Order Code RL33695
The National Institutes of Health (NIH):
Organization, Funding, and Congressional Issues
Updated December 19, 2006
Pamela W. Smith
Analyst in Life Sciences
Domestic Social Policy Division

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The National Institutes of Health (NIH):
Organization, Funding, and Congressional Issues
Summary
The National Institutes of Health is the focal point for federal health research. An
agency of the Department of Health and Human Services (HHS), it uses its $28.5 billion
budget to support more than 200,000 scientists and research personnel working at over
3,100 institutions across the U.S. and abroad, as well as to conduct biomedical and
behavioral research and research training at its own facilities. The agency consists of
the Office of the Director, in charge of overall policy and program coordination, and 27
institutes and centers, each of which focuses on particular diseases or research areas in
human health. A range of basic and clinical research is funded through a highly
competitive system of peer-reviewed grants and contracts.
The NIH appropriation shifted after FY2003 from marked growth to low or no
increases. Congress doubled the NIH budget in five years, from $13.6 billion in FY1998
to $27.1 billion in FY2003. Since then, growth has slowed to below the rate of inflation.
The President requested $28.5 billion for FY2007, roughly the same as the FY2006 level
and a decrease of 0.2% below FY2005. In inflation-adjusted (2006) dollars, the FY2007
request was 8.7% below the FY2003 level. In FY2007 appropriations bills that did not
receive final action, the House committee matched the request for NIH, and the Senate
committee provided $200 million more (0.8% over FY2006). The only major increases
in the proposals were for research related to pandemic influenza and to biodefense drugs
and vaccines. The request planned to support some 650 fewer research project grants.
The success rate for competing grant applications getting funded would be an estimated
19%, the same as FY2006, compared with 22% in FY2005 and 30%-32% during the
doubling years. Currently, FY2007 funding is continued at the FY2006 rate.
Appropriators and authorizers face many issues in working with NIH to set
research priorities in the face of tight budgets. Congress accepts, for the most part, the
priorities established through the agency’s complex process of weighing scientific
opportunity and public health needs. While the Public Health Service Act (PHSA)
provides the statutory basis for NIH programs, it is primarily through appropriations
report language, not budget line items or earmarks, that Congress gives direction to NIH
and allows a voice for advocacy groups. Challenges facing the agency and the research
enterprise, all aggravated by restrained budgets, include attracting and keeping young
scientists in research careers; improving the translation of research results into useful
medical interventions through more efficient clinical research; creating opportunities for
transdisciplinary research that cuts across institute boundaries to exploit the newest
scientific discoveries; and managing the portfolio of extramural and intramural research
with strategic planning, openness, and public accountability. In December 2006,
Congress passed a reauthorization act (H.R. 6164) that addresses many of these issues
through changes to NIH authorities. Congress also monitors ethics rules on conflicts of
interest and tracks the efficacy of procedures intended to make results of NIH-sponsored
research publicly accessible. NIH’s Internet home page is at [http://www.nih.gov];
budget information is at [http://officeofbudget.od.nih.gov/ui/HomePage.htm]; disease
funding estimates are at [http://www.nih.gov/news/fundingresearchareas.htm]; and
legislative issues tracking is at [http://olpa.od.nih.gov]. This report will be updated as
events warrant.

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Contents
Overview of the National Institutes of Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Organization of NIH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Extramural Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Intramural Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Research Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Information Dissemination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Budget . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Recent History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Sources of Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
FY2007 Request and Appropriations Actions . . . . . . . . . . . . . . . . . . . 12
Budget Discussion by Funding Mechanism . . . . . . . . . . . . . . . . . . . . . 14
Issues for Congress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Appropriations: Budgeting within Constraints . . . . . . . . . . . . . . . . . . . . . . 15
Background on Agency Budget Formulation . . . . . . . . . . . . . . . . . . . . 15
Setting Research Priorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Advocacy Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Scarce Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Success Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Young Investigators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Research Restrictions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
New Approaches? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Authorizations: Structure and Program Direction . . . . . . . . . . . . . . . . . . . . 20
Organizational Complexity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
The National Academies Study and Recommendations . . . . . . . . . . . 20
NIH Initiatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Congressional Activities on NIH Reauthorization
(the NIH Reform Act of 2006) . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Oversight: Maintaining Trust and Transparency . . . . . . . . . . . . . . . . . . . . 27
Ethics Regulations for NIH Employees
Regarding Conflicts of Interest . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Public Access to Results of NIH-Sponsored Research . . . . . . . . . . . . 28
Selected NIH Online Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
NIH Home Page [http://www.nih.gov] . . . . . . . . . . . . . . . . . . . . . . . . 31
NIH Budget [http://officeofbudget.od.nih.gov/ui/HomePage.htm] . . . 31
Legislation Affecting NIH [http://olpa.od.nih.gov] . . . . . . . . . . . . . . . 31

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List of Figures
Figure 1. NIH Appropriations FY1994-FY2007 Request . . . . . . . . . . . . . . . . . . 11
Figure 2. Effect of Inflation on NIH Budget
FY1994-FY2007 Program Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Figure 3. FY2007 NIH Budget Request by Funding Mechanism . . . . . . . . . . . . 15
List of Tables
Table 1. Components of the National Institutes of Health (NIH) . . . . . . . . . . . . . 4
Table 2. National Institutes of Health (NIH) Appropriations . . . . . . . . . . . . . . . 10
Table 3. NIH Budget by Funding Mechanism . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Table 4. Funding for NIH Roadmap Initiatives . . . . . . . . . . . . . . . . . . . . . . . . . 23
Table 5. Components of NIH, with History and Scope . . . . . . . . . . . . . . . . . . . 32

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The National Institutes of Health (NIH):
Organization, Funding, and
Congressional Issues
Overview of the National Institutes of Health
Introduction
The National Institutes of Health is the primary agency of the federal
government charged with the conduct and support of biomedical and behavioral
research. It also has major roles in research training and health information
dissemination. In both budget and personnel, it is the largest of the eight health-
related agencies that make up the Public Health Service (PHS) within the Department
of Health and Human Services (HHS).1 For FY2006, it had a total budget of $28.5
billion and total employment of more than 18,000 people. Currently, FY2007
funding is continued at the FY2006 rate. The President’s FY2007 budget requested
level funding.
Congress maintains a high level of interest in NIH for a variety of reasons:
! The NIH budget is by far the largest and most visible component of
federal civilian research and development spending. It garners great
interest during deliberations on the annual appropriations bill for the
Departments of Labor, Health and Human Services, and Education
and Related Agencies. NIH funds extramural researchers in every
state, and widespread constituencies contact Congress about funding
for particular diseases and levels of research support in general.
! NIH has increasingly come to the attention of Congress and the
American people in the last decade, thanks to greater awareness of
science advances (for example, the Human Genome Project and its
potential for guiding more personalized medicine) and public policy
debates (for instance, the use and regulation of human embryonic
stem cells). Special interest surrounded the five-year doubling of the
agency’s budget between FY1999 and FY2003. Since then, during
three years of low or no growth, Congress has increasingly
scrutinized how NIH is using its expanded resources, how it can
1 The Public Health Service also includes the Centers for Disease Control and Prevention
(CDC), the Food and Drug Administration (FDA), the Agency for Healthcare Research and
Quality (AHRQ), the Health Resources and Services Administration (HRSA), the Substance
Abuse and Mental Health Services Administration (SAMHSA), the Indian Health Service
(IHS), and the Agency for Toxic Substances and Disease Registry (ATSDR).

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most efficiently adapt to budgetary constraints, and whether its
current structure of 27 semi-autonomous institutes and centers may
be too “stovepiped” to identify and respond nimbly to important
public health challenges.
! At the end of the 109th Congress, the House and Senate agreed on the
first NIH reauthorization statute enacted since 1993. For more than
a dozen years, most policy changes have come in the appropriations
arena or through agency initiatives under its broad research
authority. Work by the authorizing committees (the House
Committee on Energy and Commerce and Senate Committee on
Health, Education, Labor, and Pensions) had led to passage of a
number of laws focusing on individual diseases or other NIH-related
topics, but no comprehensive consideration of the agency’s structure
and policies had been undertaken. In September 2006, after many
hearings and solicitation of comments and reactions from the
disparate stakeholders of the medical research community, the
Energy and Commerce Committee reported H.R. 6164, the NIH
Reform Act of 2006, which the House quickly passed. The Senate
approved a revised version in December, and the measure went to
the President. The act focuses on enhancing the authority and tools
for the NIH Director to do strategic planning, especially to facilitate
and fund cross-institute research initiatives.
Other issues of concern to Congress and the research community include:
! clinical research, and more broadly, translational research, meaning
the movement of discoveries of basic science into new preventives,
diagnostics, therapies, and cures. Initiatives are under way to make
the process quicker and more efficient, and to encourage more
medically trained young scientists to work in clinical research;
! helping young investigators (both basic and clinical) obtain their first
independent research grants faster;
! congressional and/or administrative restrictions on types of research
funded, particularly human embryonic stem cell research, and
concerns over certain areas of mental health and sexuality research;
! conflict-of-interest regulations for NIH scientists and other
employees concerning their financial holdings and their freedom to
consult with industry and outside colleagues, including questions of
impact on recruitment and retention; and
! development of policies for free public access to journal articles
stemming from NIH-supported research, and weighing that access
against the interests of publishers, including scientific societies. (A
new NIH voluntary policy for NIH-funded authors to submit their
articles to the National Library of Medicine within 12 months of
publication has had little participation.)
This report provides background and analysis on the organization, mission,
budget, and history of NIH as an agency, outlines its major responsibilities and
methods of fulfilling them, and discusses the issues facing Congress as it considered
reauthorization legislation and as it works to guide and monitor the nation’s
investment in medical research. This report will be updated as events warrant.

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Organization of NIH
History. 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). Congress has continued to create new institutes
and centers, most recently in 2000.
Structure. Today, NIH consists of the Office of the Director and 27
components — 19 institutes, 4 research centers, the National Library of Medicine,
and 3 other centers that provide central services (for details, see Table 1, below, and
Table 5, at the end of the report). 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. Congress provides
separate appropriations to 24 of the 27 ICs, to OD, and to a buildings and facilities
account (see the budget discussion later).2 NIH occupies a 317-acre main campus in
Bethesda, Maryland, as well as numerous off-campus sites, including locations in
Maryland, North Carolina, and Montana.
Authority. The agency derives its statutory authority from the Public Health
Service Act of 1944, as amended (42 U.S.C. § 201 through §300hh-11).3 Section 301
of the PHS 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 (H.R. 6164), nine of the ICs and a variety
of individual programs had time-and-dollar limits on their authorizations of
appropriations — most of the authorizations had expired, but § 301 provided
authority for the programs. The other institutes and centers and most NIH programs
did not require periodic reauthorization by Congress, and there was no overall
authorization for the agency. The new NIH Reform Act authorized total funding
levels for NIH appropriations for FY2007 to FY2009, and eliminated all of the other
specific authorizations in Title IV.
2 The three centers that do not receive their own appropriations are the Center for Scientific
Review (CSR), which receives, refers, and reviews research and training grant applications;
the Center for Information Technology (CIT), which coordinates NIH’s information
technology services; and the Clinical Center (CC), NIH’s hospital and outpatient facility for
clinical research. Those centers are funded through the NIH Management Fund, which is
financed by taps on other NIH appropriations. For further information on each component,
see the NIH Almanac, 2006-2007, at [http://www.nih.gov/about/almanac/about.htm].
3 For a compilation of the Public Health Service Act as amended through December 31,
2004, see [http://energycommerce.house.gov/108/pubs/109_health.pdf].

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Table 1. Components of the National Institutes of Health (NIH)
(for additional details on the history and major research focus of each component, see Table 5, at the end of the report)
FY2006 rev. IC Budget
(Program Level) &
Component
Website
Percent of Total NIH
Budget ($ in millions)
Office of the Director (OD) — includes program coordination offices for research on AIDS, Disease
Prevention (including Dietary Supplements, and Rare Diseases), Behavioral and Social Sciences, and
[http://www.nih.gov/icd/od]
$478
1.7%
Women’s Health
INSTITUTES
National Cancer Institute (NCI)
[http://www.nci.nih.gov]
$4,790
16.8%
National Eye Institute (NEI)
[http://www.nei.nih.gov]
$666
2.3%
National Heart, Lung, and Blood Institute (NHLBI)
[http://www.nhlbi.nih.gov]
$2,920
10.3%
National Human Genome Research Institute (NHGRI)
[http://www.nhgri.nih.gov]
$486
1.7%
National Institute on Aging (NIA)
[http://www.nia.nih.gov]
$1,046
3.7%
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
[http://www.niaaa.nih.gov]
$436
1.5%
National Institute of Allergy and Infectious Diseases (NIAID)
[http://www.niaid.nih.gov]
$4,331
15.2%
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
[http://www.niams.nih.gov]
$508
1.8%
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
[http://www.nibib.nih.gov]
$297
1.0%
National Institute of Child Health and Human Development (NICHD)
[http://www.nichd.nih.gov]
$1,264
4.4%
National Institute on Deafness and Other Communication Disorders (NIDCD)
[http://www.nidcd.nih.gov]
$393
1.4%
National Institute of Dental and Craniofacial Research (NIDCR)
[http://www.nidcr.nih.gov]
$389
1.4%
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
[http://www.niddk.nih.gov]
$1,854
6.5%

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FY2006 rev. IC Budget
(Program Level) &
Component
Website
Percent of Total NIH
Budget ($ in millions)
National Institute on Drug Abuse (NIDA)
[http://www.nida.nih.gov]
$999
3.5%
National Institute of Environmental Health Sciences (NIEHS)
[http://www.niehs.nih.gov]
$720
2.5%
National Institute of General Medical Sciences (NIGMS)
[http://www.nigms.nih.gov]
$1,934
6.8%
National Institute of Mental Health (NIMH)
[http://www.nimh.nih.gov]
$1,403
4.9%
National Institute of Neurological Disorders and Stroke (NINDS)
[http://www.ninds.nih.gov]
$1,534
5.4%
National Institute of Nursing Research (NINR)
[http://www.ninr.gov]
$137
0.5%
National Library of Medicine (NLM)
[http://www.nlm.nih.gov]
$323
1.1%
CENTERS
John E. Fogarty International Center (FIC)
[http://www.fic.nih.gov]
$66
0.2%
National Center for Complementary and Alternative Medicine (NCCAM)
[http://www.nccam.nih.gov]
$121
0.4%
National Center on Minority Health and Health Disparities (NCMHD)
[http://www.ncmhd.nih.gov]
$195
0.7%
National Center for Research Resources (NCRR)
[http://www.ncrr.nih.gov]
$1,098
3.9%
Center for Information Technology (CIT)
[http://www.cit.nih.gov]
($33*)
Center for Scientific Review (CSR)
[http://www.csr.nih.gov]
($54*)
Warren G. Magnuson Clinical Center (CC)
[http://www.cc.nih.gov]
($334*)
* Funded through the NIH Management Fund from taps on IC budgets
Total, NIH Program Level
$28,468
100%

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CRS-6
Activities
Two categories of research are sponsored by the institutes and centers:
extramural research, performed by non-federal scientists using NIH grant or contract
money, and intramural research, performed by NIH scientists in the NIH laboratories
and Clinical Center. In both the extramural and intramural programs, the research
projects are largely investigator-initiated, and span all fields of basic and clinical
medical and behavioral research. (Basic research is research in the fundamental
medical sciences, sometimes called lab or bench research, while clinical research
involves patients.) NIH also supports a range of extramural and intramural research
training programs to prepare young investigators for research careers, and engages
in a number of information dissemination activities to reach various audiences.
Extramural Research. The extramural research community includes more
than 200,000 scientists and research personnel working in over 3,100 universities,
academic health centers, hospitals, and independent research institutions in the
United States and abroad.4 About 84% of the overall NIH budget, some $24 billion,
is spent on extramural awards in the form of research grants, research and
development contracts, training awards, and a few smaller categories such as grants
for construction, facilities renovation, and medical libraries. The “research grants”
category, by far the largest, includes research project grants to individual
investigators and small teams, as well as grants to groups of researchers who work
in collaborative programs or in multidisciplinary centers that focus on particular
diseases or areas of research. Nearly three-fourths of NIH’s extramural funds go to
researchers working in institutions of higher education, particularly the nation’s 125
medical schools.5 Data on awards and recipients by state, by congressional district,
by type of institution, by subject of the research, and by a variety of other groupings
may be accessed from the website of the NIH Office of Extramural Research at
[http://grants1.nih.gov/grants/award/award.htm].
Peer Review. All applications for extramural research support are considered
under a two-tiered system of peer review. First, they are reviewed for scientific and
technical merit by committees (scientific review groups known as “study sections”)
composed primarily of nongovernment scientists who are experts in the relevant
fields of research. Most applications for research project grants are investigator-
initiated; they are assigned for review to study sections administered through the
Center for Scientific Review. Some applications are submitted in response to
solicitations by ICs for research areas the ICs wish to target and for which they have
set aside funding. The solicitations are known as RFAs and RFPs (for grants,
Requests for Applications, and for contracts, Requests for Proposals); applications
responding to them are reviewed by study sections within the ICs.
Three times a year, members of study sections convene to read, discuss, and
score the most recent batch of submitted research proposals. Each application that
appears strong enough upon first reading to have a chance of receiving funding is
4 NIH, Justification of Estimates for Appropriations Committees, FY2007, Vol. I, Overview,
pp. 1-2 [http://officeofbudget.od.nih.gov/FY07/Performance%20Budget%20Overview.pdf].
5 NIH, Office of Extramural Research, Characteristics of Awardee Organizations
[http://grants1.nih.gov/grants/award/trends/awdorg.htm].

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CRS-7
discussed and given a “priority score” that represents the average of the scores
assigned by the reviewers. That score becomes the main determinant in whether an
applicant will eventually receive funding from an IC for the research proposal. For
the most part, applications are funded in the order of their priority score percentile
until the IC has committed all of its available resources.
The funding decisions, however, are fine-tuned by a second level of peer review
in the ICs, when the applications are considered for program relevance by the
National Advisory Councils or Boards of the ICs. Advisory Councils and Boards are
composed of scientific and lay representatives. These groups sometimes recommend
funding certain applications that fall just outside the normal cutoff if the research is
of a type that an IC is particularly interested in promoting. IC staff make the final
funding decisions among the top priority proposals.
In FY2005, just over 43,000 new and renewal applications competed for
research project grants (RPGs), and 9,599 received funding, for a “success rate” of
22.3% (the comparable preliminary figures for FY2006 are 9,128 awards out of
nearly 45,700 applications, for a success rate of 20.0%).6 Some researchers submit
more than one proposal; the 43,000 applications in FY2005 were submitted by about
31,800 individual applicants, of whom 8,783, or 27.6%, received funding.7
Applicants who are not approved for funding, and who wish to try to improve their
scores based on comments from the reviewers, are allowed to revise and resubmit
their proposals twice.
Awards. The average length of an RPG award is just under four years; hence,
in any given year, about three-fourths of the grantees are in “noncompeting,” or
“continuation,” status. Each noncompeting grantee has to submit a project report to
the IC that supplied the funding, but the grantee does not have to compete for the
second, third, and fourth year of funding — the IC considers the award a budgetary
commitment. At the expiration of the award, the grantee may choose to compete for
a renewal of the project. In FY2005, in addition to awarding 9,599 new or competing
renewal awards, NIH awarded more than 27,000 noncompeting awards and nearly
2,000 small business awards, for a total of nearly 39,000 RPGs. The average annual
cost of an RPG award is about $400,000, including both direct and indirect costs.8
The direct costs, averaging 72% of the total award, cover project-specific expenses,
while the indirect costs, averaging 28%, pay for facilities and administration costs
(i.e., overhead) of the institution where the research is conducted.9
6 NIH, Office of Extramural Research, “Success Rates by Institute” (data are available for
FY1970-FY2006) [http://grants1.nih.gov/grants/award/success/Success_ByIC.cfm].
7 NIH, Office of Extramural Research, “NIH Investment in Extramural Research and
Training Programs” [http://grants1.nih.gov/grants/award/NIH_Investment.ppt#257,24,Slide
24]. (For slides with charts and data tables; access from [http://grants1.nih.gov/grants/
award].)
8 NIH, Justification of Estimates for Appropriations Committees, FY2007, Vol. I, Overview,
table on “Research Project Grants: Total Number of Awards and Dollars,” p. NIH-86
[http://officeofbudget.od.nih.gov/FY07/Tabular%20Data.pdf].
9 NIH, Justification of Estimates for Appropriations Committees, FY2007, Vol. I, Overview,
table on “Statistical Data — Grants, Direct and Indirect Costs Awarded,” p. NIH-85
(continued...)

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Intramural Research. The NIH intramural research program accounts for
about 10% of the budget. It includes more than 6,500 scientists and technical support
staff who are government employees, and several thousand additional scientific
fellows, guest researchers, and contractors. Almost all of the ICs have an intramural
research program, but the size, structure, and activities of the programs vary greatly.
Many intramural scientists are based in the Clinical Center, which facilitates
interdisciplinary collaboration and the direct clinical application of new knowledge
derived from basic research.
Research Training. Research training to prepare students and young
scientists for research careers is supported through both the extramural and
intramural research programs. Pre-doctoral and postdoctoral training opportunities
are available for both basic and clinical scientists through a variety of training grants,
fellowships, and loan repayment programs. Programs offered on the NIH campus
range from summer internships for high school students to employment for
postdoctoral scientists.
Information Dissemination. NIH has important roles in translating the
knowledge gained from biomedical research into medical practice and useful health
information for the general public. The individual institutes and centers carry out
many relevant activities, such as sponsoring seminars, meetings, and consensus
development conferences to inform health professionals of new findings; answering
thousands of telephone and mail inquiries; publishing physician and patient education
materials (many of them available on the Internet); supporting information
clearinghouses and running public information campaigns on various diseases; and
making specialized databases available. Free searching of MEDLINE citations and
other NLM databases, together with resources for health questions, is available at
[http://www.medlineplus.gov] and at [http://health.nih.gov].
Budget
Recent History. At $28.5 billion for FY2006 (and currently the same for
FY2007), NIH’s budget (see Table 2) represents nearly 50% of federal civilian (i.e.,
nondefense) spending for research and development (R&D).10 It also constitutes
some 38% of all the discretionary spending of the Department of Health and Human
Services.11 The agency has enjoyed strong bipartisan support from Congress,
reflecting the interest of the American public in promoting medical research. Even
in the face of pressure to reduce the deficit, Congress approximately doubled NIH’s
appropriation in the decade between FY1988 and FY1998. At that point, a
coordinated lobbying effort in support of NIH and an improved budget and economic
outlook led Congress to start on a new path of doubling the NIH budget during the
following five years. The base at the time was the FY1998 appropriation of $13.6
9 (...continued)
[http://officeofbudget.od.nih.gov/FY07/Tabular%20Data.pdf].
10 See CRS Report RL33345, Federal Research and Development Funding: FY2007, by
Michael E. Davey et al.
11 Department of Health and Human Services, FY2007 Budget in Brief (Feb. 2006), p. 14
[http://www.hhs.gov/budget/07budget/2007BudgetInBrief.pdf].

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CRS-9
billion, and the target was $27.2 billion for FY2003. The commitment was
essentially accomplished, although the makeup of the budget changed somewhat over
the five years.
In the post-doubling years, the pattern has been markedly different. The annual
increases for FY1999 through FY2003 were in the 14%-15% range each year. For
FY2004 and FY2005, Congress and the President, faced with competing priorities
and a changed economic climate, gave increases of between 2% and 3%, levels that
were below the then-estimated 3.5% and 3.3% biomedical inflation index for those
two years (see the discussion below). The final appropriation for FY2006 was $67
million (0.2%) below the FY2005 level, marking the first time that the NIH
appropriation had decreased since 1970. (A few months later, the FY2006 budget
dropped another $19.5 million because of a transfer within HHS — see the
discussion of the FY2007 budget request below.) The FY2007 President’s budget
requested a program level of $28.487 billion, an amount essentially equal to the
FY2006 appropriation. See Figure 1, which charts NIH appropriations from FY1994
through the FY2007 request.
Figure 2 portrays the NIH appropriation adjusted for inflation (in constant 2006
dollars) using the Biomedical Research and Development Price Index (BRDPI).12
The index, developed each year for NIH by the Bureau of Economic Analysis (BEA)
of the Department of Commerce, reflects the increase in prices of the resources
needed to conduct biomedical research, including personnel services, supplies, and
equipment. It indicates how much the NIH budget must change to maintain
purchasing power.
With the projected value of the BRDPI at 3.5% for FY2006 and 3.4% for
FY2007, the NIH budget has been losing ground in real terms each year since the end
of the doubling in FY2003. In constant 2006 dollars, the FY2003 NIH budget was
$30.2 billion, FY2004 was $30.0 billion, FY2005 was $29.6 billion, FY2006 was
$28.5 billion, and the FY2007 request level was $27.5 billion. In inflation-adjusted
terms, the FY2006 budget was 5.7% below the FY2003 level, and the FY2007
request was 8.7% below the FY2003 level.13
12 See NIH Price Indexes [http://officeofbudget.od.nih.gov/UI/GDP_FromGenBudget.htm].
13 A note of caution regarding the BRDPI and calculations made during the first half of
2006: the inflation rate is not as steep as NIH had earlier reported. On July 24, 2006, NIH
posted a notice announcing a revision of the BRDPI because of an error made by BEA in
its previous calculations. The calculation of how much purchasing power the NIH budget
has lost since FY2003 is affected by this revision. Using the previous BRDPI value, some
observers said in the first months of 2006 that the level of the FY2007 NIH budget request
represented a decrease of nearly 11% in real terms compared to the end of the doubling
period. As discussed above, the revised estimate is 8.7%. (See “July 2006 Revision of
Biomedical Research and Development Price Index: Revised FY2005 Update and
Pr oj ections for FY2006-2016” [http://officeofbudget. od.nih.gov/PDF/
BRDPI_Proj_Revised_July_2006v3.pdf].) Earlier, in February 2006, NIH had reported the
estimated increase in the BRDPI as 5.5% for FY2005; in July it revised the estimate to
3.8%. The projected future-year values had to be revised accordingly. For FY2006, the
estimate is now 3.5% instead of 4.1%, and for FY2007, it is 3.4% instead of 3.8%.

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CRS-10
Table 2. National Institutes of Health (NIH) Appropriations
(dollars in millions)
FY2005
FY2006
FY2007
FY2007
FY2007
Institutes and Centers (ICs)
actual a
rev appr b
request
H.Comm.
S.Comm.
Cancer (NCI)
$4,828.2
$4,790.1
$4,753.6
$4,753.6
$4,799.1
Heart/Lung/Blood (NHLBI)
2,941.2
2,919.8
2,901.0
2,901.0
2,924.3
Dental/Craniofacial Res (NIDCR)
391.8
389.1
386.1
386.1
389.7
Diabetes/Diges/Kidney (NIDDK)
1,713.6
1,703.8
1,694.3
1,694.3
1,707.8
Neuro. Disorders/Stroke (NINDS)
1,539.4
1,533.7
1,524.8
1,524.8
1,537.7
Allergy/Infectious Dis (NIAID) c
4,402.8
4,380.3
4,395.5
4,270.5
4,395.5
General Medical Sci (NIGMS)
1,944.1
1,934.3
1,923.5
1,923.5
1,934.9
Child Health (NICHD)
1,270.3
1,263.9
1,257.4
1,257.4
1,264.5
Eye (NEI)
669.1
666.3
661.4
661.4
666.9
Environ Health Sci (NIEHS)
644.5
640.7
637.3
637.3
641.3
Aging (NIA)
1,052.0
1,045.9
1,039.8
1,039.8
1,048.9
Arthritis/Musculo/Skin (NIAMS)
511.2
507.6
504.5
504.5
508.6
Deafness/Comm’n Dis (NIDCD)
394.3
393.2
391.6
391.6
395.2
Nursing Research (NINR)
138.1
137.2
136.6
136.6
137.8
Alcohol Abuse (NIAAA)
438.3
435.6
433.3
433.3
436.6
Drug Abuse (NIDA)
1,006.4
999.3
994.8
994.8
1,000.3
Mental Health (NIMH)
1,411.9
1,402.6
1,394.8
1,394.8
1,403.6
Human Genome Res (NHGRI)
488.6
485.7
482.9
482.9
486.3
Bio Imaging/Bioengrg (NIBIB)
298.2
296.6
294.9
294.9
297.6
Research Resources (NCRR)
1,115.1
1,098.3
1,098.2
1,123.2
1,104.3
Complemnt/Alt Med (NCCAM)
122.1
121.4
120.6
120.6
122.0
Minority Hlth/Disparity (NCMHD)
196.2
195.3
194.3
194.3
196.8
Fogarty International Center (FIC)
66.6
66.3
66.7
66.7
66.8
Library of Medicine (NLM)
315.1
314.7
313.3
313.3
315.3
Office of Director (OD) d
405.1
527.2
667.8
667.8
687.8
Buildings & Facilities (B&F)
110.3
81.0
81.1
81.1
81.1
Subtotal, Labor-HHS-ED Approp
$28,414.5
$28,329.8
$28,350.0
$28,250.0
$28,550.7
Superfund (Interior/Env Approp) e
79.8
79.1
78.4
79.4
79.4
Total, NIH discr budget auth
$28,494.4
$28,409.0
$28,428.4
$28,329.4
$28,630.1
Pre-approp Type 1 diabetes f
150.0
150.0
150.0
150.0
150.0
NLM program evaluation g
8.2
8.2
8.2
8.2
8.2
Total, NIH program level
$28,652.6
$28,567.2
$28,586.6
$28,487.6
$28,788.3
Global HIV/AIDS Fund transfer c
-99.2
-99.0
-100.0
0.0
-100.0
Total, NIH prog level w/ transfer
$28,553.4
$28,468.2
$28,486.6
$28,487.6
$28,688.3
Sources: FY2007 NIH budget justification, H.Rept. 109-515, and S.Rept. 109-287.
Note: Currently, FY2007 funding is continued at the FY2006 rate (P.L. 109-383).
a. Reflects across-the-board reduction (0.8%) of $229.390m, Labor-HHS-ED reduction of $6.787m
for salaries and expenses, and an additional $2.987m from NCI breast cancer stamp funds.
b. Reflects across-the-board rescission (1%) of $285.974m, Interior/Env reduction of $0.382m, and
HHS transfer of $19.462m to Centers for Medicare and Medicaid Services (mid-June 2006).
c. NIAID totals include funds for transfer to Global Fund to Fight HIV/AIDS, TB, and Malaria (not
in FY2007 House bill). FY2006 includes $18.0m supplemental funding from Public Health and
Social Services Emergency Fund (PHSSEF) for pandemic flu (P.L. 109-148), and a comparable
transfer of $49.5m from NIAID to OD for Advanced Development of countermeasures.
d. OD has Roadmap funds for distribution to ICs (FY2005, $59.520m; FY2006, $82.170m; FY2007,
$110.700m). FY2005 includes $47.021m transferred from PHSSEF for nuclear/radiological
countermeasures. FY2006 includes the $49.5m comparable transfer from NIAID.
e. Separate account in the Interior/Environment/Related Agencies appropriation for NIEHS research
activities mandated in Superfund legislation (formerly in VA/HUD appropriation).
f. Funds available to NIDDK for diabetes research (P.L. 106-554 and P.L. 107-360).
g. Funds from PHS program evaluation set-aside (§ 241 of the PHS Act), $8.2m for NLM each year.

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CRS-11
Figure 1. NIH Appropriations FY1994-FY2007 Request
Program Level ($ in billions)
$30
Doubling: FY98-FY03
$28.6
$28
$2 .
8 5
.
$28.5
$27
$2 .
7 9
.
$25
$27.1
.
$23.5
$20
$20.5
$17.8
.
$15
$15.6
$13.7
.
$12
$1 .
2 7
.
$10
$11.9
$10.9
$11.3
.9
$1
$5
0
FY94 FY95 FY96 FY97 FY98 FY99 FY00 FY01 FY02 FY03 FY04 FY05 FY06 FY07
Source: Figure prepared by the Congressional Research Service (CRS).
Figure 2. Effect of Inflation on NIH Budget
FY1994-FY2007 Program Level
Purchasing Power in 2006 Dollars (Billions)
Using Biomedical R&D Price Index (BRDPI)
$35.0
$30.0
$30.2
$30.0
$29.6
$28.5
$25.0
$27.1
$27.5
$24.4
$20.0
$22.0
$20.0
$18.0
$17.4
$15.0 $16.3
$16.7
16.3
$16.2
$10.0
$5.0
0
FY94 FY95 FY96 FY97 FY98 FY99 FY00 FY01 FY02 FY03 FY04 FY05 FY06 FY07
Source: Figure prepared by CRS.

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CRS-12
Sources of Funding. NIH’s budget comes from four sources: the bulk is
through the annual Labor-HHS-Education (Labor-HHS-ED) appropriation, with an
additional small amount for Superfund-related environmental work coming from the
Interior, Environment, and Related Agencies (Interior/Environment) appropriation.
Those two sources constitute NIH’s discretionary budget authority. To reach the
“program level” budget, other funds are counted that are added to or transferred from
NIH. NIH annually receives $150 million for the Type 1 Diabetes Initiative
appropriated by P.L. 107-360, and in recent years has received an extra $8.2 million
for the National Library of Medicine from a “program evaluation” transfer within the
Public Health Service (PHS) (see below). Also, in recent years, about $100 million
of the appropriation to the National Institute of Allergy and Infectious Diseases
(NIAID) has been transferred out to the Global Fund to Fight HIV/AIDS,
Tuberculosis, and Malaria.14
The NIH and other Public Health Service agencies within HHS are subject to
a budget “tap” called the PHS Program Evaluation Transfer, authorized by section
241 of the PHS Act (42 U.S.C. § 238j). It is used to fund not only program
evaluation activities, but also functions that are seen as having benefits across the
Public Health Service, such as the National Center for Health Statistics in CDC and
the entire budget of the Agency for Healthcare Research and Quality. These and
other uses of the evaluation tap by the appropriators have the effect of redistributing
appropriated funds among PHS agencies. The FY2005 and FY2006 L-HHS-ED
appropriations set the tap at 2.4%, as did the FY2007 Senate bill. The House bill
returned the maximum tap to 1.0%, the level specified in the PHS Act. Since NIH
has the largest budget among the PHS agencies, it becomes the largest “donor” of
program evaluation funds and is a relatively minor recipient.
FY2007 Request and Appropriations Actions. For FY2007, the
President requested a total program level of $28.487 billion for NIH, including
$28.350 billion in the L-HHS-ED appropriation and $78 million in the
Interior/Environment appropriation (see Table 2). At the time of the request
(February 2006), that amount represented the same overall level of funding for NIH
as in FY2006. Subsequently, in mid-June 2006, the HHS Secretary exercised his
transfer authority to give the Centers for Medicare and Medicaid Services (CMS) a
total of $40 million from other HHS discretionary accounts (to augment the funding
for the Medicare prescription drug benefit call center). NIH’s share of the transfer
was $19.5 million, dropping the FY2006 program level to $28.468 billion.
In the request, most of the IC budgets decreased by 0.5%-0.8% below their
FY2006 levels. The major increases, in the Office of the Director and in NIAID,
were related to increases for biodefense and pandemic influenza research. For more
details on the request and subsequent congressional actions, see the NIH section of
CRS Report RL33345, Federal Research and Development Funding: FY2007, by
Michael E. Davey, et al. Highlights are covered below.
14 The “NIH program level” cited in the Administration’s budget documents, however, does
not reflect the Global Fund transfer.

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CRS-13
The House and Senate Appropriations Committees reported their Labor-HHS-
ED bills, but neither chamber brought its bill to the floor. The Interior/Environment
bill (H.R. 5386, H.Rept. 109-465 and S.Rept. 109-275) passed the House and was
reported in the Senate, with $79 million for NIH, $1 million above the request.
Currently, NIH is operating at the FY2006 rate under a continuing resolution that
runs through February 15, 2007 (P.L. 109-383).
The House committee’s Labor-HHS-ED bill (H.R. 5647, H.Rept. 109-515)
recommended $28.250 billion for NIH, with the same distribution as in the request,
except for a $25 million shift of construction money from NIAID to the National
Center for Research Resources (NCRR) and the omission of the $100 million to
NIAID for transfer to the Global Fund. Counting the extra funding for diabetes as
well as the transfers, the program level from the House bill was $28.488 billion,
essentially the same as the request and $19.5 million higher than the FY2006 revised
funding level, because of the transfer to CMS.
The Senate committee’s Labor-HHS-ED bill (S. 3708, S.Rept. 109-287)
recommended $28.551 billion, for a program level of $28.688 billion. The increase
was about $220 million (0.8%) over the revised FY2006 amount and $200 million
above the request and the House amount. The Senate committee gave every NIH
account a modest increase over FY2006, reversing the cuts to IC budgets proposed
in the request. The committee gave an extra $20 million to the Office of the Director
beyond the large boost already in the request. It included the $100 million to NIAID
for transfer to the Global Fund that the House had omitted, and did not shift $25
million in construction funds from NIAID to NCRR as in the House bill.
Specific priorities highlighted in the budget request include several trans-NIH
initiatives involving multiple institutes with coordination by OD:
! Biodefense activities were requested at a total of $1.9 billion, a net
increase of $110 million (6.2%) over FY2006, including a new push
for advanced product development of vaccines and drugs that are
priority targets for acquisition by Project BioShield.15
! Support for the NIH Roadmap for Medical Research initiatives
(discussed later in this report) increased 34%, to $443 million. The
ICs and OD share funding of 28 NIH-wide initiatives under themes
of new paths to biological discovery, building multidisciplinary
research teams, and improving the clinical research enterprise.
! The Genes, Environment, and Health initiative and the long-term
National Children’s Study are looking for genetic and environmental
influences on health. The Administration had proposed terminating
the multi-agency National Children’s Study, but both the House and
Senate committees directed NIH to continue supporting it.
! Two relatively new NIH programs support additional training and
mentoring of new investigators (Pathway to Independence Awards)
and transdisciplinary clinical research and training (Clinical and
Translational Science Awards).
15 See CRS Report RS21507, Project BioShield, by Frank Gottron.

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CRS-14
Budget Discussion by Funding Mechanism. In addition to showing the
appropriation by institute, the other common way to describe the NIH budget is by
“funding mechanism.” Displaying budget data by mechanism reveals the balance
between extramural and intramural funding, as well as the relative emphasis on
support of individual investigator-initiated research versus funding of larger projects,
comprehensive research centers, agency-directed research contracts, research career
training, facilities construction, research management costs, etc. Table 3 and Figure
3 show the distribution of the NIH budget by the major funding mechanisms.
Although the President’s FY2007 request indicated proposed spending by
mechanism, including estimated numbers of awards to be supported in each category,
the appropriators did not specify in their reports how the budget should be allocated
by mechanism. FY2006 numbers in Table 3 are not adjusted for the June 2006 CMS
transfer.
The major changes to note between FY2006 and FY2007 are (1) an increase in
the number of new and competing renewal research project grants; (2) a decrease in
the number of noncompeting grants (because a large number of grants that were
started toward the end of the doubling years completed their funding cycles in
FY2006); (3) a resulting net decrease in total RPGs; (4) modest increases in research
centers, other research grants, R&D contracts, and research management and support;
(5) small decreases in research training and intramural research; and (6) a $100
million increase in the “All Other” grouping, due to biodefense funding in OD.
Table 3. NIH Budget by Funding Mechanism
(dollars in millions)
FY2005
FY2006
FY2007
% change
Mechanism
actual
approp
estimate
2007/2006
Research Project Grants (RPGs)
$15,484
$15,355
$15,123
-1.5%
Research Centers
$2,731
$2,771
$2,834
+2.3%
Other Research Grants
$1,636
$1,656
$1,677
+1.3%
Research Training
$756
$761
$760
-0.1%
R&D Contracts
$2,641
$2,700
$2,744
+1.6%
Intramural Research
$2,756
$2,768
$2,759
-0.3%
Res. Management & Support
$1,079
$1,092
$1,106
+1.3%
All Other a
$1,570
$1,484
$1,584
+6.7%
Total, NIH Program Level
$28,653
$28,587
$28,587
0.0%
# new/competing renewal RPGs
9,599
9,062
9,337
+275 grants
# noncompeting RPGs
27,385
27,385
26,468
-917 grants
# small business grants
1,924
1,880
1,866
-14 grants
Total # of RPGs
38,908
38,327
37,671
-656 grants
Source: NIH: Summary of the FY2007 President’s Budget, February 6, 2006, p. 10.
[http://officeofbudget.od.nih.gov/pdf/Press%20info%20final.pdf]
a. “All Other” includes Cancer Prevention and Control, Extramural Construction, NLM, OD,
Buildings and Facilities, Superfund, and NLM Program Evaluation.

---

CRS-15
Figure 3. FY2007 NIH Budget Request by Funding Mechanism
Total NIH Program Level = $28,587 Million
(Dollars in Millions)
Research
Management
and Support
All Other
$1,106
$1,584
Intramural
4%
6%
Research $2,759
10%
Research Project
R&D Contracts
Grants
$2,744
$15,123
10%
52%
Research
Training
Other Research
$760
Grants
Research
3%
$1,677
Centers $2,834
6%
9%
Source: Adapted from NIH: Summary of the FY2007 President’s Budget, February 6, 2006, p. 6
[http://officeofbudget.od.nih.gov/pdf/Press%20info%20final.pdf].
Issues for Congress
Congress has devoted considerable attention to NIH for decades, spurred by
constituents who have voiced their expectation that the federal government would
take the lead in cutting-edge research on prevention and treatment of disease. Since
the mid-1990s, the doubling of the NIH budget and big projects like the sequencing
of the human genome have fired the public’s imagination, generating much hope and
anticipation of further advances. More recently, however, budgetary realities and
various issues facing the research enterprise are challenging NIH and Congress to
rethink some approaches to NIH’s traditional mission. Congress is confronting those
challenges in the three spheres of appropriations, authorizations, and oversight.
Appropriations: Budgeting within Constraints
Background on Agency Budget Formulation. The NIH budget request
that Congress receives from the President each February for the next fiscal year
reflects both recent history and professional judgments about the future, because it
needs to support both ongoing research commitments and new initiatives. The
request is formulated through a lengthy process that starts more than a year before in
the institutes and centers. The budget then evolves over a number of months as it
progresses from the ICs to NIH, then to HHS and finally to the Office of
Management and Budget (OMB). At each stage, IC and NIH needs are weighed in

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CRS-16
the context of the larger budget of which they are a part. Eventually, Congress is
called upon to make similar judgments.
As a continuing process, IC leaders, with input from the scientific community,
define the most important and promising areas in their respective fields. They
consider whether the research portfolio they are already supporting needs any
rebalancing, and they decide on possible new initiatives for the coming budget year.
An annual budget retreat in May brings together the IC leaders with top NIH
management to discuss policies and priorities under various budget scenarios. They
might consider, for example, what the different emphases in their programs would
be if the appropriation turned out to be a certain percent decrease, a flat budget, or
an increase. The presentations and discussions allow NIH management to develop
the budget request they will submit to HHS, taking into account the estimate of the
amount of funding needed to support the “commitment base” of continuing awards,
the funding desired for unsolicited new research proposals, the new initiatives that
the Director wants to incorporate, and guidance from the department about the
request (for example, there might be an instruction to pay no inflationary increases
on grants). At the HHS level, NIH’s request is considered in the context of the
overall department budget, resulting in a notice back to NIH on the department’s
allowance. There are usually appeals and adjustments made before the final HHS
budget goes to OMB. The process of submission, passback, and appeals is repeated
as OMB considers the entire federal budget and tells HHS what amounts and policy
approaches are approved for incorporation into the President’s final budget that will
be sent to Congress. Once the budget is made public in early February, all agency
comments about the request are expected to support the President’s proposed levels.
Setting Research Priorities. Some people feel that the main role of the
Congress in regard to NIH should be to provide money with as few strings attached
as possible. They favor trusting the creativity of investigator-initiated research and
the NIH priority-setting process (to the extent that “good science” is driving research
priorities), with funding targeted toward the maximum exploitation of scientific
opportunity, as defined by the peer review system. They object to influences that
skew research priorities in directions they would judge not scientifically sound. In
support of that general philosophy, appropriators have traditionally tried to minimize
congressional micromanagement of NIH’s budget, and have avoided specifying
dollar amounts for particular fields of research or mechanisms of funding below the
level of the Institute and Center accounts.
At the same time, it is recognized that both Congress and NIH do weigh
numerous other factors when they make priority-setting decisions. NIH has laid out
its considerations and processes for setting research priorities in a document on its
website.16 Of paramount importance are judgments about public health needs, which
may reflect, for example, information on the health and/or economic burdens posed
by particular diseases, the populations affected, and the degree of threat to the general
public. Another factor may be the potential applicability of research on one medical
condition to broader, related fields.
16 NIH, “Setting Research Priorities at the National Institutes of Health” [http://www.nih.
gov/about/researchpriorities.htm].

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CRS-17
Advocacy Groups. In Congress, the annual appropriations process has
always been a magnet for those seeking to bolster funding for biomedical research
generally or to influence research priorities in favor of some disease or field of
science. Every congressional district includes multiple parties with an interest in
NIH. Patient advocacy organizations, sometimes termed “disease lobby groups,” are
active in sending information to their members by mail and over the Internet.
Advocacy groups have become more organized, and more demanding of a role in
setting research priorities. They educate their contacts and the interested public about
the latest developments in research and new therapies in their disease area. They
frequently track federal and state legislation pertaining to health research and health
care, and urge their members to contact their representatives for action in their areas
of interest, including support of funding for NIH. Appropriators often use report
language directing NIH to pay more attention to research on particular diseases as a
way of responding to the public’s requests.
Scientists working at universities and research institutions are also urged by
their professional organizations to contact Congress in support of more funding for
biomedical research and for federal science agencies generally. Their message is that
many advances against disease can be traced back to NIH-funded research, and that
continued improvements in human health require continued commitment to NIH. As
an example, in August 2006, the Federation of American Societies for Experimental
Biology (FASEB) provided its members with a slide presentation that they could
customize with information from their own institutions.17
Scarce Resources. Congress’s flexibility in helping NIH respond to
scientific opportunity and public health needs has been severely reduced since
FY2004. The prior five years, when Congress provided for the doubling of the NIH
budget, coincided with a time of economic expansion and federal budget surpluses.
More recent years, on the other hand, have been characterized by a return to federal
deficits and new commitments to spending on defense and homeland security. The
result has been a tightening of funds available for domestic discretionary programs.
Caps on spending in recent congressional budget resolutions have left the Labor-
HHS-ED appropriations subcommittees with difficult choices when allocating funds
for a range of social and public health programs. NIH’s budget shifted from annual
increases of around 6% to 7% before FY1999 to twice that (around 14% to 15%)
during the doubling to between 0% and 3% since FY2003, levels below the rate of
inflation. As demonstrated in Figure 2, above, if the amount proposed in the
President’s FY2007 request had been accepted by Congress, NIH would have had
8.7% less purchasing power than in FY2003.
The extra resources provided during the doubling period allowed the number of
new grants to be increased (though not doubled), the average dollar size of grants to
go up to cover the needs of more sophisticated research projects, and research
institutions, especially universities, to expand their research faculties and create more
laboratory space. Such increases tend to drive the need for yet more resources in the
future. It seems not to have been anticipated in some quarters that the NIH budget
17 Federation of American Societies for Experimental Biology, “FASEB Launches
Grassroots Campaign for NIH, ‘Supporting Medical Research in Concept Is Not Enough,’”
FASEB News, Aug. 9, 2006 [http://opa.faseb.org/pdf/PowerpointLaunch8.9.06.pdf].

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CRS-18
increases might change so dramatically after the doubling. The research community
had hoped for a “softer landing” after the doubling, with increases of perhaps 8% to
10% per year to maintain the momentum of their work. Recent NIH appropriations
that have grown less than the rate of inflation have strained certain areas of the
biomedical research enterprise, particularly investigator-initiated research.
Success Rates. A key marker for the research community of the adequacy
of NIH grant funding is the “success rate” of research project grant applications, that
is, the proportion of competing RPG applications that receive funding. NIH expected
that under the FY2007 request, the success rate would be about 19%, the same as in
FY2006, compared with 22% in FY2005. During the doubling years, the success rate
averaged 30% to 32%.18 Changes in the success rate can be driven by changes in
either the numerator (number of applications funded) or the denominator (number of
applications reviewed). The rate has dropped in some years even when the number
of competing awards increased, because the number of applications soared even
more. The increase in the number of applications received in the two years following
the doubling (FY2004 and FY2005) exceeded the increase of the previous four years,
at a time when the number of competing awards was dropping.19 In other words, in
those years, more and more applicants were chasing fewer and fewer awards.
Projections for FY2006 and FY2007 are similar. The increase in applications stems
from both the expanded research capacity at many academic medical centers and the
increase in the number of applications submitted per applicant, as researchers try
more than one route to obtain funding.
Young Investigators. NIH is concerned that prospects for a lower number
of grants and a lower success rate will further discourage young scientists from
pursuing careers in medical research. New investigators with creative ideas are the
lifeblood of the research enterprise, but the path to becoming an independent
researcher is long and challenging. Many young doctoral students and postdoctoral
scientists already observe that their more senior colleagues have had increasing
trouble in getting funded. Especially if they are physicians with the option of going
into clinical practice, they may wonder about the wisdom of devoting themselves to
years of research training that may not lead to successful competition for independent
grant support. Some may decide on other career paths, and some may choose to
pursue research opportunities overseas. In January 2006, NIH announced a new
“Pathway to Independence” program that increases support of young investigators in
order to address the ever-lengthening time that it has been taking them to get their
first grants. The new program will support promising postdoctoral scientists through
five-year awards that will have a two-year mentored phase and a three-year
independent phase.20 NIH planned to support 150 to 200 awards beginning in fall
2006, and a similar number in each of the following five years, for a total
commitment of almost $400 million.
18 NIH, Justification of Estimates for Appropriations Committees, FY2007, Vol. I, Overview,
table on “Research Project Grants: Success Rates, FY1998-FY2007,” p. NIH-87
[http://officeofbudget.od.nih.gov/FY07/Tabular%20Data.pdf].
19 NIH, Office of Extramural Research, “Success Rates by Institute” (data are available for
FY1970-FY2006) [http://grants1.nih.gov/grants/award/success/Success_ByIC.cfm].
20 See [http://grants2.nih.gov/grants/new_investigators/pathway_independence.htm] for
information on the new award, and [http://grants2.nih.gov/grants/new_investigators] for
general information on NIH’s New Investigators Program.

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CRS-19
Research Restrictions. Also generating uncertainty for some researchers
are congressional and/or administrative restrictions on types of research funded. The
major recent examples are controls on federal funding of research on human
embryonic stem cells, and congressional concerns over grant awards in certain areas
of behavioral research.
During more than 25 years of debate on the science and ethics of stem cell
research, scientists have been able to get federal funding for only a limited number
of avenues of basic research, despite what many experts feel are promising long-term
prospects for advances against debilitating diseases. Current restrictions on funding
of embryonic stem cell research involve both congressional limits in appropriations
laws and an administration policy announced by President Bush in August 2001.
Some scientists who want to work with a wide range of stem cells have sought
support from private funding or from several new state research initiatives. For
further information, see the following CRS Reports by Judith A. Johnson and Erin
D. Williams: RL33540 (Stem Cell Research: Federal Research Funding and
Oversight), RL33554 (Stem Cell Research: Ethical Issues), and RL33524 (Stem Cell
Research: State Initiatives).
The research community is also troubled by congressional attempts to cancel
funding for specific existing peer-reviewed grants.21 The targeted studies tend to be
in fields of behavioral research, including some in mental health and human sexuality
research. Sponsors and supporters of such amendments to the L-HHS-ED
appropriations bills say that NIH should not be devoting scarce resources to research
studies whose value they question. Researchers, however, including NIH leadership,
have expressed alarm at what they view as an assault on the peer review system,
saying that such studies were funded because of their technical merit and the
important research questions they addressed. In the House L-HHS-ED bill for
FY2006 (H.R. 3010, §525), funding for two grants from the National Institute of
Mental Health was canceled; the conferees on the appropriations bill, however, did
not accept the provision (H.Rept. 109-337, p. 120).22
New Approaches? While advocates warn that tight budgets will slow
research advances on the major chronic conditions that burden American society,
other commentators advise that coping with the reality of budget constraints will
require NIH and the research community to rethink some of their traditional
approaches to planning and organizing research. As NIH Director Dr. Elias Zerhouni
has noted, “As science grows more complex, it is also converging on a set of unifying
principles that link apparently disparate diseases through common biological
pathways and therapeutic approaches. Today, NIH research needs to reflect this new
reality.”23 Scientific leaders in and out of NIH urge critical examination of the best
ways to transform knowledge into medical applications and allocate resources into
the most critical priorities to maximize return on the public’s investment.
21 Jocelyn Kaiser, “House ‘Peer Review’ Kills Two NIH Grants,” Science, vol. 309 (July 1,
2005), pp. 29-31; Shirley Haley, “Amendment to Defund Current NIH Mental Health Grants
Added to House Labor-HHS Spending Measure,” Research Policy Alert, June 28, 2005.
22 For debate and inserted statements on the amendment that mandated the defunding of the
grants, see Congressional Record, daily edition, vol. 151, no. 86 (June 24, 2005), pp.
H5136-H5139.
23 Elias Zerhouni, “The NIH Roadmap,” Science, vol. 302 (Oct 3, 2003), pp. 63-64, 72.

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CRS-20
Authorizations: Structure and Program Direction
Organizational Complexity. A key element of such rethinking has been
consideration of NIH’s organizational structure, which has expanded markedly over
time along with the growth in the budget. The institutes and centers, currently
numbering 27, have always operated as a decentralized federation, with loose
coordination by the Office of the Director. The costs and complexities of
administering the enterprise have multiplied as new entities have been created by
Congress (seven of them between 1985 and 2000; see Table 5), each with its own
mission, budget, staff, review office, and other bureaucratic apparatus. Many have
wondered whether the agency has become too fragmented to be manageable, and
whether NIH is able to respond appropriately to new scientific and public health
challenges. Some have suggested consolidating the ICs into a smaller number of
units encompassing broad areas of science.24 Others have warned that such a move
could prove politically unfeasible because of the loyalties of the constituencies of the
individual ICs, and might result in a net loss of congressional and public support.
Further, although NIH wishes to emphasize a culture of inter-disciplinary teamwork,
many observers fear that the present structure of multiple independently operated
institutes may undermine important initiatives in cross-disciplinary research,
especially in fields such as the neurosciences.
The National Academies Study and Recommendations. As part of the
FY2001 appropriation, Congress directed NIH to have the National Academy of
Sciences study “whether the current structure and organization of NIH are optimally
configured for the scientific needs of the Twenty-first Century” (S. Rept. 106-293,
p. 179). The National Research Council (NRC) and the Institute of Medicine (IOM)
of the National Academies formed a Committee on the Organizational Structure of
the National Institutes of Health. The committee spent a year soliciting and assessing
the views of the basic science, clinical medicine, and health advocacy communities,
together with those of management experts and many current and former NIH
leaders. It released its recommendations in a 2003 report, Enhancing the Vitality of
the National Institutes of Health: Organizational Change to Meet New Challenges.25
The committee did not think that wholesale consolidation of institutes and
centers was the most useful approach to ensuring NIH’s ability to meet future
challenges. It did suggest a few possible consolidations, but said that those and any
other proposals for increasing or decreasing the number of ICs or OD program offices
should be subject to a public process for evaluating the scientific needs,
consequences, available resources, and level of public support for the proposed
changes. It strongly recommended mergers of some clinical research components of
the extramural and intramural research programs to improve leadership, funding, and
management of the NIH clinical research enterprise.
24 Harold Varmus, “Proliferation of National Institutes of Health,” Science, vol. 291 (Mar.
9, 2001), pp. 1903-1905.
25 National Research Council and Institute of Medicine, Enhancing the Vitality of the
National Institutes of Health: Organizational Change to Meet New Challenges
(Washington: National Academies Press, 2003) [http://www.nap.edu/catalog/10779.html].

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CRS-21
The committee recommended that Congress strengthen the role of the NIH
Director in strategic planning and budgeting for innovative, trans-NIH research.
Referring to “vast changes in the landscape of science and the nation’s health
concerns during the last half century,” the committee report noted in its executive
summary the increasingly complex environment in which scientists operate: “In
science, the importance of multi-institutional, multidisciplinary research that relies
more and more on large infrastructural investments is ever more apparent.” At NIH,
such crosscutting issues and initiatives go beyond the purviews of individual ICs.
The committee felt that more initiatives were needed and that they would require
more centralized leadership and budgeting. It recommended that the NIH Director
present such trans-NIH initiatives to Congress, with proposed funding amounting to
5% of the NIH budget in the first year, and more in subsequent years. It also
recommended that additional staff, budget, and reprogramming authority be provided
for OD operations in managing its new responsibilities, and that funding for research
management and support in all of NIH’s units be increased.
Other recommendations in the committee’s report addressed the need for more
highly innovative, high-risk research projects with potentially great payoffs, both in
extramural grants and in the intramural research program. It recommended that
Congress create a Director’s Special Projects Program to fund such research, with a
sustained commitment starting at $100 million per year and growing to as much as
$1 billion per year. To enhance public accountability and transparency, the
committee said that NIH should improve its data systems for tracking and reporting
spending by areas of research. It faulted current information management systems
and the lack of standardized coding across the ICs, and said that NIH should improve
its reporting and analysis of research accomplishments of scientists trained and
supported with NIH funds. A particular problem involves the question of how to
count research that is related but not directly applicable to a specific topic.
(Currently, NIH’s estimates of its funding for specific diseases and conditions may
be found at [http://www.nih.gov/news/fundingresearchareas.htm].) Some final
recommendations by the committee were to have more rigorous and frequent review
of the performance of top NIH and IC leadership, including the possibility of term
limits; that Congress reassess the special status of the National Cancer Institute in
regard to appointments and budget authority; and that the advisory council system be
reformed so that councils are more independent, protected from political influences,
and more involved in priority setting and planning.
NIH Initiatives. In the past few years, under the leadership of current NIH
Director Dr. Elias A. Zerhouni and with the concurrence of the appropriations
committees, NIH has undertaken several new initiatives and organizational changes
that address many of the issues highlighted by the NRC/IOM report.
NIH Roadmap. In September 2003, Dr. Zerhouni announced a series of
initiatives known collectively as the NIH Roadmap for Medical Research
[http://nihroadmap.nih.gov].26 The Roadmap had been developed over the previous
year and a half as a comprehensive plan to identify and address the major scientific
opportunities and gaps in medical research that no single institute or center at NIH
could tackle alone. NIH held meetings attended by more than 300 leaders in
26 NIH, Office of the Director, “NIH Announces Strategy to Accelerate Medical Research
Progress,” press release, Sept. 30, 2003 [http://www.nih.gov/news/pr/sep2003/od-30.htm].

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CRS-22
academia, industry, government, and the public who had been invited to discuss
today’s most compelling scientific challenges and the most important knowledge
gaps (“roadblocks”) they felt were constraining rapid progress in research and its
application to useful prevention, diagnostic, and treatment strategies. NIH leaders
further refined the ideas and developed proposed initiatives and implementation
plans. They ultimately identified 28 trans-NIH priorities and initiatives, grouped into
three main themes.
The first theme, “New Pathways to Discovery,” addresses the “daunting
complexity of biological systems” and the need to know much more about networks
of molecules and their interactions, together with the need to develop new
technologies, databases, and other scientific “tools” to pursue research at the cellular
and molecular level. Examples of resources to be established include libraries of
chemical molecules, imaging probes, nanotechnology devices, and enhanced
computational capability.
The second theme, “Research Teams of the Future,” addresses collaborative
team efforts in interdisciplinary research, high-risk research, and public-private
partnerships. Modern biomedical science represents the convergence of biological,
physical, and information sciences, and NIH wants to encourage investigators to
break out of their traditional disciplines and take on new approaches. One new
funding possibility for highly innovative researchers is the NIH Director’s Pioneer
Award [http://nihroadmap.nih.gov/pioneer], which seeks to support investigators
who will “take on creative, unexplored avenues of research that carry a relatively
high potential for failure, but also possess a greater chance for truly groundbreaking
discoveries.”27
The third theme is “Re-engineering the Clinical Research Enterprise.” NIH
characterizes this as “undoubtedly the most challenging, but critically important, area
identified through the NIH roadmap process.”28 Translating the findings of
laboratory research into products and practices that improve people’s health is the job
of clinical researchers, and is the ultimate goal of performing fundamental research.
Traditional methods of conducting clinical studies, however, are slow, complex,
costly, and tend to be limited in the number of patients they can involve. To more
quickly develop, test, and deliver new interventions, researchers could work in closer
proximity to patients. The revamped clinical research enterprise will need integrated
networks of academic centers linked to community-based health care providers and
organized patient communities. It will also require new ways of handling
information, developing research protocols, assessing clinical outcomes, harmonizing
regulations, and training more people for the clinical research workforce. In 2005,
NIH launched a new Clinical and Translational Science Awards (CTSA) program.29
Administered by NIH’s National Center for Research Resources, the program has
been developed to foster transdisciplinary clinical research and training, with the goal
of speeding the translation of the findings of “discovery” research into clinical
practice.
27 Ibid.
28 NIH, Office of Portfolio Analysis and Strategic Initiatives, “Overview of the NIH
Roadmap” [http://nihroadmap.nih.gov/overview.asp].
29 NIH, National Center for Research Resources, “Clinical and Translational Science
Awards” [http://www.ncrr.nih.gov/clinicaldiscipline.asp].

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CRS-23
Roadmap initiatives are funded by a set-aside from the budgets of all the
institutes and centers and from appropriations to the OD Director’s Discretionary
Fund. Congressional appropriators have approved the funneling of this money into
a “Common Fund” for shared needs. As shown in Table 4, the amounts have
increased each year, with the proposed contribution from each IC being 1.2% in
FY2007, for a total Roadmap funding level that equals about 1.6% of the NIH
budget.
Table 4. Funding for NIH Roadmap Initiatives
(dollars in millions)
Office of
Institute/
Roadmap
Roadmap %
Roadmap
Director
Center
% of IC
of Total
Total
Contribution
Contribution
Budgets
NIH Budget
FY2005
$239.7
$64.0
$175.7
0.6%
0.8%
FY2006
$329.5
$82.2
$247.3
0.9%
1.2%
FY2007
$442.7
$110.7
$332.0
1.2%
1.6%
Source: NIH, Justification of Estimates for Appropriations Committees, FY2007, Vol. I, Overview,
“Roadmap Contributions by Institute and Center,” p. NIH-77 [http://officeofbudget.od.nih.gov/FY07/
Tabular%20Data.pdf].
OPASI, a New Home for Trans-NIH Initiatives. Besides the Roadmap for
Medical Research, NIH has organized other interdisciplinary, trans-institute
initiatives in recent years, such as the Strategic Plan for Obesity Research, started in
FY2005, and the Neurosciences Blueprint, commenced in FY2006. The Blueprint
pools resources among 15 ICs with an interest in the nervous system for use in
cooperative research, including development of research tools and infrastructure that
serve the entire neuroscience community. In September 2005, NIH administratively
established a new office within the Office of the Director to “identify and integrate
information to support the planning and implementation of trans-NIH initiatives.”30
Called the Office of Portfolio Analysis and Strategic Initiatives (OPASI)
[http://opasi.nih.gov], it was established to give the agency “more transparent
processes and cutting-edge tools to analyze, assess, and manage the array of research
it supports, and provide better information to support planning and priority-setting
in areas of shared Institute and Center interest.”31 The aim was to achieve a
“functional integration” of NIH (without the need for structural reorganization) by
bringing together diverse components of the agency in pursuit of common scientific
purposes. NIH leaders felt that, building on the effectiveness of the Roadmap
approach, OPASI would offer further “flexibility and nimbleness” in finding and
funding cutting-edge research.32
30 HHS, NIH, “Statement of Organization, Functions, and Delegations of Authority,” 70
Federal Register 56730, Sept. 28, 2005.
31 NIH, Justification of Estimates for Appropriations Committees, FY2007, Vol. I, Overview,
p. NIH-56 [http://officeofbudget.od.nih.gov/FY07/Narrative%20by%20Activity.pdf].
32 Carla Garnett, “New NIH Portfolio Analysis Office To Provide ‘Incubator Space’ for
Novel Ideas,” NIH Record, vol. 62, no. 25 (Dec. 16, 2005), pp. 1, 6-7
(continued...)

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CRS-24
Two of the OPASI divisions focus on (1) resource development (such as
databases) and assessments to support priority setting among scientific areas and
research portfolio analysis and management (for example, to improve the coding of
disease-specific resources); and (2) program evaluations, both IC-specific and trans-
NIH, and systematic assessments such as those required by the Government
Performance and Results Act (GPRA) and the OMB Program Assessment Rating
Tool (PART) — all in order to inform evaluation of the NIH research agenda and
decisions about NIH-wide resource allocations. The third division, the Division of
Strategic Coordination, manages the current trans-NIH initiatives, including the
Roadmap, and coordinates the decision-making processes that lead to formulation of
new trans-NIH strategic initiatives. OPASI does not have grant-making authority,
but it manages the Common Fund monies to support time-limited (five to 10 years)
priority projects that are administered by the ICs. Initiatives will be reviewed
frequently for continuation, transfer to an IC, or completion, with no initiative to
remain in OPASI more than 10 years. NIH planned that the budget for the Common
Fund would grow to 1.7% of the total NIH budget in FY2008, but would not go
beyond that percentage unless the annual NIH appropriation grows by more than the
inflation rate for biomedical research.33 With passage of the NIH Reform Act in
December 2006 (see the next section), NIH is making plans to transition the
functions of OPASI into the new Division of Program Coordination, Planning, and
Strategic Initiatives.
Congressional Activities on NIH Reauthorization (the NIH Reform
Act of 2006). As discussed early in this report, statutory authority for NIH is found
primarily in Title IV of the Public Health Service Act (42 U.S.C. § 281-290b). Over
the years since the PHS Act was first compiled in 1944, Congress has amended Title
IV by adding numerous sections delineating specific responsibilities, activities, and
functions of NIH. Before the 109th Congress, systematic change to those authorities
had been undertaken only twice, in the Health Research Extension Act of 1985 (P.L.
99-158) and in the NIH Revitalization Act of 1993 (P.L. 103-43). Most of the
specific authorities established or extended in the 1993 act expired in FY1996, and
had not been updated. (The programs continued under NIH’s general authority to
conduct and sponsor research.) A number of additional laws enacted since 1993 had
addressed particular areas of research; most of those authorities had also expired.34
Over time, Congress has rearranged the provisions of Title IV and added new
32 (...continued)
[http://www.nih.gov/nihrecord/12_16_2005/story01.htm].
33 Information for this paragraph was taken from an August 2006 “Fact Sheet” on OPASI,
available at [http://opasi.nih.gov/documents/OPASI_FactSheet_Aug06.pdf].
34 Examples of such laws are the Women’s Health Research and Prevention Amendments
of 1998 (P.L. 105-340), Children’s Health Act of 2000 (P.L. 106-310), Public Health
Improvement Act of 2000 (P.L. 106-505), National Institute of Biomedical Imaging and
Bioengineering Establishment Act of 2000 (P.L. 106-580), MD-CARE Act (Muscular
Dystrophy Community Assistance, Research and Education Amendments of 2001, P.L. 107-
84), and Rare Diseases Act of 2002 (P.L. 107-280), among others. The NIH Almanac,
2006-2007, at [http://www.nih.gov/about/almanac/about.htm], includes a comprehensive
chronology of NIH-related legislation. The annual report by the Congressional Budget
Office on Unauthorized Appropriations and Expiring Authorizations may be consulted for
a chronological listing of public laws, arranged by authorizing committee, whose provisions
have expired [http://www.cbo.gov/publications/bysubject.cfm?cat=6].

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CRS-25
program authorizations and reporting requirements, but it has never initiated a major
restructuring of the agency’s organization, aside from the addition of institutes,
centers, and offices.
The recommendations of the 2003 NRC/IOM report reawakened congressional
interest in using the reauthorization process to improve NIH management and
operations. The House Committee on Energy and Commerce, which had already
held a series of hearings on NIH and research-related issues, circulated a draft bill for
discussion and held a hearing in July 2005, taking testimony from the NIH Director.35
The disparate stakeholders of the medical research community, including those in
academia, government, industry, the nonprofit sector, patient advocacy groups, and
the general public, had opportunities during the following year to provide comments
and reactions to the proposal, which resulted in changes in a number of provisions
in the draft bill. On September 19, 2006, the committee held a legislative hearing on
the third draft of the “National Institutes of Health Reform Act of 2006,” during
which representatives of major stakeholder organizations expressed their support for
the revised legislation.36 An amended version of the draft was approved by the
committee in a markup session the next day.
The bill, H.R. 6164 (H.Rept. 109-687), was introduced by Chairman Barton on
September 25, 2006, and was passed by the House under suspension of the rules on
September 26, 2006, by a vote of 414-2. In the Senate, action on the bill was
deferred until the last day of the 109th Congress. On December 8, 2006, the bill was
discharged from the Senate Committee on Labor, Health, Education, and Pensions,
and an amended version, the product of negotiations between the Senate and House
authorizers and appropriators, passed the Senate by unanimous consent. The House
agreed to the Senate amendment by voice vote, and the measure was cleared for the
President.
The law makes managerial and organizational changes in NIH, with a focus on
enhancing the authority and tools available to the NIH Director’s Office to do
strategic planning, and especially to facilitate and fund transdisciplinary, cross-
institute research initiatives. It contains no provisions relating to specific diseases
or fields of research, and does not eliminate or consolidate any existing ICs.
The law establishes a Division of Program Coordination, Planning, and Strategic
Initiatives within the Office of the Director. The Division is similar to NIH’s OPASI
(described in the previous section), except that the individual program offices in OD
will be housed in the Division (such offices coordinate research on AIDS, women’s
health, behavioral and social sciences, disease prevention, dietary supplements, and
rare diseases). While not superseding the planning and priority-setting
responsibilities of the individual institutes and centers, the measure charges the
35 U.S. Congress, House Committee on Energy and Commerce, Legislation to Reauthorize
the National Institutes of Health, hearing, 109th Cong., 1st sess., July 19, 2005, serial no. 109-
40 (Washington: GPO, 2005). For links to Energy and Commerce hearings (archived
webcasts and printed transcripts), see [http://energycommerce.house.gov/108/action.htm].
36 U.S. Congress, House Committee on Energy and Commerce, Improving NIH Management
and Operation: A Legislative Hearing on the NIH Reform Act of 2006, 109th Cong., 2nd sess.,
Sept. 19, 2006. The archived webcast and testimony of the witnesses are available at
[http://energycommerce.house.gov/108/Hearings/09192006hearing2031/hearing.htm].

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CRS-26
Director with overall program coordination of the entire research portfolio of NIH.
It requires the creation of a comprehensive electronic reporting system to catalogue
research activities from all of the ICs in a standardized format. Information from the
tracking system is intended to assist the Director and the Division in planning trans-
NIH research initiatives that cannot be handled within individual ICs.
Building on the approach of the NIH Roadmap, such trans-NIH initiatives will
be funded through a reserve account called the “Common Fund.” The law requires
the NIH Director to reserve an amount for the Common Fund that, as a percentage
of total NIH appropriations, is at least as great as in the previous year. (The original
House bill had proposed a formula for the Fund and authorized it to receive half of
all new money in the NIH appropriation until the Fund reached 5% of the total NIH
budget.) A new Common Fund strategic planning report to the Congress is required;
it is to estimate the funding needed for trans-NIH research. Proposals for trans-NIH
research will be reviewed by a new advisory body, the “Council of Councils,”
composed of representatives from the IC advisory councils, OD offices, and the
Council of Public Representatives. Proposals from investigators who are first-time
applicants are to be given “appropriate consideration,” and NIH’s traditional
emphasis on peer-reviewed, investigator-initiated research is to be maintained.
The law creates a “Scientific Management Review Board” charged with
formally and publicly reviewing NIH’s organizational structure at least once every
seven years. The board may recommend restructuring, including the creation of new
institutes, but the number of ICs is capped at the current 27. The law sets out time
frames for the Director to take action on such recommendations, and provides for
review by Congress.
The measure authorizes total funding levels for NIH, although not for the
individual ICs, for FY2007-FY2009. This is the first time the PHS Act has specified
a ceiling for overall NIH funding. From an assumed FY2006 baseline of $28.33
billion, funding increases nearly 7% to $30.33 billion for FY2007, more than 8% to
$32.83 billion for FY2008, and is authorized for such sums as needed for FY2009.
Within those amounts, appropriations are authorized for the Office of the Director
at such sums as needed for FY2007-FY2009. The law eliminates a number of
statutory authorizations of appropriations for specific programs (including those for
several institutes), but does not change NIH’s authority to run the programs.
The law requires a biennial report from the Director to Congress assessing the
state of biomedical research and reporting in detail on the research activities of NIH,
including strategic planning and initiatives, and summaries of research in a number
of broad areas. All other duplicative reporting requirements are eliminated. The law
adds new reporting requirements on clinical trials, human tissue storing and tracking,
whistleblower complaints, and special consultant hires (all of those issues have been
the subject of investigations by the House committee in the past few years). Two
demonstration programs are authorized, one to award grants that “bridge the
sciences” between the biological, behavioral, and social sciences and the physical,
chemical, mathematical, and computational sciences, and the other to fund high-risk,
high-reward research.

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CRS-27
Oversight: Maintaining Trust and Transparency
The same committees and subcommittees that handle authorizations and
appropriations for NIH have also engaged in oversight activities as specific issues or
problems have arisen. Two ongoing matters are discussed below.
Ethics Regulations for NIH Employees Regarding Conflicts of
Interest. In late 2003, investigations by the Los Angeles Times indicated that some
NIH scientists were earning outside income (including stock options in some cases)
from consulting arrangements with drug and biotech companies.37 Earlier that year,
questions had been raised about some top NIH scientists receiving honoraria for
giving lectures at institutions that received NIH funding. Many of these
arrangements were technically allowed under ethics rules that were in place at the
time. Nonetheless, NIH Director Elias Zerhouni wrote to senior NIH staff in
November 2003:
Recently Congress and the media have been scrutinizing the implementation of
ethics rules at the NIH. They are reviewing a wide range of activities that are
allowed under Federal regulations, including lecture awards, outside activities,
consultant arrangements, and financial holdings. Care must be taken to ensure
that we continue to adhere to strict ethical practices and that we avoid the
perception of conflicts of interest, even in situations where remuneration or
awards are considered permissible.38
More studies and hearings on ethics policies, and investigations of individual
cases, both by NIH and by Congress, ensued during 2004 and 2005.39 Several dozen
NIH scientists who had not complied with reporting requirements were disciplined.
In February 2005, to supplement existing ethics regulations, HHS published a new
rule focusing on outside activities, financial holdings, and awards for all NIH
employees, not just for scientists.40 Published as an interim final rule with a request
for comments, the regulation strictly limited interactions with pharmaceutical and
biotechnology companies, grantee research institutions, and other entities, as well as
investments in such companies for many NIH staff and their families. The rule was
meant to create a substantially expanded system of oversight of employee activities
to preserve the trust of the public in NIH. It was recognized, however, that the rule
could have adverse impacts on recruitment and retention of employees, and that
revisions of the rules might be desirable, especially for staff whose jobs did not
involve decisions over research policies.
37 David Willman wrote a series of articles for the Times over a number of months. The first
was “Stealth Merger: Drug Companies and Government Medical Research,” Los Angeles
Times, Dec. 7, 2003, p. A1.
38 Elias A. Zerhouni, “Awards, Travel, and Official Duty and Outside Activity Approvals,”
memo to IC Directors and OD Senior Staff, Nov. 20, 2003 [http://www.nih.gov/news/pr/
nov2003/11202003drzerhounimemo.pdf].
39 Many pertinent documents can be found on NIH’s “Conflict of Interest Information and
Resources” web page [http://www.nih.gov/about/ethics_COI.htm].
40 U.S. Department of Health and Human Services, “Supplemental Standards of Ethical
Conduct and Financial Disclosure Requirements for Employees of the Department of Health
and Human Services,” 70 Federal Register 5543-5565, Feb. 3, 2005.

---

CRS-28
The final revised regulation, published in August 2005, covered reporting of
certain financial interests, stock divestiture, outside activities, and awards.41
According to an NIH press release:
Three principles guided the crafting of the rules: (1) The public must be assured
that research decisions made at NIH are based on scientific evidence and not by
inappropriate influences; (2) Senior management and people who play an
important role in research decisions must meet a higher standard of disclosure
and divestiture than people who are not decision-makers; and (3) To advance the
science and stay on the cutting edge of research, NIH employees must be allowed
interaction with professional associations, participation in public health
activities, and genuine teaching opportunities.42
Implementation of the rules has largely quelled concern over new infractions.
Controversy persists, however, over two intramural scientists who violated NIH’s
previous ethics rules by engaging in questionable consulting activities with outside
parties without obtaining permission. One of the scientists also transferred human
tissue samples from NIH to a private company without seeking approval (which, NIH
says, would not have been granted). NIH has recommended terminating the two
scientists from their positions, but does not have final personnel authority over them
because they are officers in the Public Health Service Commissioned Corps. Action
on the matter has been stalled at the HHS level far longer than anyone involved had
anticipated, and the two men remain employed at NIH. The House Energy and
Commerce Committee held hearings in June43 and September44 2006 to investigate
the status of proceedings in the two cases.
Public Access to Results of NIH-Sponsored Research. The Internet
has given the general public unprecedented access to health and medical information.
In fact, so much is available that consumers have had to learn to be discriminating
about the reliability of what they retrieve. NIH tries to assist in this filtering effort
by providing information, links, and search capability on many of its websites, all
with the intent of helping people find information from accurate, current sources. A
well-regarded starting point is MedlinePlus [http://www.medlineplus.gov], the
consumer health site from the National Library of Medicine (NLM).
Access to the professional literature of medicine and biomedical research
remains limited, however. In the case of journal articles that stem from NIH-
41 U.S. Department of Health and Human Services, “Supplemental Standards of Ethical
Conduct and Financial Disclosure Requirements for Employees of the Department of Health
and Human Services,” 70 Federal Register 51559-51574, Aug. 31, 2005.
42 NIH Office of the Director, “NIH Announces Final Ethics Rules,” press release, Aug. 25,
2005 [http://www.nih.gov/news/pr/aug2005/od-25.htm].
43 U.S. Congress, House Committee on Energy and Commerce, Subcommittee on Oversight
and Investigations, Human Tissue Samples: NIH Research Policies and Practices, hearings,
109th Cong., 2nd sess., June 13-14, 2006. Archived webcasts and witness testimony available
at [http://energycommerce.house.gov/108/action.htm#June2006].
44 U.S. Congress, House Committee on Energy and Commerce, Subcommittee on Oversight
and Investigations, Continuing Ethics and Management Concerns at NIH and the Public
Health Service Commissioned Corps, hearing, 109th Cong., 2nd sess., Sept.13, 2006. The
archived webcast and testimony of the witnesses are available at [http://energycommerce.
house.gov/108/Hearings/09132006hearing2020/hearing.htm].

---

CRS-29
sponsored research, there is growing sentiment that taxpayers should have easy
access to the results of that research. The public can search for journal articles on
NLM’s MEDLINE/PubMed database [http://www.pubmed.gov] and retrieve
references from more than 16 million articles published in 4,800 biomedical journals
dating back to the 1950s. Although the citation and an abstract are usually available,
only occasionally will there be a link to the full article. Most often, the link leads to
a publisher’s website where a subscription to the journal is required for access to full-
text articles. The alternative for most people is to visit a university, medical school,
or hospital library to consult the hard-copy journals.
For several years, NLM has been building up a digital repository of full-text,
peer-reviewed biomedical, behavioral, and clinical research journals called PubMed
Central (PMC) [http://www.pubmedcentral.gov]. The aim is to have a publicly
accessible, stable, permanent, and searchable electronic archive of life science
literature, one separate from publishers’ databases. A large number of journals
already routinely deposit material in PMC, and generally make all of their published
articles available. Many scientists with NIH grants, however, may publish the results
of their research in journals that do not contribute articles to PMC.
In February 2005, NIH announced a new Public Access Policy
[http://publicaccess.nih.gov], formally called the Policy on Enhancing Public Access
to Archived Publications Resulting from NIH-Funded Research.45 The policy
requests each NIH-funded investigator to submit an electronic version of a final,
peer-reviewed manuscript to NLM’s existing PubMed Central database at the time
the article is accepted for publication in a journal. NIH encourages authors to make
manuscripts available to other researchers and the public immediately after they have
been published, but the policy allows a delay in releasing articles of up to 12 months.
NIH listed the following three goals on its website as an answer to the question,
“Why should there be a public resource of published peer-reviewed research findings
of NIH-funded research?”:
! creating a stable archive of peer-reviewed research publications
resulting from NIH-funded research to ensure the permanent
preservation of these vital published research findings;
! securing a searchable compendium of these peer-reviewed research
publications that the NIH and its awardees can use to manage more
efficiently and to understand better their research portfolios, monitor
scientific productivity, and ultimately, help set research priorities;
and
! making published results of NIH-funded research more readily
accessible to the public, health care providers, educators, and
scientists.46
45 “Policy on Enhancing Public Access to Archived Publications Resulting from NIH-
Funded Research,” NIH Guide for Grants and Contracts, Feb. 3, 2005, available at
[http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html].
46 NIH Office of Extramural Research, “Questions and Answers: NIH Public Access
Policy,” February 24, 2005 [http://publicaccess.nih.gov/publicaccess_QandA.htm].

---

CRS-30
NIH implemented the policy in May 2005, when it activated a manuscript
submission system for authors to deposit articles. Participation is voluntary, in
deference to publishers’ concerns about the loss of their proprietary content, and so
far has been very low. NIH reported to the Appropriations Committees in January
2006 that, for the first eight months, the rate of submission to the system had been
less than 4% of the total number of articles estimated to be eligible (1,636 new
articles submitted out of an estimated 43,000 that could have been deposited).47 In
looking into reasons for the low submission rate, NIH said that its surveys indicate
that the majority of NIH-funded scientists are aware of the Policy. It concluded the
report by observing, “NIH continues to work with researchers, journal publishers,
scientific societies, librarians, disease advocacy organizations and the general public
to improve public access.”48
There have been calls to make the submission of manuscripts mandatory. The
FY2007 House Labor-HHS-ED Appropriations bill (H.R. 5647) included a provision
(§ 220) that stated, “The Director of the National Institutes of Health (NIH) shall
require that all investigators funded by the NIH submit an electronic version of their
final, peer-reviewed manuscripts upon acceptance for publication to the NIH
National Library of Medicine’s PubMed Central as soon as practicable but no later
than 12 months after the official date of publication.” The Senate FY2007 Labor-
HHS-ED Appropriations bill (S. 3708) had no similar provision. Both committees
included report language commending NLM for developing PubMed Central. They
encouraged NLM to work with health sciences librarians and the medical library
community on issues related to copyright, fair use, peer review, and classification of
information on PubMed Central.
A bill to require similar archiving and public access policies at other federal
science agencies was introduced in May 2006, but received no action. The Federal
Research Public Access Act of 2006 (S. 2695) would have required every federal
agency with an extramural research budget of more than $100 million to develop a
public access policy that is consistent with and advances the purposes of the agency.
47 NIH, “Report on the NIH Public Access Policy,” January 2006, available at
[http://publicaccess.nih.gov/Final_Report_20060201.pdf].
48 Ibid., p. 6.

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CRS-31
Selected NIH Online Resources
NIH Home Page [http://www.nih.gov].
! health information [http://health.nih.gov];
! websites of the Office of the Director and each Institute and Center
[http://www.nih.gov/icd];
! general information on grants [http://grants1.nih.gov/grants];
! grants searchable by topic [http://crisp.cit.nih.gov/crisp/crisp_query.
generate_screen];
! grants searchable by recipient [http://grants1.nih.gov/grants/award/
awardtr.htm];
! overview of the peer review system [http://grants.nih.gov/grants/
peer/peer.htm];
! Setting Research Priorities at NIH [http://www.nih.gov/about/
researchpriorities.htm];
! background on NIH [http://www.nih.gov/about], including
organization and historical and legislative chronologies in the NIH
Almanac [http://www.nih.gov/about/almanac/index.html]; and
! current news and medical research issues pages.
NIH Budget [http://officeofbudget.od.nih.gov/ui/HomePage.htm].
! Presidents’ budget requests;
! budget justification documents prepared for the Appropriations
Committees;
! appropriations history;
! estimates of NIH spending (FY2003-FY2007) on about 210 specific
diseases, conditions, and research areas (note that these are estimates
of research activity, not set-asides by NIH or line items from
Congress) [http://www.nih.gov/news/fundingresearchareas.htm];
and
! information on the Biomedical Research and Development Price
Index (BRDPI) and other measures of inflation, including tables
[http://officeofbudget.od.nih.gov/UI/GDP_FromGenBudget.htm].
Legislation Affecting NIH [http://olpa.od.nih.gov].
! The NIH Office of Legislative Policy and Analysis (OLPA) in the
Office of the Director produces and compiles summaries of major
legislative issues relevant to NIH, and tracks pending legislation,
public laws, and hearings.
! OLPA serves as the congressional liaison office for NIH (301-
496-3471).

---

CRS-32
Table 5. Components of NIH, with History and Scope
FY2006 revised
Institute/Center
When and How Established;
program level
(Statutory Authority in Public
Acronym
Major Research Focus
Chronology of Name Changes
Health Service Act and U.S. Code)
($ millions)
(details, Table 2)
National Cancer Institute
NCI
1937 — National Cancer Institute Act
All aspects of cancer — cause,
$4,790
PHSA § 410-417D,
(P.L. 75-244).
diagnosis, prevention, treatment,
42 U.S.C. § 285-285a-10
1944 — under the PHS Act of 1944
rehabilitation, and continuing care
(P.L. 78-410), NCI became a division
of patients.
of the National Institute of Health.
National Heart, Lung, and
NHLBI
1948 — National Heart Act (P.L. 80-
Diseases of the heart, blood vessels,
$2,920
Blood Institute
655): National Heart Institute.
lungs, and blood; sleep disorders;
PHSA § 415-425,
1969 — National Heart and Lung
and blood resources management.
42 U.S.C. § 285b-285b-8
Institute.
1976 — NHLBI.
National Institute of Dental
NIDCR
1948 — National Dental Research Act
Oral, dental, and craniofacial
$389
and Craniofacial Research
(P.L. 80-755): National Institute of
diseases and disorders.
PHSA § 453,
Dental Research.
42 U.S.C. § 285h
1998 — NIDCR.
National Institute of
NIDDK
1950 — Omnibus Medical Research
Diabetes, endocrinology, metabolic
$1,854
Diabetes and Digestive and
Act (P.L. 81-692): National Institute of
diseases; digestive diseases,
Kidney Diseases
Arthritis and Metabolic Diseases.
nutrition; kidney, urologic,
PHSA § 426-434A,
1972 — National Institute of Arthritis,
hematologic diseases.
42 U.S.C. § 285c-285c-9
Metabolism, and Digestive Diseases.
1981 — National Institute of Arthritis,
Diabetes, and Digestive and Kidney
Diseases.
1985 — NIDDK.

---

CRS-33
FY2006 revised
Institute/Center
When and How Established;
program level
(Statutory Authority in Public
Acronym
Major Research Focus
Chronology of Name Changes
Health Service Act and U.S. Code)
($ millions)
(details, Table 2)
National Institute of
NINDS
1950 — Omnibus Medical Research
Convulsive, neuromuscular,
$1,534
Neurological Disorders and
Act (P.L. 81-692): National Institute of
demyelinating, and dementing
Stroke
Neurological Diseases and Blindness.
disorders; fundamental
PHSA § 457-460,
1968 — National Institute of
neurosciences; stroke, trauma.
42 U.S.C. § 285j-285j-3
Neurological Diseases and Stroke.
1975 — National Institute of
Neurological and Communicative
Disorders and Stroke.
1988 — NINDS.
National Institute of Allergy
NIAID
1955 — established under authority of
Allergic, immunologic, and
$4,331
and Infectious Diseases
Omnibus Medical Research Act (P.L.
infectious diseases.
PHSA § 446-447B,
81-692).
42 U.S.C. § 285f-285f-3
National Institute of
NIGMS
1962 — PHS Act Amendment (P.L.
Research and research training in
$1,934
General Medical Sciences
87-838) authorized the Surgeon
basic biomedical sciences (cellular
PHSA § 461,
General to establish an institute for
and molecular biology, genetics,
42 U.S.C. § 285k
general (basic) biomedical sciences.
pharmacology, physiology).
1963 — NIGMS created in the
Special focus on minority
Department of Health, Education, and
researchers.
Welfare (HEW).

---

CRS-34
FY2006 revised
Institute/Center
When and How Established;
program level
(Statutory Authority in Public
Acronym
Major Research Focus
Chronology of Name Changes
Health Service Act and U.S. Code)
($ millions)
(details, Table 2)
National Institute of Child
NICHD
1962 — PHS Act Amendment (P.L.
Reproductive biology; population
$1,264
Health and Human
87-838) authorized the Surgeon
issues; embryonic development;
Development
General to establish an institute for
maternal, child, and family health;
PHSA § 448-452G,
research on child health and human
medical rehabilitation.
42 U.S.C. § 285g-285g-10
development.
1963 — NICHD created in HEW.
National Eye Institute
NEI
1968 — National Eye Institute
Eye diseases, visual disorders,
$666
PHSA § 455-456,
Establishment Act (P.L. 90-489)
visual function, preservation of
42 U.S.C. § 285i-285i-1
(functions formerly in the institute for
sight, health problems of the
neurological diseases and blindness).
visually impaired.
National Institute of
NIEHS
1969 — The NIH Division of
Interrelationships of environmental
$720
Environmental Health
Environmental Health Sciences
factors, individual genetic
Sciences (located in Research
(established by the Surgeon General in
susceptibility, and age as they affect
Triangle Park, NC)
1965) was elevated to institute status
health.
PHSA § 463-463A,
by the Secretary of HEW.
42 U.S.C. § 285l-285l-1
National Institute on Aging
NIA
1974 — Research on Aging Act of
Biomedical, social, and behavioral
$1,046
PHSA § 443-445J,
1974 (P.L. 93-296).
research on the aging process;
42 U.S.C. § 285e-285e-11
diseases, problems, and needs of the
aged.

---

CRS-35
FY2006 revised
Institute/Center
When and How Established;
program level
(Statutory Authority in Public
Acronym
Major Research Focus
Chronology of Name Changes
Health Service Act and U.S. Code)
($ millions)
(details, Table 2)
National Institute of
NIAMS
1986 — Established under authority of
Arthritis; bone, joint, connective
$508
Arthritis and
the Health Research Extension Act of
tissue and muscle disorders; skin
Musculoskeletal and Skin
1985 (P.L. 99-158). For earlier
diseases.
Diseases
history, see NIDDK.
PHSA § 435-442A,
42 U.S.C. § 285d-285d-8
National Institute on
NIDCD
1988 — National Deafness and Other
Disorders of hearing, balance,
$393
Deafness and Other
Communication Disorders Act of 1988
smell, taste, voice, speech, and
Communication Disorders
(P.L. 100-553) (functions formerly in
language.
PHSA § 464-464F,
the institute for neurological and
42 U.S.C. § 285m-285m-6
communicative disorders and stroke).
National Institute of
NINR
1986 — National Center for Nursing
Acute and chronic illness, health
$137
Nursing Research
Research established under authority
promotion/disease prevention,
PHSA § 464V-464Y,
of the Health Research Extension Act
nursing systems, clinical
42 U.S.C. § 285q-285q-3
of 1985 (P.L. 99-158).
therapeutics.
1993 — NINR.

---

CRS-36
FY2006 revised
Institute/Center
When and How Established;
program level
(Statutory Authority in Public
Acronym
Major Research Focus
Chronology of Name Changes
Health Service Act and U.S. Code)
($ millions)
(details, Table 2)
National Institute on
NIAAA
1970 — Comprehensive Alcohol
Causes of alcoholism, how alcohol
$436
Alcohol Abuse and
Abuse and Alcoholism Prevention,
damages the body, prevention and
Alcoholism
Treatment, and Rehabilitation Act
treatment strategies.
PHSA § 464H-464J,
(P.L. 91-616) established NIAAA
42 U.S.C. § 285n-285n-2
within NIMH in PHS.
1974 — moved to Alcohol, Drug
Abuse, and Mental Health
Administration (ADAMHA) (P.L. 93-
282).
1992 — moved to NIH
(P.L. 102-321).
National Institute on Drug
NIDA
1974 — established under authority of
Social, biological, behavioral, and
$999
Abuse
Drug Abuse Office and Treatment Act
neuro-scientific bases of drug abuse
PHSA § 464L-464P,
of 1972 (P.L. 92-255).
and addiction; causes, prevention,
42 U.S.C. § 285o-285o-4
1974 — moved to ADAMHA
and treatment strategies.
(P.L. 93-282).
1992 — moved to NIH (P.L. 102-321).

---

CRS-37
FY2006 revised
Institute/Center
When and How Established;
program level
(Statutory Authority in Public
Acronym
Major Research Focus
Chronology of Name Changes
Health Service Act and U.S. Code)
($ millions)
(details, Table 2)
National Institute of Mental
NIMH
1949 — established under authority of
Brain research, mental illness, and
$1,403
Health
National Mental Health Act of 1946
mental health.
PHSA § 464R-464U,
(P.L. 79-487).
42 U.S.C. § 285p-285p-3
1967 — transferred out of NIH to PHS
(P.L.90-31).
1974 — moved to ADAMHA (P.L.
93-282).
1992 — moved back to NIH
(P.L. 102-321).
National Human Genome
NHGRI
1989 — National Center for Human
Chromosome mapping, DNA
$486
Research Institute
Genome Research (NCHGR)
sequencing, database development,
PHSA § 485B,
established.
ethical/legal/social implications of
42 U.S.C. § 287c
1993 — NCHGR authorized
genetics research.
(P.L. 103-43).
1997 — elevated to institute by the
HHS Secretary.
National Institute of
NIBIB
2000 — NIBIB Establishment Act
Research, training and coordination
$297
Biomedical Imaging and
(P.L. 106-580).
in biomedical imaging,
Bioengineering
bioengineering and related
PHSA § 464z,
technologies and modalities,
42 U.S.C. § 285r
including biomaterials and
informatics.

---

CRS-38
FY2006 revised
Institute/Center
When and How Established;
program level
(Statutory Authority in Public
Acronym
Major Research Focus
Chronology of Name Changes
Health Service Act and U.S. Code)
($ millions)
(details, Table 2)
National Center for
NCRR
1970 — Division of Research
Extramural and intramural research
$1,098
Research Resources
Resources (DRR) moved to NIH from
resources and technologies: general
PHSA § 479-481C,
PHS.
clinical research centers, computers,
42 U.S.C. § 287-287a-4
1990 — NCRR created by merging
instrument systems, animal
DRR and Division of Research
resources and facilities,
Services (statutory authority in NIH
nonmammalian research models.
Revitalization Act of 1993, P.L. 103-
43).
National Center for
NCCAM
1992 — Office of Alternative
Identifies, evaluates, and researches
$121
Complementary and
Medicine (OAM) created in OD.
unconventional health care
Alternative Medicine
1993 — OAM authorized (P.L. 103-
practices.
PHSA § 485D,
43).
42 U.S.C. § 287c-21
1999 — NCCAM created
(P.L. 105-277).
National Center on
NCMHD
1990 — Office of Research on
Research, training, and coordination
$195
Minority Health and Health
Minority Health (ORMH) created by
on minority health conditions and
Disparities
NIH in OD.
populations with health disparities.
PHSA § 485E-485H,
1993 — ORMH authorized
42 U.S.C. § 287c-31-287c-34
(P.L. 103-43).
2000 — NCMHD created
(P.L. 106-525).

---

CRS-39
FY2006 revised
Institute/Center
When and How Established;
program level
(Statutory Authority in Public
Acronym
Major Research Focus
Chronology of Name Changes
Health Service Act and U.S. Code)
($ millions)
(details, Table 2)
John E. Fogarty
FIC
1968 — established by HEW.
Focal point for NIH’s international
$66
International Center for
1985 — established in law
collaboration activities and
Advanced Study in the
(P.L. 99-158).
scientific exchanges; provides
Health Sciences
leadership in global health.
PHSA § 482,
42 U.S.C. § 287b
National Library of
NLM
1836 — established as the Library of
Collects, organizes, and makes
$323
Medicine
the Office of the Surgeon General of
available biomedical information;
PHSA § 465-478A,
the Army, later Army Medical Library
sponsors programs to improve U.S.
42 U.S.C. § 286-286d
(1922), Armed Forces Medical Library
medical library services.
(1952), and NLM under PHS (1956,
NLM Act, P.L. 84-941).
1968 — moved to NIH.
Office of the Director
OD
1930 — Ransdell Act (P.L. 71-251)
Overall NIH leadership, and liaison
$478
PHSA § 402,
created the National Institute of
with HHS. Includes special offices
42 U.S.C. § 282
Health.
for research on AIDS, women’s
health, behavioral and social
sciences, and disease prevention
(including rare diseases and dietary
supplements).
Buildings and Facilities
B&F
First separate appropriation FY1970.
Provides for the design,
$81
PHSA § 402(b),
construction, improvement, and
42 U.S.C. § 282(b)
repair of NIH clinical and
laboratory buildings.

---

CRS-40
FY2006 revised
Institute/Center
When and How Established;
program level
(Statutory Authority in Public
Acronym
Major Research Focus
Chronology of Name Changes
Health Service Act and U.S. Code)
($ millions)
(details, Table 2)
Total for appropriated
$28,468
accounts
Centers not receiving a separate appropriation (funded by taps from appropriated accounts listed above)
NIH Clinical Center
CC
1944 — authorized by the PHS Act
NIH’s hospital and outpatient
($334)
(P.L. 78-410).
facility for clinical research.
1953 — first patient admitted.
Center for Scientific Review
CSR
1946 — Division of Research Grants
Receives, assigns, and reviews
($54)
created.
research and training grant
1997 — reorganized and renamed
applications.
CSR.
Center for Information
CIT
1964 — Division of Computer
Provides, coordinates, and manages
($33)
Technology
Research and Technology (DCRT)
information technology for NIH;
established.
research to advance computational
1998 — CIT formed (DCRT combined
science.
with other offices).
Sources: NIH Almanac, 2006-2007 [http://www.nih.gov/about/almanac/index.html]. Budget figures from S. Rept. 109-287, FY2007 Labor-HHS-ED appropriation, and NIH FY2007
Budget Justification, vol. I, p. 91.

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