Daily Rules, Proposed Rules, and Notices of the Federal Government
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Sponsors are required to provide appropriate oversight of their clinical investigations to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality and integrity of the resulting data submitted to FDA.
However, the collections of information associated with this draft guidance that are not currently approved under OMB control numbers 0910-0014 or 0910-0078 are as follows:
FDA received comments that the guidance lacks specific information on development and initialization of risk assessment plans, appropriate mitigation plans, and execution of mitigation plans through the monitoring plan. Addition of use of risk management tools, along with potential applications for using risk-based monitoring strategies would help facilitate implementation.
In response to the comments, FDA included additional detail in the final guidance in an effort to enhance the quality, utility, and clarity of the information collected. Specifically, FDA included additional detail on the development of a monitoring plan, which focuses on the important and likely risks, identified by the risk assessment, to critical data and processes. In addition, FDA included additional guidance on the steps involved in performing a risk assessment and references to tools and methodologies that can be used to perform a risk assessment. FDA clarified that the guidance does not provide comprehensive detail on how to perform a risk assessment.
FDA received several comments that the guidance should specify that it is acceptable for monitoring plans to reference existing standard operating procedures (SOPs) or other documents.
The draft guidance specifies that a monitoring plan may reference existing policies and procedures in order to minimize the burden of the collection of information.
FDA received numerous comments that the lack of specific details about FDA review of the monitoring plans early enough in the IND process could delay startup of clinical trials. In addition, numerous comments requested a detailed process or procedure.
Although the draft guidance stated that CDER was considering establishing processes through which sponsors could voluntarily submit monitoring plans for CDER feedback, CDER has concluded that CDER does not have the resources necessary to commit to such a review at this time. CDER is exploring the possibility of a pilot program in this area in the future.
FDA estimates the burden of this collection of information as follows: