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U.S. Department of Health & Human Services
Summary
Charts
Complete List of Activities
Type Of Collaboration
Committee, Advisory Group, or Work Group
Health Survey
Meeting/Workshop
Public Education Campaign
Research Initiative
Resource Development
Training Initiative
Other
Agency Collaborations
Administration for Children and Families (ACF)
Administration for Community Living (ACL)
Agency for Healthcare Research and Quality (AHRQ)
Agency for Toxic Substances and Disease Registry (ATSDR)
Centers for Disease Control and Prevention (CDC)
Centers for Medicare & Medicaid Services (CMS)
Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA)
Indian Health Service (IHS)
Office of the Secretary (OS)
Substance Abuse and Mental Health Services Administration (SAMHSA)
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Report on NIH Collaborations with Other HHS Agencies for Fiscal Year 2014
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Summary
Introduction
This annual report captures the extent and nature of activities undertaken by the National Institutes of Health (NIH) in collaboration with the other agencies and divisions of the Department of Health and Human Services (HHS). As is often attributed to the philosopher and physician Aristotle (circa 300 B.C.), the whole is greater than the sum of its parts. As the Information Age has increased the creation of data and knowledge, knowledge
flow
has become as – or more – important that knowledge
stock
.
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For mission-oriented and knowledge-based organization as complex as HHS, synergy between the different components of the ‘HHS Family’ is vital to the success of the whole. In recognition of the important role of collaboration between HHS agencies, Congress added section 403A(a) of the Public Health Service Act, 42 U.S.C. § 283a(a),
Annual Reporting to Increase Interagency Collaboration and Coordination
, via Section 104 of the National Institutes of Health Reform Act of 2006. This law mandates that the NIH Director provide to the Secretary of HHS an annual report on NIH’s collaborations with other HHS agencies. This, our eighth report to the Secretary, covers fiscal year 2014.
Background
The HHS mission is to enhance the health and well-being of all Americans by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. As outlined in the
HHS Strategic Plan
, the Department sets forth four interrelated, strategic goals to achieve this mission:
Strengthen Health Care;
Advance Scientific Knowledge and Innovation;
Advance the Health, Safety, and Well-Being of the American People; and
Ensure Efficiency, Transparency, Accountability, and Effectiveness of HHS Programs.
HHS accomplishes its mission and meets its strategic goals and associated objectives, strategies, and performance goals through the work of its eleven operating divisions, including eight agencies in the United States Public Health Service and three human service agencies, which administer HHS’s multifaceted programs and initiatives. In addition, staff divisions of the Office of the Secretary provide leadership, direction, and policy guidance to the Department. Together, this ‘HHS Family’ covers a vast spectrum of activities that impact health, public health, and human services outcomes throughout the life span. With more than 115 programs across the Department, the ultimate success of all components of the HHS Family is enhanced by interagency collaborations that enable agencies to combine the knowledge base of their agency and the diverse expertise of staff to address their collective mission and enhance the public health impact of the Department’s diverse programmatic activities – such cross agency synergism is necessary to create a collaborative community within HHS that accelerates progress in medicine, health services, and public health programs.
Since its origins in 1887 as the Marine Hospital Service, the NIH has been charged with improving health through research. As the largest research arm of HHS, the NIH’s mission is “to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.” The NIH’s collaborative efforts with other HHS agencies are vital to transforming fundamental scientific and technical information into effective, knowledge-based approaches that advance the health and safety of the public, such as disease treatments, preventive interventions, protective health policies and regulations, and public health campaigns. In turn, the information provided by other HHS agencies on public health needs informs the policies and priorities of NIH-funded research.
The interagency collaborations included in this report cover joint activities undertaken by the NIH with all other components of HHS, including the
staff divisions within the Office of the Secretary (OS)
2
and the ten other operating divisions of HHS:
Administration for Children and Families (ACF)
Administration for Community Living (ACL)
Agency for Healthcare Research and Quality (AHRQ)
Agency for Toxic Substances & Disease Registry (ATSDR)
Centers for Disease Control and Prevention (CDC)
Centers for Medicare & Medicaid Services (CMS)
Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA)
Indian Health Service (IHS)
Substance Abuse and Mental Health Services Administration (SAMHSA)
FY 2014 Collaboration Themes
The NIH and other HHS operating and staff divisions collaborated on 604 activities in FY 2014. These numerous examples of cross-agency collaboration demonstrate the broad spectrum of health efforts that the NIH contributes to in partnership with the rest of the Department and are organized into six themes in this report:
Assessing the Public’s Health –
enabling better tracking of disease and disability
Improving Diagnosis and Treatment through Research –
promoting the translation of NIH’s research results into safe and effective diagnostics and treatments
Preventing Disease and Disability –
providing the evidence base for national disease and disability prevention efforts
Providing Evidence-Based Health Information –
equipping public health efforts and the American public with the latest research findings and best available health information
Keeping Americans Safe –
ensuring effective health policy and regulatory protections
Broad, Multi-Purpose Coordination –
coordinating complex strategic planning efforts that cut across the entire Department
Collaboration examples from each thematic area are included in
Figure 1
and described in the “FY 2014 Collaboration Highlights” section to follow.
Figure 1: Advancing the Public’s Health: Thematic Areas of NIH’s Collaborations with Other Agencies of the Department of Health and Human Services.
These numerous examples of cross-agency collaboration demonstrate the broad spectrum of health efforts that the NIH contributes to in partnership with the rest of the Department.
FY 2014 Collaborative Activities by the Numbers
In FY 2014, the NIH collaborated with other HHS entities on 604 activities – 439 activities that did not require NIH funding and 165 activities funded with contributions from the NIH totalling $301,123,596.
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The
Complete List of Activities Table
provides a comprehensive list of all reported activities. Over 72 new collaborations were reported in FY 2014 across a range of issues, including activities devoted to Ebola, antimicrobial resistance, aging, and health disparities. The full details for each activity, including a brief description, the year the collaboration originated, FY 2014 funding, and participating HHS agencies including the participating NIH Institutes, Centers, and Offices, can be viewed by clicking on the icon next to the “Details” column of each activity.
Each collaboration has been designated a category based on the nature of the activity –
Chart 1
illustrates how the activities break down across the following categories: Committee, Work Group, or Advisory Group (277 activities); Research Initiative (138); Resource Development, e.g., developing databases, disease registries, and information clearinghouses (70); Meeting/Workshop (45); Health Survey (30); Public Education Campaign (23); Training Initiative (9); or Other (12). Almost half (48%) of the collaborations involving funding from the NIH were research initiatives (79 funded collaborative research initiatives for a total of $164 million). For the 439 collaborations that did not involve NIH funding, many relied on the NIH’s intellectual input, most commonly in the form of committees, work groups, and advisory groups (266 activities), non-NIH funded research initiatives (59 activities), and resource development (43 activities).
Chart 2
displays the number of collaborative activities that the NIH engaged in with each HHS operating or staff division, and
Chart 3
plots the NIH’s funding contributions for those shared activities, again broken down by HHS division.
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As Chart 2 and Chart 3 illustrate, the majority of the NIH’s collaborations were with the CDC (373 activities totalling $164,408,163), the FDA (271 activities totaling $105,343,978), and the OS (177 activities totaling $31,593,075). Given the complementary missions of the CDC, FDA, and NIH, the three agencies often work closely together to build on each other’s respective strengths and achieve shared objectives. While the NIH conducts and funds basic and applied biomedical and behavioral research, the CDC engages in health promotion, prevention of disease, injury, and disability, and preparedness for new health threats, and the FDA ensures the safety of drugs, medical devices, and many other products that stem from biomedical research. There is also substantial cross-talk between the NIH and the OS, especially in the coordination of multi-agency initiatives, committees, and working groups.
FY 2014 Collaboration Highlights by Thematic Area
The following summary illustrates how the NIH works with our sister HHS agencies to help improve the health and well-being of the American public. Introduced in
Figure 1
(above), examples of specific collaborations in each of the six highlighted themes are described in greater detail in this section. Ultimately, these diverse collaborative efforts feed into the public health ecosystem, helping to foster a healthier country and healthier world.
Theme 1: Assessing the Public’s Health
Sharing the diverse knowledge-base and resources of the HHS family through cross-agency cooperation plays a pivotal role in defining the scope of public health issues, enabling better tracking of health outcomes, disease, and disability. The NIH partners with other HHS agencies to collect and use data on disease prevalence as well as to understand the factors that contribute to wellness and illness within various parts of the population. Through such surveillance efforts, the Department can set priorities regarding current and emerging public health needs, and the NIH can refine its strategic research priorities. These intra-Departmental partnerships encompass efforts to examine disease prevalence and risk factors across a range of issues, such as
cancer
,
kidney disease
, and
adolescent health behaviours
. Important collaborations also address the needs of specific groups, including
American Indian/Alaska Natives
and the
aging U.S. population
. In this section, several health surveillance efforts and national surveys are highlighted.
HHS agencies collaborate on a variety of large-scale efforts to broadly measure population health and disease. The
National Health Interview Survey (NHIS)
coordinated by the National Center for Health Statistics (NCHS) within the CDC, has collected data on the nation’s health since 1957 through personal household interviews. The NIH provides funding for the survey and several of the NIH Institutes sponsor special supplements or help design questions for the survey, and the results provide data to track health status, health care access, and progress toward achieving national health objectives. In a similar collaborative effort, the NIH also helps support the CDC’s
National Health and Nutrition Examination Survey (NHANES)
. by providing assistance in developing specific sections of the survey, such as the cardiovascular, oral health, and hearing-related components. NHANES is a large program of studies designed to assess the health and nutritional status of adults and children in the United States. The survey is unique in that it combines interviews and physical examinations to address a number of health conditions as well as nutritional status for adults and children.
There are a number intra-Departmental surveillance efforts focusing on specific diseases and health challenges, such as recent efforts aimed at understanding and lessening the harmful effects of tobacco use. The
Population Assessment of Tobacco and Health (PATH) Study
is a large-scale FDA-NIH collaboration to conduct a national longitudinal cohort study examining tobacco use and how it affects the health of Americans. The PATH study will follow an estimated 59,000 Americans for at least three years and measure and accurately report the social, behavioral, and health effects associated with tobacco-product use to provide an empirical evidence base to help inform the FDA’s tobacco regulations. Similarly, in 2010 the NIH’s National Library of Medicine (NLM) began convening the Work Group on Harmonizing Hemoglobinopathy Data Sets, a joint project with the CDC and the HRSA along with four other Institutes. The mission of the Workgroup is to create a resource for federal programs and extramural communities that facilitates the use and sharing of data regarding hemoglobinopathies. For example, the Workgroup has established a Hemoglobinopathies Uniform Medical Language to enhance surveillance and registry of these diseases.
The NIH and CDC also partner on surveillance efforts related to children and young adults, as in the collaborative
SEARCH for Diabetes in Youth
study, a multi-center study aimed at understanding more about the types of diabetes, its complications, and how having diabetes affects the lives of children and young adults. More than 20,000 participants in the study have helped determine the extent and impact of diabetes on different populations in the U.S. The NIH and CDC have also teamed up to address inconsistent practices in investigation and reporting of sudden death in the young (SDY) and sudden unexpected infant death (SUID) which hamper the ability to monitor national trends, ascertain risk factors, and design and evaluate programs to prevent these deaths. In October 2013, the NIH and the CDC launched the
Sudden Death in the Young Registry
to track cases of sudden death in the young (up to age 24), including sudden cardiac death and sudden unexpected death in epilepsy (SUDEP). The registry is an expansion of the CDC's Sudden Unexpected Infant Death Case Registry, which previously tracked sudden unexpected deaths in children up to age one year. This new resource will help researchers define the scope of the problem and set future research priorities as well as identify children at risk and test prevention strategies. The NIH's National Heart, Lung, and Blood Institute (NHLBI) will analyze data related to sudden cardiac death while the National Institute on Neurological Disorders and Stroke (NINDS) will participate in the registry by reviewing data on SUDEP. The Sudden Death in the Young Registry is jointly funded by the CDC, NHLBI, and NINDS.
Examining human interaction with environmental factors is an area of increasing importance in public health research. The
Agricultural Health Study
, sponsored by multiple NIH Institutes, the Environmental Protection Agency (EPA), and the National Institute for Occupational Safety and Health (NIOSH) of the CDC, is investigating the effects of environmental, occupational, dietary, and genetic factors on the health of agricultural workers. Focusing on individuals who are private or commercial pesticide applicators and their spouses, the study has enrolled approximately 90,000 participants in Iowa and North Carolina. In addition to the long-term effects on cancer incidence and mortality, ongoing studies are examining lung health, susceptibility to methicillin-resistant staphylococcus aureus (MRSA), and biomarkers of exposure and adverse effects in agriculture. Overall, the study will provide information that these workers can use in making decisions about their health and the health of their families, as well as inform the population about the effects of exposure to certain environmental factors.
Predicting the spread of infectious diseases is another important aspect of public health surveillance. The NIH’s Fogarty International Center (FIC) and HHS are working together on the
Multinational Influenza Seasonal Mortality Study
(MISMS)to create a resource of computational models for host-disease interactions. Such models assist public health workers as they assess and respond to outbreaks of infectious diseases. The MISMS was created to analyze national and global mortality patterns associated with influenza virus circulation, but its mission has since expanded to address the dynamic potential of the evolution and migration of the influenza virus. The global collaborations developed by MISMS work together to collect, analyze, and disseminate research findings through scientific publications, training workshops, and communication tools for investigators and decision-makers. The research findings produced by the MISMS have informed national governments, multilateral organizations, and research stakeholders on interventions for both pandemic and seasonal influenza. As of 2012, data have been acquired from more than 30 countries (representing ~3.2 billion people), resulting in over 190 publications.
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Theme 2: Improving Diagnosis and Treatment through Research
In striving to provide the best options in medical care and health practice, the NIH works across the Department to support the science needed to develop new ways to diagnose and treat the diseases and disorders that cause the greatest burdens to society. The primary goal of NIH translational and clinical research is to improve public health interventions to provide the best available care for those who need it. Cooperative efforts with other HHS agencies, such as those described in this section, help to ensure that the wealth of information gleaned from research activities can be disseminated and implemented throughout the Department and in the community.
The NIH uses partnerships to leverage talents and resources for global pediatric health. In a collaboration between the Bill and Melinda Gates Foundation, and the CDC, OS, and the
Eunice Kennedy Shriver
National Institute of Child Health and Human Development (NICHD), the NIH is addressing the issue of iron supplementation among children in areas where malaria is endemic. Malaria, a major cause of death in children in Sub-Saharan Africa, may pose a greater risk to young children taking iron supplements. Many children in malaria-endemic areas are also at risk for iron deficiency, which may impair physical and mental development. The
Iron and Malaria Project
is examining the safe and effective use of interventions (such as iron supplementation) to prevent iron deficiency and related health problems in areas where malaria and other infections are common. The NICHD leads the Project with support from the Gates Foundation and other partners, including the NIH Office of Dietary Supplements. The Project is designed not only to support new research, but also to support efforts of other organizations, including the World Health Organization (WHO), and other global health organizations to develop evidence-based programs and policies related to iron within the context of women’s, infants’, and children’s health in the United States and globally. A recent study of iron supplementation among children living in a high malaria-burden area in central Ghana found no significant difference in rates of malaria between children receiving iron supplementation and children given no iron, suggesting that supplementation should be reconsidered for children living in areas where malaria is common.
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The ACL and the NIH’s National Institute on Aging (NIA) have partnered in recent years to address the complementary goals of the two agencies to improve the health and well-being of older Americans. Through a joint research initiative,
Translational Research to Help Older Adults Maintain their Health and Independence in the Community,
the NIA and the ACL support translational research that moves evidence-based research findings towards the development of new interventions, programs, policies, practices, and tools that can be used by community-based organizations to help elderly individuals remain healthy and independent. Further, a working group of NIH and ACL staff meet regularly to identify evidence-based interventions that are ready for dissemination and implementation in community programs and to work more collaboratively on their translation into the community. Areas of interest identified to date are diverse and include family caregiving, exercise and physical activity, nutrition, elder mistreatment and abuse, falls, driving, sleep, medication management, depression and mental health, living with long-term disability, stroke, and Alzheimer’s disease. These collaborative efforts include devising strategies to evaluate the success of these dissemination and implementation efforts.
Accelerating the dissemination of research-based treatment into clinical practice is also the core mission of a partnership between the NIH’s National Institute on Drug Abuse (NIDA) and the SAMHSA, known as the
Blending Initiative
. The NIDA and the SAMHSA joined together to create the Blending Initiative in 2001 to reduce the gap that exists between the publication of research results on drug abuse and the impact on treatment delivery. This initiative draws on input from clinicians, scientists, and experienced trainers to catalyze the creation of user-friendly treatment tools and products and to facilitate the adoption of research-based interventions into front-line drug abuse treatment settings. Through this initiative, the NIDA and
SAMHSA’s Addiction Technology Transfer Centers (ATTCs)
disseminate treatment and training products based on results from studies conducted by the NIH, including those in the
National Drug Abuse Clinical Trials Network (CTN)
.
Improving health through medical care and health practice is a core mission of the
Committee on the Fetus and Newborn (COFN)
, which studies issues and current advances in fetal and neonatal care; makes recommendations regarding neonatal practice; collaborates with the American College of Obstetricians and Gynecologists (ACOG) to consider perinatal issues on which the practices of obstetrics and pediatrics merge; and works cooperatively with ACOG on new editions of Guidelines for Perinatal Care. Established in 1937, the COFN has studied and issued a number of recommendations to improve care that have reduced neonatal mortality and morbidity. The NICHD and the CDC participate in the COFN, bringing their combined expertise in child health and statistics to the work of the Committee. The COFN’s most recent recommendations include publications and statements on the risks to newborns from immersion in water during labor and delivery, skin-to-skin care of babies in NICUs, and apnea in premature infants.
The Foundation for the NIH Biomarkers Consortium
is a public-private biomedical research partnership managed by the
Foundation for the National Institutes of Health
that endeavors to discover, develop, and qualify biological markers (biomarkers) to support new drug development, preventive medicine, and medical diagnostics. Biomarkers are objectively measurable indicators of normal and abnormal biological states. Body temperature, for example, is considered an effective biomarker for fever, and blood pressure can predict the risk of stroke and coronary heart disease; however, for many diseases, clinicians lack reliable ways to identify disease and assess response to treatment. With participation by the NIH, FDA, and CMS—as well as by private sector members: the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO)—the Biomarkers Consortium is helping create a new era of personalized medicine, with more highly predictive markers that have an impact during a patient’s illness or lifespan. The goal is to combine the forces of the public and private sectors to accelerate the development of biomarker-based technologies, medicines, and therapies for the prevention, early detection, diagnosis, and treatment of disease. As of December 2013 the Consortium has launched more than 16 projects in areas as diverse as Alzheimer’s disease, cardiovascular disease, diabetes, and breast cancer. A number of other promising projects are also moving forward for implementation.
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Theme 3: Preventing Disease and Disability
Preventing disease and disability before it starts is critical to helping people live longer, healthier lives. Poor diet, physical inactivity, tobacco use, and alcohol misuse all have been shown to have terrible health consequences for Americans. Minimizing these and other risk factors can result in major public health gains. Aligning and coordinating efforts across HHS is central to the success of national prevention strategies. The NIH works to expand the evidence-base for prevention strategies and partners with other HHS agencies on more than 100 prevention activities, engaging partners across disciplines, sectors, and institutions to change the way communities conceptualize and solve problems, enhance implementation of innovative strategies, and improve individual and community well-being. Examples of interagency prevention efforts include those aimed at reducing
reducing heart attacks and strokes
,
asthma
,
smoking
,
underage drinking
, and a range of other harmful health effects and behaviors, including the following highlighted collaborations.
HHS has a long history of HIV/AIDS work within the United States and at the global level. For example, many HHS agencies contribute to the
U.S. President's Emergency Plan for AIDS Relief (PEPFAR)
, a U.S. Government initiative led by the U.S. Global AIDS Coordinator to help save the lives of those suffering from HIV/AIDS around the world. PEPFAR is the cornerstone and largest component of the U.S. President’s Global Health Initiative. Structures and systems have been established at every level of the U.S. Government working in international HIV/AIDS to ensure a unified strategic approach to combating the epidemic abroad. HHS agencies work together to assist in developing research and evaluation priorities for PEPFAR, to conduct HIV/AIDS research through the CDC, FDA, HRSA, NIH, and SAMHSA, and to help implement effective prevention, treatment, and care programs in developing countries. The NIH provides technical expertise on issues related to safety and efficacy of interventions implemented in PEPFAR programs and facilitates evaluation of PEPFAR programs through NIH-funded grants. Recent NIH research initiatives under PEPFAR have focused on testing treatment as prevention at the population level in Africa, including the prevention of mother-to-child HIV transmission.
Another major public health goal is to stem the rising rates of diabetes, the seventh leading cause of death in the United States.
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Diabetes is a debilitating disease that affects an estimated 29.1 million people in the United States—or 9.3 percent of the total population—including an estimated 8.1 million people who remain undiagnosed.
9
Type 2 diabetes, which accounts for more than 90 percent of diabetes among adults, often can be averted or delayed by lifestyle factors.
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The NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), in collaboration with the CDC and the Indian Health Service (IHS), continues to support the
Diabetes Prevention Program Outcomes Study (DPPOS)
, started in 1994. This long-term outcomes study has shown that diet and exercise or the diabetes medication, metformin, can delay the onset of diabetes by ten years.
One major contributor to increasing diabetes rates is childhood obesity – nearly 17 percent of children and teens ages two through 19 (or 12.7 million) in the United States are obese.
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Because most obese children grow up to be overweight or obese adults, preventing obesity during childhood is critical. To advance and accelerate progress in addressing the nation’s childhood obesity epidemic, the NIH and the CDC along with the U.S. Department of Agriculture (USDA) and private foundation partner, the Robert Wood Johnson Foundation (RWJF), formed the
National Collaborative on Childhood Obesity Research
(NCCOR). NCCOR’s goals are to identify intervention needs, improve child obesity surveillance, improve research and evaluation methodologies, and provide national leadership to implement evidence-based practice and policy. NCCOR also works with many non-health partners to develop sustainable environmental design and food systems strategies to reach high risk populations and communities. In building on each other’s strengths, the CDC, NIH, RWJF, and USDA are advancing the field through complementary and joint projects, such as a study to evaluate community programs to reduce childhood obesity. This public-private collaboration spurs action, provides strategic direction, and is building a strong foundation of research to guide the nation’s efforts to prevent and reduce childhood obesity.
Another serious and preventable public health problem is suicide. The CDC reports that more than 39,000 Americans die by suicide each year.
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This translates to roughly four suicides per hour, greater than the number of homicide- or motor vehicle-related fatalities. Through the
National Action Alliance for Suicide Prevention (Action Alliance)
, the federal government and private groups are bringing their collective strengths to bear on reducing suicide and suicidal behaviors. Involving numerous public members and representatives from the Departments of Defense, Education, Justice, Interior, Veterans Affairs, and HHS (including the ACL, CDC, HRSA, IHS, SAMHSA, NIH, and the Assistant Secretary for Health), the Action Alliance formed an expert group, the Research Prioritization Task Force (RPTF), to revise and update a national suicide prevention strategy. The RPTF worked to refine specific research priorities for suicide prevention, which culminated in the release of
A Prioritized Research Agenda for Suicide Prevention: An Action Plan to Save Lives
in February 2014. The Research Agenda includes an overarching goal to advance suicide prevention research more rapidly, seeking ways to reduce suicide deaths and attempts by 20% in five years and by 40% or greater in ten years, if multiple actions, informed by research, were fully implemented. The NIH, through its contributions to the RPTF, seeks to identify and fund research with the potential to prevent suicide attempts and deaths.
Theme 4: Providing Evidence-Based Health Information
As illustrated in the preceding section, the biomedical and behavioral research that the NIH funds forms much of the evidence base for understanding health risks. However, to have a tangible impact on population health, this information must be effectively and broadly communicated to the American public in order to empower individuals to make informed personal decisions about their health. To this end, the NIH works with other HHS agencies on numerous large-scale health promotion campaigns and information portals. Examples include informational websites dedicated to
diabetes
,
kidney disease
,
osteoporosis
, and
bullying
. A few other notable public health campaigns and information portals are highlighted below.
Every five years, HHS and the USDA update the Dietary Guidelines for Americans, which are recommendations for individuals ages two years and over that provide the basis for federal food and nutrition policy and education initiatives. The Dietary Guidelines encourage Americans to focus on eating a healthful diet that helps achieve and maintain a healthy weight, promotes health, and prevents disease. The recommendations are based on a rigorous review of relevant scientific evidence by the Dietary Guidelines Advisory Committee (DGAC), consisting of nationally recognized experts in the field of nutrition and chronic disease prevention. HHS’s Office of Disease Prevention and Health Promotion has the administrative leadership for the 2015 edition and is strongly supported by the USDA’s Center for Nutrition Policy and Promotion in committee and process management, as well as with evidence analysis functions. In 2014, the NIH hosted four
first meeting of the 2015 DGAC
, and the NIH, CDC, and FDA are supporting the DGAC throughout the revision process for the 2015 edition of the
Dietary Guidelines for Americans
.
The NIDDK also partners with the CDC and more than 200 public and private organizations at the federal, state, and local levels on the
National Diabetes Education Program
(NDEP). NDEP was created in 1997 to translate diabetes research results into health care practice. For example the NDEP sought to ensure the impact of the DPP clinical trial and the
Diabetes Prevention Program Outcomes Study (DPPOS)
by developing messages and materials to translate the science of diabetes prevention into clinical practice and to raise awareness among high risk individuals.
At the other end of the lifespan,
Go4Life
, an exercise and physical activity campaign led by the NIH’s NIA in partnership with the ACL, AHRQ, CDC, and OS, is designed to help individuals fit exercise and physical activity into their daily lives. Motivating older adults to become physically active for the first time, return to exercise after a break in their routines, or build more exercise and physical activity into weekly routines are the essential elements of Go4Life. Go4Life offers exercises, motivational tips, and free resources to help individuals get ready, start exercising, and keep going. The Go4Life campaign includes evidence-based exercise guides in English and Spanish, an exercise video, an interactive website, and national outreach activities.
Sponsored by the CDC, HRSA, and the NIH’s Office of AIDS Research (OAR), National Institute of Allergy and Infectious Diseases (NIAID), and NLM,
AIDSinfo
offers access to the latest, federally approved HIV/AIDS medical practice guidelines, HIV treatment and prevention clinical trials, and other research information for health care providers, researchers, people affected by HIV/AIDS, and the general public. These English- and Spanish-language websites (
InfoSIDA
) assist in the dissemination of the Public Health Service Treatment Guidelines as well as information about both approved and investigational HIV/AIDS treatments. The site also provides mobile resources and tools, such as the
HIV/AIDS Glossary App,
an on-the-go guide to the complex terminology of HIV/AIDS with easy-to-understand definitions for more than 700 HIV/AIDS-related terms in English and Spanish, as well as fact sheets that serve as a source of readily available evidence-based information.
ChildStats.gov
represents another cross-Agency web resource providing high-quality, up-to-date information on the health status of children and families. Leading this effort, the
Federal Interagency Forum on Child and Family Statistics
(Forum) is a collection of 22 federal agencies involved in research and activities related to children and families, including the HHS operating divisions of the ACF, AHRQ, CDC, HRSA, NIH, and SAMHSA. The mission of the Forum is to foster coordination and collaboration and to enhance and improve consistency in the collection and reporting of federal data on children and families. In 2014, the Forum published two reports,
America’s Young Adults: Special Issue, 2014
, and At a Glace for 2014,
America's Children: Key National Indicators of Well-Being
. In the Special Issue on America's Young Adults, the Forum extends its commitment to describing the well-being of youth as they transition into adulthood. Next year, the Forum plans to issue its customary full report, America's Children: Key National Indicators of Well-Being, in 2015. This full report contains national indicators of child well-being, including family and social environment, economic circumstances, health care, physical environment and safety, behavior, education, and health, and reports changes in these indicators over time. In addition to providing data in an easy-to-use, nontechnical format, the purpose of the report is to stimulate discussions among policymakers and the public, exchanges between data providers and policy communities, and improvements in federal data on children and families.
Theme 5: Keeping Americans Safe
Through research, regulation, and policy development, HHS agencies are committed to protecting the health and safety of all Americans. With its HHS and other federal partners, the NIH works to ensure that proper policies are in place to protect the public, including confirming that medical products are safe and effective, that emerging health and biosecurity threats can be identified and addressed swiftly, that appropriate biosafety protocols are in place to prevent laboratory accidents, and that scientific information is used in responsible ways.
The NIH is the steward of the
NIH Guidelines for Research with Recombinant and Synthetic Nucleic Acids (NIH Guidelines)
and, in this role, provides guidelines and a framework for oversight of research at NIH-funded institutions which have been adopted as a safety standard elsewhere. Updates to the
NIH Guidelines
to address emerging areas of research are done in consultation with the
NIH Recombinant DNA Advisory Committee (RAC)
, a federal advisory committee. In addition, the RAC advises NIH on the safe and ethical conduct of clinical gene therapy research through review of new protocols that employ novel technologies and the development of recommendations that enhance the scientific and ethical design of individual protocols. The RAC also discusses safety data and other emerging issues for the field of gene therapy. The CDC, FDA, USDA, and OS partner with NIH for these RAC activities. In FY2014, in addition to its regular meetings to review and assess gene therapy protocols, the RAC hosted a meeting to discuss the development of new approaches to genomic editing technologies that are being applied in clinical settings for human gene transfers.
Biosafety, biosecurity, and dual use research are issues of growing importance that require close collaboration between NIH, HHS, and the CDC. Dual use research generates information, technologies, and products that can be applied for both benevolent and harmful purposes, and therefore poses a biosecurity risk. A small subset of dual use research is considered dual use research "of concern" (DURC) because it yields information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agriculture, the environment, or other aspects of national security. For example, in late 2011, two NIH-funded studies examining mammalian transmissibility of the highly pathogenic avian influenza (HPAI, also known as “bird flu”) H5N1 viruses raised concerns regarding the potential for accidental or intentional release of an engineered virus that could cause a deadly pandemic. In response to the need for oversight of DURC, HHS – including the OS, CDC, FDA, and NIH – has been working actively with interagency partners toward the development of comprehensive federal policies. Recommendations and input from such bodies as the
National Science Advisory Board for Biosecurity (NSABB)
, managed by the NIH, and the Intragovernmental Select Agents and Toxins Technical Advisory Committee (ISATTAC), managed by the CDC, are helping to inform U.S. Government policies for identifying and managing DURC.
In September 2014, a new U.S. Government policy, the
U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern
was issued, requiring federally-funded research institutions to review their research portfolios to identify those projects that constitute DURC and to ensure that appropriate risk mitigation measures have been implemented. This new policy and its related implementation guide were developed through the National Security Staff Dual Use Research of Concern Interagency Policy Committee (NSS DURC IPC) with leadership from the NIH, CDC, and HHS.
In recognition of the links between biosafety, biosecurity, and global health, in 2014 the White House initiated the
Global Health Security Agenda
. This initiative seeks to accelerate progress toward a world safe and secure from infectious disease threats and to promote global health security as an international security priority. The agenda organizes a consortium of international partners to prioritize coordinated actions and specific, measurable steps focused on: preventing epidemics, detecting biological threats early, and rapidly responding to disease outbreaks, whether naturally occurring, intentionally produced, or accidentally caused. The NIH’s NIAID and NINDS worked alongside the HHS, CDC, and other federal and international partners as part of the Global Health Security Advisory Group (GSAG), a committee comprised of high level representatives of national health authorities for the G-8 block of countries, formed to develop and implement concrete actions to improve global health security and serve as a network for rapid response to biological, chemical, radio-nuclear terrorism (CBRN) crises.
HHS must be poised to address emergency health risks, and several interagency collaborations aid this effort. Under the leadership of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), the NIH participates in the
Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)
, the coordinating body for federal agencies in charge of employing medical countermeasures to protect the civilian population from potential adverse health impacts from chemical, biological, nuclear, or radiological threats. Medical countermeasures are medicines, devices, or other medical interventions that can lessen the harmful effects of these threats. This preparedness effort includes representatives from the OS, NIH, FDA, and CDC, as well as the U.S. Departments of Defense, Veterans Affairs, Homeland Security, and Agriculture. Legislation passed in 2013 enables HHS to develop a five-year budget plan on the medical countermeasures enterprise, which will aid strategic project coordination and communicate priorities to partners and stakeholders.
The NIH also collaborates across the Department to support HHS Diagnostics Integrated Program Team (DxIPT). DxIPT was established by the PHEMCE Executive Committee to advise leadership on investments in human health diagnostics and medical countermeasures to improve the response to chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases. In 2012, DxIPT was charged with two tasks: 1) to reevaluate the feasibility of anthrax diagnostics for asymptomatic infections and 2) to develop Quantitative Technological Readiness Levels (Q-TRLs) for diagnostics to represent milestones and activities for the product development lifecycle from discovery through post-approval. Recognizing the value in conducting research during disasters to better inform planning for future incidents, the NIH developed the
Disaster Research Response (DR2) Project
. This project aims to create an environmental health disaster research system through platforms of ready-to-go research data collection tools and a network of specially trained research responders. Administered by the NIH, the project coordinates efforts of the ASTDR, CDC, FDA, and OS (i.e., the ASPR). Elements of the system include epidemiologic questionnaires and clinical protocols, specially trained disaster researchers, environmental health disaster research networks, a reach-back roster of subject matter experts, and a support infrastructure that can be activated and deployed during public health emergencies and declared disasters. This effort will provide invaluable lessons and platforms for advancing timely post-disaster research activities.
Another major area of concern for public health is the effects of chemical exposures from various sources including food, household cleaning products, and medicines throughout the lifespan. The
Toxicology in the 21st Century (Tox21)
program, a federal collaboration involving the NIH, the FDA, and the EPA, is aimed at developing better assessment methods to quickly and efficiently test whether certain chemical compounds have the potential to lead to adverse health effects. NIH-funded scientists are using a high-throughput screening robotic system to test chemical compounds in cellular and biochemical assays for their potential to disrupt biological pathways that may result in toxicity. The Tox21 program is co-funded and co-administered by the EPA’s National Center for Computational Toxicology and the National Toxicology Program (NTP), an interagency program supported by the NIH, FDA, and EPA. Together, the NIH and the EPA bring an enormous wealth of experience in animal and computational toxicology to the Tox21 collaboration and utilize the research results to develop cost-effective approaches for prioritizing the thousands of environmental chemicals that require toxicity testing. The FDA brings expertise and safety information on pharmaceutical drugs and food substances to the collaboration. As research data are generated, both the EPA and the FDA plan to apply the knowledge gained to the products they regulate.
Theme 6: Broad, Multi-Purpose Coordination
Given the complexity of major public health challenges, there is often a need for formal cross-agency strategic planning to ensure that all of the agencies within the Department are working in concert toward larger health goals with multiple purposes. The five-year HHS Strategic Plan described above and the intergovernmental ten-year agenda for improving the nation’s health,
Healthy People 2020
, are prime examples of strategic planning endeavors that outline pathways to achieve broad health-related objectives. Other important interagency strategic planning activities are focused on achieving better outcomes in specific health topics, such as
diabetes
,
HIV/AIDS
,
tuberculosis
,
antimicrobial resistance
, and
health equity in underserved populations
, among many others. The following interagency collaborations illustrate how the NIH works with other HHS agencies and often other federal departments to coordinate broad planning efforts.
In concert with the
HHS Initiative on Multiple Chronic Conditions
, the NIH partners across the Department to improve the health of individuals who have multiple chronic conditions (e.g., two or more long-term diseases, disorders, or disabilities). Recognizing the importance of multiple chronic conditions to patients, caregivers, and the health care system, the Assistant Secretary for Health convened an HHS-wide work group on Multiple Chronic Conditions (MCC) to identify options for improving the health of this population. In 2010, the work group, in conjunction with other stakeholders, developed the
Multiple Chronic Conditions: A Strategic Framework
. The Framework serves as a national-level roadmap for assisting HHS programs and public and private stakeholders to improve the health of individuals with multiple chronic conditions. In 2014, the NIH published MCC-focused funding opportunities to: 1) investigate intervention strategies that promote self-management across MCC; 2) conduct clinical and basic research in the pathogenesis of HIV-related heart-lung, and blood diseases in adults and children; 3) address gaps in knowledge and prioritize future research opportunities in MCC including assessing the frequency with which randomized controlled trials of behavioral and psychosocial interventions have included participants with MCC; and 4) develop mobile health tools to promote effective patient-provider communications, adherence to treatment, and self-management of MCC in underserved populations. In 2014, through the Health Systems Collaboratory (an NIH-supported activity partnering with the AHRQ, FDA, and the HHS Office of the National Coordinator for Health Information Technology along with academic- and healthcare-focused centers, focused on strengthening national capacity in research partnerships with health care delivery organizations),
13
the NIH made three new awards for MCC-related research totaling up to $19.4 million over five years. In addition, the NIH funded a grant for $2.8 million over 4 years to enable collaboration between the HMO Research Network and the Claude D. Pepper Older Americans Independence Centers to create and advance an interdisciplinary research agenda focused on older adults with MCC.
14
Members of the
HHS Coordinating Committee on Women’s Health
, composed of representatives from each of the agencies and offices within HHS, advise the Assistant Secretary for Health on current and planned activities across HHS that would safeguard and improve the physical and mental health of all women in the United States. The committee has identified the prevention and intervention of domestic/intimate partner violence (IPV) as a priority focus for cross-federal initiatives. In December 2013, HHS convened
a research symposium
at the NIH with the purpose of identifying research gaps in screening and counseling for IPV in primary health care settings and to shape priorities in the national research agenda moving forward. Ultimately, the Department’s goal is to promote effective strategies for health care practitioners for screening and counseling.
In addition to interagency coordination, interdepartmental coordinating efforts also work to achieve common goals more effectively, such as the federal government’s efforts to implement the National Alzheimer’s Project Act (NAPA). Signed into law in January 2011, NAPA established the
Advisory Council on Alzheimer’s Research, Care, and Services
to coordinate research and services across federal agencies, to accelerate the development of treatments for Alzheimer’s disease and related dementias, to improve early diagnosis and coordination of care, to reduce ethnic and racial disparities in rates of Alzheimer’s disease and related dementias, and to coordinate with international efforts to fight these conditions. In addition to the ten HHS agencies involved in this collaboration, the group further coordinates efforts across the government by partnering with the Department of Veterans Affairs (VA), the National Science Foundation (NSF), and the Department of Defense (DoD). In the Spring of each year, the Advisory Council and the Secretary of HHS update the
National Plan to Address Alzheimer’s Disease
, which originated in 2012. The update reflects national progress towards accomplishing the goals set forth initially, as well as new and revised action steps.
In response to the 2012 White House Executive Order,
National Research Action
Plan on post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI). The plan was released in August 2013, and the NIH participates in a Post-traumatic Stress Disorder (PTSD)/Traumatic Brain Injury (TBI) Workgroup to plan and coordinate federal investments in research that will have an impact on treating these disorders. In addition, the NIH is co-leading the development of sophisticated data systems to provide new means for sharing research data that will be vital to leveraging research resources. To develop data sharing policies and strategies to improve TBI research, a federal interagency working group is informing the construction of a secure, centralized database for TBI research. Along with the NIH, CDC, HRSA, SAMHSA, OS, DoD, DoEd, and VA developed the
Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System
, which serves as a central repository for new data, links to current databases, and allows valid comparison of results across studies. In FY2014, the FITBIR Informatics System facilitated collaboration between laboratories through, for example, the establishment of
guidelines for the collection and submission of research biospecimens
and accelerated research progress on TBI through
advances in data sharing
.
Conclusions
HHS accomplishes its mission to enhance the health and well-being of Americans through several hundred programs and initiatives that cover a wide spectrum of activities, serving the American public at every stage of life. America’s investment in the NIH provides the nation with a unique resource—a scientific agency devoted to the creation of a knowledge base needed to conquer the most devastating human diseases and disabilities. In order for this rich knowledge base to improve health, the Department, as well as the entire federal government and the private sector, must work in concert to cultivate ground-breaking research and ensure that scientific knowledge is translated into sound regulations and policies, health services and medical interventions, and information that all Americans can use to lead healthier lives.
The NIH appreciates the opportunity to report on its multifaceted collaborations within the Department of Health and Human Services. The policies, programs, and regulatory and service activities developed and carried out by HHS operating and staff divisions are some of the most effective means that the government can use to improve the health and well-being of its citizens. The collaborative activities detailed in this report illustrate how the NIH works across the Department to cultivate partnerships, leveraging the respective strengths of all HHS agencies to support the HHS mission and strengthen the public health ecosystem.
[1]
John Hagel,
Power of Pull
, (New York: Basic Books, 2012).
[2]
The staff divisions of the Office of the HHS Secretary (OS) are: the Immediate Office of the Secretary (IOS), Assistant Secretary for Administration (ASA), Assistant Secretary for Financial Resources (ASFR), Assistant Secretary for Global Affairs (ASGA), Assistant Secretary for Health (ASH), Assistant Secretary for Legislation (ASL), Assistant Secretary for Planning and Evaluation (ASPE), Assistant Secretary for Preparedness and Response (ASPR), Assistant Secretary for Public Affairs (ASPA), Center for Faith-Based and Neighborhood Partnerships (CFBNP), Departmental Appeals Board (DAB), Office for Civil Rights (OCR), Office of the General Counsel (OGC), Office of Inspector General (OIG), Office of Intergovernmental and External Affairs (IEA), Office of Medicare Hearings and Appeals (OMHA), and the Office of the National Coordinator for Health Information Technology (ONC).
[3]
Funding levels are reported and verified by budget officers in the various Institutes, Centers, and Offices within the NIH Office of the Director. Funding levels in this report may not be consistent with those reported under the Estimates of Funding for Various Research, Condition, and Disease Categories (RCDC) at the NIH Office of Budget website at
http://report.nih.gov/categorical_spending.aspx
. The current RCDC process, implemented in 2008, uses sophisticated text data mining (categorizing and clustering using words and multi-word phrases) in conjunction with NIH-wide definitions used to match projects to categories. RCDC use of data mining improves consistency and eliminates the wide variability in defining the research categories reported. The definitions are a list of terms and concepts selected by NIH scientific experts to define a research category. The RCDC research category levels represent the NIH’s best estimates based on the category definitions.
[4]
Individual collaborative activities can involve multiple HHS agencies. Therefore, the values displayed in Chart 2 and Chart 3 reflect duplicate counts and add up to more than the total reported sums.
[5]
Multinational Influenza Seasonal Mortality Study, http://www.origem.info/misms/index.php.
[6]
Zlotkin, S, et al, “Effect of iron fortification on malaria incidence in infants and young children in Ghana: a randomized trial,” Journal of the American Medical Association, 2013 Sep 4; 310(9): 938-47.
www.ncbi.nlm.nih.gov/pubmed/24002280
.
[7]
FNIH 2013 Annual Report
,
http://2013-annual-report.fnih.org/
.
[8]
National Diabetes Information Clearinghouse,
National Diabetes Statistics Report, 2014
.
http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf
.
[9]
Ibid.
[10]
Ibid.
[11]
CDC, Childhood Obesity Fact, Prevalence of Childhood Obesity in the United States, 2011-2012. Available at
http://www.cdc.gov/obesity/data/childhood.html
.
[12]
CDC, Preventing Suicide. Available at
http://www.cdc.gov/features/preventingsuicide/?mobile=nocontent
[13]
NIH Collaboratory,
www.nihcollaboratory.org/about-us/Pages/default.aspx
.
[14]
HHS, 2014 Implementation Actions by HHS Agencies,
www.hhs.gov/ash/initiatives/mcc/implementation/actions2014.html
.
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