HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public. F. Food and Drug Administration

10/01/2002

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

 

This guidance provides the information quality guidelines for the Food and Drug Administration (FDA) requested under the Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (OMB Guideline). 1 The OMB Guidelines implement section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (Pub. L. 106-554; H.R. 5658). The OMB Guidelines direct agencies to issue their own information quality guidelines ensuring and maximizing the quality, objectivity, utility, and integrity of information, including statistical information, disseminated by the agency. This guidance is part of the U.S. Department of Health and Human Services (HHS) implementation plan developed to comply with the OMB Guidelines. The principles described in the HHS plan and OMB guidance are incorporated by reference into this guidance.

This guidance describes the nature of the information disseminated by the FDA and explains FDA's standards, policies, and procedures for ensuring the quality of the information it disseminates. The guidance also explains the administrative mechanisms that are in place to enable persons to seek and obtain correction of information maintained and disseminated by the FDA that they believe does not comply with the OMB and HHS Guidelines and this guidance.