Congressional Justification 2014

• National Advisory
  Council for
  Complementary and
  Alternative Medicine

• Office of the Director

  Josephine P. Briggs, M.D.
   Director

  Jack Killen, M.D.
   Deputy Director

  • Office of Clinical and
    Regulatory Affairs

    Catherine Meyers, M.D.
     Director

  • Office of Administrative
    Operations

    Robin Klevins
     Acting Executive Officer

  • Office of Communications
    and Public Liaison

    Alyssa Cotler, M.P.H.
     Director

  • Office of Policy,
    Planning, and Evaluation

    Karin Lohman, Ph.D.
     Director

  • Division of
    Extramural Research

    Emmeline Edwards, Ph.D.
     Director

    • Manual and Mind-Body
      Medicine Branch

      Emmeline Edwards, Ph.D.
       Acting Chief

    • Natural Products
      Branch

      Emmeline Edwards, Ph.D.
       Acting Chief

  • Division of
    Intramural Research

    Robert B Nussenblatt, M.D.
     Acting Director

  • Division of
    Extramural Activities

    Martin Goldrosen, Ph.D.
     Director

    • Office of
      Scientific Review

      Dale Birkle Dreer, Ph.D.
       Chief

    • Office of Grants Management

      George Tucker, M.B.A.
       Director

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NATIONAL INSTITUTES OF HEALTH

National Center for Complementary and Alternative Medicine

For carrying out section 301 and title IV of the PHS Act with respect to complementary and alternative medicine, $129,041,000.

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Major Changes in the Fiscal Year 2014 President's Budget Request

Major changes by budget mechanism and/or budget activity detail are briefly described below. The FY 2014 President’s Budget request for the National Center for Complementary and Alternative Medicine is $129.0 million, an increase of $1.2 million over the FY 2012 level.

Research Project Grants (-$0.311 million; total $79.952 million): NCCAM will support a total of 168 Research Project Grant (RPG) awards in FY 2014. Noncompeting RPGs will decrease by nine awards and decrease by $0.594 million. Competing RPG awards will remain at the same level and increase by $0.022 million. NIH budget policy for RPGs in FY 2014, continues FY 2012 policy of eliminating inflationary increases for future year commitments. However adjustments for special needs (such as equipment and added personnel) will continue to be accommodated.

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Fiscal Year 2014 Budget Graphs

History of Budget Authority and FTEs

Funding Levels by Fiscal Year*

Fiscal Year	Dollars in Millions
2010	128.8
2011	127.7
2012	127.8
2013	128.7
2014	129.0

*FY 2010 and FY 2011 are non-comparable for NCBI/PA

Full-Time Employees by Fiscal Year*

FY	FTEs
2010	67
2011	69
2012	69
2013	75
2014	75

*FYs 2010, 2011 and 2012 are non-comparable for DEAS transfer.

Distribution by Mechanism

FY 2014 Budget Mechanism

Mechanism	Dollars in Thousands	Percent of Budget
Research Project Grants	$79,952	62%
Research Centers	$3,233	3%
Other Research	$8,315	6%
Research Training	$3,766	3%
R&D Contracts	$9,917	8%
Intramural Research	$8,256	6%
RMS	$15,602	12%

Change by Selected Mechanism

FY 2014 Estimate Percent Change from FY 2012 Mechanism

Mechanism	Percent Change
Research Project Grants	-0.23%
Research Centers	0.0%
Other Research	-0.01%
Research Training	32.04%
R&D Contracts	5.33%
Intramural Research	0.0%
Res. Mgmt. & Support	0.00%

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NATIONAL INSTITUTES OF HEALTH
National Center for Complementary and Alternative Medicine

Authorizing Legislation

	PHS Act/Other Citation	U.S. Code Citation	2013 Amount Authorized		FY 2013 CR	2014 Amount Authorized		FY 2014 PB
Research and Investigation	Section 301	42§241	Indefinite			Indefinite
					$128,688,000			$129,041,000
National Center for Complementary and Alternative Medicine	Section 401(a)	42§281	Indefinite			Indefinite
Total, Budget Authority					$128,688,000			$129,041,000

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Justification of Budget Request

National Center for Complementary and Alternative Medicine

Authorizing Legislation: Section 301 and title IV of the Public Health Service Act, as amended.

Budget Authority (BA):

Program funds are allocated as follows:  Competitive Grants/Cooperative Agreements; Contracts; Direct Federal/Intramural and Other.

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Director’s Overview

The National Center for Complementary and Alternative Medicine (NCCAM) is the Federal Government’s lead agency for scientific research on various complementary health interventions and their potential role in integrative strategies for treating difficult health conditions and promoting better health. NCCAM is committed to building the scientific evidence needed by consumers, providers, and health policymakers regarding the safety and usefulness of these approaches to improve health and health care.

Nearly 40 percent of Americans are integrating complementary health interventions into their health care and personal health practices, at an annual cost of $34 billion dollars.¹ While decisions about the use of these interventions are sometimes made with the guidance of a professional health care provider, this is often not the case. Furthermore, both consumers and providers are often confronted with limited objective information about the safety and effectiveness of these approaches. To address these evidence gaps, NCCAM funds research across the continuum of basic, translational, and clinical research, guided by its strategic plan.²

A major focus for NCCAM is research related to chronic pain, an enormous public health problem that affects 100 million Americans and costs at least $635 billion per year in treatments and lost productivity.³ Current drug-based treatment options are only partially effective and can have serious side effects. Research exploring non-pharmacological approaches for treating chronic pain is a top priority for NCCAM. For example, in the past year, an NCCAM-funded study provided strong evidence that acupuncture may be helpful for chronic pain, and another study suggests that spinal manipulation or exercise is more effective than medication for acute neck pain. In the coming year, NCCAM will continue to support rigorous basic, translational and clinical research to understand whether such interventions add value to existing approaches and to identify the biological mechanisms by which they exert beneficial effects. NCCAM also recently embarked on an initiative to stimulate research on the use of complementary approaches to pain and symptom management in military and veteran populations. This effort encourages collaboration between NCCAM-funded researchers, other NIH institutes and centers, and researchers at the Departments of Defense and Veterans Affairs.

In addition, NCCAM’s intramural research program focuses on understanding the central mechanisms of pain and its modulation, with the long term goal of improving clinical management of chronic pain through the integration of pharmacological and non-pharmacological approaches. Of particular interest are the mechanisms by which emotion, attention, placebo effects, and other such processes modulate pain or pain processing. The program will be highly collaborative within the larger NIH neuroscience research enterprise.

Another important area of emphasis for NCCAM is continued scientific exploration of the underlying biological effects and mechanisms of action of complementary therapies. NCCAM supports many studies aimed at understanding the molecular and cellular targets of natural products and the biological mechanisms of their potential beneficial or harmful effects. This research is critical for designing human studies. Examples include studies on the anti-inflammatory effects of omega-3 fatty acids and vitamin E, and the effects of curcumin (a component of the spice turmeric) on cell-signaling pathways relevant to many disease processes. In the coming year, NCCAM will continue to support additional research under the funding opportunity announcement (FOA) “Mechanistic Research on CAM Natural Products,” and through the “Dietary Supplement Research Centers: Botanicals” (also known as the Botanical Research Centers Program) in collaboration with the NIH Office of Dietary Supplements.

Research on the safety of natural products is another major priority for NCCAM, given the widespread availability and use of these products by the public. One area of particular need is better scientific information about interactions between natural products and drugs. To investigate these issues, NCCAM is working with experts to identify the potential scope of the problem and best methods for studying it. As a result of these efforts, NCCAM plans to release a new FOA in Fiscal Year (FY) 2013, to systematically evaluate natural product-drug interactions. Additional information about this new program is highlighted in a program portrait.

NCCAM also remains committed to strengthening “real world” outcomes and effectiveness research that capitalizes on the reality that many complementary and integrative approaches are in widespread public use. As such, NCCAM leads the development of the complementary health questions which are included every five years in the National Health Interview Survey (NHIS) conducted by the Centers for Disease Control and Prevention (CDC). NCCAM also works with CDC to develop questions that are included in the National Ambulatory Medical Care Survey (NAMCS) involving interviews with 30,000 physicians. Results from the most recent NHIS and NAMCS surveys are to be released in the summer of 2013. Data from these two surveys is expected to provide the most current and comprehensive picture of the use of complementary and integrative health practices in the United States. In addition, NCCAM provides leadership to the Health Care Systems Research Collaboratory, an NIH Common Fund initiative that will develop innovative methods for conducting clinical research in partnerships with health care delivery organizations. NCCAM is overseeing the activities of the newly awarded Coordinating Center that will provide national leadership and technical expertise in all aspects of research with the Collaboratory.

Finally, to help the public make informed decisions about the use of complementary and integrative health interventions and to enable health care providers to better manage patient care, NCCAM disseminates its research findings. NCCAM provides reliable, objective, and evidence-based information through multiple channels, including its Web site, broadcast and print media, exhibit program and social media. For health care professionals, NCCAM’s website has a portal which provides links to scientific literature on complementary health practices, including reviews from the Cochrane Collaboration; clinical practice guidelines issued by third-party organizations; and online continuing education modules.⁴ In addition, NCCAM’s monthly e-newsletter, NCCAM Clinical Digest, summarizes the state of the science on complementary health practices for specific health topics. For consumers, NCCAM recently launched an online video, Scientific Results of Yoga for Health and Well-Being which highlights the research and science behind yoga as a complementary health practice.

Overall IC Budget Policy: Guided by its strategic plan, the advice of the National Advisory Council for Complementary and Alternative Medicine, and input from a diverse community of stakeholders, NCCAM builds the scientific evidence base for complementary and integrative medicine by stimulating research and increasing research capacity. In FY 2014, NCCAM will continue to fund multidisciplinary investigator-initiated research and encourage interdisciplinary research capacity building across the field of complementary and integrative health research. Areas of special emphasis include studies examining the effectiveness of complementary and integrative health approaches to alleviate chronic pain, and translational research to improve the quality, reproducibility, and comparability of clinical complementary and integrative health research. Funds are included in R&D contracts to support trans-NIH initiatives, such as the Basic Behavioral and Social Sciences Opportunity Network (OppNet).

¹  Nahin, RL, Barnes PM, Stussman BA, et. al. Costs of complementary and alternative medicine (CAM) and frequency of visits to CAM practitioners: United States, 2007. CDC National Health Statistics Report #18. 2009.

²  Exploring the Science of Complementary and Alternative Medicine (available at www.nccam.nih.gov).

³  Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, Institute of Medicine, June 2011.

⁴  http://nccam.nih.gov/health/providers.

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Program Descriptions and Accomplishments

Extramural Basic Research: Basic research on fundamental biological effects and active components of interventions is central to the development of the evidence base on complementary health approaches, and underpins the design of clinical research. NCCAM supports investigator-initiated basic research and will continue, through targeted initiatives, its support for translational research on promising complementary interventions. NCCAM funds basic research initiatives such as Mechanistic Research on CAM Natural Products, which supports development of advanced technologies and methodologies to study natural products. Similarly, rigorous research is needed to understand the interactions between natural products such as herbal medicines or other dietary supplements and prescribed medications. To this end, NCCAM will release a new Funding Opportunity Announcement (FOA) on the systematic evaluation of dietary supplement interactions with drugs. Additional information about this new program is highlighted in the program portrait below.

Budget Policy: The FY 2014 President’s Budget estimate for extramural basic research is $42.390 million or 1.1 percent above the FY 2012 level.

Extramural Clinical Research: The NCCAM extramural research program funds clinical investigations into various complementary modalities at leading biomedical and complementary and integrative health research institutions. Clinical research in this area ranges from small pilot studies to large-scale clinical trials and epidemiological studies supported through solicited research initiatives, collaboration between NIH institutes and centers and the CDC, and investigator-initiated research. As part of this effort, NCCAM will continue to explore the use of outcomes and effectiveness research in developing practice-based evidence on how complementary and integrative health approaches may aid in the management of troublesome symptoms. The benefits of this research are two-fold: it will help inform our understanding of complementary health approaches as practiced in the community, and it will provide additional data on the effectiveness of complementary interventions for particular diseases and symptoms.

Budget Policy: The FY 2014 President’s Budget estimate for extramural clinical research is $52.548 million or 1.2 percent above the FY 2012 level.

Extramural Research Training and Capacity Building: Improving the capacity of the field to carry out rigorous research of complementary health interventions is a high priority for NCCAM. To increase the number, quality, and diversity of investigators who conduct research on complementary approaches, NCCAM supports a variety of training and career development activities for pre-doctoral and post-doctoral students, practitioners, and conventional medical researchers and practitioners. For example, NCCAM is developing a training program that will fund partnerships between research intensive institutions and institutions focused on rigorous clinical research and training of practitioners in complementary modalities. The program is expected to generate a cadre of research clinicians who are able to participate fully in multi-disciplinary teams engaged in complementary and integrative health research.

Budget Policy: The FY 2014 President’s Budget estimate for extramural research training and capacity building is $10.245 million or 1.4 percent above the FY 2012 level. Support for NRSA training mechanism will be increased to cover the cost of increased stipends. The Ruth L. Kirschstein NRSA budget reflects a stipend increase to $42,000 for the entry level of experience. These increases are consistent with stipend increases recommended by the Advisory Committee to the NIH Director and the National Research Council. In addition, this increase is consistent with 42 USC 288(b)(5), which anticipates periodic adjustments in stipends “to reflect increases in the cost of living.”

Intramural Research: NCCAM’s intramural research program is focused on understanding the central mechanisms of pain and its modulation, with the long term goal of improving clinical management of chronic pain through the integration of pharmacological and non-pharmacological approaches. Among topics of particular interest are the pathways and mechanisms by which emotion, attention, placebo effects, and other such processes modulate pain or pain processing. The program both engages and leverages the exceptional basic and clinical research talent and resources of other neuroscience and neuroimaging efforts within the NIH intramural community.

Budget Policy: The FY 2014 President’s Budget estimate for intramural research is $8.256 million, the same as the FY 2012 level.

Research Management and Support (RMS): Through its RMS activities, including grants review and management, NCCAM continues to fund meritorious basic, clinical, and translational research and research training efforts. In addition, NCCAM provides important trans-NIH leadership on several initiatives. For example, NCCAM is leading a trans-NIH working task force that is developing standardized research diagnostic criteria for chronic low back pain. NCCAM also provides leadership for the Health Care Systems Research Collaboratory (HCS), an NIH Common Fund initiative that seeks to develop innovative methods for conducting clinical research in partnerships with health care delivery organizations. Furthermore, the Center provides reliable, objective, and evidence-based information to the public so they may make informed decisions about the use of complementary and integrative health therapies and also to enable health care providers to improve management of patient care.

Budget Policy: The FY 2014 President’s Budget estimate for research management and support is $15.602 million, the same as the FY 2012 level.

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