Response_to_Questions_for_RFP_2015-N-17131_CDC_Influenza_Assay_08102015.pdf

Responses to Questions/Comments for RFP 2015-N-17131 CDC Influenza Assay

1. In Section L.7. (a) (page 87) it states “Offerors are also required to e-mail a complete copy of their technical and business proposal to Thaddeus Rollins…” Later in Section L.7. (d) it states “Email or fax proposals will not be accepted.” Please confirm that Offerors are required to submit a complete technical and business proposal via e-mail to Thaddeus Rollins.

Email or fax proposals will not be accepted. Offerors are required to submit an original and six (6) copies of your proposal to the address indicated in Section L. 7 (d). Offerors must also submit one electronic version of all proposal documents (must be in MS Office 2003 Word, Excel, or PDF) on a CD with its proposal submission.

2. In Section L.7 (h) (page 88), it is noted that the Staffing section has a page limit of 5 pages. In section

L.8.C.5 (page 91), it states that “The Contractor shall also furnish a written copy of the draft subcontracting agreement” in the Staffing Plan section. Is the draft agreement excluded from the 5 page limit?

The draft agreement is excluded from the 5 pages.

3. In Section F.1 (page 56) states that deliverables are to be submitted to the “Contracting Officer’s

Representative (COR) and Contracting Officer (CO).” Under C.9 (page 38), it states “Deliverables should be delivered to the COR…” Please clarify.

The Deliverables shall be delivered to COR only as stated under C.9 (page 38).

4. In Section I-1 (page 64) FAR clause 52.246-20 Warranty of Services is included. However the prescriptive states that this clause is for FFP opportunities. Please delete this clause from the RFP requirements.

This is a Cost Plus Fixed Fee contract type requirement and FAR clause 52.246-20 Warranty of Services is not applicable to this RFP.

5. In Section I-1 (page 65) HHSAR clause 352.270-7 is entitled Paperwork Reduction Act. However, a web search identifies 352.270-7 as Conference Sponsorship Request and Conference Materials Disclaimer and clause 352.201-70 as Paperwork Reduction Act. Please clarify which clause is included in the RFP.

HHSAR clause 352.201-70 Paperwork Reduction Act is the correct clause and is applicable to this RFP.

HHSAR clause 352.270-7 is incorrect and is deleted.

6. Is it feasible to propose to fulfill a subset of the items under item 1004 “Develop Quantitative ELISAs

Vaccine Potency Optional” and perhaps item 15 “Antibody Binding Avidity Studies”?

The Government’s requirements are detailed in the Statement of Work and solicitation. Each offeror shall propose their strategies in accordance with the total requirements defined by the Government.

7. Reference Sections C.4.C.8-16 – In the case of the optional surge projects, will clinical samples provided from CDC be de-identified by the government prior to testing?

The clinical samples that the Government will provide for testing will contain a code but no other personal identifier. The Government will keep a database to link the code with personal identifiers but this information will not be given to vendor.

8. Reference Sections C.4.C.8-16 – In the case of the optional surge projects, what is the expected ramp up time for the contractor to reach full testing capacity?

The expected ramp up time for the contractor is different pending on the task. As listed in the travel table, some tasks require a 5-day training at CDC while others require a 10-day training. Nevertheless, the Government estimates that the ramp up time for contractor to reach full testing capacity should be between 6 to 8 weeks. This timeframe would allow for training at CDC, vendor’s development of in-house protocol, in-house training of personnel, vendor’s development of work plan, review of work plan by the Government, and completion of proficiency panels.

9. Reference Section C.4.A.2.1 & Section C.4.A3.1 – These section contain references to (Khuana, et al.

2011). Can you confirm that this is the correct reference or should this reference be (Khurana, et al.

2011)?

Khurana, et al. 2011 is the correct reference. Khuana, et al., 2011 is incorrect and will be deleted.

10. Reference Section B – Is the incumbent contractor (Battelle Memorial Institute) currently performing work on all the items (0001 thru 0016) listed? If not which items are new requirements and which items are follow on requirements?

Tasks 2.1, 3.1, 4, and 5 should be considered as follow-on requirements. The remaining tasks should be considered as new requirements. Each offeror shall propose their strategy in response to the SOW requirements.

11. Reference Section C.4.A.1 – Please clarify if CLIN 0001 should only include costs for the kick off meeting (Task 1a) with all remaining project management costs built into the subsequent tasks (Tasks 2-

16) budgets or if the Government intends other project management costs to be included in CLIN 0001?

CLIN0001 should only include costs associated with kick off meeting and gap analysis. Further, travel associated with gap analysis is an annual fee that should be incorporated into CLIN0001. All remaining activities under this task should be incorporated within each of the remaining tasks in the contract.

12. Reference Section C.6.1 Special Consideration, page 35 of the Solicitation – Please clarify which select agents are anticipated as part of the completion of the services.

It is impossible for the Government to provide specific influenza subtypes as these tasks are meant to be all encompassing. As such, we are requesting the work to be performed under BSL3-enhanced facilities, as needed. Select Agents could include Highly Pathogenic Avian Influenza viruses, SARS, and potentially other infectious pathogens requiring the use of BSL4 facilities. As noted, prior to testing the samples, vendor will perform diagnostic assays following CDC’s reviewed and approved protocol.

Further, prior to the initiation of the task, the Government will provide training at CDC facilities.

13. Reference Section L.8.B.8 – Please clarify which project tasks require a Startup Plan (i.e. are new requirements) and which tasks require a transition plan (i.e. a plan to continue work currently being performed by the incumbent contractor)?

Tasks 2.1, 3.1, 4, and 5 should be considered as follow-on requirements. The remaining tasks should be considered as new requirements. Each offeror shall propose their strategy in response to the SOW requirements.

14. In Section C.10 Performance Matrix the Colum for Incentives/Disincentives states, “Full payment according to payment schedule”, please explain what is meant by a “payment schedule”. Given that this is a cost reimbursable contract costs incurred would be billed on a monthly basis.

In Section C.10 Performance Matrix the Colum for Incentives/Disincentives, “payment schedule” should be deleted and replace with “ contractor’s invoice”.

15. RFP Reference: L.9 (a) “The offeror is required to include a complete Section B of the solicitation, Supplies or Services and Prices/Cost, showing proposed prices. Cost proposed shall be inclusive of all direct costs, indirect costs and fee associated with performing the services and providing the required materials.” Most of the projects include a request to price additional quantities, yet there are no item numbers for these additional quantities as a part of Section B. Where would the government like this information to be included?

Please include the additional requested information as an attachment to section B of the solicitation.

16. The SOW section C.3.1.e stipulates that “…the contractor shall provide an instrument for reading the assay.” And C.3.1.p further stipulates “…installation of instrumentation… shall be completed by the contractor.” However, given that this task pertains to validation of the current platform, will the government require a new instrument?

As noted, although the Government encourages exploration of new strategies over current platform, we prefer to continue using the existing platform until the Government determines that an updated platform is necessary. The current platform has resulted in multiple problems (as noted) including the need to remove cross-reactive antibodies from patient specimens. For validation purposes, the

Government will provide the reader specification for the purchasing of commercially available readers, if one is not readily available at the vendor’s facility that meets the reader specifications. If a new instrument is purchased, as part of the contract, the Government requires the installation of instrumentation and training of personnel on the protocol. Further, in the event a new platform were to be developed, the Government will also require the installation of new instrumentation and training of Government personnel on the protocol.