On August 11, 1999 OMB issued a request for further comment on its proposed implementation of the data access law. The Federal Register announcement provides a general background on the Shelby legislative enactment and describes some of the many arguments from comments submitted during the policy debate. OMB quotes CRE's April 5, 1999 comments extensively in the preamble discussion of some of the more substantive comments the agency received. The notice reiterates OMB's intention to publish a final version of the rule on or before September 30, 1999.

OMB's previous proposal, issued February 4, 1999, would have limited application of the data access law to "data relating to published research findings produced under an award that were used by the Federal Government in developing policy or rules." The new OMB notice requests public comment on three definitional concepts arising out of the above February 4 provision, plus a fourth concept relating to cost reimbursement. Each of these four concepts is summarized below.

(1) The definition of "research data". OMB's new proposal emphasizes that the FOIA exemptions and other traditional protections against disclosure of confidential medical and human subject research information will continue to apply to data disclosed under the new law. OMB is also attempting to alleviate any concerns that the new data access requirements will impinge on intellectual property rights or threaten public-private joint research ventures. Statutory language from FOIA exemptions 6 (medical and personal privacy) and 4 (trade secrets and confidential commercial information) is incorporated directly into the exclusionary provisions of proposed definition. The OMB reproposal thus would define research data as:

the recorded factual material commonly accepted in the scientific community as necessary to validate researching findings, but not any of the following: preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues. This "recorded" material excludes physical objects (e.g., laboratory samples). Research data also do not include:

(A) trade secrets, commercial information, materials necessary to be held confidential by a researcher until publication of their results in a peer-reviewed journal, or information which may be copyrighted or patented; and

(B) personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, such as information that could be used to identify a particular person in a research study.

(2) The definition of "published". OMB would define this key term as:

either when (A) research findings are published in a peer-reviewed scientific or technical journal, or (B) a Federal agency publicly and officially cites to the research findings in support of a regulation.

This definition of "published" clarifies somewhat the publicizing actions that would bring research findings within the scope of the new law. The definition also adds the concept that official government citation to a study would trigger FOIA disclosure requirements.

(3) Scope. OMB's latest proposal significantly narrows the scope of the new data access law. Whereas, under the previous proposal, the public would have had access to published research data "used by the Federal Government in developing policy or rules", the new proposal would limit the scope of the access to such data "used by the Federal Government in developing a regulation". OMB specifically requests comment on this proposed limitation, as well as on an additional proposed restriction that would further limit the scope of the data access law to regulations that meet a $100 million impact threshold.

(4) Cost Reimbursement. OMB also seeks comments on (a) estimates of potential costs to be incurred by federal agencies and their award recipients in carrying out the new data access policy and (b) the mechanisms available to recipients to charge to their awards the costs that they would incur (e.g., "direct" versus "indirect" charge, or by contract.

Formal comments to OMB should be addressed to:

F. James Charney
Policy Analyst
Office of Management and Budget
Room 6025
New Executive Office Building
Washington, D.C. 20503

Comments to OMB may also be submitted by email to grants@omb.eop.gov, with the full comment included in the body of the email (no attachments). The OMB comment period closes September 10, 1999.

CRE encourages individuals submitting comments to OMB to also submit their comments to CRE for posting on the CRE Interactive Public Docket.