der an award that were used by the Federal Government in developing an agency action that has the force and effect of law” (OMB, 1999). In that context, research data are defined as “the recorded factual material commonly accepted in the scientific community as necessary to validate research findings, but not any of the following: preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues”; findings are considered published if they “are published in a peer-reviewed scientific or technical journal” or if a federal agency “publicly and officially cites the research findings in support of an agency action that has the force and effect of law” (OMB, 1999). The committee recognizes that determining the vaccine safety actions that have the “force and effect of law” (if any) could have implications for access to VSD data if the Shelby Amendment is found to be applicable.

The IQA, enacted in December 2000 as Section 515 of the Treasury and General Government Appropriations Act for fiscal year 2001 (Pub. L. No. 106-554 [2000]), required OMB to issue guidelines that “provide policy and procedural guidance to Federal agencies for ensuring the quality, objectivity, utility, and integrity of information (including statistical information)” disseminated to the public by federal agencies (Information Quality Act 44 U.S.C. § 35904(d)(1) [2001]; Information Quality Act 44 U.S.C. § 3516 [2001]). The IQA also required federal agencies to develop their own information quality guidelines and to establish administrative procedures to allow people to seek correction of information that does not comply with the OMB guidance. The committee recognizes that the IQA could have implications for the ability of members of the public to dispute the quality of VSD studies if the IQA is found to be applicable to such studies.

The committee recognized that the Shelby Amendment and the IQA could have important implications for access to VSD data and preliminary findings from the VSD. The applicability of those laws to the VSD should be explored further. If the Shelby Amendment and the IQA are found to be applicable, they could affect the procedures that are used by external researchers to gain access to VSD data and by members of the public to question the quality of VSD studies.

Recommendation 2.1: The committee recommends that the NIP and NCHS seek legal advice to clarify the applicability of the Shelby Amendment and the Information Quality Act to VSD data and VSD preliminary findings.



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