ONSITE_RIM_RFP_Questions_and_Answers_Final.xlsx

ALL QUESTIONS

Key Personnel for the IDIQ Contract:

1 - IDIQ Contract Level Program Manager Designated Key Personnel for the Task Order:

12 - Project Manager(s) 20 - Supervisor(s) 14 - Senior Technical Information Specialist(s)

- If we choose to implement our own applications, will APL and QCA be available during the transition period?

- Do we have any options for a longer transition given security certification requirements and training needs?

- Are there any requirements for extracting historical information from either of these tools? If so, please provide the specific information that is to be migrated and the process to do so. Will ZAI be contracted to support this transition?

Does a solution leveraging previously approved MS Office 2010 tools (MS Access, Excel, etc.) require a separate ATO?

How long does the ATO process take?

If this normally exceeds the transition period, can the ATO process for the QCA “equal to” tool be expedited so that the transition period requirement be met? And how much time can be allocated to the transition?

Is the existing QCA tool available for use on the new contract or must an “equal to” tool be created?

Further, D.1.7 states “If the contractor equipment and software is not on the MAT List it must be approved via the formal technical approval process prior to connection to FDA’s network.”

Would the Government please indicate how long the ATO and MAT approval process typically takes and what the expectation is for having a QCA and/or APL alternative system in place if the time exceeds the 2-month transition period referenced in Section 3, I.2.6?

A description of activities that shadow the calendar of transition out events (please see CDER Appendix No. 3 for more detail on the transition-out calendar);”

Would the Government please clarify that the dates offerors are to shadow are for comparable dates in July and August as the calendars in the Appendix reflects January and February dates?

I.2.3 reads in part, “…The contractor shall develop and propose a draft Transition-In Plan as part of their proposal that identifies the action plans, personnel, procedures, deliverables, work products, and timelines to ensure a smooth transition from contract start date to full operations status at the end of the two-month period…”

Would the Government please clarify the requirement for the proposal submission with regard to a Transition Approach per the instructions in F.2(b), or a Transition In Plan as described in the CDER SOW?

If a full transition –in plan as described in the CDER SOW is required with the submittal, due to page constraints – 25 pages for all of Sub Factor 2, would the Government please exclude the Transition-In Plan from the page count for Subfactor 2?

Please clarify. Should the third bullet read “At the end of the second month of the transition-in period”?

Please clarify which delivery due date is correct and if the acknowledgement of receipt is the signed inventory list.

Is the Contractor required to delete historical data? If so what is the retention period and will the Contractor be given access to the historical data on the designated data repository or encrypted hard drive for analysis and trending?

FAR Clause 52.222-41 Service Contract Act and 52.222-17 Nondisplacement of Qualified Workers protect all employees covered by the Service Contract Act and require that they be given first right of refusal if positions are available on the follow-on contract, certain exceptions do apply. It appears that the above clause allows successor contractors to approach exempt employees assigned to the contract.

Is it the Government’s intention that this section applies to SCA employees only? And necessary personnel records include contract dates of hire for all SCA employees?

If this section is intended to include exempt personnel, then disclosure of personnel records should not be required.

Recommend that the language in this section be amended to apply to SCA employees only.

Since this is firm fixed price task order and not a cost plus type, please clarify what pro rata portion of the fee the government is referencing.

(a) For the IDIQ Contract:

To be identified at award of contract.

The narrative in Section 4.2.2 and in 4.2.3 following this heading and italicized text above describes the role of the Task Order COR(s) and Technical Leads.

Where is the role of the referenced IDIQ COR described?

Section I.2.4.5.a states “If an extra submission is marked “Desk Copy”, the document room Contractor shall be responsible for logging in the desk copy and delivering to the appropriate RPM.”

Please clarify, are Desk Copies tracked and maintained by the document room? Where are desk copies logged currently?

Should the Contractor provide a list of ODCs required to support the Task Order?

We are also unclear about the requirement to provide rationale for assigning a NAICS code to subcontracted work Will the government please clarify how this is applicable since this is an 8a procurement and there is no requirement for a small business subcontracting plan where NAICS codes would be important? Recommend amending the solicitation to remove this NAICS code requirement.

The Office-to-Office inventory is done on a monthly basis but the SOW requires updates on a weekly basis if necessary. Please clarify.

Which are the correct dates for the contract periods?

Would the Government please explain why this information is necessary on a FFP contract?

Please clarify that this information is only applicable to a time & material type task order.

Would the Government please clarify what a task mapping matrix is as it applies to this SOW as it is not referenced elsewhere?

Does FDA have a Confidentiality Agreement that they will provide to the successful Offeror or should the Offeror use their own?

If an employee refuses to sign this Agreement, will they be precluded from working on this contract despite the fact that SCA employees have first right of refusal?

Is there a need for employees to sign both a Confidentiality Agreement and an NPI Agreement? Also, if an employee refuses to sign an NPI Agreement, are they precluded from working on this contract?

Will the Government conduct these orientations for every new employee as they join the project, or just during the start-up of the contract and annually thereafter?

Paragraph C.4.23 requires employees to sign Confidentiality Agreements; Paragraph C.4.24 requires employees to sign NPI Agreements, and now this paragraph requires employees sign Non-Disclosure Agreements. Does FDA want all three of these documents to be signed by every employee working on this contract?

If a Non-Disclosure Agreement is required, will the Government provide one to the Contractor that will be used by every employee?

Section E.6 states “IDIQ Task Order 1 – Contractor Site: This pricing worksheet shall be used for the Offeror’s labor pricing pertaining to work performed at the Offeror’s facilities for all tasks described in the IDIQ SOW.”

Please clarify whether this procurement is for both on-site and off-site work. The FDA issued a Sources Sought Notice for Off-site RIM Support Services in August 2013. Has the FDA changed its mind to procure Off-Site RIM Support Services under a separate contract?

D.1.16 states “Task Order Management Plan (TOMP) … to include QAP as required in individual task orders,” but makes no mention of the Quality Control Plan.

Would the government please clarify if reference to QAP was intended to be a reference to the Quality Control Plan or to a Quality Assurance Plan? Further is the Quality Control Plan intended to be a separate deliverable or a component of the TOMP?

Would the Government please confirm that this section should reflect the requirements as listed in the CDER SOW? We recommend that the Government remove the language in Section D.1.17 b “Personnel off-board tracking (Labor force scale-down)”

In reviewing the labor categories listed in Section D.1.21, there isn’t one named Records Manager.

Please clarify whether there should be a Records Manager labor category or not.

Given that this is a records management contract and there is an IT contractor that controls the systems, would the Government confirm that this requirement only applies to those automated systems over which the contractor has control?

Given that we can’t obtain COR approval at the time of proposal submission, can we assume that the substitution of education for experience will be approved for all Labor Categories and subsequent approval will be required for future Task Orders?

Given the nature of the work and information contained in each application from a manufacturer, would an engineering degree be acceptable in addition to the three specific degrees stated?

Would the Government confirm that Offerors may also substitute one (1) year of education for one year of required experience?

Due to the requirement that this individual have management, communication, and customer service skills, we recommend that this be classified as an exempt position.

Hence, we recommend that this position should be an exempt position.

B.1-5 Pg 6-8 Section 1 D.1.21.7 Pg 62 The SR. Electronic Document Room Technician IDIQ Labor Category mapped to the Service Contract Act Category of Computer Operator 2 in the tables in B.1 through B.5.

The service contract act defines a Computer Operator 2 as follows: (taken from the DOL website)

“14042 COMPUTER OPERATOR II 9The Computer Operator II processes scheduled routines that present few difficult operating problems (e.g., infrequent or easily resolved error conditions). In response to computer output instructions or error conditions, this worker applies standard operating or corrective procedure, refers problems that do not respond to preplanned procedure, and may serve as an assistant operator, working under general supervision.”

Section D.1.21.7 states “The Senior Electronic Document Technician will be responsible for the management and oversight of the Electronic Document Room (EDR) operation… The Senior Electronic Document Technician must have demonstrated leadership, supervisory, training, communication, and records management skills. In addition, the Senior Electronic Document Technician must be detail-oriented and have the skills to maintain databases, electronic files, documentation, and computer tapes.”

The requirement stated in D.1.21.7 appears to be inconsistent with the SCA labor classification of Computer Operator II. Please modify the table so that the Electronic Document Room Technician maps to a Computer Operator 5, and an Electronic Document Room Technician maps to a Computer Operator 2.

Please confirm that this matrix is to be used only for T & M type contracts because a Fixed Price TO is negotiated prior to award, and the contractor is responsible for managing to the price at its own risk. In contrast, T&M requires this level of reporting because the Government is responsible for managing their risk.

What constitutes acceptable evidence of time of receipt for the required electronic submission?

Would the Government please clarify where the signature should be located for each volume? A cover letter? Another location in each volume?

The table in Section E.3 on page 99 which provides the number of pages for each section of the Technical Volume details the IDIQ response and then the Task Order response which is reversed from the instructions provided above. Do you want us to respond to the Task Order or the IDIQ first followed by the IDIQ or Task Order response, respectively?

Section E.6 states “Labor Rates: The pricing workbook (Attachment 5) displays an estimated quantity of labor hours for he required labor categories. This is for evaluation purposes only. …The quantities of labor hours for each labor category shown in Attachment 5 shall be used by the Offeror for computing total labor costs for this solicitation….

The labor hours provided are a derivation of both 1880 person hours per year and 1920 person hours per year resulting in the whole number full time equivalent numbers provided in the pricing worksheet. Why are we being asked to specify the annual hours for a full time equivalent when the Government has already established the annual hours and we are not allowed to deviate from these numbers?

Also, why is the Program Manager presented as 1880 person hours per year and all other labor categories are presented as 1920 person hours per year? Please clarify.