Public information; communications with state and foreign government officials--FDA. Proposed rule.
The Food and Drug Administration (FDA) is proposing to amend its regulations governing communications with State and foreign government officials. The proposed rule would permit FDA to disclose confidential commercial information to international organizations having responsibility to facilitate global or regional harmonization of standards and requirements. These disclosures would, in almost all instances, occur only with the consent of the person providing the confidential commercial information to FDA. The proposed rule would also streamline 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 proposal 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.
D018795:Device Approval / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D007255:Information Services / Q000331:legislation & jurisprudence*; D007391:International Cooperation; D014481:United States; D014486:United States Food and Drug Administration