Centers for Disease Control and Prevention (CDC)
The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this funding opportunity announcement (FOA) might differ from those used by the HHS National Institutes of Health (NIH). If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information.
National Institute for Occupational Safety and Health (NIOSH)
NIOSH Centers of Excellence for Total Worker Health® (U19)
The purpose of this Funding Opportunity Announcement (FOA) is to provide funding for Centers of Excellence for Total Worker Health®. Support of this program will further advance an emerging field of science and practice and address the needs of the 21st century workforce by means of research, intervention, and outreach activities.
October 1, 2015
October 30, 2015; September 15, 2016; September 15, 2017
September 15, 2018; and September 15, 2019.
(Updated November 17, 2015 per issuance of NOT-OH-16-002.)
December 17, 2015; November 30, 2016; November 30, 2017
November 30, 2018 and November 29, 2019.
(Updated November 17, 2015 per issuance of NOT-OH-16-002.)
March 2016; February 2017; February 2018
; and February
(Updated November 17, 2015 per issuance of NOT-OH-16-002.)
June 2016; April 2017; April 2018
and April 2019
(Updated November 17, 2015 per issuance of NOT-OH-16-002.)
September 1, 2016; September 1, 2017; September 1, 2018.
New Date December 1, 2017 per issuance of NOT-OH-16-002. (Original Expiration Date: 11/30/2019 )
Required Application Instructions
It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
|Note: You can download the latest version of the paper PHS 398 application form and instructions (revised 3/2016) at https://grants.nih.gov/grants/funding/phs398/phs398.html.|
Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
This program is described in the Catalog of Federal Domestic Assistance and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. Awards are made under the authorization of the Occupational Safety and Health Act of 1970, Section 20(a) and 21(a) (29 USC 669(a) and 29 USC 670); Federal Mine Safety and Health Act, Section 501(a), 30 USC 1 (Note), and 30 USC 951(a); Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
1. Background and Purpose
The health risks and challenges facing today’s workers and employers are significantly different than when the Occupational Safety and Health Act of 1970 was signed into law. Today’s workers face not only the traditional risks of chemical, physical, and biological hazards but also increased risks related to the changing nature of work, shifting workforce demographics and diversity, evolving employment patterns, and the changing workplace environment.
Building on four decades of scientific knowledge to prevent worker injury and illness and as an active part of the National Occupational Research Agenda (NORA) priority areas, NIOSH’s Total Worker Health® (TWH) Program supports ground-breaking research that addresses the implications of today’s changing workplace and responds to demands for information and practical solutions to the health, safety, and well-being challenges that workers face. Total Worker Health® is defined as policies, programs and practices that integrate protection from work-related safety and health hazards with promotion of injury and illness prevention efforts to advance worker well-being. This approach prioritizes a hazard-free work environment for all workers and comprehensively integrates workplace systems relevant to the control of hazards and exposures, organization of work, compensation and benefits, work-life integration/management, and organizational change management.
Evolution of the NIOSH Total Worker Health®
In 2003, NIOSH started the Steps to a Healthier U.S. Workforce Initiative to explore the benefits of integrating the protection of workers from work-related safety and health hazards with efforts to prevent illness and injury to advance the comprehensive safety, health and well-being of workers. One of the important outcomes of this initiative was the 2004 Steps to a Healthier U.S. Workforce Symposium (Steps Symposium), which received overwhelming support from the stakeholder community (Schill and Chosewood 2013). Building on this enthusiastic support, the “Steps” initiative developed into the WorkLife Initiative, and a second highly successful symposium was convened in 2007.
During these foundational years, NIOSH established extramural research Centers of Excellence to Promote a Healthier Workforce (Centers of Excellence) to support the TWH program goals. In 2005, NIOSH published an FOA, Centers for Excellence to Promote a Healthier Workforce, inviting applications to establish Centers that would conduct transdisciplinary research, education, and translation programs to facilitate the integration of health protection and activities that advance the overall well-being of workers. NIOSH funded two Centers, the Healthier Workforce Center for Excellence at the University of Iowa and the Center for Promotion of Health in the New England Workplace at the University of Massachusetts-Lowell and the University of Connecticut. A third Center, the Harvard T.H. Chan School of Public Health Center for Work, Health, & Well-being, was funded in 2006. A second FOA (RFA-OH-11-011) was published in 2011. As a result, NIOSH continued to support the three established Centers and to expand the program to another geographic region by funding a fourth Center in the Western United States, the Oregon Healthy WorkForce Center (OHWC).
In 2011, NIOSH renamed its efforts from WorkLife to the Total Worker Health® Program. In addition to continuing support of the extramural Centers of Excellence, NIOSH committed to further developing its intramural TWH research program. In 2014, NIOSH created the Office for Total Worker Health® Coordination and Research Support (Office for Total Worker Health®) to coordinate and advance extramural and intramural effort
Rationale for Total Worker Health®
Although the Office for Total Worker Health® is new, the scientific community’s interest in the integration of OSH protection with workplace policies, programs, and practices to prevent illness and advance overall health and well-being is longstanding and evidenced in a special issue of the Journal of Occupational and Environmental Medicine (2013).
More than 20 years ago, researchers (McLeroy et al. 1988; DeJoy and Southern 1993) argued for taking an ecological or systems approach to OSH. This approach would recognize that worker injury and illness have myriad causes and therefore require coordinated interventions that take into account individual as well as occupational risk factors. A comprehensive collection of conceptual and theoretical publications of research perspectives on Total Worker Health® establishes the scientific rationale for integrating health protection with workplace policies, programs, and practices that promote safety and health, prevent disease, and advance well-being.
Over the past ten years, NIOSH and its extramural Centers of Excellence have advanced the growing body of evidence that integrating OSH protection program activities and workplace programs that prevent injury and illness are more effective for safeguarding worker safety, health, and well-being than either of these programmatic activities on their own. The rationale for the TWH approach was first presented in three NIOSH-commissioned white papers at the 2004 Steps Symposium. These white papers were updated and published by NIOSH as a Research Compendium in 2012.
In November 2012, researchers, federal officials, and policy leaders came together to present and discuss emerging research, practice, and policy at the 2012 National Total Worker Health® Symposium hosted by the University of Iowa Healthier Workforce Center for Excellence. The proceedings from this meeting were published in a December 2013 special supplement to the Journal of Occupational and Environmental Medicine. The proceedings describe the emerging field and provide an early overview of the NIOSH Program launched in 2011 (Schill and Chosewood 2013). They also offer the conceptual framework for an integrated approach that identified a set of core indicators for the implementation of integrated approaches (Sorensen et al. 2013).
To identify best and promising practices for advancing Total Worker Health® in small, medium, and large workplaces, NIOSH funded an Institute of Medicine workshop in May, 2014. This workshop sought input from a wide variety of stakeholders regarding their experiences with integrating workplace safety and health interventions.
The latest science and practices on the Total Worker Health® approach were shared in October 2014, as NIOSH and partners such as the Centers of Excellence hosted the 1st International Symposium to Advance Total Worker Health®. The Symposium attracted over 350 attendees from a broad spectrum of fields, including occupational safety, ergonomics, worksite health, occupational medicine, academia, and human resources. Sessions highlighted the health and safety challenges and opportunities in industry and worker populations; methodological challenges and innovations related to TWH interventions; new theories to guide future scientific inquiry in the field; and common barriers and strategies to implementing integrated interventions.
To increase the number of work environments supporting the overall safety, health, and well-being of workers, several capacity-building resources and guidelines for integrated programs have been developed by the NIOSH-funded Centers of Excellence. For example, in 2012, the Harvard T.H. Chan School of Public Health Center for Work, Health, & Well-being developed the SafeWell Practice Guidelines: An Integrated Approach to Worker Health. In 2013, the Center for Promotion and Health in the New England Workplace (CPH-NEW) developed an interactive assessment and seven-step planning process to help create a new program or enhance and integrate existing programs, called CPH-NEW Healthy Workplace Participatory Program. For more resources on frameworks and guidelines for implementation, see http://www.cdc.gov/niosh/twh/letsgetstarted.html.
Recently, a systematic review of Effectiveness of Total Worker Health® Interventions was conducted by researchers at the Oregon Health and Science University. The team of investigators found that integrated health interventions that address injuries and chronic diseases simultaneously can improve workforce health effectively and more rapidly than those employing a limited focus.
Additionally, NIOSH established a partnership program called the NIOSH Total Worker Health® Affiliate Program. The mission of the Affiliate Program is to protect worker health and promote overall health and well-being of workers through collaborations with public and not-for-profit organizations. Today, 15 Affiliate organizations across the nation assist NIOSH with Total Worker Health® research, practice, and training efforts.
Research, intervention, outreach, and evaluation activities are necessary to advance this emerging field of science and practice if we are to address the needs of our 21st century workforce, protect worker safety and health, and achieve greater levels of worker well-being.
The purpose of this Funding Opportunity Announcement (FOA) is to support Centers of Excellence for Total Worker Health® to advance the overall safety, health, and well-being of the diverse population of workers in our nation. Centers accomplish this through multidisciplinary research, intervention, outreach and education, and evaluation activities.
The following areas are of particular interest to the Total Worker Health® perspective:
Control of hazards and exposures relates to both persistent and emerging challenges. These range from traditional chemical, physical, and biological hazards to the more pervasive, modern-day exposures related to human factors and the psychosocial work environment, including assessing and controlling risk.
Organization of work refers to the work process and the organizational practices that influence worker health, and it includes considerations such as job design, work intensification, improving the safety and health culture and climate, employee development and job security, safe staffing, overtime policies and management, shift work and long work hours, engagement, meaningful work, team-based work groups and team building, adequate breaks for meals and rest, and supporting policies that offer flexible work arrangements.
Policies for built and community environments relate to the support that workers have within the context of their workplace to improve or maintain health and well-being, such as accommodations for special needs, access to healthy food, air quality, access to safe and clean restroom facilities, safe and healthy access to the workplace, and access to health services.
Issues related to changing workforce demographics and diversity within the modern workplace include occupational health disparities, increasing workforce diversity, productive aging of the workforce and sequential careers, workers with disabilities, global and multinational workforces, multigenerational workforces, vulnerable worker populations, and a growing number of small businesses.
Issues related to compensation and benefits include paid sick leave, paid family leave, equitable wages, wage theft, paid maternity and paternity leave, paid vacation time, retirement planning, savings and pensions, work/life/family policies and programs, continuing education and tuition assistance, and comprehensive healthcare insurance.
New employment patterns refer to the transformation of the employment relationship between workers and employers due to various economic, societal, and organizational pressures. These include contracting and subcontracting employment, temporary employment, precarious/contingent employment, part-time employment, dual employers at the worksite, and organizational restructuring/downsizing/mergers.
Evolving performance management approaches represent how workers are supervised, directed, and evaluated in their daily work and the environments under which workplace demands are crafted. These are associated with the following themes: aligning workers with meaningful work, promoting engagement of employees in their work, equitable systems for appraisal and promotion, worker participation and problem solving by front-line workers, worker recognition and management /respect, and issues related to abuse of power, bullying, violence in the workplace, and discrimination.
Social and legal issues embody reasonable accommodations, health information privacy, the Affordable Care Act and health insurance, cost shifting of compensation for work-related injuries and illnesses to Social Security Disability (SSDI) and health insurance, contributions to a safer and healthier environment for the community (where workers live), and eroding workers’ compensation benefits.
Well-being supports: safety and health– enhancing culture with leadership support, policies, and programs to help workers stay active in the workforce, chronic disease prevention programs, access to confidential health care resources, work-life balance policies and programs, fatigue prevention and return-to-work policies.
Policy and built-environment supports: resources to support social and physical well-being in the community, healthy community design, access to healthy food options, safe and clean environment (air and water quality, noise levels, tobacco-free policies), access to safe green spaces and non-motorized pathways, and safe and accessible commuting options.
These comprehensive issues address concerns faced by workers in the 21st century and build upon a broad portfolio of existing and emerging safety and health research at NIOSH. For more information, refer to the following resources:
Healthy People 2020 and other National Strategic Priorities
Occupational safety and health–related Healthy People 2020 objectives are primarily addressed through NORA. NORA was established by the CDC, NIOSH, and its partners to stimulate research and improve workplace practices. Now in its second decade (2006–2016), NORA focuses on OSH in 10 sectors. To guide the development of research, practice, policy, and capacity-building activities, NIOSH recently developed a proposed National Total Worker Health® Agenda
Public Health Impact
NIOSH expects this FOA to have meaningful impact on (1) multidisciplinary research on the effects and outcomes of policies, program and practices that integrate protection from work-related safety and health hazards with promotion of injury and illness prevention efforts to advance worker well-being; (2) development and dissemination of evidence-based research and recommendations for workplace programs, policies, and practices; (3) development of audience-specific educational materials, outreach, and capacity-building resources for optimizing their uptake or adoption or adaptation for protecting workers and improving worker well-being; and (4) evaluation of results to determine the impact on occupational safety and health and reduction in burden.
Since 2005, NIOSH has supported extramural Centers of Excellence to Promote a Healthier Workforce to advance the mission of NIOSH in protecting and advancing the safety, health, and well-being of the diverse population of workers in our nation
Centers of Excellence for Total Worker Health® are expected to conduct research, planning and evaluation, and outreach and education that integrate OSH protection with interventions that protect, preserve, and advance the overall well-being of workers, communicate knowledge and best practices, and develop effective partnerships with workers, organizations and employers, NIOSH scientists, communities, and other entities.
To guide the development of research, practice, policy, and capacity-building activities, NIOSH and our stakeholders are developing strategic goals for the nation. These include the following:
A logic model for Total Worker Health® for the development of TWH research has been created and outlines the work of the Research Program in the NIOSH Office for Total Worker Health®.
In support of prior and current NIOSH initiatives, as well as national and global demands to improve the health of workers, a Center is expected to (1) serve as a leader in research activities and expert in policies, programs and practices that integrate protection from work-related safety and health hazards with promotion of injury and illness prevention efforts to advance worker well-being; (2) conduct multidisciplinary research projects on the effects and outcomes of integrated Total Worker Health® approaches; (3) conduct outreach and education activities in the region to create awareness of the value of healthier workers and workplaces that support well-being and disseminate the results of research activities; (4) establish partnerships with community agencies and organizations to encourage participation in Center projects and activities designed to advance Total Worker Health® approaches; and (5) conduct evaluation activities at the project level and at the overall Center level.
A Center is expected to develop multidisciplinary teams comprising professionals in OSH from a variety of specialty areas such as workplace health and disease prevention, including medicine, nursing, industrial hygiene, safety, ergonomics, psychology and social sciences, policy, labor education, health education, and business and economics. Centers also are expected to conduct research on policies, programs and practices that integrate protection from work-related safety and health hazards with promotion of injury and illness prevention efforts to advance worker well-being and to communicate knowledge and effective best practices in partnership with NIOSH scientists, partners, employers, and the community.
Collaborations among investigators, partners, and institutions to share existing expertise and engage in joint interventions are essential in advancing the scientific evidence related to Total Worker Health®. Centers will develop collaborative partnerships with local and state agencies, community organizations, universities, health care institutions, business groups, and labor organizations to carry out research activities, conduct outreach programs, promote awareness, and disseminate information.
Partnerships are critical to translate research into practice and encouraged by the NIOSH Research-to-Practice (r2p) program. Interdisciplinary and multidisciplinary collaboration among investigators and institutions to share existing expertise and findings is essential in advancing the science of integrating health protection with activities that advance the overall well-being of workers in the work environment.
Center applicants are expected to document that their proposed research and outreach programs meet specific regional or national workforce needs and demands.
Research supported by this program is needed to explore and demonstrate the impact of policies, program and practices that integrate protection from work-related safety and health hazards with promotion of injury and illness prevention efforts to advance worker well-being. This integrated approach is expected to result in safer and healthier work environments and an increased impact on workers’ health and well-being. For the purpose of this announcement, interventions that advance worker well-being without attention to the conditions and policies of the workplace are outside the scope of this program.
The ultimate beneficiaries are workers in the United States. However, to achieve this, a Center might target United States vulnerable worker populations to address the additional increased safety and health risks associated with occupational health disparities, changing worker demographics, and changing nature of work.
As Centers of Excellence for OSH, the TWH Centers can serve as valuable regional and national resources. Centers are strongly encouraged to engage diverse partners in their HHS Federal Health Region and to facilitate synergistic approaches to OSH. The TWH Centers should demonstrate collaborative efforts by working with a diverse and broad range of organizations to enhance worker safety and health in their region to the extent possible. While regional partnership activities are preferred, other broader collaborations beyond the region are not prohibited. Collaboration with other institutions could include: historically black colleges and universities; businesses; federal, state, or local public health and regulatory agencies; and labor and professional associations.
Centers will institute collaborative partnerships with local and state agencies, community organizations, universities, health care institutions, business groups, and labor organizations to carry out research activities, conduct outreach programs, promote awareness, and disseminate information. Collaboration with NIOSH intramural scientists and programs is also encouraged. Partnerships are critical to translate research into practice and are encouraged by the NIOSH Research-to-Practice (r2p) program. Interdisciplinary and transdisciplinary collaboration among investigators and institutions to utilize and share existing expertise is essential to advancing the science of OSH.
Centers are expected to conduct evaluation of research, programs, policies, and outreach related to the overall functioning and objectives of the Center. Evaluations are essential to demonstrate the effectiveness of outreach and the translation of interventions into workplaces and to address NIOSH goals and r2p initiatives. Evaluations also provide information for management and improve program effectiveness. The CDC Framework for Program Evaluation in Public Health may be helpful.
Translation, communication, and dissemination projects are encouraged as a means of interpreting and delivering the Center’s research findings to those in a position to adopt and implement improvements, as well as overcome barriers to improving the health of people who work.
Center of Excellence Cores
The Total Worker Health® Center of Excellence cooperative agreement is expected to support multidisciplinary research and activities that have a strong evaluation component, address the priorities in this announcement, and include dissemination of research results and information on integrated programs to the community, workers, and employers. A Center of Excellence is comprised of three required cores and components that together address the Center’s objectives:
Planning and Evaluation Core (Required /up to 20% of total costs/year)
Center Coordination and Management
Research Core (Required)
Research Surveillance Research
Pilot/Feasibility Research Program/Up to $50,000 direct cost/year (optional)
Outreach Core (Required/up to 25% of total costs/year)
Communication and Dissemination Activities
These 3 cores work cooperatively to achieve the objectives of the Center. Each Core is discussed in the following sections.
Detailed Information on Center Cores
1. Planning and Evaluation Core (Required/up to 20% of total costs/year)
The Planning and Evaluation Core is necessary to carry out the objectives of the Center and plan for new directions. It includes three required components: Center Coordination and Management, Advisory Committees, and Evaluation Program.
Center Coordination and Management
The ability of the program's principal investigator and program staff to lead a highly integrated program of research, education, outreach, and translation projects to reduce work-related health risk, promote health, and prevent disease and injury in the workplace will be a significant consideration in the evaluation of the application.
A Center must have a strong leader committed to the success of the Center of Excellence who is capable of providing scientific leadership for the administration and integration of the program. Elements of an effective planning and evaluation core include (1) the coordination and integration of Center components and activities; (2) a program logic model and an evaluation plan based on input from key stakeholders and needs assessment data in forming the overall Center strategic plan, which includes defined metrics that will be used to measure and track outputs and outcomes and describes the intended long-term goals and impact of the Center and each Center core; (3) the organization and input of the Advisory Committee(s); and (4) a plan for interactions with other NIOSH funded centers and other organizations, and communities.
The Planning and Evaluation Core should have a strategic plan complete with a vision statement, mission, and goals, detailing how the Center will implement this plan during the proposed project period. An organizational chart may be included to illustrate the structure, interactions, and key personnel of the Center. In addition, the Center will (5) organize and make available facilities to center partners to conduct activities such as seminars, workshops, reference collection, and computer support.
The principal investigator should provide a minimum of 10% time commitment (direct and in-kind), and each member of the internal advisory committee should provide a minimum of 5% time commitment for the Center of Excellence's administration and coordination
An Internal Steering/Advisory Committee comprising program directors from each core will assist the principal investigator in making scientific and administrative decisions in the operation of the Center programs.
An External Advisory Committee should comprise representatives of labor, business, public/private services, and other relevant groups. Members should be recognized leaders in the field of OSH and/or leaders in their respective disciplines, such as economics, business, labor education, labor relations, health protection, workplace well-being, health education, human resources, occupational health nursing and medicine, engineering, injury and chronic disease prevention, and surveillance and research methods to identify key issues and needs.
The applicant should provide a detailed evaluation plan identifying expected outputs and outcomes/impact for the TWH Center and for each Center program.
A data/statistical support activity should be included in the evaluation core if needed for the Center. Such an activity may be useful in performing consultative services for employer-employee partnerships.
Centers are expected to conduct evaluations of both scientific projects and activities related to the overall planning and operations of the Center. Evaluations assist in the translation of interventions into numerous workplaces that are important to NIOSH and its translational research. Evaluations also provide information for management and improve program effectiveness.
2. Research Core (Required)
The Research Core is essential to advance research relevant to the strategic goals in the proposed National TWH Agenda and to the issues relevant to the Total Worker Health® perspective, as described in the section above entitled “Purpose”. For more information, please see Guidelines for Implementing Total Worker Health®.
Research project proposals must clearly identify and address occupational burden estimates, the need for the proposed study, and the potential for public health impact.
Applicants should clearly identify their proposed individual research projects in one of four categories: 1) basic/etiologic research, 2) intervention research, 3) translational research and 4) surveillance research. Applicants will not be required to propose a specific number of projects within each research category; however, centers should consider covering the full research continuum, where feasible, when addressing their TWH issues or concerns.
Centers will likely have projects in many of the 4 research categories. There are no funding limits established for individual projects or research categories. Applicants must work within the overall funding level for the Research Core.
Research projects should be hypothesis-driven and focus on improving our understanding of integrated OSH protection interventions that promote worker well-being. The ultimate focus should be on the development, evaluation, validation, sustainability, and communication of workplace programs and approaches intended to improve the health status of people who work in various occupational sectors and in workplaces of various sizes. Research projects should target priority topics, including surveillance, methods development, translational, efficacy, effectiveness, and dissemination research, and they should be conducted as part of multidisciplinary and transdisciplinary efforts. These projects are expected to have a well-defined evaluation plan that includes process and outcome measures to determine the efficiency and effectiveness of the techniques and programs.
Many projects will test promising TWH approaches in actual work settings. Projects may examine the value and merits of integrating systems that aim to protect and promote worker health and well-being and that comprehensively address issues relevant to a Total Worker Health® approach such as control of hazards in the workplace; organization of work; worker well-being supports; new employment patterns; compensation and benefits; and changing workplace demographics.
Research Project Categories
The four types of research that will be considered for funding under this FOA are discussed briefly and examples are provided for each type.
Etiologic research builds a foundation of scientific knowledge upon which future interventions are based. Except for those projects that can be categorized as surveillance, which merit their own category, this research makes an effort to identify and document the nature and extent of the OSH problem. Examples include, but are not limited to, the following:
Intervention research engages in the development, testing, or evaluation of a solution to an OSH problem or the improvement of an existing intervention. In this context an intervention is a change in technology, equipment, training resources, or workplace policies or procedures for the purpose of improving worker safety and health. Intervention research may include but is not limited to development of a new training program, evaluation of an engineering control technology, development of new personal protective equipment (PPE), or improvement of existing PPE or the evaluation of a new workplace policy or procedure. Intervention research is differentiated from translational research through the performance of research or field tests to develop interventional strategies (that is, intervention research develops prevention strategies while translational research develops mechanisms to disseminate these strategies). Examples include, but are not limited to, the following:
Translational research discovers strategies to translate research findings and theoretical knowledge to implementable practices or technologies in the workplace. Translational research can include the development and transfer of new technologies (such as engineering controls, administrative controls, and PPE) into the workplace. It also includes research that tests the efficacy of information dissemination strategies or training programs. Although translational research can be a standalone research category, translational activities can be conducted across all types of NIOSH research projects—especially within the NIOSH r2p framework. Proposed projects must embody specific attention to evaluating and ameliorating risks from workplace conditions and exposures. Examples include, but are not limited to, the following:
Occupational health surveillance is the tracking of occupational injuries, illnesses, hazards, or exposures. Occupational surveillance data are used to guide efforts to improve worker safety and health and to monitor trends and progress over time. Surveillance research involves the (1) collection of data for the purpose of establishing or maintaining an occupational safety or health database; (2) development of surveillance methods; and/or (3) analysis of surveillance data. Examples include, but are not limited to, the following:
Pilot/Feasibility Research Program (Optional/up to $50K total costs)
Pilot projects are considered an important and integral part of support provided to the Center. Support of pilot projects in intervention effectiveness research, education, and translation is considered fundamental to sustaining the quality, breadth, and dynamics of this program. Investigators must budget for up to $50,000 total of the research core for these projects. These projects are intended to address new emerging issues, the exploration and development of new, creative intervention-effectiveness research, education, and translation projects. Short-term projects to explore the feasibility of new projects in any of the Center's program areas can be considered for funding under this program. Projects that would be conducted beyond the United States and territories must be submitted to the NIOSH program official for prior approval. The request for approval must include documentation of IRB approval from the grantee institution as well as from the appropriate IRB within the host country.
This program will enable investigators to collect sufficient data to pursue support through other funding mechanisms. Funds should be designated to provide support for short-term projects (12 months or less) to explore new areas in the Center’s core programs. Pilot projects can include, but are not limited to, the following:
Although the administrative framework for management of the Center’s Pilot project program is left to the Center Director’s discretion, certain minimal requirements must be met. Center management must include provisions for the following:
3. Outreach Core (Required/up to 25% of total cost/year)
The Outreach Core is vital to center efforts to deliver science-based information to workers across the country. Outreach can work to increase access to and adoption of the latest evidence and practice on worker safety and health through partnerships with regional and state organizations and may aim to reach diverse and high-need groups. These partnerships can provide opportunities to engage with organizations in dialogue to better understand the needs, questions, and concerns of those intended to benefit from the research NIOSH supports.
Although this core component is broad in scope, one priority is to develop a strategy for outreach to key stakeholders and across disciplines that will have an impact on worker safety and health, including reaching underrepresented groups and meeting a regional need, and to evaluate the success of these activities.
Outreach activities include, but are not limited to, the following:
Communication and Dissemination Activities
Education activities should be designed to build capacity by promoting findings and providing the necessary knowledge and skills to professional students, practicing professionals, employers, workers, policymakers, and community groups with a stake in protecting and enhancing the health of people who work. Educational activities may also involve the design, implementation, or evaluation of programs, policies, and products that integrate occupational health protection with policies, programs, and practices that promote safety and health, prevent disease, and advance the well-being of American workers in the workplace. Examples include, but are not limited to, the following:
Work with other academic departments to offer seminars, workshops, and courses on TWH for undergraduate and graduate students in various disciplines, such as Psychology and other Social Sciences, Business, Human Relations, Public Health, Health Sciences, Occupational Health, and Engineering http://www.cdc.gov/niosh/TWH/perspectives.html, http://www.cdc.gov/niosh/TWH/reports.html.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIOSH staff will assist, guide, coordinate, or participate in project activities.
The OER Glossary and the PHS 398 Application Guide provide details on these application types.
NIOSH intends to commit a total of approximately $4.8 million in FY2016 to fund 4 or 5 cooperative agreements in response to this FOA for a period of up to 5 years.
Note: Awards will be based on available funds.
The maximum amount (total cost) for each application is $1.3 million for the first 12-month project period.
Throughout the project period, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.
HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ asfr/ogapa/aboutog/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations must complete and maintain the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS 398 Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Only one application per institution (normally identified by having a unique DUNS number) is allowed.
Applicants may download the Grant Application PHS 398 for this funding opportunity announcement from Grants.gov.
The PHS 398 application instructions and forms for this funding opportunity announcement are also available at: https://grants.nih.gov/grants/funding/phs398/phs398.html.
For further assistance, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at 770.488.2700 or email@example.com.
Telecommunication for the hearing impaired or disabled is available at TTY 1-888-232-6348.
Applicants must follow the instructions in the PHS 398 Application Guide, except where instructed in this FOA to do otherwise, and conform to Application Guide requirements. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
The PHS 398 should include assurances and certifications required by the agency for a complete application. These forms can be downloaded from the following link: https://grants.nih.gov/grants/forms.htm.
Information in the remainder of this section describes special content to be included, budget restrictions, items to be addressed for a complete application, and application organization.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Nina Turner, PhD
Scientific Review Officer
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention.
1095 Willowdale Road
Morgantown, WV 26505-2845 USA
Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Concurrently, submit two photocopies of the application and three CD ROM disks containing appendix materials to this address:
Nina Turner, PhD
Scientific Review Officer
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention.
1095 Willowdale Road
Morgantown, WV 26505-2845 USA
All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed as applicable.
Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 100 pages for all appendices.
The following section supplements the instructions found in the PHS 398 Application Guide, and should be used for preparing a multi-component application.
Table of Contents
Applicants must use the PHS 398 version and instructions that are current at the time of their application. The application forms submitted in response to this announcement are complex. The scientific and programmatic information needed to properly assess them is not fully accommodated within the basic PHS 398. Consequently, applicants will need to modify and expand the PHS 398 to properly organize the necessary information for reviewers. To help facilitate an effective and efficient peer review process, the following components should constitute a complete, discrete unit within the application, with minimal duplication elsewhere. The application should consist of the following components:
All applicants should use the following outline:
Note: Each individual core, or project should constitute a complete, discrete unit within the application and should use the following outline:
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.
Part I. Overview Information contains information about Key Dates.
Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.
Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
This initiative is not subject to intergovernmental review.
All HHS/CDC awards are subject to the terms and conditions, cost principles, and other requirements described in the HHS Grants Policy Statement. Pre-award costs may be allowable as an expanded authority, but only if authorized by CDC. For more information on expanded authority and pre-award costs, go to: http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf.
Applications must be postmarked on or before the due dates in Part I. Overview Information.
Applications Involving a Single Institution
Applicants with PDs/PIs all within a single institution should follow the instructions contained in this FOA; there are no special instructions.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institutions must be requested via a subcontract to be administered by the prime institution. The prime institution should submit its budget details on PHS 398 forms, and the other institutions should attach their individual PHS 398 budget forms to those of the prime institution.
If the applicant has an FWA number, enter the 8-digit number. Do not enter the letters “FWA” before the number. If a Project/Performance Site is engaged in research involving human subjects, the applicant organization is responsible for ensuring that the Project/Performance Site operates under and appropriate Federal Wide Assurance for the protection of human subjects and complies with 45 CFR Part 46 and other CDC human subject related policies described in Part II of the SF 424 (R&R) Application Guide and in the HHS Grants Policy Statement
Upon receipt, applications will be evaluated for completeness by the CDC Procurement and Grants Office (PGO) and responsiveness by PGO and NIOSH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Only the review criteria described below will be considered in the review process. As part of the CDC mission, all applications submitted to NIOSH in support of public health research are evaluated for scientific and technical merit through the NIOSH peer review system. The review criteria described below will be considered in the review process.
As part of the initial merit review, all applications will receive a written summary statement consisting of the following:
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the projects proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Is the Center likely to have an impact in meeting the regional and national need for healthy worksites and healthy workers through research, education, and partnership activities? Does the creation or continuation of the Center push forward this field of OSH, and is it a driving national resource? Does the creation or continuation of the Center meet identified needs in TWH? Does the applicant describe how scientific knowledge be advanced by establishing comprehensive worksite programs benefitting both workplaces and employees? Are collaborative relationships that have been established at worksites likely to contribute to the knowledge, benefits, and sustainability of health protection interventions that promote comprehensive well-being programs for workers?
For Renewal applications: In addition to the criteria above, is there sufficient information provided describing how the Center has achieved the goals of the previous funding period and how the goals of the future years build on the past successes, with a particular emphasis on the successful activities that have been accomplished that could not have been realized without the Center support? Is there a plan for interactions with other NIOSH-supported TWH Centers, organizations, and communities? Does the applicant document outcomes and impacts achieved? Does the renewal application describe the program accomplishments to date? Does the applicant provide evidence of past success in meeting the national need for healthy worksites and healthy workers through research, education, and partnership activities?
For New applications: In addition to the criteria above, will the proposed Center be able to effectively advance scientific knowledge and establish comprehensive worksite programs to benefit workplaces and employees?
Does the application adequately describe the leadership ability and scientific stature of the Center Director and his or her ability to meet the program’s demands of time and effort? Are the qualifications of the Center Director and Program Directors—as evidenced by education, experience, and accomplishments—adequate to accomplish the goals and mission of the Center? Does the investigative team bring complementary and integrated expertise to the projects? Do the Center investigators have a successful track record in TWH research? Is there evidence of high-quality outputs from Center investigators, and have they contributed to improvements in TWH? Is the percent effort requested adequate? Are the qualifications, duties, and time commitments of administrative staff appropriate for contributing to the needs and conduct of the program’s outreach, education, prevention, intervention, and research activities?
What is the degree of innovation of the program? Does the Center propose novel projects, or do they build on current projects? Are new areas of investigation proposed that are challenging and have the potential for success? To what degree does the proposed program design address the distinct characteristics, specific populations, and health needs in OSH? Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches, methodologies, instrumentation, or interventions? Does the Center propose innovative approaches to achieving and maintaining highly effective outreach, research, and translation of research to practice, all relevant to the TWH field? Is the proposed project innovative or will it move the field forward? For example, does the center propose ways to maintain or expand activities that have been previously shown to be effective?
Is the entire program cohesive in integrating all projects and facilitating interdisciplinary and transdisciplinary interaction, and is it likely to produce results that are translatable into practice in the field? Is the proposed Center more than the sum of its parts, not just a collection of programs? Are the component programs and research projects well integrated with each other and designed to foster interdisciplinary interaction and national impact? If this is a pre-existing Center, has its organization and structure contributed to producing measurable results and accomplishments? Is there appropriate collaboration with public and private community organizations, professional groups, industry, and labor that will enhance the work of the Center and provide continuity? Is there a plan for dissemination of project results? Are outputs and measures of impact for the overall TWH Center and center components clearly defined and good indicators of the outcomes proposed for this program? These outputs and measures must be demonstrated on the Center’s proposal logic model. Are challenges in collaboration clearly stated? Are benchmarks for the Center’s success and progress clearly stated?
Is there evidence of institutional commitment, as demonstrated by sufficient resources, technical support, and administrative arrangements and facilities that foster collaboration among researchers? Are the quality, sufficiency, and multidisciplinary character of the education, intervention, and research environment adequate to accomplish the proposed activities? Will the Center benefit from the unique features of the academic and scientific environment? Are the facilities and equipment adequate to support the described activities of the Center? Will the environment contribute to the probability of success for the TWH Center?
The following review criteria will be used to assess each component of the Planning and Evaluation Core. Only one composite score will be provided for the Core.
Does the administrative structure facilitate communication among Center leaders and project scientists? Are there adequate administrative and management plans to support all operational facets of the Center? Does the role of the Advisory Committee include oversight and making recommendations to the Center that will be considered and adopted? Does the proposed Planning and Evaluation Core have an appropriate and adequate administrative structure with an internal organization capable of planning, conducting, and evaluating Center activities? Does the Core clearly delineate procedures and plans for center administration, planning and evaluation? Are there plans to obtain feedback from advisors, partners, stakeholders, workers, or employers to assess the quality and effectiveness of health protection and workplace well-being programs to produce healthy workers and healthier workplace environments? Does the administrative structure facilitate a highly integrated program of research, education, outreach, and translation projects to reduce work-related health risk, promote health, and prevent disease and injury in the workplace?
Does the application adequately describe the leadership ability and scientific stature of the Advisory Committees staff and the Planning and Evaluation Core leaders to meet the program’s demands of time and effort? Is there an organizational chart that illustrates the structure, interactions, and key personnel of the Center? Are there appropriate plans for organizing and convening internal and external committees to advise the Center Director? Are there appropriate plans for an Internal Advisory Committee drawn from Center staff to advise and assist the Center leaders?
Does the applicant seek to have an impact on worker safety and health by using novel approaches for TWH activities (interdisciplinary activities, research, and outreach)?
Is the Center Director adequately supported to provide long-term continuity of Center leadership? Are plans for routine management, allocation of funds, preparation of reports, and partnerships designed to effectively achieve Center objectives? Are the coordination and integration of Center components and activities adequate? Is there a plan for organized activities such as seminars, workshops, reference collection, and computer support? Does the application describe a program logic model and evaluation plan to determine the impact, quality, and effectiveness of the TWH Center and Center components? Does the application describe evaluation of scientific projects, the overall Center, and Center objectives to assess the effectiveness of the Center? Does the proposal clearly describe the tools, guidance, and methods for implementation and evaluation as well as anticipated outputs and impacts of proposed projects and activities? If needed for the Center, does the application describe a data/statistical support activity? Do the proposed evaluation efforts reflect an established organizational component within the institution? Is the evaluation component an integral part of the Center? Are the approaches and rationales clearly explained in relevant sections of the application?
Are institutional facilities and resources available to the Center’s researches and key personnel? Does the Advisory Committee comprise community leaders and stakeholders with expertise appropriate for the projects and mission of the Center? Does the research environment support high quality, multidisciplinary interaction among the Center components? Will the environment contribute to the probability of success for the TWH Center? Are institutional facilities and resources available to the TWH Center’s researchers and key personnel? Is there evidence of institutional commitment to the goals of the Center?
Individual Research Projects: Basic/Etiologic, Intervention, Translational, and Surveillance Research
(The four types of research are described in detail in the Research Core section of this FOA.)
Each research project will be individually reviewed and scored according to the five criteria listed below.
Do the projects incorporate the concepts of OSH/well-being, as specified in the announcement? Do the proposed projects address relevant issues related to TWH concepts? Are the audiences and target populations appropriate for the projects? If the aims of the projects are achieved, will scientific knowledge or clinical practice and the goals of the Center be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field? Do the projects support and benefit current management efforts to establish and maintain sustainable programs for workers that are effective and promote the health of the workers and the workplace? Can the projects be translated to the occupational health community?
Are the qualifications of the investigators appropriately evidenced by education, expertise, and previous experiences? Are sufficient staff and resources available to the researchers? Do the investigators have a successful track record in TWH research? Is there evidence of high-quality outputs from the investigators, which have contributed to improvements in TWH? Is the percent effort requested adequate? For renewal applications, does the research past performance reflect successful recruitment of highly qualified and motivated investigators (success may be determined by the number of investigators funded, researcher awards, presentations and publications, and career development)?
Does the applicant propose to use new and appropriate methodologies, technologies, tools, and concepts to ensure success? Are the projects innovative and relative to integrating the new concept of health protection and workplace well-being programs? Does the applicant seek to have an impact on worker safety and health by using synergistic approaches to the dissemination and translation of research results? Does the Center propose ways to maintain or expand activities that have been previously shown to be effective? Will the proposed projects move the field forward?
Do the proposed projects address one of the identified regional or national needs and/or demands? Is there evidence that the industries targeted for study are willing to participate and are committed to the projects? Are the proposed conceptual frameworks, methods, time lines, and analyses adequate to meet the goals of the projects? Are barriers and limitations specified by the investigators? For existing Centers, do the projects build on existing projects or are new projects proposed? For new Centers, do projects build on past/current work, or are they newly developed? Is there a plan in place to assess the success or impact of the research? Does the application describe a program logic model and evaluation plan to determine the impact, quality, and effectiveness of the projects? How are the effectiveness and impact of the research projects determined?
Are environments/sites targeted for research appropriate and known to be committed to the studies? Does the environment in which the work will be done contribute to the success of the projects? Is there evidence of institutional commitment to support the goals of the Research Core of the Center?
Pilot/Feasibility Project Research Program
The following review criteria will be used to assess the Pilot Project Research Program of the Center. Only one composite score will be provided.
Does the program have well described goals that are relevant to the TWH research agenda and to the Center goals? Is the plan to conduct the Pilot Projects Program adequate in its procedures for reviewing and funding projects, scientific review, and quality assurance? Does the program description include the scope of the project and the eligibility of applicants?
Does the program description include the qualifications of the investigators, the sufficiency of the staff, and the availability of the resources to the researchers? Is there a plan to solicit peer reviewers with the expertise to review the merit of the proposed pilot projects?
Does the program support new investigators in advancing or developing innovative TWH concepts and areas of investigation that address the Center’s mission and objectives? Does the program address emerging issues?
Is the plan for announcing the Pilot Projects Program funding adequate? Are there adequate plans for retaining copies of all Pilot Project applications, with documentation of merit reviews, relative ranking, and final action? Is there a program mechanism for tracking the results of each Pilot Project study by documenting publications, conference proceedings, and abstracts? Does the program description include how the project is evaluated and how the effectiveness and impact of the Pilot Project research are determined? Is there a mechanism for tracking the results of each pilot project study?
Is there evidence of institutional commitment to support the goals of the Pilot Project Research Program of the Center?
The following review criteria will be used to assess each component of the Outreach Core. Only one composite score will be provided.
Does the program support and promote the implementation and adoption of best practices, programs, and policies that advance worker safety, health, and well-being? Does the project include strategic partnerships and collaborations to communicate evidenced-based practices for preventing work-related illness and injury? Are culturally, linguistically, and educationally appropriate communication interventions used to promote the adoption of evidence-based health-protection practices? Does the application describe educational opportunities to researchers and practitioners on issues relevant to the integration of health protection, with comprehensive interventions that promote workers’ well-being? Does the program facilitate the translation of occupational safety and health findings into the work environment? Are appropriate occupational safety and health constituents engaged in the program? Will the proposed activities have an impact on the practitioner or ability to affect occupational safety and health? Is there a well-defined evaluation plan, including process and outcome measures, to determine the efficiency and effectiveness of the techniques or programs? For intervention efficacy and effectiveness projects, is the focus on protecting and maintaining the health status of the workforce? Is there evidence that the Outreach Core is responsive to regional needs for worker safety and health? For renewal applications, does the Outreach Core have a successful history of activities that positively impact the OSH practitioner community? Does the program adequately describe activities that will impact other institutions or agencies located within the TWH Center region? Does the application describe how to transfer existing knowledge and products to partners who can refine them to the benefit of overall worker safety, health, and well-being?
Do the Outreach Core Director and staff have expertise in OSH, and in developing, managing, and evaluating an outreach program in an institutional setting? Is there adequate administrative support for an effective outreach program?
Does the TWH Center propose new and innovative outreach approaches relevant to OSH?
Does the program facilitate the translation of OSH findings into the work environment at the local and the regional level? Are appropriate OSH constituents engaged in the program? Will the proposed activities have an impact on the practitioner or ability to affect OSH practices? Does the program description include coordination and collaboration across disciplines or explore and develop collaborative research opportunities? Does the project describe how to educate community partners and provide assistance and consultation to agencies and employers on TWH programs? Does the project include a cohesive plan for timely dissemination and translation of evidence-based techniques, tools, or programs that integrate health protection and workers’ well-being? Does the program description include an education plan to reach and involve underserved populations in their own communities and through their own organizations? Is there a plan to work with other academic departments to offer seminars, workshops, and courses on TWH for undergraduate and graduate students in various disciplines? Is the program designed to have an impact on the OSH practitioner community? Has appropriate consideration been given to collaboration with OSH stakeholders in the region? Are TWH center researchers encouraged to participate in outreach activities? Is there evidence of an interdisciplinary approach to the proposed outreach activities? Is there an adequate evaluation plan to determine if the Outreach Core is having a positive impact on the practitioner community, and worker safety and health? Do Center Advisory Committees provide evaluation input? Are there plans to incorporate feedback to improve outreach activities? Has the proposed Center demonstrated collaborative partnerships with local and state agencies, community organizations, universities, health care institutions, business groups, and labor organizations to carry out research activities, conduct outreach programs, promote awareness, and disseminate information? Is collaboration with NIOSH intramural scientists and programs also encouraged?
Are there sufficient resources for the successful delivery of high quality outreach efforts? Will the Outreach Core benefit from the environment in which the TWH Center is located? Is there evidence of an Institutional commitment to Outreach Core goals?
As applicable for the projects proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the HHS/CDC Requirements under AR-1 Human Subjects Requirements
If your proposed research involves the use of human data and/or biological specimens, you must provide a justification for your claim that no human subjects are involved in the Protection of Human Subjects section of the Research Plan.
Inclusion of Women, Minorities, and Children
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the policy on the Inclusion of Women and Racial and Ethnic Minorities in Research (http://www.cdc.gov/maso/Policy/Policy_women.pdf and http://www.gpo.gov/fdsys/pkg/FR-1995-09-15/pdf/95-22950.pdf#page=1) and the policy on the Inclusion of Persons Under 21 in Research (http://www.cdc.gov/maso/Policy/policy496.pdf).
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals, the committee will consider the progress made in the last funding period.
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
HHS/CDC policy requires that recipients of grant awards make research resources and data readily available for research purposes to qualified individuals within the scientific community after publication. Please see: http://www.cdc.gov/grants/additionalrequirements/index.html. Investigators responding to this funding opportunity should include a plan on sharing research resources and data.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. The applicant can obtain guidance for completing a detailed justified budget on the CDC website, at the following Internet address: http://www.cdc.gov/grants/interestedinapplying/applicationresources.html
Applications will be evaluated for scientific and technical merit by (an) appropriate, peer review group, in accordance with CDC peer review policy and procedures, using the stated review criteria.
As part of the scientific peer review, all applications:
For each application that is discussed, the overall impact score will be determined by a separate discussion of the peer review group after the Planning and Evaluation Core, each research project, the Pilot/Feasibility Project Research Program (if included in the application), and the Outreach Core have been discussed and scored.
Applications will be assigned to the National Institute for Occupational Safety and Health. Applications will compete for available funds with all other applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review for programmatic relevance and priority.
The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Any applications awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements. If the application is under consideration for funding, HHS/CDC will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf).
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be allowable as an expanded authority, but only if authorized by CDC.
All HHS/CDC grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement Part II: Terms and Conditions of Award (http:// www.hhs.gov/ asfr/ogapa/ aboutog/ hhsgps107.pdf).
Awardees must comply with the administrative requirements (AR) outlined in 45 Code of Federal Regulations (CFR) Part 74 or Part 92, as appropriate, as well as any additional requirements included in the FOA.
The following are additional policy requirements relevant to this FOA:
HHS Policy on Promoting Efficient Spending: Use of Appropriated Funds for Conferences and Meetings, Food, Promotional Items and Printing Publications
This policy supports the Executive Order on Promoting Efficient Spending (EO 13589), the Executive Order on Delivering and Efficient, Effective, and Accountable Government (EO 13576) and the Office of Management and Budget Memorandum on Eliminating Excess Conference Spending and Promoting Efficiency in Government (M-35-11). This policy apply to all new obligations and all funds appropriated by Congress. For more information, visit the HHS website at: http:// www.hhs.gov/ asfr/ogapa/acquisition/ effspendpol_memo.html).
Federal Funding Accountability and Transparency Act of 2006
Public Law 109-282, the Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), requires full disclosure of all entities and organizations receiving Federal funds including grants, contracts, loans and other assistance and payments through a single publicly accessible
Plain Writing Act
The Plain Writing Act of 2010 was signed into law on October 13, 2010. The law requires that federal agencies use "clear Government communication that the public can understand and use" and requires the federal government to write all new publications, forms, and publicly distributed documents in a "clear, concise, well-organized" manner. For more information on this law, go to: http:// www.plainlanguage.gov/ plLaw/index.cfm.
Tobacco and Nutrition Policies
The CDC supports implementing evidence-based programs and policies to reduce tobacco use and secondhand smoke exposure, and to promote healthy nutrition. CDC encourages all awardees to implement the following optional evidence-based tobacco and nutrition policies within their organizations. These policies build on the current federal commitment to reduce exposure to secondhand smoke, which includes The Pro-Children Act, 20 U.S.C. 7181-7184 that prohibits smoking in certain facilities that receive federal funds.
Healthy food service guidelines that at a minimum align with Health and Human Services and General Services Administration Health and Sustainability Guidelines for Federal Concessions and Vending Operations for cafeterias, snack bars, and vending machines in any facility under the control of the recipient organization and in accordance with contractual obligations for these services. The following are resources for healthy eating and tobacco free workplaces:
Applicants should state whether they choose to participate in implementing these two optional policies. However, no applicants will be evaluated or scored on whether they choose to participate in implementing these optional policies.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 75 (Part 75 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and CDC grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; CDC Project Officers are not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and HHS/CDC as defined below.
The PD(s)/PI(s) will have the primary responsibility for the following elements:
NIOSH Scientific Program Official
NIOSH/CDC recognizes the potential need for assistance, when appropriate, in such a complex and diverse project. An HHS/CDC/NIOSH Agency Scientific Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the Notice of Award.
The Scientific Program Official will be responsible for the following elements:
NIOSH Project Scientist
A NIOSH Intramural Scientist may serve as a Project Scientist to provide substantial scientific involvement and subject matter expertise for health protection with policies, programs, and practices that promote safety and health, prevent disease, and advance well-being in the workplace.
This person will assist the NIOSH Scientific Program Official in reporting or disseminating nonconfidential research results and relevant safety and health information to appropriate Federal, State, and local agencies, the scientific community, and other interested parties. His or her Specific responsibilities, in coordination with the NIOSH Scientific Program Official, may include the following:
Areas of Joint Responsibility
Joint responsibilities include participating in a conference or meeting to be held in conjunction with CDC Centers and Partners to disseminate research findings and outcomes to the public health community and stakeholders.
If more than one Center is funded, a Coordinating Committee (CC) may be formed to facilitate sharing of information about activities and accomplishments among the Centers. The following list describes responsibilities and characteristics of the CC:
Quarterly Calls between the Centers and NIOSH
Quarterly calls between the CC and NIOSH may occur to facilitate sharing of information about activities and accomplishments among the Centers. This activity will be determined by the Center grantees, the NIOSH Scientific Program Official, and the NIOSH Office for Total Worker Health® Coordination and Research Support.
Specific post-award coordination activities between Center grantees and NIOSH may include specific working groups about (or conference calls to discuss) emerging issues, ongoing/potential collaborations, accomplishments or challenges, and other topics related to integrating protection from work-related safety and health hazards with the promotion of injury and illness prevention efforts that advance worker well-being.
These activities will be determined by the Center grantees, the NIOSH Scientific Program Official, and the NIOSH Office for Total Worker Health® Coordination and Research Support.
Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement.
A final progress report, invention statement, equipment inventory list and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.
Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity depend upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.
Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law require information to be collected and reported by recipients: 1) information on executive compensation when not already reported through the SAM Registration; and 2) similar information on all sub-awards/ subcontracts/ consortiums over $25,000. It is a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable CDC grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. (http:// www.hhs.gov/asfr/ ogapa/aboutog/ hhsgps107.pdf) for additional information on this reporting requirement.
Recipient Organization must provide HHS/CDC with an original plus one hard copy of the following reports:
1. Non-Competing Grant Progress Report use form PHS 2590, posted on the HHS/CDC website http://www.cdc.gov/od/pgo/funding/forms.htm and at https://grants.nih.gov/grants/funding/2590/2590.htm), no less than 120 days prior to the end of the current budget period. The progress report will serve as the noncompeting continuation application and should include a matrix detailing information on subprojects including participating institutions, principle investigators or project directors, assurance numbers and IRB/IACUC approval dates.
2. Annual Center Report, suitable for public distribution, is submitted by September 30 each year, or the next business day. Email this report in PDF format to the NIOSH Scientific Program Official assigned to the TWH portfolio. In addition to the summary progress report required for noncompeting continuation applications, the Center Director prepares and submits separately, at the beginning of each fiscal year, a brief summary and statement of relevance of the Center and an updated contact list for all key personnel. The annual report should also include narrative descriptions of high-impact outcomes of individual programs that are noteworthy. This report will be made available on the NIOSH web page and will be used to provide information on TWH research and activities to Congress, the public, and others.
Specific guidance on report content will be provided by NIOSH.
3. Financial status report, no more than 90 days after the end of the budget period.
4. Final financial and performance reports, no more than 90 days after the end of the project period.
5. Final Invention Statement and Certification form
The Recipient Organization must forward these reports by the U.S. Postal Service or express delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this FOA.
Although the financial plans of the NIOSH provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interests of the Federal government.
A. Submission of Reports
The Recipient Organization must provide HHS/CDC with an original, plus one hard copy of the following reports:
1. Yearly Non-Competing Grant Progress Report (use form PHS 2590, posted on the HHS/CDC website, www.grants.gov and at http:// grants.nih.gov/grants/ funding/2590/ 2590.htm, is due 90 to 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application. Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.
2. Annual Federal Financial Report (FFR) SF 425 is required and must be submitted through eRA Commons within 90 days after the end of the calendar quarter in which the budget period ends.
3. A final progress report, invention statement, equipment/inventory report, and the final FFR are required 90 days after the end of the project period.
B. Content of Reports
1. Yearly Non-Competing Grant Progress Report - The grantee’s continuation application/progress report should include:
Description of Progress during Annual Budget Period: Current Budget Period Progress reported on the PHS 2590 (http:// grants1.nih.gov/ grants/funding/ 2590/2590.htm) with a detailed narrative report for the current budget period that directly addresses progress towards the Measures of Effectiveness included in the current budget period proposal.
Research Aims: list each research aim/project
Research Aim/Project: purpose, status (met, ongoing, and unmet), challenges, successes, and lessons learned
Leadership/Partnership: list project collaborations and describe the role of external partners.
Translation of Research (1 page maximum). When relevant to the goals of the research project, the PI should describe how the significant findings may be used to promote, enhance, or advance translation of the research into practice or may be used to inform public health policy. This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers, and other potential users. The PI should identify the research findings that were translated into public health policy or practice and how the findings have been or may be adopted in public health settings. Or, if they cannot be applied yet, this section should address which research findings may be translated, how these findings can guide future research or related activities, and recommendations for translation. If relevant, describe how the results of this project could be generalized to populations and communities outside of the study. Questions to consider in preparing this section include:
Public Health Relevance and Impact (1 page maximum). This section should address improvements in public health as measured by documented or anticipated outcomes from the project. The PI should consider how the findings of the project relate beyond the immediate study to improved practices, prevention or intervention techniques, inform policy, or use of technology in public health. Questions to consider in preparing this section include:
Current Budget Period Financial Progress
Status of obligation of current budget period funds and an estimate of unobligated funds projected provided on an estimated FFR.
New Budget Period Proposal
Publications/Presentations: Include publications/presentations resulting from this CDC grant only during this budget period. If no publication or presentations have been made at this stage in the project, simply indicate “Not applicable: No publications or presentations have been made."
IRB Approval Certification: Include all current IRB approvals to avoid a funding restriction on your award. If the research does not involve human subjects, then please state so. Please provide a copy of the most recent local IRB and CDC IRB, if applicable. If any approval is still pending at time of APR due date, indicate the status in your narrative.
The grantee’s continuation application/progress report should include (additional information on section B "Content of Reports"):
Successes: A description of progress on completing activities outlined in the work plan and any additional successes achieved in the past year (identified through evaluation results or lessons learned, for instance).
Challenges: A description of any challenges that might affect the ability to achieve annual and project-period outcomes, conduct performance measures, or complete the activities in the work plan, plus additional challenges encountered in the past year (identified through evaluation results or lessons learned, for instance).
Outputs, Outcomes, and Research to Practice (R2P): Provided in the purpose section of each progress report; a brief statement about expected outputs, outcomes, and/or r2p culmination of the proposed project.
Outputs are the immediate products or direct result of project activities, including publications, reports, conference proceedings, presentations/posters, investigator career development activities, databases, tools, methods, guidelines, recommendations, and education and training materials. List the products, tools, guidance, or policy documents developed and whether they are available for use by others; specify when and how they are being shared; and report on methods generated, their implementation, and their success.
Outcomes can be measured over time as either intermediate or end. Intermediate outcomes are specific changes that occur as a result of project activities, such as public or private policy changes; training or workshops based on project outputs; citations in the literature; inventions and patents; and adoption of technologies or methods developed.
r2p is the transfer and translation of knowledge, interventions, and technologies into highly effective prevention practices and products that are adopted into the workplace.
2. Annual Federal Financial Reporting
The Annual Federal Financial Report (FFR) SF 425 is required and must be submitted through eRA Commons within 90 days after the end of the calendar quarter in which the budget period ends. The FFR should only include those funds authorized and disbursed during the timeframe covered by the report. The final FFR must indicate the exact balance of unobligated funds and may not reflect any unliquidated obligations. There must be no discrepancies between the final FFR expenditure data and the Payment Management System's (PMS) cash transaction data.
Failure to submit the required information in a timely manner may adversely affect the future funding of this project. If the information cannot be provided by the due date, you are required to submit a letter explaining the reason and date by which the Grants Officer will receive the information. All CDC Financial Expenditure data due on/after October 1, 2012 must be submitted using the FFR via the eFSR/FFR system in the eRA Commons. All Federal Reporting in the Payment Management System is unchanged. All new submissions should be prepared and submitted as FFRs.
CDC's implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs will be 90 days after the end of the calendar quarter in which the budget period ends. Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter. For example, if the budget period ends 1/30/2012, the annual FFR is due 6/30/2012 (90 days after the end of the calendar quarter of 3/31/2012). Due dates of final reports will remain unchanged. The due date for final FFRs will continue to be 90 days after the project period end date.
Grantees must submit closeout reports in a timely manner. Unless the Grants Management Officer (GMO) of the awarding Institute or Center approves an extension, grantees must submit a final FFR, final progress report, and Final Invention Statement and Certification within 90 days of the end of grant period. Failure to submit timely and accurate final reports may affect future funding to the organization or awards under the direction of the same Project Director/Principal Investigator (PD/PI).
FFR (SF 425) instructions for CDC grantees are now available at http:// grants.nih.gov/ grants/forms.htm. For further information, contact GrantsInfo@nih.gov. Additional resources concerning the eFSR/FFR system, including a User Guide and an on-line demonstration, can be found on the eRA Commons Support Page: http://www.cdc.gov/grants/interestedinapplying/applicationresources.html
FFR Submission: The submission of FFRs to CDC will require organizations to register with eRA Commons (Commons) (https://public.era.nih.gov/chl/public/search/commonsRegisteredOrgs.era). CDC recommends that this one time registration process be completed at least 2 weeks prior to the submittal date of a FFR submission.
Organizations may verify their current registration status by running the “List of Commons Registered Organizations” query found at: http://era.nih.gov/commons/. Organizations not yet registered can go to https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp for instructions. It generally takes several days to complete this registration process. This registration is independent of Grants.gov and may be done at any time.
The individual designated as the PI on the application must also be registered in the Commons. The PI must hold a PI account and be affiliated with the applicant organization. This registration must be done by an organizational official or their delegate who is already registered in the Commons. To register PIs in the Commons, refer to the eRA Commons User Guide found at: http:// era.nih.gov/ commons /index.cfm.
3. Final Reports
Final reports should provide sufficient detail for CDC to determine if the stated outcomes for the funded research have been achieved and if the research findings resulted in public health impact based on the investment. The grantee’s final report should include:
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Commons Help Desk (Questions regarding eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Maria Lioce, MD, Program Official
Centers for Disease Control and Prevention
1600 Clifton Road NE, Mailstop E74
Atlanta, GA 30329-4018
Nina Turner, PhD
Scientific Review Officer
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention.
1095 Willowdale Road
Morgantown, WV 26505-2845 USA
Mary Pat Shanahan
Grants Management Specialist
OD, Environmental, Occupational Health and
Injury Prevention Services Branch–Team 1
Procurement and Grants Office
626 Cochrans Mill Road
Pittsburgh, PA 15236-0070
Other CDC funding opportunity announcements can be found at www.grants.gov.
All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Awards are made under the authorization of Sections of the Public Health Service Act as amended and under the Code Federal Regulations. This program is described in the Catalog of Federal Domestic Assistance and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. Awards are made under the authorization of the Occupational Safety and Health Act of 1970, Section 20(a) and 21(a) (29 USC 669(a) and 29 USC 670), Federal Mine Safety and Health Act, Section 501(a), 30 USC 951 (a); Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 75. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
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