Strategic Goal 2: Advance Scientific Knowledge and Innovation

Objective A:  Accelerate the process of scientific discovery to improve health

Objective B:  Foster and apply innovative solutions to health, public health, and human services challenges

Objective C:  Advance the regulatory sciences to enhance food safety, improve medical product development, and support tobacco regulation

Objective D:  Increase our understanding of what works in public health and human services practice

Objective E:  Improve laboratory, surveillance, and epidemiology capacity

Americans are living longer, healthier lives, thanks to significant advances in research. Life expectancy is at a record high of 78.7 years.  Mortality rates in the United States have experienced an almost uninterrupted decline since 1960.  However, rates of gain are inconsistent between genders and across age brackets, socioeconomic status, and racial and ethnic groups.  HHS’s health and human services systems continue to face many challenges, from providing access to quality health care for all Americans, to reducing the burden of illness and disease, to protecting the population from public health threats, to strengthening the social service safety net.

HHS is developing innovative, knowledge-based approaches to address these challenges — expanding its scientific understanding of how to advance health care, public health, human services, biomedical research, and the availability of safe medical and food products.  HHS is conducting rigorous evaluations of new approaches that reward efficiency, effectiveness, and sustainability.  HHS conducts epidemiological surveillance and population-level data collection and analysis to improve measurement of risk factors for and occurrence of injury, infectious disease, and chronic conditions, including multiple chronic conditions, a leading driver of health care expenditures.

HHS focuses on promising strategies with the potential to yield positive results from public investments, including using technology to improve collaboration, modernizing the regulatory approval process, and expanding behavioral research.  In addition, HHS is working to promote service integration and delivery, community-based approaches, and collaboration with the private sector to advance scientific knowledge.

HHS monitors progress on its efforts to advance scientific knowledge and implement innovative practices.  HHS evaluates regulatory science, science management, and the safety risks and ethical, legal, and societal implications of new technologies.  HHS uses internal and external evaluation data to determine how best to increase the pace of science and its ultimate use in practice.  For example, an evaluation of U.S. Preventive Services Task Force recommendations identified complex and interrelated factors that affect the delivery and integration of clinical preventive services.  HHS leverages its research investments to guide the transformation of clinical and translational science programs to reduce the time needed for laboratory discoveries to become treatments for patients.  HHS also uses evaluation findings to advance patient care, for example, by determining the effectiveness of health information sites geared toward particular populations of interest and the providers who serve them.

In addition to its communication efforts, HHS works with many partners to bring the rich evidence base of biomedical and behavioral research into clinical and community practice, both in terms of treatment and prevention and in policymaking that affects public health.  Research supported by HHS is not only yielding many benefits right now, but it will also have a long-term impact on the future of our nation’s health, economy, and communities.

Within HHS, the Administration for Children and Families (ACF), Administration for Community Living (ACL), Agency for Healthcare Research and Quality (AHRQ), Office of the Assistant Secretary for Planning and Evaluation (ASPE), Office of the Assistant Secretary for Preparedness and Response (ASPR), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), National Institutes of Health (NIH), Office of the Assistant Secretary for Health (OASH), Office of the National Coordinator for Health Information Technology (ONC), and Substance Abuse and Mental Health Services Administration (SAMHSA) work both independently and collaboratively to use research and development resources to improve health care, public health, and human services. These agencies sustain and contribute to a full spectrum of scientific research and development activities.

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Objective A:  Accelerate the process of scientific discovery to improve health

Medical breakthroughs, fueled by scientific discovery, have made the difference between life and death for countless Americans.  Nevertheless, the need for better health interventions remains.  Continuing to improve the health and well-being of Americans requires HHS investments, ranging from improving its understanding of fundamental biological processes to identifying the best modes of prevention and treatment.  HHS investments have improved the health of many Americans, but the path from basic discovery into safe, effective patient care can be long.

Within HHS, NIH pursues its mission to seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance health, lengthen life, and reduce illness and disability by conducting and supporting biomedical and behavioral research across a broad spectrum of scientific disciplines and approaches.  NIH research has made possible many important advances in fundamental knowledge.

HHS investments in basic biomedical and behavioral research make it possible to more accurately characterize the causes of disease onset and progression, design preventive interventions, develop better diagnostic tests, and discover new treatments and cures.  From the incremental advances in the understanding of a given disease to the groundbreaking discoveries that revolutionize approaches for treating or preventing it, investments in basic research have yielded inestimable rewards and benefits to public health.

Just as important as basic biomedical research is the translation of basic biological discoveries into clinical applications that can benefit all.  Translational research is a complex process that involves a series of intricate steps.  These steps range from the discovery of basic information about the causes of disease; to an assessment of whether that information has the potential to lead to a clinical advance; to the development and optimization of therapeutics to test in human trials; and, ultimately, to the application of the approved therapy, device, or diagnostic in the real world.  As an important part of its mission, HHS engages in a broad-based effort to ensure that scientific findings are communicated rapidly and clearly to the public.

The Department has identified several leverage points to accelerate movement along the pipeline from scientific discovery to more effective patient care.  HHS is balancing support for large-scale efforts and smaller investigator-initiated projects, building a strong scientific workforce through career training, and investing in technologies and information systems needed for comprehensive research approaches.  HHS provides researchers with access to financial and technical resources to conduct early-stage drug development for promising new therapies.  HHS also supports research that is tied to clinical practice, considering the influence of payment systems and the delivery of services.  Patient-centered outcome research activities help enhance the evidence base for the best preventive, screening, diagnostic, and treatment services.  Additionally, HHS is expanding upon opportunities for patient-centered outcomes research by building a data infrastructure to support research activities.

Finally, HHS will continue to support ethical and responsible research practices, including ensuring the protection of the humans and animals participating in health research. HHS is committed to promoting integrity in research programs and to ensuring that truthful, valid research is conducted.

Within HHS, ASPE, ASPR, CDC, NIH, and OASH will have roles in implementing the following strategies to achieve this objective.

Strategies

• Expand the knowledge base in biomedical, behavioral, and implementation science by investing in fundamental and service system research, human capital development, and scientific information systems;
• Support promising biomedical and public health research to save lives, reduce the burden of individual and multiple chronic conditions , and identify new, more effective prevention and treatment strategies;
• Expedite the development of breakthrough therapies intended to treat serious and life-threatening diseases or conditions;
• Support research that will increase our understanding of the health and health status of population subgroups such as racial and ethnic minorities, persons with disabilities, the reentry population, rural populations, and lesbian, gay, bisexual, and transgender (LGBT) populations;
• Support research efforts to improve the identification of and response to differences in efficacy of pharmaceutical and other care and treatment for underrepresented populations;
• Increase the external validity of intervention trials by ensuring that older adults and individuals with multiple chronic conditions are not unnecessarily excluded;
• Provide training and other resources that facilitate the translation of basic laboratory discoveries into practice improvements;
• Foster and establish the necessary collaboration of government and private sector research activities to achieve fastest-possible discovery and promote translation of research into practice;
• Identify critical gaps in knowledge of health care-associated infections, and implement prevention research to fill these gaps;
• Develop evidence-based infection prevention guidelines that provide the scientific foundation for interventions for prevention of health care-associated infections;
• Assist in developing the research capacity of individuals and institutes from diverse backgrounds, such as the Native American Research Centers for Health; tribal, and urban Indian epidemiology programs; Historically Black Colleges and Universities; Hispanic-serving institutions; and tribal colleges and universities; and
• Leverage public-private collaborations to adapt translational research to meet the varying needs of diverse communities in culturally and linguistically appropriate ways.

Performance Goals

• Provide research training for predoctoral trainees and fellows that promotes greater retention and long-term success in research careers.
• Provide research training for postdoctoral fellows that promotes greater retention and long-term success in research careers.
• Identify two molecular-targeted therapies for disorders of the immune system in children.
• Identify and characterize two molecular pathways of potential clinical significance that may serve as the basis for discovering new medications for preventing and treating asthma exacerbations.
• Establish and evaluate a process to prioritize compounds that have not yet been adequately tested for more in-depth toxicological evaluation.
• Identify genetic factors that enhance or reduce the risk of development and progression of chronic obstructive pulmonary disease (COPD) and validate new genetic and clinical criteria that may be added to COPD classification and contribute to better and/or earlier diagnosis or prognosis of the disease.
• Complete pre-commercial development of a point-of-care technology targeted for use in primary care setting.
• Identify circuits within the brain that mediate reward for drugs, non-drug rewards such as food or palatable substances, and aversion to drug effects, and determine the degree of overlap between these circuits.

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Objective B:  Foster and apply innovative solutions to health, public health, and human services challenges

HHS investments in research and evaluation have yielded enormous benefit to Americans’ health and well-being.  We now know that early antiretroviral therapy in people infected with HIV can significantly lower the risk of transmitting HIV to others.  We have identified how to create antibodies that could potentially target any strain of influenza virus.  And we know that environmental changes implemented at home — like mattress covers and air filters — can help vulnerable children better manage their asthma.

We also know that it is essential to engage others in helping to develop and implement solutions to improve health and well-being.  To that end, HHS is utilizing open innovation strategies to enhance how it collaborates with federal, state, local, tribal, urban Indian, nongovernmental, and private sector partners to develop innovative responses to the range of health, public health, and human services challenges we face as a nation.  More effective sharing of health information can improve decision-making and can allow for improved and diagnostic choices for health care professionals and service recipients.

As the focus on information plays a larger role, it is expected that the programs of the Department will increasingly be knowledge engines for innovation in our broader economy.  As the Health Data Initiative has demonstrated, unleashing government resources can bring many unexplored opportunities for open innovation in the private sector.  At the most recent Health Datapalooza — a conference at which HHS showcases innovations developed through the use of health and human services data — participants witnessed the development of hundreds of new tools and platforms that use health data to improve public health and the delivery of health care.  The challenge competitions in which the Department has engaged are yet another promising example of how to define key problems and promote the crowdsourcing of solutions to bring about new innovations.

Through the Open Government initiative, HHS is promoting agency transparency, public participation, and public-private collaboration.  HHS is allowing the use of social media tools and strategies for more proactive engagement with the public.  This is leading to fundamental changes in the way HHS communicates, connects, and works with the public, allowing for new ways to gather input, feedback, and new types of solutions.  Information sharing has been another key theme throughout the Department’s efforts.  HHS has initiated a number of collaborative learning consortia, collaborative databases, and tools for information sharing to enhance the public, as well as internal capacities, to share information and knowledge.

For example, the Food and Drug Administration Safety and Innovation Act (P.L. 112-144) granted new authorities, reauthorized human drug and device user fees, and authorized new user fees for generic human drugs and products shown to be highly similar (also known as biosimilar) to or interchangeable with an FDA-approved biological product.  The new authorities are intended to increase the speed and predictability of medical product reviews, to better protect the drug supply chain, to reduce drug shortages, and to speed the review of more affordable versions of drugs that are essential to holding down health care costs.  HHS is working to expedite the development of “breakthrough therapies” that have preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies to treat serious or life-threatening diseases or conditions.

Within HHS, ACF, AHRQ, ASPE, ASPR, CDC, FDA, NIH, ONC, OCR, and SAMHSA will have roles in implementing the following strategies to achieve this objective.

Strategies

• Support the design and execution of innovative solutions, including through the use of challenge and prize competitions.  Explore new ways to engage communities and leverage public-private partnerships through innovative use of challenge competitions and authorities granted to HHS under the America Competes Reauthorization Act of 2010 (P.L.111-358);
• Further strengthen the Health Data Initiative by promoting a community of data users through strategically focused data liberation, appropriate dissemination of data, and data education to enhance the value of the data;
• Continue to enhance the HealthData.gov platform to facilitate access to our data, and work with the Health Data Consortium and internal health data leads to consider strategies for educating users about the data, as well as ways to enable and incentivize the data user marketplace;
• Develop and implement innovative approaches to address the complex global regulatory environment; improve surveillance, monitoring, analysis, and reporting; and help bring to market new drugs, diagnostics, and biologic products;
• Use public health data to identify emerging threats to patient and consumer safety;
• Explore ways to integrate health data into mobile health technologies and related social networking platforms to more effectively reach health care professionals, patients, families, and other members of the public; and
• Work closely with HHS agencies and stakeholders to work through the privacy and regulatory issues associated with use of these new technologies in health care and wellness settings.

Performance Goals

• Increase the number of opportunities for the public to co-create solutions through open innovation.
• Increase the number of innovative solutions developed across the Department in collaboration with the HHS IDEA Lab.

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Objective C:  Advance the regulatory sciences to enhance food safety, improve medical product development, and support tobacco regulation

Regulatory science is the development and use of the scientific tools, standards, and approaches necessary for the assessment of regulated products, such as medical products and foods, to determine safety, quality, and performance.  Without advances in regulatory science, promising therapies may be discarded during the development process simply for the lack of tools to recognize their potential.  Conversely, many dollars and years may be expended assessing a novel therapy that might be shown to be unsafe or ineffective at an earlier stage with better tools.

Biomedical, behavioral, and social sciences research will provide the scientific evidence needed to better inform HHS regulatory authorities.  These advances will benefit every American by increasing the accuracy and efficiency of regulatory review and by reducing adverse health events, drug development costs, and the time-to-market for new medical technologies.  Advances in regulatory science also can help to prevent foodborne illnesses, and when outbreaks of foodborne illness occur, can help to identify the source of contamination quickly and to limit the impact of the outbreak.  Regulatory science innovations will allow for faster access to new medical technologies that treat serious illnesses and improve quality of life.

The Family Smoking Prevention and Tobacco Control Act (P.L. 111-31) aims to reduce the morbidity and mortality from tobacco use, including the important goal of preventing children and youth from ever starting to use tobacco.  Within HHS, NIH and FDA have formed an interagency partnership to foster tobacco regulatory research, using NIH infrastructure for the solicitation, review, and management of research, and FDA resources, authority, and expertise in tobacco regulatory science.  CDC and FDA have formed an interagency partnership to enhance tobacco-related surveys in the United States and to conduct laboratory science.

Advancing regulatory science and innovation is an objective shared by a number of agencies within HHS.  FDA and NIH are collaborating on an initiative to fast-track medical innovation to the public.  As part of the effort, the agencies established an FDA-NIH Joint Leadership Council to spearhead collaborative work on important public health and regulatory issues.  The Council works together to ensure that regulatory considerations form an integral component of biomedical research planning and that the latest science is integrated into the regulatory review process.

Within HHS, ASPR, CDC, FDA, and NIH will have roles in implementing the following strategies to achieve this objective.

Strategies

• Ensure that HHS personnel have the scientific expertise to address new challenges presented by cutting-edge medical technologies, such as nanotechnologies;
• Develop improved methods for rapidly detecting, investigating, and stopping foodborne contaminants;
• Develop science-based standards for preventive controls for food and feed safety across the “farm to table” continuum;
• Develop an innovative e-learning system to improve the speed, efficiency, and effectiveness of training and best practice dissemination related to food safety efforts in areas such as restaurant inspection and environmental assessments of foodborne illness outbreaks;
• Promote the development of new antibacterial drugs to address foodborne pathogens of public health importance;
• Increase access to safe and effective medical products;
• Develop such strategies as changes in medication packaging to prevent medication overdoses in children in collaboration with public and private partners;
• Update medical product review standards, and provide new regulatory pathways for new medical technologies, including those intended for use during public health emergencies;
• Support comprehensive and efficient regulatory review of new medical treatments and devices and new tobacco products by using high standards of transparency and scientific integrity;
• Develop and disseminate tools that can help translate basic scientific discoveries into life-saving medicines, and reduce the time, complexity, and cost of medical product development;
• Support regulatory science to facilitate medical countermeasure development and regulatory review; and
• Expand regulatory science research to support tobacco product regulation.

Performance Goals

• Decrease the average number of days to serotype priority pathogens in food (screening only).
• Develop biomarkers to assist in characterizing an individual’s genetic profile to minimize adverse events and maximize therapeutic care.
• Complete review and action on original New Animal Drug Applications (NADAs) and reactivations of such applications received during the fiscal year.

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Objective D:  Increase our understanding of what works in public health and human services practice

Working together with its public and private partners, HHS is committed to improving the quality of public health and human services practice by conducting applied, translational, and operations research and evaluations.  HHS is committed to using data for decision-making, as well as taking responsibility to describe the results achieved.  HHS has identified and refined approaches that help people make healthy choices, assist communities as they work to improve the health and well-being of their residents, support safety and stability of individuals and families, and help children reach their full potential.  HHS also monitors and evaluates programs to assess efficiency and responsiveness and to ensure the effective use of information in strategic planning, program or policy decision-making, and performance improvement.  Many HHS agencies are strengthening their evidence-based decision-making; ACF, for example, developed an agency evaluation policy to confirm a commitment to conducting evaluations and to using evidence from evaluations to inform policy and practice.

HHS is committed to identifying and supporting evidence-based prevention strategies based on systematic reviews of the scientific literature and emerging research, such as those recommended by the Guide to Community Preventive Services, a compilation of the recommendations of the independent Community Preventive Services Task Force, as well as specific interventions and strategic plans to address priority health issues, such as mental health and substance abuse, HIV/AIDS, and viral hepatitis, such as those included in the National Registry of Evidence-based Programs and Practices, the National HIV/AIDS Strategy and the Action Plan for the Prevention, Care & Treatment of Viral Hepatitis .

Across HHS, agencies are collaborating with the national Aging Services Network to implement evidence-based prevention programs to help reduce the risk of disease, disability, and injury among the elderly; disseminating information on best or promising practices, including 19 practice models for diabetes, models on health promotion, disease prevention, and injury prevention, and Web-based toolkits on implementing evidence-based practices with fidelity; using results of rigorous evaluations to design program improvement strategies for social service programs; and strengthening oral health research to clarify the interrelationships between oral disease and other medical diseases.

By prioritizing funding for evidence-based programs, and by developing directories of evidence-based programs, implementation toolkits, and other resources, HHS promotes the adoption of these strategies and provides the information the public needs to implement these programs and practices successfully.  Some human services programs, such as teen pregnancy prevention and home visiting programs, have identified evidence-based programs and incorporate requirements for the use of evidence-based programs for grantees.  As the chair of the Interagency Coordinating Committee on the Prevention of Underage Drinking (ICCPUD), HHS works with agencies across government to increase emphasis on and knowledge about evidence-based practices in the field of underage drinking.

HHS investments in public health and human services research have yielded many important findings about what works. HHS is working to identify and disseminate promising, effective approaches that are culturally competent and effective for populations with varying circumstances and needs.

Within HHS, ACF, ACL, AHRQ, CDC, HRSA, NIH, OASH, and SAMHSA will have roles in implementing the following strategies to achieve this objective.

Strategies

• Promote rigor, relevance, transparency, independence, and ethics in support of evaluation of existing programs and services research, and incorporate program evaluation efforts into program implementation and future policy direction;
• Support and train researchers, including those from diverse backgrounds, and provide communities with tools to adapt research and evaluation techniques to their own circumstances, to evaluate programs and practices, and to conduct systematic reviews more effectively; 
• Promote the replication of evidence-based programs and practices, and help public health and human services programs to implement evidence-based strategies, while continuing to fund and test innovative approaches to expand the evidence base, such as teen pregnancy prevention, home visiting, and chronic disease self-management initiatives;
• Promote and advance the development of research and evidence-based interventions that will help protect individuals across the life span from abuse, including physical, mental, emotional, and financial abuse;
• Partner with other federal agencies to conduct feasibility studies of evidence-based programs to maximize efficiencies in shared work, and identify comprehensive approaches to meeting performance standards and programmatic goals that can be integrated and sustained within existing practices;
• Develop and promote evidence-based guidelines to prevent health care-associated infections that improve the quality of care for all patients and serve as the basis for prevention tools that can be used by health care providers across health care settings;
• Work with and support interdisciplinary education, research, and public service entities to address issues, find solutions, and advance basic and applied research related to the needs of individuals with developmental disabilities and their families, including areas like supported employment, self-determination skills development, early intervention, and prevention;
• Engage with public health leaders, researchers, and professionals from other countries to learn from research, policy, and practice in these countries and to support collaborative efforts to solve mutual public health challenges;
• Build user-friendly mechanisms for disseminating evaluation findings and recommendations to the public; and
• Evaluate and provide recommendations on existing and innovative programs for adolescents and young adults, including the most vulnerable youth and young parents.

Performance Goals

• Identify three effective system interventions generating the implementation, sustainability, and ongoing improvement of research-tested interventions across health care systems.
• Increase the percentage of Community-Based Child Abuse Prevention (CBCAP) total funding that supports evidence-based and evidence-informed child abuse prevention programs and practices.
• Increase access to and awareness of the Guide to Community Preventive Services, and Task Force Findings and Recommendations for public health leaders, practitioners, and partners, using page views as proxy for use.

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Objective E:  Improve laboratory, surveillance, and epidemiology capacity

Three critical elements that underpin public health and regulatory practice — laboratory, surveillance, and epidemiological services — enable the public health field to detect emerging threats, monitor ongoing health issues and their risk factors, and identify and evaluate the impact of strategies to prevent disease and promote health.  Carrying out these activities requires quality data and specimen collection, evidence-based epidemiology, and accurate and reliable laboratory services across the departments and organizations that make up the nation’s public health infrastructure.

To this end, HHS is working to strengthen surveillance systems, including the monitoring of health care quality to ensure that best practices are used to prevent and treat the leading causes of death and disability.

HHS is building a robust data system that provides data, feedback, and tools directly to health agencies and health care facilities to improve practices and, ultimately, health.  A data system for public reporting and using electronic data sources for data collection and prevention will enhance the nation’s ability to monitor trends in critical health measures among priority populations; monitor health status, health care, and health policy concerns; and conduct in-depth studies of population health at the community level and for specific subpopulations.

Within HHS, ASPR, CDC, FDA, and SAMHSA will have roles in implementing the following strategies to achieve this objective.

Strategies

• Improve surveillance in hospital and non-hospital settings, such as outpatient clinical settings, emergency care, and nursing homes, to identify sources of and control of healthcare-associated infections and other nationally notifiable diseases;

• Improve surveillance, domestically and abroad, of adverse events, errors, or near misses in blood, organ, and tissue procedures, transplant-associated parasitic infections, urgent antimicrobial resistance, drug and medical product safety problems, and other major breaches in infection prevention in health care;

• Build and enhance state and local laboratory capacity by providing funding to develop, implement, and maintain state-of-the-art laboratory diagnostics;
• Strengthen state capacity to combat health care-associated infections by providing technical assistance, training, and national laboratory capacity to identify new and emerging health care-associated pathogens using clinical, environmental, and molecular laboratory methods;
• Assist public health laboratories in states, territories, tribal and urban Indian organizations, cities, and counties in expanding their capacity to prepare and respond to biological terrorism incidents or other emergencies involving accidental or intentional release of biological agents;
• Increase access to and sharing of data, and support for epidemiology programs at the state, local, and tribal government levels and by urban Indian organizations and other partners;
• Implement cutting-edge information technology solutions that support rapid, secure, and accurate information exchange of diverse types of information and link information among local, state, tribal and urban Indian, federal public health agencies, health care facilities, and laboratories, as well as with international regulatory counterparts, where appropriate;
• Enhance and sustain nationwide and international laboratory capacity to collect, ship, screen, store, and test specimen samples for public health threats and to conduct research and development that lead to interventions for such threats;
• Improve accessibility and integration of public and private health care databases so researchers can identify cost-saving and health protective practices;
• Develop the entry-level public health workforce through training programs in epidemiology, laboratory practice, preventive medicine, environmental health services, social determinants of health, public health leadership and management, informatics, and prevention effectiveness at federal, state, local, tribal, and territorial public health agencies; and
• Address gaps in foundational public health knowledge and skills of the existing workforce through accessible instructor-led and e-learning courses in public health, surveillance, epidemiology, prevention effectiveness, informatics, and laboratory science.

Performance Goals

• Increase the number of states that report all CD4 and viral load values for HIV surveillance purposes.
• Increase the number of CDC trainees in state, tribal, local, and territorial public health agencies.
• Increase epidemiology and laboratory capacity within global health ministries through the Field Epidemiology Training Program by increasing the number of new epidemiology residents.
• Increase epidemiology and laboratory capacity within global health ministries through the Field Epidemiology Training Program by increasing the number of total graduates.

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