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After FDA issues a final rule, FDA will conduct outreach to the affected stakeholders as part of implementing the final rule if the rule imposes substantial new obligations.
Providing industry with information on substantial new regulatory requirements benefits public health by informing industry about what is needed to comply with the law. Although it is agency practice to participate in outreach activities following the issuance of a final rule with substantial new obligations, there is no agency policy that outreach must occur in these situations. Conducting routine outreach in these situations is a cost-effective way to support industry’s compliance efforts more effectively. By knowing what is expected, this will hopefully lead to improved compliance by industry. These outreach activities may help FDA more effectively protect the public health.
FDA, working with the Department of Health and Human Services and the Office of Management and Budget, will improve the accuracy of the timetables included in the agency’s regulatory agenda published as part of the Unified Agenda.
Industry must follow the standards articulated in FDA regulations because they carry the force of law. The failure to finalize rules in a timely manner contributes to confusion among industry. FDA should improve the accuracy of projected dates provided in the agency’s regulatory agenda.