Questions_Answers_SOL_75F40126R00042.pdf

# RFP Doc Section Page # Question Answer 1 N/A N/A N/A We would like to know if this is a brand new contract OR if there is (was) an incumbent performing these services. If not brand new, could you please provide the current / previous contract number?

This is a recompete. Current FARM award #UR1757018923D/75F40125C00100 w/

Strategamy, LLC.

2 N/A N/A N/A The solicitation states that 'Only those companies certified by the U.S. Small Business Administration as an 8(a) business that have not graduated from the program are eligible for award.' Our firm is a small business but does not currently hold 8(a) certification. Please confirm whether a non-8(a) firm may participate as a subcontractor or teaming partner under an 8(a)-certified prime for this IDIQ, and if so, whether there is any limitation on the percentage of work the subcontractor may perform.

Subcontractors are not required to be 8(a) Program Participants. Offerors may propose non- 8(a) subcontractors, subject to the requirements of the solicitation and the applicable limitations on subcontracting at FAR 52.219-14. See doc SOL_RFP_75F40126R00042_Amendment_1 - page 1 - Section iv.

3 SOL_RFP_75F40126R00042 Relevant Experience, Volume I 5 The relevant experience instructions ask Offerors to provide 'a written narrative describing at least three (3) Government experiences (Federal, State, and Local, Commercial Customers) that are like this effort in terms of type, scope, complexity, technology, and size.' Please clarify whether commercial-sector contracts (i.e., non-government customers) are weighted equally with Federal, State, or Local government contracts for purposes of the Phase I relevant experience evaluation, or whether preference is given to government contracts specifically.

All exerpeience submissions are evaluated equally. "Commerical Customers" removed from project/experience type. See doc SOL_RFP_75F40126R00042_Amendment_1

4 SOL_RFP_75F40126R00042 Relevant Experience, Volume I 5 For the relevant experience projects submitted under Phase I, must the Offeror have served as the prime contractor on each referenced project, or may experience performed as a subcontractor also be submitted to satisfy the O&M, DME, and Artificial Intelligence experience requirements?

The Offeror may have performed as the Prime, subcontractor or team lead in a teaming arrangement. See doc SOL_RFP_75F40126R00042_Amendment_1

5 SOL_RFP_75F40126R00042 Relevant Experience, Volume I 5 The requirements state that 'at least one (1) project must also involve Artificial Intelligence applications to enhance the findability of relevant records or information from various IT systems or to automate regulatory review processes, document processing, or decision support capabilities.' Please confirm whether this AI-related project may be the same project submitted to satisfy the O&M or DME experience requirement, or whether it must be a distinct, fourth project narrative.

Submissions shall be three (3) separate experiences. See doc SOL_RFP_75F40126R00042_Amendment_1

6 SOL_RFP_75F40126R00042 Relevant Experience, Volume I 5 The scope identifies Appian and Java application programmers as labor categories. Will the Government accept demonstrated experience on functionally equivalent low-code/BPM platforms

(e.g., Pega, Camunda, OutSystems, ServiceNow, or Microsoft Power Platform) as satisfying the Appian labor category mapping for purposes of the Relevant Experience narrative, or is specific Appian-platform certification mandatory for any labor category mapped to the Appian role?

No. Appian is a major component of the FARM system.

7 Attachment_A_Pricing Schedule and LCAT IDIQ Labor Category Rates / Task Order #1 Pricing N/A The solicitation indicates pricing must be broken down by task sections from the SOW and separately requests 'Discounts for the Task Order' and 'Discounts for the IDIQ.' Please clarify: (a) What is the distinction between IDIQ-level discounts and TO-level discounts — does the IDIQ discount apply to the base loaded labor rates across the five-year ordering period, with TO-level discounts applied on top of

IDIQ-discounted rates? (b) How will the Total Evaluated Price be computed given that no Government-furnished hour estimate or TO-level labor mix is attached to the solicitation, and how should

Discount instructions REMOVED from Task Order #1 Pricing Tab. See doc Attachment_A_Pricing Schedule and LCAT_Amendment_1

8 Attachment_1_IDIQ_SOW 1.3.3.5. Integration with Interfacing Systems 8 Given that the summary references integration among FARM, CERES, TRAM, STARI, and WILEE but the SOW does not detail the specific data flows or shared services architecture between these systems, will the Government make available any system architecture diagrams, interface control documents, or data flow specifications describing these integration points prior to the Phase II technical approach submission?

FARM, CERES, TRAM, STARI, and WILEE integrated within FDA intranet network. FARM has bi-directional with these systems. No diagrams, documents, or specifications will be made available.

9 N/A N/A N/A For Task Order #1 – Operations & Maintenance, will incumbent contractor documentation, current system inventories, or transition-in artifacts for FARM, CERES, TRAM, STARI, and WILEE be provided to all Offerors during the solicitation period, or only to the awardee during transition?

Information will be made available to awardee during the Transition-In phase.

10 SOL_RFP_75F40126R00042 Advisory Down-Selection Notification 3 After Phase I evaluation, approximately how many Offerors does FDA anticipate advancing to Phase II? Will this anticipated quantity be disclosed in the Phase I advisory down-select notice, or should

Offerors assume that all Phase I-eligible Offerors continue to Phase II for purposes of proposal preparation and resource planning?

The Government will determine the appropriate number of Offerors for Phase II that is most beneficial to the Government. However, the Government’s advice will be a recommendation only, and those Offerors who are advised not to proceed may elect to continue their participation in the procurement. The evaluation criteria for Phase I is provided under SOL RFP 75F40126R00042 Amendment 1 11 SOL_RFP_75F40126R00042 Relevant Experience, Volume I 5 For the Phase I Relevant Experience Factor, what is the Government's recency window for submitted past performance narratives — is the standard 'within the last three (3) years from the date of proposal submission' window used, or does this procurement accept a longer window (e.g., five to ten years) for projects whose type, scope, complexity, technology, and size remain highly relevant?

Experience submissions can be ongoing or have been completed within the last three (3) years. See doc SOL_RFP_75F40126R00042_Amendment_1

12 SOL_RFP_75F40126R00042 Volume II: IDIQ Technical Proposal Instructions & Evaluation Criteria (50-page limit) (PHASE II)

7 Please confirm whether proposed Key Personnel resumes and supporting certifications must be submitted with the Phase I proposal (Tab A, 6-page Volume I / 50-page Volume II limit) or are deferred entirely to the Phase II submission (Tab B and Tab C). If Key Personnel are required in Phase I, may the resumes submitted in Phase I be replaced or supplemented at the time of any subsequent

Task Order award?

Key Personnel is required under Phase II

13 SOL_RFP_75F40126R00042 Relevant Experience, Volume I 5 Tab A requires at least three experiences that are like this effort, including at least one Operations and Maintenance project, at least one Development, Modernization and Enhancement project, and at least one involving Artificial Intelligence applications. May a single contract satisfy more than one of these three requirements if the narrative demonstrates all of the relevant elements, or must each requirement be met by a separate contract?

See response to question #5

14 SOL_RFP_75F40126R00042 Relevant Experience, Volume I 5 May an Offeror include the relevant experience of a proposed subcontractor or teaming partner in the Phase I submission, and if so, how will the Government weight subcontractor experience relative to the prime's own experience?

For purposes of Phase I, Relevant Experience Factor 1 evaluates the relevant experience of the Offeror. An Offeror may submit its experience obtained while performing as a prime contractor, subcontractor, or team lead, as provided in the solicitation. Experience performed solely by a proposed subcontractor or teaming partner will not be considered as the Offeror's relevant experience under Factor 1. If experience is performed as a subcontractor, teaming partner, or other entity the portion of the work performed by the

Offeror must be similar to the requirements in terms of type, scope, complexity, technology, and size. See doc SOL_RFP_75F40126R00042_Amendment_1

15 SOL_RFP_75F40126R00042 Relevant Experience, Volume I 6 For the Size criterion, the solicitation states that at least one relevant experience must reach a stated dollar value. Please confirm the specific dollar threshold the Government will apply, and whether the value is measured by total contract value including options or by obligated value to date.

Per the SOL_RFP_75F40126R00042 "Size: is defined as the total dollar contract value per year, at least one relevant experience is required to have a minimum dollar value

$1,000,000.00 in which they were the Prime contractor." See doc SOL RFP 75F40126R00042 Amendment 1

16 SOL_RFP_75F40126R00042 Relevant Experience, Volume I 5 Is there a recency requirement for the relevant experience projects, for example completed or active within the last three or five years?

See response to question #11

17 SOL_RFP_75F40126R00042 Relevant Experience, Volume I 55 Does the six page limit for Tab A include the cover page, and does it include any tables, graphics, or contract identification information?

Phase I shall be no greater than six (6) pages exluding the cover page and Offeror Information and Confirmation. If a cover page is used by the Quoter, it must be no greater than two (2) pages but will not be evaluated and Quoter Information and Confirmation must be no greater than one (1) page. See doc

SOL RFP 75F40126R00042 Amendment 1 18 SOL_RFP_75F40126R00042 Relevant Experience, Volume I 5 Are past performance questionnaires, CPARS records, or client points of contact required with the

Phase I submission, or is the written narrative sufficient at this stage?

No

19 SOL_RFP_75F40126R00042 Relevant Experience, Volume I - Scope, technology and incumbency

5 The DME criteria reference workflow automation using platforms such as Appian. Will the Government consider experience with other commercially available low code workflow and case management platforms as equally relevant, provided the narrative demonstrates comparable capability?

Appian is a major component of the FARM system. Appian experience is required.

20 SOL_RFP_75F40126R00042 Relevant Experience, Volume I - Scope, technology and incumbency

5 Are the FARM, CERES, TRAM, STARI and WILEE systems currently built on a specific commercial platform or technology stack? If so, please identify it, so that Offerors can address the correct technology in their narratives.

Current FARM System technology stack is provided within Attachment_1_IDIQ_SOW_Amendment_1 - Page 3 - Table 2

21 SOL_RFP_75F40126R00042 Relevant Experience, Volume I - Scope, technology and incumbency

5 Is there an incumbent contractor supporting these systems today? If so, please identify the incumbent and the current contract number.

See response to question #1

22 SOL_RFP_75F40126R00042 Relevant Experience, Volume I - Scope, technology and incumbency

5 For the Artificial Intelligence experience requirement, will the Government consider machine learning applied to enterprise search, document processing, anomaly detection, or decision support as satisfying the requirement, or is a specific class of AI capability expected?

Yes

23 SOL_RFP_75F40126R00042 Set-aside, structure and timing 1 The solicitation is identified as an 8(a) competed set-aside. Please confirm that the Offeror must hold current 8(a) certification at the time of the Phase I submission, and confirm the treatment of subcontractors who are not 8(a) participants.

The prime Offeror must meet the applicable 8(a) Program eligibility requirements at the time of submission of its Phase I proposal in accordance with FAR 52.219-18. SBA will determine the eligibility of the apparent successful Offeror in accordance with applicable 8(a) Program requirements.

Subcontractors are not required to be 8(a) Program Participants. Offerors may propose non- 8(a) subcontractors, subject to the requirements of the solicitation and the applicable limitations on subcontracting at FAR 52.219-14.

For purposes of Phase I, Relevant Experience Factor 1 evaluates the relevant experience of the Offeror. An Offeror may submit its experience obtained while performing as a prime contractor, subcontractor, or team lead, as provided in the solicitation. Experience performed solely by a proposed subcontractor or teaming partner will not be considered as the Offeror's relevant experience under Factor 1. If experience is performed as a subcontractor, teaming partner, or other entity the portion of the work performed by the

Offeror must be similar to the requirements in terms of type, scope, complexity, technology, and size. See doc SOL_RFP_75F40126R00042_Amendment_1

24 Attachment_1_IDIQ_SOW Set-aside, structure and timing 12 Please confirm the anticipated IDIQ ceiling value, the number of awards contemplated, and whether the Government intends a single award or multiple awards.

IDIQ Maximum = $25,000,000.00 / Single Award

25 SOL_RFP_75F40126R00042 Set-aside, structure and timing N/A The solicitation states the Phase II due date will be provided in the Advisory Notification letter.

Approximately how many days after the Phase I advisory notice does the Government anticipate the

Phase II submission being due?

The Phase II submission due date and time will be provided in the Advisory Notification letter.

26 SOL_RFP_75F40126R00042 Set-aside, structure and timing N/A Will the Government provide the Phase I question responses to all Offerors, and will the responses be incorporated into the solicitation by amendment?

Questions/Answers (Q&A) will be posted to SAM.Gov. Any amendments will be posted to SAM.GOV based upon Q&A period.

27 SOL_RFP_75F40126R00042 /

Attachment_A_Pricing Schedule and LCAT

Set-aside, structure and timing Attachment A includes a pricing schedule and labor category structure with suggested hours. Please confirm whether the labor categories and hour estimates are fixed for evaluation purposes in Phase II, or whether Offerors may propose an alternate labor mix.

Labor Categories are fixed. The Government removed evaluation language contained within the SOL_RFP_75F40126R00042 - Volume III: Tab B Business/Price Proposal. See doc

SOL RFP 75F40126R00042 Amendment 1 28 Attachment_1_IDIQ_SOW /

Attachment_2_TO1_SOW_OM

1.3.4.1 / 4.2.5 (Task 6) 8 / 21 The SOW references coordination with “the incumbent Contractor” for Transition-In support. Can FDA identify the incumbent contractor(s) currently supporting FARM O&M and the associated contract number/vehicle so that offerors can appropriately scope transition risk and staffing?

See answer to question #1

29 Attachment_1_IDIQ_SOW / Attachment_2_TO1_SOW_OM

1.3.4 / 6 8 / 24 Attachment_1 designates Task Area 4 (Transition-In and Transition-Out) as Labor-Hour, while Attachment_2 Section 6 states the entire Task Order Type is Firm-Fixed Price (FFP), and Tasks 6/7

(Transition-In/Out) fall under that same task order. Can FDA confirm whether Transition-In/Transition- Out support under Task Order #1 should be priced as FFP or Labor-Hour?

Transition-In & Transition-Out (Task Area 4) revised to Firm Fixed Price. See doc Attachment_1_IDIQ_SOW_Amendment_1

30 N/A N/A N/A Can we get the incumbent name and contract number? Also, what was the previous spent? How many TOs were awarded? What are the estimated resources annually?

See answer to question #1

31 Attachment_1_IDIQ_SOW 1.3.3.5 7 Section 1.3.3.5 requires the Contractor to enhance integration between FARM and interfacing systems including EASE, TRAM/CERES, STARI, G-SRS, HFP-DW, and WILEE. Can FDA provide brief descriptions

(or reference documentation) for EASE, G-SRS, and HFP-DW, as these are not defined elsewhere in the solicitation package?

See answer to question #20

32 SOL_RFP_75F40126R00042 Relevant Experience, Volume I 5 Can FDA confirm that Volume I, Tab A (Relevant Experience Criteria) is the complete past performance evaluation mechanism for Factor 1, and that no separate Past Performance Questionnaire (PPQ) or

CPARS/PPIRS-based past performance report needs to be submitted by the Offeror or distributed to references?

See answer to question #18

33 SOL_RFP_75F40126R00042 VOLUME III: TAB B: BUSINESS/PRICE PROPOSAL 11 The RFP states that price evaluation will be based on “FDA provided labor categories and hours” and that the hours listed are “suggested figures for evaluation purposes only.” However, the “Labor

Hours” column in the Task Order #1 Pricing tab of Attachment_A is blank for all labor categories, tasks, and ordering periods. Can FDA provide the suggested/estimated labor hours referenced in the

RFP text, or confirm that Offerors are to propose their own hours with no FDA-provided baseline?

Yes. See doc Attachment_A_Pricing Schedule and LCAT_Amendment_1

34 SOL_RFP_75F40126R00042 Relevant Experience, Volume I 3 / 4 / 55 Table 1 lists the 6-page limit specifically for Tab A (Relevant Experience Criteria). Section xiii describes the full “Phase I items” submission as limited to six pages excluding the cover page. Can FDA confirm whether the 6-page limit applies only to Tab A, or to the combined Volume I submission (Tabs A and

B)?

See answer to question #17

35 Attachment_2_TO1_SOW_OM Task Order #1's scope of work (Sections 3 and 4.2) is limited to Operations & Maintenance of the existing FARM system. However, Section 7 (Key Personnel) requires an Applications Programmer III

(Appian) responsible for designing, developing, implementing, and maintaining complex applications, and administering the Appian instance. Can FDA clarify whether new Appian workflow development is in scope for Task Order #1, or whether this role is limited to O&M support (bug fixes, minor enhancements) of existing Appian-based workflows?

O&M support also includes bug fixes and minor enhancements of existing Appian-based worflows

36 Attachment_A_Pricing Schedule and LCAT IDIQ Labor Category Rates The IDIQ Labor Category Rates tab instructs that “the proposal shall provide the fully burdened hourly rate for each labor category... for work performed at Contractor Site,” yet the worksheet includes separate rate columns for both “Government Site” and “Contractor Site” for every labor category and ordering period. Given the SOW's place of performance is primarily FDA facilities, can FDA confirm whether Offerors must propose rates for both Government Site and Contractor Site for every labor category, or only for the site(s) where that role is actually anticipated to perform?

Per Attachment_A_Pricing Schedule and LCAT__Amendment_1 - IDIQ Notes & Assumptions Tab - "Where work will be performed: College Park, MD (Government site) and/or North

Bethesda, MD (Government site) and Contractor sites." The Government has added language "and Government" to IDIQ Labor Category Rates tab - " See doc

Attachment_A_Pricing Schedule and LCAT_Amendment_1

37 SOL_RFP_75F40126R00042 Task Order #1 Staffing Plan 8 The Task Order #1 Staffing Plan instructions (Volume II, Tab B) direct Offerors to “complete the Task Order #1 Pricing (Attachment_A_Pricing Schedule and LCAT),” which contains fully burdened rates and cost totals. This appears to conflict with the instruction that “NO PRICE INFORMATION IS TO BE INCLUDED IN VOLUME I or VOLUME II.” Can FDA confirm whether the version of Attachment_A submitted with the Staffing Plan should exclude pricing/rate columns, and only the pricing volume (Volume III) should include the fully priced workbook?

Confirmed

38 SOL_RFP_75F40126R00042 The RFP states that teaming/partnering agreements and subcontractor letters of commitment submitted under Volume III “will not count towards the page limitation.” Can FDA confirm whether

Key Personnel resumes (3-page limit each) and letters of commitment (1-page limit each) submitted under Volume II are similarly excluded from Volume II's overall 50-page limit, or whether they count against it?

The Government can confirm Key Personnel Resumes and Letters of Commitment will be excluded from Volume II 50-page limit and should be clearly identified as an Appendix. See doc SOL_RFP_75F40126R00042_Amendment_1

39 SOL_RFP_75F40126R00042 For the "Confirmation of 8(a) status," is the Offeror required to provide a narrative statement, or should a copy of the SBA 8(a) Certification letter be attached? If the letter is attached, does it count against the 6-page limit?

See answer to question #17

40 Attachment_1_IDIQ_SOW Could the Government confrim the anticipated duration of the Transition-In and out both for the IDIQ SOW, and the Task Order #1 SOW?

30 Days for Transition-In and 30 Days for Transition-Out

41 SOL_RFP_75F40126R00042 Volume II (IDIQ Technical Proposal) has a 50-page limit. The solicitation page 8 states that resumes and letters of commitment should be submitted "in an appendix to the Staffing Approach." Can the

Government confirm that these appendices (Resumes and Letters of Commitment) are excluded from the 50-page limit?

See answer to question #38

42 SOL_RFP_75F40126R00042 The solicitation states that "The Offeror shall provide letters of commitment for everyone identified as key personnel." Can the Government clarify if a signed Letter of Commitment is required for internal candidates who are currently full-time employees of the Offeror, or is this requirement intended only for contingent hires and subcontractor personnel?

Per the SOL_RFP_75F40126R00042_Amendment_1 "The Offeror shall provide letters of commitment for everyone identified as key personnel"

43 SOL_RFP_75F40126R00042 For Volume II, Tab A (Factor 2), the instructions require a "detailed narrative," while the section title is "IDIQ Overall Understanding & Approach." Given that Tab B requires a specific, deep-dive approach to

Task Order #1 (O&M), can the Government clarify if Tab A must explicitly and individually address each of the four (4) Task Areas defined in the IDIQ SOW (1.3.1 through 1.3.4), or is the Government seeking a high-level, holistic summary of the IDIQ's strategic objectives in this section?

Tab A "shall provide a detailed narrative of it’s understanding and approach to providing the requested IDIQ services", while Tab B "shall provide a detailed narrative of its understanding and approach to performing each of the tasks described in the Task Order 1 SOW with minimum interruption to business operations".

44 SOL_RFP_75F40126R00042 Volume II, Tab B of the Solicitation provides specific response headings (e.g., Operations Approach, Maintenance & Database Support Approach, etc.), while Section 4 of the Task Order SOW defines the scope using Tasks 1 through 7. Can the Government confirm that Offerors should utilize the headings provided in the Solicitation (p. 8-10) for the technical response, integrating the requirements of SOW

Tasks 1 through 7 into those relevant sections rather than providing a separate point-by-point response to the SOW Task Areas?

Confirmed

45 SOL_RFP_75F40126R00042 The top-level instructions for Tab B (p. 8) require a narrative of the Offeror's "understanding and approach." However, the subsequent sub-headings on pages 9 and 10 (e.g., Operations Approach, Maintenance & Database Support Approach, etc.) only request the "approach." Can the Government clarify if it prefers an overarching "Project Understanding" or should Offerors address an

"Understanding and Approach" narrative into each individual section (Operations, Maintenance, Release Management etc )?

Per the SOL_RFP_75F40126R00042_Amendment_1 - Tab B: Subfactor 1: Approach to Task Order #1 (Operations & Maintenance) - "The Offeror shall provide a detailed narrative of its understanding and approach to performing each of the tasks described in the Task Order 1

SOW with minimum interruption to business operations. The narrative should describe the Offeror’s understanding of the project both from a technical and compliance standpoint."

46 SOL_RFP_75F40126R00042 The solicitation requires the submission of signed "teaming/partnering agreements." For Offerors bidding as a Joint Venture (JV), can the Government confirm that this requirement refers to the full, signed JV Agreement?

Confirmed

47 SOL_RFP_75F40126R00042 The solicitation requires "signed letters of commitment" for major subcontracts (>10%). Given that the previous paragraph also requires the submission of "teaming/partnering agreements," can the

Government clarify if a fully executed Teaming Agreement may be submitted in lieu of a separate Letter of Commitment, provided the agreement defines the contractual relationship and the proportion of work to be performed?

No. Offeror's "shall submit signed letters of commitment from the subcontractors which define the contractual relationship and identify contribution to the planned arrangement in terms of the type and proportion of work to be performed." This is in addition to the signed teaming/partner arragements submitted.

48 SOL_RFP_75F40126R00042 The solicitation requires at least three (3) project references, noting that at least one (1) must demonstrate O&M, one (1) must demonstrate DME, and one (1) must involve AI. Can the

Government clarify if a single project reference may be used to satisfy more than one of these requirements (e.g., a single project that covers O&M, DME, and AI) or is it the Government’s intent that these three specific areas be demonstrated across separate and distinct project references?

See answer to question #5

49 SOL_RFP_75F40126R00042 The current deadline for questions is August 7, 2026. Given the phased nature of this procurement, will the Government established a secondary question-and-answer period specifically for Phase

II (Technical and Pricing) after the Phase I advisory down-selection notifications have been issued?

The Government may establish a brief Q&A period specifically for Phase II.

50 SOL_RFP_75F40126R00042 RFP Table 1 defines the Volume structure for Phases 1 and 2. Please confirm if TAB B is outside the 6-page limit for Volume 1?

See answer to question #17

51 SOL_RFP_75F40126R00042 Will the government allow table of contents, cover letter, acronym list, and appendices for Volumes 1 through 3 to be excluded from the page limitations?

See answer to question #17 and #38 for page limitation exclusions. All other items will be counted towards page limits.

52 SOL_RFP_75F40126R00042 /

Attachment_A_Pricing Schedule and LCAT

RFP Volume III, Tab B states that FDA will evaluate pricing based on “FDA provided labor categories and hours for all ordering periods,” but the Labor Hours fields in Attachment A, Task Order #1 Pricing, are blank. Will FDA provide the labor hours that all offerors must use for price evaluation, or must each offeror propose its own labor hours?

Yes. See doc Attachment_A_Pricing Schedule and LCAT_Amendment_1

53 Attachment_A_Pricing Schedule and LCAT Attachment A requires separate Government Site and Contractor Site rates and prices, but the solicitation does not prescribe the labor hours to be performed at each location. Will FDA provide a common Government Site and Contractor Site hour allocation for evaluation, or must each offeror propose its own location mix?

See answer to question #36. The Government will not provide hours.

54 Attachment_A_Pricing Schedule and LCAT RFP Volume III requires pricing for all requirements and states that the basic requirement and all options will be included in the evaluated price. Attachment A states that Transition-In and Transition-

Out costs are excluded from Total Evaluated Price. Will Tasks 6 and 7 be priced but excluded from price evaluation?

Confirm Tasks 6&7 (Transition-In & Transition-Out) will be priced but excluded from price evaluation. Language added to Evaluation of Proposal section to clarify. See doc

SOL_RFP_75F40126R00042_Amendment_1

55 Attachment_A_Pricing Schedule and LCAT Attachment A, Task Order #1 Pricing, includes Labor Hours, Hourly Rate, Discount Percentage, and Proposed Rate columns, but the task-total formulas sum the Proposed Rate cells without multiplying the proposed rates by labor hours. Should offerors enter a discounted hourly rate or an extended labor price in each cell labeled “Proposed Rate”?

Discount language removed from IDIQ Labor Category Rates Tab. Attachment_A_Pricing Schedule and LCAT_Amendment_1 - Task Order #1 Pricing Tab revised to include Labor

Hours, IDIQ Government Site Rate (Fully Burdened), Discount % for TO1, TO1 Government Site Rate, Sub-Total Estimated for Labor Category (Gov Site), Labor Hours, IDIQ Contractor

Site Rate (Fully Burdened), Discount % for TO1, TO1 Contractor Site Rate, Sub-Total for Labor Category (Contractor Site). The Government is requesting discounts only at the TO level. Offeror's should complete formulas within each labor category. Formulas for each POP, Total evaluated price, and Transition services were completed by the Government.

See doc Attachment_A_Pricing Schedule and LCAT_Amendment_1

56 SOL_RFP_75F40126R00042 RFP Table 1 limits Volume II to 50 pages, while Volume II, Tab B requires key-personnel resumes, non-key-personnel resumes, key-personnel commitment letters, a draft Project Management Plan, and a

Work Breakdown Structure. Are these items excluded from the 50-page Volume II limit?

See answer to question #17 and #38 for page limitation exclusions. All other items will be counted towards page limits.

RFP – Volume III: Business/Price Proposal;

Attachment A – Task Order #1 Pricing

11; Excel tab The RFP states that the Government will evaluate pricing using FDA-provided labor categories and hours. However, the labor-hour fields in Attachment A are blank. Please provide the Government-estimated labor hours by task, labor category, site, ordering period, transition task, and FAR 52.217-8 extension period, or confirm that offerors are expected to independently propose all labor hours.

Confirmed

Attachment A – Task Order #1 Pricing

N/A – Excel tab Attachment A provides fields for labor hours and proposed hourly rates but does not provide an extended-price field calculated as labor hours multiplied by proposed rate. The existing task and summary formulas appear to total proposed hourly rates rather than extended dollar amounts. Please issue a corrected pricing workbook that calculates extended prices and total evaluated price, or provide detailed instructions for modifying the workbook.

See answer to question #55

Attachment A – Task Order #1 Pricing, Cell K9

N/A – Excel tab Cell K9, identified as the Government-site total for Option Period 4, currently contains the formula =SUM(K8,AH27,AH40,AH53,AH66,AH79), which incorporates the Option Period 3 total from cell K8 in addition to the Option Period 4 task totals. Please confirm that K8 should be removed and issue a corrected workbook with all formulas validated by the Government.

See doc Attachment_A_Pricing Schedule and LCAT_Amendment_1

Attachment A – IDIQ Labor Category Rates and Task Order #1 Pricing

N/A – Excel tabs Please clarify whether offerors must propose separate labor hours for Government-site and contractor-site performance. If so, where should the hours for each performance location be entered, since each period contains only one labor-hours column but separate Government-site and contractor-site rates?

Offerors shall propose aplicable labor hours for both sites. See doc Attachment_A_Pricing Schedule and LCAT_Amendment_1

Attachment 1 – IDIQ SOW, Section 3.3, Place of Performance; Attachment A

11; Excel tab Please clarify whether personnel working remotely using an FDA-issued laptop and FDA VPN are considered to be performing at the Contractor Site for pricing purposes, regardless of the individual employee's physical telework location.

For purposes of the pricing schedule, Government Site applies to work performed while the individual is physically located at an FDA facility. Contractor Site applies to authorized work performed at a contractor facility or other approved remote/telework location.

Attachment A – IDIQ Labor Category Rates, Instruction 4

N/A – Excel tab Instruction 4 directs offerors to provide fully burdened rates for work performed at the contractor site, but the worksheet contains rate columns for both Government-site and contractor-site performance. Please confirm whether offerors must complete both sets of rate columns for every ordering period and the FAR 52 217-8 extension

See answer to question #36

Attachment 2 – TO1 SOW, Section 6, Task Order Type; RFP – Volume III; Attachment A

24; 11; Excel tab TO1 is identified as Firm-Fixed-Price, but Attachment A requests labor hours and hourly rates. Please confirm that: (a) the labor mix and hours are required only to establish the reasonableness of the proposed FFP price; (b) the resulting FFP amount will be contractually binding regardless of actual labor hours incurred; and (c) TO1 will not be administered or invoiced as a Labor-Hour order.

Confirmed

Attachment 1 – IDIQ SOW, Section 4.5.2, Pricing of Orders

14–15 The IDIQ SOW states that task-order rates must be equal to or less than the applicable IDIQ ordering-period rates. Please confirm that each TO1 Government-site or contractor-site proposed rate must be at or below the corresponding site-specific IDIQ ceiling rate.

Confirmed

RFP – Pricing and Evaluation of Options;

Attachment A – Task Order #1 Pricing, Instruction 6

1–2, 11, 13; Excel tab

Attachment A states that transition-in and transition-out costs are excluded from total evaluated price. The RFP requires pricing for all line items and states that the Government will evaluate the basic requirement and all options, including the option to extend services. Please confirm: (a) whether Tasks

6 and 7 must be priced; (b) whether those prices will be incorporated into the awarded contract; and

(c) whether they will be excluded from the evaluated price used for the best-value tradeoff.

Confirmed

RFP – CLIN 6, FAR 52.217-8 Extension;

Attachment A

1–2; Excel tab Please confirm whether offerors must propose a separate six-month labor mix and FFP amount for the FAR 52.217-8 extension, as presented in Attachment A, or whether the extension will be evaluated using one-half of the preceding 12-month ordering-period price.

Rates for the six-month extension shall be proposed in the IDIQ Labor Category Rates tab and utilized for the Task Order #1 Pricing

Attachment A – IDIQ Labor Category Rates and Task Order #1 Pricing

N/A – Excel tabs The workbook states that discounts are requested. Please confirm that proposing a zero-percent discount will not make an offeror nonresponsive and that evaluation will be based on the final proposed rates and prices rather than the discount percentage itself.

Per the SOL_RFP_75F40126R00042_Amendment_1 "Offerors are encouraged to submit their best pricing in their initial proposal. The Government intends to evaluate proposals based on the prices submitted and may make an award without discussions."

Attachment A – IDIQ Notes & Assumptions

N/A – Excel tab The workbook identifies 1,920 productive hours per FTE per year. Please clarify whether 1,920 hours is: (a) a mandatory pricing assumption; (b) an evaluation convention only; or (c) general information that offerors may replace with their own productive-hour assumptions.

The 1,920 productive hours per FTE per year is a mandatory pricing assumption for purposes of preparing and evaluating proposals. Offerors shall use 1,920 productive hours as the annual productive-hour basis for one FTE when completing the pricing schedule and shall not substitute an alternative productive-hour assumption.

Attachment 1 – IDIQ SOW, Sections 3.4, 3.5, and 4.4; Attachment 2 – TO1 SOW, Tasks 2 and 3

11–13; 12–16 Please clarify which of the following must be included within the TO1 FFP price and which will be Government-furnished or separately reimbursable: local travel within the Washington metropolitan area; software licensing and renewals; development, testing, monitoring, and security tools; Appian-related licensing or administrative access; database, Documentum, AEM, Solr, Kafka, and other platform licenses; hardware or infrastructure upgrades; cloud consumption; and other direct costs.

See Attachment_1_IDIQ_SOW - Section 3.4 Travel. Additionally, The Government will furnish software licensing and renewals; development, testing, monitoring, and security tools; Appian-related licensing or administrative access; database, Documentum, AEM, Solr, Kafka, and other platform licenses; hardware or infrastructure upgrades; cloud consumption

Attachment 1 – IDIQ SOW, Section 4.5.2;

Attachment A

15; Excel tabs The IDIQ SOW permits labor categories to be added by mutual agreement after award. Please confirm whether offerors may add proposed labor categories to Attachment A at the proposal stage when necessary to support the SOW, or whether offerors must map all proposed personnel exclusively to the eight Government-provided labor categories

Yes, but Offeror's must provide a description of each added labor category that differs from those that are identified within the "Labor Category Descriptions" tab of Attachment_A .

RFP – Volume III, Teaming/Partnering and Major Subcontracts

11 The RFP requires a signed letter of commitment for a major subcontract exceeding 10 percent of the overall prime contract value. Please define the denominator for this calculation. Should the 10 percent threshold be calculated against: (a) the $25 million IDIQ ceiling; (b) the offeror's total proposed IDIQ evaluated price; (c) the offeror's TO1 price; or (d) the anticipated value of work actually subcontracted?

The 10% threshold shall be calculated using the offeror’s total proposed IDIQ evaluated price for all ordering periods, including all evaluated option periods and the FAR 52.217-8 extension and enforced at all Task Order level.

RFP – Table 1, Proposal Volumes; Section XIII, Proposal Due Dates

4; 55–56 Please confirm that Volume III, Business and Pricing, is due on the same date as the Phase II Volume II technical submission. The Phase II due-date instructions currently refer only to Volume II.

Confirmed. See doc SOL_RFP_75F40126R00042_Amendment_1

RFP – Table 1; Factor 1 Instructions; Section XIII, Phase I Submission

4–7; 55 Table 1 identifies the six-page limit specifically for Tab A, while the Phase I submission instruction states that the Phase I response may not exceed six pages excluding the cover page. Please confirm whether Tab B, Offeror Information and Confirmation, is excluded from the six-page limit.

See answer to question #17

RFP – Volume II Instructions and Evaluation Criteria

4; 7–10 Please confirm whether the 50-page limit applies collectively to Volume II Tabs A, B, and C. Please also identify whether the following are included in or excluded from the 50-page limit: cover page; table of contents; acronym list; draft IDIQ PMP; TO1 draft PMP; TO1 WBS; staffing plan; Service Delivery Quality Assurance Plan; risk register or risk table; technical assumptions; resumes; letters of commitment; and teaming or subcontracting agreements

Confirmed 50-page limit applies collectively to Volume II Tabs A, B, and C. See answer to question #17 and #38 for page limitation exclusions. All other items will be counted towards page limits. Teaming/Partner Arragements & Letters of Commitment for Volume III do not have a page limit associated and are not counted towards the page limitation.

RFP – TO1 Staffing Plan and Key Personnel

8–9 The RFP establishes individual page limits for resumes and letters of commitment but does not state whether they count against the 50-page technical limit. Please confirm that resumes and letters of commitment may be submitted as appendices outside the 50-page limit.

See answer to question #38

Attachment 1 – IDIQ SOW, Section 3, Deliveries or Performance; RFP – Volume II, Tab B

10; 8 The IDIQ SOW directs the contractor to submit a draft contract-level PMP with its proposal, while the RFP separately requests a TO1 draft PMP and WBS. Please confirm whether offerors must submit: (a) one integrated PMP covering both the IDIQ and TO1; or (b) a separate IDIQ-level PMP and TO1 PMP.

Please also confirm their page-limit treatment.

B

RFP – Proposal Content and TO1 Draft

PMP/WBS

4; 8 The RFP requires the technical proposal and TO1 pricing to be cross-referenced to the WBS but prohibits price information in Volume II. Please confirm that the WBS may identify task numbers, labor categories, staffing quantities, and work packages but must not contain hourly rates, extended prices or total prices

Confirmed

RFP – Proposal Preparation, Proposal Content, and Section XIII

2–4; 55–56 Please provide the required electronic packaging convention, including: whether each volume must be a single PDF or each tab must be a separate PDF; required file names; whether resumes and commitment letters should be combined or separate; whether multiple emails are permitted;

maximum attachment size; and whether compressed ZIP files are permitted.

SOL_RFP_75F40126R00042 - Table 1. is the required submission format. Single PDF format is requested for each Volume of the solicitation with Phase & Tabs clearly identified. The

Pricing Workbook will be in excel format. The subject line of the response email shall read:

“75F40126R00042– Food Applications Regulatory Management (FARM) IDIQ–Phase I” or

“75F40126R00042– Food Applications Regulatory Management (FARM) IDIQ–Phase II” depending on phase submission. Resumes & Letters of Commitment should be combined within their appropriate Volume. Multiple emails and/or compressed ZIP files are permitted. See doc SOL_RFP_75F40126R00042_Amendment_1

RFP – Factor 1, Relevant Experience Criteria

5 The RFP requires at least three relevant experiences but does not establish a maximum. May an offeror submit more than three projects within the six-page limit, and will all submitted projects be evaluated?

SOL_RFP_75F40126R00042 - Volume I: Relevant Experience Criteria Submission Instructions & Evaluation - Tab A: Factor 1: Relevant Experience Criteria updated to remove

"at least" from instructions. Offeror's shall provide a written narrative describing three (3) seperate Government Experiences. See doc SOL_RFP_75F40126R00042_Amendment_1

RFP – Factor 1, Relevant Experience Criteria

5 Please confirm that one relevant-experience project may satisfy more than one mandatory element.

For example, the same project may demonstrate O&M, DME, and AI experience; provided the narrative clearly substantiates each element.

See answer to question #5

RFP – Factor 1, Relevant Experience Criteria

5–7 Please identify any recency requirement for submitted experience, such as whether the project must have been performed or completed within the past three or five years.

See response to question #11

RFP – Factor 1, Required Contract Information and Size

6 May offerors submit ongoing contracts? If so, should the reported value be: (a) total awarded ceiling value; (b) funded or obligated value to date; (c) value of the current order; or (d) value of work actually performed through the proposal date?

See response to question #11 and information contained on page 6&7 within the

SOL_RFP_75F40126R00042

RFP – Factor 1, Required Contract Information;

Volume III Teaming Requirements

6–7; 11 The instructions permit submission of subcontract experience and request prime-contractor contact information for such references. Please clarify: (a) whether the prime offeror may rely on experience performed by a proposed subcontractor or teaming partner; (b) whether such experience will be evaluated equally with the prime offeror's own experience; and (c) whether a minimum number of the three projects must have been performed by the prime offeror.

See response to question #23

RFP – Factor 1, Required Contract Information

6–7 When a proposed subcontractor's project is submitted, should the project be listed as an experience of the subcontractor that performed the work, or may it be presented as a combined team experience?

Please confirm that the narrative should clearly identify the entity that performed each portion of the work

See response to question #23

RFP – Factor 1, Definition of Size

6 Please confirm that the requirement for at least one $1 million project performed as prime applies specifically to the proposing 8(a) prime offeror and cannot be satisfied by a proposed subcontractor's prime contract. Please also confirm whether the $1 million threshold is based on the value of the specific task order being submitted rather than the ceiling of the underlying IDIQ.

See response to question #23. Further, per the SOL_RFP_75F40126R00042_Amendment_1 "is defined as the total dollar contract value per year, at least one relevant experience is required to have a minimum dollar value $1,000,000.00 in which they were the Prime contractor."

86 RFP – Factor 1, Definition of Size and Required Contract Information

6 When a subcontract experience is submitted, will FDA evaluate size based on the offeror or team member's subcontract value, or the total value of the prime contract or task order?

Offeror

RFP – Factor 1, Definition of Complexity

6 Please clarify whether the threshold of at least 800 requests annually means: (a) 800 helpdesk tickets;

(b) 800 change requests; (c) the combined total of helpdesk tickets and change requests; or (d) any comparable mixture of production-support requests. Please also confirm whether each submitted experience must meet this threshold or whether it is sufficient for one experience to demonstrate this complexity

800 represents an estimate for all types of change requests including helpdesk tickets. Each submitted experience must meet this threshold.

RFP – Factor 1, Definition of Technology;

Attachment 1 – IDIQ SOW, Table 2

6; 3–4 Must a single experience demonstrate all or most of the FARM technology stack, or may the offeror demonstrate technology relevance collectively across its submitted projects? Please confirm that functionally comparable technologies may receive credit even when they are not the exact product or version listed in Table 2.

Per the SOL_RFP_75F40126R00042_Amendment_1 - Tab A: Factor 1: Relevant Experience Criteria - "The government will assess its level of confidence that the Offeror’s relevant experience submissions demonstrate performance on current and/or previous contracts that are relevant to the Statement of Work in terms of type, scope, complexity, technology, and size." Type, Scope, Complexity, and Technology are required for all experieence submissions. The $1,000,000.00 Size is required for at least one expereience.

RFP – Factor 1, AI Experience; Attachment 1 – IDIQ SOW, Sections 1.3.3.2 and 1.3.3.4

5–6; 7–8 Please clarify whether the mandatory AI experience must have been deployed in a production environment or whether an operational pilot, proof of concept, prototype, or tested implementation will qualify. Please also confirm whether the AI experience must be in a regulatory environment or whether comparable enterprise document processing, search, findability, workflow automation, or decision-support experience is acceptable

Per the SOL_RFP_75F40126R00042_Amendment_1 - Tab A: Factor 1: Relevant Experience Criteria - "One (1) project must also involve Artificial Intelligence applications to enhance the findability of relevant records or information from various IT systems or to automate regulatory review processes, document processing, or decision support capabilities."

RFP – Factor 1, Required Contract Information

6–7 For subcontract projects, please confirm that the prime-contractor contact replaces the Government Contracting Officer contact rather than being provided in addition to it.

Per the SOL_RFP_75F40100042_Amendment_1 "if a subcontract, contact information for the prime contractor, not the customer, shall be included"

RFP – TO1 Staffing Plan and Key Personnel;

Attachment 2 – TO1 SOW, Section 7

8–9; 25 Please confirm that the only TO1 key-personnel positions are: IT Project Manager Level III; IT Business Analyst Level III; Database Specialist Level III; Software Engineer Level II; and Applications Programmer Level III–Appian. Please confirm that the Java Applications Programmer, System Architect, and Quality

Assurance Analyst shown in Attachment A are non-key positions unless otherwise designated by the offeror

Confirmed

RFP – TO1 Key Personnel; Attachment 2 – TO1 SOW, Section 7

9; 25 The RFP states that the Project Manager may either possess a PMI certification or demonstrate in narrative form that the candidate meets PMI certification requirements. The TO1 SOW states PMI certified PMP. Please confirm whether an active PMP certification is mandatory for the proposed

Project Manager or whether narrative equivalency is acceptable.

Per the SOL_RFP_75F40126R00042_Amendment_1 - Tab B: Subfactor 1 -TASK ORDER #1 KEY PERSONNEL - "The Offeror shall indicate whether their project manager has been certified by the Project Management Institute or demonstrate clearly in narrative form that the candidate meets all the requirements of PMI certification."

Attachment 2 – TO1 SOW, Section 7, Database Specialist Level III

25 The TO1 SOW identifies the Database Specialist as a Certified DBA but does not specify the certifying organization or certification level. Please identify acceptable certifications and confirm whether Oracle

Database certification is mandatory.

No specific certification organization is required in the solicitation. The Government requests a Database Specialist Level III, Certified DBA.