Q A_1146395.docx

1. “Does FDA have a research approach in mind (focus groups, survey, etc) or shall offerors recommend an approach?”

A. Please carefully note the criteria we have included in the statement of work under Section C.3.1., which outlines an approach somewhat different from the examples in your inquiry. Also, please note the emphasis found in the Background section and outlined in the Technical Capabilities section of the solicitation. We will be most likely to endorse proposals that meet an evidentiary standard that can support policy decisions; that are at least of the quality found in existing published work on OTC labeling issues; that propose to rigorously test hypotheses about the influence of PDP presentation and branding on consumer or patient comprehension of safety information, using testing or experimental protocols; and that complement quantified outcomes with equally rigorous qualitative inquiry that helps explain results. We have also suggested a preference for work to be carried out in a clinical setting, although other controlled settings might be adequate. We do not believe surveys and focus groups would be central to an optimal design.