ResponsestoVendorQuestions.pdf

FDA RESPONSES TO CONTRACTOR QUESTIONS RELATED TO COMBINED SYNOPSIS NO: FDA-SOL-12- 1099989

1. I wanted to know if subcontractors experience and past performance be allowed for the CPIC RFP opportunity?

FDA Answer No. 1: The contractor may submit experience and past performance information for subcontractors. It is best practice to identify the amount of time the subcontractor would be working on the project since this is an 8a set aside and contractor’s must show compliance with the Limitation of Subcontracting Clause. In addition, it is best practice to provide relevant and past performance information for the prime contractor. Companies that submit relevant and past performance information only for subcontractors will receive a lower adjectival score on relevant experience and will be considered higher risk.

2. How many new SOPs should be expected in the base year?

FDA Answer No. 2: Most SOP’s have already been written. This task is completed and probably should have been left out of the SOW.

3. Page 12 of Task Order No. 1 refers to "Task No. 3". Should this be 'Task No. 1"?

FDA Answer No. 3: This is an administrative error. Attachment has been revised to reflect correct Task Order No.

4. Attachment 4 in the Labor Categories and Rates tab has Year 1, Year 2, Year 3, Year 4, and Year

5. Should this be Base Year, Option Year 1, Option Year 2, Option Year 3, and Option Year 4?

FDA Answer No 4: Attachment No. 4 is for the Indefinite Quantity / Indefinite Delivery Pricing.

IDIQ contracts do not have Option Periods. Only the Task Orders are subject to the Option Periods (if applicable).

5. Attachment 4 in the Labor Categories and Rates tab has one column for annual level of effort.

a. Should there be two columns with one for on-site rates and one for off-site rates?

FDA Response to No. 5a: A tab has been added to Attachment No. 4

b. Should there be a totals column for on site, off site, and grand total?

FDA Response to No. 5b: This allows the Government to view how the contractor anticipates utilizing the labor mix for the work as defined in the IDIQ SOW. This also gives the contractor the flexibility to propose a different ceiling. A deviation from the Government’s maximum IDIQ ceiling would require the contractor’s rationale in the assumptions tab.

c. Should the spreadsheet include annual subtotals?

FDA Response to No. 5c: Yes. The subtotals are not annual ceilings. It’s requested for cost analysis purposes and ease of evaluation.

d. Should the spreadsheet include a five year total?

FDA Response to No. 5d: Yes. Again, the contract may propose a different IDIQ ceiling and provide justification in the assumptions tab.

6. Attachment 4 includes a BOE. This is often used for cost plus contracts. Is this applicable to Firm Fixed Price and Labor Hour?

FDA Response No. 6: A basis of Estimate applies to both Fixed Price and Labor Hour contracts.

Requesting the Labor Rate Build up and / or the price build up for Fixed Price equipment / tasks is not unusual and / or unreasonable.

7. Attachment 2 specifies 12 point font for resumes submitted with the staffing plan. Should this be Calibri 11 point font as specified in the Format section?

FDA Response No. 7: Calibri 11 point font is preferred. See revisions in Attachment No. 2.

8. Relevant Experience, Sub-Factor 2 - Examples of Work Performed has a page limit of 9 pages.

Many CPIC deliverables are longer than 9 pages.

FDA Response No. 8: Attachment 2 has been revised. The actual deliverables no longer are included in the overall page count. Examples of work performed will be accepted as an attachment to the Task Order Proposal.

9. Does this page limit (or any other) include the actual examples of CPIC deliverables?

FDA Response No. 9: See answer above.

10. If this page limit does not include the actual CPIC deliverables, is it to be used for a description of the deliverables?

FDA Response No. 10: The Government is looking for actual Deliverables.

11. There are a number of documents due with the proposal. Are the following included in any page limitations?

A. Draft QAP (IDIQ) B. Risk Management Plan (IDIQ) C. Draft TOMP (TO 1) D. Project Schedule (Project Plan) (TO 1) E. Staffing Plan (TO 1)

FDA Response No. 11: See Revised Attachment No. 2 for documents not included in the page

no. restrictions.

12. Page 10 of Attachment 2 states "If the Offeror adjusts the suggested Level-of-Effort in Column J this may change the suggested Maximum price and must be explained". No suggested Level-of- Effort was provided. How should this read?

FDA Response No. 12: It has been changed to read as follows: “Please note the suggested ceiling of $17.3 may be subject to change based on the contractor’s proposed level of effort”.

The Government reserves the right to keep the ceiling at $17.3M. See revised Attachment 2

13. What type of order is Task Order No. 1? Is this to be awarded Firm Fixed Price or Labor Hour?

FDA Response No. 13: The Government is contemplating awarding a Labor Hour Task Order due to higher risk due to the inability to adequately scope. This may change in future years as the requirement becomes more stable, that is why the OIM task order is only for 12 months.

14. Is the BOE in Attachment 4 only for the prime contractor’s operational costs?

FDA Response No. 14:

15. Attachment 5 refers to the "OIM Task Order" in the Base Period tab. Is this Task Order No. 1?

FDA Response No. 15: Yes, Task Order No. 1 is the Office of Information Management (OIM) Task Order

16. Should Attachment No. 5 include on site and off site rates and totals?

FDA Response No. 16: The Attachment has been revised to include On-Site and Off-Site Rates.

Please note the primary place of performance is the Government’s site in Rockville, MD and OIM does not anticipate the contractor working on the Contractor’s site.

17. Does this assume Firm Fixed Price will produce a consistent monthly total that can be multiplied by 12 to get an annual total?

FDA Response No. 17: The Government understands in a Labor Hour environment the level of effort may not be equal from month to month. The request for a “Monthly Level of Effort” will be used for cost analysis and price reasonableness determinations.

If not, then how should the monthly total be addressed as it could vary from month to month if awarded as a Labor Hour contract?

FDA Response No. 17b: Based on the information in the SOW, the contractor may document in the assumptions tab where there may be increased and / or decreased effort and how it was accounted for in the overall proposed price / month by month basis.

18. Attachment 2 includes a "Statement of Relative Order of Importance". This includes the statement "Price is of less importance than technical capabilities, key personnel/staffing, risk management, and past performance combined".

18a. What is “risk management” in this statement?

FDA Response No. 18a: The FDA requested the contractor QAPs and Risk Management Plans at both the IDIQ and Task Order Level. So it’s overall risk management on both levels.

18b. Is this risk associated with past performance? Should risk management be removed from this sentence?

FDA Response No. 18b: No. Past performance risk will be assessed via one of the following or combination of: review of the Past Performance Questionnaires, phone interviews, and review of information in publicly available Past Performance websites such as, the Contractor Performance Assessment Retrieval System (CPARs)

18. The SBA’s 8(a) program was established to promote small businesses. Does section 8.1 in the IDIQ define this as an 8(a) “small business” competition? Should numbers (20) or (21) be marked?

FDA Response to No. 18: The two clauses require the 8a contractor to consider SDB businesses as joint ventures, teaming partners, and subcontractors. The intent of not checking the clauses, was to promote competition amongst 8a vendors and not limit 8a responses by being overly restrictive as to whom they may enter into joint ventures and / or subcontract with. The pertinent 8a clauses are in full text: 52.219-17 & 18.

19. The proposal published on fedbizopps.gov states that this is NAICS code 541611 with a size limitation of $14.0M. The solicitation does not state the appropriate NAICS code to support the small business size standard. Is 541611 the correct NAICS code for the work under this solicitation?

FDA Response No. 19: The size standard to NAICs code 541611 is $7.0M as stated in the combined synopsis cover page. 541611 is the appropriate NAICs.

20. Potential Mismatch between SOW and Proposal Criteria. In Attachment 1 - Task Order SOW there are two tasks: Task # 1 - Task Order Management and Task # 2 - CPIC Mgmt and Operations Support.

FDA Response No. 20: Task # 1 and #2 in the Task Order SOW are subtasks for Task Order Number 1.

21. In Attachment 2 - Instructions to Offerors, Sub-Factor # 1 asks for a response to Task Order # 1 but the text seems to refer to the content of Task # 2. Should Sub-Factor 1 be written to address the requirements of Task # 1, # 2 or both?

FDA Response No. 21: The FDA will be evaluating the Contractor’s understanding and approach to content in both Sub-Task No. 1 and Subtask No. 2 of the Task Order No. 1.

22. Key Personnel. Attachment 1 - Task Order SOW lists a "CPIC Mid-Level Analyst" as a key personnel. However, that labor category does not match the labor category descriptions provided in Attachment # 3: IDIQ Labor Category Descriptions. Is a CPIC Mid-Level Analyst equivalent to a CPIC Program Analyst or CPIC Specialist?

FDA Response No. 22: The SOW has been revised to take out Mid-Level Analyst and replaced with “CPIC Specialist”

23. Proposal Format / Resumes. The Instructions suggest that there will be resumes for the entire response and then resumes for Task Order response (Sub-Factor 1). Can the same resumes be used? Should we include all "resumes for all personell listed in the staffing plan" in both sections?

FDA Response No. 23: Only Task Order No. 1 Key Personnel will be evaluated. There are some general “IDIQ program managemen” tasks identified in the IDIQ SOW which may require a small level of effort, but the level of effort is charged to the task orders, so in essence all personnel will be billing against Task Order No. 1. As more task orders are issued, the other task orders will carry a percentage of the IDIQ program management level of effort.

Whether or not to submit “Non-Key” Personnel resumes is a business decision.

24. Proposal Format / Layout. Is it correct to assume that Volume I: Technical proposal will have a cover page and table of contents (page 2) and then another cover page and table of contents within the response to task order #1 as part of Sub-Factor 1 (see page 3)?

FDA Response No. 24: That is correct

25. QUESTION: Attachment 2 lists three types of “acceptable examples” (Return on Investment (ROI) documentation, CPIC Best Practices, and Integrated Baseline Reviews). Are these the only types of examples the government will consider or is the offeror free to submit other relevant examples of CPIC work?

FDA Response No. 25: The vendor may submit other examples of CPIC Work.

26. QUESTION: RFP Section 3.7 describes four tasks, including “Task 4 – Training,” but we could not find a description of Task 4. Is the Task 3 subheading labeled “Training” part of Task 3 or was it the government’s intent to label this Task 4? At the end of that same paragraph, there is a phrase that reads “Training topics may include:” but we could not find any training topics. Please clarify training requirements.

FDA Response No. 26: The Solicitation Document has been revised to ensure that “Training” is a separate task and is labeled Task No. 4. The six bullets under the phrase “Training topics may include” are the possible training topics.

27. QUESTION: Section 3.6 (page 8 of the RFP) contains a sentence that says "this shall be documented in the draft Quality Assurance Plan (QAP) provided with [emphasis added] the proposal.” We could not locate the instructions for providing a QAP with the proposal.

FDA Response No. 27: The contractor shall utilize industry best practices for development of a Quality Assurance Plan.

28. QUESTION: Attachment 2: Instructions to Offerors, page 2 states, “The Technical Volume should be organized to align with the tasks in the Statement of Work.” Is it correct to assume that the reference to SOW tasks refers to IDIQ Statement of Work in Section 3 of the RFP and, for the Task Order SOW, Attachment 1, with particular emphasis on Section 4 (Description of Tasks)?

FDA Response No. 28: Yes.

29. Task Order 1 states on page 6 "Perform Earned Value Management (EVM) activities such as developing monthly cost and schedule reports. Generate quarterly reports on overall health of Major investments (See GFI Appendix B: Investment List)."

29a. Does this include aggregating and inputting cost and schedule information for individual investments?

FDA Response No. 29a. For Task Order 1, this may or may not be required as the ProSight forms change frequently due to changes in the A-11. The FDA CPIC office may require reports with data collected from ProSight to compile a report. This task may also be in response to data calls. For Task Order 1, it does not include aggregating and inputting cost and schedule information for the investments. The FDA CPIC office manages the portfolio, not the investments.

29b. Does this include developing any cost and schedule reports for individual investments from source data?

FDA Response No. 29b: Not for Task Order 1. This may be more relevant to the Center Task Orders and not the OIM CPIC Task Order.

29c. If so, how many reports per month? Or are these reports summary reports that report on the cost and schedule information that has been submitted into ProSight by others?

FDA Response No. 29c: This may not occur each month, but as needed. They would be reports based on the information submitted by others. The FDA CPIC office does not enter data for any of the investments. This is done by the Investment Managers. The monthly updates occur each month, so this may be once a month.

29d. Task Order 1 states on page 7 as a deliverable "(7) EVM Reports". Is this meant to be one summary EVM report each month? If not, then how many reports each month?

FDA Response No. 29d: As written, the shall develop EVM Reports monthly and quarterly reports on overall health of investments.

30. The CPIC Solicitation (page 4 of 47) in 1.1 (b) states “Estimated maximum ceiling for this contract is $17.3 million”. However, in Attachment 2, IDIQ Pricing Sheet Instructions on (page 10 of 16) state: “Please note the Government is suggesting a Maximum IDIQ ceiling of $20M”. What is the maximum ceiling for this procurement?

FDA Response No. 30: The estimated Maximum Ceiling is $17.3M. Attachment No. 2 has been revised.

31. Will all evaluators of “Volume 1, Factor I, Sub-factor 1: Task Order No. 1 Proposal” also review “Volume 1, Factor 1, Sub-factor II: IDIQ Technical Approach and Understanding”. In other words, can offerors assume that points made in one section will be known to reviewers of the other?

FDA Response No. 31: The Evaluators will be the same.

32. In Attachment 2, Technical Proposal (page 2 of 16) calls out Task order Proposal as (Tab II of Volume I: shall not exceed 15 pages), which suggests that the technical proposal should be the second major section of the response. In the same document under A. Technical Approach and Understanding (page 3 of 16) it is listed as “A.1 Sub-Factor 1 - Proposal Response to Task Order #1” which implies it should be the first major section of the proposal. What ordering of the various section of the response is required by the government?

FDA Response No. 32:

TAB I – Should be the contractor’s approach to the IDIQ requirements.

TAB II – Should be the contractor’s approach to the Task Order requirements.

33. Attachment 4, Pricing Table CLIN 1002 mentions a Project Manager LCAT, but does not include a description for it in attachment 3. Would the Government provide a LCAT description for the Project Manager position?

34. Attachment 2, (page 8 of 16) under pricing instructions, the Government indicates that “The suggested LCATs are meant to be a guideline for vendors, by which they may propose their own categories.” Please confirm that the offeror needs to provide an LCAT description for any new LCATs that they may decide to propose above and beyond the seven provided by the government?

FDA Response to No. 34: Yes, the contractor shall provide descriptions of equivalent and / or new LCATs in the assumptions tab.

35. Attachment 6, Past Performance Questionnaire, section 4 (page 4 of 5) states “suggested alternative approaches to problem” and “displayed initiative to solve problems” and “no” and “default” and “convenience” and “pending terminations”. Please provide more clarifications and instructions to the evaluator on how to respond to this section.

FDA Response No. 35: The past performance form will not be revised. The Government will rely on narratives for clarification. If there is some ambiguity the Government will call the evaluator for clarity.

36. Would the government consider substituting years of experience in lieu of a degree requirement – more specifically, would the government consider 4 years of experience in IT project management and related activities in lieu of a Bachelor’s degree?

FDA Response to No. 36:

37. Would the government consider allowing an 11x17 foldout page for a graphic and counting it as two pages?

FDA Response to No. 37: Yes.

38. The Government requires respondents to provide 3 examples of past work in Volume I, Factor II, Sub-Factor 2: Examples of Work Performed (page 6 of 16). The page limitation for this section is: 9 pages. Suggested examples are: “Return on Investment (ROI) documentation, CPIC Best Practices, and Integrated Baseline Reviews”. As we’ve delivered them, our instances of these documents invariably exceed 9 pages. In addition, most of these are confidential to our clients. As such, we would have to gain permission to provide them in full to the FDA. Would the government accept extracts of sanitized versions, with client identifiable information removed, of these documents, which would resolve both problems?

FDA Response No. 38: The Government will accept Redacted copies of deliverables.

39. CPIC solicitation section 3.6 Contract level program management (page 8 of 47) requires the offerors to submit a draft Quality Assurance Plan (QAP) as well as a Risk Management Plan.

Please provide instructions on which section of the proposal should be submitted under and the evaluation factors used to evaluate these plans.

FDA Response No. 39: The QAP and Risk Management Plan are not included in the page count for technical approach to IDIQ SOW and will be accepted as Attachments.

40. Attachment 2 (page 14 of 16), statement of relative order of importance states that “price is less important than technical capabilities, key personnel/staffing, risk management, and past performance combined”. Technical Capabilities, key personnel/staffing, risk management, and past performance factors indentified in this section are somewhat different than the factors and sub-factors listed on top of page 15 of 16 of attachment 2.

Which factors will be used to evaluate the proposals?

FDA Response No. 40: For consistency purposes the sentence has been changed as follows:

“Price is of less importance than technical understanding / approach, relevant experience, and management plan.”