According to the FDAAA, failure to comply with its provisions may result in civil penalties of as much as $10 000 per day (assessed by the FDA) and could affect funding for federally funded trials that are out of compliance.3 The immediate goal is to have NIH-funded trials be 100% compliant under this act, and the NIH is committed to working with NIH-funded investigators to ensure they understand their responsibilities regarding submission of research results. We understand that reporting the results of clinical trials takes time and effort. Data for all prespecified outcomes must be analyzed and required information must be submitted in a structured format to the ClinicalTrials.gov data submission system, which is being refined to make the process as simple as possible. The NIH is committed to supporting the clinical trial community; for example, ClinicalTrials.gov is increasing the availability of individualized, one-on-one staff assistance during the results submission process. Thus, with the implementation of clearer requirements, augmented support materials and resources, and facilitated reporting, the NIH expects that investigators and sponsoring organizations will have the necessary tools to provide accurate, complete, and timely trial results submissions. However, for grantees who are subject to the amendments act and fail to comply after sufficient notification, the law is clear that NIH and other federal funders of clinical trials must then withhold further funding for the grant and any future grant to the grantee.3 In addition, the timely reporting of clinical trials will be taken into consideration during review of subsequent applications for funding.