FDA1081735_Response.pdf

Government Response to Contractor Questions for FDA1081735

1. Contractor Question: Under Part 3 - Technical Requirements, Section 3.2.4 - Stimuli Construction, Requirement 3.2.4.2 states that "The Contractor shall be responsible for editing existing ads or creating new ads to be used for stimuli based on criteria set forth by FDA." Is there a percentage of ad content that the FDA anticipates being new versus existing?

Government response: The percent of ad content that will be new will vary by ad but will be less than 100%.

2. Contractor Question: 3.2.5.1 What evidence do we need in general, and also specifically for low incidence conditions, that recruited participants have the conditions they claim to? Can we have a set of criteria and screening questions from the past which apply to one of the populations that had the lowest response rate or participation rate from past tests as an example?

Government Response: Participants who have self-identified as having been diagnosed with the medical condition or otherwise meeting criteria (e.g., are a certain age or gender) are considered eligible for the study. We cannot provide screening questions or participation rates from past tests.

3. Contractor Question: 3.2.5.1 Do you have a standard from previous work or requirements for incentive payments? For example, is there an average amount paid per participant for similar studies? May we use sweepstakes as an incentive? May we offer charitable donations as payment?

Government Response: There is no average incentive nor is there a restriction on the type of incentive.

Typically the incentives are determined by the internet panel being used for the study.

4. Contractor Question: 3.2.9.1 Is there a standard for the maximum weight size above which we should not go?

Government Response: There is no standard for the maximum weight size. However, samples should be reasonable approximations of the target population.

5. Contractor Question: 4.2.4/4.3.4. Will any of the tests overlap in time, so that two tests would be happening simultaneously? Is there a minimum amount of time between one test and the subsequent one or could one end the same day the next one begins? Will tests begin just before/during major holidays like Christmas? Because the timing is based on calendar days there are scenarios where it could be very difficult to meet the print copy testing requirement of 6 calendar days for Stimuli Creation / Editing. For example, if the FDA package came on Dec 23rd then the stimuli would be due on Dec 29th.

Government Response: Yes, tests may overlap in time. There is no minimum amount of time between tests. We are unlikely to begin before or during major holidays.

6. Contractor Question: Is FDA1081735 a new requirement? If not, could you provide the following incumbent information?

Government Response: The previous contractor was SuccessTech Management Services, HHSF223200810019I, awarded 9/22/2008.

7. Contractor Question: We are a large business. So we can determine if it makes sense for us to find an 8a partner, would you please tell me what % of the contract performance (revenue or labor) on this contract must be the 8a firm (as opposed to a large business sub).

Government Response: The 8(a) must perform 51% of the work in order not to violate their 8(a) status.

8. Contractor Question: Is this RFQ open to all business sizes or only for competitive 8a?

Government Response: This solicitation has a set-aside for only competitive 8(a).

9. Contractor Question: Is it the Government’s expectation that a probability-based sample be used for each study?

Government Response: No.

10. Contractor Question: Historically, what has the response rate been for similar FDA studies?

Government Response: We cannot give past response rates.