Report on NIH Collaborations with Other HHS Agencies for Fiscal Year 2012

Introduction

This annual report captures the extent and nature of activities undertaken by the National Institutes of Health (NIH) in collaboration with other agencies and divisions of the Department of Health and Human Services (HHS). As first articulated by the philosopher and physician Aristotle (circa 300 B.C.), the whole is greater than the sum of its parts. For an organization as complex as HHS, which has 11 operating divisions, many additional staff divisions, and more than 300 programs, synergy between the different components of the Department is vital to the success of the whole. Recognizing this, 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 sixth report to the Secretary, covers fiscal year 2012.

Background

The HHS mission is to provide essential human services and to protect the health of all Americans 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 5 strategic goals to achieve this mission:  1) Strengthen Health Care; 2) Advance Scientific Knowledge and Innovation; 3) Advance the Health, Safety, and Well-Being of the American People; 4) Increase Efficiency, Transparency, and Accountability of HHS Programs; and 5) Strengthen the Nation’s Health and Human Services Infrastructure and Workforce. Eleven operating divisions, including eight agencies in the United States Public Health Service and three human service agencies, administer HHS’s multifaceted programs. In addition, staff divisions provide leadership, direction, and policy guidance to the Department.  Each HHS operating and staff division is an essential part of the larger public health ecosystem, fulfilling a unique role, from providing access to quality health care for all Americans, to reducing illness and disease and extending healthy life, to protecting our population from known and unknown public health threats, to maximizing the impact of the social service safety net. With more than 300 programs across the Department, the ultimate success of all components of the HHS public health ecosystem is interrelated –  HHS agencies can achieve more together than by working in isolation. Interagency collaborations enable HHS agencies to capitalize on the strengths of individual mission areas to enhance the public health impact of the Department’s diverse programmatic activities – such cross agency synergism is necessary to accelerating progress in medicine 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 knowledge into useful applications that reach all Americans, such as disease treatments, preventive interventions, protective health policies and regulations, and public health campaigns. Information gathered by other HHS agencies on public health needs, in turn, 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) and the Office of the Surgeon General (OSG), and the 10 other operating divisions of HHS:

• Administration for Children and Families (ACF)
• Agency for Healthcare Research and Quality (AHRQ)
• Administration for Community Living (ACL)
• 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)

Overview of FY 2012 Collaborative Activities

In FY 2012, the NIH collaborated with other HHS operating and staff divisions on 601 activities – 387 activities that did not require NIH funding and 214 activities funded with contributions from the NIH totaling $392,608,474.¹ The Complete List of Activities Table provides a comprehensive list of all reported activities.  The full details for each activity, including a brief description, the year the collaboration originated, FY 2012 funding, and participating NIH Institutes, Centers, and Offices as well as HHS agencies, 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:  Advisory Group; Health Survey; Meeting/Workshop; Public Education Campaign; Research Initiative; Resource Development (e.g., database, disease registry, information clearinghouse); Training Initiative; or Other. The 4 most common types of collaboration involve:  1) research initiatives; 2) advisory groups; 3) committees, work groups, or task forces (a subset of the “Other” category); and 4) meetings and workshops.  Nearly half of the collaborations involving funding from the NIH were research initiatives, which made up 46 percent of all funded activities (99 funded collaborative research initiatives for a total of $242 million). For those collaborations that did not involve NIH funding, many relied on the NIH’s intellectual input, commonly in the form of advisory groups, committees, or meetings.

Chart 2 displays the number of collaborative activities that the NIH engaged in with each HHS operating/staff division, and Chart 3 plots the NIH’s funding contributions for those shared activities, again broken down by HHS division.   As Chart 2 and Chart 3 illustrate, the majority of the NIH’s collaborations were with the CDC (371 activities totaling $184,311,296), the FDA (235 activities totaling $159,398,037), and the HHS Office of the Secretary (OS) or Office of the Surgeon General (OSG) (167 activities totaling $39,255,828). Given the complementary missions of the CDC, FDA, and NIH, the 3 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 2012 Collaboration Highlights

The following summary describes how the NIH works with our sister HHS agencies to help improve the health and well-being of the American public.  These examples of cross-agency collaboration illustrate the broad spectrum of health efforts that the NIH contributes to in partnership with the rest of the Department and are organized into 6 themes in this report:

1. Understanding the Public’s Health – enabling better tracking of disease and disability
2. Improving Health through Ensuring the Use of Effective Diagnostics and Treatments –promoting the translation of NIH’s research results to health practice
3. Preventing Disease and Disability – providing the evidence base for national disease and disability prevention efforts
4. Empowering Americans with Evidence-Based Health Information – equipping public health efforts with the latest research findings and best available health information
5. Keeping Americans Safe – ensuring effective health policy and regulatory protections
6. Strategic Interagency Planning to Improve Public Health – coordinating broad planning efforts that cut across the entire Department

Ultimately, these diverse collaborative efforts feed into the public health ecosystem, helping to foster a healthier country and healthier world.

Understanding the Public’s Health

Cross-agency cooperation plays a pivotal role in defining the scope of public health issues, enabling better tracking of disease and disability. The NIH partners with other HHS agencies to collect data on disease prevalence as well as to understand the factors that contribute to wellness and illness within various parts of the population. These partnerships encompass efforts to examine disease prevalence and risk factors across a range of issues, such as cancer, kidney disease, adolescent health behaviors, and tobacco use.  Important collaborations also address the needs of specific groups, including American Indian/Alaska Natives and the aging U.S. population.

The CDC and NIH often collaborate on large-scale efforts to broadly measure population health and disease.  One such example is the National Health Interview Survey (NHIS) (coordinated by the National Center for Health Statistics (NCHS) within the CDC), which has collected data on the nation’s health since 1957 through personal household interviews. The NIH provides funding and several 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. The NIH also works with the CDC/NCHS on components of the National Health and Nutrition Examination Survey (NHANES), which combines both interviews and physical examinations to assess the health and nutritional status of adults and children. Partnerships for disease-specific surveillance efforts are also strong between the NIH and CDC, as in the collaborative SEARCH for Diabetes in Youth 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 United States.

NIH research efforts to understand and improve public health are also enhanced by data-sharing partnerships with the CMS. A number of NIH studies that follow large populations over long periods of time have linked their data collection of biological information with CMS data regarding hospital and doctor visits, prescription drug use, and other information available for Medicare and Medicaid patients.  These data are being used to augment the NIH studies by enabling researchers to study determinants related to medical care access, quality, cost, and outcomes. Among the studies benefiting from this collaboration are endeavors sponsored by the National Heart, Lung, and Blood Institute, including the Cardiovascular Health Study, the Framingham Heart Study, the Jackson Heart Study (focused on the African American population), the Atherosclerosis Risk in Communities Study, the Multi-Ethnic Study of Atherosclerosis, and the Women’s Health Initiative. In addition, the NIH Clinical Center has a data-sharing agreement with the CMS for studies that could generate results that foster improvements in medical service quality, utilization, and effectiveness for Medicare and Medicaid beneficiaries.

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, 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 more than 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.

Controlling and predicting the spread of infectious diseases is another important aspect of public health. The NIH and CDC are working together on the Models of Infectious Disease Agent Study (MIDAS), a collaboration of research and informatics groups that are developing computational models of the interactions between infectious agents and their hosts, disease spread, prediction systems, and response strategies. As reported in one 2012 study, researchers funded through the MIDAS program adapted modern weather prediction techniques into a new computer model for local forecasts of seasonal flu.² These computational models should improve the public health workforce’s ability to understand and respond to outbreaks of infectious diseases.

Improving Health through Ensuring the Use of Effective Diagnostics and Treatments

In striving to provide the best options in medical care, 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 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 Best Pharmaceuticals for Children Act (enacted in 2002, reauthorized in 2007, and made permanent by The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)) directs the Secretary of HHS, acting through the Director of the NIH, to establish a program for pediatric drug development. The goal of the Best Pharmaceuticals for Children Act (BPCA) Program (http://bpca.nichd.nih.gov/) is to improve pediatric therapeutics through preclinical and clinical drug trials that lead to drug labeling changes by the FDA.  The NIH prioritizes drugs and therapeutics in need of study, sponsors the necessary pediatric clinical trials, and submits data to the FDA for labeling change. More than 20 NIH Institutes provide funding for these studies, and the NIH and FDA work collaboratively on study design teams. Clinical trials in the BPCA Program are now being designed and conducted through the BPCA Pediatric Trials Network, awarded to Duke University in September 2010.

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. To date, the Consortium has launched 10 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.

The NIH often collaborates with other HHS agencies to inform best practices and provide evidence-based information to health care providers, activities that are critical to improving the quality, safety, efficiency, and effectiveness of health care. Since 1997, several HHS agencies including the NIH, CDC, AHRQ, and HRSA have participated in the Partners in Information Access for the Public Health Workforce (Partners), a collaboration of U.S. government agencies, public health organizations, and health sciences libraries to provide timely, convenient access to public health resources on the Internet.  Partners enables the public health workforce to find and use evidence-based information effectively to improve and protect the public's health. In related efforts, the HHS Office of the National Coordinator for Health Information Technology (ONC) is spearheading the use of health IT, including the use of electronic health records (EHRs) instead of paper medical records, to enable health care providers to better manage patient care through secure use and sharing of health information. The NIH, AHRQ, CDC, HRSA, and IHS have contributed to the development of the ONC’s Clinical Decision Support (CDS) system through participation in the CDS Federal Collaboratory, a federal community of interest formed in 2008. The CDS provides a variety of health IT tools to enhance decision-making in the clinical workflow. These tools include computerized alerts and reminders to care providers and patients, clinical guidelines, focused patient data reports, documentation templates, diagnostic support, and relevant medical reference information, among other tools.

Accelerating the dissemination of research-based treatment into clinical practice is a priority for HHS and is the core mission of a partnership between the NIH and SAMHSA, known as the Blending Initiative. The NIH and 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 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 NIH’s National Institute on Drug Abuse (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).

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 with its partner 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 heart attacks and strokes, asthma, HIV/AIDS, smoking, underage drinking, and a range of other harmful health effects and behaviors, including the following highlighted collaborations.

Stemming the rising rates of diabetes, the 7^th leading cause of death in the United States, is a major public health goal. Diabetes is a debilitating disease that lowers average life expectancy by up to 15 years and affects an estimated 25.8 million people in the United States—or 8.3 percent of the total population—including an estimated 7 million people who remain undiagnosed. Type 2 diabetes, which accounts for more than 90 percent of diabetes among adults, often can be averted or delayed by lifestyle factors. The NIH continues to support the Diabetes Prevention Program, started in 1994, with an investment of $8.9 million in FY 2012.  This long-term outcomes study, in collaboration with the IHS and CDC, has shown that diet and exercise or the diabetes medication, metformin, can delay the onset of diabetes by 10 years.

A major contributor to increasing diabetes rates, more than 33 percent of children and adolescents in the United States are overweight or obese.  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 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 mission is to improve the efficiency, effectiveness, and application of childhood obesity research in an effort to halt—and reverse—childhood obesity through enhanced coordination and collaboration. 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 $27 million 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 36,000 Americans die by suicide each year. 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, and NIH; the Surgeon General; the Assistant Secretary for Health; and the SAMHSA), the Action Alliance formed an expert task force to revise and update a national strategy and released the 2012 National Strategy for Suicide Prevention: Goals and Objectives for Action. The Action Alliance has selected four priorities that, when accomplished, will help the group reach its goal of saving 20,000 lives in the next five years: 1) Integrate suicide prevention into health care reform and encourage the adoption of similar measures in the private sector; 2) Transform health care systems to significantly reduce suicide; 3) Change the public conversation around suicide and suicide prevention; and 4) Increase the quality, timeliness, and usefulness of surveillance data regarding suicidal behaviors.  The NIH, through its contributions to the Action Alliance’s Research Task Force, seeks to identify and fund research with the potential to prevent suicide attempts and deaths.

Empowering Americans with 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, eye health, bullying, and nutrition and exercise in children. A few other notable public health campaigns and information portals are highlighted below.

AIDSinfo, a service of HHS, 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. 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.

Go4Life, an exercise and physical activity campaign led by the NIH’s National Institute on Aging in partnership with the ACL, AHRQ, and CDC, the Surgeon General, and the 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 an evidence-based exercise guide in both English and Spanish, an exercise video, an interactive website, and national outreach activities.

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 government 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. The Forum's 2012 report, America's Children in Brief: Key National Indicators of Well-Being, 2012, provides a summary of national indicators of child well-being and monitors changes in these indicators over time. In addition to providing data in an easy-to-use, non-technical 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.

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, for example, that medical products are safe and effective, that emerging health and biosecurity threats can be identified and addressed swiftly, and that scientific information is used in responsible ways.

One biosecurity issue of growing importance is dual use research of concern (DURC)—that is, life sciences research that generates products, information, or technologies that can be applied for both helpful and harmful purposes, potentially posing a significant biologic threat to public health and/or 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 this and other emerging DURC issues, HHS – including the OS, CDC, FDA, and NIH – has been working actively with interagency partners toward the development of a comprehensive federal policy for DURC oversight. Recommendations and input from federal advisory bodies including the National Science Advisory Board for Biosecurity (NSABB) and the NIH Recombinant DNA Advisory Committee, both 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 March 2012, a new U.S. Government policy was issued, requiring federal funding agencies to review their research portfolios to identify those projects that constitute dual use research of concern and to ensure that appropriate risk mitigation measures have been implemented. In addition, a new HHS Framework for addressing specific concerns about research on HPAI H5N1 viruses was published in February 2013, outlining a robust review process for research proposals involving HPAI H5N1 viruses with certain specified characteristics. The multidisciplinary review called for by this Framework takes into account the scientific and public health benefits, the biosafety and biosecurity risks, and the appropriate risk mitigation measures pertinent to the proposed research. HHS developed the Framework with extensive public consultation, including an open meeting of the NSABB, a public international consultative workshop, and a solicitation of written public commentary.

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 Countermeasure 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.

To further facilitate these efforts, a trans-NIH program, Countermeasures Against Chemical Threats (CounterACT), has been developed to support basic, translational, and clinical research aimed at the discovery and identification of better therapeutic medical countermeasures or diagnostic technologies against chemical threat agents such as sarin, cyanide, and botulinum toxin. CounterACT facilitates the movement of these medical countermeasures through the regulatory process in collaboration with other federal departments and agencies, such as the Biomedical Advanced Research and Development Authority (HHS BARDA), to enable a more rapid and effective response during a chemical emergency. In addition, the NIH contributes to Chemical Hazards Emergency Medical Management (CHEMM), a web resource for planning for and response to mass-casualty incidents involving chemicals. This effort, coordinated by the HHS Office of the Assistant Secretary for Preparedness and Response, also includes content from the CDC, the NIH, and the Department of Defense. The site includes general emergency response guidelines, first responder safety information, decontamination procedures, medical management guidance, and general chemical classification information.

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 Environmental Protection Agency (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 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 FDA plan to apply the knowledge gained to the products they regulate.

The NIH also collaborates across the Department on issues of patient safety, helping to minimize the occurrence of adverse medical events. For example, the HHS Safety Reporting Portal (SRP) streamlines the process of reporting product safety issues to the FDA and NIH. This portal represents one of the initiatives of the Federal Adverse Events Task Force, which includes representatives from the AHRQ, CDC, FDA, NIH, and HHS’s Office of Human Research Protection. The Safety Reporting Portal has established greater harmonization among federal agencies for the reporting of adverse events and product problems.  Certain researchers, food manufacturers, and drug manufacturers are required by law to submit safety reports through the portal. Furthermore, the Web-based system enables anyone with Internet access the ability to report a safety concern about a medical product, as well as foods, cosmetics, animal feed, and veterinary products.

Strategic Interagency Planning to Improve Public Health

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. The 5-year HHS Strategic Plan described above and the intergovernmental 10-year agenda for improving the nation’s health, Healthy People 2020, are prime examples of strategic planning endeavors which outline pathways to achieve broad health-related objectives. Other important cross-agency strategic planning activities are focused on achieving better outcomes for 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 to coordinate broad planning efforts that cut across the entire Department.

A recent area of focused trans-HHS planning is the interagency effort to implement the National Alzheimer’s Project Act (NAPA), which President Obama signed into law in January 2011. The Advisory Council on Alzheimer’s Research, Care, and Services is working to carry out NAPA's charge to coordinate research and services across agencies, accelerate the development of treatments for Alzheimer’s disease and related dementias, improve early diagnosis and coordination of care, reduce ethnic and racial disparities in rates of Alzheimer’s disease and related dementias, and 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 May 2012, the Advisory Council and the Secretary of HHS released the National Plan to Address Alzheimer’s Disease, establishing five ambitious goals that broadly span the various missions of HHS agencies both to prevent future cases of Alzheimer's disease and to better meet the needs of the millions of American families currently facing this disease:

• Prevent and Effectively Treat Alzheimer's Disease by 2025
• Optimize Care Quality and Efficiency
• Expand Supports for People with Alzheimer's Disease and Their Families
• Enhance Public Awareness and Engagement
• Track Progress and Drive Improvement

In concert with the HHS Initiative on Multiple Chronic Conditions, the NIH has been partnering 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 to identify options for improving the health of this population. The work group, in conjunction with other stakeholders, developed 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 2012, the NIH and other HHS agencies co-sponsored multiple expert meetings to discuss promising science related to treating and managing patients with multiple chronic conditions and to identify gaps in current knowledge.  For example, the AHRQ and the NIH’s National Institute on Aging co-sponsored an expert panel meeting to assess the current state of available health measures for individuals with multiple chronic conditions and to foster the development or refinement of additional promising outcome measures.

The Interagency Autism Coordinating Committee is another example of both interagency and interdepartmental collaboration in strategic planning and cooperation. This group coordinates all efforts within HHS concerning autism by developing a Strategic Plan for Autism Spectrum Disorder Research and advising the HHS Secretary on issues related to autism.  Membership of the Committee includes the directors of five NIH Institutes, six other HHS agencies (ACL, AHRQ, CMS, CDC, FDA, and HRSA), the Department of Education, and the DoD, as well as a number of public stakeholders to ensure that a variety of perspectives from within the autism community are considered in the Committee’s strategic planning and coordination efforts. The exchange of information between agencies and the public facilitated by the IACC has catalyzed several endeavors to benefit those with autism and their families. In 2012, the IACC consulted more than 40 experts in autism diagnosis, biology, etiology, treatment, lifespan, and services research fields to inform its update of the strategic research plan. The IACC also released a portfolio analysis that collected information from both public and private funders to chart the current autism research investment landscape to inform implementation of the plan.

In response to the 2012 White House Executive Order, Improving Access to Mental Health Services for Veterans, Service Members, and Military Families, the NIH has been working closely across HHS and with the Departments of Defense and Education to develop a National Research Action Plan on post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI). The NIH participates in a Post-traumatic Stress Disorder (PTSD)/Trauma 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, the CDC, HRSA, SAMHSA, and OS, and the Departments of Defense, Education, and Veterans Affairs are developing the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System, which will serve as a central repository for new data, link to current databases, and allow valid comparison of results across studies. The FITBIR Informatics System has the potential to facilitate collaboration between laboratories and accelerate research progress against this major medical problem.

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] Funding levels reported in the fiscal year 2012 Intra-Agency Collaborations Reporting System (CRS) may not be consistent with funding levels 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 process, implemented in 2008 through the RCDC system, 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 research category levels represent the NIH’s best estimates based on the category definitions.

[2] Shaman J, Karspeck A. Forecasting seasonal outbreaks of influenza. Proc Natl Acad Sci U S A. 2012 Dec 11;109(50):20425-30. doi: 10.1073/pnas.1208772109. Epub 2012 Nov 26. PubMed PMID: 23184969; PubMed Central PMCID: PMC3528592.