PREFACE

We are pleased to present these comments on behalf of the Center for Regulatory Effectiveness ("CRE")¹ concerning the proposed revisions to section ___.36 of OMB Circular A-110, as published in the Federal Register on February 4, 1999 (64 Fed. Reg. 5684).

CRE strongly supports public access to federally funded research data, and we applaud the efforts of the Office of Management and Budget ("OMB") to implement a workable data access policy. A number of higher order principles underlie this position and inform the following CRE comments on data access. These principles include the propositions that:

• The viability of the scientific process depends on the ability of researchers to openly and honestly challenge the conclusions of fellow researchers.

• Rigorous scrutiny of research studies by fellow scientists heightens the reliability of the conclusions presented in those studies.

• Data access is not a new concept. The scientific community, including researchers, leading universities, professional and academic organizations, and publishers of major scientific journals, have long recognized that appropriate access to data underlying researchers' conclusions is an integral part of the scientific process. Government agencies likewise have adopted policies whereby researchers are required to make their data available to the public and to other scientists for use in criticism of scientific study.

• The recently enacted federal legislation coheres these well-established precedents. The new law represents an attempt to implement more uniform policies and procedures for the sharing of federally sponsored research data with the public.

• Federal government policy should attempt to foster a collegial environment among researchers with respect to the sharing of data, both for purposes of enabling fair scientific criticism and as a means to further additional research in related areas.

• Researchers have a professional obligation to make their conclusions subject to independent criticism before their work is made the basis of public policy. Research that is so preliminary that no conclusions can fairly be drawn from it should be described as such and should not be relied upon in government decision making.

• Regulated entities should have a right to consider and independently evaluate data from studies that underlie regulations affecting those entities' interests.

• The federal government and the American people have a right to close examination of research that is funded with taxpayer dollars.

• Revisions to Circular A-110 will not be the final word on federal data access policy. OMB will establish a framework, and other agencies will issue their own regulations to conform to that framework.

• In practice, only an extremely small percentage of federal research studies will be directly affected by the revised data access policy. For the overwhelming majority of studies, no FOIA requests will ever be filed.

¹ CRE was established in 1996, with the passage of the Congressional Review Act, to provide Congress with independent analyses of agency regulations. From this initial organizing concept, CRE has grown into a nationally recognized clearinghouse for methods to improve the federal regulatory process. CRE has no members, but it receives, from time to time, financial support, services in-kind and work product from trade associations and private firms. Consequently, at any one time, CRE benefits from the input or advice of literally hundreds of small and large firms. The views expressed in these comments are those of CRE, not necessarily those of its participants.