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 it 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 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 Quality Assurance Approach (IDIQ) (Attachment) B. Risk Management Approach (IDIQ) (Attachment) C. Draft Task Order Management Plan (to include general Draft Project Plan) (TO 1) (Tab II of Volume I) D. Draft Project Schedule (TO 1) (Attachment) E. Staffing Plan (TO 1) (Attachment)

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:

PART I: If the proposed pricing is a combination of the prime and subcontractor's pricing then the BOEs need to include both subcontractor and prime contractor cost.

PART II: In regards to the latter part of the question “operational costs”. If what it takes to perform the contract includes not just operational cost but other costs that the offeror builds into their pricing then BOEs are needed to show those other costs as well.

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. a. 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. 17a: 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.

b. 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: Please note the FDA is not looking for full blown Risk Management Plans. Rather the FDA is requesting an overall Risk Management “Approach” as an Attachment to the IDIQ. The contractor shall also address Risk Management in their response to the Task Order. The Risk Management Approach for the Task Order should be included in the Task Order Management Plan Outline. 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)

19. 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.

20. Question No. 20: 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. 20: The size standard to NAICs code 541611 is $7.0M as stated in the combined synopsis cover page. 541611 is the appropriate NAICs.

21. Question No. 21: 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. 21: Task # 1 and #2 in the Task Order SOW are subtasks for Task Order Number 1.

22. Question No. 22: 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. 22: 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.

23. Question No. 23: 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. 23: The SOW has been revised to take out Mid-Level Analyst and replaced with “CPIC Specialist”

24. Question No. 24: 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. 24: 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.

25. Question No. 25: 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. 25: That is correct

26. QUESTION No. 26: 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. 26: The vendor may submit other examples of CPIC Work.

27. QUESTION No. 27: 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. 27: 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.

28. QUESTION No. 28: 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. 28: The contractor shall utilize industry best practices for development of a CPIC related Quality Assurance Approach / Plan.

29. QUESTION No. 29: 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. 29: Yes.

30. Question No. 30: 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)."

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

FDA Response No. 30a. 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.

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

FDA Response No. 30b: Not for Task Order 1. This may be more relevant to the Center Task Orders and not the OIM CPIC Task Order.

30c. 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. c: 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.

30d. 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. d: As written, the contractor shall develop EVM Reports monthly and quarterly reports on overall health of investments.

31. Question No. 31: 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. 31: The estimated Maximum Ceiling is $17.3M. Attachment No. 2 has been revised.

32. Question No. 32: 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. 32: The Evaluators will be the same.

33. Question No. 33: 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. 33:

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.

34. Question No. 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. Question No. 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. Question No. 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: The Government may consider personnel that do not meet the minimum qualifications as long as the resume supports that the person has the CPIC Skills identified under each Labor Category Description. This is a subjective judgment made on behalf of the Government evaluators.

37. Question No. 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. Question No. 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. Question 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 IDIQ Quality Assurance Approach and Risk Management Approaches are not included in the page count of TAB I and will be accepted as Attachments. The Task Order Risk Management Approach should be covered in the Task Order Management Plan (Attachment 3 of TAB II / see question 42 for clarification regarding organization of proposal and page limits) Also, the FDA is not looking for full blown QAPs and Risk Management Plans, rather approaches to both.

40. Question 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.”

41. Question No. 41: Is the Executive Summary included in the Page Count?

FDA Response No. 41: No. The Executive Summary page limit is 2 pages.

42. Question No. 42: Please confirm the Page count Breakdown:

FDA Response:

Technical Proposal TAB 1:

A. IDIQ technical approach: 10 pages B. Relevant Projects: 6 pages C. Management Plan: 5 pages

Not included:

D. Cover Page E. Table of Contents F. Dividers G. Executive Summary (Not to Exceed 2 pages) H. Draft Quality Assurance Approach (IDIQ) (Not to Exceed 5 pages)(Attachment 1 of TAB

1)

I. Risk Management Approach (IDIQ) (Not to Exceed 5 pages)(Attachment 2 of TAB 1)

Section 2:

J. Task Order Proposal: 15 pages

Not included in the 15 page count:

K. Task Order Cover Page – 1 page L. Cover Sheet;

M. Table of Contents;

N. Dividers;

O. Resumes (Attachment 1 of TAB II: All resumes are limited to 3 pages each) P. Letters of commitment from Key Personnel (Attachment 2 of TAB II: Not to exceed 2 pages each) Q. Draft Task Order Management Plan Outline (Attachment 3 of TAB II:) (For Clarification purposes: The FDA is not looking for a full blown TOMP – rather we would like to see more of an outline of the plan to include a general Draft Project Plan and Task Order Risk Management)( Not to Exceed 10 pages)

R. Draft Project Schedule (Attachment 4 of TAB II)(Not to Exceed 7 pages) S. Staffing Plan (Attachment 5 of TAB II: Not to Exceed 5 pages) T. Examples of Work Performed – (Attachment 6 of TAB II: Not to Exceed 50 pages)

43. Question No. 43: The Sub-factor numbering is not consistent. There is an A1 and A2, but two

B1s.

a. Please confirm if this is a typo?

FDA Response No. 43a: Yes

b. Kindly also validate if our response should reflect two sections as B1 or correct the typo.

FDA Response No. 43b: It should be B.1 – Subfactor 1 and B.2 Subfactor 2

44. Question No. 44: Here it is noted that Resumes (shall not exceed 3 pages per resume) however on Page 5, it is noted that Each resume shall not exceed two (2) pages, single-sided, using a 12-point font.

a. Please clarify the maximum number of pages for each resume:

FDA Response No. 44a: 3 pages

b. Please clarify if resumes are required for key personnel only:

FDA Response No. 44b They are only required for Key Personnel

45. Question No. 45: A task order project management plan including narrative descriptions of critical elements and decision points, project plan, and a timetable for key deliverables (Draft Project Schedule / Gantt Chart), including those required in Section III of the task order, with specific delivery dates for each.

a. Does that Gantt chart need to be part of the 15 page response to Task Order 1?

FDA Response 45a. No

Kindly consider our recommendation that the chart be included as an Attachment instead so the Government can get the full benefit of detailed schedule information.

FDA Response 45b. Yes it may be included as an attachment

46. Question No. 46: Traceability to Staffing Plan: The business proposal should provide sufficient detail to determine whether the proposed staffing solution represents the best value to FDA.

Is this applicable to the Task Order Pricing only?

FDA Response 46 Yes

47. Question No. 47: Under FORMAT the solicitation references Pricing.xls. There is no attachment of that name.

Does Pricing.xls refer to the RFP Attachments 4 and 5?

FDA Response No. 47: Yes

48. Question No. 48: Fixed Price Line Items: Indicate the total price for each fixed price task.

Provide sufficient backup information (e.g. labor categories, labor rates, hours to be worked, consultant fees, travel costs etc.) to allow the FDA to conduct a meaningful analysis.

What Fixed Price Line Items is the government expecting for this proposal? Per page 12 the Government is contemplating issuance of a Labor Hour Task Order.

FDA Response No. 48: That is correct the Task Order is Labor Hour. The paragraph is General pricing information.

49. Question No. 49: Under TAB 3 and 4: Travel and Other Direct Costs: Please note that the Government anticipates minimal travel during the life of the contract. The contractor shall estimate the amount of travel per contract year, include the number of persons, days for lodging, transportation costs, per diem costs, and provide a description explaining the need for travel. The total amount identified for each contractor year will be the ceiling amount for travel / ODCs for that Contract Year.

a. What should be use as the basis to estimate travel for the life of this engagement? Can the government provide a historic estimate for the number of trips and sample locations to help us build a reasonable estimate?

FDA Response to 49a: Travel estimates may vary from company to company. The majority of work is in Rockville, MD / DC area at the Government’s site. There is no anticipation of travel outside of the area.

b. Could the government provide a definition of “minimal travel”?

To enable a fair comparison of the price proposals can the government indicate a travel budget that all vendors can factor into their proposal?

FDA Response to 49b: The Government does not anticipate Travel, but cannot factor in the needs of individual companies.

50. Question No. 50: If the contractor intends to claim Other Direct Cost during the life of the contract they should be cited in the Other Direct Cost tab of the IDIQ pricing sheet. Please Note:

Task Orders issued will not honor the cost of miscellaneous materials, all ODC costs must be identified in the IDIQ contract.

a. To help us estimate ODCs can the government elaborate what Government Furnished

Property with be provided?

FDA Response No. 50: The work is on the Governments Site and equipment will be provided for the contractor do the work requested. If the FDA approves the contractor to work off-site the Government will issue laptops and Network Tokens.

51. Question No. 51: Task Order Pricing: TAB 2&3 - Travel and Other Direct Costs.

Please clarify the following:

a. Please Note the proposed travel and ODC costs for Task Order No. 1 are actual costs and the need should be reflected in the Contractor’s Task Order Technical Proposal.

FDA Response No. 51a: If the vendor identifies travel and ODC costs in their business proposal the basis should be associated with an actual purpose.

b. In addition, the amount requested should also be traceable to the proposed costs in the

IDIQ Pricing Sheet and should not exceed the travel and / or ODC ceiling for each contract year.

FDA Response No. 51b:

If the contractor knows that it may purchase a product several times to conduct work identified in the IDIQ SOW and intends to also purchase the product for Task Order 1, the Firm Fixed Price identified in the IDIQ ODC tab for Yr 1 should be the same price offered in the Task Order ODC tab. Therefore it’s traceable.

Please note: To include or not to include ODCs in the pricing sheet is a business decision of the contractor. It is best practice to explain how the ODCs would be beneficial to the Government.

c. Is the Government asking to refer to costs in the Technical Proposal?

FDA Response No. 51c: Absolutely NOT. The contractor’s Technical approach should support the proposed level of effort NOT cite the proposed costs.

52. Question No. 52: SUPPORTING DOCUMENTATION Since this requirement is a commercial acquisition the contractor shall provide Supporting Documentation via catalog pricing and / or verification of the same rates charged to industry customers for similar services. The purpose of this request is to assist the Government in determination of the proposed rates / prices to be fair, reasonable, and in line with the current market for similar services. The supporting documentation should be in Volume III of the contractor’s proposal and separately tabbed as “Supporting Documentation”. The contractor shall provide a minimum of two examples. The Government will accept catalog pricing, invoices, copies of pricing schedules from previous purchase orders / contracts. If the contractor does not have supporting documentation due to lack of experience the Government will accept market research indicating that the proposed rates / prices are in line with current market pricing.

Please confirm that the supporting documentation requested applies to the Task Order Pricing proposal only.

FDA Response No. 52: This refers to pricing identified in the IDIQ Pricing Sheet and Task Order Pricing. The Government will utilize to determine IDIQ Labor Rates to be fair and reasonable.

53. Question No. 53: What Percentage of the Work is expected to be conducted on-site?

FDA Response No. 53: Currently, the Government expects 100% to be conducted on-site for Task Order 1. The Government does not know what site future task orders will be conducted at. It varies from Center to Center depending on the type of work and available office space.

54. Question No. 54: The past performance instructions say “Contracts or orders must have been completed within three years of the quote due date.” On page Page 5 the B: RELEVANT EXPERIENCE allows projects performed within the last five (5) years.

Was this difference in the two volumes intentional?

FDA Response No. 54: The FDA wants more recent years for past performance as it is an assessment of how well the contractor is performing.

55. Question No. 55: Section 3.6 “The Contractor shall provide contract-level project management to establish control, management, monitoring and notification mechanisms, ensuring that contracted tasks stay on track and important milestones are met, this shall be documented in the draft Quality Assurance Plan (QAP) provided with the proposal.” No QAP was provided with the Proposal. The Quality Assurance Plan is typically a deliverable prepared for the project with client input.

Is the expectation that the offeror submit a full QA Plan or the Quality Assurance Approach?

56. FDA Response No. 56: The Government is looking for a general Quality Assurance Approach

57. Question No. 57: In Section 3.6 Contract Level Program Management, it is requested that the contractor provide a Risk Management Plan. The Risk Management Plan is typically a deliverable prepared for the project after conducting an analysis of the client environment. A generic risk plan is not useful for the engagement.

We recommend asking for the Risk Management approach with the Proposal and including the Risk Management Plan as a deliverable.

FDA Response No. 57: The FDA is fine with a generic Risk Management Approach

58. Question No. 58: The government has indicated that the Program Manager must be certified as a Project Management Professional (PMP) by the Project Management Institute (PMI).

However, PMP Certified is also listed under Preferred Qualifications.

Is the PMP certification required or preferred?

FDA Response No. 58: Preferred