CDC-IRR - Final Questions and Answers.doc

Request for Proposals (RFP) 2008-N-10242

CDC Influenza Reagent Resource (CDC-IRR) Pre-Solicitation Conference

Additional Questions and Answers

April 18, 2008 The following questions were received after the March 11 deadline for receipt of questions and/or during the March 14 pre-proposal conference:

31. Question:

What relationship, if any, will the CDC-IRR program have with the

NIAID supported BEI Resources program?

Answer:

The Biodefense and Emerging Infections Research Resources Repository

(BEI Resources) was established by the National Institute of Allergy and

Infectious Diseases (NIAID) to provide reagents, tools and information for studying Category A, B, and C priority pathogens and emerging infectious disease agents. BEI Resources acquires authenticates, and produces reagents that scientists need to carry out basic research and develop improved diagnostic tests, vaccines, and therapies.

In addition to supplying the Biodefense community with materials, BEI

Resources also encourages and supports the deposit of materials from researchers and institutions. Depositing materials with BEI Resources has many advantages to the researcher and the Biodefense community including secure storage, community access and distribution; all while protecting the intellectual property rights of the depositor.

BEI Resources is managed under contract by American Type Culture

Collection (ATCC). A seven-year contract to manage BEI Resources was awarded to ATCC in September 2003. The BEI Resources program reflects a coordinated effort between NIAID, CDC, USDA, and ATCC.

See: http://www.beiresources.org/.

Certain similarities will exist between the BEI Resources and the CDC

Influenza Reagent Resources (CDC-IRR) programs. However, where

NIAID’s contract is intended to assist individual scientists in the conduct of research, the primary focus of the CDC-IRR is to support pandemic preparedness programs of the CDC and its institutional public health partners.

The CDC-IRR contract will be competed, awarded, administered and function as an independent project.

32. Question:

Will the influenza-based initiatives of the BEI resources program be rolled into the CDC IRR?

Answer:

There is no plan to pursue this approach.

33. Question:

Will the selected contractor need to coordinate activities with BEI

Resources to avoid duplication of effort?

The CDC and NIAID Project Officers for each contract will be responsible for any and all program coordination necessary to ensure the overall success of both projects.

The CDC anticipates that materials acquired or produced under the CDC IRR contract will be shared from CDC to NIAID as appropriate, to broaden the selection of products available to scientists and researchers. However, any such transfer would be out of existing CDC-IRR inventories, and at the specific direction of the CDC Project Officer. The only coordination between the BEI Resources contractor and the CDC-IRR contractor would be to ensure that MTAs were in place (if required) to document the shipment.

34. Question:

Quite a few of the organisms, reagents and materials mentioned in the

CDC IRR SOW appear to be duplicates of those being developed or already developed for the BEI Resources program. Will the CDC make an effort to avoid duplication of effort with BEI Resources.

Answer:

See the answers to Questions 31, 32 and 33.

35. Question:

Does the CDC want the contractor to develop reverse genetic strains of highly pathogenic viruses for use in non-BSL3 labs?

The CDC will provide reverse genetic strains.

36. Question:

Second paragraph on page 3 of the SOW refers to “Item 15 below.”

However there is no Item 15. Please clarify.

Reference should have been to “Item 11.f below”. This will be corrected in the RFP Statement of Work.

37. Question:

Surge issues are generally difficult to handle by contractors unless known

FTEs or laboratory capacity are specified and covered in the contract. Is this what is meant by “Quantity B”?

“Quantity B” represents the government’s best quantity/volume estimates of certain items that will be required in larger than routine (Quantity A) requirements, in the event of an influenza pandemic. The offeror’s plans to meet the increased surge requirements of an influenza pandemic and the additional costs of implementing the offeror’s plans to provide increased quantities of specified items should be reflected in both the technical and cost proposals, in section to address “Option” performance requirements.

38. Question:

What is the anticipated amount of storage space for -80 degrees C, -20 degrees C, 4 degrees C and RT storage?

Technical proposals should address individual offeror’s plans for proper storage of materials specified for routine (Quantity A) acquisition and storage quantities; and, plans to accommodate larger (Quantity B) acquisition and storage quantities, in the event of an influenza pandemic.

39. Question: How long would you expect it to take to produce the entire stock to be available through the storefront? (The specifications state that pilot batches be available every three weeks.)

The RFP will clarify that the CDC Influenza Reagent Resource is to be fully operational; and, stocked at routine (Quantity A) quantities of specified viruses and reagents within 24 months of contract award.

Technical proposals should address individual offeror’s plans to meet this requirement. The government will provide additional guidance in the

RFP, to assist in prioritizing production and/or acquisition of certain items that may be considered more critical than others.

40. Question:

Do you have a feel for the anticipated throughput/output of the products through the storefront? If we made 150 stocks, would you expect them to last 1 week? 1 month? 5 year, etc?

Inventory levels and annual production (quantity and volume) estimates for individual viruses and reagents will be clarified in the RFP, to assist offerors in preparation of technical and cost proposal submissions.

41. Question:

Could you describe whether there is an IT component to the contract beyond the web storefront?

Technical proposals should include individual offeror’s plans to meet the performance requirements of the RFP. The extent to which information technology should be utilized will vary from one proposal to the next, based on proposed methodology and approach; however, the government would expect, as a minimum, that information technology would be utilized to assist the contractor in meeting the shipping, ordering, inventory, and web access requirements of this contract.

42. Question:

It would be helpful if the government could revise Appendices to reflect burn rate for materials to be stocked?

See the answer to Question 40.

43. Question:

There is a reference to Appendix D on page 4 of the SOW, but Appendix

D is not included. Please clarify.

Appendix D was originally provided to assist in preparation of RT-

PCR

reagent kits; however, the document was removed due to intellectual property concerns. Appropriate clarification and guidance will be provided in the Request for Proposals (RFP).

44. Question:

Will there be small business requirements?

It is likely that the government will specify small and disadvantaged business subcontracting goals for this requirement. This will be clarified in the RFP.

45. Question:

Are all of the asterisked kits in the SOW deliverables for Year 1?

Is this the number of kits that will need to be produced each year?

In Section IV.C of the SOW, quantities specified for kits and panels represent annual production quantities of each.

However, please see Section II of the SOW, which states: “This is a new

CDC requirement. All quantities presented with asterisk notation (1*, 2*, 3*, etc.) in the Statement of Work reflect the government’s best estimates of anticipated need during performance of the contract. They are being provided to assist potential offerors in formulating estimated costs of performance; and, are not intended to restrict in any way the government’s ability to request more or less than stated quantities of viruses, reagents, kits, etc., during actual performance of the contract.”

46. Question:

Do all the products and reagents need to have a 510K?

No. For proposal purposes, offerors should anticipate that no products or reagents will require a 510K.

47. Question:

If we have a novel product, is there an option to use it; or, is it left to the discretion of the contractor?

Initial proposal submissions should reflect the offeror’s best overall plan (methodology and approach) to accomplishing the performance requirements of this contract, which may include the use of novel products and/or unique approaches. The government will evaluate in accordance with technical evaluation criteria specified in the

RFP; and, the successful contractor’s proposal will be incorporated into the contract, as a basis of award.

Subsequent to award of the contract, and prior to performance of any task requirement of this contract, the contractor will draft and the government will approve, Standard Operating Procedures (SOPs), consistent with the methodology and approach reflected in the contractor’s successful technical proposal, to address contractor handling and storage of viruses and reference reagents; and, contractor performance of all contract tasks.

Once the contract SOPs have been approved, they will govern the performance of all work conducted under this contract. Any proposed change to approved SOPs will be fully discussed with the government and approved in writing prior to implementation; see Section IV.A of the

SOW.

48. Question:

If materials produced and retested by CDC do not meet CDC specs but are due to poor starting materials provided by the CDC, will the contractor still be reimbursed for costs incurred to produce those materials?

Technical and cost proposals should contemplate contractor evaluation of starting materials as part of their quality management system for this project. Reasonable costs of evaluating starting materials would be allowable under any resultant contract.

49. Question:

Are WHO reagents exempt from the GMP requirement?

The Statement of Work will be revised to clarify that WHO reagents are to be produced at the GLP level.

50. Question:

Please clarify legal liabilities and indemnifications in the final RFP.

The government is in the process of making important decisions as far as the subject matter of your question is concerned. The answer to your question will not be made available until the solicitation is actually issued.