16-223-SOL-00101_QA.pdf

Question # Question Answer

1 In Attachment A, Page 7, Task Area 6: Are the semi-annual update meetings to be held bi-annually or quarterly?

Semi-Annual Update Meetings – Contractor shall coordinate quarterly meetings with responsible government staff (COR, and if necessary, CO) for the purpose of reporting the status of the overall contract and the individual task orders. During these meetings, Contractor shall report on costs and burn rates, schedule, demonstrations, presentations, transitions activities, site visits and any other factors which may impact task orders or the overall contract.

This should read that the contractor shall coordinate monthly meeting with the COR and interested parties to go over the invoice, usually at the place where the contract is being performed. In addition every six months the contractor will coordinate a six month performance review. This is normally held at the White Oak Resarch center and the office director and others will attend.

2 In Attachment C, Page 11, Paragraph 4.2: Please clarify/confirm that paragraph 4.2 should be associated with Task Area 1 as 4.1.7.

4.2 DQRS Tasks

DQRS functions shall be performed at the FDA facility in White Oak. The Contractor shall perform the following tasks in accordance the DQRS SOP, attached in Appendix B:

• Follow the DQRS SOP for identifying source type, numbering of the reports to facilitate sorting, tracking, and forwarding

• Report each priority 1 report to FDA’s consumer Safety Officer in charge within 24 hours of receipt of the report by the contractor

• Produce an assignment letter for each priority 2 report and for each priority 3 report. The contractor shall produce standard notification letters to manufacturers as determined by DQRS management o Process each assignmeThe contract and almost all the FTE will be offsite at space that the contractor will lease. However a small number of FTE work onsite at the FDA White Oak Campus. These specialized workers help the office of compliance with adverse data entry. We thought it would be clearer to give this a seperate section

3 In Attachment C, Page 11, Paragraph 4.3: Please clarify/confirm that paragraph 4.3 should be associated with Task Area 1 as 4.1.8.

4.3 Develop and Update Standard Operating Procedures (SOPs)

The contractor shall develop and update both FAERS and DQRS SOPs in coordination with the FDA by performing the following:

• Update, issue, and post legacy SOPs as needed.

• Maintain a change history of all SOPs related to this contract and assure that only current SOPs are posted on the FDA provided intranet o Ensure Intranet SOPs are consistent with OIMT policies

• Ensure that appropriate FDA personnel review and approve all SOPs prior to issuance

• Perform SOP revisions within 21 days from notification by COR

• Ensure that up-to-date SOPs are available electronically to all contractor personnel and FDA/CDER intranet users

• Ensure that all hyperlinks used within SOPs are maintained

• Review SOPs on an annual basis and provide COR with a summary of changes needed This program is very SOP driven. The contractor will be responsible for writing SOP for our work area's 4.1 and 4.2 but also any other area that could benefit from an SOP like 4.5 training or many parts of 4.6 project management. As soon as anything changes in our process the contractor will be asked to update the SOP and send it to the COR. Read appendix b on task order one for a flavor for the depth of SOP's

In the solicitation, page 9, under 9.2.3: Will the Government provide an estimate of additional facilities for multiple, concurrent off-site future awarded task orders beyond the Task Order 1?

The Government will evaluate if the documentation provides evidence that the Offeror has the ability to possess a fully functional facility for the sample task order and its ability to acquire additional facilities for multiple, concurrent off-site task orders that adheres to FDA IT Facilities Requirements. As stated it is expected the offerors to provide a fully funcional facility for in response to task order one. However, it is anticipated there will be additional task orders requested/awarded and ideally these should all be at the same location. The FDA is anticipating a response from the offeror which discusses/addresses how additional task orders would be handled as far as using existing or acquiring additional space.

5 Can the Government please provide an expected start date?

It is anticipated to have the base contract awarded in Dec, as well, the government reservse the right to award the sample task order as the first task order to the IDIQ.

In the solicitation, page 7, Vol 4. Price: The solicitation requires labor categories be priced with on site and off site rates. Attachment E – Pricing Worksheet format does not differentiate between on site and off site rates for each year. Will there be an updated Attachment E to include the ability to price both rates?

The contractor may add the necessary columns or add a worksheet to include the off site labor rates under Attachment E.

7 In the solicitation, page 7, Vol 4. Price: Attachment 8 is referenced but not included.

Will there be an Attachment 8 issued? Any reference to Attachment 8 is to be Attachment J.

In the solicitation, page 2, under 8.1: “Each of these volumes shall not be located or bound with any other volume...” and Page 7, Sect. 8.2 states “…submit proposals via email…”. Does the Government want only email submission? Yes, the government only wants e-mail submissions.

9 In the solicitation, page 2, under 5.2: Reads that ODCs will be fixed cost, will the Government agree for ODCs to be cost reimbursable?

The ODCs proposed at the task order level as stated at 5.2, will be fixed under the FFP Task Order. It is anticipated, at the task order level, the ODC would be paid at cost.

In Attachment C, Page 14, Paragraph 4.5.1: Can the Government please clarify the references to "Section 6.5. FAERS-DMP Tasks and 6.6 DQRS Tasks."? These are not valid section numbers.

The contractor shall prepare a Training Plan due 10 days after contract award.

The training plan shall be in accordance with the processing metrics stated in Sections 6.5 FAERS-DMP Tasks and 6.6 DQRS Tasks. The content of the Training Plan shall include: This should be pointing the potential offerors to our SOP for DMP and DQRS in Appendix B and you should also look on Attachment C (TO1 SOW ) on p 6 and p 10 for how many reports per hour the training goals should be

11 In Attachment C, Page 14, Paragraph 4.5.1: Can the Government please clarify the reference to Section 6.1.1.4.1? This is not a valid section numbers.

A quality assurance program for data entry as described in Section 6.1.1.4.1.

Any discussion of data entry shall take into account accuracy, throughput and environment. "as described in 6.1.1.4.1 should be struck " We do not give a specific example of a data entry quality program.

In Attachment C, Page 20-21, Paragraph 4.6.9: Can the Government please clarify the references in the deliverable tables? The section numbers and content are not aligned. See revised table attached to this amendment.

In Attachment I: Can the Government please confirm that a signed FDA Form 3398 is not to be included in the proposal? If it is to be included in the proposal, can the Government please specify who needs to complete, and in what volume it should be submitted.

The FDA Form 3398 is not required at the time of proposal. It will be required at the time of contract award.

14 In the solicitation, page 3, under 8.1: Will the government allow us to include an Executive Summary that is excluded from the page count?

An executive summary may be provided, but it will not be considered part of the solicitation, and will not be evaluated.

In the solicitation, page 5, under 8.1: “The Offeror shall provide rationale and narrative description of its proposed management approach to performing the work required in Attachment C. This should describe its organizational structure and how it proposes to manage this task and include the Task Order Management Plan.”

Does the government intend to require an actual Task Order Management Plan? If so, can it be an attachment that is excluded from the page count?

We do require an actual Task Order Management plan and it is part of the page count

In the solicitation, page 7, under 8.2: In light of the release date and due date for questions, would the government please extend the proposal due date by 2 weeks to November 4, 2016? No

In the solicitation, page 22, under 14.3: The Place of Performance section references the locations of FDA’s Centers and Offices. It also notes that the location for the performance may be specified in each task order.

Does FDA anticipate that there could be some on-site work under this contract? yes there may be on-site work.

There is no solicitation cover page such as an SF1449, SF33, etc. included in the solicitation package.

Would the government please provide a solicitation cover page with this information included? No on page 7 of Attachment A (IDIQ SOW), 5.5 Task Aread 6, bullet 2 under Meetings:

“Semi-Annual Update Meetings – Contractor shall coordinate quarterly meetings with responsible government staff . . . . “

Would the government please clarify if the meetings are to be semi-annual or quarterly? Please see answer to Question #1

20 On page 14 of Attachment C (TO SOW), 4.5.1, Bullet 3: Can the government please advise on the location of Section 6.1.1.4.1? Please see answer to Question #11

On page 19 of Attachment C (TO SOW), 4.6.8, 8th sentence: “The contractor shall provide a detailed pictorial representation of all network equipment in the building.”

Since our building is a multi-tenant facility, a complete pictorial for all tenants is not feasible. Would the government accept a detailed pictorial of the network equipment that would be used for this contract?

This is acceptable but we need to understand all the shared equipment. For example your network cables may terminate into a Multiplexer (MUX) that many tenants share. We would like to understand the buidings archeticture .

We do not want to see a diagram with just a line that says "internet" and be told that the building "has a robust internet connection" we would want much more details including if you building has more than one internet provider in case one fails.

22 Is this a follow-on requirement? If so, could you please provide the incumbent contract number for this opportunity? If not, is this a new requirement? This is a follow on requirement. The current contract is HHSF22320100031I.

Per guidance in the FAR 5.203(c), agencies shall allow at least a 30-day response time for receipt of bids or proposals from the date of issuance of a solicitation. Would the FDA please extend the proposal due date to October 30 to provide the offerors time to prepare their response?

FAR 5.203(c ) begins, "Except for the acquisition of commercial items (see 5.203(b)), ...". It was my determination, initially, that a 21 day response time for commercial services would be acceptable, however please see answer to Question #28.

Reference RFP page 5 of 26, Evaluation Factor 4: Off-Site Facilities to the IDIQ. To allow competition by small companies within the Washington DC metropolitan area who have adequate facilities to meet the solicitation needs, would the FDA please increase the location of the offeror’s facility to within a 30-mile radius of the FDA White Oak Campus? Based on FDA support to offsite facilities, the FDA requires the 20-mile radius.

It appears that the work performed on the FDA Offsite fully integrated records facility (FIRF) contract that includes processing and coding CDRH MedWatch adverse event reports is also covered under this solicitation. Is it FDA’s intent to move the current Offsite FIRF CDRH MedWatch task to this new contract after award? No

In section 9.1. Factor 1 what government wanted to mean ‘within short suspense periods’. If there is a gap of 3 months between two task orders will that be considered as concurrent Task Orders ‘within short suspense periods’ for the evaluation of Factor 1? Short suspense is to be interpreted as 30 days.

27 Will government accept sub-contractors' past performance?

Past Performance may be for Prime or Subcontractor as necessary. Though a greater risk may be assigned if none are provided by the prime.

28 The timeline for the submission of the response of a voluminous proposal like this is too short . Will the government extend the submission deadline for one more week?

Yes, the government has extended the deadline for responsese in this amendment.

Are the developers of the AgTracker system (and their subcontractors) precluded from bidding on this procurement since they have knowledge of the new system and its future enhancements that are not available to the other bidders? No, they are not precluded

30 Must all work be performed within the United States? If teleworking is permitted, may work be performed offshore by non-U.S. citizens? All work for this contract must be performed within the United States.

On page 3 of the solicitation, section 8.1b General Formatting Instructions, The following items are not included in the stated page limitations:

• Cover Page

• Table of Contents

• Glossary

• Dividers

• Resumes

• Letter of Commitments

• Contractor Teaming Arrangements (if applicable)

To keep the pagination cleaner and easier to follow, as the resumes are not included in the page limitation, is it acceptable to have them in an appendix referenced from the key personnel section of the proposal response?

May we also include letters of commitment in this appendix?

Any items, not included in the page limits, may be submitted in a fashion which is typical for the type of exclusion. Appendix to the proposal is acceptable.

Though items in the appendix, which are not on the exclusion list, will not be evaluated.

On page 5 of the solicitation, section 8.1c Evaluation Factor 4: Off-Site Facilities to the IDIQ, "The Offeror shall also provide the following documentation in support of the sample task order:

• The facility is owned or leased by the Offeror;"

May the Offeror provide proof of the facility lease as an attachment to this volume, and exempt it from the overall page count? This should part of the page limit

On page 5 of the solicitation, 8.1c Evaluation Factor 4: Off-Site Facilities to the IDIQ, The Contractor must provide a detailed architectural blue print of the proposed facility showing individual data entry workstations.

May the Offeror provide the architectural blue print as an attachment to this volume, and exempt it from the overall page count? This is part of the page limit

On page 6 of the solicitation, 8.1c VOLUME 3 Past Performance, "A listing of at least three past performance references to whom the FDA may contact. The listing shall include the references Company Name, DUNS, Contract type, Contract Value, Period of Performance, Current Company POC who may be reached, Phone Number and email."

Would the FDA please clarify if the DUNS number to be provided is for the referenced agency/company, or if it is the DUNS number of the vendor providing the services?

As stated is would be the referenc's DUNS. If the reference does not have a DUNS, then this would not be applicable.

On page 7 of the solicitation, Volume 4, "Indicate on Attachment E (Pricing table) all labor categories proposed under this IDIQ"

The RFP does not include labor categories and labor category descriptions.

a) Is the Offeror to propose labor categories and descriptions for the IDIQ contract that are also to be used for bidding the sample task order?

b) Should the Offeror propose IDIQ labor categories only for the sample task order or should we also propose labor categories that will be used for potential future task orders?

c) Since future task orders and requirements are unknown at this time, will FDA allow new labor categories to be added as needed for future task orders?

d) If each bidder can propose its own labor categories, FDA is likely to receive a myriad of labor categories, descriptions, and rates. How will FDA evaluate IDIQ labor categories and rates as part of the price proposal?

a) yes

b) the contractor is responsible to propose labor categories/rates which would encompass all task areas described under the base contract.

c) based on the task area descriptions in the SOW, it is the responsibility of the potential offeror to provide what is determined to be the labor categories to meet all anticipated work.

d) the labor rates will be evaluated based on the proposed labor categories, descriptions and rates through contracted historical values as well as through current market research to determine rates as reasonable.

On page 7 of the solicitation, Volume 4, "Indicate on Attachment E (Pricing table) all labor categories proposed under this IDIQ"

How and where in the offeror’s proposal should the labor categories be identified and the labor category descriptions presented?

The contractor may either add a worksheet or include the labor categories/descriptions on any existing worksheet which they determine is most applicable under Attachment E.

On page 7 of the solicitation, Volume 4, "Labor categories will include onsite and offsite rates as applicable within the worksheet.

The offeror may manipulate this worksheet as necessary to appropriately show the labor rate in accordance with the SCA and the formulation of the fully loaded rate."

The RFP states the Offeror may manipulate the Excel worksheet to present information in accordance with the SCA. May the Offeror also manipulate the Excel pricing worksheet to support pricing information for on-site and off-site rates, as applicable? Yes.

On page 7 of the solicitation, Volume 4, "All labor rates are to be fully loaded labor rates."

Can facility costs be bid as an ODC or must they be included as part of the Offeror’s Contractor Off-site Rates? This is up to the offeror in according with it's accounting system.

On page 7 of the solicitation, Volume 4, "Each Attachment E worksheet applicable to a Task Order SOW, shall be filled out with rates proposed on the BASE IDIQ Pricing Table, and any proposed fixed Materials/ ODCs. The Task Order SOWs are reflective of the work to be performed under this IDIQ"

Would the FDA please confirm that Materials /ODCs are only those items specifically required by the task order SOW and not items required by the IDIQ?

The Materials/Other Direct Costs under the Base IDIQ worksheet tab, are for the base contract, and will be set through the life of the contract. The Materials/ODCs on the Task Order worksheet tab, are either specific to that task order, and cannot be pulled from the Base IDIQ Materials/ODCs list, or are pulled from the Base IDIQ Materials/ODCs list.

On page 9 of the solicitation, 9.2.3 Evaluation Factor 4 Offsite Facilities. "4) Sub- Factor D: The proposed facility square footage must be contiguous and capable of supporting the functions outlined in ID/IQ SOW Task areas. Current footage for task order one footprint is 2600 contiguous usable square feet"

Since there is only one sample task order and future task orders are unknown, would FDA please confirm that we are only required to demonstrate a lease that includes 2,600 contiguous square feet for the sample task order? See answer to Question #4

9.4 Pricing, "Price will be evaluated separately from past performance and the technical factors, and will be evaluated for fairness and reasonability in terms of reasonable and realistic pricing - that the proposed prices are calculated based on reasonable and realistic assumptions.

Offerors are cautioned that an unrealistically low price, or unbalanced pricing of line items, as proposed initially or subsequently, may be grounds for eliminating a quote from further consideration, either on the basis that the Offeror does not understand the required services or has made an imprudent offer. The Government will evaluate the Offeror’s ability to deliver an efficient, low-risk price service at a fair and reasonable price. As part of this evaluation, the Government will evaluate:

- Offerors proposed Labor Hour (LH) price in response to the sample task order (Attachment E) will be evaluated for reasonableness and realism for the work to be performed. The final proposed and evaluated price of the first task order will be the awarded value.

- Compliance with Limitations on Subcontracting: Whether the Offeror has demonstrated its ability to comply with the limitations on subcontracting clause.

How will the Government evaluate the labor categories and rates proposed that are not used in the sample task for fairness and reasonability in terms of “reasonable and realistic pricing” as each offeror may propose different labor categories and rates?

See answer to Question #35d

With regards to Attachment C - Task Order SOW, while the Government has provided historical workload levels, expected future workload levels are not shown.

Given the new electronic mandate and the implementation of AgTracker that will change the workflow and workloads for manual processing, what are the Government’s estimated workloads for the one-year task order period of performance?

New software and regulations are changing our labor mix but this is still playing out. We ask that bidders compete against a known historical standard.

43 With regards to Attachment C - Task Order SOW, will the task order be issued as a Fixed Price, Labor Hour, or T&M type task? Task order one is anticipated to be a labor hour task order.

With regards to Attachment C - Task Order SOW, we understand there is a Technical Writer currently supporting this task. Is a Technical Writer required on the task moving forward?

It is up to the offerer to determine the required labor categories for their technical solution to the tasks described in teeh statemenet of work.

On page 4 of Attachment C - Task Order SOW, 4.1 Task Area 1 – FAERS-DMP Document Processing, Handling, Correspondence, and Delivery, Figure 1 depicts and describes the processes and flow of information including input of adverse event reports to FDA

The figure was not included, however, Appendix F to Attachment C appears to be the processing flow. Would FDA please confirm that Appendix F is the figure referenced in this part of the SOW? This is correct where it is stated "Figure 1" it should state Appendix F

On page 4 of Attachment C - Task Order SOW, 4.1 Task Area 1 – FAERS-DMP Document Processing, Handling, Correspondence, and Delivery, The contractor is responsible to hire a courier service and oversee their work. This is detailed in the SOP in Appendix B and the courier route from the SOPs are found in Appendix C.

The cost for the courier is charged on the invoice to FDA and a receipt from the courier service is included in the invoice.

Must the Offeror use an external courier service or may the contractor provide its own internal courier? Will the courier be required to provide his or her own vehicle or will the courier be required to use a FDA vehicle?

The SOW is hereby restated to remove "to hire a courier service" and replaced with "for courier service"

Attachment C - Task Order SOW, on page 11 Section 4.2 DQRS, "DQRS functions shall be performed at the FDA facility in White Oak." and page 21, Section 6. Place of Performance, "The contractor will be required to work at the contractor site and provide courier services to multiple FDA facilities each weekday. See Appendix C"

Please confirm that the DQRS staff are required to work on-site at White Oak?

Does FDA have a specific number of FTEs or minimum number of FTEs expected to work on-site to support DQRS?

Are the staff supporting DQRS (see Section 4.2) the only contractor staff required to work on-site?

DQRS staff are the only contractor staff required to work onsite under task order one. Other tasks orders my have off site or onsite requiremets.

Contractors must determine the number of FTE used in their bid taking into account the workload parameters given. In the case of DQRS this is going to be a small number of people but we do not have a minimum. Under task order one DQRS is onsite at White Oak. Ohter task order may be onsite or offsite.

On page 13-14 of Attachment C - Task Order SOW, 4.4 Task Area 2 – Transition Work Activities, "The FDA will grant a 60-day Transition Period in order to transition from contractor to contractor… If the current contractor wins the new award and keeps the same physical facility no transition will be needed. If the current contractor wins the new award and changes to a new physical facility a transition of 30 calendar days will be used."

As transition included in the technical proposal is a non-price factor, subject to being evaluated adjectivally, will the incumbent contractor be rated higher than other offerors who cannot complete the transition within a 0-30 day timeframe? If so, it would appear that the solicitation provides an unfair advantage for the incumbent contractor. How will FDA evaluate the Offeror’s Transition Plan? How will the FDA evaluate the Offeror’s transition price?

The 30 day transition timeframe only applies to the incumbant should they change to a new physical facility. All offerors will be evaluated based on their individual technical solution to the SOW and its transition requirments as stated.

On page 19 of Attachment C - Task Order SOW, Section 4.6.8 Facility Preparation, "The contractor is required at the time of proposal submission to possess the fully improved facility to perform the SOW Task Areas.

If the work area needs to be prepared before FDA personnel can start work a project plan shall show all the steps and dates when each step will be completed."

These two sentences in Section 4.6.8 appear to be in conflict, as the first requires the facility to be fully improved at time of proposal submission, while the second provides for a Project Plan to prepare the facility. Would the Government please confirm that we need only provide a Project Plan for how we will prepare the facility for Day One operations?

The first sentence refers to the physical facility the second refers to the contractors ability to succefully take over each of the data entry steps so that at the end of the transition period they can take over all aspects of data entry and keep up with incoming work, all at the level of quality FDA expects

Attachment C - Task Order SOW, on page 19 Section 4.6.9 Infrastructure Setup, "However the contractor facility should be able to accommodate an FDA network node which would be a high speed dedicated optical link in case performance becomes an issue with VPN or a policy change where FDA IT may in the future mandate a dedicated line. The contractor infrastructure shall include two different Internet Service Providers (ISP’s) to minimize downtime. The contractor will supply all hardware needed to connect FDA computer equipment to one ISP by traditional wires. In addition the second ISP will use wireless connection for quick switch over in case of primary ISP failure." and page 22, Section 9 – Government Furnished Equipment/ Government Furnished Information (GFE/GFI), "FDA will provide any required hardware and software for performance under this task order. Following task order award, contractor shall provide full inventory of government equipment."

The ability to accommodate the FDA network node is not a current requirement but may be in the future. Also the components to connect in the future are not provided in the solicitation. Will the Government please confirm that any equipment needed for connection to FDA (other than by VPN) will be provided either by FDA as GFE or will be reimbursed by FDA on future task orders?

All work for this contract must be done on FDA provided computers. If VPN connections are feasable and allowed by FDA security then the contractor will need to provide a robust internet architecture to support all of the VPN connections and this should be detailed. VPN will need to be supported at the begining of the contract in any event because it takes a miniumum of several months for FDA to build out a dedicated network node if that ends up being required. If FDA decides to build out a network node then in addition to the computers FDA will end up supplying other network equipment like a network router and other network monitoring hardware and software tools. Bidders should detail the current readiness of their building and show how it can accomidate VPN at first and is able to accomidate a network node if needed.

If FDA does need to build a network node they will need dedicated space for their equipment. FDA will supply needed equipment but the contractor may need to do things like enclose FDA data lines in pipe to meet FDA security requirements and may need to drill to make room for these pipes. These costs to accomindate FDA equipment will be the responsibility of the contractor.