Q and A's for Sentinel July 31 2009.doc

ANSWERS TO PROSPECTIVE OFFEROR’S QUESTIONS

SENTINEL PROJECT

RFP NO. 09-223-SOL-00112

JULY 31, 2009

QUESTION NO.1:

How should data source fees be presented for pricing purposes?

ANSWER NO. 1:

See Amendment #3; Added CLIN 0016.

QUESTION NO. 2:

If the organization participates on the RFP response as a subcontractor (i.e. data source provider), will such organization be eligible to compete for future Sentinel related RFPs?

ANSWER NO. 2:

We cannot determine eligibility for future Sentinel related

RFPs at this time. See also statement at the end of B.2, Background and H.4.

QUESTION NO. 3:

Section B.5, Page 5: The place of performance is not specified in the RFP. Should the Offeror provide rates for work at its facilities (i.e. contractor-site rates)?

ANSWER NO. 3:

The Offeror shall provide off site rates.

QUESTION NO.4:

Section B.6, Page 7 & 8 (Pricing schedule, Footnote #6): Will the Government allow substituting a MS degree in epidemiology with one year of experience for the equivalent of a BS/BA with three years of experience for CLIN 0008, Junior Epidemiologist?

ANSWER NO. 4:

See Amendment #3.

QUESTION NO. 5:

Section L.9, Page 52: We assume that any past performance questionnaires that were submitted prior to the release of RFP Amendment 2 will be evaluated if the Offeror provides a table in Volume III that indicates the three references the Government should consider as part of its evaluation. Is this assumption correct? We also assume that the Government will disregard and destroy any additional questionnaires other than the ones specified in Volume III by the Offeror? Is that assumption correct?

ANSWER NO. 5:

Yes, any past performance questionnaires that were submitted prior to the release of RFP Amendment 2 will be evaluated if the Offeror provides a table in Volume II that indicated the three references the Government should consider as part of its evaluation. Yes, the Government will disregard and destroy and additional questionnaires other than the ones specified in Volume III by the Offeror.

QUESTION NO. 6:

Section L.8, Page 52: Factor # 3 Management and Staffing requests that a level of effort be provided for key, technical, and administrative personnel and address the area specified in Section C. Since it appears the Government’s intent is to evaluate the knowledge and experience of key personnel as part of this factor will the Government remove the requirement to provide a level of effort since the level of effort is specified at the task order level?

ANSWER NO. 6:

The Government will not remove the requirement to provide a level of effort since the level of effort is specified at the task order level.

QUESTION NO. 7:

Reference B.5, pages 5, 6, Would the government entertain an option submitted with the proposal for the technical solution for the Sentinel system, which could then be exercised as a task order on the awarded contract? If so, would it count against a page count within technical and could technical labor categories be included in this optional portion of the proposal?

ANSWER NO. 7:

You may, at your discretion, submit alternate proposals, provided that you also submit a proposal for performance of the work as specified in the statement of work. Such proposals may be considered if overall performance would be improved or not compromised and if they are in the best interest of the Government. Alternative proposals shall be clearly identified. Alternative proposals will not be counted in the page count for technical proposals.

QUESTION NO. 8:

Reference C.1.c.2a, page 8, Does the government intend to provide a basic technical infrastructure at the onset of the contract for the storage and analysis of collected data sets?

ANSWER NO. 8:

The Government does not intend to provide a basic technical infrastructure at the onset of the contract for the storage and analysis of collected data sets

QUESTION NO. 9:

Reference B.2, page 4,If this proposal is not to create the Sentinel System, does the government anticipate an opportunity in the future to propose on the creation of the Sentinel system? Or is this the only opportunity, given the potential COI language for contractors to participate on the Sentinel Initiative?

ANSWER NO. 9:

See Answer #2.

QUESTION NO. 10A:

RFP Reference: Section B, Pgs 7-8. Detailed descriptions, to included education and experience, were provided for all labor categories, with the exception of the Database Manager and Research Assistant.

Will the government provide vendors with a more detailed description including levels of education and experience and required knowledge for the Database Manager and Research Assistant?

ANSWER NO. 10A:

See amendment #3.

QUESTION NO. 10B:

Are the labor categories provided meant to be an exhaustive list of the labor categories required to support this contract?

ANSWER NO. 10B:

The labor categories provided in the solicitation are the government’s minimum requirement.

QUESTION NO. 11A:

RFP Reference: Section L.5, Pg 49. Our preferred method of electronic proposal delivery is to transmit Zipped Files that are password protected and to provide the decryption password via a separate transmission.

In order to implement secure delivery of our proposal via e-mail as required , does the FDA, OAGS have the capability to accept “.zip” Files?

ANSWER NO. 11A:

Yes, we can accept zip files.

QUESTION NO. 11B:

If not, does FDA, OAGS have a preferred method for receiving encrypted files?

ANSWER NO. 11B:

See Answer 13A.

QUESTION NO. 12A:

RFP Reference: Attachment 4, SB Subcontracting Plan, Pgs 63-77. Attachment 4 to the FDA Sentinel RFP states that bidders are to break down small business allocations for the base and option periods in dollar amounts and percentages. Since the FDA anticipates a single IDIQ contract award and does not provide any information concerning anticipated task order values, nor planned annual funding allocations, we are trying to determine how to calculate the dollar values that align with our small business contracting goals. One approach would be to calculate the dollar values against the maximum contract amount of $120M and spread the allocations across the base and option years. On other IDIQ contracts, we have identified an anticipated dollar amount based on sample task orders and program work structures provided in the RFP. This solicitation does not provide sufficient information to execute that option. On one recent IDIQ contract we provided only percentages.

Will it be acceptable to base the dollar amounts on the maximum contract value?

ANSWER NO. 12A:

It will be acceptable to base the dollar amounts on the maximum contract value.

QUESTION NO. 12B:

Will the FDA provide a total planning value or base/option period values for the purpose of calculating the dollar values?

ANSWER NO. 12B:

Please use the contract maximum value of $120M and specify the dollar amount for subcontracting for each year.

QUESTION NO 12C:

Will the FDA accept subcontract allocations provided as percentage work share allocations only?

ANSWER NO. 12C:

The offeror shall adhere to the instructions in subcontracting plan.

QUESTION NO. 13:

RFP Reference: Section B2, Pg 4 states “…Provide a “laboratory” for developing and evaluating scientific methodologies that might later be used in a fully-operational Sentinel Initiative.

Will the “laboratory” augment and enhance the FDA’s current methods with new innovative, advanced analytical and statistical methods (related to signal detection, signal strengthening, and signal validation), specifically for analyzing aggregated summary level data with current FDA data holdings.

ANSWER NO. 13:

Methods developed under this contract are intended to be applied to automated healthcare data.

QUESTION NO. 14A:

RFP Reference: Section B2, Pg 4 states “The contractor that is awarded this contract may be excluded for future work on the Sentinel Initiative described in paragraph B2, Background.

It is not clear from what activities the awardee may be excluded. Please specify future limitations placed on a contractor if they are awarded this work.

ANSWER NO. 14A:

See Answer #2.

QUESTION NO. 14B:

How does the FDA envision paying for the data provided under this contract?

ANSWER NO. 14B:

See Answer #1.

QUESTION NO. 15:

RFP Reference: Section L10, Pg 53 states “In the Volume V, the Offeror shall include a detailed cost estimate and basis of estimate. All Offeror’s labor rates shall be consistent with the Price Proposal as detailed in Volume I and B5.

Please elaborate on the methodology for pricing the RTOP. Does the government request to use the hours provided?

ANSWER NO. 15:

See Answer #7.

QUESTION NO. 16:

Page 50, Section L.8, 1st Paragraph states that the 15 page count excludes key personnel information. It is our assumption that resumes of the key personnel including individual’s publications are part of the key personnel information, and therefore, do not count towards the page limit.

ANSWER NO. 16:

Yes, resumes of the key personnel including individual’s publications are part of the key personnel information, and therefore, do not count towards the page limit.

QUESTION NO. 17:

Regarding the healthcare data, it is our understanding that the data will be priced as a separate line item as part of the solution proposed in response to each task order. Can FDA please verify that? If our assumption is wrong, will FDA please clarify how they intend to reimburse the Contractor for the use of data.

ANSWER NO. 17:

See answer #1.

QUESTION NO. 18:

RFP Ref C.1.b.1.b The modified RFP states that there is a preference for the Contractor to be a holder of automated healthcare data systems. The Evaluation Criteria in section M does not provide preferential points to Contractors who are holders of healthcare data. Is that correct? If not, would FDA please clarify?

ANSWER NO. 18:

The fact that an Offerror is a holder of automated healthcare data is a component that will be evaluated in Factor # 2 Technical Approach.

QUESTION NO. 19:

It is our understanding that FDA is looking for a solution that best meets its requirement regardless of whether the Contractor is a Data Holder or not. Is that correct? If our understanding is incorrect, would FDA please clarify?

ANSWER NO. 19:

It is not a requirement for the Contractor to be a data holder. See also answer #19.

QUESTION NO. 20:

Can we provide a list of publications as an appendix to the Technical Volume?

ANSWER NO. 20:

Yes, you can provide a list of publications as an appendix to the Technical Volume.

QUESTION NO. 21:

Page 4 of the Revised RFP states: "The contractor that is awarded this contract may be excluded for future work on the Sentinel Initiative described in paragraph B.2, Background." Does this clause apply only to prime contractors, or is it possible that subcontractors to the winning prime offeror will be excluded for future work on the Sentinel Initiative as well?

ANSWER NO. 21:

See Answer #2.

QUESTION NO. 22:

The Sample Task Order notes that the sample task proposal will be evaluated in accordance with the evaluation criteria in Section M of the RFP. Will this evaluation be done per Section M.2.3 ("…evaluated to determine their ability to demonstrate their technical capabilities for evaluation purposes only on the Sample RTOP") or for all criteria listed in Section M? If all evaluation criteria in section M are being used for evaluation, will they be weighted similarly to the evaluation of the Basic Technical Proposal?

ANSWER NO. 22:

See amendment #3. The sample task order will be evaluated as described in Section M.2.3.Section M.2.3.

QUESTION NO. 23:

We would like to confirm that the workplan deliverable for the Sample Task Order is still to cover all items detailed in the ‘Descriptions of Deliverables’ on pg 59 even after the alterations to the Detailed Requirements as part of Amendment 2 to the RFP. If so, are the evaluation weighting the same as in the main IDIQ evaluation criteria.

ANSWER NO. 23:

See Answer #22.

QUESTION NO. 24:

How does the requirement that all data sources be non-federal apply to combination data sources, such as Health Information Exchanges which include both federal and non-federal data? Can data from federal sources be excluded from these combination data sources so that they can be utilized in the execution of this contract? (pg. 50)

ANSWER NO. 24:

It is acceptable if your dataset contains linkages to Federal data sources in order to achieve capture of all health care events.

QUESTION NO. 25:

Are the CV’s for key personnel involved in the Basic Tech Proposal as they were with the Sample RTOP?

(L.10, pg52): Exclusive of cover, table of contents and Key Personnel CVs, the Sample RTOP’s Technical Volume IV shall be limited to 10 pages.

ANSWER NO. 25:

Yes, CV’s for key personnel involved in the Basic Tech Proposal are as they were with the Sample RTOP .

QUESTION NO. 26:

What is the required date of submission of the Past Performance Questionnaire?

ANSWER NO. 26:

By the response date of August 10 at 9:00am est. You can submit past performance questionnaires before you submit your proposal, but you still have to list them in

Volume III.

QUESTION NO. 27:

Please clarify the requirement related to the submission of the Commitment to Protect Non-Public Information Agreement. On page 22 of the amendment, the FDA indicates that “…all Contractor and subcontractor employees are required to sign the Contractor’s Commitment to Protect Non-Public Information Agreement form…” On page 23, the FDA indicates that “…each Contractor/subcontractor employee who may have access to non-public Department information under this task order shall complete the Commitment to Protect Non-Public Information Agreement form…” We are a large firm with thousands of employees. It seems neither practical nor necessary for “all” employees to sign the agreement. Please confirm that the FDA intends that it is only individuals (or key individuals) who are expected to be involved in this work who must sign the Agreement, or please clarify otherwise.

ANSWER NO. 27:

Everyone involved with the contract shall sign the agreement.

QUESTION NO. 28:

Please clarify the requirements related to the Small Business Subcontracting Plan. The RFP is unclear as to whether a plan must be submitted (regardless of whether we intend to subcontract anything), or whether a plan only needs submission in the setting of our intention being to use subcontractors.

ANSWER NO. 28:

A subcontracting plan must be submitted if applicable.

QUESTION NO. 29:

Is there a format we need to follow for CV’s?

ANSWER NO. 29:

There is no format to follow.

QUESTION NO. 30A:

Page 3 of Amendment 2 states, “The objective of this contract is not to create the Sentinel System, but to provide the necessary support to facilitate the development of the Sentinel Initiative and carry out mandates delineated in FDAAA, including, but not limited to, requirements in Section 905. This will be carried out via the development of specific tasks, as deemed necessary by the Agency, and outlined below in the Scope of Work.”

Is our interpretation correct that (1) the FDA is looking for a data coordinating center (DCC) that has access to at least 3 private data sources that can be used to conduct pharmacovigilance for newly marketed medications, but (2) the development of the structural architecture for the Sentinel’s distributed network model will be informed over the course of the task orders under this IDIQ? If this is not a correct interpretation, could FDA clarify its intentions about this procurement and any future, related procurements?

ANSWER NO. 30A:

Yes; As stated in Section B.2, the objective of this contract is to develop the scientific operations needed for the

Sentinel Initiative. There is no requirement for a structural architecture in this procurement.

QUESTION NO. 30B:

For example, is the FDA looking to the DCC only to understand the potential structural issues in participating in a distributed network without using the contractor to resolve exactly how to do the proposed future work.

ANSWER NO. 30B:

See answer #30A.

QUESTION NO. 31A:

On page 4 of Amendment 2, the RFP states, “The contractor that is awarded this contract may be excluded for future work on the Sentinel Initiative described in paragraph B.2, Background.”

Could the FDA explain the reasons that the awardee of the current RFP might be excluded from future work on the Sentinel Initiative? Does the term “may be excluded” absolutely preclude procurements for the Sentinel Initiative to the awardee, or is it quite possible that the awardee would not, in fact, be precluded from such work.

ANSWER NO. 31A:

See Answer #2.

QUESTION NO. 31B:

Could the FDA clarify whether this exclusion flows down from the awardee to any or all subcontractors to the awardee? That is, are subcontractors (whether large or small business subcontractors) precluded from future work on the Sentinel Initiative?

ANSWER NO. 31B:

See Answer #2.

QUESTION NO. 31C:

Could the FDA explain what such future work might include, if the awardee (and possibly its subcontractors) cannot participate in it?

ANSWER NO. 31C:

See Answer #2.

QUESTION NO. 31D:

Could the FDA explain, then, how the awardees of future work might be expected to collaborate with the awardee of this procurement, if such future work goes only to contractors other than the awardee of this procurement?

ANSWER NO. 31D:

See Answer #2.

QUESTION NO. 32:

On page 7, we appreciate the additional CLIN labor groups. This set, however, still does not quite cover the skills and tasks we have envisioned for some staff whom we regard as essential to this procurement. Thus: Is it acceptable for us to we include other CLIN levels as well as those specified in the amendment?

ANSWER NO. 32:

See Answer #7.

QUESTION NO. 33:

P. 50 states "The Offeror shall provide documentation that verifies their ability to provide access..." Please describe the possible forms of documentation acceptable.

ANSWER NO. 33:

Acceptable documentation would include, but is not limited to, a letter of intent, a teaming arrangement, or a subcontracting agreement.

QUESTION NO. 34:

P. 50 also states "Submissions including responses with federal data sources will disqualify the Offeror’s entire proposal package." Could you please define/quantify 'federal data sources'?

ANSWER NO. 34:

Federal data sources are data environments that solely consist of data from United States government agencies. This would include, but is not limited to, the Department of Defense, the Department of Veterans Affairs, or the Center for Medicare & Medicaid Services. However, data accessed directly from a state, such as state run Medicaid programs, are not considered a Federal data source for the purpose of this procurement. See also answer #26.

QUESTION NO. 35:

I am trying to find out if FDASOL091056109 is a new requirement or if there is an incumbent performing the work. I am looking for the following details:

1. Incumbent awardee

2. award date

3. contract value

4. contract number

ANSWER NO. 36:

This is a new requirement.