Q A- HCV.docx

Questions and Answers

1. What is the expectation on funding for individual applicant above and beyond the in-kind tests? Is there a targeted range that jurisdictions should shoot for (Is there a specific amount of budget—or range—that we should be applying for?) These services are to be procured under a contracting mechanism known as a purchase order. The terminology used in the question leans towards a grant or cooperative agreement. The Contractor is to evaluate the tasks identified within the Statement of Work and formulate pricing based on the tasks required.

2. Would there be an opportunity to use budget to apply toward procurement of more than the 250-300 in-kind tests that are projected? Pricing must be determined based on what is written in the Statement of Work alone. Funding will not be allowed to be carried over to other testing.

3. It seems unclear in the RFQ – are there 250 tests or 300 tests meant to be included in each demonstration site? If a state establishes two demonstration sites, is there a potential for a 500-600 test allocation? Each selected site will receive 300 rapid tests in-kind, but will need to price confirmatory antibody testing (e.g., RIBA) and phlebotomists in the option phase. Each site will be selected on its own merits, so no one proposal should include more than one site.

4. Can you clarify the direction in part VIII (“Minimum Personnel Qualifications/Requirements”) where, point #2, that “two orders will be awarded …” Does this mean that within each applicant’s proposal TWO sites must be identified? If so, can you provide further direction on the intent behind setting up 2 demonstration sites within the jurisdiction? i.e., would the better proposal reflect a site with higher amount of variation in staff resource, geographic location, and target population, such as one detention facility-based public health office and one community-based, IDU-focused homeless clinic? Or are you looking for the variation to lie ONLY with regard to the targeted risk population? The meaning of “two orders will be awarded” is to say that two separate orders will be awarded as a result of each solicitation.

5. What is the budget period for this project? Will the funding be limited to full expenditure during a single fiscal period or can the funds be expended across two fiscal periods? (24 months rather than 12 months). This order consists of one base year and one option year. The funding cannot carry over from one year to the next as many are accustomed to in cooperative agreements.

6. What is the projected timeline for FDA approval of the HCV rapid test? The FDA does not provide projections for the approval of new tests. Legally, the FDA cannot take longer than 12 months to render a decision, but sometimes FDS requests additional information from an applicant which resets the 12 month clock. The current pre market application has been submitted as a supplement to an already approved test, and these are often approved on a faster schedule, but that could just as easily not be the case as well. It is a fairly unpredictable process beyond this limited information.

7. Do we have from industry reps any projected cost per test following FDA approval? The rapid tests will be provided in-kind, so they do not need to be included in the budget.

8. This is my first time applying for an opportunity using the Purchase Order format. I just wanted to confirm that we only fill out page 1 of the Word Document in order to apply. Please see the section identified as “Instructions to Offerors-Commercial Items” of the Request for Quote for guidance.

9. I’m totally unfamiliar with the “Request for Quotations” method of procurement and need a little guidance regarding the format of the application. As this is a Request for Quote , the Government is not allowed to give any guidance towards submitting a quote. In addition, there is not a particular format required. The Contractor is only asked to provide adequate documentation in accordance with the Instructions to Offerers, provided in the Request for Quote.

10. Who is eligible to submit a quote? This procurement is not resticted.

11. What can we ask for in a budget to cover the cost of training, administering and completing the paperwork reporting and doing the analysis and rewriting the policies? How do we prepare that budget as ther is no budget page. As indicated in the Instructions to Offerors, of the Request for Quote, the Contractor shall propose any and all resources needed in order to perform the services annotated in the Statement of Work.

12. Does the CDC expect to receive from bidders 2 quotes, one for the Base Period and one for Option 1 or a single quote that encompasses both the Base and Option 1 periods? In accordance with 52.217-5 Evaluation of Options (July 1990) , the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

13. What is the unit for the base period; is unit 1 HCV rapid test or is the unit all the required work for the base period, i.e., revision of current hepatitis C testing protocols and creating HCV best practices? What is the unit for the Option 1 period; is it 1 HCV rapid test or is the unit the completion of all the work associated with Option 1 tasks? If the units are 1 HCV rapid test, is it then expected that the unit cost be the sum of all the associated costs of all the work to be performed (PS and OTPS costs) divided by the total number of HCV tests performed (250 or 300)? It is for all of the work required under the base period, and all of the required work for the option period.

14. The solicitation says that bids will be evaluated on the basis of Technical Approach, Personnel, Facilities, and Price. Please point out to me where there is discussion in the solicitation in providing a narrative that will support the quote(s) submitted. If a narrative is required, what is the structure of the narrative? How should it be attached to the quote? In accordance with the Revised Request for Quote, the evaluation section states:

The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

· Technical Approach- The Contractor shall provide detailed methodology and approach on how the project is to be organized, staffed and managed to meet the requirements of the statement of work. The information shall include a projected schedule for each deliverable and resource requirements by deliverable. In addition, the Contractor shall included a detailed statement demonstrating their understanding of the requirement as specified in the statement of work.

· Personnel- The Contractor shall provide information on the experience and qualifications of proposed personnel. The Contractor shall provide projected roles and responsibilities of the Contractor’s team by labor category and projected hours for each deliverable.

· Facilities- The Contractor shall provide information on the facilities and equipment proposed for use.

· Price- A detailed cost breakdown of all proposed labor, other direct costs (materials, supplies, travel, subcontracts, consultants, etc.), with supporting documentation, (vendor quotes, market research, etc) are to be addressed in the cost proposal.

15. There are a number of eligibility and requirement stipulations in 52.212-1 Instructions to Offerors—Commercial Items. It appears that some of these are not valid for this solicitation, e.g. the requirement that a bidder have at least 500 employees. What is required of the bidders and what is not required as per 52.212-1 Instructions to Offerors—Commercial Items? The NAICS code and small business size standard for this acquisition is 500 employees. That does not mean that the Contractor must have 500 employees. It means that a Contractor must have less than 500 employees to be considered a small business. Due to the fact that this procurement in not restricted, a large business may submit a quote. Furthermore, non-applicable situations have been addressed in the Revised Request for Quote.

16. Is an organization required to have a North American Industry Classification System (NAICS) code in order to submit a bid and if so, where can it get one if it doesn't have one? The NAICS code applies to the type of work being performed. The successful offeror must be registered in www.ccr.gov as indicated in the Request for Quote prior to award.

17. Are we required to submit the bid on form SF 1449? No