Wednesday, July 20, 2005
HHS administers more than 300 programs. Comprised of ten large and diverse Operating Divisions, including the NIH, CDC, FDA, and the federal Medicare and Medicaid agency, HHS is the U.S. government's principal agency for protecting the health of all Americans and providing essential human services, especially to those who are least able to help themselves. In the course of carrying out their program missions, HHS agencies disseminate a wide variety of information to the public, ranging from research and statistical reports to expert and authoritative health and medical information. Many of these dissemination products rank among the most highly regarded and highest quality scientific, research and statistical information within the federal government, and in many instances they set the national and international standards for quality.
Consequently, HHS is committed to supporting, developing and disseminating information consistent with the objectives of the Information Quality Act. It has long been an HHS goal to ensure that the best available scientific and technical information is used to support regulatory and programmatic decision making.
Requirements of the Information Quality Act
The OMB Guidelines in turn directed federal agencies to do three things:
HHS Implementation of the Information Quality Act
However, our Guidelines incorporate standard HHS wide standards and procedures whenever possible, including the administrative request for correction mechanism.
Third, we created a department-wide HHS Information Quality Working Group to ensure a coordinated and integrated approach across HHS, assure implementation in a manner appropriate to agency statutes and missions, and build upon existing agency administrative procedures and data and scientific quality review mechanisms.
Fourth, within HHS, we implemented the Information Quality Act by working closely with OMB and our stakeholders in the health and human services communities, including a notice and public comment process on draft Guidelines .
The HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public were developed within the framework of the OMB Guidelines. The purposes of the HHS Guidelines are to provide policy and procedural guidance to agency staff, and to inform the public about agency policies and procedures. Part I of the HHS Guidelines describes department-wide umbrella policies, guidelines and operating procedures. Part II of the HHS Guidelines describes component agency-specific guidelines in order to address specific program statutes and missions for operating divisions such as the Centers for Medicare & Medicaid Services, the Food and Drug Administration and the National Institutes of Health. Responsibility for implementing the Guidelines within HHS Operating Divisions rests with the head of the agency or program unit disseminating the information.
Overall departmental level responsibility for oversight and coordination of the implementation of the Guidelines within HHS rests with the Office of the Assistant Secretary for Planning and Evaluation. In addition, oversight and coordination across HHS is supported by our department-wide work group, led by the Office of Secretary and composed of senior representatives from all HHS Operating Divisions.
The HHS Information Quality Work Group was created to assure maximum sensitivity and understanding of the underlying science and data issues that might be raised within a very large federal science and public health agency with complex and diverse programs. It also was created as a mechanism to achieve an integrated departmental implementation of the Information Quality Act by developing a uniform HHS set of principles and Guidelines format, a forum for addressing common issues and approaches, and a means to provide on-going monitoring of implementation problems and issues. HHS views the Guidelines as an evolving document and information quality as an evolving process.
As I indicated, our Guidelines contain an administrative complaint mechanism that allows affected persons to seek and obtain correction of information that they believe does not comply with the Guidelines. We established a common format for submitting information quality requests for corrections and requests for reconsideration (i.e., appeals) to HHS agencies.
Generally, the HHS approach calls for requesters to submit requests for correction that contain:
The HHS website contains instructions about how to submit a request for correction and identifies the official to whom requests are to be submitted. Although our goal is to respond to all requests for correction within 60 calendar days of receipt, our experience is that actual response times generally are considerably longer because of the extensive expert staff time involved and the wide array of agency scientific and legal reviews are involved in developing a response. In cases where the request requires more than 60 calendar days to resolve, HHS informs the requestor that more time is required and indicates the reason why and an estimated decision date.
HHS Operating Divisions assign requests for corrections to individuals who have a high level of expertise in the subject area of the information dissemination that is being challenged. Both Information Quality Work Group and operating division staff closely monitor the development of responses to requests and reconsiderations in order to encourage expeditious treatment. The requestor may appeal (i.e., request a reconsideration) within 30 days of receipt of the HHS decision.
Our position on appeals is very liberal; we consider any request for reconsideration that is submitted. The HHS Guidelines require that the agency official who handles the original request "will not have responsibility for resolving the appeal." Generally, the appeal is handled at least one level above the originating office. In most cases, very senior level agency officials have responded to appeals, including the Acting Commissioner of the Food and Drug Administration, the Deputy Director of the National Institute of Environmental Health Sciences, NIH, the Director of the National Heart, Lung and Blood Institute, NIH and the Associate Director for Science in the Centers for Disease Control and Prevention.
Experience with the Correction Process
All requests for correction and for reconsideration are taken very seriously by the agency. Here are three examples of requests that resulted in some corrective action:
HHS Information Quality Website
Thank you for the opportunity to testify. I would be happy to answer any questions you may have.
Last Revised: July 21, 2005