VSD Response to Questions.doc.docx

Response to Questions - VSD Requirement

1. For the task orders we are asked to provide a profile of the personnel to be assigned to each task order (page 67), which implies a paragraph style narrative. In the table on the same page, it specified resumes detailing relevant experience and training for proposed Key Personnel. Can the government provide guidance on their expectation for the format and length of the personnel profiles and resumes. For the resumes, should full CVs be provided, NIH style biosketches, or other format.

Response:

The specific instructions for all the task orders are found in the table. Offerors will be evaluated on what is outlined in that table. See page 67 of the solicitation.

The contractor needs to address all the requirements detailed in the table. CDC would prefer to receive NIH style bio sketches. Please refer to http://grants.nih.gov/grants/funding/phs398/phs398.html for further guidance.

2. The task order proposal instructions, section 2, on page 67 indicate that we should provide “time and effort (labor hours) of proposed staff on this project and other projects”.

a. Is the request for a simple table listing each staff member and the total hours they will spend on the project, or is additional detail requested?

A table would be fine. The table should summarize what is being proposed in the response to the specific task order. The staffing table should also illustrate how the staff link with the specific task order – proposed hours, labor category, etc.

b. What is meant by “other projects”? Should each task order specify staff hours on the other sample task orders?

Response:

For each sample task order included in the solicitation, each Offeror must respond to what is requested in the table on page 67. For section 2 of the table on page 67, we would like to know the proposed total hours for staff for the specific task order. We would also like to know if staff’s time will be dedicated to other projects (within VSD as well as other projects). This information should be included as part of the response in Volume 2.

3. The task order proposal instructions, section 3, on page 68, include the following:

Offeror shall adequately describe the resources they propose to complete the work described in the PWS and a rational for their proposed approach. The Offeror shall identify any resources (facilities, hardware, software, communications, etc) that would be required above and beyond that already addressed as part of each Request for Task Order Proposal.

a. This appears to relate to the Performance Work Statement and not to the task orders located in Solicitation Section J. Please clarify whether each task order proposal should include our approach to completing the work described in the PWS. Please clarify what is meant by any resources beyond that already addressed as part of each Request for Task Order Proposal, and where this information should be placed in our response to the RFP.

Page 68, section 3 pertains to resources that are to be utilized for each sample task order. The Offeror should include this information in Volume 2.

4. The task order proposal instructions, section 3, page 68, include the following:

The Offeror shall clearly indicate how the metrics in the PWS will be monitored and corrective action taken if appropriate. Plans for security and confidentiality of information/data/data files shall be described. The Offeror shall demonstrate the ability to provide appropriate facilities for conducting the project. The Offeror shall specify its approach for maintaining control of all contract change management issues.

a. Please clarify whether this relates to the PWS or the sample task order, and whether each of the four task order proposals should include this information.

Response:

Section 3, page 68 relates to the PWS of each of the sample task orders. The Offeror should include this information in Volume 2.

5. Is there a page limit for responses to this solicitation? Or a page limit for the various sections (business proposal, technical proposal, responses to sample task orders)?

Response:

· Technical proposal:

· Volume 1 (mandatory criteria) should be no more than 10 pages (not including attachments)

· Volume 2 (response to the technical approach for each of the sample task orders):

· Sample task order 1: no more than 20 pages

· Sample task order 2: no more than 20 pages

· Sample task order 3: no more than 20 pages

· Sample task order 4: no more than 20 pages

· Volume 3 (General approach): no more than 15 pages

*This does not include attachments such as CVs, appendices, etc.

· Business proposal: no limit

6. We are in receipt of the above mentioned solicitation number as it relates to the Vaccine Safety Datalink (VSD) Project. We recognize that responses for base period funding are due in less than one month. I have one quick question as it relates to this solicitation. If a site does not participate in the base period of funding, does it preclude them from participating in one of the upcoming “Option Periods” that occur at a later time, assuming the administration continues to fund the option periods?

Offeror must submit a proposal in response to this solicitation to be eligible to receive a contract award. Those contractors that receive a basic contract award will be the only companies eligible to participate on future requirements during the 10 year period of performance of the VSD contract.

7. According to Sample Task Order #1 (VSD infrastructure activities), the dynamic data files and annual cycle files are to be created within 180 days of contract award, with data updates to occur at pre-specified intervals thereafter. Knowing that sites new to the VSD will need to first create these data files, would proposals that provide alternate delivery timelines for Sample Task Orders #2, #3, and #4 that are based on initiation of analytic activities following creation of these initial data files be considered unacceptable?

Proposing a new delivery schedule will be considered unacceptable.

8. Is there a page limit the task order proposal?

Response:

See question 5

9. Does CDC have a limit on the file size they can accept via email?

Response:

Proposals must be submitted by mail or hand delivered. Offerors must submit 1 original and 6 copies to CDC. Email responses will not be accepted. Please see solicitation amendment 00001.

10. Section B.6., page 5, section C.3., page 7, and section F.2., page 12 state that the term of this IDIQ contract is a two year base period and four two year option periods, comprising a ten year ordering period. Sample Task Order #1, infrastructure, lists only a base contract year four optional year periods, for a total of five years. Please clarify whether this is a 5 year or a 10 year contract.

Response:

The basic contract consists of a two year base period and 4 two year options for a total of 10 years. Each task order will have its own period of performance. Sample task order #1 consists of a 12 month base period and four (4) twelve month option periods for a total of 5 years.

11. I would like clarification on the submission deadline for the email and paper applications in response to referenced solicitation. Are both the electronic and mail copies due by 2:00 pm on June 11th?

Response:

See response to question 9.

12. Are offerers required to respond to all sample task orders 1-4 (in other words, none of the sample task orders are considered optional task orders but are required)?

Response:

Page 67, section A states that Offerors shall respond with individual proposals for each of the sample task orders. Therefore, Offerors must respond to all 4 mandatory sample task orders. If an offeror does not submit a response to all 4 mandatory sample task order the proposal will not be considered for evaluation.

13. Are protocols for the task orders 3 and 4 being requested to be submitted with the technical proposals for the sample task orders (versus a narrative description of the approach to writing the protocols)?

Response:

All task orders should respond in a narrative format as described in the table on page 67. For the task order methodology and technical approach, each sample task order has additional instructions included. Vendors to sample task orders 3 and 4 should respond to the specific task order instructions. No protocol will be written for this submission of the solicitation.

14. The general instructions L.8 B mentions "contractors shall include a subcontracting agreement between the prime and subcontractor for any subcontracting proposed." We are assuming that a letter of intent/consortium letter is sufficient. Is this the case, or is an already fully executed subcontract agreement expected to be submitted with the proposal?

Response:

A letter of intent is sufficient.

15. With reference to the request for sample task order proposal table on pages 67-68 under Personnel/Staff Expertise & Experience, it requests a table of employee turnover rates of over the past three years. Is this being requested with reference to the project/task order employees, or is it referring to all employees of the offeror's institution as a whole?

Response:

We would like to know your company’s turnover rates for each of the proposed labor categories included in your response for each sample task order. Please provide this in your responses to each task order in Volume 2.

16. Similarly, in the subsequent section (Management plan), it requests an organizational chart from the offeror. Is this also specific to the VSD project/task order or is it referring to the offeror's institution as a whole?

Response:

This applies to the specific task order. Please provide this in your responses to each task order in Volume 2.

17. Lastly, under the Business proposal instructions, c) requests a spreadsheet list of all labor categories over the life of the contract (for all five (5) contract years). We would like clarification as to whether the intent is for 5 years (9/1/2012 through 8/31/2017) as indicated in the infrastructure activities task order, or the 5 contract period options (which are 2 years each) for a total of 10 years.

Response:

Offerors must submit for all ten (10) years. Please see solicitation amendment 00001.

18. The Business Proposal Instructions part b) request pricing for all sample task orders. Is this requested for the base period only for each task order or also on all optional periods for the task orders?

Response:

Offerors must submit pricing for all periods within each sample task order.

19. Is Attachment J7 to be submitted along with the proposal?

Response:

This form will be required before performance of work. It does not need to be signed as part of the proposal response.

20. Sample task order 1(infrastructure) indicates in section F that it includes contribution of data to assessments. So, although preparation of automated data for analysis is part of sample task orders 2 through 4 and is done for each study, should that work be covered in the pricing for the infrastructure task order 1 and not included in the pricing for the individual studies task orders 2-4?

Response:

Yes.

21. Similarly, for study-specific administrative and project management tasks for task orders 2-4, should pricing for this be incorporated into pricing for task order 1 and not the other task orders since task order 1 is inclusive of all administrative tasks?

Response:

Yes.

22. Among the mandatory criteria listed on pg 66 of the solicitation, the ability to identify vaccine manufacturer is listed as necessary. As part of standard claims data, we are only able to identify manufacturers, when there a vaccine is manufactured by a single company. However, if there are multiple sources for the particular vaccination, especially when generic, then we are unable to pinpoint the specific manufacturer without supplemental data such as medical record review or registry matches (neither of which would provide immediate answers). Would this limitation disqualify our application for this submission?

Response:

We expect that Offerors have a functioning vaccine registry that includes manufacturer data.

23. Several of the task orders request detailed information regarding how our site will expeditiously handle IRB and DUA processes. We have spoken with the IRB manager and HIPAA compliance officer at our site. Both have indicated that if we were able to obtain a letter from the CDC indicating that the VSD is public health surveillance project, we could receive and exemption from IRB review and we could contribute data without the use of DUAs. Will the CDC be issuing such a letter for the VSD, or at least for the near-real time surveillance (RCA – Task Order #4)

Response:

Some suggested methods to expeditiously handle IRB and DUA processes include:

· IRB:

· Umbrella IRB approval for the VSD project

· Reliance to another VSD site

· DUA: Umbrella DUA execution

For VSD surveillance projects such as RCA for which there is clear documentation that the activity is not designed to contribute to generalizable knowledge, CDC is willing to consider issuing a letter stating that the work is not research and is being conducted for public health surveillance.

24. In task order #1, completion of cycle files is listed as a deliverable 180 days after the contract is signed. Is this specifically for sites that are new to the VSD? For legacy sites, do our 2011 cycle files are which are due 9/1/2012 in the current contract fulfill this? It would not be feasible to submit the 2012 cycle files on 3/1/2013, as the claims data is not yet close to complete at that date.

Response:

Yes. The 180 days allows for new sites to create cycle 2011 files. For legacy sites that have already created cycle 2011 files, these cycle files would be submitted to CDC as a deliverable under this under this new IDIQ contract. These legacy sites could submit these data earlier than described in the deliverable schedule and could work on responding to data quality issues in the cycle 2011 files. Cycle 2012 data files would not be expected to be delivered until CDC exercises the option to continue this task order for another year. See amended delivery schedule in sample task order 1. Please see solicitation amendment 00001.

25. Clause H.7 - Health Insurance Portability and Accountability Act of 1996 (Sept 2008). This clause implies that Contractors may be acting under public health authority from the CDC in performance of this contract. Will the CDC be issuing Contractors this authority?

Response:

All contractors shall follow HIPAA regulations.

26. H.16 (c) - Organizational Conflicts of Interest - Special Clause. Could you provide an example of work, or the type of work, stemming directly from a Contractor's work on this contract that would constitute a conflict?

Response:

If an Offeror has a potential organizational conflict of interest they can discuss the specific case with CDC.

27. H.16 (g) - This clause seems to conflict with the special rights in data FAR clause (52.227-17) listed in Section I-1. Could you please clarify?

Response:

Subparagraph (g) is removed from H.16. Please see solicitation amendment 00001.

28. H.10 - Dissemination of Information (May 1998) and H.35 - Review and Comment (May 1998). These two clauses indicate that publications and presentations will need to be reviewed by both the COTR and the Project Officer. Could you please confirm this?

Response:

Yes. Clearance is needed for publications and presentations. Please refer to http://www.cdc.gov/OD/foia/policies/clearance.pdf

H.35 has been removed from the solicitation. Please see solicitation amendment 00001.

29. Where will the hub be located (e.g., at CDC or at a VSD site)? We are trying to determine whether the contractor will have physical or logical (electronic) access to a HHS system (p. 19 of Solicitation document).

Response:

A task order will be issued to fund one contractor to host the hub server at their site. CDC will not be hosting the hub server.

30. We need to modify the following clause to avoid restriction of academic freedom in publishing when do we address this? H.10 Dissemination of Information (May 1998) No information related to data obtained under this contract shall be released or publicized without the prior written consent of the Contracting Officer Technical Representative.

Response:

H.10 will be applicable to the VSD IDIQ contract and awarded task orders.

31. This is a task orders contract does ERS apply to it? G.3 Electronic Subcontracting Reporting System (eSRS) (Dec 2005)

Should contractors be submitting ISRs for Task or Delivery orders?

eSRS does not currently accept ISRs for Task and Delivery Orders.

SBA is working with the Office of Federal Procurement Policy (OFPP) and other agencies to develop a Government-wide policy. The feature will not be "turned on" until there is an official, written policy issued by either OFPP or SBA.

All eSRS submissions shall be in accordance with eSRS procedures which can be found at http://www.esrs.gov/

32. Shall we list all commitments for the PI only, or the institution as a whole?

Your proposal must list any current commitments with the Government relating to the work or services and indicate whether these commitments will or will not interfere with the completion of work and services as contemplated under this proposal.

Response:

If you are referring to section L9, E4, page 64, then it is for the company as a whole.

33. How should the purchase of IT equipment, related software and on-going maintenance be presented for reimbursement by CDC under this contract?

(2)It is an HHS policy that offers provide all equipment and facilities necessary for performance of contracts, unless otherwise specified. If equipment must be acquired, you must include in your proposal a description and the estimated cost of each item, and state whether you propose to furnish the item with your own funds.

Response:

If you are referring to L9, e7: The Government is not requiring that equipment will need to be acquired. Therefore, Offerors are responsible for all equipment, facilities, etc. Offerors shall not include equipment or facility costs in any proposals.

34. Do NIH salary cap rates apply?

Response:

There is a salary rate limitation clause 352.231-70 that contractors must follow. Please see solicitation amendment 00001.

35. Is there a cap for future year’s budget escalation?

Response:

Please see response to Question 34.

36. Is this asking for reporting of 100% of the staff’s effort (other support)? Is it for all years they are budgeted on multi-year awards? Time and effort (labor hours) of proposed staff on this project and other projects.

Please see response to Question 2.

37. Are there page limits for the technical proposal, business proposal, or any of the sections contained within either of these sections?

Please see response to Question 5. Please see solicitation amendment 00001.

38. Is it mandatory to apply of all 4 sample task orders?

Response:

Yes

39. Are email and hardcopies of the proposal due on the same date?

Response:

Please see response to Question 9. Email responses will not be accepted. Please see solicitation amendment 00001.

40. Is the required Past Performance Information synonymous with Corporate Experience and Capability (L.11.C. page 70)?

Response:

No, these are separate criteria.

41. Should “L.11 Optional Task Orders” be read as L.12 Optional Task Orders since “L.11 Technical Proposal Instructions” precedes it? Subsequently, “L.12 Systems Security” would be reads as “L.13”?

Response:

Yes, please see solicitation amendment 00001.

42. Is there no Attachment J.3?

Response:

Yes, J.3 Attachment is the VSD Data Dictionary

43. Small Disadvantage Business Participation is included by reference, What percent participation is the CDC requiring?

Response:

Clause is removed. Please see solicitation amendment 00001.

44. H.38 Identification and Disposition of Data and Samples. In multi-site studies the data will be share with several contract holders. Will CDC mandate the signing of Data use agreements to ensure the safety and proper use of data? Please clarify the process to be implemented.

Response:

Participating sites are responsible for complying with applicable HIPAA requirements. CDC does not mandate this.

45. If the contractor would like to use the data for non-government purposes, it appears that the contractor can submit a request to the CO and upon approval of the CO; the contractor can proceed with the use of this data. Please highlight the limitations.

Response:

Please see rights in data clause- special works (FAR 52.227-17) which defines the rights of both parties.

46. The questions and answers are vital to our decision to participate. This has an impact on our participating subcontractors including small businesses. We respectfully request a three week extension to incorporate your feedback and clarifications into our response?

Response:

It is our intent to quickly provide answers to all questions. We will, however, extend the deadline until June 15, 2012.

47. Sample Task Order #1: Infrastructure Activities. This SOW covers the PMO and infrastructure for an individual contractor to support the distributed network of the VSD. It is not clear in the IDIQ or the sample task that the CDC is awarding one infrastructure contract or one per-IDIQ prime contractor award. Please clarify Response:

This is a multiple award IDIQ contract. It is the intent of the government to make multiple awards for the basic IDIQ contract. Offerors that receive basic IDIQ contract awards will be eligible to receive sample task order awards and be eligible to complete for future task orders. As listed on page 67, the government reserves the right to make a single award or multiple awards for each sample task order.

It is the intent of the government to award multiple contracts for sample task order #1.