Vaccine Research Center Clinical Monitoring Initiative

Clarification to Solicitation Questions 1/19/17:

1. The Appendix A Precis says there will be 20 Subjects in Part 1 and 130 Subjects in Part 2. However Attachment 5 Sample Task Order in the original RFP states there are only 20 subjects. Can you please clarify the correct number of subjects? Interested offeror's should follow the precis in Appendix A.

2. In our response to the Sample Task Order, should the response be separate and added as an Attachment or Appendix? Or is the intent to include the Task Order response into the overall IDIQ SOW response? The Task Order response shall be a part of the overall ‘Technical Proposal' and shall not exceed the 200 page limit.

Clarification to Solicitation Questions:

1. The Business Questions posted for both solicitations are identical and titled "Business Questions - NIHAO2017059 - General Clinical Research Support Services". Were there 2 different sets of Business Questions that we should receive, i.e one for the Clinical Monitoring and one for the General Clinical Research Support Services RFPs? A revised copy has been uploaded to FBO.

2. Within the Business Q&A responses received, the responses to Questions 10 and 18 indicate that pricing only for sample Task Orders should be provided. Meanwhile the response to Question 26 indicates there should be a set of costs/prices for the sample Task Order and a separate set of prices/costs covering the IDIQ contract. IDIQs in general have no work or reimbursement associated with them but do provide a respondent's capabilities. The Task Order on the other hand has a specific task which can be priced based on the descriptions and assumptions provided.

a. Please clarify if you are expecting to receive sample Task Order pricing and IDIQ pricing or just sample Task Order pricing for both RFPs. If you are expecting pricing for the IDIQ distinct from the Task Order, what is the work of the IDIQ? Our understanding is that there is no funding attached to the base IDIQ and instead the response is a discussion of capability, while the sample Task Order would have pricing attached.

Offeror's are being requested to propose their Task Order Pricing as well as propose their ceiling rates for the entire IDIQ Contract. Please note that offeror's will only be evaluated on their sample Task Order prices. The IDIQ Contract ceiling rates are being requested for all proposed labor categories. This is to reflect additional labor categories that are not proposed in the sample Task Order.

The ceiling rates for the IDIQ Contract must be used for the sample Task Order (i.e. no discounts provided on the sample Task Order when compared to the IDIQ Contract).

Note - fixed fee will be based on the proposed rates in the sample Task Order (should it be awarded) as well as proposed rates in future Task Order's.

b. If you do require IDIQ base contract, can you provide a level of effort guideline for pricing and how would the Government fund the IDIQ beyond the individual Task Orders issued? The government is not requiring overall pricing for the base IDIQ contract.

3. The responses to Questions 18 and 30 indicated that a revised table was uploaded under "Revised Business Plan". There were two documents posted to the General Clinical Research Support Services page, a responses to Q&A document and Attachment 8, can you please indicate what is being referred to as the "Revised Business Plan"? Please see the "Revised Business Proposal Instructions" - Attachment 08 BPI, which was uploaded to FBO for the revised table.

Introduction
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Vaccine Research Center (VRC) has a requirement for General Clinical Research Support Services.

Description
The Contractor will coordinate clinical monitoring activities and complete all necessary clinical trial activities to support the VRC's clinical research efforts and enable the VRC to rapidly establish collaborations with academic institutions and health research organizations in response to the urgent research demands of global importance.

This IDIQ will be a small business set-aside and administered and used primarily to support Vaccine Clinical Research initiatives. However, other NIH programs may initiate Task Orders under this IDIQ as necessary to help accomplish their mission.

For this solicitation, the NIAID requires proposals to be submitted Online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or e-mail is not acceptable.

For directions on using eCPS, go to the website https://ecps.niaid.nih.gov and then click on "How to Submit."

All questions must be submitted no later than Wednesday December 14, 2016 at 12:00pm to sharee.richardson@nih.gov. Responses will be submitted on or about December 19, 2016.