Comment on FR Doc # E9-25757

It is critical that the Paperwork Reduction Act distinguish between voluntary vs. mandatory reporting requirements. The failure to make this distinction markedly hampers research projects funded through the federal government by requiring that a survey be submitted for formal OMB review that often requires 12-19 months. Ironiically, our group was unable to evaluate the effect of regulatory burden on clinical and epidemiological reserach in the US - we had the funding, the project was identified as a high priority by the NIH and a large group of multicenter research groups, and a short and completely voluntary survey had been designed. However, the requiremnt for OMB review killed the project, leaving a critical information gap in efforts to improve research oversight. There needs to be a mechanism for providing an exception to the requirement for OMB review for voluntary surveys that are part of program review, quality improvment, and research projects.