On April 24, 2019, the U.S. Office of Management and Budget (OMB) issued a memorandum to executive departments and agencies that revises the standards for information used in regulatory functions (Memorandum) with potentially dramatic consequences for the scientific studies and analyses used in certain rulemaking, risk assessments and policy or guidance documents. The Memorandum updates OMB’s Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity of Information Disseminated by Federal Agencies, 67 Fed. Reg. 8452 (Feb. 22, 2002) (2002 Guidelines), which interpreted agency responsibilities under the Information Quality Act, 44 U.S.C. § 3516. Agencies, including the Environmental Protection Agency (EPA), the Department of the Interior, the Food and Drug Administration (FDA), and the Department of Health and Human Services have their own information quality guidelines that implement OMB’s 2002 Guidelines.
The 2019 Memorandum directs agencies to expand peer review processes, to increase public access to data, to ensure reproducibility of analyses and to make the request for correction process more responsive. The majority of the changes apply to “influential information,” which the 2002 Guidelines define as information that could have a substantial impact on important public policy or private-sector decisions. Agencies retain discretion to designate which information is influential without review by OMB.
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