15-223-SOL-00106_Questions_and_Answers.pdf

Index Question Answer

1 If you could please provide us with the GFI attachment B, it is not in the attachment zip file and contains the technical specifications for compatibility with their architecture requirements.

This reference was in error, and has been removed.

2 Section 3.5 Compatibility with FDA’s Environment states “Please see GFI Appendix B for current technical reference architecture standards.” We cannot find GFI Appendix B. Please provide the location or a link to review this information.

See question 1.

3 The services level of effort for the initial one-month period of performance is unclear. Please explain what the Government is expecting with respect to services for the initial one-month trial period.

Please review the task order SOW where it defines the Government's expectations regarding the contractor's involvement during the first month. It is the responsibility of the contractor to determine what level of effort is adequate to complete the task and subtasks identified in the Task Order SOW.

4 SOW Section 3.2 FDA Master Approved Technologies List (MAT). Please provide this list or a link to review the list of approved and not approved technologies that include applications (software), infrastructure and peripherals (hardware), and scientific software and devices.

This list is not readily available to the public. FDA staff will be responsible for reviewing the MAT list and seeking approval.

5 Our system is fully web deployed and only accessible via browser. Many times you mention web-based capability of the system. Which we fully meet. However, we have a deployment infrastructure question. We offer our system in client's private cloud as well. Will we be deploying our system servers in your environment - thus our system will be deployed on your cloud? Or will you be accessing the system on our global cloud environment? Could you provide any more detail on the cloud requirements?

The FDA will host the solution within its own environment.

A web based solution will be deployed and accessed completely internal to the FDA.

The FDA does not have a private cloud.

The IDIQ SOW has been amended to clarify this fact.

6 Does the Government prefer a hosted solution or a cloud solution? See answer to question 5 7 Our question is – would Citrix based technology to web enable our solution and make It accessible via IE or Firefox be an acceptable solution.

Yes, either VDI or Citrix would be acceptable.

8 On the tab called Services IDIQ, the LOE numbers in column E are already filled in. Can we change these LOE numbers or are these numbers FDA estimates that need can't be changed?

The level of effort estimates in the IDIQ pricing sheet should not be changed as they are in place for evaluation purposes and consistency when in evaluating vendor proposals. The contractor may change the level of estimates in the Task Order Pricing sheet at their discretion as they are ultimately responsible for determining the Level of Effort with the definitized work described in the Task Order SOW.

9 Would you consider opening this up for full and open competition or will you at least accept responses from non-small business entities?

No, at this time the Government will not open the solicitation for full and open competition. Responses must conform to the 100% small business set-aside standard for the applicable NAICS code.

10 Will subcontractor capabilities be considered in the evaluation of proposals for this requirement?

Yes. 2 of the 4 relevant experiences may be from a subcontractor. See Attachment 8.

11 Who are the small business vendors that responded to the market research, and, of these, which vendors has the FDA been communicating regarding this effort?

The Government cannot provide this information, as it is not releasable.

12 Can you clarify if this is a Total Small Business set aside or competitive 8(a) set side?

This is a Total Small Business Set Aside. This is NOT a competitive 8(a) Set Aside.

13 I was curious if this was a follow-on requirement. If so, would it be possible for you to provide the incumbent information (we need the contract number and contractor).

This is a new requirement. There is no incumbent.

14 We work with all of the major ELN’s on the market and would like to know if we can bid more than one product since you may Pilot more than one product. By allowing us to bid several products, we can bid some of the large vendor products as well as some really good small business ELN’s.

Yes, but each product/solution must be a self-contained and complete separate proposal. Each proposal, including multiple proposals from the same vendor, will be evaluated individually and will not reference other proposals from the same vendor.

15 Can [we] submit more than one proposal for different ELN Vendors? See answer to Question 14.

16 Are multiple proposals from the same bidder allowed for different products See answer to Question 14.

17 Will you consider answering any other questions should they arise? See combined synopsis/solicitation announcment.

These are the Questions and Answers from the canceled solicitation 15-223-SOL-00106 (ELN)

18 The turn-around time for proposal submission is extremely short to provide a quality proposal. Would the Government please extend the proposal due date at least one week?

N/A

19 We therefore are requesting a one-week extension on the due date to September 4, for which we would be grateful if you would kindly grant.

See answer to Question 18

20 Will the FDA extend the response deadline by two (2) weeks, 9/11/2015, to allow time for answers to questions to be fully considered and proposals adjusted accordingly?

See answer to Question 18

21 The ELN requirement for the full deployment is for a hosted solution within the FDA's environment. Does the same requirement hold true for the one-month evaluation? Or would the FDA consider running the trial on a 100% cloud version of the Offeror's software, which is an exact identical environment to its hosted deployment product?

The proposed ELN solution, including the one month evaluation, shall be hosted at the FDA Scientific Data Center (SDC) and virtually available to scientists in remote locations. The FDA will not consider runnin the trial on a 100% cloud version of the Offeror's software.

22 . In Attachment 1, Section 5.2, the last ELN Mandatory Requirement states: "Device/Platform diagnostic". Is there a requirement for a diagnostic or should "diagnostic" read "agnostic"?

Agnostic

23 Q1. The application we are proposing is licensed by Concurrent users rather than Named users. In our experience there is a ratio of Named to Concurrent users that satisfies the needs of the user base. Is it acceptable to specify this ratio and utilize it in the licensing pricing matrix?

Clarification received by offeror: There are two typical ways of licensing software applications, through Named(Total) users and through Concurrent users. Named user licensing requires a license for each user who will have access to the system.

Concurrent user licensing requires a license for the maximum number of users allowed to be logged into the system at the same time. Typically not all prospective users are logged into the system at the same time and hence the number of concurrent users is less than the number of named users. The application we are proposing uses the Concurrent License model. Is it acceptable to list licensing based on Concurrent users while providing the ratio to assure that all users will be accommodated on the system?

Named licenses are not a FDA requirement. The offeror may propose a technical solution with other licensing structures, so long as the FDA requirements are met.

24 Q2. In order to satisfy the requirements specified by the Use Cases it is necessary to configure the proposed software application. Is it the FDA's expectation that this installation and configuration activity will occur: A. before the start of the 20 day pilot or B. as part of the 20 day pilot

Installation shall occur before the start of the pilot. Vendor will be assisted during the initial installation of the software.

25 Q3. The proposed software solution provides alternate ways of system configuration to satisfy the Use Cases. Will we have access to FDA SME's for during this configuration activity?

Yes.

26 Q4. Is there a requirement to perform configuration on-site.

[Clarification] Does the FDA require the configuration (system/methods, etc) work to be performed on-site or, if capabilities allow, can this work be performed remotely?

Yes - if the offeror does not have a FDA Enterprise accounts, and the ability to VPN into the Enterprise.

27 Q5. The FDA has stated that it will host the pilot within its own environment. Will the FDA provide the elements that we specify within our response? This includes the VDI, Database, necessary hardware (i.e. laptops with VPN access), and necessary accounts to access this environment for installation and initial setup of the pilot.

The Government will provide access to FDA computers and access rights, including VPN, as nessecary.

28 Q6. Please confirm that the only required documentation for the Pilot is; Training Materials; User Guide and Weekly Status Reports.

Yes

29 (1) There appears to have been some typographical problems in separating lines near the end of the Non-Mandatory list on page 9 (i.e., it looks like some items have been spliced together or split in the middle of the line). Below is our best guess at how these items are intended to be separated; would you confirm if this is correct?

• Meets future lab quality standards (ISO, cGLP)

• Access to ELN controlled by Principal Investigator

• Single Sign-On/Active Directory Integration

• Developer Application Program Interface provided

• “Offline” Mode

• Auto save feature

Correct, the list has been corrected accordingly.

30 (2) The last item in the Mandatory Requirements list (appearing by itself at the top of page 9) is listed as “Device/ Platform diagnostic.” Can we assume that the writer intended this to mean device/ platform agnostic?

See Question 22.

31 (3) One of the Mandatory Requirements states "Supports PIV & digital signatures”. The only other mention of PIV is in the Use Case Scenario 3, where it refers to signing off that work is complete using PIV cards. Is this (i.e., signing off completed work) the only form of support for PIV required of the system? Is it expected that PIV will be used in any other way? Is it expected that users will be scanning a physical card through some linked physical reader at the time of signing off, or will there be numeric key that is entered? Is PIV expected to be stored for any length of time during a single session? Please fill us in with all the available technical details to understand which of the PIV capabilities are being required of the ELN.

Refrence to PIV removed

32 Question #1: The twenty page limit for the proposal appears to be too few given all of the requirements that need to be addressed. Will the Government please consider increasing the page limit by 10 or more pages and also not including the past performance section in the page limit?

No. The page limit remains at 20.

33 Question #2: The RFP States “Text in graphics and charts shall be no smaller than 9-point Arial Narrow; text in tables shall be no smaller than 9-point Arial”. Please confirm that this means that text in tables can be no smaller than 9-point in the Arial family? I.e., 9-pt Arial Narrow?

Confirmed that text can NOT be smaller than 9-point.

34 Question #3: SubFactor 2 – Understanding and Evaluation Factors. The Instructions States “…… the technical proposal shall consist of a narrative description of the offerors understanding of the task order requirements and its specific approach to perform the work in compliance with applicable standards and requirements. The narrative shall clearly describe the Offeror’s understanding of the task order pilot and how the offeror intends to satisfy the requirements of the SOW.” Further, the Evaluation of Factor 1, SubFactor 2 States that “The FDA will evaluate the extent to which: The Offer’s software meets the requirements of the TO”. How are we to show that our software meets the requirements of all of the Case Studies given the 20 page limit for the proposal? Is the Government looking for detail on how our software meets the requirements of all of the Case Studies in this section, or are you that level of detail in this section? Or are you looking for additional information on the Technical Functionality and Features asked for in Factor 1, SubFactor 1?

It is the offeror's decision how to show that their offer meets requirements. The page limit remains at 20 pages.

35 Question #4: Are the assigned software evaluators required to evaluate each ELN product? Yes.

36 Question #5: Are the assigned software evaluators required to perform their regular jobs in addition to this project? If so, would the Government consider shortening the evaluation / Pilot period to one week? The reason is because in our experience, evaluators typically only log onto the system for the first two or three days, and then not again until the Pilot is almost over when they need to write-up their evaluation.

Evaluators will conduct evaluations as a part of their 'regular jobs.' No, the Government will not shorten the evaluation / Pilot period to one week.

37 [Large Bussiness] [Do we] we need to partner with a third party that qualifies as a small business (less than $27.5 million) in order to submit a proposal

Large business may partner with small businesses as appropriate so long as the offeror complies with the Small Business requirements of the solicitation, and the Subcontracting Clause 52.219-14 -- Limitations on Subcontracting.

Offerors are advised to review the SBA Non-Manufacturing Rule (NMR) at https://www.sba.gov/content/non-manufacturer-waivers. The NMR is an exception to the performance requirements, and provides that a firm that is not a manufacturer may qualify as a small business on a supply contract set aside for small business if, among other things, it supplies the product of a small business made in the United States. 15 USC § 637(a)(17); 13 CFR § 121.406.

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