Zdrowie i gospodarka · 27/01/1995

Public Information; Communications With State and Foreign Government Officials

The Food and Drug Administration (FDA) is proposing to amend its regulations governing communications with officials of State and foreign governments. This proposal will permit FDA to disclose to, and receive from, these officials certain nonpublic information without being compelled to disclose the information to the public generally. This proposal addresses the nonpublic exchange of two types of information. First, it allows the disclosure of nonpublic safety, effectiveness, or quality information concerning FDA-regulated products to State government officials. Second, it allows the disclosure of draft proposed rules and other nonpublic predecisional documents concerning regulatory requirements or activities between FDA and either State or foreign government officials. This action is necessary to enhance cooperation in regulatory activities, to eliminate unfounded contradictory regulatory requirements, and to minimize redundant application of similar requirements.