Public Information; Communications With State and Foreign Government Officials

The Food and Drug Administration (FDA) is amending its regulations governing communications with State and foreign government officials. This final rule permits FDA to receive and to disclose nonpublic safety, effectiveness, or quality information concerning FDA- regulated products to State government officials and to receive or to disclose draft proposed rules and other nonpublic, predecisional documents concerning regulatory requirements or activities to State or foreign government officials. In both cases, disclosures to or by State or foreign government officials would not require FDA to make the information or documents available to the public. This action is necessary to enhance cooperation in regulatory activities, to eliminate unwarranted contradictory regulatory requirements, and to minimize redundant application of similar requirements.