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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 2015
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Summary
Introduction
“Teamwork is the ability to work together toward a common vision. The ability to direct individual accomplishments toward organizational objectives. It is the fuel that allows common people to attain uncommon results.” - Andrew Carnegie
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). Tasked with improving the health of the American public, HHS consists of many agencies and divisions, and synergy between these different components 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 ninth report to the Secretary, covers fiscal year 2015.
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. 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 their knowledge and diverse expertise to accomplish their collective mission. Such cross-agency teamwork 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, NIH has been charged with improving health through research. As the largest research arm of HHS, 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.” 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 NIH with all other components of HHS, including the
staff divisions within the Office of the Secretary (OS)
1
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 2015 Collaboration Themes
NIH and other HHS operating and staff divisions collaborated on 624 activities in FY 2015. These numerous examples of cross-agency collaboration demonstrate the broad spectrum of health efforts that 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 2015 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 2015 Collaborative Activities by the Numbers
In FY 2015, NIH collaborated with other HHS entities on 624 activities.
The Complete List of Activities
provides a comprehensive list of all reported activities. Over 50 new collaborations were reported in FY 2015 across a range of issues, including activities devoted to emerging infectious diseases, pediatric clinical trials, aging, and mental illness. The full details for each activity, including a brief description, the year the collaboration originated, 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 (274 activities); Research Initiative (132); Resource Development, e.g., developing databases, disease registries, and information clearinghouses (69); Meeting/Workshop (54); Public Education Campaign (28); Health Survey (24); Training Initiative (11); or Other (32).
Chart 2
displays the number of collaborative activities that NIH engaged in with each HHS operating or staff division.
2
As Chart 2 illustrates, the majority of NIH’s collaborations were with the CDC (398), the FDA (269), and the OS (165). Given the complementary missions of the CDC, FDA, and NIH, the three agencies often work closely together to build on each other’s strengths and achieve shared objectives. While 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 NIH and the OS, especially in the coordination of multi-agency initiatives, committees, and working groups.
FY 2015 Collaboration Highlights by Thematic Area
The following summary illustrates how 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 strengthen the HHS ecosystem, helping to foster a healthier country and healthier world.
Theme 1: Assessing the Public’s Health
An understanding of the state of the population’s health is critical for the Department to set priorities regarding current and emerging public health needs, and for NIH to refine its strategic research priorities. Cross-agency cooperation takes advantage of the knowledge and resources throughout HHS to define the scope of public health issues and enable better tracking of health outcomes, disease, and disability. NIH partners with other HHS agencies to collect and use data on disease prevalence as well as to understand the factors that influence health within and across various parts of the population. 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 behaviors
. 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 ongoing 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. 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, 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 of intra-Departmental surveillance efforts focusing on specific diseases and health challenges. For example, 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 is following about 46,000 Americans, ages 12 years and older, for at least three years to 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, the National Mental Health Field Study Test, a joint NIH-SAMHSA project begun in 2015, aims to develop a test that can be used to study the prevalence and patterns of specific mental disorders in the U.S.
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 and complications of diabetes, and how it affects the lives of young people. More than 20,000 participants in the study have helped determine the extent and impact of diabetes on different populations in the U.S. To enable better tracking of sudden and unexpected death in the young, NIH and CDC launched the
Sudden Death in the Young Registry
in 2013 for cases of sudden death in people under age 24, including sudden cardiac death and sudden unexpected death in epilepsy. The registry, jointly funded by CDC and NIH, is an expansion of the CDC's Sudden Unexpected Infant Death Case Registry, and 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.
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 includes nearly 90,000 participants in Iowa and North Carolina, and 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. To improve the assessment of public health impacts due to multiple chemical exposures, NIH has partnered with the Agency for Toxic Substances & Disease Registry (ATSDR) to produce a Guidance Manual for Assessing Health Impacts of Multiple Chemicals and Other Stressors. This manual is an updated revision of ATSDR’s 2004
Guidance Manual for the Assessment of Joint Toxic Action of Chemical Mixtures
, and is particularly important for understanding health impacts to individuals living near hazardous waste sites, as determining the health effects of multiple exposures can be much more complex than measuring those due to a single hazardous substance.
Theme 2: Improving Diagnosis and Treatment through Research
In striving to provide the best options in medical care and health practice, NIH works across the Department to help develop new, more effective ways to diagnose and treat disease and promote good health. 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.
Public health crises can require cooperation between many organizations to coordinate a response, and afterward, they represent an opportunity for these groups to come together to evaluate the challenges and successes, and to implement the lessons learned. One lesson that emerged from the Ebola virus epidemic was the need for a system to quickly test investigational products, sometimes with limited resources, during this type of crisis. The NIH’s National Institute of Allergy and Infectious Diseases (NIAID), FDA, CDC, and the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), held the 2015
Clinical Trial Designs for Emerging Infectious Diseases
workshop to examine ethical and methodological considerations behind clinical trial design choices and discuss options for clinical trials of vaccines and therapies under different circumstances. This information can improve preparedness for future infectious disease outbreaks.
NIH uses partnerships to leverage talents and resources to help address global pediatric health. In a new, 2015 collaboration between the non-profit Critical Path Institute, the FDA, and the NIH’s
Eunice Kennedy Shriver
National Institute of Child Health and Human Development (NICHD), NIH is helping to establish a new framework for pediatric clinical trials around the world. The
Critical Path Institute (C-Path) Global Pediatrics Trials Consortium
involves clinicians, academics, patient advocates, regulators, and others working to create an independent, non-profit global pediatric trials network. The goal of this project is “to facilitate the development of innovative and quality medicines according to the highest ethical and scientific standards to help extend and enhance the lives of infants, children, and adolescents.”
3
The ACL and NIH’s National Institute on Aging (NIA) have partnered in recent years to address their complementary goals to improve the health and well-being of older Americans. A joint research initiative,
Translational Research to Help Older Adults Maintain their Health and Independence in the Community
, supports translational research aimed at developing new interventions, programs, policies, practices, and tools that can be used by community-based organizations to help elderly individuals remain healthy and independent. Additionally, a working group of NIH and ACL staff meet regularly to identify evidence-based interventions that are ready for dissemination and implementation, to work more collaboratively on their translation into the community, and to explore strategies for evaluating these efforts. Current areas of interest 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.
Improving fetal and neonatal health through medical care and health practice is a core mission of the
Committee on the Fetus and Newborn
(COFN), established in 1937. The COFN studies issues and current advances in fetal and neonatal care, makes recommendations regarding neonatal practice, and collaborates with the American College of Obstetricians and Gynecologists (ACOG) to consider perinatal issues and develop new editions of Guidelines for Perinatal Care. NICHD and CDC participate in the COFN, which has studied and issued a number of recommendations to improve care that have reduced neonatal mortality and morbidity. 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. For example, hemoglobin A1C is used as a biomarker of blood sugar control in diabetics, and cholesterol measurements can predict the risk of stroke and coronary heart disease. However, many diseases lack reliable biomarkers for assessing disease status and response to treatment. The Biomarkers Consortium, with NIH, FDA, CMS, and private sector members: the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO), is helping create a new era of personalized medicine. Their 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 2015, the Consortium has launched more than 18 projects in areas as diverse as Alzheimer’s disease, cardiovascular disease, diabetes, and breast cancer.
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, and coordinating efforts across HHS is central to the success of national prevention strategies. 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
heart attacks and strokes
,
asthma
,
smoking
,
underage drinking
, along with many others, including the following highlighted collaborations.
To coordinate prevention research in areas with methodological challenges, NIH’s Office of Disease Prevention (ODP) and AHRQ have partnered on the
Pathways to Prevention (P2P) program
. The P2P program hosts workshops on selected topics to identify research gaps, address scientific weaknesses, suggest research needs, and move the field forward through evidence-based assessment. Workshop topics in 2014 and 2015 included
The Role of Opioids in the Treatment of Chronic Pain
,
Advancing the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
, and
Total Worker Health
.
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, and helps to ensure a unified strategic approach to combating the epidemic. HHS agencies work together to assist in developing research and evaluation priorities for PEPFAR, to conduct HIV/AIDS research through CDC, FDA, HRSA, NIH, and SAMHSA, and to help implement effective prevention, treatment, and care programs in developing countries. 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.
4
Diabetes is a debilitating disease that affects an estimated 12-14 percent of adults in the U.S.
5
Type 2 diabetes, which accounts for more than 90 percent of diabetes among adults, often can be averted or delayed by lifestyle factors. NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), in collaboration with 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.
6
To address this childhood obesity epidemic, NIH and CDC, along with the U.S. Department of Agriculture (USDA) and the Robert Wood Johnson Foundation (RWJF), have 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. 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.
Theme 4: Providing Evidence-Based Health Information
The biomedical and behavioral research that 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 and empower individuals to make informed personal decisions about their health. To this end, 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.
Together with CDC and CMS, NIH’s National Institute of Neurological Disorders and Stroke (NINDS) began the
Mind Your Risks
campaign in 2015 to educate the public about the risks of high blood pressure. While many Americans are aware that high blood pressure increases the risk of heart attack or stroke, emerging evidence is also linking uncontrolled blood pressure to cognitive impairment and dementia later in life.
Mind Your Risks
provides information about this research, links to resources, and encourages individuals to take steps to manage their risks by controlling high blood pressure, quitting smoking, lowering high cholesterol, eating healthy, and keeping active.
Every five years, HHS and the USDA update the Dietary Guidelines for Americans. These recommendations for individuals aged two years and over provide the basis for federal food and nutrition policy and education initiatives, and encourage Americans to focus on eating a diet that helps achieve and maintain a healthy weight, promotes health, and prevents disease. The guidelines are based on a rigorous review of scientific evidence by the Dietary Guidelines Advisory Committee (DGAC), which consists of nationally recognized experts in the field of nutrition and chronic disease prevention. HHS’s Office of Disease Prevention and Health Promotion provided administrative leadership for the 2015 edition with strong support from the USDA’s Center for Nutrition Policy and Promotion.
The 2015 DGAC
held seven meetings, and NIH, CDC, and FDA supported the DGAC throughout the revision process for the 2015-2020 edition of the
Dietary Guidelines for Americans
, released in December 2015.
NIDDK also partners with 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, 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.
To help older individuals fit exercise and physical activity into their daily lives, the campaign
Go4Life
is led by NIH’s NIA, in partnership with ACL, AHRQ, CDC, and OS. 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 CDC, HRSA, and NIH’s Office of AIDS Research (OAR), NIH’s 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.
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 HHS and other federal partners, 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.
To improve surveillance of disease-causing bacteria and foodborne disease, NIH, in collaboration with CDC and FDA, began the
Pathogen Detection Project
in 2015. This system, hosted by NIH’s National Center for Biotechnology Information (NCBI), integrates genetic sequence data for bacterial pathogens found in food, the environment, and human patients. Currently focused on sequencing and analyzing genetic material from four bacteria groups that cause foodborne illness in the U.S.– Salmonella, Listeria, Campylobacter, and Escherichia coli and Shigella – the goal of this project is to uncover potential sources of contamination and assist with investigations and outbreak responses.
Enhancing biosafety and biosecurity in health science research is a high priority and requires close collaboration between federal departments and agencies. The HHS Biosafety and Biosecurity Council – composed of OS, NIH, CDC, FDA, and other HHS representatives – advises the HHS Secretary and senior Department leadership, fosters intradepartmental coordination and collaboration, and recommends Department-wide policy on biosafety and biosecurity matters. HHS in turn has been working actively with interagency partners toward the development and implementation of comprehensive federal policies that support vital research and manage potential risks. The
National Science Advisory Board for Biosecurity (NSABB)
, managed by NIH; the Intragovernmental Select Agents and Toxins Technical Advisory Committee (ISATTAC), managed by CDC; and the Federal Experts Security Advisory Panel (FESAP), co-chaired by HHS, are helping to inform federal biosafety and biosecurity policies on various issues, including
dual use research of concern (DURC)
and gain-of-function research of concern (GOFROC). DURC is research that has the potential to yield 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. NIH is managing a
deliberative process
on behalf of the U.S. government that will inform federal policy development on the funding and oversight of GOFROC—a subset of DURC studies which have the potential to generate pathogens with the potential to cause pandemic disease.
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 focused on achieving specific and measurable steps toward preventing epidemics, detecting biological threats early, and rapidly responding to disease outbreaks. NIH’s NIAID and NINDS worked alongside 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 chemical, biological and 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), 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. Recognizing the value in conducting research during disasters to better inform planning for future incidents, NIH developed the Disaster Research Response Program. Administered by NIH, the program coordinates efforts of ASTDR, CDC, FDA, and OS 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. 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 is a federal collaboration involving NIH, FDA, and EPA aimed at developing better ways to quickly and efficiently test whether certain chemical compounds have the potential to lead to adverse health effects, using a high-throughput robotic screening system of cellular and biochemical assays. The Tox21 program is co-funded and co-administered by EPA’s National Center for Computational Toxicology and the National Toxicology Program (NTP), an interagency program supported by NIH, FDA, and EPA. These groups are collaborating on a variety of
Tox21 projects
, including the development of assessments for estrogen and androgen activity, and an evaluation of the potential for the Tox21 system to reduce the use of animals for acute oral toxicity testing.
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. The five-year HHS Strategic Plan described above and the interdepartmental 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 NIH works with other HHS agencies and other federal departments to coordinate broad planning efforts.
As the American population ages, it is increasingly important to promote policies that improve care coordination and facilitate community integration for the elderly and those with disabilities. Toward this goal, NIH, ACL, CMS, and FDA contributed to the workshop,
Policy and Research Needs to Maximize Independence and Support Community Living
on October 6, 2015, at The National Academies of Sciences, Engineering, and Medicine. Held by the
Forum on Aging, Disability, and Independence
, the meeting brought together experts in the field to discuss research and policy gaps, explore ways to address financial and workforce needs, and promote community services and technologies to support independence and community participation for this population. Previously, this forum held a workshop on
The Personal Care Workforce
, and another was held on June 27, 2016, on
Strengthening the Workforce to Support Community Living and Participation for Older Adults and People with Disabilities
.
A new collaboration in 2015 across all HHS agencies addresses the needs of individuals with serious mental illness and those at high risk for developing it. The HHS Secretary’s Initiative on Serious Mental Illness has three main goals: promoting early engagement in care to reduce the duration of untreated serious mental illness; improving the quality of this care through stronger measurement and accountability; and increasing access to community-based treatment and support services.
To support the
HHS Initiative on Multiple Chronic Conditions
, NIH partners across the Department to improve the health of individuals who have multiple chronic conditions. Recognizing the impact of multiple chronic conditions on patients, caregivers, and the health care system, the Assistant Secretary for Health convened an HHS-wide work group on Multiple Chronic Conditions (MCC). In 2010, the work group, along with other stakeholders, developed the
Multiple Chronic Conditions: A Strategic Framework
, which serves as a national-level roadmap for improving the health of individuals with multiple chronic conditions. In 2014, 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 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, 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). The Advisory Council and the Secretary of HHS update the
National Plan to Address Alzheimer’s Disease
yearly, to reflect national progress towards accomplishing the goals set forth initially, as well as new and revised action steps.
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 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.
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 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]
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).
[2]
Individual collaborative activities can involve multiple HHS agencies. Therefore, the values displayed in Chart 2 reflect duplicate counts and add up to more than the total reported sums.
[3]
http://c-path.org/critical-path-institute-establishes-the-global-pediatric-clinical-trials-network-pre-launch-consortium/
.
[4]
National Diabetes Information Clearinghouse,
National Diabetes Statistics Report, 2014
.
http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf
.
[5]
Prevalence of and Trends in Diabetes Among Adults in the United States, 1988-2012. Menke A et al.
JAMA
. (2015)
http://www.ncbi.nlm.nih.gov/pubmed/26348752
[6]
CDC, Childhood Obesity Fact, Prevalence of Childhood Obesity in the United States, 2011-2012. Available at
http://www.cdc.gov/obesity/data/childhood.html
.
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