July 13, 2001

AAMC Objects to OMB's Proposed "Daughter of Shelby" Directive

The AAMC has strong concerns for a notice [66 FR 34489] of proposed guidelines published by the Office of Management and Budget (OMB) on June 28 that would purportedly arbitrate the "quality, objectivity, utility, and integrity" of all information disseminated by federal agencies (including the NIH and the National Science Foundation). The heart of the notice requires federal agencies to develop administrative mechanisms for "affected persons" to "seek and obtain correction" of information, as required by a provision in the FY 2001 Treasury/Postal Appropriations Act (PL 106-554).

At a meeting of the National Academies on March 13, James Tozzi of the Center for Regulatory Effectiveness described the legislated provision as the "daughter of Shelby," in reference to 1998 legislation requiring public access to research data under the Freedom of Information Act. Industry proponents have advocated for both provisions (data access and data quality) as a means to contest research findings that may form a basis for public health, environmental, or other regulation.

Of particular concern to AAMC are the proposed OMB guidelines in defining quality, utility, objectivity, and integrity of governmental information set forth the following criterion: "[W]ith respect to scientific research, the results must be substantially reproducible upon independent analysis of the underlying data." This criterion, though an idealized characterization of scientific communication, would be inoperative as a constructive guideline to federal oversight of research and the use of scientific information. It also unnecessarily reprises many contentious and highly problematic issues - such as the definition of "data" - addressed in the OMB's final rule on the Shelby provision.

The AAMC is currently preparing a response to the OMB's proposed guidelines. The Association believes that peer review plays, and should continue to play, the decisive role in the validation and dissemination of scientific or other research, whether that research includes federal involvement or not. The proposal for federal agencies or external interests to serve as a censor for peer reviewed scientific communication is unwarranted and profoundly objectionable.

Public comments are due to OMB by Aug. 13 and should be addressed to Brooke Dickson, Office of Information and Regulatory Affairs, OMB, Washington, DC 20503. OMB intends to finalize the comments before Sept. 30; federal agencies will have one year to develop and implement procedures in compliance with the final guidelines.

Information: Steve Heinig, AAMC Division of Biomedical and Health Sciences Research, 202-828-0488.