dr. shuren. on the five 10-k, some issues revolving around that which i've been trying to follow closely. many companies are providing us feedback that they're expensive significant shift in requirements for various five 10-k's, particularly concerns are risen about new requirements being communicated by the fda during the five 10-k review that go beyond previously sufficient data requirements. if true this concerns me because in many instances fda has not issued any new guidance on public communication regarding policy changes. so the question is has the fda change its data requirements for submission types without issuing updated guidance, documents, and if so can you tell me why the change in the consistency? >> first of all i want to say that oftentimes if we're asking a company for additional data, sometimes it's in response to the data they provided to us, that there had been issues in what was submitted. one thing i will ask is if you companies he believes that something has been changed a

dr. shuren, the industry and the fda agreed to have an independent, two-phase assessment and program evaluation to object ily assess the fda's premarket review process. can you explain how fda was involved in setting the parameters of this assessment? >> certainly. we put out calls for independent contractors -- [inaudible] and that was a -- my acoldies. we had put out a call to have an independent contractor perform the assessment, and booz allen hamilton is that contractor. we worked on a draft statement of work which we put out to the public for comment. we had discussions with industry on what should go into that statement of work, and then finally, we've been overseeing the process for the contractor. we get updates on the progress they make, but it is independent, so we don't know what they're actually going to report to us. our understanding is they have gone out, they have had conversations with stakeholders, particularly industry, they've conducted focus groups, and we're expecting to get their first report very soon, and we have a public commitment to make that available to the public