Data Access

CRE Analysis

1. Scope -- What government activity should trigger Data Access?

Comment by Pharmaceutical Research and Manufacturers of America (PhRMA)

CRE Response:

CRE agrees that the term "policy or rule" in the February 1999 OMB proposal needed further clarification. CRE stated in its April 5, 1999 comments that the term was too limited because it could arguably exclude many important federal actions such as surveys, risk assessments, and federal reports. CRE argued that the Circular A-110 should be clarified to make certain that data that form the bases of studies underlying these important government initiatives also must be publically disclosed unless otherwise exempted.

In its August 11, 1999 reproposal, OMB indicated that it is considering limiting the scope of the rule to "regulations" only, and invited comment on this narrower interpretation of the Shelby Amendment. In issuing its narrowed reproposal, OMB stressed the administrative difficulties that could arise if the data access law were made applicable to other agency actions that do not rise to the level of formal rulemaking.

While CRE continues to believe that its original position is justified, we also understand OMB's desire for a bright line test in determining the law's application.

Although OMB's August 11 position differs from CRE's April recommendation, the reproposal may be a workable first step in implementation. OMB can start with their August position and see how the system works. If there are too many risk analyses, surveys, or other important activities that fall through the net and are not covered, however, then OMB should expand the rule at a later time.