Order Code RL34098
Public Health Service (PHS) Agencies:
Background and Funding
July 23, 2007
Pamela W. Smith, Coordinator,
Sarah A. Lister, Donna V. Porter, Bernice Reyes-Akinbileje,
Andrew R. Sommers, Ramya Sundararaman,
Susan Thaul, and Roger Walke
Domestic Social Policy Division

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Public Health Service (PHS) Agencies:
Background and Funding
Summary
The U.S. Public Health Service (PHS) originated in an act of July 16, 1798, that
authorized marine hospitals for the care of American merchant seamen. Over the
years, the scope and responsibilities of the act and the service have broadened. The
Public Health Service Act of July 1, 1944, revised and consolidated into one law all
legislation existing at that time relating to programs and activities of the PHS. The
act, codified at 42 U.S.C. § 201 et seq., has been amended and extended nearly every
year since 1944 and currently includes 29 titles.
The PHS Act is administered by the Department of Health and Human Services
(HHS) through eight operating agencies. Those agencies are
! the Agency for Healthcare Research and Quality (AHRQ),
! the Agency for Toxic Substances and Disease Registry (ATSDR),
! the Centers for Disease Control and Prevention (CDC),
! the Food and Drug Administration (FDA),
! the Health Resources and Services Administration (HRSA),
! the Indian Health Service (IHS),
! the National Institutes of Health (NIH), and
! the Substance Abuse and Mental Health Services Administration
(SAMHSA).
The Agency for Toxic Substances and Disease Registry is administered by the
Director of the CDC, and the two agencies are discussed together in this report.
Together, the PHS agencies administer more than 300 programs that cover a wide
spectrum of health-related activities.
Funding for the PHS agencies is provided through three different appropriations
acts. Total appropriations to these agencies for FY2007 totaled more than $49.5
billion. (This report does not yet reflect the effects of FY2007 supplemental
appropriations.)
For each of the PHS agencies, this report describes the mission, organization,
key programs, history, and legislative authorities, and provides budget tables for
FY2006 through the FY2008 request. It will be updated as legislative and other
events warrant.

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CRS Staff Contacts
Area of Expertise
Name
Phone
Public Health Service (PHS) generally
Pamela Smith
7-7048
Sarah Lister
7-7320
Agency for Healthcare Research and
Andrew Sommers
7-4624
Quality (AHRQ)
Centers for Disease Control and
Sarah Lister
7-7320
Prevention (CDC) / Agency for Toxic
Substances and Disease Registry
(ATSDR)
Food and Drug Administration (FDA)
Susan Thaul
7-0562
Donna Porter (foods)
7-7032
Health Resources and Services
Bernice Reyes-Akinbileje
7-2260
Administration (HRSA)
Indian Health Service (IHS)
Roger Walke
7-8641
National Institutes of Health (NIH)
Pamela Smith
7-7048
Substance Abuse and Mental Health
Ramya Sundararaman
7-7285
Services Administration (SAMHSA)

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Contents
Overview and History of the Public Health Service . . . . . . . . . . . . . . . . . . . . . . . 1
Agency for Healthcare Research and Quality (AHRQ) . . . . . . . . . . . . . . . . . . . . . 5
Mission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Organization and Key Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
History and Legislative Authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Centers for Disease Control and Prevention (CDC)/Agency for Toxic
Substances and Disease Registry (ATSDR) . . . . . . . . . . . . . . . . . . . . . . . . . 9
Mission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Organization and Key Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
History and Legislative Authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Food and Drug Administration (FDA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Mission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Organization and Key Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
History and Legislative Authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Health Resources and Services Administration (HRSA) . . . . . . . . . . . . . . . . . . . 20
Mission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Organization and Key Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
History and Legislative Authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Indian Health Service (IHS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Mission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Organization and Key Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
History and Legislative Authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
National Institutes of Health (NIH) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Mission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Organization and Key Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
History and Legislative Authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Substance Abuse and Mental Health Services Administration (SAMHSA) . . . . 33
Mission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Organization and Key Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
History and Legislative Authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Additional Congressional Research Service (CRS) Reports . . . . . . . . . . . . . . . . 37
Agency Overview Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Appropriations Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Links to Selected Reports on Current Legislative Issues . . . . . . . . . . . . . . . 37
List of Tables
Table 1. Titles in the Public Health Service Act . . . . . . . . . . . . . . . . . . . . . . . . . . 1

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Table 2. Public Health Service (PHS) Agency Budgets: Summary Table . . . . . . . 4
Table 3. Agency for Healthcare Research and Quality (AHRQ) . . . . . . . . . . . . . . 8
Table 4. Centers for Disease Control and Prevention (CDC)/Agency for
Toxic Substances and Disease Registry (ATSDR) . . . . . . . . . . . . . . . . . . . 13
Table 5. Food and Drug Administration (FDA) . . . . . . . . . . . . . . . . . . . . . . . . . 19
Table 6. Health Resources and Services Administration (HRSA) . . . . . . . . . . . . 23
Table 7. Indian Health Service (IHS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Table 8. National Institutes of Health (NIH) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Table 9. Substance Abuse and Mental Health Services
Administration (SAMHSA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

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Public Health Service (PHS) Agencies:
Background and Funding
Overview and History of the Public Health Service
The Public Health Service Act (PHS Act) authorizes programs for the conduct,
support, and coordination of “research, investigations, experiments, demonstrations,
and studies relating to the causes, diagnosis, treatment, control, and prevention of
physical and mental diseases and impairments of man, including water purification,
sewage treatment, and pollution of lakes and streams.”1 The Department of Health
and Human Services (HHS) is the executive branch department responsible for
carrying out the provisions of the PHS Act.
The Public Health Service originated in an act of July 16, 1798. That act
authorized marine hospitals to care for American merchant seamen. Over the years,
the scope and responsibilities of the PHS Act and the Service have broadened. The
Public Health Service Act of July 1, 1944, revised and consolidated into one law all
legislation existing at that time relating to programs and activities of the PHS. The
act has been amended and extended nearly every year since 1944 and currently
includes 29 titles. A list of titles in the act is provided in Table 1. A compilation of
the PHS Act, as amended through December 31, 2004, is available at
[http://energycommerce.house.gov/108/pubs/109_health.pdf].
Table 1. Titles in the Public Health Service Act
Title I
Short Title and Definitions
Title II
Administration and Miscellaneous Provisions
Title III
General Powers and Duties of Public Health Service
Title IV
National Research Institutes
Title V
Substance Abuse and Mental Health Services Administration
Title VI
Assistance for Construction and Modernization of Hospitals and Other
Medical Facilities
Title VII
Health Professions Education
Title VIII
Nursing Workforce Development
Title IX
Agency for Healthcare Research and Quality
Title X
Population Research and Voluntary Family Planning Programs
1 Section 301 of the PHS Act, codified at 42 U.S.C. § 241(a).

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CRS-2
Title XI
Genetic Diseases, Hemophilia Programs, and Sudden Infant Death
Syndrome
Title XII
Trauma Care
Title XIII
Health Maintenance Organizations
Title XIV
Safety of Public Water Systems
Preventive Health Measures with Respect to Breast and Cervical
Title XV
Cancers
Title XVI
Health Resources Development
Title XVII
Health Information and Health Promotion
Title XVIII
President’s Commission for the Study of Ethical Problems in Medicine
and Biomedical and Behavioral Research
Title XIX
Block Grants
Title XX
Adolescent Family Life Demonstration Projects
Title XXI
Vaccines
Title XXII
Requirements for Certain Group Health Plans for Certain State and
Local Employees
Title XXIII
Research with Respect to Acquired Immune Deficiency Syndrome
Health Services with Respect to Acquired Immune Deficiency
Title XXIV
Syndrome
Title XXV
Prevention of Acquired Immune Deficiency Syndrome
Title XXVI
HIV Health Care Services Program
Title XXVII
Assuring Portability, Availability, and Renewability of Health
Insurance Coverage
Title XXVIII
National Preparedness for Bioterrorism and Other Public Health
Emergencies
Title XXIX
Lifespan Respite Care
Sources: Compiled by CRS from U.S. House of Representatives, Committee on Energy and
Commerce, Compilation of Selected Acts Within the Jurisdiction of the Committee on Energy and
Commerce: Health Law, August 2005 [http://energycommerce.house.gov/108/pubs/109_health.pdf],
and P.L. 109-442, Lifespan Respite Care Act of 2006.
Reorganization Plan No. 3 of 1966 transferred all statutory power and functions
of the Surgeon General and other officers and agencies of the PHS to the Secretary
of Health, Education, and Welfare (HEW).2 In 1979, the Department of Education
Organization Act (P.L. 96-88) provided for a separate Department of Education, and
2 The House and Senate held hearings on President Johnson’s reorganization plan, but no
further legislative action was taken. The plan became effective June 25, 1966, 80 Stat.
1610.

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CRS-3
HEW was officially redesignated as HHS on May 4, 1980. HHS has designated eight
agencies as Public Health Service operating divisions.3 Those agencies are
! the Agency for Healthcare Research and Quality (AHRQ),
! the Agency for Toxic Substances and Disease Registry (ATSDR),
! the Centers for Disease Control and Prevention (CDC),
! the Food and Drug Administration (FDA),
! the Health Resources and Services Administration (HRSA),
! the Indian Health Service (IHS),
! the National Institutes of Health (NIH), and
! the Substance Abuse and Mental Health Services Administration
(SAMHSA).
The Agency for Toxic Substances and Disease Registry is administered by the
Director of the CDC, and the two agencies are discussed together in this report.
The missions and key functions of the PHS agencies vary. Two of them
principally conduct and support research: NIH conducts and supports basic, clinical,
and translational medical research, and AHRQ conducts and supports research on the
quality and effectiveness of health care services and systems. One agency, IHS,
provides or directly funds health care services for members of the nation’s federally
recognized Indian tribes. Two agencies support the provision of health care services,
or the systems that provide them, for a number of other special populations: HRSA
funds programs and systems to improve access to health care among low-income
populations, pregnant women and children, persons living with HIV/AIDS, rural and
frontier populations, and others, and SAMHSA funds programs and systems that
provide mental health and substance abuse prevention and treatment services.
CDC/ATSDR develops and supports public health prevention programs and systems,
such as disease surveillance and provider education programs, for a full spectrum of
acute and chronic diseases and injuries, including public health emergencies such as
bioterrorism. Although the agencies above have limited regulatory responsibilities,
if any, the FDA’s mission is almost entirely regulatory, ensuring the safety of foods
and the safety and effectiveness of drugs, vaccines, medical devices, and other health
products.
Table 2 presents total budgets for each of the agencies for FY2006 through the
FY2008 request. Detailed budget tables are provided with each agency discussion.
(This report does not yet reflect the effects of FY2007 supplemental appropriations.)
Five of the agencies (AHRQ, CDC, HRSA, NIH, and SAMHSA) receive the bulk of
their funding through the annual appropriations act for the Departments of Labor,
Health and Human Services, Education, and Related Agencies (Labor-HHS-ED).
ATSDR and IHS funds are provided through the Interior, Environment, and Related
Agencies appropriation, and FDA receives its funding from the Agriculture, Rural
Development, Food and Drug Administration, and Related Agencies appropriation.
3 The HHS “family of agencies” also includes the following, which are not part of the PHS:
Office of the Secretary, Administration for Children and Families, Administration on Aging,
and Centers for Medicare and Medicaid Services. See links at [http://www.hhs.gov/].

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CRS-4
A unique budget feature for the agencies funded under the Labor-HHS-ED
appropriation and authorized by the PHS Act is the PHS “Evaluation Set-Aside”
Fund, authorized by PHS Act § 241 (42 U.S.C. § 238j). This funding is available to
the five PHS agencies mentioned, as well as several offices within the Office of the
HHS Secretary, to assess the effectiveness of federal health programs and to identify
ways to improve them. The annual Labor-HHS-ED appropriations act specifies the
amount of funds that may be set aside for evaluation (currently 2.4% of the eligible
portions of agency budgets).4 HHS identifies the amount of set-aside funds available
to each PHS agency. The entire budget of AHRQ is funded through the evaluation
set-aside, and selected programs in the other four agencies also receive funds through
this transfer mechanism.
For each of the PHS agencies, this report describes the mission, organization,
key programs, history, and legislative authorities, and provides budget tables for
FY2006 through the FY2008 request. It will be updated as legislative and other
events warrant.
Table 2. Public Health Service (PHS) Agency Budgets:
Summary Table
(dollars in millions)
FY2007
FY2008
final
Pres.
% change
Agencies
FY2006
enacted
request
FY08 vs. FY07
Agency for Healthcare Research and Quality (AHRQ) a
Discretionary budget authority
$0.0
$0.0
$0.0
0.0%
Total program level
$318.7
$319.0
$329.6
3.3%
Centers for Disease Control and Prevention (CDC)/Agency for Toxic Substances and
Disease Registry (ATSDR)
Discretionary budget authority
$6,389.9
$6,012.7
$5,791.7
-3.7%
Total program level
$8,631.6
$9,185.4
$8,821.9
-4.0%
Food and Drug Administration (FDA)
Discretionary budget authority
$1,494.7
$1,574.2
$1,640.7
4.2%
Total program level
$1,876.5
$2,007.7
$2,068.9
3.0%
Health Resources and Services Administration (HRSA)
Discretionary budget authority
$6,630.3
$6,458.6
$5,859.8
-9.3%
Total program level
$6,679.0
$6,510.6
$5,908.7
-9.2%
4 Most of the funds appropriated for CDC, HRSA, NIH, and SAMHSA are available for
PHS evaluations except, by HHS convention, for funds appropriated for certain block grants
(Prevention, Substance Abuse, and Mental Health), for program management activities, and
for Buildings and Facilities, as well as some programs not authorized by the PHS Act, such
as the Maternal and Child Health Block Grant in HRSA. For further details, see Use of
Public Health Service Evaluation Set-Aside Authority for FY 2005, available at
[http://aspe.hhs.gov/rcc/SetAsideReport/FY2005.pdf], and Evaluation in the Department
of Health and Human Services at [http://aspe.hhs.gov/pic/perfimp/2002/appendixa.htm].

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CRS-5
FY2007
FY2008
final
Pres.
% change
Agencies
FY2006
enacted
request
FY08 vs. FY07
Indian Health Service (IHS)
Discretionary budget authority
$3,045.3
$3,180.2
$3,270.7
2.8%
Total program level
$3,843.5
$3,978.4
$4,121.0
3.6%
National Institutes of Health (NIH)
Discretionary budget authority
$28,409.0
$29,078.0
$28,699.7
-1.3%
Total program level
$28,468.2
$29,137.2
$28,557.9
-2.0%
Substance Abuse and Mental Health Services Administration (SAMHSA)
Discretionary budget authority
$3,203.2
$3,206.1
$3,046.4
-5.0%
Total program level
$3,324.5
$3,327.0
$3,167.6
-4.8%
Total for PHS Agencies a
Discretionary budget authority
$49,172.4
$49,509.8
$48,309.0
-2.4%
Source: Derived from agency tables in this report (Table 3 through Table 9).
a. AHRQ is financed through PHS evaluation funds, which are included in other agencies. Therefore,
AHRQ is not included in the total for discretionary budget authority. (A total program level for
PHS agencies cannot be calculated without additional information on the distribution of PHS
evaluation funds across multiple HHS agencies.)
Agency for Healthcare Research and
Quality (AHRQ)
Mission
The Agency for Healthcare Research and Quality (AHRQ) is the lead agency
charged with supporting research designed to improve the quality of health care, to
increase the efficiency of its delivery, and to broaden access to the most essential
health services. To accomplish these goals, it funds, conducts, and disseminates
research aimed at reducing the costs of care, promoting patient safety, and increasing
the effectiveness of health-care services.
Organization and Key Programs
The agency is divided into nine major functional components, consisting of four
offices and five research centers. The offices, centers, and key program areas are
described below.5 Unlike the National Institutes of Health (NIH) or the Centers for
Disease Control and Prevention (CDC), which each have separate funding streams
for major organizational entities such as centers or institutes, AHRQ funds are
targeted to specific programs or objectives (e.g., comparative effectiveness, patient
safety, and health disparities). Budget dollars are then allocated to AHRQ’s centers
5 For additional information, see [http://www.ahrq.gov/about/offcntrs.htm].

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CRS-6
by the Director, according to research priorities identified by Congress or the
Department of Health and Human Services. Therefore, Table 3, which describes
AHRQ’s budget, does not provide funding stream data for the separate research
centers at AHRQ. Instead, budget figures are displayed according to several broad
program categories, also described below.
Offices and Research Centers
The Office of the Director is charged with ensuring that AHRQ’s strategic
objectives are achieved. The Office of Performance Accountability, Resources, and
Technology coordinates agency-wide program planning and administrative
operations. The Office of Extramural Research, Education, and Priority Populations
(OEREP) directs the scientific review process, manages AHRQ’s research training
programs, monitors and evaluates ongoing research, and supports or conducts studies
on priority populations and health disparity populations. The Office of
Communications and Knowledge Transfer implements and manages programs for
disseminating the results of AHRQ activities and AHRQ-funded research.
The Center for Outcomes and Evidence (COE) conducts and supports research,
assessments, and demonstrations on safety, quality, effectiveness, and cost-
effectiveness. It serves as a repository for evidence-based information on
therapeutics, technologies, and health-care practices. COE summarizes these
findings and provides an array of tools and products to promote and facilitate
evidence-based clinical decisions. The Center for Primary Care, Prevention, and
Clinical Partnerships (CP3) focuses on research addressing the effectiveness and
quality of primary and preventive health-care services. CP3 serves as a locus for
research on health information technology. It also supports work on the preparedness
of the health-care system to deal with bioterrorism, natural disasters, and pandemic
flu. The Center for Delivery, Organization, and Markets (CDOM) conducts and
supports qualitative and quantitative studies on how organizational dynamics in the
health sector affect access and costs. For instance, its research examines how market
forces influence payment methods, financial and non-financial incentives, safety net
funding, and employer purchasing strategies. The Center for Financing, Access, and
Cost Trends (CFACT) manages studies of the cost and financing of health care,
including research analyzing trends and patterns of health expenditures, public and
private insurance coverage, utilization of care, and access to care for various subsets
of the general population. CFACT’s work includes modeling and projections of
health-care use, population health status, and overall health-care expenditures. The
Center for Quality Improvement and Patient Safety (CQuIPS) supports research
addressing patient safety, including studies on health-care quality measurement and
medical error reporting. In addition, it develops and disseminates reports aimed at
decreasing medical errors, risks, and hazards in health-care settings.
Program Areas
The AHRQ budget, presented in Table 3, is organized according to program
areas. These are (1) Research on Healthcare Costs, Quality and Outcomes (HQCO),
which consists of patient safety research, and non-patient safety research; (2) the
Medical Expenditure Panel Survey; and (3) program support.

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CRS-7
Medical errors result in considerable morbidity, mortality, and costs to the
health-care system. With the increased focus on patient safety stimulated by the
release of the Institute of Medicine’s 1999 report, To Err Is Human, and with a
substantial budget increase from Congress directed toward patient safety, AHRQ
embarked on a strategic approach to develop a large, targeted patient safety research
initiative. The ongoing objectives of this effort include developing public-private
partnerships to build capacity for medical error reduction activities, examining the
effect of working conditions on patient safety, and reviewing different methods of
reporting medical errors.
Among its patient safety research programs, AHRQ is actively involved with
researching the advantages and disadvantages associated with health information
technology (HIT). HIT broadly refers to the use of computers and computer
programs to store, protect, retrieve, and transfer clinical, administrative, and financial
information electronically within health-care settings. Clinicians and researchers
believe that electronic health records could play an important role in coordinating
care, especially for people with chronic conditions, such as diabetes or asthma, who
frequently see multiple providers. An AHRQ priority is the dissemination of new
knowledge and best practices from pioneers in this field.
Nearly 60% of AHRQ’s budget is awarded as grants and contracts to researchers
at universities and other research institutions for the purpose of studying issues other
than patient safety. Recently, AHRQ has placed a high priority on research regarding
the care of individuals with chronic conditions and/or multiple co-morbidities. It has
expressed a particular interest in funding studies of patient-centered care that
evaluate different efforts to redesign structural processes to target sicker individuals.
This includes interventions that empower patients, improve patient-provider
communication, and facilitate the coordination of care, such as telehealth, electronic
health records, disease-management programs, medication therapy compliance
programs, and Web-based applications for patients and health-care providers. AHRQ
has also devoted considerable resources to eliminating health disparities,
investigating strategies to reduce racial, ethnic, and socioeconomic inequities in
access to health-care services. To this end, it produces an annual report to Congress,
the National Healthcare Disparities Report.6
The comparative effectiveness program, which helps policy makers, clinicians,
and patients determine which medical treatments work best for certain health
conditions, grew out of Section 1013 of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (P.L. 108-173). The program supports
the development of new scientific information through research on the outcomes of
health-care services and therapies, including pharmaceuticals, and by comparing
different therapies used to treat the same condition.7
Cosponsored by AHRQ and the National Center for Health Statistics in CDC,
the Medical Expenditure Panel Survey (MEPS) is a survey of health-care use by the
civilian population living in the United States. MEPS produces nationally
6 See [http://www.ahrq.gov/qual/nhdr06/nhdr06.htm].
7 For more information, see [http://www.effectivehealthcare.ahrq.gov].

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CRS-8
representative statistics on health-care utilization and expenditures. It also collects
data on health conditions, health insurance, and coverage. MEPS is composed of
three different but related surveys: the Household Component (HC), the Medical
Provider Component (MPC), and the Insurance Component (IC). The MEPS HC
Survey collects detailed data on demographic characteristics, health conditions,
health status, access to care, satisfaction with care, and health insurance coverage.
The MPC Survey supplements and validates information on medical care events
reported in the MEPS HC by contacting medical providers and pharmacies identified
by household respondents. Lastly, the IC Survey collects data on health insurance
plans obtained through private and public-sector employers.8
History and Legislative Authorities
AHRQ has evolved from a succession of agencies concerned with fostering
health services research and health-care technology assessment. The Omnibus
Budget Reconciliation Act of 1989 (P.L. 101-239) added a new Title IX to the PHS
Act and established the Agency for Health Care Policy and Research (AHCPR), a
successor agency to the former National Center for Health Services Research and
Health Care Technology Assessment (NCHSR). AHCPR was reauthorized in 1992
(P.L. 102-410).
On December 6, 1999, President Clinton signed the Healthcare Research and
Quality Act of 1999 (P.L. 106-129), which renamed AHCPR as the Agency for
Healthcare Research and Quality (AHRQ) and reauthorized it through FY2005. The
new name was intended to underscore that AHRQ is a scientific research agency, not
an entity that determines federal health-care policies and regulations. The word
“Quality” was added to the agency’s name to emphasize its lead role in coordinating
all federal health-care quality improvement efforts.
Table 3 presents funding levels for AHRQ programs for FY2006 through
FY2008. As described in the introduction to this report, AHRQ receives all of its
funding through the PHS Evaluation Set-Aside, rather than through provision of new
budget authority in appropriations.
Table 3. Agency for Healthcare Research and Quality (AHRQ)
(dollars in millions)
FY2007
FY2008
% change
final
Pres.
FY08 vs.
Activities FY2006
enacted
request
FY07
Research on Health Costs, Quality, and Outcomes (HCQO)
Budget Authority
0.0
0.0
0.0
0.0
Evaluation Tap fundinga
$260.7
$261.0
$271.6
4.1%
Patient Safety Research (non-add)
(84.0)
(84.0)
(93.9)
11.8%
Health Information Technology (non-add)b
(49.9)
(49.9)
(44.8)
-10.2%
8 For more information about MEPS, see [http://www.meps.ahrq.gov/mepsweb].

---

CRS-9
FY2007
FY2008
% change
final
Pres.
FY08 vs.
Activities FY2006
enacted
request
FY07
Comparative Effectiveness (non-add)
(15.0)
(15.0)
(15.0)
0.0
Medical Expenditure Panel Surveys (MEPS)
Budget Authority
0.0
0.0
0.0
0.0
Evaluation Tap fundinga
55.3
55.3
55.3
0.0
Program Support
Budget Authority
0.0
0.0
0.0
0.0
Evaluation Tap fundinga
2.7
2.7
2.7
0.0
Total, AHRQ budget authority
0.0
0.0
0.0
0.0
Evaluation Tap Fundinga
318.7
319.0
329.6
3.3%
Total, AHRQ program level
$318.7
$319.0
$329.6
3.3%
Sources: Adapted by CRS from AHRQ Operating Plan for FY2007 (March 2007), reflecting final
funding levels under P.L. 110-5, Revised Continuing Appropriations Resolution, 2007; House
Appropriations Committee table (April 17, 2007); and AHRQ FY2008 Justification of Estimates for
Appropriations Committees, at [http://www.ahrq.gov/about/cj2008/cj2008.pdf].
Note: Numbers may not add due to rounding.
a. AHRQ receives its entire funding through transfers from other PHS agencies under the PHS
program evaluation set-aside (§ 241 of the PHS Act).
b. Patient safety research includes health information technology.
Centers for Disease Control and Prevention
(CDC)/Agency for Toxic Substances and Disease
Registry (ATSDR)
Mission
According to the Centers for Disease Control and Prevention (CDC), its mission
is “to promote health and quality of life by preventing and controlling disease, injury,
and disability.”9 CDC is the nation’s principal public health agency, providing
coordination and support for a variety of population-based disease and injury control
activities. Approximately 75% of the agency’s funding is spent extramurally through
grants, contracts, and cooperative agreements to various stakeholders, including state,
local, municipal, and foreign governments, non-profit organizations, academic
institutions, and others. Upon the request and under the authority of a state or foreign
government, CDC provides technical assistance, including workforce support,
specialized laboratory services, data management, and other services to support
public health investigations. The agency does not directly deliver either health-care
or public health services to individuals.
9 See the CDC website at [http://www.cdc.gov/].

---

CRS-10
CDC coordinates, analyzes, and disseminates public health information derived
from a number of health surveys and disease surveillance systems that it manages.
The information may be used to develop public health recommendations, such as
immunization schedules for children. CDC also publishes Morbidity and Mortality
Weekly Report (MMWR), a weekly journal reporting on public health investigations
and surveillance findings.
CDC performs many of the administrative functions for the Agency for Toxic
Substances and Disease Registry (ATSDR), and the Director of CDC serves as the
Administrator of ATSDR. Congress established ATSDR in 1980 in the
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA, P.L. 96-510, the “Superfund” law) to investigate and reduce the harmful
effects of exposure to hazardous substances on human health.10
Organization and Key Programs
The current structure of CDC was implemented in April 2005 in a
reorganization called “The Futures Initiative.”11 The agency has more than 8,500
permanent employees and approximately 6,000 contract employees.12 CDC occupies
several main campuses in Atlanta, GA, and several other sites, including locations
in Colorado, Maryland, Ohio, West Virginia, and Washington, DC. The agency’s
organizational components are described below.
! The Office of the Director manages and directs agency activities.
! The Coordinating Center for Environmental Health and Injury
Prevention houses two operating divisions. The National Center
for Environmental Health/Agency for Toxic Substances and Disease
Registry (NCEH-ATSDR) provides national leadership in preventing
and controlling disease and death resulting from the interactions
between people and their environment. The National Center for
Injury Prevention and Control (NCIPC) works to prevent death and
disability from non-occupational injuries, including those that are
unintentional (e.g., falls, fires, drowning, poisoning, and motor
vehicle crashes) and those that result from violence (e.g., homicide,
suicide, and domestic violence).
! The Coordinating Center for Health Information and Service
houses three operating divisions. The National Center for Health
Statistics (NCHS) provides statistical information that guides public
health policy and activities. The National Center for Public Health
10 See “Public Health Issues and the Agency for Toxic Substances and Disease Registry,”
in CRS Report 97-312, Superfund Fact Book, by Mark Reisch and David M. Bearden.
11 See [http://www.cdc.gov/futures/] and the CDC organizational chart at
[http://www.cdc.gov/about/organization/orgChart.htm].
12 See CDC’s current annual report, The State of CDC, FY2006, (employment statistics are
on p. 35) at [http://www.cdc.gov/about/stateofcdc/cdrom/SOCDC/SOCDC2006.pdf].

---

CRS-11
Informatics (NCPHI) provides leadership in the application of
information technology to public health. The National Center for
Health Marketing (NCHM) provides leadership in health marketing
science and in its application to public health.
! The Coordinating Center for Health Promotion houses three
operating divisions. The National Center on Birth Defects and
Developmental Disabilities (NCBDDD) provides national leadership
for preventing birth defects and developmental disabilities and for
improving the health and wellness of people with disabilities. The
National Center for Chronic Disease Prevention and Health
Promotion (NCCDPHP) works to prevent premature death and
disability from chronic diseases such as heart disease, cancer,
diabetes, and arthritis, and promotes healthy personal behaviors.
The Office of Genomics and Disease Prevention provides national
leadership in fostering understanding of human genomic discoveries
and how they can be used to improve health and prevent disease.
! The Coordinating Center for Infectious Diseases houses four
operating divisions. The National Center for Immunization and
Respiratory Diseases (NCIRD) supports research and programs for
vaccine-preventable diseases. The National Center for Zoonotic,
Vector-Borne, and Enteric Diseases (NCZVED) works to prevent
illness, disability, and death caused by infectious diseases
domestically and globally. The National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention (NCHHSTP) provides national
leadership in preventing and controlling human immunodeficiency
virus (HIV) infection, sexually transmitted diseases, and
tuberculosis. The National Center for Preparedness, Detection, and
Control of Infectious Diseases (NCPDCID) focuses on improving
preparedness and response capacity for new and complex infectious
disease outbreaks.
! The Coordinating Office for Global Health provides national
leadership, coordination, and support for CDC’s global health
activities, in collaboration with global health partners.
! The Coordinating Office for Terrorism Preparedness and
Emergency Response (COTPER) provides strategic direction for
CDC to support terrorism preparedness and emergency response
efforts.
! The National Institute for Occupational Safety and Health
(NIOSH) ensures safety and health for all people in the workplace
through research and prevention.

---

CRS-12
History and Legislative Authorities
In 1946, the Communicable Disease Center was created from the Office of
Malaria Control in War Areas, in Atlanta, GA. The original agency was established
in 1942 to control malaria and other mosquito-borne diseases in U.S. military
personnel training in the southeastern United States. In 1970, CDC was renamed the
Center for Disease Control to reflect its added responsibilities for noncommunicable
diseases. CDC’s mission continued to expand to include programs in occupational
and environmental health, family planning and reproductive health, and chronic
diseases. A major reorganization in 1980, and its renaming to the Centers for
Disease Control, emphasized the importance of health promotion and education in
the agency’s mission. In 1992, Congress added the words “and Prevention” to the
agency’s name, to recognize its role in the prevention of disease, injury, and
disability. In enacting the change, Congress specified that the agency may continue
to use the acronym “CDC” because of its recognition within the public health
community and among the public.13
Many of CDC’s activities are not specifically authorized but are based in broad,
permanent authorities in the PHS Act. For example, Section 301 authorizes the
Secretary of HHS to conduct research and investigations as necessary to control
disease; Section 307 authorizes the Secretary to cooperate with and provide
assistance to foreign nations; and Section 317 authorizes the Secretary to award
grants to states for preventive health programs. Some other CDC programs (e.g.,
lead poisoning prevention) are explicitly authorized in the PHS Act, primarily in Title
III.
Four CDC operating divisions are explicitly authorized in statute. NIOSH was
established in permanent authority in the Occupational Safety and Health Act of
1970.14 The National Center on Birth Defects and Developmental Disabilities was
established in Section 317C of the PHS Act by the Children’s Health Act of 2000 and
is authorized through FY2007.15 The National Center for Health Statistics was
established in Section 306 of the PHS Act by the Health Services Research, Health
Statistics, and Medical Libraries Act of 1974. The Center’s authorities expired in
FY2002 and FY2003. ATSDR was established in the Comprehensive Environmental
Response, Compensation and Liability Act of 1980 (CERCLA).16 Its appropriations
authority expired in 1994.17 NCHS and ATSDR have continued to receive annual
appropriations despite their expired authorities.
13 Information on CDC history is available in Centers for Disease Control and Prevention,
“CDC: The Nation’s Prevention Agency,” MMWR, vol. 41, no. 44 (November 6, 1992), p.
834.
14 29 U.S.C. § 671.
15 42 U.S.C. § 247b-4.
16 42 U.S.C. § 9604(I).
17 42 U.S.C. § 9611(m).

---

CRS-13
CDC has few regulatory authorities. Public health regulatory authorities, such
as professional licensing, facility inspection, quarantine, and contact tracing, are
generally based in state law. CDC’s limited regulatory authorities include certain
authorities to regulate laboratories in which potential bioterrorism agents are handled,
and authority for disease control functions concerning entries of persons, goods, and
conveyances from other countries.
Most CDC programs are funded through the Departments of Labor, Health and
Human Services, Education, and Related Agencies (L-HHS-ED) annual
appropriation. ATSDR is funded separately from other CDC programs, in the
Interior, Environment, and Related Agencies annual appropriation. Table 4 presents
funding levels for CDC programs for FY2006 through FY2008. Occasionally, upon
the request of the chairman of a Labor, Health and Human Services, Education, and
Related Agencies Appropriations Subcommittee, the CDC Director will submit
directly to the chairman a “professional judgment” budget, outside of the usual
budget request published by the White House Office of Management and Budget in
February of each year. A CDC “professional judgment” budget for FY2008 requests
almost $1 billion above the agency’s FY2007 level.18
Table 4. Centers for Disease Control and Prevention
(CDC)/Agency for Toxic Substances and Disease
Registry (ATSDR)
(dollars in millions)
FY2007
FY2008
% change
final
Pres.
FY08 vs.
Programs
FY2006a
enacted
request
FY07
Infectious Diseases, budget authority
$1,682.4
$1,791.4
$1,781.6
-0.5%
PHS Program Evaluation
Set-Aside (non-add)b
(12.8)
(12.8)
(12.8)
Infectious Diseases, program level
1,695.2
1,804.2
1,794.4
-0.5%
Health Promotion
958.0
959.7
958.7
-0.1%
Health Information and Service,
budget authority
84.7
88.4
108.4
22.6%
PHS Program Evaluation
Set-Aside (non-add)b
(134.2)
(134.2)
(135.1)
0.7%
Health Information and Service,
program level
218.9
222.7
243.5
9.3%
Environmental Health and Injury
287.5
288.1
287.7
-0.1%
Occupational Safety and Health,
budget authority
175.8c
167.0
165.9
-0.7%
PHS Program Evaluation
Set-Aside (non-add)b
(87.1)
(87.1)
(87.1)
Occupational Safety and Health,
program level
262.9c
254.1
253.0
-0.4%
18 See [http://www.fundcdc.org/documents/CDCFY2008PJ_000.pdf].

---

CRS-14
FY2007
FY2008
% change
final
Pres.
FY08 vs.
Programs
FY2006a
enacted
request
FY07
Global Health
379.6d
334.0
379.7
13.7%
Terrorism
1,631.2e
1,541.3
1,504.4
-2.4%
Public Health Research, budget
authority
0.0
0.0
0.0
PHS Program Evaluation
Set-Aside (non-add)b
(31.0)
(31.0)
(31.0)
Public Health Research, program
level
31.0
31.0
31.0
0.0%
Public Health Improvement and
Leadership
264.1f
189.8
190.4
0.3%
Preventive Health and Health Services
Block Grant
98.9
99.0
0.0
-100.0%
Buildings and Facilities
158.3
134.4
20.0
-85.1%
Business Services Support
317.6
344.3
319.9
-7.1%
Pandemic Influenza supplemental
appropriations
277.0g
0.0
0.0
Subtotal, Labor-HHS-ED
appropriation
$6,315.0
$5,937.5
$5,716.7
-3.7%
ATSDR (Interior/Environment
appropriation)
74.9
75.2
75.0
-0.3%
Total, CDC/ATSDR budget
authority
$6,389.9
$6,012.7
$5,791.7
-3.7%
Total, PHS Program Evaluation
Set-Asideb
265.1
265.1
266.0
0.3%
Vaccines for Children (VFC),h current
law
1,974.3
2,905.3
2,762.0
-4.9%
User feesi
2.2
2.2
2.2
Total, CDC/ATSDR program level
$8,631.6
$9,185.4
$8,821.9
-4.0%
Sources: Adapted by CRS from CDC FY2007 Joint Resolution Detail Table, reflecting final funding
levels under P.L. 110-5, Revised Continuing Appropriations Resolution, 2007, and FY2008
Congressional Justifications for CDC and ATSDR, at [http://www.cdc.gov/fmo/fmofybudget.htm].
Note: Numbers may not add due to rounding.
a. FY2006 reflects 1% rescission and HHS internal transfer.
b. Funds from PHS program evaluation set-aside (§ 241 of the PHS Act).
c. Includes $10 million in supplemental funding for mining safety.
d. Includes $68 million in FY2006 emergency supplemental appropriations.
e. Includes $55 million in FY2006 emergency supplemental appropriations.
f. Includes $75 million in FY2006 emergency supplemental appropriations.
g. Amounts from P.L. 109-148 and P.L. 109-234.
h. The Vaccines for Children (VFC) program provides free pediatric vaccines to doctors who serve
eligible children. The VFC program is funded entirely by federal Medicaid appropriations and
is administered by CDC’s National Center for Immunization and Respiratory Diseases.
i. CDC is authorized to collect fees from researchers and others who use certain of the agency’s
databases.

---

CRS-15
Food and Drug Administration (FDA)
Mission
The Food and Drug Administration (FDA) website, at [http://www.fda.gov], has
a brief statement of its mission:
! To promote and protect the public health by helping safe and
effective products reach the market in a timely way.
! To monitor products for continued safety after they are in use.

! To help the public get the accurate, science-based information
needed to improve health.
Organization and Key Programs
FDA regulates more than $1 trillion worth of products, which account for 25
cents of every dollar spent annually by American consumers. It regulates the safety
of foods (including animal feeds) and the safety and effectiveness of drugs, biologics
(e.g., vaccines), and medical devices.
The organization charts of FDA overall and its components are available at
[http://www.fda.gov/opacom/7org.html]. Six centers within FDA represent the broad
program areas for which the agency has responsibility; other offices have agency-
wide responsibilities:
! The Office of the Commissioner is responsible for agency-wide
management of policies and activities. [http://www.fda.gov/
oc/default.htm]
! The Center for Biologics Evaluation and Research (CBER) is
responsible for the safety of the nation’s blood supply and routinely
examines blood bank operations for record keeping and testing for
contaminants. It also ensures the safety, purity, and effectiveness of
biologics (medical preparations made from living organisms and
their products), such as insulin and vaccines. [http://www.fda.gov/
cber/].
! The Center for Devices and Radiological Health (CDRH)
regulates medical devices. The marketing approval process varies
based on two criteria: (1) whether a device is new, which requires
demonstration of safety and effectiveness, or substantially equivalent
to an approved device, and (2) which of three classes of risk to the
public that FDA assigns to it. [http://www.fda.gov/cdrh/]
! The Center for Drug Evaluation and Research (CDER) evaluates
new drug applications; no prescription drug can enter interstate
commerce unless and until FDA determines, based on data from

---

CRS-16
clinical trials, that it is safe and effective when used for the
population and clinical condition described in its labeling. In
addition to this premarket review, FDA is responsible for the
postmarket safety and effectiveness of approved products. It has
some authority to influence direct-to-consumer advertising; review
adverse event reports from manufacturers, clinicians, consumers,
and studies described by manufacturers or in peer-reviewed journals;
and alert clinicians or the public to newly identified possible risks.
FDA follows similar procedures for changes in labeling and dosage
or other modifications to an approved product, and for
nonprescription drugs. In addition to direct appropriations, user fees
paid by pharmaceutical companies support CDER’s premarket
review and, to a lesser extent, postmarket safety activities.
[http://www.fda.gov/cder/]
! The Center for Food Safety and Applied Nutrition (CFSAN) is
responsible for protecting the safety and wholesomeness of the food
supply, except for meat and poultry products, which are regulated by
the U.S. Department of Agriculture. It preapproves for safety the
addition of certain chemicals to food products (such as food and
color additives). CFSAN tests food samples to determine whether
any substances, such as pesticide residues or heavy metals, are
present in unacceptable amounts. It also sets standards for label
information to assist consumers in knowing what is present in the
foods they are buying. [http://www.cfsan.fda.gov/list.html]
! The Center for Veterinary Medicine (CVM) regulates animal
drugs and devices to ensure safety and effectiveness, and regulates
the safety of animal feeds, including pet food. [http://www.fda.gov/
cvm/default.html]
! The National Center for Toxicological Research (NCTR), located
in Arkansas, conducts research on the biological effects of widely
used chemicals. NCTR does not have regulatory responsibilities.
[http://www.fda.gov/nctr/index.html]
! The Office of Regulatory Affairs conducts FDA’s compliance
act i v i t i es , including ins p ect i o n an d enf o r cem ent .
[http://www.fda.gov/ora/]
History and Legislative Authorities
Until the beginning of the 20th century, charlatans peddled adulterated and
mislabeled medicines throughout the United States without penalty. In 1902,
Congress passed the Biologics Control Act after 13 children died from a diphtheria
vaccine contaminated with tetanus. In 1906, Congress passed the Food and Drugs
Act. These were the first in a series of laws intended to assure Americans that the
medicines they used did no harm and actually worked — that they are, in other
words, safe and effective.

---

CRS-17
Over the next 60 years, Congress passed two major pieces of legislation
expanding FDA authority in pursuit of those goals. It passed the Federal Food, Drug,
and Cosmetic Act (FFDCA) in 1938, which authorized FDA food-related activities
and required that drugs be proven safe before they could be sold in interstate
commerce. Then, in 1962, in the wake of the thalidomide tragedy, Congress
amended the law to require that drugmakers prove the effectiveness of their products
as well.19 Since 1962, FDA’s authority and regulatory scope have continued to
evolve.
As an agency, FDA and its predecessors have had several administrative homes
in the federal government. The box below tracks the highlights of its organizational
moves.20
FDA Organizational Timeline
1862
New Bureau of Chemistry in the new U.S. Dept. of Agriculture (USDA)
1927
Bureau of Chemistry became the Food, Drug, and Insecticide Administration
1931
Renamed: the USDA Food and Drug Administration (FDA)
1940
FDA transferred from USDA to the Federal Security Agency (FSA)
1953
FSA became the Dept. of Health, Education, and Welfare (HEW)
1968
FDA (remaining in HEW) became part of the Public Health Service (PHS)
1980
HEW (without Education) became the Dept. of Health and Human Services (HHS)
The FFDCA is the principal source of FDA’s authority.21 The Act consists of
the following chapters, governing the majority of FDA’s activities:
Chapter I:
Short Title.
Chapter II:
Definitions.
Chapter III:
Prohibited Acts and Penalties.
Chapter IV:
Food. Pursuant to the definition in Section 201, food is defined to
include foods for humans, as well as animal feeds, including pet
food.
Chapter V:
Drugs and Devices. Includes provisions regarding the regulation of
human drugs and medical devices, and animal drugs; certain
provisions regarding biological products; and certain special
provisions such as those regarding pediatric drug studies.
Chapter VI:
Cosmetics.
19 Kefauver-Harris Drug Amendments to the FFDCA, P.L. 87-781 (1962).
20 See FDA and USDA Web pages at [http://www.fda.gov/opacom/backgrounders/
miles.html] and [http://www.fsis.usda.gov/About_FSIS/Agency_History/index.asp].
21 The FFDCA is codified at 21 U.S.C. § 301 et seq. The FDA website offers the text of
FFDCA chapters (current through December 2004); a cross-reference to corresponding
sections in Title 21, Chapter 9 of the U.S. Code; and significant amendments to the FFDCA,
at [http://www.fda.gov/opacom/laws/].

---

CRS-18
Chapter VII:
General Authority. Includes, among other things, authority to
promulgate regulations, and to conduct inspections and
investigations.22
Chapter VIII:
Imports and Exports.
Chapter IX:
Miscellaneous.
FDA is also responsible for certain provisions in other laws, most notably the
Public Health Service (PHS) Act.23 The PHS Act contains certain specific provisions
that are implemented by FDA, such as mammography quality standards.24 The Act
also contains certain broad provisions that are implemented by FDA. An example
is FDA’s enforcement of a ban on the interstate sale of baby turtles, which can cause
Salmonella infections, as an exercise of the HHS Secretary’s broad authority under
the PHS Act to control diseases.25
FDA’s authority to regulate most human biologics — products such as vaccines,
blood and blood components — flows from provisions in the PHS Act (Section 351)
and in specific sections of the FFDCA.26 Furthermore, different types of biologics
may be regulated by either CDER or CBER.27 Veterinary biologics, such as animal
vaccines, are not regulated by FDA. They fall under a separate law, the Virus,
Serum, and Toxin Act, which is administered by USDA.
Budget. FDA has an annual budget of about $2 billion. Table 5 presents FDA
funding levels for FY2006 through FY2008. FDA’s budget has two funding streams:
direct appropriations (budget authority, or BA) and industry user fees. In FDA’s
annual appropriation, Congress sets both the total amount of appropriated funds and
the level of user fees to be collected that year. Appropriated funds are largely for
salaries and expenses ($1.569 billion in FY2007), with a much smaller amount for
buildings and facilities ($5 million in FY2007). User fees ($433.5 million in
FY2007) come from several programs: the three major user fee programs provide
support for FDA’s prescription drug, medical device, and animal drug activities,
whereas smaller amounts come from mammography clinic certification fees and
export and color certification fees. The FY2007 total for FDA — the program level
— was $2.008 billion, 7% above the level enacted for FY2006.
22 In general, FDA’s regulations are found in Title 21 of the Code of Federal Regulations.
FDA maintains a current searchable version of Title 21 on its website at
[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm].
23 A listing of the many other laws containing provisions for which FDA is responsible is
available at [http://www.fda.gov/opacom/laws/#other].
24 Public Health Service Act, Sec. 354, 42 U.S.C. § 263b.
25 Public Health Service Act, Sec. 361, 42 U.S.C. § 264.
26 See FDA, Center for Biologics Evaluation and Research, “Frequently Asked Questions,”
June 4, 2007, at [http://www.fda.gov/cber/faq.htm].
27 See FDA, “Transfer of Therapeutic Biological Products to the Center for Drug Evaluation
and Research,” June 30, 2003, at [http://www.fda.gov/oc/combination/transfer.html].

---

CRS-19
Although the FDA’s authorizing committees in Congress are the committees
with jurisdiction over public health issues — the Senate Committee on Health,
Education, Labor, and Pensions, and the House Committee on Energy and Commerce
— FDA’s assignment within the appropriations committees reflects its origin within
the Department of Agriculture. The appropriations subcommittees on Agriculture,
Rural Development, FDA, and Related Agencies have jurisdiction over FDA’s
budget, even though the agency has been part of various federal health agencies
(HHS and its predecessors) since 1940.
Table 5. Food and Drug Administration (FDA)
(dollars in millions)
FY2007
FY2008
% change
final
Pres.
FY08 vs.
Program area
Funds
FY2006
enacted
request a
FY2007
Foods
BA
$438.7
$457.1
$466.7
2.1%
Fees
—
—
—
—
Total
438.7
457.1
466.7
2.1%
Human drugs
BA
297.7
315.1
324.4
3.0%
Fees
219.8
255.2
232.4
-9.0%
Total
517.6
570.4
556.8
-2.4%
Biologics
BA
139.0
144.5
155.1
7.3%
Fees
56.5
65.7
60.8
-7.6%
Total
195.5
210.3
215.8
2.6%
Animal drugs and feeds
BA
89.6
94.7
94.8
0.1%
Fees
9.3
9.5
11.5
20.8%
Total
98.9
104.3
106.3
2.0%
Devices and radiological healthb
BA
220.6
230.7
240.1
4.1%
Fees
39.9
42.2
45.3
7.1%
Total
260.5
272.9
285.4
4.6%
Toxicological research (NCTR)
BA
40.7
42.1
36.5
-13.3%
Fees
—
—
—
—
Total
40.7
42.1
36.5
-13.3%
Headquarters and Office of the
BA
86.9
90.5
88.6
-2.2%
Commissionerb
Fees
30.5
32.1
32.9
2.3%
Total
117.4
122.6
121.4
-1.0%
GSA rent
BA
116.4
126.9
131.5
3.7%
Fees
17.3
19.1
26.9
40.5%
Total
133.7
146.0
158.4
8.5%
Other rent and rent-related
BA
57.2
67.6
98.0
45.0%
(including White Oak
Fees
0.8
1.1
9.1
766.9%
consolidation)
Total
57.9
68.6
107.1
56.1%
Export and color certification
BA
—
—
—
—
funds
Fees
7.6
8.5
9.5
12.0%
Total
7.6
8.5
9.5
12.0%
Subtotal, Salaries & Expenses
BA
1,486.8
1,569.2
1,635.7
4.2%
Fees
381.8
433.5
428.3
-1.2%
Total
1,868.6
2,002.8
2,064.0
3.1%

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CRS-20
Buildings & Facilities
BA
7.9
5.0
5.0
0.0%
Fees
—
—
—
—
Total
7.9
5.0
5.0
0.0%
Total, FDA Budget Authority
BA
1,494.7
1,574.2
1,640.7
4.2%
Fees
381.8
433.5
428.3
-1.2%
Total, FDA Program Level
Total $1,876.5
$2,007.7
$2,068.9
3.0%
Sources: Adapted by CRS from FDA Operating Plan for FY2007 (March 2007), reflecting final
funding levels under P.L. 110-5, Revised Continuing Appropriations Resolution, 2007, and FDA,
Fiscal Year 2008 Justification of Estimates for Appropriations Committees, February 2007, at
[http://www.fda.gov/oc/oms/ofm/budget/documentation.htm].
Notes: Totals may not add due to rounding. BA = budget authority, also referred to as direct
appropriations. Fees = collected user fees. Total program level = budget authority plus user fees.
a. Does not include proposed generic drug user fee ($15.7 million).
b. Includes mammography user fees.
Health Resources and Services
Administration (HRSA)
Mission
The Health Resources and Services Administration (HRSA) — “the access
agency” — provides leadership and support for health services and resources for
people who are uninsured, isolated, or medically vulnerable. According to HRSA,
its programs target 44 million Americans who lack health insurance, 50 million
Americans who live in rural and poor urban areas where health-care services are
scarce, 900,000 people living with HIV/AIDS, and 87,000 Americans who are
waiting for an organ transplant.
HRSA provides leadership for and support of health services through grants to
community-based organizations; colleges and universities; hospitals; state, local, and
tribal governments; associations; national groups; and foundations. These grantees
provide various services that include the identification of recruitment and training
needs for the state and national health workforce; recruitment and retention of
qualified health professionals to serve in the primary care workforce; administration
of programs relating to implementation of state maternal and child health service
programs; development of integrated information systems to enhance quality of and
access to health services in underserved populations; and management of the federal
response to health care needs for persons living with HIV/AIDS. In addition, HRSA
administers the program for community health centers (CHCs), which provides
grants for basic primary medical services to people who live in rural and urban areas
and experience financial, geographic, cultural, or other barriers to health care.
Organization and Key Programs
HRSA is headquartered in Rockville, MD, and is organized into six bureaus, 13
offices, and one center. The agency, restructured several times between 2003 and

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CRS-21
2007 by the Bush Administration, currently has the following organizational
components:
! The Bureau of Primary Health Care aims to increase access to
primary and preventive health care and improve the health status of
underserved and vulnerable populations. Its largest program, Health
Centers, provides grants to nearly 3,700 health centers and clinics
that provide routine access to health care for 14 million people living
in inner city and rural areas.
! The Maternal and Child Health Bureau seeks to strengthen the
infrastructure for maternal and child health services. The Maternal
and Child Health Block Grant, Healthy Start, and Emergency
Medical Services for Children, offered by state and local health
agencies, are among its larger programs.
! The HIV/AIDS Bureau administers programs consolidated by the
Ryan White HIV/AIDS Treatment Modernization Act.28 The
programs provide life-saving and life-extending services for people
living with HIV/AIDS. According to HRSA, these programs reach
more than 500,000 individuals throughout the country each year,
making it the federal government’s largest discretionary grant
program for people living with HIV/AIDS.
! The Bureau of Health Professions aims to provide national
leadership in the development, distribution, and retention of a
diverse, culturally competent health workforce. Grants to
institutions target education and training opportunities at all
academic levels, from elementary through post-graduate education.
Individuals who are specializing in primary care medicine and
dentistry, geriatrics, and allied health professions, among others,
benefit from these grants.
! The Bureau of Clinician Recruitment and Service administers
programs authorized under various titles of the PHS Act. The
National Health Service Corps (authorized in Title III) and various
health professions and nursing programs (authorized in Titles VII
and VIII, respectively) attract and recruit individuals from all
backgrounds to study and work in medicine, nursing, dentistry,
mental and behavioral health services, and other allied health fields.
! The Healthcare Systems Bureau provides leadership and direction
in the development of national programs and services for health
emergency preparedness, vaccine injury compensation, bone marrow
transplantation, organ transplantation and procurement, and poison
control centers, among other functions.
28 P.L. 109-415 was signed on December 19, 2006.

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CRS-22
Among HRSA’s 13 offices, some focus on specific populations or health care
issues, while others are involved with the agency’s management. The Office of Rural
Health Policy (ORHP) is significant in its mission to promote access to health-care
services in rural populations. ORHP is responsible for informing and advising the
Secretary of HHS on matters affecting rural health care. Other offices address issues
related to minority health and health disparities, international health, health
information technology, federal assistance management, financial management,
legislation, communications, and performance review, among other things. A new
Center for Quality coordinates activities related to strengthening and improving the
quality of health care in HRSA programs and on behalf of its service populations.29
History and Legislative Authorities
In 1935, Congress authorized the first programs for maternal and child health
services and general health grants to states in various sections of the Social Security
Act. Around 1940, these programs were transferred to the newly created Federal
Security Agency (FSA) and later administered in the Bureau of Medical Services and
Bureau of State Services. In 1953, the Department of Health, Education and Welfare
(HEW) was created at cabinet level and replaced the FSA. Federal support for health
services continued to evolve in HEW, and new targets for service focused on migrant
health, health workforce development, and hospital and health facility construction.
Within HEW, two new agencies, the Health Services Administration and Health
Resources Administration, were created in 1973. In 1982, the Secretary of HHS
merged the two agencies into the present-day HRSA.
Currently, HRSA supports a variety of programs established under various
authorities. Although the majority of programs are authorized in the PHS Act, a few
are authorized in the Social Security Act. For example, the Community Health
Centers Program, National Health Service Corps, Children’s Hospitals Graduate
Medical Education Program, Organ Transplant and Bone Marrow Programs,
Telehealth Program, and State Offices of Rural Health are authorized in Title III of
the PHS Act. Also, all Ryan White HIV/AIDS programs are consolidated in Title
XXVI of the PHS Act. Maternal and Child Health Block Grants and the Rural
Health Policy Development Programs are authorized in various sections of the Social
Security Act. Finally, the Black Lung Program, which supports clinics that provide
services to retired coal miners and others, is authorized in Section 427(e) of the
Federal Mine Safety and Health Amendments Act (P.L. 95-164), which amended the
Federal Coal Mine Safety Act of 1969.
Table 6 presents funding levels for HRSA programs for FY2006 through
FY2008.
29 See more information at HRSA’s website, at [http://www.hrsa.gov/about/default.htm].

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CRS-23
Table 6. Health Resources and Services Administration (HRSA)
(dollars in millions)
%
FY2007
FY2008
change
final
Pres.
FY08
Bureaus, Offices, and Programs
FY2006
enacted
request
vs. FY07
Health Centersa
$1,785.1
$1,988.0
$1,988.5
0.0%
Other BPHC Programs
18.1
18.2
18.3
0.0%
Subtotal, Bureau of Primary Health Care
(BPHC)
1,803.2
2,006.3
2,006.8
0.0%
National Health Service Corps
125.4
125.7
116.0
-7.7%
Other — clinician loan programs
37.1
37.1
48.5
30.7%
Subtotal, Bureau of Clinician Recruitment and
Service
162.5
162.8
164.5
1.0%
Title VII Health Professions
143.8
183.5
9.7
-94.7%
Title VIII Nursing Workforce Development
113.8
113.9
56.8
-50.1%
Children’s Hospitals Graduate Medical Education
296.8
297.0
110.0
-63.0%
Subtotal, Bureau of Health Professions
554.4
594.3
176.5
-70.3%
Maternal and Child Health Block Grant
692.5
693.0
693.0
0.0%
Healthy Start
101.4
101.5
100.5
-1.0%
Other MCHB Programs
40.7
40.7
2.2
-85.8%
Subtotal, Maternal and Child Health Bureau
(MCHB)
834.6
835.2
795.7
-4.7%
Subtotal, HIV/AIDS Bureau
2,036.3
2,118.9
2,132.9
0.7%
Subtotal, Healthcare Systems Bureau
75.2
69.1
60.7
-12.2%
Subtotal, Rural Health Programs
167.8
167.9
24.7
-85.3%
Other HRSA Programs
Family Planning
282.9
283.1
283.1
0.0%
Bioterrorism Hospital Grants to Statesb
494.7
NA
NA
NA
Telehealth + Program Management
151.2
153.1
151.0
-1.4%
Subtotal, Other HRSA Programs
928.8
436.3
434.1
-0.5%
Total, Health Resources and Services account
$6,562.9
$6,390.7
$5,795.8
-9.3%
Health Education Assistance Loans (HEAL)
2.9
2.9
2.9
0.0%
Vaccine Injury Compensation Program
64.5
65.0
61.1
-6.0%
Total, HRSA discretionary budget authority
$6,630.3
$6,458.6
$5,859.8
-9.3%
National Practitioner Data Bank (User Fees)c
15.7
16.2
18.9
16.7%
Health Care Integrity and Protection Data Bank
(User Fees)c
4.0
3.8
0.0
-100%
Family-to-Family Health Information Centers
(mandatory)d
0.0
3.0
4.0
33.3%
PHS Program Evaluation Set-Asidee
25.0
25.0
25.0
0.0%
HEAL Liquidating Account
4.0
4.0
1.0
-75.0%
Total, HRSA program level
$6,679.0
$6,510.6
$5,908.7
-9.2%
Sources: Adapted by CRS from HRSA Operating Plan for FY2007 (March 2007), reflecting final
funding levels under P.L. 110-5, Revised Continuing Appropriations Resolution, 2007, and House
Appropriations Committee table (April 17, 2007).
Notes: Numbers may not add due to rounding. “NA” means not applicable (program transferred to
the Office of the HHS Secretary.) In 2007, HHS announced creation of the new Bureau of Clinician
Recruitment and Service and transfer of the following programs from the Bureau of Health

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CRS-24
Professions: National Health Service Corps, Nursing Scholarship Program, Nursing Education Loan
Repayment Program, Faculty Loan Repayment Program, and the Native Hawaiian Scholarship
Program (72 FR 19540, April 18, 2007). This table reflects the change by posting those programs
under a header for the new Bureau.
a. FY2006 includes $4 million in one-time supplemental funding for communications equipment for
health centers affected by Hurricane Katrina and other hurricanes of the 2005 season, in P.L.
109-234.
b. Appropriations for bioterrorism hospital grants to states were transferred to the HHS Office of the
Secretary in FY2007, pursuant to P.L. 100-5, Revised Continuing Appropriations Resolution,
2007.
c. User fees available for Bureau of Health Professions.
d. Mandatory funds for Maternal and Child Health Bureau appropriated in the Deficit Reduction Act
of 2005 (P.L. 109-171).
e. Additional funds for Ryan White AIDS programs from PHS program evaluation set-aside (§ 241
of PHS Act).
Indian Health Service (IHS)
Mission
The Indian Health Service (IHS) provides, or funds the provision of, direct
health-care services to members of the nation’s 561 federally recognized Indian30
tribes (totaling about 1.8 million Indians in 35 states) who are in IHS service delivery
areas.31 Services are provided through IHS-funded clinics, hospitals, health centers,
and other facilities, operated by IHS itself, Indian tribes, tribal organizations, or urban
Indian organizations. Health-care services are also provided through contracts with
private health services providers. Besides services, IHS also funds the construction,
equipping, operation, and maintenance of health-care and sanitation facilities.
IHS health-care services cover almost the entire range of clinical health services,
including ambulatory, inpatient, preventive, mental health, and dental care. IHS’s
public health services include home and community sanitation facilities, public
health nurses, and epidemiology. Besides providing general clinical health services,
IHS also focuses on special Indian health problems, such as fetal alcohol syndrome,
diabetes prevention and treatment, alcoholism and mental health, hepatitis B, and
maternal and child health.
Eligible Indians receive free IHS health services regardless of their ability to
pay. The federal government considers its provision of these health services to be
based on its trust responsibility for Indian tribes, a responsibility derived from federal
treaties, statutes, court decisions, executive actions, and the Constitution (which
assigns authority over Indian relations to Congress). IHS programs are not
entitlement programs, but rather are funded through discretionary appropriations,
plus reimbursements from third-parties, including Medicare and Medicaid. Available
funding is not sufficient to cover all Indian health services needs, however, so IHS
30 In this report, the term “Indian” means American Indians and Alaska Natives. The latter
term includes the Eskimos (Inuit and Yupik), Aleuts, and American Indians of Alaska.
31 IHS also funds limited health services to Indians in certain urban areas.

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CRS-25
does not provide the same health-care services in all areas. Services vary from place
to place and from time to time.
Organization and Key Programs
To carry out its roles for health-care services and health-care facilities, the IHS
is organized into a headquarters office, 12 regions (each directed by an area office),
and 167 service units (each assigned to an area office).32 At the headquarters level,
and within area offices and service units where relevant, there are programmatic
offices for the following activities:
! clinical and preventive health services, including clinical and
community services, behavioral health, nursing services, oral health,
and diabetes treatment and prevention;
! public health support, including disease prevention and
epidemiology, and health professions recruitment and scholarship
programs; and
! environmental health and engineering, including health facilities
planning and construction, sanitation facilities construction, facilities
operation, engineering, and environmental health services.
Direct clinical health care is provided through 48 inpatient hospitals and 603
ambulatory facilities (which include 272 health clinics, 154 health stations, 166
Alaska village clinics, and 11 school health centers). Fifteen of the hospitals and 511
of the ambulatory facilities are operated by tribes and tribal organizations, under
contracts and compacts pursuant to the Indian Self-Determination and Education
Assistance Act of 1975.33 The remaining facilities are operated by the IHS. In
addition, IHS funds 34 urban Indian health projects in 41 urban sites through federal
contracts and grants.34
The IHS offers information on its programs through its website at
[http://www.ihs.gov].
History and Legislative Authorities
Health-care services for Indians developed gradually over the course of the 19th
century, pursuant to congressional appropriations but without an explicit statutory
32 A service unit is an administrative entity within a defined geographical area, through
which services are directly or indirectly provided to eligible Indians. A service unit may
cover a number of small reservations, or, conversely, a large reservation may be covered by
several service units.
33 P.L. 93-638, act of January 4, 1975, 88 Stat. 2203, as amended; 25 U.S.C. § 450 et seq.
34 Statistics in this paragraph are from U.S. Department of Health and Human Services,
Indian Health Service, Justification of Estimates for Appropriations Committees, Fiscal
Year 2008, pp. CJ-121 and CJ-251, at [http://www.hhs.gov/budget/docbudget.htm].

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CRS-26
establishment of an Indian medical agency. What health services were provided were
under the War Department before 1849, and under the Department of the Interior
after 1849, when the Bureau of Indian Affairs (BIA) was transferred to the new
department. While the number of BIA hospitals and physicians gradually increased
in the late 19th and early 20th centuries, BIA did not have a bureau-wide medical
supervisor until 1908. The Snyder Act of 192135 authorized federal programs for
Indians within the BIA, including health care, but did not establish an Indian medical
agency. In 1954, Congress passed the Transfer Act, directing that Interior’s and the
BIA’s responsibilities, functions, and facilities for Indian health care be transferred
to the Surgeon General of the Public Health Service in the Department of Health,
Education, and Welfare.36 The transfer occurred on July 1, 1955, and since then, IHS
has been a part of the PHS.
Besides general statutory authority under the Snyder Act and the Transfer Act,
specific IHS programs are authorized by the Indian Sanitation Facilities Act of
1959,37 authorizing the PHS to construct sanitation facilities for Indian communities
and homes; the Indian Health Care Improvement Act (IHCIA) of 1976,38 which
established many specific IHS programs, such as urban health, professions
recruitment, and mental health, and also authorized IHS (through amendments to the
Social Security Act) to make direct collections from Medicare/Medicaid and third-
party insurers; and the Indian Self-Determination and Education Assistance Act of
1975,39 which provides for tribal administration of federal Indian programs,
especially BIA and IHS programs, under self-determination contracts and self-
governance compacts.
Unlike most other PHS agencies, the IHS receives its appropriations under the
Interior, Environment, and Related Agencies Appropriations Act, not under the
Labor-HHS-Education Appropriations Act.
The Snyder Act, as it currently stands, can be considered a permanent, general
authorization for IHS. The IHCIA’s authorizations of appropriations, however,
which are more program-specific, expired at the end of FY2001. Congress continues
to appropriate funds for IHS and has been considering IHCIA reauthorization bills
since the 106th Congress. The IHCIA reauthorization bills in the 110th Congress, S.
1200 and H.R. 1328, have been ordered reported from a committee, although the
House bill must be considered by other committees of jurisdiction.
Table 7 presents funding levels for IHS programs for FY2006 through FY2008.
35 Act of November 2, 1921, 42 Stat. 208, as amended; 25 U.S.C. § 13.
36 P.L. 83-568, act of August 5, 1954, 68 Stat. 674, as amended; 42 U.S.C. § 2001 et seq.
37 P.L. 86-121, act of July 31, 1959, 73 Stat. 267; 42 U.S.C. § 2004a.
38 P.L. 94-437, act of September 30, 1976, 90 Stat. 1400, as amended; 25 U.S.C. § 1601 et
seq., and 42 U.S.C. § 1395qq, § 1396j (and amending other sections).
39 P.L. 93-638, act of January 4, 1975, 88 Stat. 2203, as amended; 25 U.S.C. § 450 et seq.

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CRS-27
Table 7. Indian Health Service (IHS)
(dollars in millions)
FY2007
FY2008
% change
final
Pres.
FY08 vs.
Programs
FY2006
enacted
request
FY07
Health Services
Clinical Services
Hospitals and Health Clinics
$1,339.5
$1,442.5
$1,493.5
3.5%
Dental Health
117.7
126.9
135.8
7.0%
Mental Health
58.5
61.7
64.5
4.7%
Alcohol and Substance Abuse
143.2
150.6
162.0
7.6%
Contract Health Care
499.6
499.6
551.5
10.4%
Catastrophic Health Emergency Fund
17.7
17.7
18.0
1.5%
Subtotal, Clinical Services
2,176.2
2,298.9
2,425.3
5.5%
Preventive Health
Public Health Nursing
49.0
53.0
56.8
7.2%
Health Education
13.6
14.5
15.2
5.2%
Community Health Reps.
52.9
55.7
55.8
0.1%
Immunization (Alaska)
1.6
1.7
1.8
3.2%
Subtotal, Preventive Health
117.1
124.9
129.6
3.7%
Other Health Services
Urban Health Projects
32.7
34.0
0.0
-100%
Indian Health Professions
31.0
31.7
31.9
0.6%
Tribal Management
2.4
2.5
2.5
1.8%
Direct Operations
62.2
63.8
64.6
1.3%
Self-Governance
5.7
5.8
5.9
1.5%
Contract Support Costs
264.7
264.7
271.6
2.6%
Collections (non-add)
(648.2)
(648.2)
(700.3)
(8.0%)
Subtotal, Other Health Services
398.7
402.5
376.5
-6.5%
Subtotal, All Health Services
2,692.1
2,826.3
2,931.5
3.7%
Health Facilities
Maintenance and Improvement
51.6
52.7
51.9
-1.4%
Sanitation Facilities Construction
92.1
94.0
88.5
-5.9%
Health Care Facilities Construction
37.8
24.3
12.7
-47.9%
Facilities/Environmental Health Support
150.7
161.3
164.8
2.2%
Equipment
20.9
21.6
21.3
-1.6%
Subtotal, Health Facilities
353.2
353.9
339.2
-4.2%
Total, IHS discretionary budget authority
$3,045.3
$3,180.2
$3,270.7
2.8%
Collections
$648.2
$648.2
$700.3
8.0%
Special Diabetes Program for Indians a
$150.0
$150.0
$150.0
0%
Total, IHS program level
$3,843.5
$3,978.4
$4,121.0
3.6%
Sources: FY2008 IHS budget justification, IHS FY2007 operating plan.
Note: Numbers may not add due to rounding.
a. Funds available to IHS for Special Diabetes Program for Indians (P.L. 105-33, P.L. 106-554, and
P.L. 107-360).

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CRS-28
National Institutes of Health (NIH)
Mission
The National Institutes of Health is the primary agency of the federal
government charged with conducting and supporting biomedical and behavioral
research. It also has major roles in research training and health information
dissemination. According to the NIH website, “Its mission is science in pursuit of
fundamental knowledge about the nature and behavior of living systems and the
application of that knowledge to extend healthy life and reduce the burdens of illness
and disability.”40
NIH is the largest of the PHS agencies, with a budget of $29.1 billion in FY2007
and total employment of more than 18,000 people. Over 80% of NIH’s annual
funding goes out through grant, contract, and training awards to extramural scientists
who work in universities, academic health centers, hospitals, and independent
research institutions in the United States and abroad. The NIH intramural research
program, accounting for about 10% of the budget, includes more than 6,500 scientists
and technical support staff who are government employees, and several thousand
additional scientific fellows, guest researchers, and contractors. The remainder of the
budget is for research management, administration, and physical infrastructure.
Organization and Key Programs
The agency’s organization consists of the Office of the NIH Director and 27
institutes and centers. The Office of the Director (OD) sets overall policy for NIH
and coordinates the programs and activities of all NIH components, particularly
trans-institute research initiatives and issues. The individual institutes and centers
(ICs), each of which focuses on particular diseases, areas of human health and
development, or aspects of research support, plan and manage their own research
programs in coordination with the Office of the Director. As shown in Table 8,
Congress provides separate appropriations to 24 of the 27 ICs, to OD, and to a
buildings and facilities account. (The remaining three centers, not included in the
table, are funded through the NIH Management Fund, financed by taps on other NIH
appropriations.) NIH occupies a 317-acre main campus in Bethesda, MD, as well as
numerous off-campus sites, including locations in Maryland, North Carolina, and
Montana.
The institutes and centers, listed in the order found in appropriations acts, are
briefly described below.41 Each leads a national research and information program
in the research areas indicated.
! Office of the Director (OD) has charge of overall NIH leadership,
and liaison with HHS. It includes special offices for research on
40 See [http://www.nih.gov/about/].
41 For further information on each component, see [http://www.nih.gov/icd/]. See also the
NIH Almanac, 2006-2007, at [http://www.nih.gov/about/almanac/about.htm].

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CRS-29
AIDS, women’s health, behavioral and social sciences, and disease
prevention (including rare diseases and dietary supplements).
! National Cancer Institute (NCI, established 1937). All aspects of
cancer — cause, diagnosis, prevention, treatment, rehabilitation, and
continuing care of patients.
! National Heart, Lung, and Blood Institute (NHLBI, established
1948). Diseases of the heart, blood vessels, lungs, and blood; sleep
disorders; and blood resources management. It also administers the
NIH Woman’s Health Initiative.
! National Institute of Dental and Craniofacial Research (NIDCR,
established 1948). Infectious and inherited oral, dental, and
craniofacial diseases and disorders.
! National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK, established 1948). Diabetes, endocrinology, metabolic
diseases; digestive diseases and nutrition; and kidney, urologic, and
hematologic diseases.
! National Institute of Neurological Disorders and Stroke (NINDS,
established 1950). Convulsive, neuromuscular, demyelinating, and
dementing disorders; fundamental neurosciences; stroke, trauma.
! National Institute of Allergy and Infectious Diseases (NIAID,
established 1948). Infectious, immunologic, and allergic diseases.
! National Institute of General Medical Sciences (NIGMS,
established 1962). Research and research training in basic
biomedical sciences (cellular and molecular biology, genetics,
pharmacology, physiology). Special focus on minority researchers.
! National Institute of Child Health and Human Development
(NICHD, established 1962). Reproductive biology; population
issues; embryonic development; maternal, child, and family health;
medical rehabilitation.
! National Eye Institute (NEI, established 1968). Eye diseases,
visual disorders, visual function, preservation of sight, health
problems of the visually impaired.
! National Institute of Environmental Health Sciences (NIEHS,
established 1969). Interrelationships of environmental factors,
individual genetic susceptibility, and age as they affect health.
! National Institute on Aging (NIA, established 1974). Biomedical,
social, and behavioral research on the aging process; diseases,
problems, and needs of the aged.

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CRS-30
! National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS, established 1986). Arthritis; bone, joint,
connective tissue and muscle disorders; skin diseases.
! National Institute on Deafness and Other Communication
Disorders (NIDCD, established 1988). Normal mechanisms and
disorders of hearing, balance, smell, taste, voice, speech, and
language.
! National Institute of Nursing Research (NINR, established 1986).
Management of acute and chronic illness, health promotion/disease
prevention, nursing systems, clinical therapeutics.
! National Institute on Alcohol Abuse and Alcoholism (NIAAA,
established 1970). Causes of alcoholism, how alcohol damages the
body, prevention and treatment strategies.
! National Institute on Drug Abuse (NIDA, established 1973).
Social, biological, behavioral, and neuro-scientific bases of drug
abuse and addiction; causes, prevention, and treatment strategies.
! National Institute of Mental Health (NIMH, established 1949).
Brain research, mental illness, and mental health.
! National Human Genome Research Institute (NHGRI, established
1989). Chromosome mapping, DNA sequencing, database
development, ethical/legal/social implications of genetics research.
! National Institute of Biomedical Imaging and Bioengineering
(NIBIB, established 2000). Research, training and coordination in
biomedical imaging, bioengineering and related technologies and
modalities, including biomaterials and informatics.
! National Center for Research Resources (NCRR, established
1962). Extramural and intramural research resources and
technologies, including general clinical research centers, computers,
instrument systems, animal resources and facilities, and
nonmammalian research models.
! National Center for Complementary and Alternative Medicine
(NCCAM, established 1999). Identifies, evaluates, and researches
unconventional health-care practices.
! National Center on Minority Health and Health Disparities
(NCMHD, established 1993). Research, training, and coordination
on minority health conditions and populations with health
disparities.

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CRS-31
! John E. Fogarty International Center (FIC, established 1968).
Focal point for NIH’s international collaboration activities and
scientific exchanges; provides leadership in global health.
! National Library of Medicine (NLM, established 1956). Collects,
organizes, and makes available biomedical information; sponsors
programs to improve biomedical communications and U.S. medical
library services.
! NIH Clinical Center (CC, established 1953). NIH’s hospital and
outpatient facility for clinical research.
! Center for Scientific Review (CSR, established 1946). Receives,
assigns, and reviews research and training grant applications.
! Center for Information Technology (CIT, established 1964).
Provides, coordinates, and manages information technology for NIH;
research to advance computational science.
History and Legislative Authorities
NIH traces its roots to 1887, when a one-room Laboratory of Hygiene was
established at the Marine Hospital in Staten Island, New York. Relocated to
Washington, DC, in 1891, and renamed the Hygienic Laboratory, it operated for its
first half century as an intramural research lab for the Public Health Service.
Congress designated the lab the National Institute of Health in 1930 (P.L. 71-251).
It moved to donated land in the Maryland suburbs in 1938. By 1948, several new
institutes and divisions had been created, and the agency became the National
Institutes of Health (P.L. 80-655). As indicated in the list above, Congress continued
to add new institutes and centers for several decades, most recently in 2000.
Section 301 of the Public Health Service Act (42 U.S.C. § 241) grants the
Secretary of HHS broad permanent authority to conduct and sponsor research. In
addition, Title IV, “National Research Institutes” (42 U.S.C. § 281-290b), authorizes
in greater detail various activities, functions, and responsibilities of the NIH Director
and the institutes and centers. All of the institutes and centers are covered by specific
provisions in the PHS Act. Prior to passage of the NIH Reform Act of 2006 (P.L.
109-482), nine of the ICs and a variety of individual programs had time-and-dollar
limits on their authorizations of appropriations. Most of the authorizations had
expired, but § 301 provided authority for the programs. The other institutes and
centers and most NIH programs did not require periodic reauthorization by Congress,
and there was no overall authorization for the agency. The new NIH Reform Act
authorized total funding levels for NIH appropriations for FY2007 to FY2009 and
eliminated all of the other specific authorizations in Title IV.
Table 8 presents funding levels for NIH accounts for FY2006 through FY2008.

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CRS-32
Table 8. National Institutes of Health (NIH)
(dollars in millions)
FY2007
FY2008
% change
final
Pres.
FY08 vs.
Institutes and Centers (ICs)
FY2006a,b
enacteda
request
FY2007
Cancer (NCI)
$4,790.1
$4,797.6
$4,782.1
-0.3%
Heart/Lung/Blood (NHLBI)
2,919.8
2,922.9
2,925.4
0.1%
Dental/Craniofacial Research (NIDCR)
389.1
389.7
389.7
0.0%
Diabetes/Digestive/Kidney (NIDDK)
1,703.8
1,705.9
1,708.0
0.1%
Neurological Disorders/Stroke (NINDS)
1,533.7
1,535.5
1,537.0
0.1%
Allergy/Infectious Diseases (NIAID)c,d
4,429.8
4,417.2
4,592.5
4.0%
General Medical Sciences (NIGMS)
1,934.3
1,935.8
1,941.5
0.3%
Child Health/Human Development (NICHD)
1,263.9
1,254.7
1,264.9
0.8%
Eye (NEI)
666.3
667.1
667.8
0.1%
Environmental Health Sciences (NIEHS)
636.2
642.0
637.4
-0.7%
Aging (NIA)
1,045.9
1,047.3
1,047.1
0.0%
Arthritis/Musculoskeletal/Skin (NIAMS)
507.6
508.2
508.1
0.0%
Deafness/Communication Disorders (NIDCD)
393.2
393.7
393.7
0.0%
Nursing Research (NINR)
137.2
137.4
137.8
0.3%
Alcohol Abuse/Alcoholism (NIAAA)
435.6
436.3
436.5
0.1%
Drug Abuse (NIDA)
999.3
1,000.6
1,000.4
0.0%
Mental Health (NIMH)
1,402.6
1,404.5
1,405.4
0.1%
Human Genome Research (NHGRI)
485.7
486.5
484.4
-0.4%
Biomedical Imaging/Bioengineering (NIBIB)
296.6
296.9
300.5
1.2%
Research Resources (NCRR)
1,098.3
1,133.2
1,112.5
-1.8%
Complementary/Alternative Med (NCCAM)
121.4
121.6
121.7
0.1%
Minority Health/Health Disparities (NCMHD)
195.3
199.4
194.5
-2.5%
Fogarty International Center (FIC)
66.3
66.4
66.6
0.2%
Library of Medicine (NLM)
314.7
320.9
312.6
-2.6%
Office of Director (OD)d,e
477.7
1,096.4
517.1
-52.8%
Buildings & Facilities (B&F)
85.5
81.1
136.0
67.7%
Subtotal, Labor/HHS Appropriation
$28,329.8
$28,998.9
$28,621.2
-1.3%
Superfund (Interior approp to NIEHS)f
79.1
79.1
78.4
-0.9%
Total, NIH discretionary budget authority
$28,409.0
$29,078.0
$28,699.7
-1.3%
Pre-appropriated Type 1 diabetes fundsg
150.0
150.0
150.0
0.0%
NLM program evaluationh
8.2
8.2
8.2
0.0%
Total, NIH program level
$28,567.2
$29,236.2
$28,857.9
-1.3%
Global Fund transfer (AIDS/TB/Malaria)c
-99.0
-99.0
-300.0
203.0%
Total, NIH program level after transfer
$28,468.2
$29,137.2
$28,557.9
-2.0%
Sources: Adapted by CRS from NIH Operating Plan for FY2007 (March 2007), reflecting final
funding levels under P.L. 110-5, Revised Continuing Appropriations Resolution, 2007, and House
Appropriations Committee table (April 17, 2007).
a. The FY2007 program level is an increase of $669.049m (2.4%) over FY2006. FY2006 and
FY2007 do not reflect comparative transfers to HHS ($0.542m) or among NIH ICs that are
shown in the FY2008 budget justification. FY2007 does not reflect the transfer of $99.0m from
NIH to the Office of the Secretary, as mandated by the supplemental appropriations act, P.L.
110-28 (see note d).
b. FY2006 reflects across-the-board rescission (1%), Interior reduction, and HHS transfer of
$19.462m to Centers for Medicare and Medicaid Services. Also reflects Director’s transfer of
$4.480m from NIEHS to B&F. Does not include $6.896m in NCI breast cancer stamp funds.

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CRS-33
c. NIAID totals include funds for transfer to the Global Fund to Fight HIV/AIDS, TB, and Malaria.
FY2006 includes $18.0m supplemental funding (P.L. 109-148) transferred from the Public
Health and Social Services Emergency Fund (PHSSEF) for pandemic flu.
d. FY2006 and FY2007 include $49.5m in NIAID for Advanced Development of Medical Counter-
measures. The FY2008 request funds the Advanced Development program in the HHS
Assistant Secretary for Preparedness and Response. Not reflected in the table: For FY2007,
the war/emergency supplemental appropriations act (P.L. 110-28, May 25, 2007) transferred
Advanced Development funding to the PHSSEF ($49.5m from NIAID and $49.5m from OD).
e. OD has Roadmap funds for distribution to ICs (FY2006, $82.170m; FY2007, $483.000m; FY2008,
$121.540m). In FY2007, all Roadmap/Common Fund money is in OD; in other years, IC
budgets are tapped for Roadmap contributions.
f. Separate account in the Interior/Environment/Related Agencies appropriation for NIEHS research
activities related to Superfund.
g. Funds available to NIDDK for diabetes research under PHS Act § 330B (P.L. 106-554 and P.L.
107-360).
h. Additional funds from program evaluation set-aside (§ 241 of PHS Act).
Substance Abuse and Mental Health Services
Administration (SAMHSA)
Mission
SAMHSA supports states’ efforts to enhance prevention and treatment programs
for substance abuse and mental health disorders. SAMHSA provides federal support
for these services by administering two block grants (one for substance abuse
prevention and treatment services, the other for mental health services), two other
formula grants, and discretionary grants to local communities, states, and private
entities to address the public health issues of substance abuse and mental illness.
SAMHSA funds a wide range of activities, including strategic planning, education
and training, prevention programs, early intervention, and treatment services.
In April 2006, SAMHSA published a matrix of the priority mental health and
substance abuse issues addressed by the agency, along with the agency’s cross-
cutting principles.42 The priority issue areas include individual health concerns such
as co-occurring mental health and substance abuse disorders, suicide, and behavioral
health issues for individuals with hepatitis and HIV/AIDS; societal issues such as
homelessness and criminal justice; and systems-level issues such as treatment
capacity and workforce development. In addition, SAMHSA has identified
principles to guide program, policy, and resource allocation within the agency. These
principles include use of evidence-based practices, evaluation, collaboration, cultural
competence, stigma reduction, and cost-effectiveness.
42 SAMHSA, Matrix of Priorities, April 2006, at [http://www.samhsa.gov/Matrix/Matrix_
Brochure_2006.pdf].

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CRS-34
Organization and Key Programs
For FY2007, SAMHSA has a budget of $3.3 billion and a staff of approximately
540.43 For a breakdown of the agency’s budget, see Table 9. SAMHSA is composed
of three centers of operation, as described below. Each center has a director who
reports to SAMHSA’s Administrator. Each center has general authority to fund
states and communities to address priority substance abuse and mental health needs.
This authority, called Programs of Regional and National Significance (PRNS),
authorizes SAMHSA to fund projects that (1) translate promising new research
findings into community-based prevention and treatment services, (2) provide
training and technical assistance, and (3) target resources to increase service capacity
where it is most needed. SAMHSA determines its funding priorities in consultation
with states and other stakeholders. SAMHSA offers information on its programs
through its website at [http://www.samhsa.gov].
SAMHSA centers are as follows:
! Center for Mental Health Services (CMHS).44 CMHS supports
mental health services provided by the states and local governments
through its mental health block grant and discretionary grant
programs. CMHS is authorized to prevent mental illness and
promote mental health by providing funds to evaluate, improve, and
implement effective treatment practices, address violence among
children, provide technical assistance to state and local mental health
agencies, and collect data.
! Center for Substance Abuse Prevention (CSAP).45 CSAP aims
to improve the quality of substance abuse prevention practices
nationwide. Through its discretionary grant programs, CSAP
provides states, communities, organizations, and families with tools
to promote protective factors and to reduce risk factors for substance
abuse. CSAP also supports the National Clearinghouse for Alcohol
and Drug Information (NCADI), the largest federal source of
information about substance abuse research, treatment, and
prevention available to the public.
! Center for Substance Abuse Treatment (CSAT).46 CSAT aims
to promote the quality and availability of community-based
substance abuse treatment services for individuals and families who
need them. CSAT works with states and community-based groups
to improve and expand existing substance abuse treatment services
under the formula-based substance abuse prevention and treatment
43 SAMHSA, Justification of Estimates for Appropriations Committees, Fiscal Year 2008,
p. Overview-9, available from [http://www.samhsa.gov/Budget/FY2008/index.aspx].
44 See [http://mentalhealth.samhsa.gov/cmhs/].
45 See [http://prevention.samhsa.gov/].
46 See [http://csat.samhsa.gov/].

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CRS-35
block grant. CSAT also supports SAMHSA’s free treatment referral
service to link people with the community-based substance abuse
services they need.
History and Legislative Authorities
SAMHSA’s predecessor agency, the Alcohol, Drug Abuse and Mental Health
Administration (ADAMHA), was established in 1974. In 1992, Congress passed the
ADAMHA Reorganization Act (P.L. 102-321), which, among other things,
established SAMHSA as a services agency with programs focused on people with or
at risk for mental or substance abuse disorders. The Act also moved the three
research institutes — National Institute of Mental Health (NIMH), National Institute
on Drug Abuse (NIDA), and National Institute on Alcohol Abuse and Alcoholism
(NIAAA) — to NIH, and renamed ADAMHA as SAMHSA to reflect its focus on
funding community-based services.
SAMHSA is authorized under Title V of the PHS Act, as amended.
SAMHSA’s block grants are authorized under PHS Act Title XIX, Part B.
SAMHSA was last authorized in 2000, as part of the Children’s Health Act.47 At the
time of that reauthorization, most of the agency’s programs were extended for three
years, through FY2003, and the block grant funding formula was not modified. The
2000 reauthorization focused on improving mental health and substance abuse
services for children and adolescents, implementing proposals to give states more
flexibility in the use of block grant funds, and replacing some existing categorical
grant programs with general authority to give the Secretary of HHS more flexibility
to respond to those who require mental health and substance abuse services.
Two SAMHSA programs have authorizations that will expire at the end of
FY2007: Suicide Technical Assistance Center (PHS Act § 520C) and Youth Suicide
Early Intervention and Prevention Strategies (PHS Act § 520E).
47 P.L. 106-310, Titles XXXI-XXXIV.

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CRS-36
Table 9. Substance Abuse and Mental Health Services
Administration (SAMHSA)
(dollars in millions)
%
FY2007
FY2008
change
final
Pres.
FY08 vs.
Centers FY2006a
enacted
request
FY07
CMHS
Programs of Regional and National Significance
$263.1
$263.3
$186.6
-29.1%
Mental Health Block Grant
406.6
406.8
406.8
0.0%
PHS Program Evaluation Set-Aside (non-add)b
21.8
21.4
21.4
0.0%
Children’s Mental Health
104.0
104.1
104.1
0.0%
Projects for Assistance in Transition from
Homelessness (PATH formula grant)
54.2
54.3
54.3
0.0%
Protection and Advocacy for Individuals with
Mental Illness (PAIMI formula grant)
34.0
34.0
34.0
0.0%
Subtotal, CMHS budget authority
861.9
$862.4
$785.8
-8.9%
CSAT
Programs of Regional and National Significance
394.4
394.6
347.8
-11.9%
PHS Program Evaluation Set-Aside (non-add)b
4.3
4.3
4.3
0.0%
Substance Abuse Prevention and Treatment Block
Grant
1,678.2
1,679.4
1,679.4
0.0%
PHS Program Evaluation Set-Aside (non-add)b
79.2
79.2
79.2
0.0%
Subtotal, CSAT budget authority
2,072.6
2,074.0
2,027.2
-2.3%
CSAP
Programs of Regional and National Significance
192.8
192.9
156.5
-18.9%
Subtotal, CSAP budget authority
192.8
192.9
156.5
-18.9%
Program Management
Program Management
76.0
76.7
77.0
0.4%
PHS Program Evaluation Set-Aside (non-add)b
16.0
16.0
16.3
1.9%
Total, Program Management budget authority
76.0
76.7
77.0
0.4%
Total, SAMHSA budget authority
$3,203.2
$3,206.1
$3,046.4
-5.0%
Total, PHS Program Evaluation Set-Asideb
121.3
120.9
121.2
0.2%
TOTAL, SAMHSA program level
$3,324.5
$3,327.0
$3,167.6
-4.8%
Sources: Adapted by CRS from SAMHSA Operating Plan for FY2007 (March 2007), reflecting final
funding levels under P.L. 110-5, Revised Continuing Appropriations Resolution, 2007, and House
Appropriations Committee table (April 17, 2007).
Note: Numbers may not add due to rounding.
a. FY2006 reflects 1% rescission and HHS internal transfer.
b. Additional funds from PHS program evaluation set-aside (§ 241 of PHS Act).

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CRS-37
Additional Congressional Research
Service (CRS) Reports
Agency Overview Reports
RL33022, Indian Health Service: Health Care Delivery, Status, Funding, and
Legislative Issues, by Donna U. Vogt and Roger Walke.
RL33695, The National Institutes of Health (NIH): Organization, Funding, and
Congressional Issues, by Pamela W. Smith.
RL33997, Substance Abuse and Mental Health Services Administration (SAMHSA):
Reauthorization Issues, by Ramya Sundararaman.
Appropriations Reports
RL33412, Agriculture and Related Agencies: FY2007 Appropriations, by Jim
Monke, Coordinator. (FDA)
RL34011, Interior, Environment, and Related Agencies: FY2008 Appropriations, by
Carol Hardy Vincent, Coordinator. (ATSDR, IHS)
RL34076, Labor, Health and Human Services, and Education: FY2008
Appropriations, by Pamela W. Smith, Coordinator. (AHRQ, CDC, HRSA, NIH,
SAMHSA)
Links to Selected Reports on Current Legislative Issues
Biomedical Research Policy: Stem Cells, Genetics, and Other Research Areas:
[http://apps.crs.gov/cli/cli.aspx?PRDS_CLI_ITEM_ID=2257&from=3&fromId=13].
Drugs and Medical Devices: Safety, Effectiveness, and Availability:
[http://apps.crs.gov/cli/cli.aspx?PRDS_CLI_ITEM_ID=2678&from=3&fromId=13].
Food Supply: Safety, Affordability, and Nutrition:
[http://apps.crs.gov/cli/cli.aspx?PRDS_CLI_ITEM_ID=2621&from=3&fromId=13].
Public Health and Medical Preparedness and Response:
[http://apps.crs.gov/cli/cli.aspx?PRDS_CLI_ITEM_ID=2628&from=3&fromId=13].

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