Format for submission to FDA

Colleagues, One of my clients is approaching submission of an NDA to FDA. I did the pop PK analysis; the files that I generated are in three formats - text, PDF, and csv. NONMEM text output is saved in two formats (text and PDF); NONMEM tables are saved in two formats (text and csv); graphics created in R are saved in PDF format. Datasets used for each step of the analysis are archived in two formats, text (an exact copy of the input file plus an exact copy of the FDATA file) and csv (the FDATA file formatted as csv). Our plan (based on my other recent submissions to FDA, none of which has elicited any complaints from them), was to submit these documents in the formats described above. However, my client received a request from FDA that: "datasets [used in the analysis] should be submitted as SAS transport (*.xpt) files". In addition, the company managing the submission wants to convert all my other csv files to xpt format (although there was no specific request for this). Can anyone (particularly anyone at FDA) clarify this for me? In that NONMEM will not accept .xpt files, I am surprised that FDA would want datasets in that format. Should my client honor the request or should they explain to the project manager that NONMEM requires text files so we plan to submit these files in text format (either .txt or csv). Thanks for any insights on this. Dennis Dennis Fisher MD P < (The "P Less Than" Company) Phone: 1-866-PLessThan (1-866-753-7784) Fax: 1-415-564-2220 www.PLessThan.com