ATTACHMENT D - RESPONSES TO QUESTIONS - PMO 8 27 2024 FINAL.pdf

ATTACHMENT D

Solicitation No.

Sentinel System 3.0 PMO

ATTACHMENT D: RESPONSES TO QUESTIONS FORM

Attachment F - RFP Question Submittal Form; Solicitation No. 75F40124R00181

Prospective Offerors must use this form to submit all questions in relation to Solicitation No.

75F40124R00181 The RFP Reference column should identify the RFP Section Title/Attachment associated with the question being asked.

# RFP

Reference

Section & Page #s Question Agency Response

1 Instructions to Offerors

Page 7 We are currently managing multiple year-end proposals. Could we request an extension of the submission deadline by an additional seven days?

The Government is not in a position to allow an extension for this procurement.

2 Labor Category Position Section

Could we request that the government consider lowering the educational requirement for the roles of Program Manager, Lead Scientific Project Manager II, and Project Manager II from a master’s degree to a bachelor’s degree? We propose this adjustment for candidates who have extensive experience, such as 12 years or more in the field, to better align with the depth of expertise needed for these positions.

The roles of Program Manager, Lead Scientific Project Manager II, and Project Manager II requirement at the master’s degree will remain to support the complexity and number of scientific studies and projects to support the future Sentinel 3.0 Data Hub procurement.

Instructions to Offerors

Pages 6 and 7 In the table on page 6, the government indicates there are 4 volumes. However, on page 7 the government indicates there are 2 volumes. Will the government clarify how many volumes the offeror should submit?

An amendment will be issued to clarify the Instructions to Offerors.

Offerors

Page 8 In the bulleted list of summary data to provide for prior relevant experience the government requests “Contract/Task Order Type”. Will the government clarify what it means by “type”?

Relevant experience for a contract would include but not limited to: Single Contract Award, Multiple IDIQ Contract Award with Task Orders, Blanket Purchase Agreement;

and Task Order Types include but not limited to: Time & Materials, Labor-hour, and Firm Fixed Price.

Offerors

Pages 10-11 In the table starting at the bottom of page 10 and continuing to page 11, the government instructs the offeror to include a cover letter, table of contents, and introduction to Factor 2. If the offeror provides these items at the beginning of volume, will it satisfy this requirement?

instructions for Factor 2.

Offerors

Pages 11 and 14-15 In the table on page 11, the government instructs offerors to address in the Technical Approach “Section 1 – The Offeror shall provide a comprehensive narrative demonstrating that it understands of all aspects of the requirements and standards. Section 2 – The Offeror shall provide a detailed written narrative demonstrating that its technical approach meets or exceeds all

The Offeror is responsible for reviewing the complete PWS solicitation and addressing the requirements and standards, as applicable, and submitting any/all responsive documents or attachments. The Government is will not provide an exhaustive list of requirement and standard details as this is a PWS. Written Submissions refers to all documents that are required to be submitted throughout the RFP solicitation. The Government will not requirements and standards for all PWS Task Areas 1-10…” However, in the Evaluation section page pages 14-15, the government says “FDA will evaluate whether the Offeror meets the technical requirements and the depth to which the Offeror has proposed an adequate Program Management Plan (PMP) inclusive of a Quality Management Plan, Risk Management Plan, Communication Management Plan, and Staffing Plan that demonstrates the capabilities to satisfy or exceed the requirements and standards of the PWS;

and that the Key Personnel meet minimum requirements.” (my highlights).

Will the government clarify what details are required as part of the Technical Approach? If these various plans are required (PMP, QMP, etc.), will the government provide additional page count to address these items?

provide an additional page count for PMP, QMP, RMP and Staffing Plan.

2. PROPOSAL

INSTRUCTIONS

Page 5, Page 12 Page 5 states: “The Offeror shall submit electronic documents using Microsoft Office suite products without the use of “macros”.” While page 12 states: “The pricing data shall be submitted in both PDF and MS Excel format for verification and evaluation purposes.” Please clarify if technical volume I submissions may be submitted as PDF files.

The Offeror may submit the Technical Volume 1 in PDF provided the proposal is also submitted in MS Word.

3. EVALUATION Page 10, Page 11 Please clarify that based on the table on Pages 10 and 11 the Government wants a separate cover page, table of contents, and introduction explicitly for the technical approach, or if the cover page, table of contents, and introduction should be for the whole Volume 1.

The Offeror shall include the cover page, table of contents, and introduction for the whole Volume I and not explicitly for the technical approach.

3. EVALUATION Page 10, Page 11 Please clarify if the cover page and table of contents count towards the 30 page limit for Volume I.

The following items are not included in the 30-page limit: Cover Sheet, Table of Contents, and Resumes.

3. EVALUATION Page 7 Page 7 reads: “Volume I response is limited to 30 pages” Please clarify if that is for the whole Volume (Factors 1, 2, and 3) or only Factor 2 Technical Approach.

Volume I is for the whole Volume (Factors 1, 2, and 3).

FACTOR NO. 2 -

TECHNICAL

APPROACH

Page 6, page 7 The table on page 6, Section 3 Evaluation indicates there will be 4 volumes, while the second paragraph on page 7 states:

“A complete proposal shall consist of two separate volumes. Volume I- Technical and Volume II Business/Price Proposal.” Please clarify how many volumes and distinct files the Government would prefer to receive.

See response to Question 3.

12 Factor No. 3 – Past Performance

Page 6 For Factor No. 3 – Past Performance, please clarify if the offeror should submit any content in section, or if the Government will only be considering PPQs sent in directly to the Government and PPIRS/CPARs.

The Offeror is not required to submit any content in this section. The Government will evaluate the extent to which the Offeror’s proposal demonstrates (within the last five (5) years) and successful performance of work similar in scope and size (dollar amount) to the requirements set forth in the statement of work.

Offerors are cautioned that the government may use data in addition to that provided be each offeror, to include data obtained from possible other sources such as Government past performance data bases (e.g., Contractor Performance Assessment Reporting System (CPARS) in evaluation of past performance.)

3. EVALUATION Page 7 Page 7 states: “Additionally, a PPQ shall be submitted for each of the past examples cited.” Please clarify if the ‘past examples’ refers to contracts references in Factor 1 Demonstrated Relevant Experience, or if it refers to separate examples described in Factor 3

– Past Performance.

The Government clarifies that the PPQ “past examples” refers to Factor 1 Demonstrated Relevant Experience;

however, the government shall evaluate all past performance as a risk assessment.

14 FACTOR NO. 1 –

DEMONSTRATE

D RELEVANT

PAST

EXPERIENCE

Page 7 Please clarify if the contract references provided for in Factor 1 Demonstrated Relevant Experience must be the same used in Factor 3 – Past Performance.

The contract references provided in Factor 1 Demonstrated Relevant Experience do not need to be the same used in Factor 3 – Past Performance.

15 FACTOR NO. 1 –

DEMONSTRATE

D RELEVANT

PAST

EXPERIENCE

Page 8 How many experience references may be cited in Factor 1 Demonstrated Relevant Experience?

Factor 1 states, “The Offerors may provide up to three (3) relevant recent examples of demonstrated prior experience in their submission. At least one (1) prior experience shall come from the offeror who will be the prime contractor for this requirement. Recent is defined as within the last five (5) years, and relevant is defined as being of a similar scope and complexity with the requirements in the

PWS.”

16 FACTOR NO. 3 –

PAST

PERFORMANCE

Page 15 Page 15 states “The government will assess its level of confidence that the Offeror possesses past performance experience from at least two (2) contracts and/or projects” Please clarify if there is a maximum number of contracts an offeror may submit Factor No. 3 Past Performance is a for this factor.

See response to Question 12. The Offeror is not required to submit any content in this section. The Government will evaluate the extent to which the Offeror’s proposal demonstrates (within the last five (5) years) and successful performance of work similar in scope and size (dollar amount) to the requirements set forth in the statement of work.

Offerors are cautioned that the government may use data in addition to that provided be each offeror, to include data obtained from possible other sources such as Government past performance data bases (e.g., Contractor Performance Assessment Reporting System (CPARS) in evaluation of past performance.)

17 FACTOR NO. 1 –

DEMONSTRATE

D RELEVANT

PAST

EXPERIENCE

Page 10 Please clarify that item #4 in the table should be a reference to PWS Task Area 8, not Task Area 7

On page 10, Table Item #4 references the PWS Task Area 7 Program Management Plans, starting on page 25 in Task Order 1.

18 FACTOR NO. 3 –

PAST

PERFORMANCE

Page 15 Can the Offeror submit CPARs in lieu of a

PPQ?

The solicitation requires the Offerors to arrange for the submission of the PPQs.

Each Organization that the PPQ is sent to will be responsible for completing the PPQ and then emailing an electronic copy to the Contract Specialist, Howard Yablon.

19 PROPOSAL

INSTRUCTIONS

N/A Given a number of questions are about the PPQs and past performance references, will the Government please consider a week extension to give time for PPQ turn around and modifications following Q&A?

See response to Question 1. The Government is not in a position to allow an extension for this procurement.

20 Attachment A, Sentinel Coordinating center, page 5

Is it the Government’s intention to incorporate the former functions of the SOC, IC and CBOC under the SCC as part of the PMT?

It is the Government’s intention to incorporate some of the former functions contracted to SOC, IC, and CBOC under the FDA SCC in conjunction with the PMO contractor. Reference Attachment Section A

1.3. for the description of the functions of the Sentinel 3.0 components.

21 Attachment A Page 8 diagram Would performing work under the PMO contract and bidding/winning/performing work under the Data Hub IDIQ create an OCI from

There are no known organizational and consultant conflicts of interest as it pertains to this acquisition. Consistent with the provision 3409.507-1 Conflict of Interest the Government’s perspective? Certification will be part of this solicitation to address any organizational or personal conflict of interest.

https://www.acquisition.gov/far/part-

9#FAR_9_508

22 Attachment A Page 4, Section 1.3 Is it the Government’s intention to contract directly with each data provider or to have the PMO subcontract to each one separately?

It is the Government’s intention to contract directly with each data provider.

23 Attachment A Page 4, Section 1.3 Will the PMO be responsible for data collection, cleansing reformatting, or is that under the SCC?

The PMO will not be responsible for data collection and cleansing, and reformatting.

This will be the responsibility of the SCC in conjunction with the contractors in the Sentinel 3.0 Data Hub.

24 Attachment A Page 5, Section 1.3.1 Is the PMT a contracted function or performed by the Government?

The PMT work is performed by the Government as described in Section 1.3.1:

“The Sentinel Coordinating Center (SCC) which is staffed by the FDA Sentinel Core Team (SCT) and is in the Office of Surveillance and Epidemiology (OSE), CDER.

The SCT is led by the Associate Director for Sentinel and is divided in two teams: the Epidemiology Team (EpiT) and the Program Management Team (PMT).”

25 Attachment A Page 4, Section 1.3 Is it the Government’s intention to take over former activities of the Innovation Centers or will that be addressed in a later procurement?

The SCT is responsible for providing the scientific, regulatory, strategic, and operational direction to the Sentinel System

3.0. Future methods development projects

will be the responsibility of the SCC in conjunction with the contractors in the Sentinel 3.0 Data Hub.

26 Attachment A Page 4, Section 1.3 Is it the Government’s intention to have the PMO take over the former activities under the CBOC or the former TO3 or will those activities be procured separately?

It is the Government’s intention to incorporate some of the former functions contracted to SOC, IC, and CBOC under the FDA SCC in conjunction with the PMO contractor. Reference Attachment Section A

1.3. for the description of the functions of the Sentinel 3.0 components.

27 Instructions_to_ offeror_and_ev aluation.docx_F

INAL_8_19_202

4_1_30_PM.pdf

3. Evaluation, Pgs. 6-7 The table on pg. 6 lists 4 volumes within the evaluation factors: Demonstrated Relevant Experience, Technical Approach, Past Performance, and Pricing. However, on pg. 7 it states “A complete proposal shall consist of two separate volumes. Volume I-Technical and Volume II Business/Price Proposal.”

(a) Please confirm that there should be four distinct volumes submitted as a part of the proposal submission. (b) Please confirm that the Offeror should submit each volume (I-IV) as a separate file.

See response to Question 3.

https://www.acquisition.gov/far/part-9#FAR_9_508

28 Instructions_to_ aluation.docx_F

INAL_8_19_202

4_1_30_PM.pdf

3. Evaluation, Pg. 7 RFP states: “All text of the body in Phase I Volume I response shall be black.”

Please clarify if this is a Phased approach and, if so, what components of the proposal are expected to be submitted for Phase I.

See response to Question 3.

29 Instructions_to_ aluation.docx_F

INAL_8_19_202

4_1_30_PM.pdf

3. Evaluation, Pg. 6-7 RFP states that the Volume I response is limited to 30 pages. Based on the table on Pg. 6, Volume I is Demonstrated Relevant Experience. (a) Please confirm that the page count for Volume I Demonstrated Relevant Experience is 30 pages and (b) please denote page limitations for the remaining Volumes II-

IV.

See response to Question 3.

An amendment will be issued to clarify the Instructions to Offerors.

There is no page limitation for Volume II.

30 Instructions_to_ offeror_and_ev aluation.docx_F

INAL_8_19_202

4_1_30_PM.pdf

3. Evaluation, Pg. 7 For Volume III Past Performance, (a) Please confirm that the Offeror should submit completed PPQs and (b) that PPQs should be the only component submitted within Volume III.

Each Organization that the PPQ is sent to will be responsible for completing the PPQ and then emailing an electronic copy to the Contract Specialist, Howard Yablon. Also, see response to Question 3 for the answer to b.

31 ATTACHMENT_

A_-

_IDIQ_SENTINEL

_SOW_8_19_20

24.pdf and

ATTACHMENT_

H_-

_TASK_ORDER_

1_-

_PWS_SENTINE

L_3.0_PMO.pdf _8_19_2024.pdf

IDIQ & Task Order Performance Work Statement - Sentinel Program Management Services and Operations

As Task Order and IDIQ task areas/deliverables are identical, please confirm that Offeror only needs to submit a single technical approach, and that separate technical responses to the IDIQ SOW (Attachment A) and Task Order 1 PWS (Attachment H) should not be submitted.

32 Instructions to Offeror / General

Background and Purpose Is there any potential OCI with future Sentinel work for the bidders that respond to this PMO IDIQ?

There are no known organizational and consultant conflicts of interest as it pertains to this acquisition. Consistent with the provision 3409.507-1 Conflict of Interest Certification will be part of this solicitation to address any organizational or personal conflict of interest.

https://www.acquisition.gov/far/part-

9#FAR_9_508

33 Instructions_to_ aluation.docx_F

INAL_8_19_202

4_1_30_PM.pdf

FACTOR NO. 1 –

DEMONSTRATED

RELEVANT PAST

EXPERIENCE, Pg. 7-8

For relevant experience examples within Volume I, can relative experience examples be federal, commercial and state/local quals?

Yes, relevant experience examples within Volume I can be contracts with federal, commercial and state organizations.

Howard – can you address local quals?

34 Instructions_to_ aluation.docx_F

INAL_8_19_202

4_1_30_PM.pdf

2. Proposal Instructions To give Offerors enough time to incorporate answers to questions, will the government consider extending the due date by two weeks?

The Government is not in a position to allow an extension for this procurement.

35 ATTACHMENT_

A_-

_IDIQ_SENTINEL

_SOW_8_19_20

24.pdf and

ATTACHMENT_

H_-

_TASK_ORDER_

1_-

_PWS_SENTINE

L_3.0_PMO.pdf _8_19_2024.pdf

5. Contract Type / Ceiling Amount – pg. 32 and 5.

Contract Type / Ceiling Amount – pg. 32

In Attachment A, the IDIQ estimated total value is shown as $9,500,00.00. In the second referenced document, Attachment H, the total estimated value is also $9,500,000.00. Additionally, Task Order i has same task areas/deliverables as the

IDIQ.

Based on this, are we to assume that Task Order 1 is comprised of the entire IDIQ or is the gov planning to issue additional task orders in the future under this IDIQ?

The Government has established a ceiling of $9.5M for the total value of the IDIQ contract that allows for future task orders within scope, noting that the IDIQ and Task Order I are slightly different.

36 ATTACHMENT_

B_Copy_of_Prici ng_Table_- _Sentinel_PMO _IDIQ.xlsx_FINA L.xlsx

IDIQ Summary Page - Task 10-Transition-Out Serv

The instructions section is unclear, and the Analysis Summary section seems to be part of the IGCE process. Please clarify the instructions for completion of the pricing table for both the IDIQ and Task Order 1.

An amendment will be issued to clarify the Instructions to Offerors.

Attachment B – Copy of Pricing Table – Sentinel PMO IDIQ, Analysis Summary section tab has been removed and Attachment I – Copy of Pricing Table Sentinel Task Order

37 ATTACHMENT_

A_-

_IDIQ_SENTINEL

_SOW_8_19_20

24.pdf

12. Key Personnel, pg. 28 Please confirm that the Offeror should only submit resumes for the three listed Key Personnel: Program Manager, Project Manager Lead, and Information Technology Lead.

The Government requires resumes for Key Personnel: Program Manager, Project Manager Lead, and Information Technology Lead; and all Labor Categories listed in Attachment C (a.k.a. Attachment E) in the solicitation.

38 ATTACHMENT_

B_Copy_of_Prici ng_Table_- _Sentinel_PMO _IDIQ.xlsx_FINA L.xlsx

Task 1-Collaboration Platform - Task 10- Transition-Out Serv

With this being the IDIQ workbook, is the Offeror required to fill out each Task worksheet in this workbook, or is the govt. only looking for the ceiling rates for each contract period?

Yes, the Offeror is required to complete both:

Attachment B – Copy of Pricing Table – Sentinel PMO IDIQ and Attachment I – Copy of Pricing Table Sentinel Task Order

39 ATTACHMENT_

B_Copy_of_Prici ng_Table_- _Sentinel_PMO _IDIQ.xlsx_FINA L.xlsx

Total ALL-Projects Is the Offeror required to fill out the referenced worksheets?

Yes, the Offeror is required to complete both:

Attachment B – Copy of Pricing Table – Sentinel PMO IDIQ and Attachment I – Copy of Pricing Table Sentinel Task Order

40 Instructions to Offerors

Pages 6 and 7 In the table on page 6, the government indicates there are 4 volumes. However, on page 7 the government indicates there are 2 volumes. Will the government clarify how many volumes the offeror should submit?

41 Instructions to

Page 8 In the bulleted list of summary data to provide for prior relevant experience the government requests “Contract/Task Order Type”. Will the government clarify what it means by “type”?

Relevant experience for a contract would include but not limited to: Single Contract Award, Multiple IDIQ Contract Award with Task Orders, Blanket Purchase Agreement;

and Task Order Types include but not limited to: Time & Materials, Labor-hour, and Firm

42 Instructions to

Pages 10-11 In the table starting at the bottom of page 10 and continuing to page 11, the government instructs the offeror to include a cover letter, table of contents, and introduction to Factor 2. If the offeror provides these items at the beginning of volume, will it satisfy this requirement?

An amendment will be issued to clarify the instructions for Factor 2.

43 Instructions to Offerors

Pages 11 and 14-15 In the table on page 11, the government instructs offerors to address in the Technical Approach “Section 1 – The Offeror shall provide a comprehensive narrative demonstrating that it understands of all aspects of the requirements and standards. Section 2 – The Offeror shall provide a detailed written narrative demonstrating that its technical approach meets or exceeds all requirements and standards for all PWS Task Areas 1-10…” However, in the Evaluation section page pages 14-15, the government says “FDA will evaluate whether the Offeror meets the technical requirements and the depth to which the Offeror has proposed an adequate Program Management Plan (PMP) inclusive of a Quality Management Plan, Risk Management Plan, Communication Management Plan, and Staffing Plan that demonstrates the capabilities to satisfy or exceed the requirements and standards of the PWS;

and that the Key Personnel meet minimum requirements.” (my highlights).

Will the government clarify what details are required as part of the Technical Approach? If these various plans are required (PMP, QMP, etc.), will the government provide additional page count to address these items?

The Offeror is responsible for reviewing the complete PWS solicitation and addressing the requirements and standards, as applicable, and submitting any/all responsive documents or attachments. The Government is will not provide an exhaustive list of requirement and standard details as this is a PWS. Written Submissions refers to all documents that are required to be submitted throughout the RFP solicitation. The Government will not provide an additional page count for PMP, QMP, RMP and Staffing Plan.

44 Instructions to Offerors

Page 8 In the bulleted list of summary data to provide for prior relevant experience the government requests “Contract/Task Order Type”. Will the government clarify

Relevant experience for a contract would include but not limited to: Single Contract Award, Multiple IDIQ Contract Award with Task Orders, Blanket Purchase Agreement;

and Task Order Types include but not limited what it means by “type”? to: Time & Materials, Labor-hour, and Firm

45 Attachment H - Task Order 1

Section 3, Task Area 5, Given that there is not enough time to provide an accurate estimate for potential software costs and that requirements would need to be vetted and finalized before software purchasing decisions can be made, would FDA provide a plug (or placeholder) dollar amount for the potential software license and hosting costs (e.g., medical code look-up tool)?

Yes, the Government agrees to allow an estimated dollar amount for the potential software licenses and hosting costs.

46 Instructions to Offeror and Evaluation

Evaluation, Page 7 Based on the overlap of the tasks in the IDIQ and PWS (SOW) and with a 30-page limit, can FDA confirm that our written response for the Technical Volume should address both the task areas in the Task Order 1 PWS (SOW) and the IDIQ task areas and that a separate response to the IDIQ tasks is not required?

47 Instructions to Offeror and Evaluation

Factor No. 1 – Demonstrated Relevant Past Experience, pages 7-

Given the short turnaround time for response, will FDA accept a CPARS as a substitute for one of the required PPQs?

The Government requires documentation that the Offerors have submitted PPQs to up to three (3) relevant recent examples of demonstrated prior experience in their submission.

48 Instructions to

Evaluation

1.1 Solicitation

Information, page 2

Can FDA confirm that proposed additional LCATs should be included in the Business Volume for both the IDIQ and for Task Order 1?

Yes, the Government confirms that the additional Labor Categories should be included in Business Volume for both the IDIQ and for Task Order 1.

50 Instructions to

Evaluation

Evaluation, Page 7 Can the FDA confirm that resumes in the appendix are excluded from the 30-page limit for the Technical Volume?

The Government confirms that resumes are not included in the page limit.

51 Attachment C Key Personnel, Page 2 Will FDA accept additional years of experience as a substitute for a Masters degree for the IT Project Manager key personnel role, per similar substitution allowances in GSA schedules?

The Government will accept additional years of experience as a substitute for a Masters degree only for the IT Project Manager Key Personnel Role.

52 Instructions to Offeror and Evaluation

Evaluation, Page 7 Has FDA conducted an assessment of alternatives for software to support the collaboration portal? If so, can FDA provide that assessment to the vendors?

The FDA has not conducted an assessment of alternatives (or equivalent) for software listed in the Attachment B - Task Order 1 Task Area 1, f, i, ii, iv (i.e., Jira, Wiki, BitBucket by Atlassian) to support the collaboration portal. However, FDA has conducted an evaluation of the Medical Code Look-Up Tool and include in the solicitation.

53 Attachment B –

Copy of pricing table Sentinel

PMO IDIQ

IQIQ Summary page and all sheets

There are two mentions of Project Manager II (line 18 and line 25). Is that intentional?

The Government confirms that the two mentions of Project Manager II (line 18 and line 25) was intentional.

ATTACHMENT

C: KEY

PERSONNEL

ATTACHMENT A

- IDIQ SENTINEL

SOW

Labor Category Position

Section 12 (key personnel)

Please confirm that Program Manager and Lead Scientific Project Manager II mentioned in the Attachment C, correspond to the two of the three key personnel at the IDIQ level –Program Manager and Project Manager Lead – mentioned in ATTACHMENT A - IDIQ SENTINEL SOW, section 12 Also, which labor category in Attachment C corresponds to the Information Technology Lead position in Attachment A section 12

The alignment of the labor categories listed in Attachment A: IDIQ Sentinel 3.0 PMO Section 12. Key Personnel and Attachment E

– Key Personnel Labor Categories are provided below:

• Program Manager aligns with Program Manager

• Project Manager Lead aligns with Project Manager II

• Information Technology Lead aligns with IT Project Manager

Attachment A – IDIQ Sentinel

SOW

Section 12 (key personnel)

Will the three indicated key personnel at the IDIQ level be fully funded (as full-time contractor employees) for the life of the IDIQ for retention purposes?

Attachment B – Copy of Pricing Table – Sentinel PMO IDIQ and Attachment I – Copy of Pricing Table – Sentinel PMO Task Order 1 requires the Offerors to propose the number of labor hours required to complete the work.

Attachment A – IDIQ Sentinel

SOW

CAS Cost Accounting System, Please confirm that this contract will have provisions for only T&M, FFP and LH task orders. No cost-reimbursable task orders will be made. As such the CAS requirements related to Cost reimbursement including invoicing (page 98, item e) would not apply.

The Government confirms that this contract will have provisions for only T&M, FFP and LH task orders and no cost-reimbursable task orders will be made. However, Other than Certified Cost and Pricing Data will be required as part of the PMO Monthly Report.

57 ATTACHMENT

C: KEY

PERSONNEL

Labor Category Position

Please confirm that the key personnel listed in IDIQ PMO SOW and Task Order 1 SOW are the only key positions applicable for this RFP response.

Please confirm that the Attachment C provides the labor category descriptions for both key and non-key positions and that not all positions listed in Attachment C are key personnel required for IDIQ and Task 1.

The Government confirms that the Key Personnel listed in the IDIQ PMO SOW and Task Order 1 PWS are the only Key Personnel labor categories applicable to this

RFP.

The Government confirms that the Attachment C – Key Personnel – Labor Category List Descriptions provides the labor category descriptions for both key and non-key personnel positions are the key personnel positions required for both the IDIQ and Task Order 1.

58 Attachment A Task Area 6, pages 20-21 Given that Task Area 6 is optional and details on the scope are limited, can FDA confirm that vendors do not need to submit pricing for Task Area 6 in the pricing tables?

The Government confirms that the Offerors do not need to submit pricing for Task Area 6 in the pricing tables.

59 Since this is a WOSB set-aside procurement, would the FDA expect the small business work-share requirements (minimum 51% of the labor dollars) to be applied at each individual task order level or at the overall IDIQ level, for

Yes, the FDA expects the small business work-share requirements (minimum 51% of the labor dollars) to be applied at each individual task order level and at the overall IDIQ level, for compliance purposes.

compliance purposes?

60 Attachment A

IDIQ SOW

Section 20, p. 100 Could the Government provide the attachment for IT Security and Privacy?

Attachment A IDIQ SOW List of Attachments page 49/53 list item “Attachment D- FDA IT Security and Privacy” will be posted on SAM.gov

61 n/a Could the Government consider an extension to allow at least 7 days after vendors receive responses back from Q&A to make necessary revisions?

The Government is not in a position to allow an extension for this procurement.

62 Attachment A PWS, and Attach E – Key Personnel Labor Category List

Section 12, Page 38 (Instructions);

Attachment E

The labor category titles in Attachment A: IDIQ Statement of Work in the Key Personnel table do not match with Attachment E – Key Personnel Labor category List. Will the Government revise each list so that they align to each other?

The Government has provided the alignment of the labor categories below in the Attachment A: IDIQ Sentinel 3.0 PMO Section 12. Key Personnel and Attachment E

– Key Personnel Labor Categories:

• Program Manager aligns with Program Manager

• Project Manager Lead aligns with Project Manager II

• Information Technology Lead aligns with IT Project Manager

63 Instructions Section 3, page 6 The table lists four separate volumes, whereas the instruction narrative describes two. Can the Government confirm the number of volumes and their components?

64 Instructions Factor No. 3, page 12 The Government states it may use CPARs. Will the Government accept CPARS in lieu of PPQs, given the short timeframe to respond to the solicitation, without any rating penalty?

The Government is not in a position to allow an extension for this procurement.

65 Attachment H Throughout Can the Government confirm that the Government will provide necessary software licenses to the Contractor for the Website, code repository, and collaboration platform? For example, the Government lists tools such as Atlassian and Jira.

The Contractor will purchase the licenses for the code repository and Collaboration Platform tools.

For the Sentinel Initiative Website, the Contractor will support and pay for the transfer of the website domain and provide the hosting platform.

66 Attachment H Task Area 1, p. 9; and 10.

Performance Evaluation Plan, pp. 35-36

Can the Government confirm that the Government does not require the Contractor to provide cloud hosting services, and that all hosted services will be hosted behind the Government firewall?

See Figure 2: Schematic of the Sentinel System 3.0.

The Collaboration Platform Requirements section indicates that the contractor shall “…b. Provide a secure Collaboration Platform in a cloud-based environment that includes a Collaboration Portal.” Page 10 The Collaboration Platform is located outside of the FDA firewall and shall “h.

Comply with the Federal Information Security Management Act (FISMA), Federal Risk and Authorization Management

Program (FedRAMP), and Section 508 of the Rehabilitation Act (IT Accessibility Laws and Policies - Section508.gov) compliant”. Page

Although the PMO Contractor will have access to Government Furnished laptops, the Collaboration Platform is located outside of the FDA firewall and can be accessed via the Government Furnished laptops.

67 General Will the FDA respectfully move the due date to 4 to 6 weeks so we have adequate time to put together a comprehensive response?

The Government is not in a position to allow an extension for this procurement.

68 General Would FDA consider changing this request to SDVOSB set aside.

No

69 General We are currently managing multiple year-end proposals and would greatly appreciate an extension of the submission deadline of the proposal mentioned for

'SENTINEL SYSTEM 3.0: PROGRAM

MANAGEMENT ORGANIZATION (PMO)' by seven additional days.

70 General We respectfully request that you make this a multi-award ID/IQ and award it to F&O and SB categories.

71 General request 6 weeks extension to proposal due date

No

72 General consideration for recategorizing the FDA Sentinel procurement from a Woman Owned Small Business WOSB set aside to a Woman Owned Business, Other Than Small.

No

73 General a 4-week extension on the proposal deadline

No

74 General Is there an incumbent on this contract? No

75 General Could you please confirm that the scope of the Program Management Organization (PMO) opportunity mentioned below is the same scope

Confirmed included with the RFI notice?

76 General will this procurement be restricted to Small Businesses and will there be any socio-economic restrictions?

Woman owned small business