Public Information; Communications With State and Foreign Government Officials

The Food and Drug Administration (FDA) is issuing final regulations governing communications with State and foreign government officials. The rule states that FDA may disclose confidential commercial information to international organizations having responsibility to facilitate global or regional harmonization of standards and requirements. These disclosures will, in almost all instances, occur only with the consent of the person who submitted the confidential commercial information to FDA. The rule also streamlines the process for FDA officials to disclose certain nonpublic, predecisional documents (such as draft rules and guidance documents) to State and foreign government officials. The rule does not alter current procedures for sharing documents that contain confidential commercial information. These changes are intended to facilitate information exchanges with State and foreign governments and certain international organizations.