive Ordering Process For this specific opportunity, will there only be one

Offeror awarded within each technical area (i.e., Operations, Innovation, Community Outreach)?

In Year 1, FDA anticipates awarding only one Offeror for each task order technical area. As discussed at the Pre-Proposal Forum on March 11, 2019, any contractor awarded the IDIQ contract can compete for subsequent task orders in Years 2-5. Such opportunities can arise if

FDA elects not to award an option year for an existing contractor for a specific technical area, issues a completely new task order in a different technical area, or elects to award a second

Operations, Innovation or Community Building and Outreach Center, among other possible scenarios.

Question5:

Section C Sentinel BaseIDIQ.docx: Can the same contractor be a subcontractor on one TO and a prime on another?

Yes, so long as this arrangement doesn’t cause any conflict of interest problems to arise.

Question6:

Section B-M Sentinel Base IDIQ.docx: On page 7, there is a statement that reads, “Rates shall be provided for Contractor provided facilities in the Washington, D.C. metro area.” Can you clarify if this means that contractors must have dedicated staff and space located in the Washington, D.C.

metro area?

The contractor does not need to be located or work in the Washington D.C. metro area.

Question7:

(start pg 42, Section B-M Sentinel Base IDIQ) If a contractor were to prime on only one TO, would that contractor be expected to submit all volumes as listed in this section?

To apply to a single task order only, Offerors must submit technical and price proposals for the

IDIQ (Vol 1 and 2) and all relevant volumes for the specific task order to which they are applying.

For example, Offerors must submit 4 volumes to respond to the Innovation Center solicitation

(Volumes 1, 2, 6, and 7). To apply for the Operations Center, Offeror must submit 5 volumes

(Volumes 1, 2, 3, 4, and 5).

Question8:

Can you please clarify what the Minimum Mandatory Requirements (MMRs) are for TO 2 IC (pg

47), to insure the MMRs are not referring to the two factors on pgs 44-45 (those seem to be specific to TO1 OC).

The MMR factors only relate to task order 1.

Question9:

Page 48 states: “The Offeror’s Innovation Center Task Order proposal will be evaluated per the task order requirements only if the Offeror’s Operating Center task order proposal is deemed eligible for award”. Why would a contractor submitting a proposal for only the Innovation Center

(TO 2) also submit one for the Operating Center (TO 1)? Please clarify.

If a contractor is submitting a proposal for TO 2, Innovation Center, that proposal will only be evaluated against the factors relating to the award of task order 2.

Question10:

Page 54 states: “VOLUME VII. Task Order #2 – Innovation Center Task Order Price Proposal. The price proposal shall represent the Offeror’s response to the requirements of Task Order #1. The price evaluation consists of the combination of all proposed pricing over the contract’s performance period including the sample pricing matrix”.

Why would a contractor submitting a proposal for the Innovation Center (TO 2) need to have a price proposal to represent Task Order #1 requirements? Please clarify.

You only need to submit a price proposal for the task order that you wish work on.

Question6:

Attachment 7 TO 2, pg 3, third bullet point: Would a contractor need to demonstrate/prove ownership of data at the time of proposal or just assure that we would have access to needed data in our scientific network given evolving innovation project needs?

Response:

For the Innovation Center, the contractor shall demonstrate that they will have the capacity to access the needed data to complete the scope of work described in Task Order 2.

Question7:

Attachment 7 TO2 pg 7: Are the brief (max 4 page) proposals for the two innovation projects expected to be included in the TO 2 proposal or are those considered deliverables/expectations in the post-award period?

Response:

The 4-page proposals for the two sample innovation projects shall be included in the response to the solicitation to Task Order 2. Offerors shall also include responses to these 2 sample innovation projects in the price proposal for the Task Order 2. However, as stated in Section 6, “FDA may choose to fund these projects solely at its discretion.”

Question8:

Can you please clarify to what extent Catalyst is included in the Sentinel Initiative, and are IRB rules different for Catalyst as they are for Sentinel?

Response:

FDA Catalyst is a subcomponent of the Sentinel Initiative. Reference is made to page 59 of

Section_B-M_Sentinel_Base_IDIQ document, “Unlike the Sentinel System, its activities may involve interventions and interactions with patients or providers in addition to use of routinely collected data.” FDA Catalyst activities that involve interactions and interventions will require

IRB approval. Similarly, reference is made to Section C16. Sentinel System Activities are Public

Health Practice, Not Research, that states that Sentinel System activities are considered public health practice, and are not under the purview of IRB.

Question11:

Please confirm if the subject solicitation is a Pre-solicitation or an actual RFP, with a due date of

March 22, 2019 at 4:30 PM EST.

This is Pre-Solicitation. The final RFP will post on 3/25

Question12:

Do we correctly assume that this is the DRAFT solicitation and that due date for proposals will be announced at a future time?

The final RFP is due to be released on 3/25 and the final proposal is due May 24 4:00 PM EST.

Question13:

The FedBizOpps banner shows a response date of March 22, while L.11, page 49, shows a response date for questions of March 11. Which date is correct?

These dates are for draft solicitation. The final solicitation shall state when questions are due.

Question14:

I am following up on the information provided to industry in the 2/5/2019 Special Notice for the

Sentinel Initiative, solicitation FDA-19-SN-1209951. I have been monitoring FBO and have not seen the solicitation posted to date. Are you able to provide any information on when the solicitation will be posted? Thank you!

Final solicitation shall be posted on 3/25.

Question15:

Given the requirements of the solicitation, will the Government allow the formation of

Contractor Teaming Arrangements (CTAs) in response to the solicitation?

Response:

Vendors can form any type of arrangement they think is necessary to meet the requirements of the SOW. If a teaming arrangement is proposed, the offeror will need to clearly state that. The teaming agreement must be included as part of the proposal.

Question16:

How many IDIQ contracts does the government intend to award?

The government doesn’t have a set number in mind.

Question17:

Does the government intend to award all three task orders when the IDIQ is awarded or is there the potential that a task order will not be awarded and could be part of a future task order competition?

The Government intends to award the 3 task orders at time of award. The government also reserves the right to issue future task orders after the award of the first 3 task orders.

Question18:

Will there be additional task orders issued at a later date and, if so, how many task orders per year is the government considering?

Response:

Future task orders will be awarded through competitive procedures to the companies in the

IDIQ pool. The government doesn’t have a set number of task orders in mind now.

Question19:

Will an offeror be limited to only receiving one of the task order awards?

No.

Question20:

If an offeror is only interested in responding to one of the three task orders (as indicated in Section

C4 that offerors can "compete for any one or more of the task areas in this IDIQ"), can an offeror only submit the Technical and Price Volumes associated with a specific task order as well as the

IDIQ?

Yes.

Question21:

If an offeror is allowed to only submit the Technical and Price Volumes associated with a specific task order and the IDIQ, can an offeror only address the corresponding task area within the IDIQ

Technical and Price volumes?

For the IDIQ requirement, the offeror will be evaluated by the factors laid out in section M.

Question22:

If an offeror is allowed to only submit the Technical and Price Volumes associated with either

Task Order #2 or #3 along with the IDIQ, will this waive the need for the Task Order #1 Minimum

Mandatory Requirements (MMRs)?

Response:

The MMR are only applicable to Task Order 1. If you do not submit a proposal for task order one, you won’t be held to those standards.

Question23:

If the government intends to award IDIQ contracts to offerors that are not provided an initial task order award, will the government update this section?

Overcome by events and answered in previous questions.

Question24:

Can the government provide a maximum amount for each of the 3 task areas over the five year

IDIQ?

Question25:

Since staff supporting this contract may be located outside of the Washington, D.C. metro area, can the government remove "in the Washington, D.C. metro area" from this statement?

Response:

Please see answer relating to previous question. Your staff does not need to be in the Washington

D.C. area.

Question26:

If an offeror is required to respond to more than one task order, can a company provide the same resource across each Task Order (even though the hours would be greater than one full-time equivalent) to ensure that this individual is evaluated properly and accounted for from a cost perspective on an awarded Task Order?

Response:

The offeror is required to provide a proposal that is fair, reasonable and realistic. If the offeror is proposing that key personnel are going to work on multiple task orders which equals more than a full-time equivalent, the burden falls onto the contractor to prove this is realistic.

Question27:

If an offeror is not required to respond to all task orders, will the government update this section accordingly?

Done.

Question28:

Can the government allow offerors to use a font size of no smaller than 10 for tables and 9 for graphics?

Response:

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

Question29:

Can the government verify that matrices, charts or other graphics are not included in the page count? Can these be included as an appendix?

They can be included as an appendix, however, they will count toward the total page count.

Question30:

Can the government confirm that the Subcontracting Plan is only required for responses to Task

Order 1 and only applies to this Task Order?

The subcontracting plan is applicable to the over-arching IDIQ contract.

Question31:

Can the government provide information on how the Subcontracting Plan will be incorporated into the evaluation of Task Order 1?

Response:

The government will review the offeror’s ability to meet the small business goals mandated to the FDA. Again, this will relate to the over-arching IDIQ level contract

Question32:

Given the size and complexity of the response to the solicitation, can the government provide offerors at least 60 days from the release of the final solicitation to submit their proposals?

Question33:

Can an offeror only respond to those areas that align with the Task Orders that they intend to pursue?

Response:

The offeror must meet the requirements as stated in section M for the solicitation as it relates to task orders they wish to submit proposal on as well as the over-arching IDIQ contract.

Question34:

Can this plan be provided as an appendix and not included in the page count?

This question is unclear.

Question35:

Can the resumes and letters of commitment be provided as an appendix and not included in the page count?

Resumes shall not exceed 2 pages. Resumes/Letter of Commitment will not be counted as part of the technical proposal page count.

Question36:

Can the government verify that there is no past performance volume and that this past performance information should be provided in the Technical Proposal Volume 1 and is not included in the page count?

Response:

The offeror is required to submit the past performance questionnaire. Past Performance questionnaires will not be included in the page count.

Question9:

Since these requirements are not applicable to Task Orders #2 and #3, can the government confirm that these minimum mandatory requirements are only necessary if the offeror intends to pursue Task Order #1.

Response:

The Minimum Mandatory Requirements (MMRs) only apply to task order #1. Offerors do not need to meet the minimum mandatory requirements for Task Order 1 to be eligible for an IDIQ award.

Question10:

Since these requirements are not applicable to Task Order #2, can the government remove this statement in order for offerors to pursue Task Order #2 without pursuing Task Order #1?

Response:

The Minimum Mandatory Requirements (MMR) only apply to task order #1. Refer to

Instructions Section L4: Volume III, Task Order #1 Operating Center Minimum Mandatory

Requirements (MMR). You may skip task order #1 and apply to only task order #2. The specific changes will be addressed in the forthcoming amendment.

Question37:

Can the resumes and letters of commitment be provided as an appendix and not included in the page count?

Resumes shall not exceed 2 pages. Resumes/Letter of Commitment will not be counted as part of the technical proposal page count.

Question11:

Since these requirements are not applicable to Task Order #3, can the government remove this statement in order for offerors to pursue Task Order #3 without pursuing Task Order #1?

Response:

The Minimum Mandatory Requirements (MMR) only apply to task order #1. Refer to

Instructions Section L4: Volume III, Task Order #1 Operating Center Minimum Mandatory

Requirements (MMR). You may skip task order #1 and apply to only task order #3. The specific changes will be addressed in the forthcoming amendment.

Question38:

Section L states, "The Offeror is expected to provide two (2) references relating to past performance work on contracts of the same size, dollar value or complexity." Can the government modify both statements to be "similar in scope, size (dollar amount) or complexity"?

Past Performance will be evaluated based on the scope, size (dollar amount) and complexity.

Question39:

Given that labor rates and not a total price is being provided for the IDIQ, can the government clarify what is meant by "combination of all proposed pricing"?

Response:

The offeror is required to complete the pricing matrix as it relates to the IDIQ contract as well as the task orders.

Question12:

Given the statement that contractors may compete for one or two of the task areas, can the government confirm that responses to the IDIQ SOW need only address the corresponding task areas (i.e., not all three of the task areas)?

Responses to the IDIQ SOW must address all areas in the IDIQ statement of work, but not all tasks within each individual Task Order statement of work for the OC, IC, and CBOC. The IDIQ

SOW is broad, while the SOWs for each task order are very specific. Offerors applying to only the IC, for example, may devote less time and effort to responding to IDIQ sections related to the OC or CBOC. However, IDIQ contractors will be selected based upon the ability to meet all

IDIQ requirements.

Question40:

Will there be an open session for bidders to get questions answered?

All questions and answers will be posted to FBO

Question41:

One of our questions is will one award be made for all three centers or will there be potentially multiple awardees?

Response:

The government intends to award multiple IDIQ contracts as well as the initial 3 task orders.

However, a vendor may be awarded more than 1 task order if they are determined to be the best value to the government.

Question42:

Do the resumes (of not more than 2 pages) count towards the page limit of the technical proposals (e.g., Volume I, Volume VI)?

See previous response concerns resumes and letters of commitment.

Question43:

Is there a Section A or B, or Attachments 1-3? These were not available on the fbo.gov site.

All attachments shall be provided when the official RFP is released.

Question44:

Can past performance questionnaire references be from other FDA contracts?

Question45:

Is a subcontracting plan required for IC Task Order #2 Technical Proposal?

As stated in previous answer, the subcontracting plan only relates to the IDIQ contract.

Question13:

Are international collaborators allowed?

Given the need to work closely and collaboratively with FDA, including frequent meetings and travel to the FDA White Oak Campus, Offerors seeking to be the prime contractor for a Sentinel

Center (OC, IC, CBOC) must reside in a commutable distance to the FDA White Oak Campus, defined as located within the continental United States. However, collaborators from outside the continental United States are eligible to join the collaborators network within any Sentinel

Center.

Question14:

Document: Section_B-M_Sentinel_Base_IDIQ.docx Page 7, Section B5. The solicitation says, “Rates shall be provided for Contractor provided facilities in the Washington DC metro area.” Later, in Section F2, on p. 12, the solicitation says, “The place of performance will be at the contractor’s facility, except for any meetings, presentations, training, and events deemed necessary by the government.” Does the government expect offerors to secure facilities in the Washington DC metro area? What “rates” is the government referring to on p. 7?

Section B5: “Rates shall be provided for Contractor provided facilities in the Washington DC metro area” will be removed in the amended version. The Contractor is not expected to secure facilities in the Washington DC area. Section F2 is correct, that “the place of performance is at the contractor’s facility, except for any meetings, presentations, training, and events deemed necessary by the government.”

Question46:

Page 14, Section G7. The solicitation says, “The Contractor shall submit one (1) original copy of each invoice to the address below.” A postal address and an e-mail address are included. In the same section, on p. 15, the solicitation says, “An electronic invoice shall be in adobe acrobat (PDF) format.” Does the government expect the Contractor to submit invoices by mail or electronically or both?

All invoices must be submitted electronically.

Question15:

Page 18, Section H2.2. Will the determination of “applicable…security and privacy requirements” referred to here be completed and communicated to offerors prior to 22 March 2019?

No, this information will not be released prior to 22 March 2019. It will be released along with the conformed (final) solicitation.

Question47:

Page 34, Section I1. FAR 52.204-1, Approval of Contract (DEC 1989) is incorporated by reference. Who is the designated agency official mentioned by the clause?

The contracting officer.

Question48:

Pages 34-36, Section I1. The following FAR clauses in Section I1 are out of date. Will the government update them to the most recent version of the clause?

FAR

Number

Name Date in

Solicitation

Most

Recent

Version

52.203-5 Covenant Against Contingent Fees. APR 1984 MAY

52.203-7 Anti-Kickback Procedures. OCT 2010 MAY

52.203-10 Price or Fee Adjustment for Illegal or

Improper Activity.

JAN 1997 MAY

52.203-12 Limitation on Payments to Influence

Certain Federal Transactions.

JAN 1997 OCT 2010

52.203-17 Contractor Employee Whistleblower

Rights and Requirement to Inform

Employees of Whistleblower Rights.

OCT 2010 APR 2014

52.209-6 Protecting the Government’s Interest

When Subcontracting with Contractors

Debarred, Suspended, or Proposed for

Debarment.

AUG 2013 OCT 2015

52.219-8 Utilization of Small Business Concerns. JUL 2013 OCT 2018

52.219-9 Small Business Subcontracting Plan Alt

II

OCT 2001 Clause:

AUG

Alternate:

NOV

52.219-14 Limitations on Subcontracting. NOV 2011 JAN 2017

52.222-

Prohibition of Segregated Facilities FEB 1999 APR 2015

52.222-26 Equal Opportunity. MAR 2007 SEP 2016

52.222-35 Equal Opportunity for Veterans. SEP 2010 OCT 2015

52.222-36 Equal Opportunity for Workers with

Disabilities.

OCT 2010 JUL 2014

52.222-37 Employment Reports on Veterans. SEP 2010 FEB 2016

52.232-17 Interest. OCT 2010 MAY

52.232-23 Assignment of Claims. JAN 1986 MAY

52.233-1 Disputes. JUL 2002 MAY

52.249-5 Termination for the Convenience of the

Government (Educational and Other

Nonprofit Institutions).

SEP 1996 AUG

All clauses will be updated by release of the final RFP.

Question49:

Pages 34-36, Section I1. Some FAR clauses in Section I1 have no date. Should offerors assume that the government is using the most recent version of the clause, as shown in the table below?

FAR Number Name Most Recent Version

52.203-15 Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009.

JUN 2010

52.203-16 Preventing Personal Conflicts of Interest. DEC 2011

52.204-10 Reporting Executive Compensation and First-Tier

Subcontract Awards.

OCT 2018

52.204-15 Service Contract Reporting Requirements for Indefinite-

Delivery Contracts.

OCT 2016

52.210-1 Market Research. APR 2011

All clauses will be updated by release of the final RFP.

Question50:

Page 42, Section L1. "The Offeror shall provide proposals via email consisting of Volumes I, II, III, IV, V, VI, VII, VIII, and IX labeled separately." Is the Government implying that a respondent must apply to lead all 3 centers (OC, IC, CBOC)?

The contractor is not required to submit proposal for all three task orders.

Question16:

Page 47, Section L7 and page 48 Section L9, " The Task Order Contract Technical Proposal will be evaluated per Section M - Evaluation Criteria For Award only if the Offeror received a “Pass” evaluation rating on the MMR." Are there unique Minimum Mandatory Requirements (MMR) for either the Innovation Center or the Community Building and Outreach Center?

Minimum Mandatory Requirements (MMR) only apply to task order #1. Refer to Section L4:

Task Order #1 Operating Center Minimum Mandatory Requirements. This change will be addressed in the forthcoming amendment.

Question51:

Page 48, Section L8. Would the Government please clarify if the bold text should refer to "Innovation Center"? "The Offeror’s Innovation Center Task Order proposal will be evaluated per the task order requirements only if the Offeror’s Operating Center task order proposal is deemed eligible for award. (See Section J, Attachment 9(Pricing Matrix) – Task Order #2 – Innovation Center)"

Per section M, please follow respective evaluation factors for each of the task orders.

Question52:

Page 49, Section L.10. Should the section header refer to Volume IX rather than Volume XI?

Please follow the header titles in the final solicitation.

Question53:

Page 49, Section L.10. Would the Government please clarify if the bold text should refer to "Community Building Outreach Center"? "The Offeror’s Community Building and Outreach Center Task Order proposal will be evaluated per the task order requirements only if the Offeror’s Innovation Center task order proposal is deemed eligible for award. (See Section J, Attachment 9 (Pricing Matrix)– Task Order #3 – Community Building and Outreach Center)"

All task order will be evaluated in accordance with the criteria laid out in section M of the solicitation. Each task order has specific evaluation factors that must be followed.

Question54:

Page 55, last section - Should the section header refer to Volume IX, rather than XI?

Corrected.

Question55:

Do the resumes for Key Personnel count toward the page limits for each volume?

Question56:

Do the organizational commitment letters from participating institutions count toward the page limit for Volume III?

Any commitment letter will not count against the page count. However, commitment letters shall be capped at one page.

Question57:

Do the preliminary Data Use Agreements count toward the page limit for Volume III?

Do References count toward the page limit for each volume?

Are offerors required to sign the FDA Non-Disclosure Form prior to proposal submission?

Will there be 3 IDIQs (one per center) or a single IDIQ for this award?

DUAs won’t count toward the page limit.

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.

Yes, all vendors must submit their Non-Disclosure Form with their proposal.

The government has not determined the number of awardees. This will be based on the proposals submitted and what is the best value to the government.

Question17:

Attachment_9_Sentinel_Pricing_Matrix.xlsx Tab: TO#1 Labor-ODC Would the Government please define the OC Inflation Rate Per Year (cell A259)?

How does the OC Inflation Rate Per Year differ from the Fully Burdened Labor Inflation Rate Per Year (cell A258)?

The OC Inflation Rate Per Year (cell A259) will be removed in the forthcoming amended version.

Question18:

Tab: TO#2 Labor-ODC Would the Government please define the IC Inflation Rate Per Year (cell A132)?

How does the IC Inflation Rate Per Year differ from the Fully Burdened Labor Inflation Rate Per Year (cell A131)?

Would the Government please define G&A Rate?

The OC Inflation Rate Per Year (cell A123) will be removed in the forthcoming amended version.

Question19:

Tab: TO#3 Labor-ODC Would the Government please define the CBOC Inflation Rate Per Year (cell A82)?

How does the CBOC Inflation Rate Per Year differ from the Fully Burdened Labor Inflation Rate Per Year (cell A81)

The OC Inflation Rate Per Year (cell A82) will be removed in the forthcoming amended version.

Question20:

May offerors include additional Labor Categories?

Question58:

In our review of the draft Sentinel solicitation it appears that the government intends to make separate awards per task area. Section B. (E) references this scenario stating that “All Offerors within a technical area will receive e-mail notification advising of the availability of each proposed task order requirement.” However, Section M3 (Evaluation Criteria, Volume 1 IDIQ Contract

Technical Proposal) states that the Contractor would need to meet all task areas to receive an

IDIQ.

We make the following recommendations:

*Per section C4 IDIQ Scope of Work, Contractors may compete for any one or more of the task areas in the IDIQ. We recommend adjusting the criteria of the Volume 1 IDIQ Contract Technical

Proposal to reflect that the contractor has to demonstrate the ability to execute all task and subtasks identified for only the particular task area(s) for which the Contractor proposed. This approach allows the Government to obtain services from the strongest companies for each task area vs. a more limited competition only from companies that propose under all task areas.

For example, Company ABC proposes only under task areas 2 & 3. In this case, they would only have to meet the task area and task order requirements for task areas 2 & 3 to be awarded an

IDIQ contract. Under this scenario, Company ABC would not respond to task area one or task order #1.

*Will the Government adjust the IDIQ criteria to allow for contractors to only bid and be evaluated under the task areas for which they bid? This approach allows the Government to obtain services from the strongest companies for each task area vs. a more limited competition only from companies that propose under all task areas.

Yes this is a pre-solicitation per what was stated in FBO. We included everything that would be included in the RFP to get industry feedback.

Question59:

The solicitation posted FebBiz Ops is confusing, it shows the request is a pre-solicitation but documents read like an RFP. Please confirm if the posting is a pre-solicitation or if it is an RFP.

This is a draft RFP, not a pre-solicitation.

Question60:

(Section B-M Sentinel Base IDIQ) Section B2 Page 3 The quantities of services ordered under this contract shall be accomplished by the issuance of task orders that will describe the contract type, objectives, scope, period of performance, and deliverables. Can the government provide an annual forecast for the release of additional Task Orders beyond the initial three Task Orders?

No. Any future task order will be solicited amongst the vendors selected to the IDIQ pool.

Question21:

(Section B-M Sentinel Base IDIQ) Section G6 Page 14 The contractor shall provide the names and qualifications of the key personnel assigned to this contract. Given that companies will be awarded an IDIQ and may not receive initial tasks orders or may receive a single task order, can the government consider reevaluating the need for the existing 5 key personnel at the IDIQ level, but rather require the offeror to identify a single key person (i.e., Program Manager) that would serve as the point of contact relative to the IDIQ contract and responding to Task Orders?

Response:

Reference is made to B5. Prices and Costs that lists the Key Personnel and identifies which ones are relevant to each task order. Offerors shall include the key personnel relevant to the Sentinel

Center(s) for which they are applying. However, IDIQ awards will be made based upon the ability to meet all requirements in the IDIQ statement of work (but not the individual task order statements of work).

Question22:

(Section B-M Sentinel Base IDIQ) Section H4.3.c Page 30 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. Can the government clarify that the actual information on past work, work-in-progress, and work that the company may be pursuing must be included upon award of a Task Order and all that is required in the plan is the process for providing that information?

Response:

All Offerors shall submit a database, which could be a spreadsheet, containing information on past work, work-in-progress and work that company is pursuing as part of the application.

Offerors shall also submit a COI plan.

Question23:

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. In lieu of providing a database with the required information, can a company provide a spreadsheet?

Yes, a spreadsheet accompanied by a COI plan would also fully satisfy this requirement.

Question24:

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. Given that the number of past and existing contracts will be significantly large for the breadth of work across the federal market place, can the government limit the information to just those that are relevant to this solicitation?

The Government only wants relevant past performance as identified in that section.

Question25:

(Section B-M Sentinel Base IDIQ) Section H4.3.c Page 30 The contractor shall retain the above information, where applicable, for any subcontractors or consultants performing work under this contract. Given that subcontractors may not want to release this type of competitive information to their prime contractor, can it be sufficient for subcontractors to certify that there is no conflict of interest in lieu of providing this information?

No. If you can’t provide the data you will not meet the requirement.

Question61:

(Section B-M Sentinel Base IDIQ) Section L Page 42 Past Performance

Information Can the government allow past performance references from subcontractors to be used for the required past performance information?

Response:

No. We are only looking for past performance information when the vendor was the prime contractor.

Question26:

(Section C Sentinel Base IDIQ) Section C5.1.2 Page 5 C5.1.2. Platform for Communication with

Stakeholders and Scientific Collaboration Can the government align this subtask to the subtasks in Attachment 6 - TO 1?

IDIQ Section C5.1.2 aligns with Sections 3.1 to 3.5 in Task Order 1.

Question27:

(Section C Sentinel Base IDIQ) Section C9 Page 8 Meetings and Training - Operations Center

Can the government clarify which task/subtask these costs should be captured in Attachment 9 -

Sentinel Pricing Matrix for Task Order #2?

Training and meetings will have a specific line in the revised pricing matrix.

Question28:

(Attachment 6 - TO 1) Section 3.1 Page 3 The OC shall obtain all required Institutional Review

Board (IRB) approvals for activities that involve interventions or interactions with health plan members or providers (e.g., FDA Catalyst). Can the government clarify if there is an existing IRB that is funded through another contract?

There is no existing IRB funded through another contract for FDA Catalyst.

Question29:

(Attachment 6 - TO 1) Section 3.3 Page 3 The OC shall develop and maintain a public website for the Sentinel Initiative to include content provided by the OC, IC, CBOC and other systems within the Sentinel Initiative Can the government provide a list of applications and websites that the current contractor is responsible for maintaining and supporting?

Response:

There are two primary public facing sites that are maintained by the Sentinel Operations Center.

The links are posted below.

https://www.sentinelinitiative.org/ https://dev.sentinelsystem.org/repos?visibility=public

Question30:

(Attachment 6 - TO 1) Section 3.3 Page 3 The OC shall develop and maintain a public website for the Sentinel Initiative to include content provided by the OC, IC, CBOC and other systems within the Sentinel Initiative Can the government provide the infrastructure specifications for each application and website (e.g., hardware, software, operating systems, storage, etc.) that is supported by the current contractor?

https://www.sentinelinitiative.org/ https://dev.sentinelsystem.org/repos?visibility=public

The data infrastructure requires a FISMA-moderate level compliant hosting environment and licensed software for a Git-client for an open source distributed software version control system.

The website is required to be hosted on a FISMA compliant server. The contractor shall be able to operate Drupal, the website’s content management system and develop and maintain the website in three separate environments (development, staging, and production). The website shall also have Secure Sockets Layer Encryption (SSL certificates) for each website environment (development, staging, production).

Question31:

(Attachment 6 - TO 1) Section 4.1 Page 4 The OC shall establish and maintain business partnerships and Data Use Agreements (DUAs) with different types of organizations including academia, healthcare providers, contract research organizations, and technology companies.

Can the FDA confirm that the existing data use agreements are with FDA and that they will transition to the awardee?

No, the existing data use agreements are between the Contractor and its data partnership network with the exception of the Medicare, which is a data use agreement between FDA and

CMS.

Question32:

(Attachment 6 - TO 1) Section 5.1 Page 8 The OC shall maintain the current Sentinel System suite of analysis tools developed with numerous capabilities. Can the government provide an architecture diagram with specifications of the current Sentinel System suite?

Extensive technical documentation for the Sentinel analytic tools can be found here:

https://www.sentinelinitiative.org/sentinel/surveillance-tools/routine-querying-tools https://www.sentinelinitiative.org/sentinel/surveillance-tools/software-toolkits https://www.sentinelinitiative.org/sentinel/surveillance-tools/software-toolkits

Question33:

suite of analysis tools developed with numerous capabilities. Can the government provide information as to where the Sentinel System is hosted (e.g., contractor facility, FDA data center, cloud service)?

Response:

The data infrastructure of the Sentinel System is currently hosted on a Microsoft Azure platform under a subcontract with the Harvard Pilgrim Healthcare Institute. All source data reside at each of the participating data partners who maintain physical and operational control of their data behind their own firewall. The distributed network is currently facilitated by PopMedNet open source software.

https://www.popmednet.org/

The full list of data partners can be found here:

https://www.sentinelinitiative.org/sentinel/data/data-partners

Question34:

suite of analysis tools developed with numerous capabilities.

What are the existing analysis tools (e.g., SAS) supported by the current contractor?

Response:

All core analytic tools are written in SAS statistical software, however other commonly used support tools use different software. Further information can be found here:

Question35:

(Attachment 6 - TO 1) Section 5.6 Page 13 To meet FDA’s program tracking needs, the

OC shall establish, maintain and improve a ‘Business Informatics Workflow Tracking and

Reporting System’

Can the government clarify if these tool already exist and if they will be made available to the awarded contractor?

https://www.popmednet.org/ https://www.sentinelinitiative.org/sentinel/data/data-partners

The current Sentinel contractor uses Atlassian software (JIRA, confluence, etc.) to track and report query information. The current regulatory contents should be able to be migrated to different business work flow platforms to enable a transition to a new contractor.

https://www.atlassian.com/

Question36:

(Attachment 6 - TO 1) Section 4.1.1 Page 6 The OC shall develop, maintain and update a Data

Characteristics Table describing each of its proposed data resource(s). Can Attachment 2 be provided as an appendix and not included in the page count?

Yes, attachment 2 can be provided as an appendix and not included in the page count.

Question37:

(Attachment 6 - TO 1) Section 4.1.1 Page 6 The OC shall develop, maintain and update a Data

Characteristics Table describing each of its proposed data resource(s).

Can a sample of data sources be provided as opposed to all potential sources?

Response:

Offerors may group data sources by type and provide a description of the characteristics of the data that are common to that group. Offerors responding to Task Order 1 the Operations Center shall provide data characteristics on all data sources used to meet the minimum mandatory requirements, not all potential or future data sources.

Question38:

(Attachment 7 - TO 2) Section 3.1 Page 3 The Contractor shall establish an Leadership Team to oversee all aspects of operations for the Innovation Center (IC). Can any proposed infrastructure in support of the Innovation Center be hosted in a FISMA compliant cloud environment?

Response:

Any data infrastructure proposal will require FDA review by the relevant information security teams to determine compliance with FISMA requirements.

https://www.atlassian.com/

Question39:

(Attachment 7 - TO 2) Section 3.1 Page 3 The IC shall be capable of managing an estimated 1-

3 new projects, depending on scope and size of each project. Can the government clarify if this is 1-3 new projects per year, over the entire period of performance or provide the appropriate timeframe?

The Government anticipates 1-3 new projects per year.

Question40:

(Attachment 7 - TO 2) Section 4 Page 4 The master plan shall take between 9 and 18 months to develop and be jointly authored with FDA. Will the government allow the awarded contractor to initiate projects or introduce technologies prior to the completion of the master plan?

Response:

During the development of the Master Plan, if a clear and pressing priority emerges, then FDA may consider initiating a work order in Year 1.

Question41:

(Attachment 7 - TO 2) Section 5 Page 6 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). Can Attachment 2 be provided as an appendix and not included in the page count?

Yes, attachment 2 can be provided as an appendix and not included in the page count.

Question42:

(Attachment 7 - TO 2) Section 5 Page 6 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). Can a sample of data sources be provided as opposed to all potential sources?

See response to Q37.

Question43:

(Attachment 7 - TO 2) Section 6 Page 7 The contractor shall provide brief proposals (max 4 pages) for the following innovation projects, including cost estimates. Can the government clarify if there is any issue providing cost estimates in the Technical Proposal?

Response:

Do not provide cost estimates in the technical proposal. Only provide cost estimates in the pricing matrix.

Question44:

(Attachment 7 - TO 2) Section 6 Page 7 The contractor shall provide brief proposals (max 4 pages) for the following innovation projects, including cost estimates. Can these proposals be provided as an appendix and not included in the page count?

The responses to the sample innovation projects should be included in the technical proposal.

Question45:

(Attachment 8 - TO 3) Section 4 Page 4 The master plan shall take approximately 12 months to develop and be jointly authored with FDA, unless otherwise agreed upon with FDA.

Will the government allow the awarded contractor to initiate projects prior to the completion of the master plan?

Response:

may consider initiating a work order in Year 1.

Question46:

(Attachment 8 - TO 3) Section 5 Page 5 Scientific challenges: In collaboration with FDA, OC and the IC, the CBOC shall design and conduct at most one (1) technical competition per year.

Can the government confirm that scientific challenges will not take place during the base period given that the master plan shall take approximately 12 months to complete?

Response:

may consider initiating a work order in Year 1 for a technical competition.

Question47:

(Attachment 9 - Sentinel Pricing Matrix) TO #2 Labor-ODC N/A 4. Task 2: Master Plan for Integration of Innovative Technologies While there are pricing rows for items 4.1 through

4.7, there are no pricing rows for the effort corresponding to Section 4, which includes the overall development of the master plan. Can the government clarify if there should be effort associated with the overall development of the master plan?

Yes, the Offeror shall provide price estimates for only task order deliverables.

Question48:

(Attachment 9 - Sentinel Pricing Matrix) TO #2 Labor-ODC N/A 5. Task 3: Innovation

Projects and IC Collaboration Activities Since it is not known exactly how many projects as well as which projects will be funded, can the government provide the amount of funding that will be allocated to innovation projects and provide separate rows for offerors to build-up the cost for IC collaboration activities?

Response:

The sample innovation projects can serve as an example of the scope of a typical innovation project.