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April 19, 2002

Mr. Dennis P. Williams
Deputy Assistant Secretary and
Acting Chief Information Officer
Department of Health and Human Services
Room 503H
200 Independence Avenue, S.W.
Washington, DC 20201

Re: HHS Data Quality Guidelines

Dear Mr. Williams:

I am writing to you with respect to HHS's forthcoming Data Quality guidelines as they pertain to FDA in both its own capacity and as Chair of the federal interagency Risk Assessment Consortium (RAC). The RAC was established pursuant to Executive Order 13100 in 1998 as part of the President's Food Safety Initiative.

The key purpose of the RAC is to improve food-related risk assessments and, thus, to reduce risk. In that the RAC's work will be subject to the requirements of the new Data Quality law contained in the FY 2001 Consolidated Appropriations Act (P.L. 106-554 codified at 44 U.S.C. 3516 note), it is important that HHS' guidelines implementing the Data Quality law be cognizant of FDA's risk assessment and risk reduction responsibilities as Chair of the RAC. Requirements for HHS' Data Quality guidelines have been specified by OMB, see 67 FR 8451.

Given FDA's leadership role in developing federal initiatives to reduce food safety risks, it is important that:

  • Uniform Federal Risk Measurement Standards. HHS should ensure the establishment of uniform Data Quality standards and measurements for reduced risk initiatives throughout the government.
  • Data Quality Standards Apply to Third-Party Submissions. The Department should very clearly state that the Data Quality guidelines apply to third-party data submissions that are utilized by the agency, including information submitted pursuant to the correction process. Please note that OIRA Administrator Dr. John Graham specifically stated that Data Quality guidelines apply to third-party data submissions intended for agency use in his remarks to the National Economists Club on March 7th and described on the our website,
  • Data Quality Standards Apply to Agency Determinations of the Effectiveness of Risk Reduction Initiatives. HHS should very clearly state that the Data Quality standards and information correction process annunciated in the Department's guidelines apply to any agency determinations as to the effectiveness of any proposed risk reduction initiatives.
  • A copy of this letter is being placed in CRE's online database of agency-specific Data Quality materials. For more information about CRE, please see our website,


    Jim J. Tozzi