Public Health Service (PHS) Agencies: Background and Funding

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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
discretionary appropriations to these agencies for FY2008 totaled $50.6 billion.
For each of the PHS agencies, this report describes the mission, organization, key programs,
history, and legislative authorities, and provides budget tables for FY2007 through the FY2009
request. It will be updated as legislative and other events warrant.

Overview and History of the Public Health Service........................................................................1
Agency for Healthcare Research and Quality (AHRQ)..................................................................5
Miss ion ...................................................................................................................................... 5
Organization and Key Programs...............................................................................................5
History and Legislative Authorities...........................................................................................7
Centers for Disease Control and Prevention (CDC)/Agency for Toxic Substances and
Disease Registry (ATSDR)...........................................................................................................9
Miss ion ...................................................................................................................................... 9
Organization and Key Programs...............................................................................................9
History and Legislative Authorities..........................................................................................11
Food and Drug Administration......................................................................................................13
Miss ion .................................................................................................................................... 13
Organization and Key Programs.............................................................................................14
History and Legislative Authorities.........................................................................................15
Health Resources and Services Administration (HRSA)..............................................................18
Miss ion .................................................................................................................................... 18
Organization and Key Programs.............................................................................................19
History and Legislative Authorities.........................................................................................20
Indian Health Service (IHS)..........................................................................................................23
Miss ion .................................................................................................................................... 23
Organization and Key Programs.............................................................................................23
History and Legislative Authorities.........................................................................................24
National Institutes of Health (NIH)...............................................................................................26
Miss ion .................................................................................................................................... 26
Organization and Key Programs.............................................................................................27
History and Legislative Authorities.........................................................................................29
Substance Abuse and Mental Health Services Administration (SAMHSA).................................31
Miss ion .................................................................................................................................... 31
Organization and Key Programs.............................................................................................32
History and Legislative Authorities.........................................................................................33
Additional Congressional Research Service (CRS) Reports.........................................................35
Links to Selected Reports on Current Legislative Issues........................................................35
Table 1. Titles in the Public Health Service Act..............................................................................1
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)..................................................................................................12
Table 5. Food and Drug Administration (FDA)............................................................................17

Table 6. Health Resources and Services Administration (HRSA).................................................21
Table 7. Indian Health Service (IHS)............................................................................................25
Table 8. National Institutes of Health (NIH).................................................................................30
Table 9. Substance Abuse and Mental Health Services Administration (SAMHSA)....................34
Author Contact Information..........................................................................................................36
Key Policy Staff............................................................................................................................36

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 ¹
streams.” 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://ene rgyc o mme rce.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 a}^{nd Duties of Pu}^{blic Health Service}
^{Title IV}^{National Research I}^nstitutes
^{Title V}^Substanc^{e Ab}^{use and}^{Mental H}^e^a^{lth Services Administration}
^{Title VI}^{Assistance for Const}^{ruction a}^nd^{Modernization of Hospitals and Other}^{Medical Facilit}^ies
^{Title VII}^{Health Professions Ed}^ucation
^{Title VIII}^Nursing^{Workforce Developmen}^t
^{Title IX}^{Agency for}^{Healthcare Resea}^rch^{and Quality}
^{Title X}^{Population Research and Volunta}^{ry Family Planning Programs}
^{Title XI}^{Genetic Diseases, Hemop}^{hilia Programs, and Sudden In}^{fant Deat}^h^Syndrome
^{Title XII}^{Trauma Care}
^{Title XIII}^{Health Mainte}^nance^Orga^nizations
^{Title XIV}^{Safety of Public Water Systems}
^{Title XV}^{Preventive Health}^Meas^{ures with}^{Respect to Breast a}^{nd Cervical Cancers}
^{Title XVI}^{Health Resources Developme}^nt
^{Title XVII}^{Health In}^{formation and Health}^Pr^omotion
^{Title XVIII}^{President’s Commission for the Study of Et}^{hical Problems in Medic}^{ine and Biomedical and}^{Behavioral Research}
^{Title XIX}^{Block Grants}

¹^Se^c^tion³⁰¹^of^the^P^H^{S A}^c^{t, c}^odi^fⁱ^e^d^a^t^{42 U}^.^S^.^C^.^{§ 2}⁴¹⁽^a⁾^.

^{Title I}^{Short Title and Definitions}
^{Title XX}^{Adolescent Family Life Demonstration Projects}
^{Title XXI}^Vaccines
^{Title XXII}^Requirement^{s for Certain}^Grou^p^{Health Plans for Certai}^{n State an}^{d Local Employees}
^{Title XXIII}^{Research with Res}^{pect to Ac}^quir^{ed Immu}^{ne Deficiency Synd}^rome
^{Title XXIV}^{Health Services with Res}^{pect to}^{Acquired Im}^mu^{ne Deficiency Syn}^drome
^{Title XXV}^{Prevention of Acq}^{uired Imm}^une^{Deficiency Syndrome}
^{Title XXVI}^{HIV Health Care Ser}^{vices Progra}^m
^{Title XXVII}^{Assuring Portability, Availabil}^ity,^{and Renewability of Health I}^nsu^ra^{nce Coverage}
^{Title XXVIII}^{National Preparedness}^{for Bioterrorism and Othe}^{r Pu}^{blic Health}^Emerge^ncies
^{Title XXIX}^{Lifespan Res}^{pite Care}
^Sources:^{Compiled by CRS from U.S. House of Representatives,}^{Committee on Ene}^{rgy and Com}^merce,
^{Compilation of Selected Acts}^{Within the Jurisdiction of the Committee}^oⁿ^{Energy and}^{Commerce: Health Law}^{, August}
²⁰⁰^{5 http://ene}^{rgycommerce.ho}^u^se.gov/¹⁰^8/^pub^s/10^{9_health.pdf,}^a^ndP.L. 109-442^{, Lifes}^{pan Res}^{pite Care Act}
^{of 20}^06.
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 ²
Welfare (HEW). In 1979, the Department of Education Organization Act (P.L. 96-88) provided
for a separate Department of Education, and HEW was officially redesignated as HHS on May 4, ³
1980. HHS has designated eight agencies as Public Health Service operating divisions. 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,

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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 FY2007 through the FY2009 request.
Detailed budget tables are provided with each agency discussion. 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 through the
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
appropriation. As part of the President’s annual budget proposal, HHS presents a common request
for all of its components. Documents supporting the HHS budget request for FY2009, including a
summary called the Budget in Brief and links to the “Congressional justification” materials
prepared for the Appropriations Committees, may be found at http://www.hhs.gov/budget/
docbudget.htm.
The PHS Evaluation Set-Aside, also called the PHS Evaluation Tap, is a unique budget transfer
feature for agencies and offices authorized by the PHS Act and funded by the Labor-HHS-ED
appropriations act. Section 241 of the PHS Act (42 U.S.C. § 238j) authorizes the Secretary to use
a portion of eligible appropriations to assess the effectiveness of federal health programs and to
identify ways to improve them. Funds are also used for activities that support the infrastructure
for evaluation of health programs, such as data-gathering and analysis. Although the PHS Act
limits the set-aside to no more than 1% of program appropriations, in recent years the annual
Labor-HHS-ED appropriations act has specified a higher maximum amount of funds that may be ⁴
set aside for evaluation (currently 2.4% of the eligible portions of agency budgets).
HHS identifies the amount of set-aside funds to be “tapped,” primarily from the appropriations of
NIH, HRSA, CDC, and SAMHSA, and determines the amount of funding to be made available to
each “recipient” agency or program, including several offices within the Office of the HHS
Secretary. Many of the recipient programs are specified by Congress in the appropriations act.

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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. See the individual
agency budget tables for specifics.
For each of the PHS agencies, this report describes the mission, organization, key programs,
history, and legislative authorities, and provides budget tables for FY2007 through the FY2009
request. It will be updated as legislative and other events warrant.
Table 2. Public Health Service (PHS) Agency Budgets: Summary Table
^(doll^a^{rs in mi}^llions)
^FY20⁰⁷^FY20⁰⁸^FY20^{09 Pres.}^{% chan}^{ge FY09 vs.}
^Agencies^actual^enacted^request^FY08
^{Agency f}^{or Healthcare Resea}^{rch a}^nd^{Quality (AHRQ)}
^{Discretionary budget}^{0 0}⁰^0.0%
^authority
^{Total program level}³¹⁹³³⁵³²⁶^-2.7%
^{Centers for Disease Control}^{and Prevention (CDC)/}
^{Agency f}^{or T}^{oxic Substan}^{ces and Disease Registry (ATSDR)}
^{Discretionary budget}^6,06^{0 6,12}⁴^5,69¹^-7.1%
^authority
^{Total program level}^9,11⁶^9,20⁹^8,79⁷^-4.5%
^{Food an}^{d Dru}^{g A}^{dministration (FDA)}
^{Discretionary budget}^1,58^{3 1,72}⁰^1,77¹^2.9%
^authority
^{Total program level}^1,97⁴^2,27⁰^2,40⁰^5.7%
^{Health Resources and Servic}^{es Administration (HRSA)}
^{Discretionary budget}^6,39^{8 6,86}⁴^5,87²^-14.5%
^authority
^{Total program level}^6,44⁷^6,91⁷^5,92²^-14.4%
^{Indian Health Service (IHS)}
^{Discretionary budget}^3,18^{0 3,34}⁶^3,32⁵^-0.6%
^authority
^{Total program level}^4,10³^4,28²^4,26¹^-0.5%
^{National Institut}^{es of Health}^(NIH)
^{Discretionary budget}^28,9^{78 29,3}⁰⁷^29,3⁰⁷^0.0%
^authority
^{Total program level}^29,0³⁸^29,1⁷¹^29,1⁶⁵^0.0%
^{Substance Ab}^{use and Mental Health S}^{ervices Administration (SAMHSA)}
^{Discretionary budget}^3,20^{6 3,23}⁴^3,02⁵^-6.5%
^authority
^{Total program level}^3,32⁷^3,35⁶^3,15⁹^-5.9%
^{Total for PHS Agen}^cies^a
^{Discretionary budget}^49,4⁰⁵^50,5⁹⁶^48,9⁹¹^-3.2%

^FY20⁰⁷^FY20⁰⁸^FY20^{09 Pres.}^{% chan}^{ge FY09 vs.}
^Agencies^actual^enacted^request^FY08
^authority
^Source:^{Derived from age}^{ncy ta}^{bles in this re}^{port (}^{Table 3}^thro^ugh^Ta^{ble 9}^).
^Note:^T^{otals and percentage}^{s m}^{ay not comp}^{ute exac}^{tly due to ro}^unding.
^a.^{AHRQ is financed t}^hroug^{h PHS e}^{valuation funds, whic}^{h come f}^{rom the a}^pprop^{riations of other ag}^encies.
^{Therefore, AHRQ is not include}^{d in the total for discretionary b}^u^{dget authority. (A total program level for}
^{PHS agencies can}^{not be calc}^{ulated without additional}^{information on the distribution of PHS evalua}^tion
^{funds ac}^{ross multiple H}^{HS agenci}^es.)

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.
The agency is divided into nine major functional components, consisting of four offices and five ⁵
research centers. The offices, centers, and key program areas are described below. 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 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 PriorityPopulations (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

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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.
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 ⁶
annual report to Congress, the National Healthcare Disparities Report.
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 ⁷
different therapies used to treat the same condition.
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 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 ⁸
on health insurance plans obtained through private and public-sector employers.
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

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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 FY2007 through FY2009. 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)
^(doll^a^{rs in mi}^llions)
^FY20⁰⁷^FY20⁰⁸^FY20^{09 Pres.}^{% chan}^{ge FY09}
^Activiti^es^actual^enacted^request^{vs. FY0}⁸
^{Research o}ⁿ^{Health Costs, Quality, and Outcomes (HCQ}^O)
^{Budget Authority}⁰⁰⁰^0.0%
^{PHS Evaluation Tap f}^unding^a²⁶¹²⁷⁷²⁶⁸^-3.3%
^{Patient Safety Research (non-add)}^b⁽³⁴⁾⁽³⁴⁾⁽³²⁾^-6.0%
^{Health Information Technology (non-}^{(50) (45)}⁽⁴⁵⁾^0.0%
^add)^b
^{Total AHRQ patient safety program}^b^{(84) (79)}⁽⁷⁷⁾^-2.7%
^(non-add)
^{Comparative Effectiveness (non-add)}⁽¹⁵⁾⁽³⁰⁾⁽³⁰⁾^0.0%
^{Medical Expenditure Panel S}^{urveys (MEPS)}
^{Budget Authority}⁰⁰⁰^0.0%
^{PHS Evaluation Tap f}^unding^a⁵⁵⁵⁵⁵⁵^0.0%
^Progr^{am Supp}^ort
^{Budget Authority}⁰⁰⁰^0.0%
^{PHS Evaluation Tap f}^unding^a³³³^0.0%
^{Total, AHRQ discretionary}^{0 0}⁰^0.0%
^{budget autho}^rity
^Total^{, PHS Evaluation Tap fu}^nding^a³¹⁹³³⁵³²⁶^-2.7%
^{Total, AHRQ pr}^ogra^{m level}³¹⁹³³⁵³²⁶^-2.7%
^Source:^{Adapted b}^y^{CRS from}^AHRQ,^{Justification of Estimates fo}^{r Appropriations Committee}^{s, Fiscal}^{Year 2009}^{, at}
^{http://www.ahrq.gov/}^about/cj200^9/cj20^09.pdf.
^Note:^T^{otals and percentage}^{s m}^{ay not comp}^{ute exac}^{tly due to ro}^unding.
^a.^{AHRQ receives its e}^{ntire fu}^nding^throug^{h tra}^nsfers^{from othe}^{r PH}^{S agencies unde}^{r the P}^{HS Evaluat}^{ion Set-}
^{Aside (§ 241 of the}^{PHS Act).}
^b.^{AHRQ’s patient safet}^{y progra}^{m includes both}^{Patient Safety Resea}^{rch a}^{nd Health I}^{nformation Tech}^nology.

According to the Centers for Disease Control and Prevention (CDC), its mission is “to promote ⁹
health and quality of life by preventing and controlling disease, injury, and disability.” 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.
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 several peer-reviewed journals, including 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 ¹⁰
reduce the harmful effects of exposure to hazardous substances on human health.
The current structure of CDC was implemented in April 2005 in a reorganization called “The ¹¹
Futures Initiative.” The agency has more than 8,500 permanent employees and approximately ¹²
6,000 contract employees. 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.

⁹^Se^e^the^{CDC w}^e^bsite^a^t^http^://w^ww^.c^dc^.g^ov^/.
¹⁰^S^{ee “P}^u^b^lⁱ^c^Heal^t^h^Issu^{es an}^{d t}^h^{e Agen}^c^y^f^o^{r T}^o^xi^{c S}^u^b^s^t^aⁿ^{ces an}^d^Di^{sease Regi}^st^r^y^,^”ⁱⁿ^CRS^Rep^o^r^t⁹⁷^-³¹²^,
^Supe^r^f^un^{d F}^a^c^t^Bo^ok^,^by^Ma^r^k^R^e^is^c^h^a^{nd D}^a^vⁱ^{d M}^.^B^e^a^r^de^n.
¹¹^Se^e^htt^p^://w^w^w^.^c^dc^.g^ov^/f^uture^s^{/ a}^{nd t}^h^e^CD^{C org}^a^niz^a^tio^na^{l c}^h^a^r^t^a^t^htt^p^://w^w^w^.c^dc^.g^ov^/^a^bout/^o^rg^aⁿ^iz^a^tion/
^or^g^C^ha^r^t^.htm^.
¹²^S^{ee CDC’s cu}^rren^t^ann^u^a^l^repo^rt^,^T^h^{e St}^a^t^e^o^f^C^D^C^,^F^Y²⁰⁰⁶^{, p. 35}^,^a^t^htt^p^://w^w^w^.c^dc^.g^ov^/^a^bout/^s^ta^te^of^c^d^c^/^c^d^rom^/
^SO^C^D^C^/^SO^C^D^C²⁰⁰^6.^pdf^.

• 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 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.
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 ¹³
health community and among the public.
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 ¹⁴
permanent authority in the Occupational Safety and Health Act of 1970. The National Center on
Birth Defects and Developmental Disabilities was established in Section 317C of the PHS Act by ¹⁵
the Children’s Health Act of 2000. Its appropriations authority expired in 2007. 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. Its appropriations authorities
expired in FY2002 and FY2003. ATSDR was established in the Comprehensive Environmental ¹⁶
Response, Compensation and Liability Act of 1980 (CERCLA). Its appropriations authority ¹⁷
expired in 1994. NCBDDD, NCHS, and ATSDR have continued to receive annual
appropriations despite their expired authorities.
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

¹³^Iⁿ^f^o^r^m^a^{tion on C}^D^C^his^t^or^y^is^av^a^ila^ble^{in C}^e^nte^r^s^f^o^r^Dⁱ^s^e^a^s^e^C^ontr^o^{l a}ⁿ^d^P^r^e^v^eⁿ^ti^on,^“^C^D^C^{: T}^h^e^N^a^tion’^s
^P^r^even^tⁱ^oⁿ^A^g^en^c^y^,^”^M^MWR^,^v^o^{l. 41}^{, n}^o^.⁴⁴⁽^N^ov^e^m^be^r^{6, 19}⁹²⁾^,^{p. 8}³⁴^.
¹⁴^{29 U}^.^S.C^.^§⁶⁷^1.
¹⁵^{42 U}^.^S.C^.^§²⁴^7b-^4.
¹⁶^{42 U}^.^S.C^.^§⁹⁶⁰⁴⁽ⁱ⁾^.
¹⁷^{42 U}^.^S.C^.^§⁹⁶¹¹⁽^m⁾^.

potential bioterrorism agents are handled, and authority for disease control functions concerning ¹⁸
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 FY2007 through FY2009.
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 requested almost $1 billion above the agency’s ¹⁹
FY2007 level.
Table 4. Centers for Disease Control and Prevention (CDC)/Agency for Toxic
Substances and Disease Registry (ATSDR)
^(doll^a^{rs in mi}^llions)
^FY20⁰⁷^FY20⁰⁸^FY20^{09 Pres.}^{% chan}^{ge FY09}
^Progr^ams^actual^enacted^request^{vs. FY0}⁸
^{Infectious Diseases, b}^{udget aut}^hority^1,79^{7 1,89}²^1,85⁷^-1.8%
^(BA)
^{Pandemic and seasonal influenza (non-}^a^{(73) (157)}⁽¹⁶⁰⁾^1.8%
^add)
^{PHS Evaluation Tap f}^unding^b¹³¹³¹³^0.0%
^{Infectious Diseases, p}^{rogram leve}^l^1,81⁰^1,90⁵^1,87⁰^-1.8%
^{Health Promotion, BA}⁹⁴⁷⁹⁶¹⁹³²^-3.0%
^{Health In}^{formation and Service,}^BA¹³⁶⁹⁰¹³³^48.0%
^{PHS Evaluation Tap f}^unding^b¹³⁴¹⁸⁷¹⁵¹^-19.0%
^{Health In}^{formation and Service,}^{270 277}²⁸⁴^2.7%
^{program level}
^Environme^{ntal Health a}^{nd Inju}^ry,^BA²⁸³²⁸⁹²⁷¹^-6.4%
^Occu^{pational Safety and Health,}^BA²²⁸²⁸⁷¹⁸⁴^-36.0%
^{PHS Evaluation Tap f}^unding^b⁸⁷⁹⁵⁸⁷^-7.9%
^Occu^{pational Safety and Health,}^{315 382}²⁷¹^-29.0%
^{program level}
^{Global Health, BA}³⁰⁷³⁰²³⁰²^0.1%
^{Public Health Researc}^{h, BA}⁰⁰⁰^0.0%
^{PHS Evaluation Tap f}^unding^b³¹³¹³¹^0.0%
^{Public Health Researc}^{h, program}^level³¹³¹³¹^0.0%

¹⁸^For^m^o^r^e^inf^o^r^m^a^{tion, s}^e^e^C^R^S^R^e^por^{t R}^L³⁴¹⁴^4,^Ex^te^ns^iv^e^l^y^D^r^ug-^Re^sⁱ^s^t^aⁿ^t^Tu^be^r^c^ulos^is⁽^X^D^R^-^T^B)^:^Em^e^r^gin^g
^Public^H^e^a^lth^Thr^e^a^t^s^a^{nd Q}^uar^aⁿ^tine^an^{d I}^s^o^l^ati^oⁿ^{, by}^K^a^thle^eⁿ^{S. Sw}^e^ndim^a^{n a}^{nd N}^a^nc^y^Le^e^J^o^ne^s^.
¹⁹^Se^e^htt^p^://w^w^w^.^f^undc^dc^.org^/^doc^um^eⁿ^ts^/^C^D^C^FY²⁰⁰⁸^P^J^_0⁰⁰^.p^df^.

^FY20⁰⁷^FY20⁰⁸^FY20^{09 Pres.}^{% chan}^{ge FY09}
^Progr^ams^actual^enacted^request^{vs. FY0}⁸
^{Public Health Im}^proveme^{nt and}^{203 225}¹⁸²^-19.0%
^{Leadership, BA}
^{Prev. Health and Health}^Services^Block^{99 97}⁰^-100.0^%
^{Grant, BA}
^{Buildings and Facilit}^{ies, BA}¹³⁴⁵⁵⁰^-100.0^%
^{Business Services Su}^{pport, BA}³⁷⁸³⁷²³³⁸^-9.1%
^{Terrorism, BA}^1,47³^1,47⁹^1,41⁹^-4.1%
^{Subtotal, Labor-HHS-ED}^5,98^{5 6,05}⁰^5,61⁸^-7.1%
^{discretionary BA}
^ATSDR^{, BA (Interior/Environme}^nt^{75 74}⁷³^-1.6%
^approp^riations)
^{Subtotal, CDC/ATSDR}^6,06^{0 6,12}⁴^5,69¹^-7.1%
^{discretionary BA}
^Total^{, P}^{HS Evaluation Tap fu}^nding^b²⁶⁵³²⁶²⁸³^-13.2%
^{Vaccines for Children (VFC)}^c^2,73⁶^2,70²^2,76⁶^2.4%
^EEOICPA^d^(proposed)⁵²⁵⁵⁵⁵^0.0%
^{User fees}^e²²²^0.0%
^{Total, CDC/ATSDR pro}^gra^m^9,11^{6 9,20}⁹^8,79⁷^-4.5%
^leve^l
^Source:^{Adapted b}^y^{CRS from}^CDC,^{Budget Request Summary, Fi}^{scal Year 2009}^{, FY2009 Discretio}^{nary All-}
^{Purpose Table, p}^{p. 16-}^{18, at htt}^p:^{//www.cdc.gov/}^{fmo/fmofybudget.}^htm.
^Note:^T^{otals and percentage}^{s m}^{ay not comp}^{ute exac}^{tly due to ro}^{unding. BA is budget a}^{uthority, th}^e
^{discretionary app}^{ropriation for t}^{he p}^{rogram. Program level is the}^{total available funding for the}^pro^gram.
^a.^{Levels reflect a}^{proposed consolidation of influenza fu}^{nding. For th}^{e FY200}^{9 re}^{quest, CDC ha}^{s cons}^oli^dated
^{all funding for pa}^{ndemic and seas}^{onal influenza within th}^{e In}^fectiou^{s Diseases budget}^rathe^{r tha}^{n displaying it}
^{within several b}^{udget categories. FY2007}^{and FY2}⁰⁰^{8 amoun}^{ts refl}^{ect compara}^{ble fu}^nding.
^b.^{Funds from PHS}^{Evaluation Set-Aside (§ 241 of the}^{PHS Act).}
^c.^{The Vaccines for C}^{hildren (VFC) program}^{provides free}^{pediatric vaccines to doctors who serve}^eligible
^{children. The VFC program is f}^uⁿ^{ded entirely by federal}^{Medicaid approp}^{riations and is administere}^{d by}
^{CDC’s National Center for Imm}^{unization and Respiratory Diseas}^es.
^d.^{EEOICPA is t}^{he E}^nergy^Em^{ployees Occu}^{pational Illness Compen}^s^{ation Program Act. The FY200}^{9 r}^equest
^{includes an additional $55 million in mandatory f}^{unding to s}^u^p^port^req^{uired activities that are car}^{ried out by}
^{NIOSH. Prior to FY200}^{9, fu}^{nding for these a}^{ctivities was provided by th}^{e Depart}^{ment of}^{Labor t}^h^r^{ough an}
^{interagency ag}^reeme^{nt. The FY20}^{07 a}^{nd FY20}^{08 amou}^nts^{reflect c}^{omparable f}^unding.
^e.^{CDC is authorized to col}^{lect fees from resea}^rche^{rs and ot}^{hers w}^{ho use ce}^{rtain of th}^{e agenc}^{y’s databases.}

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.
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 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 human 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. In
addition, CFSAN regulates the safety and labeling of cosmetics.
http://www.cfsan.f da.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 activities,
including inspection and enforcement. http://www.fda.gov/ora/
Until the beginning of the 20^th 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.
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 ²⁰
well. 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 ²¹
government. The box below tracks the highlights of its organizational moves.
FDA Organizational Timeline
¹⁸⁶²^{New Burea}^{u of Ch}^emis^{try in t}^he^{new U.S. Dept. of Agriculture (USDA)}
¹⁹²⁷^{Bureau of C}^hemistry^{became t}^h^e^Food,^{Drug, and Insecticide Adm}^inistration
¹⁹³¹^{Renamed: the USDA Food and D}^{rug Administration (FDA)}
¹⁹⁴⁰^{FDA transfer}^{red from USDA to the Federal Security Age}^{ncy (FSA)}
¹⁹⁵³^{FSA became the De}^{pt. of Health,}^{Education, and Welfare (H}^EW)
¹⁹⁶⁸^{FDA (remaining in HEW)}^becam^{e part of t}^{he Pu}^{blic Health Servic}^{e (PHS)}

²⁰^K^e^f^a^uve^r^-^H^a^r^rⁱ^s^D^r^ug^A^m^e^ndm^ents^to^the^FFD^C^A^{, P}^.^L^.⁸⁷^-⁷⁸¹⁽¹⁹⁶²⁾^.
²¹^Se^e^FD^A^a^{nd U}^S^D^A^We^{b pa}^g^e^s^a^t^http^://w^w^w^.^f^da^.g^ov^/^opa^c^o^m^/^ba^c^k^g^r^ounde^rs^/m^ile^s^.^ht^m^l^a^nd
^http:^//w^w^w^.f^sⁱ^s^.^us^da^.g^ov^/A^bout_^FSI^S/^A^g^eⁿ^cy^_H^is^tor^y^/ⁱⁿ^d^e^x^.a^s^p^.

¹⁹⁸⁰^{HEW (without Ed}^{ucation) becam}^{e the Dept. of Healt}^{h and H}^umaⁿ^{Services (HHS)}
The FFDCA is the principal source of FDA’s authority.²² The Act consists of the following
chapters, governing the majority of FDA’s activities:
FFDCA Chapters
^{Chapter I:}^{Short Title.}
^{Chapter II:}^Definitions.
^{Chapter III:}^{Prohibited Acts and Penalties.}
^{Chapter IV:}^Food^{. Pursuant to t}^{he definition in Section 20}^{1, food is defined to include foods for huma}^{ns, as}
^{well as animal feeds, including pet food.}
^{Chapter V:}^{Drugs and Devices. I}^{ncludes p}^{rovisions regarding the reg}^{ulation of huma}^{n drug}^{s and medical}
^{devices, and animal drugs; certain}^{provisions regarding biological products; and certain}^special
^{provisions suc}^{h as those}^regardin^{g pediatric drug st}^udies.
^{Chapter VI:}^Cosmetics.
^{Chapter VII:}^{General A}^{uthority. Includes, amo}^{ng other t}^{hings, aut}^{hority to pro}^{mulgate regulations, and to}²³
^{conduct ins}^{pections and inve}^stigations.
^{Chapter VIII:}^{Imports a}^{nd E}^xports.
^{Chapter IX:}^{Miscellaneous.}
FDA is also responsible for certain provisions in other laws, most notably the Public Health ²⁴
Service (PHS) Act. The PHS Act contains certain specific provisions that are implemented by ²⁵
FDA, such as mammography quality standards. 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 ²⁶
authority under the PHS Act to control diseases.
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 ²⁷
FFDCA. Furthermore, different types of biologics may be regulated by either CDER or ²⁸
CBER. 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.

²²^T^h^e^FFD^C^A^is^c^odifⁱ^e^d^a^t^{21 U}^.^S.C^.^§³^{01 e}^t^s^e^{q. T}^h^e^FD^A^w^e^bsite^of^f^e^r^s^the^te^x^t^of^FFD^C^A^c^h^a^p^te^r^s⁽^c^ur^r^e^nt
^t^h^rou^g^h^Decem^b^e^r^{2004); a}^c^r^os^s^-re^fe^re^nc^e^{to c}^o^rre^s^p^o^ndi^ng^s^e^c^tions^{in T}^itle^21,^Cha^p^te^r⁹^of^the^U^.^{S. Co}^de^{; a}ⁿ^d
^sigⁿ^if^ic^aⁿ^{t a}^m^eⁿ^d^m^eⁿ^{ts to the}^FF^DCA^,^a^t^http://w^ww^.^f^da^.g^ov^/^opa^c^o^m^/^la^w^s^/.
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^http:^//www^.f^da^.g^ov^/^o^c^/^c^o^m^b^ina^tion/^traⁿ^sf^e^r^.htm^l.

Budget. FDA has a total budget of nearly $2.3 billion for FY2008. Table 5 presents FDA funding
levels for FY2007 through FY2009. 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 ($1.714 billion in FY2008), with a much
smaller amount for buildings and facilities ($6 million in FY2008). User fees ($549 million in
FY2008) 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
FY2008 total for FDA—the program level—was $2.270 billion, 15.0% above the FY2007 actual
level.
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.
For additional information on FDA, see CRS Report RL34334, The Food and Drug
Administration: Budget and Statutory History, FY1980-FY2007, coordinated by Judith A.
Johnson.
Table 5. Food and Drug Administration (FDA)
^(doll^a^{rs in mi}^llions)
^FY20⁰⁷^FY20⁰⁸^FY20⁰⁹^{% chan}^{ge FY09}
^Progr^{am area}^Funds^actual^enacted^request^a^{vs. FY0}⁸
^{Foods BA}⁴⁵⁷⁵¹⁰⁵⁴³^6.4%
^{BA 315}³⁵³³⁵⁸^1.3%^Human^drugs
^{Fees 228}³²⁷³⁸¹^16.4%
^{Total 544}⁶⁸⁰⁷³⁹^8.6%
^{BA 146}¹⁵⁵¹⁵⁸^1.9%^Bio^logics
^{Fees 56}⁸¹⁸⁷^8.2%
^{Total 202}²³⁶²⁴⁵^4.0%
^{BA 95}⁹⁷¹⁰⁴^6.7%^{Animal drugs and fe}^eds
^{Fees 11}¹²¹⁶^37.0%
^{Total 106}¹⁰⁹¹¹⁹^9.9%
^{BA 231}²³⁸²⁴²^1.6%^{Devices and radiolog}^{ical health}^b
^{Fees 37}⁴⁶⁴⁹^7.1%
^{Total 268}²⁸⁴²⁹¹^2.5%
^Toxicol^{ogical research (NCTR)}^BA⁴²⁴⁴⁴⁶^4.1%
^{BA 92}⁹⁷⁹⁹^2.0%^Headquart^{ers a}^{nd Office of t}^he^b
^Commissioner^{Fees 20}³⁶⁴⁰^10.8%

^FY20⁰⁷^FY20⁰⁸^FY20⁰⁹^{% chan}^{ge FY09}
^Progr^{am area}^Funds^actual^enacted^request^a^{vs. FY0}⁸
^{Total 111}¹³³¹³⁹^4.3%
^{BA 127}¹³¹¹³¹^0.0%^{GSA rent}
^{Fees 12}²⁹²⁵^-11.4%
^{Total 139}¹⁵⁹¹⁵⁶^-2.0%
^{BA 68}⁸⁹⁸⁹^0.0%^Other^{rent a}^{nd re}^{nt-related (including}
^{Fees 18}¹⁰²⁰^92.9%^{White Oak consolidation)}
^{Total 86}⁹⁹¹⁰⁹^9.8%
^{Fees 10}¹⁰¹⁰^8.4%^Export^{and color certification fu}ⁿ^ds

^{BA 1,57}²^1,71⁴^1,76⁹^3.2%^{Subtotal, Salaries & Expense}^s
^{Fees 391}⁵⁴⁹⁶²⁸^14.4%
^{Total 1,96}⁴^2,26⁴^2,39⁷^5.9%
^{Buildings & Facil}^ities^BA¹⁰⁶²^-60.5%
^{Total, FDA Budget Authority}^BA^1,58³^1,72⁰^1,77¹^2.9%
^{Total, FDA User Fees}^Fees³⁹¹⁵⁴⁹⁶²⁸^14.4%
^{Total, FDA Progra}^{m Level}^Total^1,97⁴^2,27⁰^2,40⁰^5.7%
^Source:^{Adapted b}^y^{CRS from FDA,}^{Justification of Estimates for Appropriations Committee}^{s, Fiscal Yea}^{r 2009,}^at
^{http://www.fda.gov/}^{oc/oms/ofm/budget/documentation.htm.}
^Notes:^T^{otals and percentage}^s^{may not comp}^{ute e}^{xactly due to}^{rounding. BA = b}^{udget aut}^{hority, also referred}
^{to as direct appro}^{priations. Fees = collected user fees. Total progr}^{am level = budget a}^uthority^plus^{user fe}^es.
^a.^{The FY200}^{9 re}^qu^{est includes a t}^{otal of $35.5 million in new or pr}^{oposed user fee}^{s: Direct to Consumer}
^{advertising ($14.0}^million)^{, proposed Gene}^{ric Drug Use}^{r Fee Act (}^$16.6^million)^{, and proposed Ani}^mal
^{Generic Dr}^{ug User}^{Fee Act ($}^4.8^milli^on).
^b.^{Includes mam}^mograph^{y use}^{r fees}^.

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, for example, the 47 million
Americans who lack health insurance, over 50 million Americans who live in rural and poor
urban areas where health care services are scarce, more than 1 million people living with ²⁹
HIV/AIDS, and over 94,000 Americans who are waiting for an organ transplant.

²⁹^H^R^SA^,^J^u^stific^atioⁿ^{of Estim}^ate^s^{for A}^ppro^p^ri^a^tio^{ns Committe}^e^s^,^Fisc^{al Ye}^ar²⁰⁰⁹^,^p.^3,^avai^l^a^b^l^{e at}
⁽^c^onti^nue^d.^..)

HRSA funds projects to support 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 health centers, 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.
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 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
over 4,000 health centers and clinics that provide routine access to health care for
over 17 million people living in inner city and rural areas.
• The Bureau of Clinician Recruitment and Service administers programs
authorized under various titles of the PHS Act. 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 Professions: National Health
Service Corps, Nursing Scholarship Program, Nursing Education Loan
Repayment Program, Faculty Loan Repayment Program, and the Native
Hawaiian Scholarship Program (which has not been funded in recent years).
These programs 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 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. Many of these
programs are authorized in Title VII, Health Professions Education and Title
VIII, Nursing Workforce Development.
• The Maternal and Child Health Bureau seeks to strengthen the infrastructure
for maternal and child health services. The Maternal and Child Health Block

^(...c^on^tin^ue^d)
^f^t^p://f^tp.hrs^a^.^g^o^v^/^a^bout^/^budg^e^tjus^tif^ic^a^tion09.^pdf^#pa^g^e⁼^10.

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 ³⁰
HIV/AIDS Treatment Modernization Act. 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 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.
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 ³¹
HRSA programs and on behalf of its service populations.
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 the 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, in the PHS Act, Title III authorizes 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. Title VII authorizes programs for health workforce development, and Title VIII
authorizes programs for nursing workforce development. Title XXVI consolidates all Ryan White

³⁰^P^.^L^.¹⁰^9-⁴¹⁵^w^a^s^sⁱ^gⁿ^e^d^{on D}^e^c^e^m^b^e^r^19,²⁰⁰⁶^.
³¹^Se^e^m^o^re^inf^o^r^m^a^{tion a}^t^HRSA^’s^w^e^bsite^,^at^h^t^t^p^:^/^/^www^.^h^rsa.^go^v/^ab^o^u^t^/^d^efau^l^t^.^h^t^m^.

HIV/AIDS programs. Various sections of the Social Security Act authorize Maternal and Child
Health Block Grants and the Rural Health Policy Development Programs. Finally, Section 427(e)
of the Federal Mine Safety and Health Amendments Act (P.L. 95-164) authorizes the Black Lung
Program, which supports clinics that provide services to retired coal miners and others.
Table 6 presents funding levels for HRSA programs for FY2007 through FY2009. For detailed
appropriations on programs in Title VII and Title VIII, see CRS Report RS22438, Health
Professions Programs in Title VII and Title VIII of the Public Health Service (PHS) Act:
Appropriations History (FY2002-FY2009), by Bernice Reyes-Akinbileje and Mary Vennetta
Wright.
Table 6. Health Resources and Services Administration (HRSA)
^(doll^a^{rs in mi}^llions)
^FY20⁰⁷^FY20⁰⁸^FY20^09Pres.^{% chan}^ge
^{Bureaus, Offices, an}^{d Pro}^gra^ms^actual^enacted^request^{FY09 vs}^{. FY0}⁸
^{Health Center}^s^1,98⁸^2,06⁵^2,09²^1.3%
^{Other BPHC Programs}¹⁸¹⁸¹⁸^2.1%
^{Subtotal, Bureau of Prima}^{ry Health}^2,00^{6 2,08}³^2,11⁰^1.3%
^{Care (BPHC)}
^{National Health Service Corps}¹²⁶¹²³¹²¹^-2.0%
^{Loan Repayme}^{nt/Fellowships (Sec. 738)}^a¹¹⁰^-100^%
^Nursing^{Scholarships/Loan}^Repay^{ment (Sec.}^b^{31 31}⁴⁴^41.9%
⁸⁴⁶⁾
^{Subtotal, Bureau of Clinician}^{158 155}¹⁶⁵^6.1%
^{Recruitment and Service (BCRS)}
^{Health Professions}^a^{183 193}⁰^-100.0^%
^Nursing^{Workforce Developmen}^t^b¹¹⁹¹²⁶⁶⁶^-47.3%
^{Children’s Hospitals Graduate}^M^edical^{297 302}⁰^-100.0^%
^Education
^{Pt. Navigator Outreach/C}^hronic^Disease^{0 3}⁰^-100.0^%
^Prevent
^{Subtotal, Bureau of Health Professions}^{599 623}⁶⁶^-89.4%
^(BHPr)
^{Maternal a}^{nd Child Health Block Grant}⁶⁹³⁶⁶⁶⁶⁶⁶^0.0%
^{Healthy Start}¹⁰²¹⁰⁰¹⁰⁰^0.0%
^{Other MCHB}^Programs⁴¹⁷⁹³⁹^-51.2%
^{Subtotal, Maternal and Child Hea}^{lth Bureau}^{835 845}⁸⁰⁴^-4.8%
^(MCHB)^c
^{Subtotal, HIV/AIDS Bureau}^d^2,11³^2,14²^2,14³^0.1%
^{Subtotal, Hea}^{lthcare System}^{s Bureau}⁷⁵⁸²⁶⁸^-16.9%
^{Subtotal, Rural Health Progr}^ams¹⁶⁸¹⁷⁵²⁵^-85.9%
^{Health Care-Related Facilit}^{ies and Activities}⁰³⁰⁴⁰^-100.0^%
^{Parklawn Building Lease Replacement}⁰⁰³⁶^na

^FY20⁰⁷^FY20⁰⁸^FY20^09Pres.^{% chan}^ge
^{Bureaus, Offices, an}^{d Pro}^gra^ms^actual^enacted^request^{FY09 vs}^{. FY0}⁸
^{Telehealth + Program Ma}^nageme^nt¹⁵³¹⁴⁸¹⁴⁸^0.1%
^{Family Planning}²⁸³³⁰⁰³⁰⁰^0.0%
^Su^{btotal, Other HRSA Progr}^ams⁴³⁶⁷⁵²⁴⁸⁴^-35.7%
^{Total, Heal}^{th Resources an}^d^Services^6,39^{1 6,85}⁶^5,86⁵^-14.5%
^acc^{ount, discretionary}
^{Health Edu}^{cation Assistance Loa}^{ns (HEA}^L)³³³^2.1%
^{Vaccine Injur}^{y Compen}^{sation Program direct}^{4 5}⁵^-16.2%
^operations
^T^{otal, HRSA discretionary b}^udget^6,39^{8 6,86}⁴^5,87²^-14.5%
^authority
^{National Practitioner Data Bank (User}^{16 19}¹⁹^1.8%
^Fees)e
^{Health Care I}^{ntegrity a}^{nd Protection Data}^e^{4 4}⁰^-100.0^%
^{Bank (User Fees)}
^{Family to Fami}^{ly Health Informati}^{on Centers}^f^{3 4}⁵^25.0%
^(mandatory)
^{PHS Evaluation Tap f}^unding^g²⁵²⁵²⁵^0.0%
^{HEAL Liq}^{uidating Account}¹¹¹^0.0%
^T^{otal, HRSA prog}^{ram level}^6,44⁷^6,91⁷^5,92²^-14.4%
^Source:^{Adapted b}^y^{CRS from}^HRSA,^{Justification of Estimates for Appropriations Committe}^{es, FY200}⁹^{, All}^-Purpose
^{Table, p. 7, at ftp://ftp.hr}^{sa.gov/about/budgetjustification09.pdf}^#pag^e=14.
^Notes:^T^{otals and percentage}^s^{may not comp}^{ute e}^{xactly due to}^rounding.
^a.^{Total appropriations for Title VII programs ar}^{e obtained b}^y^{adding the ap}^{propriation for Sec. 7}^38,
^{administered by the}^{BCRS, to the appro}^{priations for the}^{various h}^{ealth professions}^{programs admi}^nistered
^{by the}^{BHPr. Total appropriations for Title VII programs ar}^{e as follows: FY2007, $1}^{85 million; FY2008, $}¹⁹⁴
^mill^{ion; and FY2009}^req^{uest, $}^0.
^b.^{Total appropriations for Title VIII programs a}^{re obtained}^{by adding the ap}^prop^{riation for Sec. 846,}
^{administered by the}^{BCRS, to the appro}^{priations for the}^{various n}^{ursing workforc}^{e development}^p^rograms
^{administered by the}^{BHPr. Total approp}^{riations for Title VIII prog}^{rams are as}^{follows: FY2007, $1}⁵⁰^million;
^FY2008,^$1^{56 million; and FY200}^{9 re}^{quest, $}¹¹⁰^million.
^c.^Excludes^{mandatory f}^{unding for}^{Family to Fami}^{ly Health Informatio}^{n Cente}^rs.
^d.^{Excludes t}^{he amou}^{nt for PHS}^Eva^{luation Tap funding (}^$²⁵^million).
^e.^{User fees available for Bu}^{reau of}^{Health Professions.}
^f.^{Mandatory f}^{unds for}^Mater^{nal an}^{d Child Health Bureau a}^p^p^ropriat^{ed in the Deficit Reduction Act of 20}⁰⁵
⁽P.L. 109-171^).
^g.^Additi^{onal funds for Ryan}^White^{AIDS programs from P}^{HS Evaluat}^{ion Set}^{-Aside (}^§^{241 of PHS Act).}

The Indian Health Service (IHS) provides, or funds the provision of, direct health care services to ³²
members of the nation’s 562 federally recognized Indian tribes (totaling about 1.8 million ³³
Indians in 35 states) who are in IHS service delivery areas. 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 statutes, treaties, 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 does
not provide the same health care services in all areas. Services vary from place to place and from
time to time.
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 163 service units (each ³⁴
assigned to an area office). 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;

³²^In^t^hⁱ^s^repo^rt^,^t^h^{e t}^e^rm^“In^dⁱ^an^”^mean^s^Am^eri^c^an^In^dⁱ^aⁿ^{s an}^{d A}^l^a^s^{ka Nat}ⁱ^v^es.^T^h^{e l}^a^t^t^e^{r t}^e^r^mⁱⁿ^cl^u^d^e^{s t}^h^{e E}^s^ki^m^o^s
^(In^uⁱ^t^an^{d Yu}^pi^k),^A^l^eu^t^s^,^an^d^A^m^eri^can^In^dⁱ^an^s^o^f^A^l^a^s^ka.
³³^{IHS a}^l^{so f}^uⁿ^d^{s lim}^ite^{d he}^a^{lth se}^r^v^ic^e^s^{to India}ⁿ^s^{in c}^e^r^taⁱⁿ^ur^ba^{n a}^r^e^a^s^.
³⁴^A^se^r^v^ic^e^{unit is a}ⁿ^a^d^mⁱ^nistra^tiv^e^eⁿ^tity^w^{ithin a}^de^fⁱ^ne^{d g}^e^og^ra^p^h^ic^a^l^a^r^e^a^,^thro^ug^{h w}^h^ic^{h se}^rv^ic^e^s^a^r^e^dire^c^tly^or
^indire^c^tly^prov^ide^d^{to e}^ligⁱ^b^le^In^dⁱ^aⁿ^{s. A}^se^rv^ic^e^{unit m}^a^y^c^o^v^e^{r a}ⁿ^u^m^b^e^r^of^s^m^a^{ll re}^s^e^rv^a^{tions, or, c}^onv^e^r^se^l^y^{, a}^la^rg^e
^r^e^s^e^r^v^a^{tion m}^a^y^be^c^o^v^e^r^e^{d b}^y^s^e^v^e^r^a^{l s}^e^r^v^ic^e^units^.

• 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 46 inpatient hospitals and 633 ambulatory facilities
(which include 304 health clinics, 143 health stations, 166 Alaska village clinics, and 20 school
health centers). Fifteen of the hospitals and 550 of the ambulatory facilities are operated by tribes
and tribal organizations, under contracts and compacts pursuant to the Indian Self-Determination ³⁵
and Education Assistance Act of 1975. The remaining facilities are operated by the IHS. In
addition, IHS funds 34 urban Indian health projects in 41 urban sites through federal contracts ³⁶
and grants.
The IHS offers information on its programs through its website at http://www.ihs.gov.
Health care services for Indians developed gradually over the course of the 19^th century, pursuant
to congressional appropriations but without an explicit statutory 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 Interior. While the number of BIA hospitals and physicians gradually ^th^th
increased in the late 19 and early 20 centuries, BIA did not have a bureau-wide medical ³⁷
supervisor until 1908. The Snyder Act of 1921 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 ³⁸
in the Department of Health, Education, and Welfare. 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 ³⁹
programs are authorized by the Indian Sanitation Facilities Act of 1959, authorizing the PHS to
construct sanitation facilities for Indian communities and homes; the Indian Health Care ⁴⁰
Improvement Act (IHCIA) of 1976, which established many specific IHS programs, such as
urban health, professions recruitment, and mental health, and which also amended the Social
Security Act to authorize IHS to make direct collections from Medicare/Medicaid and third-party ⁴¹
insurers; and the Indian Self-Determination and Education Assistance Act of 1975, which

³⁵^P^.^L^.^93-⁶³^{8, a}^c^t^of^J^a^nua^r^y^{4, 19}^75,⁸⁸^Sta^t^.²²⁰³^{, a}^s^a^m^e^nde^{d; 25}^U^.^S.C^.^§⁴⁵^{0 e}^t^s^e^q.
³⁶^Sta^tis^tic^sⁱⁿ^this^pa^r^a^g^r^a^{ph a}^r^e^f^r^om^U^.^{S. D}^e^pa^r^t^m^e^{nt of}^H^e^a^{lth a}ⁿ^{d H}^u^m^a^{n Se}^r^v^ic^e^s^{, I}^ndiaⁿ^H^e^a^lth^Se^r^v^ic^e^,
^J^u^stific^ati^{on of Estimate}^s^f^o^r^Ap^p^r^opr^iatⁱ^oⁿ^{s Committe}^e^s^{, Fisc}^a^l^Y^e^{ar 20}⁰⁹^,^pp^.^C^J^-¹²³^an^{d C}^J^-²¹⁸^.
³⁷^A^c^{t of}^N^o^v^e^m^b^e^r^{2, 1}⁹²¹^,⁴²^Sta^t^{. 2}^08,^a^s^a^m^e^nde^d;^{25 U}^.^S.C^.^§¹³^.
³⁸^P^.^L^.^83-⁵⁶^{8, a}^c^t^of^A^u^g^u^s^t^{5, 19}⁵⁴^{, 6}⁸^Sta^t^.⁶⁷^{4, a}^s^a^m^e^nde^{d; 42}^U^.^S.C^.^{§ 2}⁰⁰¹^e^t^s^e^q^.
³⁹^P^.^L^.^86-¹²^{1, a}^c^t^of^J^u^ly^{31, 1}⁹⁵⁹^,⁷³^Sta^t^.²⁶^7;^{42 U}^.^S.C^.^§²⁰^04a^.
⁴⁰^P^.^L^.^94-⁴³^{7, a}^c^t^of^Se^pte^m^be^r³⁰^{, 19}⁷⁶^{, 9}⁰^Sta^t^.¹⁴^00,^a^s^a^m^e^nde^d^;²⁵^U^.^S.C^.^§¹⁶⁰¹^e^t^s^e^q.,^aⁿ^d⁴²^U^.^S.C^.^§
¹³⁹^5q^q,^§¹³^96j⁽^a^nd^a^m^e^nding^o^t^he^r^s^e^c^tions⁾^.
⁴¹^P^.^L^.^93-⁶³^{8, a}^c^t^of^J^a^nua^r^y^{4, 19}^75,⁸⁸^Sta^t^.²²⁰³^{, a}^s^a^m^e^nde^{d; 25}^U^.^S.C^.^§⁴⁵^{0 e}^t^s^e^q.

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 ^th^th
considering IHCIA reauthorization bills since the 106 Congress. In the 110 Congress, the
Senate’s IHCIA reauthorization bill (S. 1200) was passed by the Senate on February 26, 2008,
and forwarded to the House, while the House bill (H.R. 1328) has been ordered reported from one
committee and must be considered by two other committees of jurisdiction.
Table 7 presents funding levels for IHS programs for FY2007 through FY2009. For further
information on IHS, see CRS Report RL33022, Indian Health Service: Health Care Delivery,
Status, Funding, and Legislative Issues, by Roger Walke.
Table 7. Indian Health Service (IHS)
^(doll^a^{rs in mi}^llions)
^FY20⁰⁷^FY20⁰⁸^FY20^{09 Pres.}^{% chan}^{ge FY09}
^Progr^ams^actual^enacted^request^{vs. FY0}⁸
^{Health S}^ervices
^{Clinical Services}
^{Hospitals and Health Clinics}^1,41¹^1,48⁴^1,52²^2.6%
^{Dental Health}¹²⁵¹³⁴¹³⁸^3.2%
^{Mental Health}⁶¹⁶⁴⁶⁶^3.6%
^{Alcohol and Substance A}^buse¹⁴⁸¹⁷³¹⁶²^-6.5%
^{Contract Health Car}^e⁵⁴³⁵⁵³⁵⁶³^1.9%
^{Catastrophic Health}^Emerg^ency^Fund^N/A²⁷²⁵^-6.0%
^{Subtotal, Clinical Services}^2,28⁹^2,43⁴^2,47⁶^1.7%
^Preventi^{ve H}^ealth
^{Public Health N}^ursing⁵²⁵⁶⁵⁸^4.2%
^{Health Edu}^cation¹⁴¹⁵²⁵^1.6%
^{Community Health Re}^ps.⁵⁵⁵⁵⁵⁶^1.6%
^Immu^{nization (Alaska)}²²²^1.6%
^{Subtotal, Prevent}^ive^Heal^th¹²³¹²⁸¹³¹^2.7%
^{Other Health Serv}^ices
^{Urban Health}^Projects³⁴³⁵⁰^-100.0^%
^{Indian Health Profes}^sions³¹³⁶²²^-39.7%
^{Tribal Management}²²³^1.6%
^{Direct Operations}⁶⁴⁶⁴⁶³^-1.6%

^FY20⁰⁷^FY20⁰⁸^FY20^{09 Pres.}^{% chan}^{ge FY09}
^Progr^ams^actual^enacted^request^{vs. FY0}⁸
^{Self-Governance 6}⁶⁶^1.6%
^{Contract Sup}^{port Costs}²⁷⁰²⁶⁷²⁷²^1.6%
^{Subtotal, Other Heal}^{th Servi}^ces⁴⁰⁷⁴¹⁰³⁶⁵^-11.1%
^{Subtotal, Hea}^{lth Services}^2,81⁹^2,97²^2,97²^0.0%
^{Health Facil}^iti^es
^Maintena^{nce and}^Imp^rovement⁵⁵⁵³⁵³^0.0%
^{Sanitation Facil}^{ities Construction}^{94 94}⁹⁴^0.0%
^{Health Care Facilities Construction}²⁶³⁷¹⁶^-56.8%
^Facilit^{ies/Environmental Health}^{165 170}¹⁶⁹^-0.3%
^Support
^Equi^{pment 22}²¹²¹^0.0%
^{Subtotal, Hea}^{lth Facili}^ties³⁶¹³⁷⁵³⁵³^-5.7%
^{Total, IHS discretionary bud}^get^3,18^{0 3,34}⁶^3,32⁵^-0.6%
^authority
^Collect^{ions 773}⁷⁸⁶⁷⁸⁶^0.0%
^{Special Diabetes Program for Indi}^ans^a¹⁵⁰¹⁵⁰¹⁵⁰^0.0%
^T^{otal, IHS program level}^4,10³^4,28²^4,26¹^-0.5%
^Source:^{Adapted b}^y^{CRS from I}^HS,^{Justification of Estimates for Ap}^{propriations Committee}^{s, Fiscal Yea}^{r 2009}^{, Al}^l-
^{Purpose Table, p. CJ-3, at}^http://^www.ihs.gov/^{NonMedicalPrograms/BudgetFormulation/}
^{bf_cong_justifications.asp.}
^Note:^T^{otals and percentage}^{s m}^{ay not comp}^{ute exac}^{tly due to ro}^unding.
^a.^{Funds av}^ail^a^{ble to IHS for Specia}^{l D}ⁱ^{abetes Pro}^gram^{for Indi}^{ans (}P.L. 105-33^,P.L. 106-554^,P.L.

107-360^{, and}P.L. 110-173^{; 4}²^{U.S.C. 254c-3).}

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 ⁴²
disability.”
NIH is the largest of the PHS agencies, with a budget of $29.2 billion in FY2008 (see Table 9)
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 working in universities,

⁴²^Se^e^htt^p^://w^w^w^.nih.g^ov^/a^bout/^.

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.
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 9, 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 ⁴³
below. 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 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.

⁴³^F^o^{r f}^u^rt^h^e^{r i}ⁿ^f^o^rm^atⁱ^oⁿ^on^each^co^m^pone^nt,^s^e^e^http:^//w^w^w^.nih.^gov/ⁱ^c^d^/^.^S^{ee al}^so^t^h^e^N^I^H^Alm^a^nac^,²⁰^06-²⁰⁰⁷^{, a}^t
^http:^//w^w^w^.nih.g^ov^/^a^bout/^a^lm^aⁿ^a^c^/^a^bout.^h^tm^.

• 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.
• 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.
• 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.
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 NIH Reform Act added a number of authorities for the NIH

Director, authorized total funding levels for NIH appropriations for FY2007 to FY2009, and
eliminated all of the other specific authorizations in Title IV.
For additional information on NIH, see CRS Report RL33695, The National Institutes of Health
(NIH): Organization, Funding, and Congressional Issues, by Pamela W. Smith, and the NIH
section of CRS Report RL34048, Federal Research and Development Funding: FY2008, by John
F. Sargent Jr. et al.
Table 8. National Institutes of Health (NIH)
^(doll^a^{rs in mi}^llions)
^FY20⁰⁷^a^FY20⁰⁸^b^FY20^{09 Pres.}^{% chan}^{ge FY09}
^{Institutes and Centers (ICs)}^actual^enacted^request^{vs. FY0}⁸
^{Cancer (NCI)}^4,79⁵^4,80⁵^4,81⁰^0.1%
^Heart/Lu^{ng/Blood (NHLBI)}^2,91⁹^2,92²^2,92⁵^0.1%
^{Dental/Craniofacial Research (NI}^DCR)³⁹⁰³⁹⁰³⁹¹^0.1%
^{Diabetes/Digestive/Ki}^{dney (NIDDK)}^1,70⁶^1,70⁷^1,70⁸^0.1%
^{Neurological Disorders/Stroke}^1,53^{5 1,54}⁴^1,54⁵^0.1%
^(NINDS)
^{Allergy/Infectious Diseases (NIAI}^D)^c^,d^4,36⁶^4,56¹^4,56⁹^0.2%
^General^{Medical Sciences (NIG}^M^S)^1,93⁶^1,93⁶^1,93⁸^0.1%
^{Child Health/Human Dev}^elopment^1,25^{4 1,25}⁵^1,25⁶^0.1%
^(NICHD)
^{Eye (N}^EI)⁶⁶⁷⁶⁶⁷⁶⁶⁸^0.1%
^Environme^{ntal Health Sciences}^(NIE^HS)⁶⁴²⁶⁴²⁶⁴³^0.1%
^{Aging (NIA)}^1,04⁷^1,04⁷^1,04⁸^0.1%
^{Arthritis/Mus}^{culoskeletal/Skin (NIAMS)}⁵⁰⁸⁵⁰⁹⁵⁰⁹^0.1%
^{Deafness/Commu}^{nication Disord}^ers^{394 394}³⁹⁵^0.2%
^(NIDCD)
^Nursing^Research^(NI^NR)¹³⁷¹³⁷¹³⁸^0.1%
^{Alcohol Abuse/Alcoholism (NIAAA)}⁴³⁶⁴³⁶⁴³⁷^0.1%
^{Drug Ab}^{use (NIDA)}^1,00⁰^1,00¹^1,00²^0.1%
^{Mental Health (}^NIM^H)^e^1,40⁴^1,40⁵^1,40⁷^0.1%
^Human^Ge^{nome Researc}^{h (NH}^G^RI)⁴⁸⁶⁴⁸⁷⁴⁸⁸^0.2%
^Biomedica^{l Imaging/Bioengineering}^{298 299}³⁰⁰^0.5%
^(NIBIB)
^{Research Resour}^{ces (NCRR)}^1,14⁴^1,14⁹^1,16⁰^1.0%
^{Complementary/Alternative Med}^{121 122}¹²²^0.1%
^(NCCAM)
^{Minority Health/Health Dispa}^rities^{199 200}²⁰⁰^0.1%
^(NCMHD)
^{Fogarty Inter}^{national Center (FI}^C)⁶⁶⁶⁷⁶⁷^0.1%
^{Library of}^{Medicine (NLM)}³²⁰³²¹³²³^0.8%

^FY20⁰⁷^FY20⁰⁸^FY20^{09 Pres.}^{% chan}^{ge FY09}
^{Institutes and Centers (ICs)}^actual^a^enacted^b^request^{vs. FY0}⁸
^{Office of Director (OD)}^d^1,04⁷^1,10⁹^1,05⁷^-4.7%
^{Common Fund (non-add)}⁽⁴⁸³⁾⁽⁴⁹⁶⁾⁽⁵³⁴⁾^7.7%
^{Buildings & Facil}^{ities (B&F)}⁸¹¹¹⁹¹²⁶^5.6%
^{Subtotal, Labor/HHS}^28,8^{99 29,2}³⁰^29,2³⁰^0.0%
^Appr^opriation
^Superf^{und (I}^{nterior ap}^{prop to N}^I^EHS)^f^{79 78}⁷⁸^0.0%
^T^{otal, NIH discretionary bud}^get^28,9^{78 29,3}⁰⁷^29,3⁰⁷^0.0%
^authority
^Pre-approp^{riated Type 1 diabetes}^funds^g^{150 150}¹⁵⁰^0.0%
^{PHS Evaluation Tap f}^unding^h⁸⁸⁸^0.0%
^{Global Fund tran}^{sfer (AIDS/TB/Malaria)}^c^-99^-295^-300^1.8%
^T^{otal, NIH program level}^29,0³⁸^29,1⁷¹^29,1⁶⁵^0.0%
^Source:^{Adapted b}^y^{CRS from}^NIH,^{Justification of Estimate}^{s for Appropriations Committee}^{s, Fiscal}^Ye^{ar 2009}^,
^{Tabular Data, p. TD-1, at http://officeofbudget.od.nih.gov/}^UI/20^08/^tabular%^20data.pdf.
^Note:^T^{otals and percentage}^{s m}^{ay not comp}^{ute exac}^{tly due to ro}^unding.
^a.^FY2007^{reflects t}^{he tra}^nsfe^{r of $}^{99 million from NIH}^{to the O}^{ffice of the Secreta}^{ry, as mandated}^b^y^the
^FY2007^su^ppleme^{ntal app}^{ropriations act,}P.L. 110-28^{(see note d). FY2007 also reflects compa}^rat^ive
^transfe^{rs to HHS ($}^0.54^{2m) and}^{among NIH}^ICs.
^b.^{The FY200}⁸^{program level is an i}^{ncrease of}^$1³³^milli^{on (0.5%) over FY20}^{07. FY20}^{08 in}^{cludes com}^parative
^{IC trans}^{fers f}^{rom NH}^{LBI to NID}^{DK ($0.816}^{million) and from NL}^{M to NIDCR ($0.4}⁵⁵^milli^on).
^c.^{NIAID totals include fu}^{nds for t}^r^{ansfer to t}^{he Global Fu}^{nd to Fight HIV/AIDS, TB, and Malaria.}
^d.^{For FY2007, t}^{he war/eme}^rgenc^y^sup^{plemental ap}^{propriations act (}P.L. 110-28^{, May 2}^{5, 20}^{07) t}^ransfer^red
^{funding for}^{the Adva}^{nced Development of}^{Medical Countermeas}^u^{res to the Assista}^{nt Secretar}^{y for}
^Preparednes^{s and Res}^{ponse ($}⁴⁹^{.5m from N}^{IAID and $}^49.5^{m fro}^{m OD).}
^e.^FY2008^amount^{reflects t}^rans^fer^{of $0.98}^{3 million from Office of t}^{he Secretary}^{to NI}^{MH to administer the}
^Interage^{ncy A}^{utism Coordinating Committee.}
^f.^{Separate accou}^{nt in t}^{he I}^{nterior/Environme}^{nt/Related Agencies ap}^{propriation for N}^IEHS^researc^{h a}^ctivities
^{related to Superfu}^nd.
^g.^{Funds available to NIDDK for diabetes res}^earch^u^{nder PHS Act §}^{330B (a}^{uthorized by}P.L. 106-554^,P.L.

107-360^{, and}P.L. 110-173^).

^h.^Additi^{onal funds for}^NLM^{from P}^{HS Evaluation Set-Aside (§ 241 of}^{PHS Act).}

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 ⁴⁴
issues addressed by the agency, along with the agency’s cross-cutting principles. 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.
For FY2008, SAMHSA has a total budget of nearly $3.4 billion and a staff of approximately ⁴⁵
534. 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).⁴⁶ 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).⁴⁷ CSAP aims to improve the
quality of substance abuse prevention practices nationwide. Through its
discretionary grant programs, CSAP provides states, communities, organizations,

⁴⁴
^SA^MH^S^A^,^M^a^trix^{of Pri}^o^ritie^s^,^A^p^{ril 200}^{6, a}^t^htt^p^://w^ww^.sa^m^hs^a^.^g^o^v^/^Ma^trix^/Ma^t^rix^_^Broc^hure^_²⁰^06.^pdf^.
⁴⁵^SA^MH^SA^,^J^u^stific^ation^of^Estim^ate^s^{for A}^ppr^oprⁱ^a^tio^{ns Commit}^t^e^e^s^{, Fisc}^{al Ye}^ar²⁰⁰⁹^,^avai^l^a^b^l^{e at}
^http:^//w^w^w^.s^am^hs^a^.^g^o^v^/^B^udg^e^t/FY²⁰⁰^9/^SA^MH^S^A^_C^J²⁰⁰^9.p^d^f^.
⁴⁶^Se^e^htt^p^://m^eⁿ^ta^lhe^a^lth.sa^m^hsa^.^gov^/c^m^h^s/.
⁴⁷^Se^e^htt^p^://p^re^v^e^ntion.sa^m^h^sa^.g^ov/.

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).⁴⁸ 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 block grant. CSAT also supports SAMHSA’s free treatment referral
service to link people with the community-based substance abuse services they
need.
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 (42 U.S.C. § 290aa—290kk-

3). In PHS Act Title XIX, SAMHSA’s block grants are authorized under Part B (42 U.S.C. §

300x-1—300x-66) and some additional programs are authorized under Part C (42 U.S.C. § ⁴⁹

300y—300y-11). SAMHSA was last reauthorized in 2000, as part of the Children’s Health Act.

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.
Currently, authorizations for all of SAMHSA programs have expired. For additional information
on SAMHSA, see CRS Report RL33997, Substance Abuse and Mental Health Services
Administration (SAMHSA): Reauthorization Issues, by Ramya Sundararaman.

⁴⁸^Se^e^htt^p^://c^sa^t.sa^m^h^sa^.g^ov^/.
⁴⁹^P^.^L^.¹⁰^6-3¹⁰^,^T^itle^{s XXX}^I-^XX^XIV^.

Table 9. Substance Abuse and Mental Health Services Administration (SAMHSA)
^(doll^a^{rs in mi}^llions)
^FY20⁰⁷^FY20⁰⁸^FY20^{09 Pres.}^{% chan}^{ge FY09}
^Centers^actual^enacted^request^{vs. FY0}⁸
^{Center for Mental Health Se}^{rvices (CMHS)}
^{Programs of Regional and National Significance}²⁶³²⁹⁹¹⁵⁵^-48.1%
^{Mental Health Block Gra}^nt⁴⁰⁷⁴⁰⁰⁴⁰⁰^0.0%
^{PHS Evaluation Tap f}^{unding (non-a}^dd)^a⁽²¹⁾⁽²¹⁾⁽²¹⁾^0.0%
^{Mental Health Block G}^{rant, progra}^{m level (non-}
^{add) (428)}⁽⁴²¹⁾⁽⁴²¹⁾^0.0%
^{Children’s Mental Health}¹⁰⁴¹⁰²¹¹⁴^12.0%
^{Projects for Assistance in Tra}^{nsition from}
^{Homelessness (PATH form}^{ula gr}^ant)⁵⁴⁵³⁶⁰^12.0%
^{Protection and Advocacy for Indi}^{viduals with}
^{Mental Illness (PAIM}^{I form}^{ula gra}^nt)^{34 35}³⁴^-2.5%
^{Subtotal, CMHS budget auth}^ority⁸⁶²⁸⁸⁹⁷⁶³^-14.2%
^{PHS Evaluation Tap f}^unding^a^{21 21}²¹^0.0%
^{Subtotal CMHS program level}⁸⁸⁴⁹¹¹⁷⁸⁴^-13.9%
^{Center for Substan}^{ce Ab}^{use Treatment (CSAT)}
^{Programs of Regional and National Significance}³⁹⁵³⁹⁶³²⁶^-17.7%
^{PHS Evaluation Tap f}^{unding (non-a}^dd)^a^{(4) (4)}⁽¹¹⁾^160.3%
^{PRNS, program level (non-add)}⁽³⁹⁹⁾⁽⁴⁰⁰⁾⁽³³⁷⁾^-15.8%
^Substanc^{e Ab}^{use Preve}^{ntion and}^Treatment
^{(SAPT) B}^{lock Grant}^1,67⁹^1,68⁰^1,69⁹^1.1%
^{PHS Evaluation Tap f}^{unding (non-a}^dd)a⁽⁷⁹⁾⁽⁷⁹⁾⁽⁷⁹⁾^0.0%
^{SAPT Block Grant, progr}^{am level (non-add)}^(1,759)^(1,759)^(1,779)^1.1%
^{Subtotal, CSAT budget auth}^ority^2,07⁴^2,07⁶^2,02⁵^-2.5%
^{Subtotal, PHS Evaluation Tap fu}ⁿ^ding^a⁸⁴⁸⁴⁹⁰^17.5%
^{Subtotal, CSAT prog}^{ram level}^2,15⁸^2,15⁹^2,11⁵^-2.0%
^{Center for Substan}^{ce Ab}^{use Prevention (CSAP)}
^{Programs of Regional and National Significance}¹⁹³¹⁹⁴¹⁵⁸^-18.6%
^{Subtotal, CSAP budget auth}^ority¹⁹³¹⁹⁴¹⁵⁸^-18.6%
^{Subtotal, Program Man}^agem^{ent budget}
^{authority 77}⁷⁵⁷⁵^0.0%
^{PHS Evaluation Tap f}^unding^a¹⁶¹⁸²²^22.5%
^{Subtotal, Program Man}^agem^ent
^prog^{ram level}⁹³⁹³⁹⁷^4.3%
^{St. Elizabe}^{ths Hospital Build}ⁱ^{ngs &}
^Faciliti^{es 0}⁰¹^na
^{Data Evaluation}⁰⁰²^na
^{Total, SAMHSA budget authority}^3,20⁶^3,23⁴^3,02⁵^-6.5%

^FY20⁰⁷^FY20⁰⁸^FY20^{09 Pres.}^{% chan}^{ge FY09}
^Centers^actual^enacted^request^{vs. FY0}⁸
^Total^{, PHS Evaluation Tap fu}^nding^a^{121 122}¹³³^8.9%
^T^{OTAL, SAMHSA pro}^gram^leve^l^3,32^{7 3,35}⁶^3,15⁸^-5.9%
^Source:^{Adapted b}^y^{CRS from}^{SAMHSA, Justification of Estimates}^{for App}^{ropriations Committees, Fiscal Year}
²⁰⁰^{9, p. E}^xec^{utive Summar}^y-4.
^Note:^T^{otals and percentage}^{s m}^{ay not comp}^{ute exac}^{tly due to ro}^unding.
^a.^Additi^{onal funds from PHS}^Evalua^{tion Set-Aside (}^§^{241 of PHS Act)}^.

Agency Overview Reports CRS Report RL34334, The Food and Drug Administration: Budget
and Statutory History, FY1980-FY2007, coordinated by Judith A. Johnson.
CRS Report RL33022, Indian Health Service: Health Care Delivery, Status, Funding, and
Legislative Issues, by Roger Walke.
CRS Report RL33695, The National Institutes of Health (NIH): Organization, Funding, and
Congressional Issues, by Pamela W. Smith.
CRS Report RL33997, Substance Abuse and Mental Health Services Administration (SAMHSA):
Reauthorization Issues, by Ramya Sundararaman.
Appropriations Reports
CRS Report RL34132, Agriculture and Related Agencies: FY2008 Appropriations, by Jim
Monke.
CRS Report RL34448, Federal Research and Development Funding: FY2009, by John F. Sargent
Jr. et al.
CRS Report RL34461, Interior, Environment, and Related Agencies: FY2009 Appropriations, by
Carol Hardy Vincent et al.
CRS Report RL34076, Labor, Health and Human Services, and Education: FY2008
Appropriations, by Pamela W. Smith, Gerald Mayer, and Rebecca R. Skinner.
Biomedical Research Policy and Funding:
http://apps.cr s.gov/ cli/cli.aspx?PRDS_CLI_ IT EM_ID=2257&from= 3&fromId=13.
Drugs, Biologics, and Medical Devices:

http://apps.cr s.gov/ cli/cli.aspx?PRDS_CLI_ IT EM_ID=2678&from= 3&fromId=13.
Food Safety and Nutrition:
http://apps.cr s.gov/ cli/cli.aspx?PRDS_CLI_ IT EM_ID=2621&from= 3&fromId=13.
Public Health and Emergency Preparedness:
http://apps.cr s.gov/ cli/cli.aspx?PRDS_CLI_ IT EM_ID=2628&from= 3&fromId=13.
^P^a^m^e^{la W}^.^S^m^it^h^,^Co^o^r^dⁱⁿ^a^to^r ^Ju^di^t^h^A^.^Johⁿ^s^oⁿ
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^An^al^y^s^{t i}ⁿ^P^u^b^{lic Healt}^h^Sp^{ecialist i}ⁿ^Dr^u^g^Sa^f^e^t^y^aⁿ^d^Ef^f^e^c^tiv^eⁿ^es^s
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^{Area o}^f^Expertise^Name^Phone
^{Public Health Service (PHS) gene}^rally^{Pamela Smith}^7-70⁴⁸
^{Sarah Lister}^7-73²⁰
^{Agency for}^{Healthcare Resea}^rch^{and Quality}^{Andrew Sommers}^7-46²⁴
^(AHRQ)
^{Centers for Disease Cont}^{rol and Prevention}^{Sarah Lister}^7-73²⁰
^{(CDC) / Agency for Toxic Substa}^{nces a}^{nd Disease}
^{Registry (ATSDR}⁾
^{Food and Drug Administration (F}^DA)^{Susan Tha}^{ul (drugs)}^7-05⁶²
^{Donna Porter (foods)}^7-70³²
^{Judith Joh}^{nson (biologics)}^7-70⁷⁷
^{Erin Williams (devices)}
^{Sarah Lister (animal feed a}^nd^7-73²⁰

^drugs)

^{Area o}^f^Expertise^Name^Phone
^{Health Resources a}^{nd Services A}^{dministration}^{Bernice Reyes-Akinbileje}^7-22⁶⁰
^(HRSA)
^{Indian Health Service (I}^HS)^{Roger Walke}^7-86⁴¹
^{National Institutes of}^{Health (NI}^H)^{Pamela Smith}^7-70⁴⁸
^Substanc^{e Ab}^{use and}^{Mental H}^e^a^{lth Services}^{Ramya Sundararama}ⁿ^7-72⁸⁵
^{Administration (SAMHSA)}