Regulacje i polityka gospodarcza · 27.12.1995

Procedures for Handling Confidential Information in Rulemaking

The Food and Drug Administration (FDA) is publishing a statement regarding the procedures generally followed by the agency with respect to the use of confidential commercial information, trade secrets, and other confidential or sensitive information during rulemaking. In brief, FDA does not place into a public docket trade secret, confidential commercial information, or information whose disclosure would constitute a clearly unwarranted invasion of privacy or would reveal the identity of confidential sources. FDA tries to assure that clearly proprietary information is not unwittingly made available to the public, but also advises that information submitted to a public docket during a rulemaking proceeding does not carry a reasonable expectation of confidentiality.