1. Item Number 13 in the Work Statement was not included in the RFP. Please clarify if this was an error in the numbering sequence, or whether this was an unintentional omission of an entire Work Statement.

   Answer: Unfortunately, this is an error in the numbering sequence due to numbering of notes along with the tasks. The Work Statement is complete as it appears – there are 17 tasks.




2. It is understood that the Contractor will not be expected to provide computer hardware to the NARSA investigators in order to accommodate the requirements for establishment of communication links. Please confirm that all required computer software packages for the NARSA investigators, however, should be considered and included as an allowable cost in the Offeror's budget.

   Answer: All required computer software packages for the NARSA investigators will be considered an allowable cost under the contract and should be included in the Offeror’s cost estimate.




3. It is acknowledged that the Offeror must propose appropriate computer hardware and software to meet the requirements of Work Statement #12, and thus, it is understood that hardware and software required specifically by the Contractor to perform the Work Statement is an allowable cost for inclusion in Offeror's requested budget. Please confirm, however, whether additional items of equipment, such as freezers, refrigerators, or facsimile machines are considered to be allowable costs for inclusion in Offeror's requested budget.

   Answer: Note 14 clearly states, "This contract shall not support the purchase of general purpose ADP equipment." Further, DHHS policy is to require Contractors to have general purpose office equipment, e.g. facsimile machines. Hardware that is needed to specifically address the requirements of the work statement that are not general purpose ADP equipment will be allowable expenses under the contract. Freezers and refrigerators dedicated to NARSA will be allowable costs under the contract.




4. Work Statement #16 requires the Offeror to "furnish drafts of representative Standard Operating Procedures, and an outline of the remainder as part of the Technical Proposal". Please provide further clarification of the definition of "representative" ? Is it the Government's intent to have Offeror select a functional NARSA activity or component of its own choosing and provide a detailed set of Standard Operating Procedures (SOPs) for this "representative" functional component, and an outline of SOPs for the other functional components? Please advise if the draft of Representative SOPs, and the outline of the remainder should be included in the Technical Proposal as a part of the 100 pages for sections 4A-D, or if it is acceptable for these SOPs to be included as an Appendix.

   Answer: Representative Standard Operating Procedures could address procedures related to operating the registry and/or repository components such as receiving, processing, shipping and storing of isolates; manuscript preparation for publication, etc. The draft of the representative SOP could be included as an appendix as could the outline of the remaining SOPs.




5. Work Statement #15 requires that the Contractor shall "collaborate" and "coordinate" with other NIAID components addressing the emergence of antimicrobial resistance, which will include collaboration with NIAID supported grantees conducting research on the development of staphylococcal vaccines and immunotherapies. Please provide further clarification of the intent and meaning of the words "collaborate" and "coordinate" so that Offeror may be responsive to this Work Statement and provide appropriate discussion regarding implementation of this activity, as well as identification of associated costs. Offeror specifically seeks guidance and information pertaining to the potentiality for significant scientific collaboration with other NIAID grantees in research projects involving human subject participation in vaccine therapy trials.

   Answer: By "coordinate" we mean to act together in a smooth, concerted way. By "collaborate" we mean to work jointly with others on intellectual endeavors. While similar in meaning, these words are not identical and specify behaviors that will contribute to the accomplishment of the specified work. The offeror will be expected to coordinate and collaborate with our grant-supported researchers who will constitute the NARSA investigators and with other, to-be-established, NIAID-supported components addressing antimicrobial resistance in S. aureus. For example, we may establish an infrastructure to conduct clinical studies and trials of antibacterial interventions. These could include vaccines and/or novel antibacterials active against S. aureus that are resistant to available antibiotics. The NARSA network would be expected to establish important linkages with that effort.




6. Is it possible for the Government to provide Offeror with an estimate of the anticipated number of guests which will be invited to the annual meeting each year?

   Answer: The core group of attendees will consist of the NARSA investigators, CDC, FDA and NIH employees. In all, we estimate that approximately 10-20 Government employees will be included; however, this contract will not cover the travel or per diem expenses of the Government employees. In addition, NARSA investigators may want to bring co-investigators to the meeting but these will be at no cost to the contract. The necessary room size for the meetings should probably accommodate 75 people.




7. Please advise if the separate cost estimate for Option #1 should be premised upon the assumption of two new epidemiological studies per year, starting in year two?

   Answer: Yes. Offerors should estimate costs for two epidemiological studies per year starting in year two.




8. Please confirm that the two draft protocols for the epidemiological studies will not be reviewed "separately" by reviewers who will not have access to the other sections of the technical proposal. Offeror specifically seeks guidance as to whether references to the other portions of the contract proposal within the content of the two epidemiological studies are reasonable.

   Answer: We anticipate that reviewers of the epidemiological studies will be the same group and therefore have access to the full proposal.




9. Specifically identify the anticipated level of detail to be presented in the draft protocols for the two epidemiological studies? Is it expected that the following sections will be addressed in detail:

   a. Objectives
   b. Approach
   c. Methods
   d. Schedule
   

   Please identify if other sections such as "Literature Cited" should be addressed within the draft protocol.

   Answer: In addition to the sections indicated, the hypothesis (es) to be tested should be clearly stated, the methods section should address the statistical analyses planned, and the literature cited (references) should be included.




10. Offeror acknowledges that Federal Employees may participate in an active role on proposed project related activities as unpaid consults or collaborators. Please advise and confirm of the acceptability, however, of identifying a governmental entity as a subcontract site.

    Answer: There are no NIH policies or regulations which preclude the use of a Government agency as a subcontractor.




11. As we understand it, this is a proposed 7-year contract. To estimated travel costs (required in the RFP), will it be acceptable to assume that we could select one of the cities that has a (3) beside it as a possible site, and can we simply increase 1998 costs for that city by some percentage for each subject year?

Answer: A city with 3 investigators would be a logical choice for a meeting site along with the application of a growth/inflation factor for out-years.




12. Please confirm that since "Past Performance Information" is referenced and cited in the RFP as an applicable section of the "Optional RFP Instructions and Provisions", for this solicitation, that "Qualifications of the offeror" does not apply and should not be included in Offeror’s Business Proposal.

    Answer: The Past Performance reference listed in Attachment E, section 2 of the RFP was not intended and is hereby deleted. Offeror’s are expected to complete the "Qualification of the offeror" and include it in the Business Proposal.

The Proposal Due Date remains June 25, 1998 at 4:00 P.M. (EST)

Except as provided herein, all terms and conditions of the RFP document NIH-NIAID-DMID-98-24, remain unchanged and in full force and effect.

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