Amendment_One.docx

RFP-NIAID-DAIT-NIHAI2014005

Amendment One

Changes to the RFP

1. ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES, is amended to read as follows:

To provide services, facilities, expertise, and capabilities for the development of radiation/nuclear medical countermeasures (MCMs) for the mitigation or treatment of acute radiation syndrome (ARS) and delayed effects of acute radiation exposure (DEARES). The contractor will not identify or conduct basic research on new medical countermeasures. The NIAID anticipates that products selected by the Government for screening, testing, and development will come from industry, academic, and Government agencies.

2. SECTION L-INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, paragraph 1.c.1 (TYPE OF CONTRACT AND NUMBER OF AWARDS), is amended to read as follows:

It is anticipated that one award will be made from this solicitation and that the award will be made on/about 7/31/2105.

3. Attachment 11, Additional Business Proposal Instructions and Uniform Cost Assumptions, SECTION 5, is changed to SECTION 4.

Questions

1. The Government has provided an approximate level of effort (LOE) for Task Order A-1. Is the specified LOE required for the task order cost estimate (13,374 direct labor hours), or should offerors use the provided LOE as guidance and propose their own estimated level of effort?

Response: The specified LOE of 13,374 direct labor hours is not a requirement and can be used for guidance purposes.

2. In regard to Attachment 5, Task Order B-1, Section C.III, Technical Requirements and Attachment 11, Section 3.1.D, Cost Proposal for Task Order B-1, what is the nature of the candidate compounds that are being evaluated in this Task Order - large molecule (biologic) or small molecule? What is the proposed route of administration and initial dose? Will product-specific assays for PK/PD be transferred to the Offeror at Task Order initiation? If so, what types of assays? Is the Offeror responsible for monitoring the stability of the candidate compounds or will the manufacturer provide test article as needed?

Response: The candidates could be large or small molecules. Routes of administration and initial dose would depend on information provided by the source of the material. No PK is specified in the Cost Proposal, although studies could utilize secondary endpoints that would be appropriate for the syndrome studied, or other syndromes that may arise from the irradiation. Assume that stability of the candidate has been established by the manufacturer and the candidate compounds will be used within the time period in which it is stable.

3. In regard to Attachment 7, Section C.III, Technical Requirements and Attachment 11, Section 3.1.F - Cost Proposal for Sample Task Order C-1, will a recovery period and/or PK/TK collections be needed for the 14-day GLP safety study in rats? The current assumptions regarding this study “assume one 14-day GLP safety study in rats using a total of 42 animals (21 male, 21 female)" do not provide for a sufficient number of animals to complete the evaluations listed in items 3.a and 3.b.

Response: The studies covered in 3a and 3b described in the Statement of Work (Attachment 7) is to provide a list of capabilities that the Offeror can provide and a general approach. The Cost Proposal (Attachment 11) is to evaluate how the Offeror would approach a basic study and also for costing purposes. The number of animals was set in order to allow for comparison among Contract proposals. The language in the Cost Proposal does not include PK/TK.

4. In regard to Attachment 7, Sample Task Order C-1, Section C.II, Scope and Section C.III.3, Technical Requirements, the "Note" under Section C.II states that "[v]alidated methods for testing pharmacodynamics are available," which differs from Section C.III.3 which states "[t]hese shall include the development of validated analytical methods for assessing concentrations of test article or active metabolite in biological fluids, such as blood, for testing pharmacokinetics, validated methods for testing pharmacodynamics, and other parameters, such as immunogenicity." What type of validated assays are available for PD? Should the Offeror make assumptions for the types of assays for immunogenicity and PK?

Response: The Note in Section C.II applies to a specific Sample Task Order used for comparison purposes. The Statement of Work described in Section III encompasses a range of activities that could be covered under this Task Area.

5. In regard to Attachment 9, Sample Task Order E-1, Section C.II, Scope and C.III, Technical Requirements, the "Note" under Section C.II states that "[t]he research lab has produced 1 gram of material." Is the Offeror to assume the post-purification yield is 1 g/L? The fermentation yield will dictate the pilot scale production size for this sample task order. How long is the stability program for the drug substance and drug product - 12-months, 2 years, or longer or should the Offeror propose their own program for these products?

Response: For the post purification yield, no information is available. Offeror should propose its own stability program for these products.

6. In regard to Section L.2.c.4 (pg. 95) - Requirements for Certified Cost or Pricing Data and Data Other than Cost or Pricing Data, item (b)(1) states "[t]he format specified in paragraph L.2.c.3. Certified Cost or Pricing Data, subparagraph 3. formats for Submission of Line Item Summaries shall be used for the submission of cost data." We are unable to locate paragraph L.2.c.3, paragraph 3 that shows the format for submission of cost data. Can you please clarify where we can find the line item summary?

Response: Please see page 93 of the RFP, Section L.2.c.3, subparagraph b of Data Other Than Certified Cost or Pricing Data.

7. What is the dollar amount for the Small Business Plan?

Response: The proposed total other direct costs for the 5-year period (from your cost spreadsheet) is the amount for the Small Business Subcontracting Plan.