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U.S. Department of Health and Human Services

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Next Steps: Public Disclosure Policy Report

View Next Steps PDF (24 KB)

Phase II

The Task Force will solicit comments on the draft proposals for public comment set forth in this report for 60 days. Comments will be solicited via www.regulations.gov as well as the FDA Web site, www.fda.gov/transparency. As part of the comments, FDA is seeking public input on which draft proposals should be given priority and the tools, techniques, and processes the Agency can use to improve transparency and efficiency, while reducing costs.

Based on this input, the Task Force will recommend specific proposals to the Commissioner for consideration. The Task Force’s recommendations will consider feasibility and priority, considering other Agency priorities that require resources. Some of the draft proposals may require extensive resources to implement, and some may require changes to regulations and possibly even legislation. As a result, the Task Force may ultimately recommend some, but not all, of the draft proposals for implementation.

For proposals that are implemented, FDA will assess whether implementation is allowing the Agency to more effectively achieve its mission of protecting and promoting the public health.


Phase III

The final phase of the Transparency Initiative will address FDA’s transparency to regulated industry. The Task Force published a notice soliciting comments until April 12, 2010. Comments were also solicited via the FDA Transparency Blog. These comments will be used to inform draft proposals the Task Force will put forward this summer on ways FDA may improve transparency to regulated industry and foster a more efficient and cost-effective regulatory process.