Strategy for Implementing Data Access Objectives

Planned Project Work Activities

Introduction

Data Access is a crucial tool to ensure that federal regulations are sound and do not impose unnecessary burdens upon businesses and other elements of society. When an agency relies upon a scientific study as the basis for a regulation, the underlying data should be available to the public for validation purposes - particularly where such study is financed with taxpayer funds. And indeed, academics and virtually all other scientists have advocated the general principle of "data sharing."

The FY 1999 Omnibus Appropriations Act (P.L. 105-277) and conference report ushered in a major Data Access advancement with real world implications. After two rounds of public comments and much debate, OMB issued a final rule to revise Circular A-110 and make underlying data from federally funded research available to the public through the Freedom of Information Act (FOIA). The rule took effect November 8, 1999. It has prospective effect, applying to agency research grants after the effective date, and to renewals of ongoing grants after the effective date. Attention now turns to the separate agencies and their drafting of conforming regulations to implement the OMB rule.

While there has been significant progress in implementing the Data Access law, continuing efforts will be required to ensure that the agencies implement OMB's mandate. In other words, the job is not yet done. In addition, efforts should be made to further the Data Quality portions of the new law. Because it is difficult to prove suspected inaccuracies and methodological weaknesses without access to studies' underlying data, it is important that there be a mechanism through which Data Quality problems can be brought to the attention of federal agency officials. There should also be a mechanism to petition for the correction of such information dissemination by the government or of regulations based upon such data. By advancing both elements - Data Access and Data Quality - real gains can be made in achieving transparent and rational regulations.

Purposes of the Paper

This paper is will:

• Present a work plan for the Data Access initiative and discuss its various elements.

• Discuss how each element ties in with overall Data Access objectives.

Data Access Work Activities

I. Facilitation of Agency Conforming Regulations to Implement the OMB Data Access Rule

As noted above, the OMB final rule is a necessary but not sufficient condition for achieving real Data Access. The next step is for agencies to translate OMB's mandate into practice through adoption of agency conforming regulations that put the Data Access rule into practical effect at the agency level and that tailor OMB's requirements to the specific characteristics of the agency's program. The following activities are designed to facilitate early adoption of conforming Data Access regulations by the federal agencies.

Interaction with Agency Officials Regarding Conforming Regulations

• Efforts will be made to identify those officials at federal regulatory agencies who will be responsible for drafting conforming regulations to implement the Data Access rule. Through the Center for Regulatory Effectiveness (CRE), these officials will be offered advice and assistance in their implementation efforts. While all relevant agencies will be contacted, special attention will be given to the following key agencies:

- EPA
- OSHA
- NIH
- FDA

Progress Report on Agency Conforming Regulations on the CRE Website

• The CRE Website will be used in several ways to facilitate agency progress on conforming regulations for Data Access. The first will be to provide a progress report for all relevant (i.e., grant-awarding) federal agencies to apprize interested parties of where each agency stands in terms of implementing the Data Access rule.

  This publicly available report - which can be seen by members of Congress, OMB, and other key policymakers - will promote accountability and keep pressure on the agencies to implement the provisions of P.L. 105-277.

• The CRE Website will also serve as a vehicle for the agencies to share their approaches, challenges, and solutions regarding implementation of the Data Access rule. To further this goal, CRE will:

  - Post agency drafts and comments on the Website. (This will demonstrate agency progress and leadership.)

  - Establish an Interactive Public Docket, which will allow agency officials and other interested parties to communicate and exchange their views on implementation-related issues.

• Through such Website interaction, CRE will maintain its reputation as a source of expertise on Data Access and will continue to help shape agency thinking during this important implementation period.

Preparation of Model Agency Conforming Regulation for Data Access

• CRE will draft a model conforming Data Access regulation for use by agencies in promulgating their own standards. Research in this regard will focus on the needs of four key agencies -- EPA, OSHA, NIH, and FDA -- and initial marketing efforts will focus on those agencies as well. Such activity would yield several benefits:

  1. It would serve as a catalyst for drafting of conforming regulations by these and other agencies.

  2. It would shape the thinking of these agencies, which are the most significant sources of federal research grants in areas with the greatest regulatory impact.

  3. It would provide an opportunity to schedule discussions with key agency officials and to further dialogue.

• This effort to formulate and promote draft conforming regulations for Data Access would involve the following steps:

  - Undertake research to ascertain what processes these agencies currently have for Data Access.

  - Draft model agency conforming regulation based upon the OMB final rule.

  - Identify and meet with relevant agency staff to discuss implementation and the model rule.

  - Mobilize key outside interests to advance implementation of the model conforming regulation or some variant with the agency.

• At an appropriate time, the model regulation could be placed on the CRE Website to solicit public comment. These fresh ideas would help maintain progress on Data Access implementation efforts.

II. Symposium on Cost Reimbursement

One of the key provisions of the Data Access rule, which has concerned both researchers and the federal agencies, has been the issue of cost reimbursement for the expenses associated with complying with the FOIA requests pursuant to the Data Access rule. The final rule requires that FOIA requesters reimburse researcher grantees for complying with Data Access requests, but the details of this procedure are not clearly set forth.

Because problems with cost reimbursement could seriously delay the public's ability to obtain data under the new law, CRE plans to sponsor a meeting for federal agency officials to discuss and seek practical solutions to the cost reimbursement issue. Details of the symposium include:

• The Cost Reimbursement Symposium will be held March 16, 2000, in Washington, D.C.

• All relevant federal agency officials who would deal with cost reimbursement under the new Data Access law will be invited to participate in the symposium.

  - In addition to general discussion, agencies will be encouraged to share with the broader group any prototype cost reimbursement models they may have developed.

• Highlights of the symposium will be placed on the CRE Website.

  -- CRE's traditional non-attribution policy will be maintained so as to encourage open discussion and debate.

III. Coalition Building

• CRE will maintain contact with key stakeholder groups to share information and discuss strategy throughout the final implementation of the Data Access rule by the federal agencies.

• The same groups will also be cultivated as a base of support for upcoming Data Quality efforts.

Conclusions

Ongoing efforts are needed to secure full implementation of the Data Access rule. The activities outlined above are designed to maintain the momentum of the Data Access initiative and to realize full agency implementation of the provisions of P.L. 105-277.

By assisting the agencies on the cost reimbursement issues and in the drafting of their conforming regulations, our goals are to lighten the perceived burden on agency officials, to advance favorable language in the conforming regulations, and to encourage expedient implementation of the Data Access provisions. In this way, increased public access to federal research data, and the concomitant regulatory and policy benefits, may finally be achieved.