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HHS in the 21st Century: Charting a New Course for a Healthier America (2009)

Chapter: Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services

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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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Suggested Citation:"Appendix H Statutory Framework for the Organization and Management of the U.S.Department of Health and Human Services." Institute of Medicine. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press. doi: 10.17226/12513.
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H Statutory Framework for the Organization and Management of the U.S. Department of Health and Human Services Darrel J. Grinstead, J.D. Hogan & Hartson, LLP BACKGROUND AND PURPOSE The purpose of this paper is to describe and analyze the relevant statutes and other legal authority under which the U.S. Department of Health and Human Service (the department or HHS) was established and is currently organized. This paper has been commissioned by the Insti- tute of Medicine (IOM) of the National Academies to assist an ad hoc committee assembled by the IOM to examine the current mission, gov- ernance, and organizational structure of the department. The committee is charged with making recommendations to Congress and HHS to en- sure that the department is aligned to meet the public health and health care challenges that our nation faces. The department was first established as a cabinet-level entity in 1953 as the Department of Health, Education, and Welfare (HEW). The name was changed to the Department of Health and Human Services in 1980 when the education functions were spun off to the Department of Educa- tion. 1 From the beginning, the department was charged with administer- ing two major statutes that had been on the books for years prior to that time: the Social Security Act and the Public Health Service Act. These two statutes still comprise the majority of the authorities administered by the department. However, there were many other statutes and programs that completed the mission of the department, and all of this statutory authority continued to grow and change in ways designed to meet the evolving health and human services needs of the nation. This multiplicity of governing laws, and the great variety in the extent to which they con- 1 P.L. 96-88, October 17, 1979. 209

210 HHS IN THE 21ST CENTURY strain management’s organizational decisions, make it difficult to articu- late general principles or rules that will fully describe the statutory land- scape of the department’s structure and the discretion left to the secretary to reorganize the department. For that reason, this paper provides (1) an overview of the general and specific organizational authority of the secretary; (2) a discussion of how that authority has been exercised historically; (3) an analysis, based on the current organization of the department, of the specific statutory provisions that may currently constrain that authority and how those con- straints vary substantially among the different parts of the department; and (4) suggestions of means by which statutory limits on the secretary’s authority to organize the department can be addressed. A more detailed listing of statutory directions and constraints affecting the secretary’s organizational authority over the components of the department is con- tained in the appendix to this paper. GENERAL AUTHORITY OF THE SECRETARY TO ORGANIZE THE DEPARTMENT Reorganization Plan No. 1 of 1953 As noted above, the department was created, and the cabinet-level position of the secretary of health, education, and welfare was estab- lished, when President Eisenhower submitted Reorganization Plan No. 1 of 1953, which was approved by the Congress on April 1, 1953. 2 The Reorganization Plan essentially elevated the Federal Security Agency (which then contained the Social Security Administration, the Public Health Service, the Office of Education, and several smaller agencies) to cabinet status. The combined agencies were taken whole into the new department, along with the head of those agencies, such as the commis- sioner of Social Security and the surgeon general, who thereafter re- ported to the HEW secretary rather than the President. 2 Reorganization Plan No. 1 of 1953 was issued under the authority of the Reorganiza- tion Act of 1949, which gave the President broad authority to reorganize the executive branch. To eliminate any doubt over the constitutionality of such broad authority, Con- gress ratified the Reorganization Plan by passing a statue giving it an effective date. 42 U.S.C.A. § 3501. The broad authority in the Reorganization Act of 1949 has since ex- pired.

APPENDIX H 211 Although the original organization of the department reflected the preexisting organization of its constituent agencies, from the very begin- ning the secretary had broad authority to reorganize the various functions and components of the department. Section 6 of Reorganization Plan No. 1 provides: The Secretary may from time to time make such provi- sions as the Secretary deems appropriate authorizing the performance of any of the functions of the Secretary by any other officer, or by any agency or employee, of the Department. Under this authority, which is still in place, as well as under a broadly applicable statute that gives similar authority to the heads of all executive departments, 3 the secretary has authority to assign the per- formance of functions vested in him by law to subordinate officers or organizations within the department as long as such assignments are not inconsistent with law. With this important qualification, which is exam- ined later, the secretary has broad authority to reorganize the department through the redistribution of functions for which he is responsible. 4 Reorganization Plan No. 3 of 1966 Almost all of the statutory provisions that establish the programs and the mission of the department place the authority to administer those functions in the secretary. Thus, the statutes creating the Social Security Act programs administered by the department, such as Medicare and Medicaid, as well as the Public Health Service Act programs, place the authority to carry out the thousands of program functions, including the making of grants, the payment of program benefits, and the issuance of regulations, in the position of the secretary. This was not always the case. When Reorganization Plan No. 1 was issued, most of the Public Health Service Act (PHSA) authorities were placed in the surgeon general. This remained so until 1966 when Reorganization Plan No. 3 was issued. That 3 5 U.S.C. § 301 reads as follows: The head of an executive department or military de- partment may prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property. 4 1980 WL 16137 (Comp. Gen.), B-199491.

212 HHS IN THE 21ST CENTURY plan, which was also approved by the Congress, transferred all the func- tions and authority of the surgeon general to the secretary of health, edu- cation, and welfare. With the adoption of Reorganization Plan No. 3, a major statutory impediment to the exercise of the secretary’s reorganiza- tion authority with respect to Public Health Service (PHS) programs was removed. As seen later, however, in the 40-plus years since the adoption of this plan, organizational requirements imposed by statute have in- creasingly reemerged. At the time of Reorganization Plan No. 3, the PHS was composed of four agencies: the National Institutes of Health, the Bureau of Medical Services, the Bureau of State Services, and the Office of the Surgeon General. All the authorities of PHS had to be administered through one of these offices. In submitting the Reorganization Plan, the President stated that this organizational structure was outmoded in light of the many new health problems and issues that had arisen and the many new programs that had been adopted in the 20 years since that organizational structure was created. He pointed out that the secretary also administered other programs not within PHS, such as Medicare, Medicaid, and the regulation of food and drugs through the Food and Drug Administration (FDA), that required the secretary to have the ability to coordinate health activities across program lines. He therefore proposed, and Congress ap- proved, that the secretary should have broad authority to reorganize these programs according to modern principles of organizational design so that all of these programs could be administered in an integrated and efficient manner. 5 Since that time, most of the statutory authorities administered by the department have been placed in the secretary, and the theory of Reor- ganization Plan No. 3 was for the secretary to have broad discretion to organize those functions into subunits of the department; to delegate the performance of those functions to the various officers who are in charge of those subunits; and to reorganize those functions, subunits, and offi- cers largely as he sees fit. However, limits on that authority have been enacted by Congress in numerous statutory provisions creating specific offices and officials in the department and in some cases specifying the reporting relationship between those officials and the secretary. These statutory provisions impose the most significant legal constraints on the secretary’s ability to reorganize the department, and as we see later, most of these statutory directions as to how functions of the department should 5 42 U.S.C.A. § 202, note.

APPENDIX H 213 be organized apply to the programs authorized by the Public Health Ser- vice Act. HISTORY OF THE SECRETARY’S EXERCISE OF REORGANIZATION AUTHORITY Over the past 65 years of the department’s existence, secretaries have used their authority to reorganize the department in many ways. Initially, the department was organized somewhat along the lines of the combined components. Public Health Service components were originally organ- ized under the surgeon general, who reported to the secretary. The Old- Age, Survivors, and Disability Insurance (OASDI) programs remained with the commissioner of Social Security, but various other programs authorized by the Social Security Act, mainly those providing assistance to state-operated welfare programs, were delegated to a new entity cre- ated by the secretary, the commissioner of Social and Rehabilitation Ser- vices (SRS). To this new entity, through secretarial delegation, also went such programs as the Older Americans Act and the Rehabilitation Act. When Medicare and Medicaid were enacted in 1965, the secretary dele- gated Medicare to the commissioner of Social Security, presumably be- cause it was a direct assistance program with eligibility established under Title II of the Social Security Act, like the OASDI program. Medicaid, on the other hand, being a state grant program, was delegated to the commissioner of SRS. These organizational decisions were made by the secretary administratively, under his reorganization authority discussed above, because the Social Security Act and the other authorities affected were vested by statute in the secretary and contained no provisions in- structing the secretary how to organize them. In the ensuing years, the secretary used the reorganization authority discussed above to move programs around and to abolish and create of- fices and agencies as necessary to reflect mission and program changes, and to implement different theories of organization and management. Thus, in 1977, when a different secretary decided it made more sense to have the two major health care assistance programs, Medicare and Medi- caid, administered under a single administrative unit, the secretary used his authority to move both programs into a new component that he cre- ated, the Health Care Financing Administration (HCFA), under a newly created administrator. Similarly, he abolished the SRS and its commis- sioner and assigned all of its programs to a new assistant secretary for

214 HHS IN THE 21ST CENTURY human development services. After the enactment of Reorganization Plan No. 3 in 1966, which removed the Public Health Services programs from the authority of the surgeon general and vested them in the secre- tary, the secretary redelegated those programs to the operational control of the assistant secretary for health. Those programs remained with the assistant secretary for health until 1995 when a different secretary choose to have each of the major public health programs (National Institutes of Health, Centers for Disease Control and Prevention, Substance Abuse and Mental Health Services Administration, Indian Health Service, Agency for Healthcare Research and Quality, etc.) report directly to the secretary. The secretary has similar broad authority to reorganize and assign functions to his senior staff (i.e., those officials at the assistant secretary level). Reorganization Plan No. 1 initially assigned an undersecretary (executive level 3) 6 and two assistant secretaries to the department. Ad- ditional assistant secretaries and a general counsel were subsequently added, but the functions and responsibilities of the assistant secretaries (with the exception of the assistant secretary for aging, the assistant sec- retary for families and children, and the assistant secretary for admini- stration and management) are not specified in the statute. Thus, the secretary was and remains free to change the title, role, and responsibili- ties of most of the assistant secretaries. Of the secretary’s senior staff, only the general counsel’s title and functions are specified in law. 7 The remaining senior staff positions (chief of staff, executive secretary, direc- tor of intergovernmental affairs, director of the Office for Civil Rights, etc.) are all positions created under the secretary’s general organizational authority and those positions may be abolished or changed at the secre- tary’s discretion. The purpose of the foregoing discussion has been to demonstrate the extent of the secretary’s reorganization authority over a large portion of the department’s programs. Virtually all of the programs vested in the secretary under the Social Security Act, and the remaining programs cur- rently administered through the Administration for Families and Chil- dren, are not subject to statutory constraints as to their organizational placement within the department. Nor is the secretary limited in his au- thority to organize and assign functions to his senior staff. For reasons beyond the scope of analysis in this paper, however, the programs au- 6 The position of undersecretary was elevated to deputy secretary (executive level 2) in 1990. 7 42 U.S.C.A. § 3504.

APPENDIX H 215 thorized under the Public Health Service Act and related statutes are sub- ject to considerably more direction from Congress with regard to how they should be organized and to which official they are to be assigned. The extent of those statutory constraints is discussed in the following section. Statutory Provisions Affecting the Authority to Reorganize the Department As indicated in the preceding discussion, there is great variety among the statutes authorizing the department’s programs in the extent to which they impose organizational limitations. There is also considerable variety in the types of statutory organizational directives that Congress has placed on those programs. Some discussion of the means by which Con- gress has adopted organizational instructions for the various programs may be useful. There are numerous examples in which Congress has directed that a specifically named program office be established to administer a specific program or group of programs. For example, section 306 of the PHSA provides: “There is established in the Department of Health and Human Services the National Center for Health Statistics. . . .” The act says noth- ing more about where the center is to be placed organizationally, thus giving the secretary discretion as to where it is to be located and through what official it is to report to the secretary. Where the statute creates an office to administer only a single pro- gram, this type of provision creates little or no organizational constraint on the secretary because he can place that office where he wants. This paper does not focus on such provisions. However, where Congress has created a major organizational entity that is charged with the administra- tion of a entire subset of the department’s programs (e.g., the establish- ment of the Substance Abuse and Mental Health Services Administration [SAMHSA] by section 501 of the PHSA), compliance with that statute may substantially restrict the secretary’s options for organizing his pro- grams. Those are the types of provisions examined in this paper. Some statutes, particularly the PHSA, specify that the secretary is to perform a particular program function “acting through” a particular pro- gram official or “through” a named program office (which may or may not have been created by statute). For example, numerous provisions in the PHSA provide, “The Secretary, acting through the Director of the

216 HHS IN THE 21ST CENTURY Centers for Disease Control and Prevention [or some other PHSA agency], shall carry out a program to [make grants or conduct research in a particular area of concern].” This type of provision is also a major im- pediment to any attempt by the secretary to reassign functions as he or she deems appropriate; accordingly, we examine the effects of such pro- visions. The remainder of this section attempts to analyze the significant statutory provisions that impinge on the secretary’s authority to reorgan- ize the major programs of the department. (We do not look at the hun- dreds of advisory committees and boards created by statute, because those provisions do not affect basic organizational decisions, and in any event the secretary is able to manage and control those entities through the Federal Advisory Committee Act.) For convenience, this analysis has been organized according to the existing operating components of the department. Organizing the paper in this way is not meant to suggest that any such component must be preserved in any reorganization because, as we have seen, some of those components do not have statutory status. To make this task manageable and the paper useful, we do not list every such statutory provision. Where a type of statutory provision ap- plies to several programs within an operating component, those provi- sions are discussed generically. However, for the convenience of the committee, we have attached an appendix listing statutory provisions that we believe have to be considered in the context of any reorganization study of the department. 8 Administration for Children and Families The Administration for Children and Families (ACF) was created administratively in 1991 as the successor to the Office of Human Devel- opment Services. The programs it administers are established under title IV of the Social Security Act (including Temporary Assistance for Needy Families, Child Welfare Services, Adoption Assistance, and Child Support Enforcement) and under a variety of other statutes providing for assistance to disadvantaged and vulnerable populations (refugees, disad- vantaged children, Native Americans, and individuals with disabilities). 8 While we have attempted to be thorough in identifying the relevant statutory provi- sions, given the time allotted and the size of the task, we cannot guarantee that our listing is exhaustive. Further research may be warranted in light of particular options that are developed by the committee.

APPENDIX H 217 ACF is headed by an assistant secretary appointed by the President and confirmed by the Senate. That position was created by section 416 of the Social Security Act as the “Assistant Secretary for Family Support.” The only duty of that office specified by law is administration of the Tempo- rary Assistance for Needy Families block grant program and the Child Support and Establishment of Paternity program; however, nothing pre- vented the secretary from assigning the assistant secretary additional du- ties, so the title of that position was changed administratively to the “Assistant Secretary for Children and Families.” We could find no other statutory provisions limiting the secretary’s authority to reorganize or reassign any of these programs or officials to other parts of the depart- ment. Administration on Aging Of the non-PHS agencies in the department, the Administration on Aging (AoA) is subject to the most limiting statutory provisions dictating its organizational placement and structure. Section 201 of the Older Americans Act 9 establishes the Administration on Aging and creates the position of assistant secretary for aging, appointed by the President with the advice and consent of the Senate. The statute requires that there be a direct reporting relationship between the assistant secretary and the sec- retary, and in performing his functions under the statute the assistant sec- retary must be directly responsible to the secretary. None of the functions of AoA (including those carried out in the regional offices) may be dele- gated to an official who is not directly responsible to the secretary. The statute also specifies the creation of certain offices within AoA, including an Office for American Indians, Alaskan Natives, and Hawai- ian Programs; an Office of Long-Term Ombudsman Program; and an office responsible for elder abuse and prevention services. Centers for Medicare and Medicaid Services (CMS) As discussed earlier, programs authorized under the Social Security Act (SSA), such as Medicare and Medicaid, are subject to almost no statutory directions or limitations with respect to how or where they are 9 42 U.S.C.A. § 3011.

218 HHS IN THE 21ST CENTURY organized. The secretary has discretion to assign the administration of those programs to whatever entity within the department he may choose or create and to designate the official he chooses to be in charge of those programs. Likewise, there are no statutory directions or limitations on the internal organization of whatever unit he specifies to administer those programs. As we have seen, no statutory provision directs that Medicare and Medicaid, or any of the components thereof, be administered by the same organizational unit within the department. The only statutory provisions we have found that appear to affect the organization of CMS are in section 1117 of the SSA. Subsection (a) thereof requires that the administrator of the Health Care Financing Ad- ministration (HCFA) shall be appointed by the President with the advice and consent of the Senate. Subsection (b) establishes within the admini- stration the position of chief actuary, requires that he be in direct line authority to the administrator, and specifies that he may be removed only for cause. Interestingly, section 1117 does not create the position of ad- ministrator; it merely requires that it be an advice and consent position. That provision did not prevent the secretary from renaming HCFA as the Centers for Medicare and Medicaid Services in 2001, nor would it seem to prevent the secretary from eliminating that position and/or reorganiz- ing the functions thereof. Agency for Healthcare Research and Quality Section 901 of the PHSA establishes within PHS the Agency for Healthcare Research and Quality (AHRQ) and specifies that it be headed by a director appointed by the secretary. The statute requires that the functions of the agency specified in title IX of the PHSA shall be carried out through the director. Title IX contains no other organizational directions or limitations on AHRQ. However, other parts of the PHSA contain a number of provi- sions directing the secretary to carry out certain functions through AHRQ (e.g., the conduct of studies to support organ donation and organ recov- ery, preservation, and transportation [sec. 377C]; the conduct of a re- search, evaluation, and assessment program on the impact and cost- effectiveness of HIV treatments [sec. 2673]). (The appendix to this paper contains a list of the provisions.) There are other provisions requiring or encouraging consultation with AHRQ by the secretary and other officials

APPENDIX H 219 with respect to certain of their functions, but these do not seem to im- pinge on organizational decisions. Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) began life as the Communicable Disease Center in 1946. It was transferred to the new Department of Health, Education, and Welfare along with other parts of the Public Health Service in 1953 under Reorganization Plan No. 1. Its name was changed to the Center for Disease Control in 1970 (apparently without statutory direction or ratification) and changed again administra- tively to the Centers for Disease Control and Prevention in 1980 to re- flect a new organization of the agency. So far as we can ascertain, all this was done without explicit statutory authority, because we can find no statute creating or naming the agency, although by this date there were many references in the Public Health Service Act and other statutes to the Center for Disease Control. However, in 1992, P.L. 102-531 amended all statutory references to the Center for Disease Control to the Centers for Disease Control and Prevention. Since there is no statute establishing CDC or its director, or directing how or through whom it reports to the secretary, the secretary has con- siderable discretion as to how it is organized, where it should be placed within the department, and what its relationship should be to other com- ponents that have related missions. However, the statute is very specific with respect to the programs that are to be administered through CDC. Although there are few directions in law as to the internal organization of CDC, 10 the Public Health Service Act is replete with provisions directing that various programs or activities of the PHS shall be carried out “through” the CDC. While not dictating a particular organizational struc- ture or reporting relationship, these dozens of statutory provisions will have to be taken into account in any restructuring of PHS programs. The functions and activities that the statute requires to be performed through CDC are listed in the appendix. 10 Section 317C of the PHSA establishes within CDC a center to be known as the Na- tional Center for Birth Defects and Developmental Disabilities. We are not aware of other organization entities that are made part of CDC by statute. The National Institute of Oc- cupational Safety and Health was established within HHS in 1970 (29 U.S.C.A. § 671), but its organizational placement within CDC was an administrative decision.

220 HHS IN THE 21ST CENTURY Food and Drug Administration The Food and Drug Administration (FDA), along with the commis- sioner of food and drugs, was transferred to the department as part of the 1953 Reorganization Plan. Its statutory origins were with the Department of Agriculture, but it had been transferred to the Federal Security Agency in 1940. In 1988, its statutory status was made explicit by section 503 of the Health Omnibus Program Extension Act (21 U.S.C.A. § 393(a)) that “established in the Department of Health and Human Services the Food and Drug Administration” and the position of commissioner of food and drugs, who is appointed by the President with the advice and consent of the Senate. The secretary is to oversee the operation of FDA and to carry out his responsibility to ensure the safety of food and the safety and ef- fectiveness of drugs through FDA. The Food, Drug, and Cosmetic Act does not specify the internal or- ganization of FDA. The only statutory provisions we could find relating to particular components of FDA are (1) the Best Pharmaceuticals for Children Act, adopted in 2002, which created within FDA an Office of Pediatric Therapeutics, and (2) a provision added to the Food, Drug, and Cosmetic Act in 2007 creating an Office of the Chief Scientist in the Of- fice of the Commissioner. National Institutes of Health No component of the department is subject to greater statutory con- trol with respect to its internal organization than the National Institutes of Health (NIH). NIH is established as an agency of the PHS by section 401 of the PHSA, which also specifies that there are 24 statutorily named national research institutes and national centers. As discussed below, the secretary may add new institutes or terminate existing ones, except that the total number of such institutes and centers may not exceed 27. Sec- tion 402 establishes the position of the director of NIH, who shall be ap- pointed by the President with the advice and consent of the Senate. The statute does not require that there be a direct reporting relationship be- tween the director and the secretary. 11 Title IV of the PHSA sets forth in detail the mission, programs, and grant authority of each of the institutes and centers of NIH. It also con- 11 These sections were substantially revised by the National Institutes of Health Reform Act of 2006, section 101, which became law on January 15, 2007.

APPENDIX H 221 tains provisions specifying the organizational structure of each institute. (Special statutory provisions relating to the organization of the institutes are set forth in the appendix.) Section 405 provides that the director of the National Cancer Institute shall be appointed by the President (no ad- vice and consent) and the directors of the remaining institutes shall be appointed by the secretary. That section also requires that the director of each national research institute shall report directly to the director of NIH. Although the statute contains detailed statutory instructions as to the organization of NIH and its components, it also provides authority for the secretary and the director to change that organizational structure. Section 401(d)(2) permits the secretary to establish additional institutes within NIH (subject to the numerical limit of 27 discussed above) if he deter- mines this necessary to carry out the research, training, and information missions of NIH. That section also permits the secretary to reorganize the functions of any institute or to abolish any institute if he determines that it is no longer required. Such additions, abolishments, or reorganizations may not be put into effect before the expiration of 180 days after the congressional committees having jurisdiction over NIH are provided written notice of such action. 12 Section 401(c) requires that within the Office of the Director there shall be a Division of Program Coordination, Planning, and Strategic Initiatives, which shall contain six named offices and any other office within the Office of the Director existing on January 14, 2007. 13 Not- withstanding this specificity, section 401(c)(3) permits the director of NIH, after a series of public hearings and with the approval of the secre- tary, to reorganize, add to, terminate, or transfer the functions of these offices if he or she determines that the management and efficiency of the offices would be improved by such a reorganization. Section 401(c)(4) permits each institute director, after a series of public hearings and with the approval of the director, to reorganize the divisions and other organ- izational units of the institute as necessary to improve the management and operation of the institute. All of these reorganization authorities may override the specific statutory organizational provisions discussed above. 12 The relevant committees are the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate. 13 The named offices are the Office of AIDS Research, the Office of Research on Women’s Health, the Office of Behavioral and Social Sciences Research, the Office of Disease Prevention, the Office of Dietary Supplements, and the Office of Rare Diseases.

222 HHS IN THE 21ST CENTURY A provision was added to section 401 as part of the National Insti- tutes of Health Reform Act of 2006 requiring the secretary to establish a Scientific Management Review Board within NIH for the purpose of ad- vising the secretary and NIH officials on the use of the reorganization authorities discussed above. The board, which is composed of a mix of institute directors and individuals who are not officers or employees of the United States but who have interests in NIH, is to issue a report, not less often than every seven years, providing its recommendations regard- ing the use of those authorities. Other than board recommendations call- ing for the establishment, termination, or consolidation of one or more institutes, or a reorganization of the Office of the Director, a recommen- dation of the board for a reorganization must be implemented within three years, unless the director of NIH submits a report to the congres- sional committees of jurisdiction containing specific objections to such recommendations. Health Resources and Services Administration We could find no provision of law creating the Health Resources and Services Administration (HRSA), which was created administratively in 1982 by combining several offices (including the Health Resources Ad- ministration, the Health Services Administration, the Bureau of Health Facilities, and the Bureau of Health Professions) into a single agency. Although HRSA is not a statutory entity, the PHSA contains dozens of references to the agency, principally provisions requiring that the secre- tary carry out certain functions or programs through HRSA. (See appen- dix.) Nor does the statute specify any particular organizational structure for HRSA, but it does refer to a number of organizational units with the agency, including the Office of Rural Health Policy (42 U.S.C. 912), the Maternal and Child Health Bureau (sec. 330A(d)), the Office for the Ad- vancement of Telehealth (sec. 330K), the Division of Organ Transplanta- tion (sec. 379), the Division of Nursing (sec. 464X), and the Division of Trauma and Emergency Medical Systems (sec. 1201). Most of the re- maining major units within HRSA were created administratively to re- flect the wide variety of programs that have been delegated to the agency.

APPENDIX H 223 Substance Abuse and Mental Health Services Administration The Substance Abuse and Mental Health Services Administration (SAMHSA) was created as an agency of the PHS by section 501 of the PHSA. That section also created within SAMHSA the Center for Sub- stance Abuse Treatment, the Center for Substance Abuse Prevention, and the Center for Mental Health Services. The statute establishes an admin- istrator, to be appointed by the President with the advice and consent of the Senate, and it permits the administrator, with the approval of the sec- retary, to appoint a deputy administrator. The statute permits, but does not require, the appointment within SAMHSA of an associate adminis- trator for alcohol prevention and treatment policy, and it requires the ap- pointment of an associate administrator for women’s services. The statute does not require that there be a direct reporting relationship be- tween the administrator and the secretary. The statute specifies that the directors of each of the three main cen- ters within SAMHSA shall administer a precise set of activities within his or her bailiwick. The statute also places the authority for some pro- grams and activities within SAMHSA in the secretary, In this respect, SAMHSA is similar to NIH in that the statute is inconsistent about pro- gram activities in terms of whether those activities are placed in the sec- retary to be delegated to a particular official or at his discretion, or whether the statute vests the activity directly in a named official. To the extent that the statute names a particular statutorily created official to carry out certain activities, the secretary’s discretion to reorganize those activities is limited. Agency for Toxic Substances and Disease Registry The Agency for Toxic Substances and Disease Registry (ATSDR) was established in HHS in 1980 by section 104(i) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA; also known as “Superfund”). That section requires that the administrator of the agency shall report directly to the surgeon general, but since all of his functions and authority were transferred to the secretary by the 1966 Reorganization Plan, the direct reporting relationship is to the secretary. Subsequent statutory enactments assigning various functions relating to toxic substances to the secretary (e.g., the requirement in 10 U.S.C.A. § 2704 to develop certain toxicological profiles) have required that the sec-

224 HHS IN THE 21ST CENTURY retary shall carry out those functions through ATSDR. (See appendix for the list of functions so assigned.) Indian Health Service The Indian Health Service (IHS) was established by statute as part of the PHS by section 601 of the Indian Health Care Improvement Act of 1988. 14 That section also specifies that IHS shall be administered by a director who shall be appointed by the President with the advice and con- sent of the Senate. The statute specifies that the director shall report to the secretary of HHS through the assistant secretary for health. The stat- ute requires that IHS “shall be an agency within the Public Health Ser- vice of the Department of Health and Human Services, and shall not be an office, component, or unit of any other agency of the Department.” The statute goes on to provide that the secretary shall carry out, through the director of IHS, all his authorities with respect to IHS and other pro- grams administered by the secretary through which health care is pro- vided to Indians based on their status as Indians. This statutory provision would seem to preclude the reorganization of any such program under another agency or office within the department. Regional Offices There is very little in the statutes about the establishment or role of the regional offices of the department. A few programs (e.g., AoA) refer to regional offices but merely affirm that certain requirements as to or- ganizational responsibilities shall apply to the regional offices as well. The secretary is largely free to establish or revise the role of the regional offices through reorganization. 14 42 U.S.C.A. § 1661.

APPENDIX H 225 Organization of the Health Functions of Other Federal Agencies Undersecretary for Health in the Department of Veterans Affairs The health function in the Department of Veterans Affairs (VA) is headed by an undersecretary for health. He or she is appointed by the President, with Senate confirmation, and is directly responsible to the secretary of veterans affairs for the operation of the Veterans Health Administration, including all health functions and facilities of the de- partment. Unlike most other presidential appointees in the executive branch, the undersecretary is required to be appointed without regard to political affiliation or activity, but rather on the basis of professional qualifications as a health care practitioner or administrator and prior ex- perience in connection with veterans health programs (38 U.S.C.A. § 305). The statute calls for a commission to be established whenever a va- cancy occurs in the office of undersecretary for the purpose of nominat- ing at least three qualified individuals for appointment to the position by the President. After those names are submitted to the President, he may ask the commission to submit additional nominations for his considera- tion. The commission is composed of (1) three persons representing clinical care, medical research, and education activities affected by the Veterans Health Administration; (2) two persons representing veterans served by the Veterans Health Administration; (3) two persons with ex- perience in or similar to the management of veterans health services or research; (4) the deputy secretary of veterans affairs; (5) the chairman of a Special Medical Advisory Group in the department; and (6) at the sec- retary’s discretion, a former undersecretary or chief medical officer of the VA. The statute formerly established a term of office of four years for this position, but that provision was eliminated in 2006. 15 The Department of Agriculture’s Food Safety Inspection Service The Office of the Undersecretary for Food Safety was created by section 261 of the Department of Agriculture Reorganization Act of 15 P.L. 109-461, § 210(a)(1), (2).

226 HHS IN THE 21ST CENTURY 1994, title II of P.L. 103-354. That section merely states that the under- secretary shall be delegated those functions and duties under the jurisdic- tion of the Department of Agriculture that are primarily related to food safety. The undersecretary is appointed by the President, with the advice and consent of the Senate, from among individuals with specialized training or significant experience with food safety or public health pro- grams. The principal responsibility of the undersecretary is overseeing the policies and programs of the Food Safety and Inspection Service (FSIS) of the Department of Agriculture. The FSIS is responsible for the imple- mentation and enforcement of the food safety laws that are the responsi- bility of the department—the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act. Through the administrator of FSIS, the undersecretary supervises a staff of ap- proximately 7,500 persons, including scientists, international food safety experts, field office food inspectors, enforcement officers, and others. The FSIS is the largest category of employees in the Department of Ag- riculture. ADDRESSING STATUTORY ORGANIZATIONAL ISSUES IN A REORGANIZATION As we have seen, statutory provisions that establish or direct organ- izational features of the department differ in the extent to which they cre- ate a serious barrier to administrative reorganization. For example, the mere creation of an office to carry out a given function, does not con- strain the ability of the secretary to place that function or office where he or she sees fit. On the other hand, the creation of a particular office within the department or within a component of the department and a statutory assignment to that office of a particular set of programs and functions are requirements that must be given some effect. However, such a provision does not necessarily bar the secretary from accomplish- ing organizational objectives. For example, in 1978, after Congress had directed that the commissioner on aging should report directly to the Of- fice of the Secretary, the secretary was able to achieve his goal of having the Administration on Aging be part of the Office of Human Develop- ment Services (OHDS) by placing OHDS within the Office of the Secre- tary.

APPENDIX H 227 There are a number of major components of the department that were not created by statute but seem to have acquired statutory status over the years by having been statutorily assigned certain functions by name (e.g., HRSA, CDC, CMS). We do not believe that the fact that a statute refers to an agency by a name that was established administratively would pre- vent the secretary from renaming, abolishing, or consolidating that agency. Some meaning could be given to the statutory assignment of functions or programs to that agency by simply reassigning those func- tions or program within the reorganization. There are other ways of dealing with what appear to be hard-and-fast statutory instructions regarding organization. Section 201 of the PHSA states that “[t]he Public Health Service in the Department of Health and Human Services shall be administered by the Assistant Secretary for Health under the supervision and direction of the Secretary.” Yet that provision did not prevent the secretary from reorganizing the functions of PHS to create a direct reporting relationship between the secretary and the major components of the PHS. Apparently effect was given to this requirement by having the assistant secretary have some indirect role in the administration of the PHS agencies. Thus, there are a number of ways to deal with reorganizational pro- posals that may involve statutory constraints. In the end, it will be neces- sary to review such proposals against the statutory framework discussed above. The statutes, although an important concern, should not ultimately prevent the adoption of management reforms and organizational changes that are necessary to achieve the most efficient and effective operation of the programs the agency is charged with administering. APPENDIX: STATUTORY CONSTRAINTS ON HHS ORGANIZATION Administration on Children and Families • SSA, sec. 416. The programs under the part [Temporary Assis- tance to Needy Families] and part D [Child Support Enforce- ment] shall be administered by an Assistant Secretary for Family Support. . . . (42 U.S.C. § 616)

228 HHS IN THE 21ST CENTURY • SSA, sec. 454. “The Secretary shall establish, within the De- partment of Health and Human Services a separate organiza- tional unit, under the direction of a designee of the Secretary, who shall report directly to the Secretary and who shall— [administered the Office of Child Support Enforcement]. . . .” (42 U.S.C. § 652) • “(a) Grants authorized; (1) In general, [t]he Secretary of Health and Human Services, acting through the Administration of Chil- dren and Families, in partnership with the Secretary of Housing and Urban Development, shall award grants, contracts, or coop- erative agreements for a period of not less than 2 years to eligible entities to develop long-term sustainability and self-sufficiency options for adult and youth victims of domestic violence, dating violence, sexual assault, and stalking who are currently homeless or at risk for becoming homeless.” (42 U.S.C. § 14043e-3. Subchapter on Violence Against Women. Collaborative grants to increase the long-term sta- bility of victims.) Agency for Healthcare Research and Quality • “(c) Coordination of activities through units of Department; (1) The Secretary shall coordinate all health services research, evaluations, and demonstrations, all health statistical and epide- miological activities, and all research, evaluations, and demon- strations respecting the assessment of health care technology undertaken and supported through units of the Department of Health and Human Services. To the maximum extent feasible such coordination shall be carried out through the Agency for Healthcare Research and Quality and the National Center for Health Statistics.” (42 U.S.C. § 242b. Subchapter on General Powers and Du- ties. Research and Investigations. General authority respect- ing research, evaluations, and demonstrations in health statistics, health services, and health care technology.) • “(a) Development of supportive information; The Secretary, act- ing through the Director of the Agency for Healthcare Research and Quality, shall develop scientific evidence in support of ef- forts to increase organ donation and improve the recovery, pres- ervation, and transportation of organs.”

APPENDIX H 229 “(c) Research and dissemination; The Secretary, acting through the Director of the Agency for Healthcare Research and Quality, as appropriate, shall provide support for research and dissemi- nation of findings….” (42 U.S.C. § 274f-3. Subchapter on General Powers and Du- ties. Organ Transplants. Studies relating to organ donation and the recovery, preservation, and transportation of organs.) • “(a) In general; There is established within the Public Health Service an agency to be known as the Agency for Healthcare Re- search and Quality, which shall be headed by a director ap- pointed by the Secretary. The Secretary shall carry out this subchapter acting through the Director.” (42 U.S.C. § 299. Subchapter on Agency for Healthcare Re- search and Quality. Establishment and General Duties. Mis- sion and Duties.) • “(1) In general; The Secretary, acting through the Director and in consultation with the Commissioner of Food and Drugs, shall establish a program for the purpose of making one or more grants for the establishment and operation of one or more centers to carry out the activities specified in paragraph (2).” (42 U.S.C. § 299b-1. Subchapter on Agency for Healthcare Research and Quality. Health Care Improvement Research. Private-public partnerships to improve organization and de- livery.) • “(2) Annual report; Beginning in fiscal year 2003, the Secretary, acting through the Director, shall submit to Congress an annual report on national trends in the quality of health care provided to the American people.” (42 U.S.C. § 299b-2. Subchapter on Agency for Healthcare Research and Quality. Health Care Improvement Research. Information on quality and cost of care.) • “(a) Requirement; (1) In general; To avoid duplication and en- sure that Federal resources are used efficiently and effectively, the Secretary, acting through the Director, shall coordinate all research, evaluations, and demonstrations related to health ser- vices research, quality measurement and quality improvement activities undertaken and supported by the Federal Government.” (42 U.S.C. § 299b-6. Subchapter on Agency for Healthcare Research and Quality. Health Care Improvement Research.

230 HHS IN THE 21ST CENTURY Coordination of Federal Government quality improvement efforts.) • “(a) Research, demonstrations, and evaluations; (1) Improvement of effectiveness and efficiency; (A) In general; To improve the quality, effectiveness, and efficiency of health care delivered pursuant to the programs established under titles XVIII, XIX, and XXI of the Social Security Act … the Secretary acting through the Director of the Agency for Healthcare Research and Quality (in this section referred to as the ‘Director’), shall con- duct and support research to meet the priorities and requests for scientific evidence and information identified by such programs with respect to—(i) the outcomes, comparative clinical effec- tiveness, and appropriateness of health care items and services (including prescription drugs); and (ii) strategies for improving the efficiency and effectiveness of such programs, including the ways in which such items and services are organized, managed, and delivered under such programs.” (42 U.S.C. § 299b-7. Subchapter on Agency for Healthcare Research and Quality. Health Care Improvement Research. Research on outcomes of health care items and services.) • “(a) Establishment of program; (1) In general; The Secretary, acting through the Director of the Agency for Healthcare Re- search and Quality, shall—(A) conduct and support research with respect to the outcomes, effectiveness, and appropriateness of health care services and procedures in order to identify the manner in which diseases, disorders, and other health conditions can most effectively and appropriately be prevented, diagnosed, treated, and managed clinically; and (B) assure that the needs and priorities of the program under subchapter XVIII of this chapter are appropriately reflected in the development and peri- odic review and updating (through the process set forth in sec- tion 299b-2 of this title) of treatment-specific or condition- specific practice guidelines for clinical treatments and conditions in forms appropriate for use in clinical practice, for use in educa- tional programs, and for use in reviewing quality and appropri- ateness of medical care.” (42 U.S.C. § 299b-12. Subchapter on General Provisions, Peer Review, and Administrative Simplification. General Provisions. Research on outcomes of health care services and procedures.)

APPENDIX H 231 • (a) Purpose; The Secretary, acting through the Director of the Centers for Disease Control and Prevention and the Director of the Agency for Healthcare Research and Quality, shall award grants and contracts to fund research on effective interventions in the health care setting that prevent domestic violence, dating violence, and sexual assault across the lifespan and that prevent the health effects of such violence and improve the safety and health of individuals who are currently being victimized. (42 U.S.C. § 13973. Subchapter on Violence Against Women. Safe Homes for Women. Research on Effective In- terventions to Address Violence Against Women. Research on effective interventions in the health care setting.) Centers for Disease Control and Prevention • “(e) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall expand, intensify, and co- ordinate the activities of the Centers for Disease Control and Prevention with respect to preterm labor and delivery and infant mortality.” (42 U.S.C. § 241. Subchapter on General Powers and Duties. Research and Investigations. Research and investigations generally.) • “(a) In general; The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the Commissioner of Food and Drugs, shall improve (including by educating physi- cians and other health care providers) the collection of, and pub- lish as it becomes available, national data on—(1) the prevalence of food allergies; (2) the incidence of clinically significant or se- rious adverse events related to food allergies; and (3) the use of different modes of treatment for and prevention of allergic re- sponses to foods.” (42 U.S.C. § 242r. Subchapter on General Powers and Du- ties. Research and Investigations. Improvement and publica- tion of data on food-related allergic responses.) • “(a) Prevention; (1) Public education; The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall carry out a program to educate health profes-

232 HHS IN THE 21ST CENTURY sionals and paraprofessionals and the general public on the pre- vention of lead poisoning in infants and children. In carrying out the program, the Secretary shall make available information con- cerning the health effects of low-level lead toxicity, the causes of lead poisoning, and the primary and secondary preventive meas- ures that may be taken to prevent such poisoning.” “(b) Technology assessment and epidemiology; The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, directly or through grants or contracts— [conduct various activities relation to the detection and treatment of lead toxicity in children].” (42 U.S.C. § 247b-3. Subchapter on General Powers and Du- ties. Federal-State Cooperation. Education, technology as- sessment, and epidemiology regarding lead poisoning.) • “(d) Technical assistance, data management, and applied re- search; (1) Centers for Disease Control and Prevention; Under the existing authority of the Public Health Service Act [42 U.S.C.A. § 201 et seq.], the Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention, shall make awards of grants or cooperative agreements to provide technical assistance to State agencies to complement an intramu- ral program and to conduct applied research related to newborn and infant hearing screening, evaluation and intervention pro- grams and systems.” (42 U.S.C. § 247b-4a. Subchapter on General Powers and Duties. Federal-State Cooperation. Early detection, diagno- sis, and interventions for newborns and infants with hearing loss.) • “(b) Studies on relationship between prematurity and birth de- fects; (1) In general; The Secretary of Health and Human Ser- vices, acting through the Director of the Centers for Disease Control and Prevention, shall, subject to the availability of ap- propriations, conduct ongoing epidemiological studies on the re- lationship between prematurity, birth defects, and developmental disabilities.” “(c) Pregnancy risk assessment monitoring survey; (1) In gen- eral; The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall establish systems for the collection of mater- nal-infant clinical and biomedical information, including elec-

APPENDIX H 233 tronic health records, electronic databases, and biobanks, to link with the Pregnancy Risk Assessment Monitoring System (PRAMS) and other epidemiological studies of prematurity in order to track pregnancy outcomes and prevent preterm birth.” (42 U.S.C. § 247b-4f. Subchapter on General Powers and Duties. Federal-State Cooperation. Research relating to pre- term labor and delivery and the care, treatment, and out- comes of preterm and low birthweight infants.) • “The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish fellowship and training programs to be conducted by such Centers to train indi- viduals to develop skills in epidemiology, surveillance, labora- tory analysis, and other disease detection and prevention methods. Such programs shall be designed to enable health pro- fessionals and health personnel trained under such programs to work, after receiving such training, in local, State, national, and international efforts toward the prevention and control of dis- eases, injuries, and disabilities. Such fellowships and training may be administered through the use of either appointment or nonappointment procedures.” (42 U.S.C. § 247b-8. Subchapter on General Powers and Du- ties. Federal-State Cooperation. Fellowship and training pro- grams.) • “(a) Surveillance on juvenile diabetes; The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall develop a sentinel system to collect data on ju- venile diabetes, including with respect to incidence and preva- lence, and shall establish a national database for such data.” (42 U.S.C. § 247b-9. Subchapter on General Powers and Du- ties. Federal-State Cooperation. Diabetes in children and youth.) • “(a) In general; The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall—(1) conduct local asthma surveillance activities to collect data on the preva- lence and severity of asthma and the quality of asthma manage- ment; (2) compile and annually publish data on the prevalence of children suffering from asthma in each State; and (3) to the ex- tent practicable, compile and publish data on the childhood mor- tality rate associated with asthma nationally.” (42 U.S.C. § 247b-10. Subchapter on General Powers and

234 HHS IN THE 21ST CENTURY Duties. Federal-State Cooperation. Compilation of data on asthma.) • “(a) In general; The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall expand and intensify programs (directly or through grants or contracts) for the following purposes: [to conduct education and research on the effects of folic acid in the prevention of birth defects].” (42 U.S.C. § 247b-11. Subchapter on General Powers and Duties. Federal-State Cooperation. Effects of folic acid in prevention of birth defects.) • “(a) In general; The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall carry out programs—[to carry out various activities related to the implica- tions and prevention of prenatal smoking, alcohol and illegal drug use].” (42 U.S.C. § 247b-13. Subchapter on General Powers and Duties. Federal-State Cooperation. Prenatal and postnatal health.) • “(b) Community water fluoridation; (1) In general; The Secre- tary, acting through the Director of the Centers for Disease Con- trol and Prevention and in collaboration with the Director of the Indian Health Service, shall establish a demonstration project that is designed to assist rural water systems in successfully im- plementing the water fluoridation guidelines of the Centers for Disease Control and Prevention that are entitled ‘Engineering and Administrative Recommendations for Water Fluoridation, 1995’ (referred to in this subsection as the ‘EARWF’).” (42 U.S.C. § 247b-14. Subchapter on General Powers and Duties. Federal-State Cooperation. Oral health promotion and disease prevention.) • “(a) Surveillance; (1) In general; The Secretary, acting through the Centers for Disease Control and Prevention, shall—(A) enter into cooperative agreements with States and other entities to conduct sentinel surveillance or other special studies that would determine the prevalence in various age groups and populations of specific types of human papillomavirus (referred to in this section as ‘HPV’) in different sites in various regions of the United States, through collection of special specimens for HPV using a variety of laboratory-based testing and diagnostic tools; and (B) develop and analyze data from the HPV sentinel surveil-

APPENDIX H 235 lance system described in subparagraph (A).” “(b) Prevention activities; education program; (1) In general; The Secretary, acting through the Centers for Disease Control and Prevention, shall conduct prevention research on HPV….” (42 U.S.C. § 247b-17. Subchapter on General Powers and Duties. Federal-State Cooperation. Human papillomavirus [Johanna’s law].) • “(a) Agreements for purchases; (1) In general; Not later than 180 days after October 27, 1992, the Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the Administrator of the Health Resources and Services Administration, shall enter into negotiations with manufacturers of vaccines for the purpose of establishing and maintaining agreements under which entities described in para- graph (2) may purchase vaccines from the manufacturers at the prices specified in the agreements.” (42 U.S.C. § 256c. Subchapter on General Powers and Du- ties. Primary Health Care. Bulk Purchases of Vaccines for Certain Programs. Bulk purchases of vaccines for certain programs.) • “(a) With respect to activities that are authorized in sections 280b and 280b-1 of this title, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall carry out such activities with respect to interpersonal vio- lence within families and among acquaintances.” (42 U.S.C. § 280b-1a. Subchapter on General Powers and Duties. Prevention and Control of Injuries. Interpersonal vio- lence within families and among acquaintances.) • “(a) Permitted use; The Secretary, acting through the National Center for Injury Prevention and Control at the Centers for Dis- ease Control and Prevention, shall award targeted grants to States to be used for rape prevention and education programs conducted by rape crisis centers, State sexual assault coalitions, and other public and private nonprofit entities. . . .” (42 U.S.C. § 280b-1b. Subchapter on General Powers and Duties. Prevention and Control of Injuries. Use of allotments for rape prevention education.) • “(a) Authority to award grants; (1) In general; The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall award grants to eligible State, tribal, terri-

236 HHS IN THE 21ST CENTURY torial, or local entities to strengthen the response of State, tribal, territorial, or local health care systems to domestic violence, dat- ing violence, sexual assault, and stalking.” (42 U.S.C. § 280g-4. Subchapter on General Powers and Du- ties. Additional Programs. Grants to foster public health re- sponses to domestic violence, dating violence, sexual assault, and stalking.) • “(a) In general; The Secretary, acting through the Centers for Disease Control and Prevention and in consultation with the Di- rector of the National Institutes of Health, shall—[conduct re- search and education activities relating to physical activity and the prevention of obesity].” (42 U.S.C. § 280h-1. Subchapter on General Powers and Du- ties. Programs to Improve the Health of Children. Applied research program.) • “(a) In general; The Secretary, acting through the Director of the Centers for Disease Control and Prevention, and in collabora- tion with national, State, and local partners, physical activity or- ganizations, nutrition experts, and health professional organizations, shall develop a national public campaign to pro- mote and educate children and their parents concerning—(1) the health risks associated with obesity, inactivity, and poor nutri- tion; (2) ways in which to incorporate physical activity into daily living; and (3) the benefits of good nutrition and strategies to improve eating habits.” (42 U.S.C. § 280h-2. Subchapter on General Powers and Du- ties. Programs to Improve the Health of Children. Education campaign.) • “(a) In general; The Secretary, acting through the Director of the Centers for Disease Control and Prevention, in collaboration with the Administrator of the Health Resources and Services Administration and the heads of other agencies, and in consulta- tion with appropriate health professional associations, shall de- velop and carry out a program to educate and train health professionals in effective strategies to—(1) better identify and assess patients with obesity or an eating disorder or patients at- risk of becoming obese or developing an eating disorder; (2) counsel, refer, or treat patients with obesity or an eating disorder; and (3) educate patients and their families about effective strate- gies to improve dietary habits and establish appropriate levels of

APPENDIX H 237 physical activity.” (42 U.S.C. § 280h-3. Subchapter on General Powers and Du- ties. Programs to Improve the Health of Children. Health professional education and training.) • “(b) Centers of excellence in autism spectrum disorder epidemi- ology; (1) In general; The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, subject to the availability of appropriations, award grants or cooperative agreements for the establishment of regional centers of excel- lence in autism spectrum disorder and other developmental dis- abilities epidemiology for the purpose of collecting and analyzing information on the number, incidence, correlates, and causes of autism spectrum disorder and other developmental dis- abilities.” (42 U.S.C. § 280i. Subchapter on General Powers and Du- ties. Programs Relating to Autism. Developmental disabili- ties surveillance and research program.) • “(a) In general; The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the Advisory Committee on Heritable Disorders in New- borns and Children established under section 300b-10 of this ti- tle, shall provide for—(1) quality assurance for laboratories involved in screening newborns and children for heritable disor- ders, including quality assurance for newborn-screening tests, performance evaluation services, and technical assistance and technology transfer to newborn screening laboratories to ensure analytic validity and utility of screening tests; and (2) appropri- ate quality control and other performance test materials to evalu- ate the performance of new screening tools.” (42 U.S.C. § 300b-12. Subchapter on Genetic Diseases, He- mophilia Programs, and Sudden Infant Death Syndrome. Genetic Diseases. Laboratory quality.) • “(a) In general; Not later than 180 days after April 24, 2008, the Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the Administra- tor and State departments of health (or related agencies), shall develop a national contingency plan for newborn screening for use by a State, region, or consortia of States in the event of a public health emergency.” (42 U.S.C. § 300b-14. Subchapter on Genetic Diseases, He-

238 HHS IN THE 21ST CENTURY mophilia Programs, and Sudden Infant Death Syndrome. Genetic Diseases. National contingency plan for newborn screening.) • “(d) Coordinating committee regarding year 2020 health objec- tives; The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish a committee to coordinate the activities of the agencies of the Public Health Service (and other appropriate Federal agencies) that are carried out toward achieving the objectives established by the Secretary for reductions in the rate of mortality from breast and cervical cancer in the United States by the year 2020.” (42 U.S.C. § 300k. Subchapter on Preventive Health Meas- ures with Respect to Breast and Cervical Cancers. Estab- lishment of program of grants to States.) • “(b) Grants and contracts for additional purposes; After consulta- tion with the Administrator of the Agency for International De- velopment, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall under section 242l of this title make grants to, enter into contracts with, and provide technical assistance to, international organizations con- cerned with public health and may provide technical assistance to foreign governments, in order to support—(1) projects for training individuals with respect to developing skills and techni- cal expertise for use in the prevention, diagnosis, and treatment of acquired immune deficiency syndrome; and (2) epidemiologi- cal research relating to acquired immune deficiency syndrome.” (42 U.S.C. § 300cc-15. Subchapter on Research with Re- spect to Acquired Immune Deficiency Syndrome. Research Authority. Support of international efforts.) • “(b) Epidemiological and demographic data; (1) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall develop an epidemiological data base and shall provide for long-term studies for the purposes of—(A) col- lecting information on the demographic characteristics of the population of individuals infected with the etiologic agent for acquired immune deficiency syndrome and the natural history of such infection; and (B) developing models demonstrating the long-term domestic and international patterns of the transmission of such etiologic agent.” (42 U.S.C. § 300cc-20. Subchapter on Research with Re-

APPENDIX H 239 spect to Acquired Immune Deficiency Syndrome. Research Authority. Additional authority with respect to research.) • “(a) In general; The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish fel- lowship and training programs to be conducted by the Centers for Disease Control and Prevention to train individuals to de- velop skills in epidemiology, surveillance, testing, counseling, education, information, and laboratory analysis relating to ac- quired immune deficiency syndrome.” “The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall establish an office for the purpose of ensuring that, in car- rying out the duties of the Secretary with respect to prevention of acquired immune deficiency syndrome, the Secretary develops and implements prevention programs targeted at minority popu- lations and provides appropriate technical assistance in the im- plementation of such programs.” (42 U.S.C. § 300ee-1. Subchapter on Prevention of Acquired Immune Deficiency Syndrome. Establishment of office with respect to minority health and acquired immune deficiency syndrome.) • “(a) Development and dissemination of guidelines; Not later than 90 days after November 4, 1988, the Secretary of Health and Human Services (hereafter in this section referred to as the ‘Sec- retary’), acting through the Director of the Centers for Disease Control and Prevention, shall develop, issue, and disseminate emergency guidelines to all health workers and public safety workers (including emergency response employees) in the United States concerning—(1) methods to reduce the risk in the workplace of becoming infected with the etiologic agent for ac- quired immune deficiency syndrome; and (2) circumstances un- der which exposure to such etiologic agent may occur.” “(c) Development and dissemination of model curriculum for emergency response employees; (1) Not later than 90 days after November 4, 1988, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall develop a model curriculum for emergency response employees with re- spect to the prevention of exposure to the etiologic agent for ac- quired immune deficiency syndrome during the process of responding to emergencies.”

240 HHS IN THE 21ST CENTURY (42 U.S.C. § 300ee-2. Subchapter on Prevention of Acquired Immune Deficiency Syndrome. Information for health and public safety workers.) • “(a) Comprehensive information plan; The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall annually prepare a comprehensive plan, in- cluding a budget, for a National Acquired Immune Deficiency Syndrome Information Program. The plan shall contain provi- sions to implement the provisions of this subchapter. The Direc- tor shall submit such plan to the Secretary. The authority established in this subsection may not be construed to be the ex- clusive authority for the Director to carry out information activi- ties with respect to acquired immune deficiency syndrome.” (42 U.S.C. § 300ee-31. Subchapter on Research with Re- spect to Acquired Immune Deficiency Syndrome. National Information Programs. Availability of information to general public.) • “(b) Allocations; (2) After consultation with the Director of the Office of Minority Health and with the Indian Health Service, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, not later than 90 days af- ter November 4, 1988, publish guidelines to provide procedures for applications for funding pursuant to paragraph (1) and for public comment.” (42 U.S.C. § 300cc-34. Subchapter on Prevention of Ac- quired Immune Deficiency Syndrome. National Information Programs. Authorization of appropriations.) • “(a) In general; In the case of States whose laws or regulations are in accordance with subsection (b) of this section, the Secre- tary, acting through the Centers for Disease Control and Preven- tion, shall make grants to such States for the purposes described in subsection (c) of this section.” (42 U.S.C. § 300ff-33. Subchapter on HIV Health Care Ser- vices Program. Care Grant Program. Provisions Concerning Pregnancy and Perinatal Transmission of HIV.)

APPENDIX H 241 Food and Drug Administration • “(g) Regulation of combination products; (4)(A) Not later than 60 days after October 26, 2002, the Secretary shall establish within the Office of the Commissioner of Food and Drugs an of- fice to ensure the prompt assignment of combination products to agency centers, the timely and effective premarket review of such products, and consistent and appropriate postmarket regula- tion of like products subject to the same statutory requirements to the extent permitted by law. (F) The Secretary, acting through the Office, shall review each agreement, guidance, or practice of the Secretary that is specific to the assignment of combination products to agency centers and shall determine whether the agreement, guidance, or practice is consistent with the require- ments of this subsection.” (21 U.S.C. § 353. Title 21: Food and Drugs. Federal Food, Drug, and Cosmetic Act. Drugs and Devices. Exemptions and consideration for certain drugs, devices, and biological products.) • “(h) Guidance of documents; (3) The Secretary, acting through the Commissioner, shall maintain electronically and update and publish periodically in the Federal Register a list of guidance documents. All such documents shall be made available to the public.” (21 U.S.C. § 371. Federal Food, Drug, and Cosmetic Act. General Authority. General Administrative Provisions. Regulations and hearings.) • “(a) In general; The Secretary, acting through the Commissioner of Food and Drugs, shall automate appropriate activities of the Food and Drug Administration to ensure timely review of activi- ties regulated under this chapter.” (21 U.S.C. § 379d. Title 21: Food and Drugs. Federal Food, Drug, and Cosmetic Act. General Authority. General Ad- ministrative Provisions. Automation of Food and Drug Ad- ministration.) • “(2) General powers; The Secretary, through the Commissioner, shall be responsible for executing this chapter and for—(A) pro- viding overall direction to the Food and Drug Administration and establishing and implementing general policies respecting the management and operation of programs and activities of the

242 HHS IN THE 21ST CENTURY Food and Drug Administration; (B) coordinating and overseeing the operation of all administrative entities within the Administra- tion; (C) research relating to foods, drugs, cosmetics, and devices in carrying out this chapter; (D) conducting educational and pub- lic information programs relating to the responsibilities of the Food and Drug Administration; and (E) performing such other functions as the Secretary may prescribe.” (21 U.S.C. § 393. Title 21: Food and Drugs. Federal Food, Drug, and Cosmetic Act. Miscellaneous. Food and Drug Administration.) National Institutes of Health • “(a) Establishment; priorities; Subject to available appropria- tions, the Secretary, acting through the National Institute of Mental Health, the National Institutes of Health, and the Ad- ministration on Aging, shall promote the establishment of family support groups to provide, without charge, educational, emo- tional, and practical support to assist individuals with Alz- heimer’s disease or a related memory disorder and members of the families of such individuals.” (42 U.S.C. § 247a. Subchapter on General Powers and Du- ties. Family support groups for Alzheimer’s disease pa- tients.) • “(a) Appointment; The National Institutes of Health shall be headed by the Director of NIH who shall be appointed by the President with the advice and consent of the Senate. The Direc- tor of NIH shall perform functions as provided under subsection (b) of this section and as the Secretary may otherwise prescribe. (b) Duties and authority; In carrying out the purposes of section 241 of this title, the Secretary, acting through the Di- rector of NIH— (1) shall carry out this subchapter, including being responsi- ble for the overall direction of the National Institutes of Health and for the establishment and implementation of general policies respecting the management and opera- tion of programs and activities within the National Insti- tutes of Health;”

APPENDIX H 243 [There follows a list of 22 more general and specific func- tion to be carried out by the Secretary through the Director.] “(h) Increased participation of women and disadvantaged indi- viduals in biomedical and behavioral research; The Secretary, acting through the Director of NIH and the Directors of the agencies of the National Institutes of Health, shall, in conducting and supporting programs for research, research training, recruit- ment, and other activities, provide for an increase in the number of women and individuals from disadvantaged backgrounds (in- cluding racial and ethnic minorities) in the fields of biomedical and behavioral research.” “(i) Data bank of information on clinical trials for drugs for seri- ous or life-threatening diseases and conditions; (1)(A) The Secre- tary, acting through the Director of NIH, shall establish, maintain, and operate a data bank of information on clinical tri- als for drugs for serious or life-threatening diseases and condi- tions (in this subsection referred to as the ‘data bank’).” “(j) Expanded clinical trial registry data bank; (2) Expansion of clinical trial registry data bank with respect to clinical trial in- formation; (A) In general; (i) Expansion of data bank; To en- hance patient enrollment and provide a mechanism to track subsequent progress of clinical trials, the Secretary, acting through the Director of NIH, shall expand, in accordance with this subsection, the clinical trials registry of the data bank de- scribed under subsection (i)(1) of this section (referred to in this subsection as the ‘registry data bank’). The Director of NIH shall ensure that the registry data bank is made publicly available through the Internet. (B) Inclusion of results; The Secretary, act- ing through the Director of NIH, shall—[expand the registry data bank and ensure its availability to the public].” “(5) Coordination and compliance; (C) Quality control; (i) Pilot quality control project; Until the effective date of the regulations issued under paragraph (3)(D), the Secretary, acting through the Director of NIH and the Commissioner of Food and Drugs, shall conduct a pilot project to determine the optimal method of veri- fication to help to ensure that the clinical trial information sub- mitted under paragraph (3)(C) is non-promotional and is not false or misleading in any particular under subparagraph (D).”

244 HHS IN THE 21ST CENTURY (42 U.S.C. § 282. Subchapter on National Research Institute. National Institutes of Health. Director of the National Insti- tutes of Health.) • “The Secretary, acting through the Director of NIH, shall estab- lish an electronic system to uniformly code research grants and activities of the Office of the Director and of all the national re- search institutes and national centers. The electronic system shall be searchable by a variety of codes, such as the type of research grant, the research entity managing the grant, and the public health area of interest. When permissible, the Secretary, acting through the Director of NIH, shall provide information on rele- vant literature and patents that are associated with research ac- tivities of the National Institutes of Health.” (42 U.S.C. § 282b. Subchapter on National Research Insti- tute. National Institutes of Health. Electronic coding of grants and activities.) • “(b) Duties and authority; grants, contracts, and cooperative agreements; (1) In carrying out the purposes of section 241 of this title with respect to human diseases or disorders or other as- pects of human health for which the national research institutes were established, the Secretary, acting through the Director of each national research institute—(A) shall encourage and sup- port research, investigations, experiments, demonstrations, and studies in the health sciences related to—[various general health issues]. . . . The Secretary, acting through the Director of each national research institute—(C) shall, subject to section 300cc- 40b(d)(2) of this title, receive from the President and the Office of Management and Budget directly all funds appropriated by the Congress for obligation and expenditure by the Institute.” (42 U.S.C. § 284. Subchapter on National Research Insti- tutes. General Provisions Respecting National Research In- stitutes. Directors of national research institutes.) • “(a) List of priority issues in pediatric therapeutics; (1) In gen- eral; Not later than one year after September 27, 2007, the Secre- tary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs and experts in pediatric research, shall develop and pub- lish a priority list of needs in pediatric therapeutics, including drugs or indications that require study. The list shall be revised every three years.”

APPENDIX H 245 “(b) Pediatric studies and research; The Secretary, acting through the National Institutes of Health, shall award funds to entities that have the expertise to conduct pediatric clinical trials or other research (including qualified universities, hospitals, laboratories, contract research organizations, practice groups, federally funded programs such as pediatric pharmacology re- search units, other public or private institutions, or individuals) to enable the entities to conduct the drug studies or other re- search on the issues described in subsection (a) of this section. The Secretary may use contracts, grants, or other appropriate funding mechanisms to award funds under this subsection.” “(c) Process for proposed pediatric study requests and labeling changes; (3) Requests for proposals; If the Commissioner of Food and Drugs does not receive a response to a written request issued under paragraph (2) not later than 30 days after the date on which a request was issued, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs, shall publish a re- quest for proposals to conduct the pediatric studies described in the written request in accordance with subsection (b) of this sec- tion;” “(d) Dissemination of pediatric information; Not later than one year after September 27, 2007, the Secretary, acting through the Director of the National Institutes of Health, shall study the fea- sibility of establishing a compilation of information on pediatric drug use and report the findings to Congress.” (42 U.S.C. § 284m. Subchapter on National Research Insti- tutes. General Provisions Respecting national Research Insti- tutes. Program for pediatric studies of drugs.) • “(c) Report to Congress; Not later than the end of fiscal year 2009, the Secretary, acting through the Director of NIH, shall conduct an evaluation of the activities under this section and submit a report to the Congress on the results of such evalua- tion.” (42 U.S.C. § 284n. Subchapter on National Research Insti- tutes. General Provisions Respecting National Research In- stitutes.) • “(b) Clinical trial infrastructure/innovative treatments for juve- nile diabetes; The Secretary, acting through the Director of the National Institutes of Health, shall support regional clinical re-

246 HHS IN THE 21ST CENTURY search centers for the prevention, detection, treatment, and cure of juvenile diabetes. (c) Prevention of type 1 diabetes; The Sec- retary, acting through the appropriate agencies, shall provide for a national effort to prevent type 1 diabetes.” (42 U.S.C. § 285c-9. Subchapter on National Research Insti- tutes. Specific Provisions Respecting National Research In- stitutes. National Institute of Diabetes and Digestive Kidney Diseases. Juvenile diabetes.) • “(c) Report to Congress; Not later than the end of fiscal year 2009, the Secretary, acting through the Director of NIH, shall conduct an evaluation of the activities under this section and submit a report to the Congress on the results of such evalua- tion.” (42 U.S.C. § 284m. Subchapter on National Research Insti- tutes. General Provisions Respecting National Research In- stitutes. Certain demonstration projects.) • “The Secretary, acting through the Director of the National In- stitutes of Health, shall provide administrative support and sup- port services to the Director of the Center and shall ensure that such support takes maximum advantage of existing administra- tive structures at the agencies of the National Institutes of Health.” (42 U.S.C. § 287c-34. Subchapter on National Research In- stitutes. Other agencies of NIH. Establishment of National Center on Minority Health and Health Disparities. General provisions regarding the center.) • “(a) In general; The Secretary, acting through the Director of the National Institutes of Health, shall establish a program to enter into contracts with qualified health professionals under which such health professionals agree to conduct clinical research, in consideration of the Federal Government agreeing to repay, for each year of service conducting such research, not more than $35,000 of the principal and interest of the educational loans of such health professionals.” (42 U.S.C. § 288-5a. Subchapter on National Research Insti- tutes. Awards and Training. Loan repayment program re- garding clinical researchers.) • “(a) Applications for biomedical and behavioral research grants, cooperative agreements, and contracts; regulations; (1) The Sec- retary, acting through the Director of NIH, shall by regulation

APPENDIX H 247 require appropriate technical and scientific peer review of—(A) applications made for grants and cooperative agreements under this chapter for biomedical and behavioral research; and (B) ap- plications made for biomedical and behavioral research and de- velopment contracts to be administered through the National Institutes of Health.” (42 U.S.C. § 289a. Subchapter on National Research Insti- tutes. General Provisions. Peer review requirements.) • “(b) Ethical review of research; (5) Ethics advisory boards; (J) The Secretary, acting through the Director of the National Insti- tutes of Health, shall provide to each ethics board reasonable staff and assistance to carry out the duties of the board.” (42 U.S.C. § 289a-1. Subchapter on National Research Insti- tutes. General Provisions. Certain provisions regarding re- view and approval of proposals for research.) • “If the Secretary determines, after consultation with the Director of NIH, the Commissioner of the Food and Drug Administration, or the Director of the Centers for Disease Control and Preven- tion, that a disease or disorder constitutes a public health emer- gency, the Secretary, acting through the Director of NIH—(1) shall [take various actions to expedite action to address such emergency].” (42 U.S.C. § 289c. Subchapter on National Research Insti- tutes. General Provisions. Research on public health emer- gencies; report to Congressional committees.) • “(a) Establishment of guidelines; The Secretary, acting through the Director of NIH, shall establish guidelines for the following: (1) The proper care of animals to be used in biomedical and be- havioral research. (2) The proper treatment of animals while be- ing used in such research. Guidelines under this paragraph shall require—(A) the appropriate use of tranquilizers, analgesics, an- esthetics, paralytics, and euthanasia for animals in such research; and (B) appropriate pre-surgical and post-surgical veterinary medical and nursing care for animals in such research. Such guidelines shall not be construed to prescribe methods of re- search. (3) The organization and operation of animal care com- mittees in accordance with subsection (b) of this section.” (42 U.S.C. § 289d. Subchapter on National Research Insti- tutes. General Provisions. Animals in research.)

248 HHS IN THE 21ST CENTURY • “(a) In general; The Secretary shall, acting through the Director of NIH, establish a nonprofit corporation to be known as the Foundation for the National Institutes of Health (hereafter in this section referred to as the ‘Foundation’).” (42 U.S.C. § 290b. Subchapter on National Research Insti- tutes. Foundation for the National Institutes of Health. Estab- lishment and duties of Foundation.) • “(a) In general; The Secretary, acting through the Director of the National Institutes of Health (in this section referred to as the “Director”), shall establish a comprehensive program of con- ducting basic and clinical research on trauma (in this section re- ferred to as the “Program”). The Program shall include research regarding the diagnosis, treatment, rehabilitation, and general management of trauma.” (42 U.S.C. § 300d-61. Subchapter on Trauma Care. Inter- agency Program for Trauma Research. Establishment of program.) • “(a) In general; The Secretary, acting through the Director of the National Cancer Institute and the Director of the National Insti- tute of Allergy and Infectious Diseases, shall for each such Insti- tute establish a clinical evaluation unit at the Clinical Center at the National Institutes of Health.… (b) Personnel and adminis- trative support; (1) For the purposes described in subsection (a) of this section, the Secretary, acting through the Director of the National Institutes of Health, shall provide each of the clinical evaluation units required in such subsection—(A)(i) with not less than 50 beds; or (ii) with an outpatient clinical capacity equal to not less than twice the outpatient clinical capacity, with respect to acquired immune deficiency syndrome, possessed by the Clinical Center of the National Institutes of Health on June 1, 1988; and (B) with such personnel, such administrative support, and such other support services as may be necessary.” (42 U.S.C. § 300cc-11. Subchapter on Research with Re- spect to Acquired Immune Deficiency Syndrome. Clinical evaluation units at National Institutes of Health.) • “(a) Grants and contracts for research; (1) Under section 242 of this title, the Secretary, acting through the Director of the Na- tional Institutes of Health—(A) shall, for the purpose described

APPENDIX H 249 in paragraph (2), make grants to, enter into cooperative agree- ments and contracts with, and provide technical assistance to, in- ternational organizations concerned with public health….” (42 U.S.C. § 300cc-15. Subchapter on Research with Re- spect to Acquired Immune Deficiency Syndrome. Research Authority. Support of international efforts.) • “(2) A grant or contract under paragraph (1) shall be provided in accordance with policies established by the Secretary, acting through the Director of the National Institutes of Health, and af- ter consultation with the advisory council for the National Insti- tute of Allergy and Infectious Diseases.” (42 U.S.C. § 300cc-16. Subchapter on Research with Re- spect to Acquired Immune Deficiency Syndrome. Research Authority. Research centers.) • “(a) Administrative support for Office; The Secretary, acting through the Director of the National Institutes of Health, shall provide administrative support and support services to the Di- rector of the Office and shall ensure that such support takes maximum advantage of existing administrative structures at the agencies of the National Institutes of Health.” (42 U.S.C. § 300cc-45. Subchapter on Research with Re- spect to Acquired Immune Deficiency Syndrome. Office of AIDS Research. General Provisions. General provisions re- garding Office.) [NOTE: Title IV of the PHSA vests in the Director of each of the separate insti- tutes within NIH the authority to carry out the functions of the institute. The statute also creates within some of the institutes separate subunits to carry out particular functions. Because of the volume of such provisions (there are at least 19 statutorily created institutes and 5 national centers, plus the Library of Medi- cine) we have not attempted to list the organizational features of each institute.] Agency for Toxic Substances and Disease Registry • “(f) Functions of HHS to be carried out through ATSDR.—The functions of the Secretary of Health and Human Services under this section shall be carried out through the Administrator of the Agency for Toxic Substances and Disease Registry of the De- partment of Health and Human Services established under sec-

250 HHS IN THE 21ST CENTURY tion 104(i) of CERCLA (42 U.S.C. 9604(i)).” (10 U.S.C. § 2704. Title 10: Armed Forces. Subtitle A: Gen- eral Military Law. Service, Supply, and Procurement. Envi- ronmental Restoration. Commonly found unregulated hazardous substances.) • “(1) The Secretary of Health and Human Services (hereafter in this subsection referred to as the ‘Secretary’), acting through the Director of the Centers for Disease Control, (CDC), and the Di- rector of the National Institute of Environmental Health Sci- ences, shall jointly conduct a study of the sources of lead exposure in children who have elevated blood lead levels (or other indicators of elevated lead body burden), as defined by the Director of the Centers for Disease Control.” (15 U.S.C. § 2704. Title 15: Commerce and Trade. Toxic Substances Control. Subchapter on Lead Exposure Reduc- tion. Lead abatement and measurement.) Indian Health Service • “(a) Establishment . . . there is established within the Public Health Service of the Department of Health and Human Services the Indian Health Service. The Indian Health Service shall be administered by a Director, who shall be appointed by the President, with the ad- vice and consent of the Senate. The Director of the Indian Health Service shall report to the Secretary through the Assistant Secre- tary for Health of the Department of Health and Human Ser- vices.” “(b) Agency status The Indian Health Service shall be an agency within the Public Health Service of the Department of Health and Human Ser- vices, and shall not be an office, component, or unit of any other agency of the Department.” (25 U.S.C. § 1661) The Indian Health Service was created under this provision which is codified in title 25, United States Code—Indians. However it contains many references to the Secretary of Health and Human Services, includ- ing the following:

APPENDIX H 251 • “$10,000,000 shall remain available until expended, for the es- tablishment of an Indian Catastrophic Health Emergency Fund (hereinafter referred to as the ‘Fund’). On and after October 18, 1986, the Fund is to cover the Indian Health Service portion of the medical expenses of catastrophic illness falling within the re- sponsibility of the Service and shall be administered by the Sec- retary of Health and Human Services, acting through the central office of the Indian Health Service.” (25 U.S.C. § 1683. Title 25: Indians. Chapter 18: Indian Health Care. Subchapter: Miscellaneous. Indian Catastrophic Health Emergency Fund.) • “(a) Implementation; The Secretary of the Interior, acting through the Bureau of Indian Affairs, and the Secretary of Health and Human Services, acting through the Indian Health Service, shall bear equal responsibility for the implementation of this chapter in cooperation with Indian tribes.” (25 U.S.C. § 2413. Chapter 26: Indian Alcohol and Sub- stance Abuse Prevention and Treatment. Subchapter on Co- ordination of Resources and Programs. Department of responsibility.) Also see 42 U.S.C. § 1616a, which requires the Secretary, through the Indian Health Service to establish a program known as the Indian Health Service Loan Repayment Program, and 42 U.S.C. § 1621d, which requires the Secretary, acting through the [Indian Health] Service, to con- duct a study of the feasibility and desirability of funding hospice services for Indians. Substance Abuse and Mental Health Services Administration • “(d) Authorities; The Secretary, acting through the Administra- tor, shall— (1) supervise the functions of the agencies of the Admini- stration in order to assure that the programs carried out through each such agency receive appropriate and equi- table support and that there is cooperation among the agencies in the implementation of such programs;” [There follows a list of 17 instructions as to the organi-

252 HHS IN THE 21ST CENTURY zation and functions of SAMHSA.] (42 U.S.C. § 290aa. Subchapter on Substance Abuse and Mental Health Services Administration. Organization and General Authorities. Substance Abuse and Mental Health Services Administration.) • “(a) Requirement of annual collection of data on mental illness and substance abuse; The Secretary, acting through the Adminis- trator, shall collect data each year on—(1) the national inci- dence and prevalence of the various forms of mental illness and substance abuse; and (2) the incidence and prevalence of such various forms in major metropolitan areas selected by the Ad- ministrator.” (42 U.S.C. § 290aa-4. Subchapter on Substance Abuse and Mental Health Services Administration. Organization and General Authorities. Data collection.) • “(a) Establishment; (1) In general; The Secretary, acting through the Administrator of the Substance Abuse and Mental Health Services Administration, shall make grants to public and non- profit private entities for the purpose of carrying out [various] programs….” (42 U.S.C. § 290bb-25. Subchapter on Substance Abuse and Mental Health Services Administration. Center for Sub- stance Abuse Prevention. Grants for services for children of substance abusers.) • “(a) Program authorized; The Secretary, acting through the Di- rector of the Prevention Center, may make grants to public and nonprofit private entities to develop and implement model sub- stance abuse prevention programs to provide early intervention and substance abuse prevention services for individuals of high- risk families and the communities in which such individuals re- side.” (42 U.S.C. § 290bb-25a. Subchapter on Substance Abuse and Mental Health Services Administration. Centers and Programs. Center for Substance Abuse Prevention. Grants for strengthening families.) • “(a) Program authorized; The Secretary, acting through the Ad- ministrator of the Substance Abuse and Mental Health Services Administration, and in consultation with the Administrator of the Office of Juvenile Justice and Delinquency Prevention, the Di- rector of the Bureau of Justice Assistance and the Director of the

APPENDIX H 253 National Institutes of Health—(1) shall award grants or con- tracts to public or nonprofit private entities to establish not more than four research, training, and technical assistance centers to carry out the activities described in subsection (c) of this section; and (2) shall award a competitive grant to 1 additional research, training, and technical assistance center to carry out the activities described in subsection (d) of this section.” (42 U.S.C. § 290bb-34. Subchapter on Substance Abuse and Mental Health Services Administration. Centers and Pro- grams. Center for Mental Health Services. Youth inter- agency research, training, and technical assistance centers.) • “In general; The Secretary, acting through the Director of the Center for Mental Health Services, and in consultation with the Director of the Center for Substance Abuse Treatment, the Ad- ministrator of the Office of Juvenile Justice and Delinquency Prevention, and the Director of the Special Education Programs, shall award grants on a competitive basis to State or local juve- nile justice agencies to enable such agencies to provide aftercare services for youth offenders who have been discharged from fa- cilities in the juvenile or criminal justice system and have serious emotional disturbances or are at risk of developing such distur- bances.” (42 U.S.C. § 290bb-35. Subchapter on Substance Abuse and Mental Health Services Administration. Centers and Pro- grams. Center for Mental Health Services. Services for youth offenders.) • “(a) In general; The Secretary, acting through the Administrator of the Substance Abuse and Mental Health Services Administra- tion, shall award grants or cooperative agreements to eligible entities to—[carry out various activities with respect to youth suicide prevention].” (42 U.S.C. § 290bb-36. Subchapter on Substance Abuse and Mental Health Services Administration. Centers and Pro- grams. Center for Mental Health Services. Youth suicide early intervention and prevention strategies.) • “For the purpose of carrying out section 290cc-22 of this title, the Secretary, acting through the Director of the Center for Men- tal Health Services, shall for each of the fiscal years 1991 through 1994 make an allotment for each State in an amount de- termined in accordance with section 290cc-24 of this title. The

254 HHS IN THE 21ST CENTURY Secretary shall make payments, as grants, each such fiscal year to each State from the allotment for the State if the Secretary ap- proves for the fiscal year involved an application submitted by the State pursuant to section 290cc-29 of this title.” (42 U.S.C. § 290cc-21. Subchapter on Substance Abuse and Mental Health Services Administration. Projects for Assis- tance in Transition from Homelessness. Formula grants to States.) • “(a) Programs and services; (1) Development; The Secretary, acting through the Administrator of the Substance Abuse and Mental Health Services Administration, shall be responsible for fostering substance abuse prevention and treatment programs and services in State and local governments and in private indus- try. (2) Model programs; (A) In general; Consistent with the re- sponsibilities described in paragraph (1), the Secretary, acting through the Administrator of the Substance Abuse and Mental Health Services Administration, shall develop a variety of model programs suitable for replication on a cost-effective basis in dif- ferent types of business concerns and State and local governmen- tal entities. (B) Dissemination of information; The Secretary, acting through the Administrator of the Substance Abuse and Mental Health Services Administration, shall disseminate infor- mation and materials relative to such model programs to the State agencies responsible for the administration of substance abuse prevention, treatment, and rehabilitation activities and shall, to the extent feasible provide technical assistance to such agencies as requested.” (42 U.S.C. § 290dd. Subchapter on Substance Abuse and Mental Health Services Administration. Miscellaneous Pro- visions Relating to Substance Abuse and Mental Health. Substance abuse among government and other employees.) • “(a) Grants to certain public entities; (1) In general; The Secre- tary, acting through the Director of the Center for Mental Health Services, shall make grants to public entities for the purpose of providing comprehensive community mental health services to children with a serious emotional disturbance.” (42 U.S.C. § 290ff. Subchapter on Substance Abuse and Mental Health Services Administration. Children with Seri- ous Emotional Disturbances. Comprehensive community mental health services for children with serious emotional

APPENDIX H 255 disturbances.) • “In general; For the purpose described in subsection (b) of this section, the Secretary, acting through the Director of the Center for Mental Health Services, shall make an allotment each fiscal year for each State in an amount determined in accordance with section 300x-7 of this title. The Secretary shall make a grant to the State of the allotment made for the State for the fiscal year if the State submits to the Secretary an application in accordance with section 300x-6 of this title.” (42 U.S.C. § 300x. Subchapter on Block Grants Regarding Mental Health and Substance Abuse. Block Grants for Community Mental Health Services. Formula grants to states.) • “(a) In general; For the purpose described in subsection (b) of this section, the Secretary, acting through the Center for Sub- stance Abuse Treatment, shall make an allotment each fiscal year for each State in an amount determined in accordance with section 300x-33 of this title. The Secretary shall make a grant to the State of the allotment made for the State for the fiscal year if the State submits to the Secretary an application in accordance with section 300x-32 of this title.” (42 U.S.C. § 300x-21. Subchapter on Block Grants Regard- ing Mental Health and Substance Abuse. Block Grants for Prevention and Treatment of Substance Abuse. Formula grants to States.) • “(b) State plan; (3) Authority of center for substance abuse pre- vention; With respect to plans submitted by the States under sub- section (a)(6) of this section, the Secretary, acting through the Director of the Center for Substance Abuse Prevention, shall re- view and approve or disapprove the provisions of the plans that relate to prevention activities.” (42 U.S.C. § 300x-32. Subchapter on Block Grants Regard- ing Mental Health and Substance Abuse. Block Grants for Prevention and Treatment of Substance Abuse. Application for grant; approval of State plan.) • “(b) Allocations for technical assistance, national data base, data collection, and program evaluations; (2) Activities of center for substance abuse prevention; Of the amounts reserved under paragraph (1) for a fiscal year, the Secretary, acting through the Director of the Center for Substance Abuse Prevention, shall ob-

256 HHS IN THE 21ST CENTURY ligate 20 percent for carrying out paragraph (1)(C), section 300x- 58(a) of this title with respect to prevention activities, and section 290bb-21(d) of this title.” (42 U.S.C. § 300x-35. Subchapter on Block Grants Regard- ing Mental Health and Substance Abuse. Block Grants for Prevention and Treatment of Substance Abuse. Funding.) Health Resources and Services Administration • “(a) Training; The Secretary of Health and Human Services, act- ing through the Administrator of the Health Resources and Ser- vices Administration and in collaboration with the Administrator of the Centers for Medicare & Medicaid Services and the Direc- tor of the Centers for Disease Control and Prevention, shall conduct education and training programs for physicians and other health care providers regarding childhood lead poisoning, current screening and treatment recommendations and require- ments, and the scientific, medical, and public health basis for those policies.” (42 U.S.C. § 247b-3a. Subchapter on General Powers and Duties. Federal-State Cooperation. Training and reports by the health resources and services administration.) • “(c) Statewide newborn and infant hearing screening, evaluation and intervention programs and systems; Under the existing au- thority of the Public Health Service Act [42 U.S.C.A. § 201 et seq.], the Secretary of Health and Human Services (in this sec- tion referred to as the ‘Secretary’), acting through the Adminis- trator of the Health Resources and Services Administration, shall make awards of grants or cooperative agreements to de- velop statewide newborn and infant hearing screening, evalua- tion and intervention programs and systems for the following purposes”: [To develop and monitor the efficacy of statewide newborn and infant hearing screening, evaluation and intervention programs and systems]. (42 U.S.C. § 247b-4a. Subchapter on General Powers and Duties. Federal-State Cooperation. Early detection, diagno-

APPENDIX H 257 sis, and interventions for newborns and infants with hearing loss.) • “(a) In general; The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall es- tablish a program to fund innovative oral health activities that improve the oral health of children under 6 years of age who are eligible for services provided under a Federal health program, to increase the utilization of dental services by such children, and to decrease the incidence of early childhood and baby bottle tooth decay.” (42 U.S.C. § 247d-8. Subchapter on General Powers and Du- ties. Federal-State Cooperation. Coordinated program to im- prove pediatric oral health.) • “(6) Participation of certain eligible health clinics; (C) Not later than 1 year after October 17, 2000, the Secretary shall submit to the appropriate committees of the Congress a report evaluating the extent to which adoption information and referral, upon re- quest, are provided by eligible health centers. . . . The reports re- quired by this subparagraph shall be conducted by the Secretary acting through the Administrator of the Health Resources and Services Administration and in collaboration with the Director of the Agency for Healthcare Research and Quality.” (42 U.S.C. § 247b-3a. Subchapter on General Powers and Duties. Federal-State Cooperation. Training and reports by the Health Resources and Services Administration.) • “(c) Statewide newborn and infant hearing screening, evaluation and intervention programs and systems; Under the existing au- thority of the Public Health Service Act [42 U.S.C.A. § 201 et seq.], the Secretary of Health and Human Services (in this sec- tion referred to as the ‘Secretary’), acting through the Adminis- trator of the Health Resources and Services Administration, shall make awards of grants or cooperative agreements to de- velop statewide newborn and infant hearing screening, evalua- tion and intervention programs and systems for the following purposes….” (42 U.S.C. § 247b-4a. Subchapter on General Powers and Duties. Federal-State Cooperation. Early detection, diagno- sis, and interventions for newborns and infants with hearing loss.) • “(a) In general; The Secretary, acting through the Administrator

258 HHS IN THE 21ST CENTURY of the Health Resources and Services Administration, shall es- tablish a program to fund innovative oral health activities that improve the oral health of children under 6 years of age who are eligible for services provided under a Federal health program, to increase the utilization of dental services by such children, and to decrease the incidence of early childhood and baby bottle tooth decay.” (42 U.S.C. § 247d-8. Subchapter on General Powers and Du- ties. Federal-State Cooperation. Coordinated program to im- prove pediatric oral health.) • “(a) In general; (1) Continuation and expansion of program; The Secretary, acting through the Administrator of the Health Re- sources and Services Administration, Maternal and Child Health Bureau, shall under authority of this section continue in effect the Healthy Start Initiative and may, during fiscal year 2001 and subsequent years, carry out such program on a national basis.” (42 U.S.C. § 254c-8. Subchapter on General Powers and Du- ties. Primary Health Care. Health Centers. Healthy Start for infants.) • “(a) Grants; The Secretary, acting through the Administrator of the Health Resources and Services Administration (referred to in this section as the ‘Secretary’) shall award grants to eligible en- tities to enable such entities to provide for improved emergency medical services in rural areas.” (42 U.S.C. § 254c-15. Subchapter on General Powers and Duties. Primary Health Care. Health Centers. Rural emer- gency medical service training and equipment assistance program.) • “(3) Annual reporting required; (D) Report to Congress; Not later than the end of fiscal year 2011, the Secretary, acting through the Administrator of the Health Resources and Services Administration, shall submit a report to the Congress—(i) sum- marizing the information submitted in reports to the Secretary under subparagraph (B); (ii) describing the results of the pro- gram carried out under this section; and (iii) making recommen- dations for improvements to the program.” (42 U.S.C. § 256e. Subchapter on General Powers and Du- ties. Primary Health Care. Support of Graduate Medical Education Programs in Children’s Hospitals. Program of payments to children’s hospitals that operate graduate medi-

APPENDIX H 259 cal education programs.) • “(a) Establishment; The Secretary, acting through the Adminis- trator of the Health Resources and Services Administration, shall by one or more contracts establish and maintain a C.W. Bill Young Cell Transplantation Program (referred to in this sec- tion as the ‘Program’), successor to the National Bone Marrow Donor Registry, that has the purpose of increasing the number of transplants for recipients suitably matched to biologically unre- lated donors of bone marrow and cord blood, and that meets the requirements of this section.” (42 U.S.C. § 274k. Subchapter on General Powers and Du- ties. General Powers and Duties. C.W. Bill Young Cell Transplantation Program. National program.) • “(a) In general; The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall make not less than 5, and not more than 20, grants to States for the purpose of assisting grantees in carrying out demonstration pro- jects—(1) to identify low-income individuals who can avoid in- stitutionalization or prolonged hospitalization if skilled medical services, skilled nursing care services, homemaker or home health aide services, or personal care services are provided in the homes of the individuals; (2) to pay the costs of the provision of such services in the homes of such individuals; and (3) to coor- dinate the provision by public and private entities of such ser- vices, and other long-term care services, in the homes of such individuals.” (42 U.S.C. § 280c. Subchapter on General Powers and Du- ties. Health Care Services in the Home. Grants for Demon- stration Projects. Establishment of program.) • “(a) In general; (1) Establishment of program; The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall make grants to eligible entities to pay the Federal share of the cost of providing the services speci- fied in subsection (b) of this section to families in which a mem- ber is—(A) a pregnant woman at risk of delivering an infant with a health or developmental complication; or (B) a child less than 3 years of age—(i) who is experiencing or is at risk of a health or developmental complication, or of child abuse or neglect; or (ii) who has been prenatally exposed to maternal substance abuse.” (42 U.S.C. § 280c-6. Subchapter on General Powers and Du-

260 HHS IN THE 21ST CENTURY ties. Health Care Services in the Home. Grants for Home Visiting Services for at-Risk Families. Projects to improve maternal, infant, and child health.) • “(a) Statewide newborn and infant hearing screening, evaluation and intervention programs and systems; The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall make awards of grants or cooperative agreements to develop statewide newborn and infant hearing screening, evaluation and intervention programs and systems for the following purposes”: (42 U.S.C. § 280g-1. Subchapter on General Powers and Du- ties. Additional Programs. Early detection, diagnosis, and treatment regarding hearing loss in infants.) • “Grants; The Secretary, acting through the Director of the Health Resources and Services Administration, shall award grants under this section to develop interdisciplinary training and education programs that provide undergraduate, graduate, post- graduate medical, nursing (including advanced practice nursing students), and other health professions students with an under- standing of, and clinical skills pertinent to, domestic violence, sexual assault, stalking, and dating violence.” (42 U.S.C. § 294h. Subchapter on Health Professions Educa- tion. Interdisciplinary training and education on domestic violence and other types of violence and abuse.) • “(f) Peer review regarding certain programs; (3) Administration; This subsection shall be carried out by the Secretary acting through the Administrator of the Health Resources and Services Administration.” (42 U.S.C. § 295o-1. Subchapter on Health Professions Edu- cation. General Provisions. Generally applicable provisions.) • “(e) Peer review regarding certain programs; (3) Administration; This subsection shall be carried out by the Secretary acting through the Administrator of the Health Resources and Services Administration.” (42 U.S.C. § 296e. Subchapter on Nursing Workforce De- velopment. General Provisions. Generally applicable provi- sions.) • “(a) Authorization of grant program; From amounts appropriated under subsection (j) of this section, the Secretary, acting through the Administrator of the Health Resources and Services Admini-

APPENDIX H 261 stration (referred to in this section as the ‘Administrator’) and in consultation with the Advisory Committee on Heritable Disor- ders in Newborns and Children (referred to in this section as the ‘Advisory Committee’), shall award grants to eligible entities to enable such entities—[to carry out various activities to enhance, improve or expand the ability of State and local public health agencies to provide screening, counseling, or health care services to newborns and children having or at risk for heritable disor- ders].” (42 U.S.C. § 300b-8. Subchapter on Genetic Diseases, He- mophilia Programs, and Sudden Infant Death Syndrome. Genetic Diseases. Improved newborn and child screening for heritable disorders.) • “(a) In general; The Secretary, acting through the Administrator of the Health Resources and Services Administration (referred to in this part as the ‘Administrator’), in consultation with the Di- rector of the Centers for Disease Control and Prevention and the Director of the National Institutes of Health, shall establish and maintain a central clearinghouse of current educational and fam- ily support and services information, materials, resources, re- search, and data on newborn screening. . . .” (42 U.S.C. § 300b-11. Subchapter on Genetic Diseases, He- mophilia Programs, and Sudden Infant Death Syndrome. Genetic Diseases. Clearinghouse of newborn screening in- formation.) • “(a) In general; The Secretary, acting through the Administrator of the Health Resources and Services Administration (referred to in this section as the ‘Administrator’), shall make grants to pro- tection and advocacy systems for the purpose of enabling such systems to provide services to individuals with traumatic brain injury.” (42 U.S.C. § 300d-53. Subchapter on Trauma Care. Miscel- laneous Programs. State grants for protection and advocacy services.) • “(a) Eligible areas; The Secretary, acting through the Adminis- trator of the Health Resources and Services Administration, shall, subject to subsections (b) through (c) of this section, make grants in accordance with section 300ff-13 of this title for the purpose of assisting in the provision of the services specified in section 300ff-14 of this title in any metropolitan area for which

262 HHS IN THE 21ST CENTURY there has been reported to and confirmed by the Director of the Centers for Disease Control and Prevention a cumulative total of more than 2,000 cases of AIDS during the most recent period of 5 calendar years for which such data are available.” (42 U.S.C. § 300ff-11. Subchapter on HIV Health Care Ser- vices Program. Emergency Relief for Areas with Substantial Need for Services. General Grant Provisions. Establishment of program of grants.) • “(a) In general; The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall make grants for the purpose of providing services described in section 300ff-14 of this title in transitional areas, subject to the same provisions regarding the allocation of grant funds as apply under subsection (c) of such section.” (42 U.S.C. § 300ff-19. Subchapter on HIV Health Care Ser- vices Program. Emergency Relief for Areas with Substantial Need for Services. Traditional Grants. Establishment of pro- gram.) • “(a) In general; The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall award grants to public and nonprofit private entities (including a health facility operated by or pursuant to a contract with the In- dian Health Service) for the purpose of providing family- centered care involving outpatient or ambulatory care (directly or through contracts) for women, infants, children, and youth with HIV/AIDS.” (42 U.S.C. § 300ff-71. Subchapter on HIV Health Care Ser- vices Program. Women, Infants, Children, and Youth. Grants for coordinated services and access to research for women, infants, children, and youth.)

I Committee and Staff Biographies Leonard D. Schaeffer, Chair, is currently chairman of the board of Surgical Care Affiliates, LLC, and a senior adviser for Texas Pacific Group, a private equity firm. Mr. Schaeffer is the founding chairman of the Board of Directors of WellPoint Inc., the largest health benefits com- pany in the United States. From 1992 through 2004, he was chairman and chief executive officer (CEO) of WellPoint Health Networks Inc. Mr. Schaeffer was the administrator of the U.S. Health Care Financing Administration from 1978 to 1980 and has served in a variety of posi- tions in state and federal government. He is the Judge Robert Maclay Widney Chair and Professor at the University of Southern California, is a member of the Institute of Medicine (IOM), and is on the board of the Brookings Institution and several public and private corporations. David W. Beier, J.D., is senior vice president of global government and corporate affairs for Amgen. In this role, he is responsible for shaping Amgen’s policy on global health care issues; driving health economics and outcomes research; overseeing corporate communications and phi- lanthropy; and managing relationships with U.S. federal and state agen- cies and legislatures, as well as international governmental entities and organizations. Mr. Beier joined Amgen from the international law firm of Hogan & Hartson where, as a partner, he utilized his extensive back- ground in business and government to represent trade associations and biotechnology, pharmaceutical, and health care companies. Mr. Beier previously served as chief domestic policy adviser to Vice President Al Gore. Before his White House service, Mr. Beier served as vice president of government affairs and public policy for Genentech and staff counsel 263

264 HHS IN THE 21ST CENTURY in the U.S. House of Representatives. He received a B.A. from Colgate University and his J.D. from Albany Law School. Kathleen Buto, M.P.A., is vice president for health policy, government affairs, at Johnson & Johnson (J&J). She has responsibility for providing policy analysis and developing positions on a wide range of issues, in- cluding the Medicare drug benefit, government reimbursement, coverage of new technologies, and regulatory requirements. In addition to review- ing how federal, state, and international government policies affect J&J products and customers, she is responsible for helping to identify areas of opportunity for J&J to take leadership in shaping health care policy. Prior to joining J&J, Kathy was a senior health adviser at the Congressional Budget Office, helping to develop the cost models for the Medicare drug benefit. Before that, she spent more than 18 years in senior positions at the Health Care Financing Administration, including deputy director, Center for Health Plans and Providers, and associate administrator for policy. In these positions, she headed the policy, reimbursement, and coverage functions for the agency, as well as managing Medicare’s fee- for-service and managed care operations. Ms. Buto received her bachelor of arts from Douglass College and her master’s in public administration from Harvard University. Molly Joel Coye, M.D., is founder and CEO of the Health Technology Center (HealthTech), a nonprofit education and research organization established in 2000 to advance the use of beneficial technologies in pro- moting healthier people and communities. Dr. Coye is vice chair of the Board of Directors of the Program for Appropriate Technology in Health, one of the largest and most innovative nonprofit organizations working in international health; a member of the Board of Directors of Aetna, Inc.; and a member of the Advisory Council for the Health Evolu- tion Partners Innovation Network and the Institute of Medicine. Dr. Coye has served as commissioner of health for the State of New Jersey and director of the California Department of Health Services; head of the Di- vision of Public Health at the Johns Hopkins School of Hygiene and Pub- lic Health; executive vice president for HealthDesk Corp. and the Good Samaritan Health System in San Jose, California; and director of the Lewin Group West Coast office. She has served on the Board of Trustees of the American Hospital Association and the American Public Health Association, the Board of Directors of the California Endowment, and

APPENDIX I 265 the China Medical Board, and as a member of the National Academy of Public Administration. Robert Graham, M.D., is professor of family medicine, and the Robert and Myfanwy Smith Chair in the Department of Family Medicine at the University of Cincinnati, School of Medicine, a position he has held since March of 2005. Dr. Graham has previously been associated with the discipline of family medicine as the executive vice president-CEO of the American Academy of Family Physicians (1985–2000), the head of the Academy’s Foundation (1988–1997), and the administrative officer of the Society of Teachers of Family Medicine (1973–1975). In addition to his activities in family medicine, Dr. Graham has held a number of leadership responsibilities in the federal health sector, including the posi- tion of administrator of the Health Resources and Services Administra- tion (HRSA) (1981–1985), during which time he held the rank of rear admiral in the Commissioned Corps of the U.S. Public Health Service and served as an assistant surgeon general. He also served in senior posi- tions at the Agency for Healthcare Research and Quality (2001–2004), HRSA (1976–1979), and the Health Services and Mental Health Admini- stration (1970–1973). From 1979–1980, he served as a professional staff member of the U.S. Senate Subcommittee on Health. Mark B. McClellan, M.D., Ph.D., is the director of the Engelberg Cen- ter for Health Care Reform at the Brookings Institution. McClellan is also the Leonard D. Schaeffer Chair in Health Policy. Dr. McClellan has a highly distinguished record in public service and in academic research. He is the former administrator for the Centers for Medicare and Medi- caid Services (2004–2006) and the former commissioner of the Food and Drug Administration (2002–2004). He also served as a member of the President’s Council of Economic Advisers and senior director for health care policy at the White House (2001–2002). In the Clinton administra- tion, Dr. McClellan was deputy assistant secretary of the treasury for economic policy from 1998–1999, supervising economic analysis and policy development on a range of domestic policy issues. Dr. McClellan was also an associate professor of economics and associate professor of medicine (with tenure) at Stanford University, from which he was on leave during his government service. He directed Stanford’s Program on Health Outcomes Research and was also associate editor of the Journal of Health Economics, and coprincipal investigator of the Health and Re- tirement Study, a longitudinal study of the health and economic status of

266 HHS IN THE 21ST CENTURY older Americans. A graduate of the University of Texas at Austin, Dr. McClellan earned his M.P.A. from Harvard’s Kennedy School of Gov- ernment in 1991, his M.D. from the Harvard-Massachusetts Institute of Technology (MIT) Division of Health Sciences and Technology in 1992, and his Ph.D. in economics from MIT in 1993. He completed his resi- dency training in internal medicine at Brigham and Women’s Hospital, Boston. Dr. McClellan has been board certified in internal medicine and has been a practicing internist during his academic career. Stanley B. Prusiner, M.D., is the director of the Institute for Neurode- generative Diseases at the University of California, San Francisco (UCSF). Dr. Prusiner discovered prions, a class of infectious self- reproducing pathogens primarily or solely composed of protein. For his prion research he received the Albert Lasker Award for Basic Medical Research in 1994 and the Nobel Prize in physiology or medicine in 1997. He received a bachelor of science degree in chemistry from the Univer- sity of Pennsylvania and later received his M.D. from the University of Pennsylvania School of Medicine. He then completed an internship in medicine at UCSF. Later he moved to the National Institutes of Health (NIH), where he studied glutaminases in Escherichia coli in the labora- tory of Earl Stadtman. After three years at NIH, Dr. Prusiner returned to UCSF to complete a residency in neurology. Upon completion of the residency in 1974, he joined the faculty of the UCSF Neurology Depart- ment. Since that time, he has held various faculty and visiting faculty positions at both UCSF and UC Berkeley. Dr. Prusiner won the Nobel Prize in physiology or medicine in 1997 for his discovery of prions—a new biological principle of infection. He coined the term prion, which comes from “proteinaceous infectious particle” to refer to a previously undescribed form of infection due to protein misfolding. He was elected to the National Academy of Sciences in 1992 and to its governing coun- cil in 2007. He is also an elected member of the American Academy of Arts and Sciences (1993), the Royal Society (1996), the American Phi- losophical Society (1998), the Serbian Academy of Sciences and Arts (2003), and the Institute of Medicine. Donna E. Shalala, Ph.D., became professor of political science and president of the University of Miami on June 1, 2001. President Shalala has more than 25 years of experience as an accomplished scholar, teacher, and administrator. Born in Cleveland, Ohio, President Shalala received her A.B. in history from Western College for Women and her

APPENDIX I 267 Ph.D. from the Maxwell School of Citizenship and Public Affairs at Syracuse University. A leading scholar on the political economy of state and local governments, she has also held tenured professorships at Co- lumbia University, the City University of New York (CUNY), and the University of Wisconsin–Madison. She served as president of Hunter College of CUNY from 1980 to 1987 and as chancellor of the University of Wisconsin–Madison from 1987 to 1993. In 1993, President Clinton appointed her secretary of the Department of Health and Human Services (HHS), where she served for eight years, becoming the longest-serving HHS secretary in U.S. history. Stephen M. Shortell, Ph.D., M.P.H., is the Blue Cross of California Distinguished Professor of Health Policy and Management and professor of organization behavior at the University of California, Berkeley, and is dean of the School of Public Health. Dr. Shortell is known as a leading academic voice advocating reform of the nation’s health system. His re- search has helped establish determinants of health outcomes and quality of care for health care organizations. As the Blue Cross of California Distinguished Professor of Health Policy and Management, Shortell holds a joint appointment at University of California (UC) Berkeley’s School of Public Health and the Haas School of Business. He also is af- filiated with UC Berkeley’s Department of Sociology and UC San Fran- cisco’s Institute for Health Policy Studies. Dr. Shortell has received the Baxter-Allegiance Prize, considered the highest honor worldwide in the field of health services research. He also has received the Distinguished Investigator Award from the Association for Health Services Research and the Gold Medal from the American College of Healthcare Execu- tives for his contributions to the field. Dr. Shortell received his bache- lor’s degree from the University of Notre Dame, his master’s degree in public health from the University of California at Los Angeles, and his Ph.D. in behavioral science from the University of Chicago. Before com- ing to UC Berkeley in 1998, Dr. Shortell held teaching and research posi- tions at Northwestern University, the University of Washington, and the University of Chicago. Susanne A. Stoiber, M.P.A., M.S., is currently consulting with the Commonwealth Fund High Performance Health Care System project. Previously, she has served in a series of senior positions in the National Academies and the U.S. Department of Health and Human Services from 1975 through 2007. She was named executive director (chief operating

268 HHS IN THE 21ST CENTURY officer) of the Institute of Medicine in 1998. Her responsibilities in- cluded management of IOM program operations and support of the Insti- tute’s governance and membership functions. In the Department of Health and Human Services, Ms. Stoiber held a number of senior posi- tions in the Office of the Secretary and at the National Institutes of Health. She was three times appointed as a deputy assistant secretary for health—planning and evaluation (1979 and 1995); health promotion and disease prevention (1996); and deputy assistant secretary for planning and evaluation, program systems (1997). Her accomplishments included coordination of Healthy People 2010—the nation’s prevention agenda, and oversight of the department’s evaluation program and Government Performance and Results Act–related strategic planning. She received her bachelor of arts and master of public administration degrees from the University of Colorado, and a master of science degree from the London School of Economics. Louis W. Sullivan, M.D., is the founding dean and first president of the Morehouse School of Medicine (MSM). With the exception of his tenure as secretary of the U.S. Department of Health and Human Services from 1989 to 1993, he was president of MSM for more than two decades. On July 1, 2002, he left the presidency, but continues to assist in national fundraising activities on behalf of the school. A native of Atlanta, Geor- gia, Dr. Sullivan graduated magna cum laude from Morehouse College in 1954 and earned his medical degree cum laude from Boston University School of Medicine in 1958. He is certified in internal medicine and he- matology. In 1975, Dr. Sullivan became the founding dean and director of the medical education program at Morehouse College. In 1989, he accepted an appointment by President George H. W. Bush to head HHS. In this post, Sullivan managed the federal agency responsible for the ma- jor health, welfare, food and drug safety, medical research, and income security programs serving the American people. In January 1993, he re- turned to MSM and resumed the office of president. A member of nu- merous medical organizations, including the American Medical Association and the National Medical Association, Dr. Sullivan was the founding president of the Association of Minority Health Professions Schools. He is a former member of the Joint Committee on Health Policy of the Association of American Universities and the national Association of Land Grant Colleges and Universities. He was a member of the Sulli- van Commission on the Future of Higher Education (2007) and chairman of the Sullivan Commission on Diversity in the Healthcare Workforce

APPENDIX I 269 (2003–2004). He is chairman of the Sullivan Alliance to Transform the Health Professions and is chairman of the National Health Museum. David N. Sundwall, M.D., is a primary care physician who has more than two decades of experience in public policy and service. After 23 years of working in various government and private-sector health posi- tions in Washington, DC, he has returned home to lead the Utah Depart- ment of Health. He currently serves as president of the Association of State and Territorial Health Officers. Dr. Sundwall earned his medical degree at the University of Utah College of Medicine and completed fur- ther training at the Harvard Family Medicine Residency Program. He remains on the faculty of the University of Utah School of Medicine as associate professor in the Department of Family and Preventive Medi- cine. In a distinguished career of academic appointments, public service, and policy development, Dr. Sundwall has been widely recognized for his professional achievements and contributions to health care policy and advocacy. He holds three medical school faculty appointments, including clinical associate professor, Department of Community and Family Medicine, Georgetown University College of Medicine, Washington, DC. He has held numerous positions in the public health sector: From 1994 to 2004, he was president of the American Clinical Laboratory As- sociation; from 1988 to 1994, he was vice president and medical director of American Healthcare Systems, an alliance of not-for-profit multihos- pital systems. Prior to that appointment, he was an administrator in the Health Resources and Services Administration. Dr. Sundwall has served as an adviser, task force member, and chairman of numerous committees involved with public health policy and quality, including those connected with the Centers for Disease Control and Prevention and the Food and Drug Administration. In addition, his federal experience included serving as the assistant surgeon general in the Commissioned Corps of the U.S. Public Health Service. During this period, he had adjunct responsibilities at the Department of Health and Human Services (HHS), including co- chairman of the HHS secretary’s Task Force on Medical Liability and Malpractice, and was the HHS secretary’s designee to the National Commission to Prevent Infant Mortality. Gail L. Warden, serves as president emeritus of the Detroit-based Henry Ford Health System and served as its president and CEO from April 1988 to 2003. Prior to this role, Mr. Warden served as president and CEO of Group Health Cooperative of Puget Sound as well as executive

270 HHS IN THE 21ST CENTURY vice president of the American Hospital Association. He serves as a di- rector of Picker Institute Inc. He has been a director of National Research Corp. since January 2005. He served as a director of Comerica Inc. from July 2000 to December 31, 2006. Mr. Warden serves in numerous lead- ership positions as chairman of several national health care committees and as board member for many other health care–related committees and institutions. In addition, he is a professor of health management and pol- icy for the University of Michigan School of Public Health. He serves the Detroit, Michigan, community through memberships on various local governing committees and groups. Mr. Warden received an honorary doctorate in public administration from Central Michigan University and an honorary doctorate of humane letters from Rosalind Franklin Univer- sity of Medicine and Science; a master of hospital administration from the University of Michigan; and a bachelor of arts from Dartmouth Col- lege. Myrl Weinberg, M.A., is president of the National Health Council, the only organization of its kind that brings together all segments of the health care community to provide a united voice for 100 million people with chronic diseases and disabilities and their family caregivers. Made up of 120 national health-related organizations, its core membership in- cludes 50 of the nation’s leading patient advocacy groups. Ms. Weinberg has served on the health sciences policy board of the Institute of Medi- cine, the board of the AcademyHealth Coalition for Health Services Re- search, as a founding member of the Association for the Accreditation of Human Research Protection Programs, and is chair of the governing board of the International Alliance of Patients’ Organizations. She also served on the congressionally mandated IOM committee created to as- sess how research priorities are established at the National Institutes of Health (NIH) and was a member of the National Research Council- Institute of Medicine committee on the organizational structure of NIH. Ms. Weinberg earned a bachelor’s degree in psychology at the Univer- sity of Arkansas and a master’s degree in special education at George Peabody College. Catherine E. Woteki, Ph.D., is global director of scientific affairs for Mars, Inc., a multinational food, confectionery, and pet care company. She joined Mars, Inc., in August 2005 and, in this role, manages the company’s scientific and regulatory positions on matters of health, nutri- tion, and food safety. Prior to joining Mars, Inc., Dr. Woteki held posi-

APPENDIX I 271 tions in academia and government. From 2002 to 2005, she was dean of agriculture and professor of human nutrition at Iowa State University. From 1997 to 2001, she served as the first undersecretary for food safety at the U.S. Department of Agriculture (USDA), overseeing the Food Safety and Inspection Service and the U.S. government’s Office for the Codex Alimentarius Commission, and coordinating U.S. government food safety policy development and USDA’s continuity of operations planning. She also worked for two years in the White House Office of Science and Technology Policy, where she coauthored the Clinton ad- ministration’s science policy statement “Science in the Public Interest,” and served as the deputy undersecretary for research in USDA. Dr. Woteki is a nutritional epidemiologist, and her research interests include nutrition and food safety policy, risk assessment, and health survey de- sign and analysis. Staff Biographies Judith A. Salerno, M.D., M.S., is executive officer of the Institute of Medicine of the National Academies. Dr. Salerno served as deputy direc- tor of the National Institute on Aging (NIA) at the National Institutes of Health from 2001 to 2007, where she had oversight of more than $1 bil- lion in aging research conducted and supported annually by the NIA, including research on Alzheimer’s and other neurodegenerative diseases; frailty and function in late life; and the social, behavioral, and demo- graphic aspects of aging. A geriatrician, Dr. Salerno is vitally interested in improving the health and well-being of older persons, and has de- signed public-private initiatives to address aging stereotypes, novel ap- proaches to support training of new investigators in aging, and award- winning programs to communicate health and research advances to the public. Before joining the NIA in 2001, Dr. Salerno directed the contin- uum of geriatrics and extended care programs across the country for the U.S. Department of Veterans Affairs (VA), Washington, DC. While at the VA, she launched widely recognized national initiatives for pain management and improving end-of-life care and directed a national pro- gram of geriatric and long-term care services of more than $3 billion an- nually. Dr. Salerno earned her M.D. degree from Harvard Medical School in 1985 and a master of science degree in health policy from the Harvard School of Public Health in 1976. She also holds a certificate of added qualifications in geriatric medicine and was associate clinical pro-

272 HHS IN THE 21ST CENTURY fessor of health care sciences and of medicine at the George Washington University until 2001. Andrea M. Schultz, M.P.H., is an associate program officer in the Ex- ecutive Office of the Institute of Medicine. Ms. Schultz joined the IOM Board on Health Sciences Policy in 2004 where she worked on a number of reports, including Genes, Behavior, and the Social Environment: Mov- ing Beyond the Nature/Nurture Debate; Reusability of Facemasks Dur- ing an Influenza Pandemic: Facing the Flu; Organ Donation: Opportunities for Action; and Cord Blood: Establishing a National He- matopoietic Stem Cell Bank Program. In 2006 she moved to the IOM’s Executive Office and Office of Reports and Communications where she provided health policy research support on a variety of issues for the IOM president and executive officer, coordinated an effort to collect and catalog impact data on IOM reports, and helped lead the IOM’s Quality Improvement effort. Currently Ms. Schultz is working with the IOM’s Committee on Improving the Organization of the U.S. Department of Health and Human Services to Advance the Health of Our Population. She received her M.P.H. in health policy with honors in August 2007 from George Washington University. Her capstone project analyzed key state-level health care reform initiatives. Ms. Schultz received her B.S. in cellular molecular biology from the University of Michigan in 2004. Katharine Bothner is a research associate in the Institute of Medicine’s Executive Office. She began working with the IOM in October 2006 as a senior program assistant with the Roundtable on Evidence-Based Medi- cine. She received a B.S. in chemistry with high distinction from the University of Virginia in 2004. With a focus in biochemistry, she con- ducted her thesis research on a cytostatic cancer therapy involving cal- cium channels. After completing her undergraduate studies, Ms. Bothner taught high school science for two years in Baltimore, Maryland, with Teach for America. More than 70 percent of her biology students passed the Maryland High School Assessment test, a figure nearly twice the city average. Amy Packman is the administrative assistant for the Board on Health Sciences Policy. She previously served as a senior project assistant for the Clinical Research Roundtable. Prior to joining the IOM, she worked as a project manager for a medical education and publishing firm in

APPENDIX I 273 Washington, DC. She graduated from Whitman College in Walla Walla, Washington, with a B.A. in biology. Judith L. Estep is a program associate with the Board on Health Sci- ences Policy. She has worked at the National Academies-Institute of Medicine since 1986 and has provided administrative support for more than 56 published reports. Her interests outside the Institute of Medicine include family (13 grandchildren), reading, needlework, 4-wheeling, and working her draft horses for competition.

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The U.S. Department of Health and Human Services (HHS) profoundly affects the lives of all Americans. Its agencies and programs protect against domestic and global health threats, assure the safety of food and drugs, advance the science of preventing and conquering disease, provide safeguards for America's vulnerable populations, and improve health for everyone. However, the department faces serious and complex obstacles, chief among them rising health care costs and a broadening range of health challenges. Over time, additional responsibilities have been layered onto the department, and other responsibilities removed, often without corresponding shifts in positions, procedures, structures, and resources.

At the request of the U.S. House of Representatives Committee on Oversight and Government Reform, HHS in the 21st Century assesses whether HHS is "ideally organized" to meet the enduring and emerging health challenges facing our nation. The committee identifies many factors that affect the department's ability to address its range of responsibilities, including divergence in the missions and goals of the department's agencies, limited flexibility in spending, impending workforce shortages, difficulty in retaining skilled professionals, and challenges in effectively partnering with the private sector.

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