It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) 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. 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.

Part 1. Overview Information
Part 2. Full Text of the 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

Traditional occupational safety and health protection programs have primarily concentrated on ensuring that work is safe and that workers are protected from the harms that arise from work itself.

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, and evolving employment patterns. The changing workplace environment also contributes to stress, mental health effects, chronic diseases and other impacts on population health and well-being.

At the time of publishing this FOA, the COVID-19 pandemic has changed the workplace environment and increased worker concerns about economic insecurity, mental health and well-being, isolation and other challenges of working remotely, and reintegrating back into the workplace safely. New and daily challenges in the workplace, families, and communities create emerging conditions that increase allostatic loading (the wear and tear of ongoing stress experienced by individuals) and may affect cognitive reserve and resilience, and potentially lead to cognitive decline. Gender, age and socioeconomic characteristics of workers may affect their sensitivity to these emerging conditions.

The National Institute for Occupational Safety and Health s (NIOSH) TWH Program builds on four decades of scientific knowledge through the recognition that work is a social determinant of health; job-related factors such as wages, hours of work, workload and stress levels, interactions with coworkers and supervisors, access to paid leave, and health-promoting workplaces all can have an important impact on the well-being of workers, their families, and their communities. TWH 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. The NIOSH TWH program supports ground-breaking research and practical applications that address 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.

Evolution of the NIOSH TWH Program

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.

In 2005, NIOSH published a Funding Opportunity Announcement (FOA), Centers for Excellence to Promote a Healthier Workforce ,inviting applications to establish Centers (TWH Centers of Excellence) 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. The Centers of Excellence (COE) are crucial to gaining knowledge that can help workers, employers, and communities. NIOSH funded two Centers in 2005 and added a third Center 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. Also, in 2011, NIOSH renamed its efforts from WorkLife to the TWH Program. In addition to continuing support of the extramural COE, 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 TWH) to coordinate and advance extramural and intramural efforts as an active part of the National Occupational Research Agenda (NORA) priority areas.

In 2015, NIOSH published a 3rd FOA (PAR-15-361) and currently NIOSH funds six Centers of Excellence for TWH. Centers are located at the Colorado School of Public Health, University of Colorado Anschutz Medical Campus in Aurora, CO; the University of Connecticut/University of Massachusetts in Lowell, MA; Harvard University in Boston, MA; the University of Iowa in Iowa City, IA; Oregon Health and Science University in Portland, OR; and at the University of Illinois-Chicago in Chicago, IL. For a history of funded TWH COE, see https://www.cdc.gov/niosh/twh/centers.html.

The National TWH Agenda (2016-2026) was published in April 2016, and focuses on advances in TWH in four domains of research, practice, policy, and capacity-building. The CDC/NIOSH TWH Program continues to evolve in response to demands for research and solutions to the safety, health, and well-being challenges that workers and their employers face.

Rationale for TWH

More than 20 years ago, researchers (McLeroy et al. 1988; DeJoy and Southern 1993) argued for taking an ecological or systems approach to Occupational Safety and Health (OSH). This approach acknowledges that worker injury and illness can have myriad causes and therefore requires coordinated interventions that consider individual as well as occupational risk factors. A comprehensive collection of conceptual and theoretical publications of research perspectives on TWH 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 TWH Symposium hosted by the University of Iowa Healthier Workforce Center of 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 TWH in small, medium, and large workplaces, NIOSH funded an Institute of Medicine workshop in May 2014. This workshop sought input from a diverse number of stakeholders regarding their experiences with integrating workplace safety and health interventions.

Science and practices on the TWH 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. Over 350 attendees from a broad spectrum of fields, including occupational safety, ergonomics, worksite health, occupational medicine, academia, and human resources discussed health and safety challenges and opportunities in industry and worker populations; methodologies and innovations related to TWH interventions; and common barriers and strategies to implementing integrated interventions.

A 2nd International Symposium to Advance TWH, Work & Well-Being: How Safer, Healthier Work Can Enhance Well-Being , was held on May 8 11, 2018, with the goals to reaffirm the commitment to the safety and health of workers by prioritizing safety in all jobs, redesigning the way work is organized to promote a workplace environment that optimizes healthy opportunities through leadership, management and supervision, and revealing new strategies to redesign work to improve worker well-being through new links and solutions for work and chronic disease risks, and novel research methods and interventions for advancing TWH. Nearly 400 participants from nonprofit, government, private, and academic institutions shared their perspectives, research findings and successful practical applications of TWH.

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.

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. Since this review, dozens of additional peer-reviewed research publications have been authored and published.

As the TWH field continues to evolve, an increased need has developed for trained occupational safety and health professionals with the knowledge, skills, and experience to apply integrated approaches for protecting workers from job hazards and for promoting worker well-being.

Within the National TWH Agenda (2016-2026), NIOSH outlines strategic goals for building capacity, and identifies core competencies and specific professionals who would benefit from this education and training. At both the 2014 and 2018 International Symposia to Advance Total Worker Health, research and training experts from academia, business, labor and government organizations explored subjects and issues relevant to current training initiatives and confirmed the needs and benefits of a multidisciplinary training program. In addition, a Roundtable discussion convened in November 2017, that brought experts and key stakeholders together to further identify strategies for effective training curricula and programs (certificate, continuing education and others). These efforts culminated in the drafting of core competencies for TWH professionals, and the identification of target audiences and the means for delivering needed education and training (Newman et al. 2020).

NIOSH has developed the NIOSH Strategic Plan: FY’s 2019-2023 that introduces strategic, intermediate, and activity goals that guide occupational health and safety research priorities and service work. The strategic goals represent the major health and safety issues facing the U.S workforce. NIOSH has identified certain areas where extramural research is specifically encouraged to fill a gap or provide a capacity that NIOSH cannot. The seventh strategic goal is to promote safe and healthy work design and well-being, this goal includes the TWH intermediate goals that embrace specific actions needed to achieve, or help achieve, the strategic goal.

NIOSH also established the NIOSH TWH Affiliate Program partnership 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 nonprofit organizations. Today, approximately 50 affiliate organizations across the nation assist NIOSH with TWH research, practice, and training efforts. On July 9, 2019, NIOSH and partners published a 17-chapter edited volume on TWH, with contributions from over 60 researchers and practitioners at the forefront of the TWH, that brings together the state-of-the-science integrative prevention strategies that safeguard and ensure the health and well-being of workers https://www.cdc.gov/niosh/twh/newsletter/twhnewsv8n2.html#7.

Building on previous accomplishments, further efforts are necessary to continue to develop effective policies, programs and practices to address the challenges and needs of the 21st century workforce, protect worker safety and health, and achieve greater levels of worker well-being.

TWH High Priority Topic Areas

To address evolving challenges and opportunities related to worker safety, health, and well-being, the TWH program highlights critical priority areas and emerging issues currently relevant to advancing worker well-being. These are not intended to be an exhaustive list, imply a hierarchy of importance, or be mutually exclusive. The program’s latest research interests and needs are:

• Opioid and Other Substance Use Disorders in the Workplace
• TWH Outreach, Education, and Training
• Measuring Worker Well-Being
• Future of Work
• Healthy Work Design and Well-Being
• Workplace Mental Health and Worker Well-Being

Interested applicants may refer to the following website for more information and references https://www.cdc.gov/niosh/twh/priority.html.

TWH Research and Translation Topic Areas

The broad spectrum of issues and research topics related to TWH can be considered for the purposes of this announcement (TWH Relevant Issues). The primary areas of current focus have been identified in a volume of papers published in 2019 (Edited Volume of TWH). Present research opportunities stem in part from the growing evidence of the link between work and health, moving beyond the identification and remedy of workplace hazards and chemical and physical exposures. Further, changes in how and where people work, including changes in technology, economic globalization, and the impacts of the increase in nonstandard work arrangements, and the development of new forms of work, present important opportunities for research and translation efforts.

Healthy People 2020 and the National Occupational Research Agenda

The United States Public Health Service (PHS) is committed to achieving nationwide improvements in health for a society in which all people live long, healthy lives. The vision, mission, and goals are found in Healthy People 2020. The objectives of Healthy People 2020 related to occupational safety and health (OSH) are primarily addressed through the National Occupational Research Agenda (NORA). NORA, established by NIOSH and its partners to stimulate research and improve workplace practices, provides a framework to guide OSH research. The goal of NIOSH research programs is to support relevant, high quality, effective projects that demonstrate impact in reducing occupational disease and injury. Detailed information about the NORA Program Portfolio can be found on the NIOSH Program Portfolio website.

Looking forward, Healthy People 2030 is the fifth edition of Healthy People. It aims at new challenges and builds on lessons learned from its first 4 decades. HHS has approved the Healthy People 2030 framework which is based on recommendations made by the Secretary s Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030.

NORA Sectors and Health and Safety Cross-sectors

In the Project Description/Abstract, state which industry sector(s) and health and safety cross-sector(s) the proposed work will address. Provide a clear rationale for how the intended outcomes of the proposed project will contribute to the specified strategic and intermediate goals. Provide a statement about which NORA sector(s) and cross-sector(s) and which NIOSH intermediate goals of the NIOSH Program Portfolio are being addressed (if applicable).

Public Health Impact

TWH Centers are expected to have a significant and sustained 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.

Relevant Work

NIOSH has supported extramural Centers of Excellence to Promote a Healthier Workforce since 2005 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.

The purpose of this FOA is to solicit meritorious applications for Centers of Excellence for TWH to develop and conduct multidisciplinary research, intervention, outreach and education, and evaluation activities that advance the overall safety, health, and well-being of the diverse population of workers in our nation.

Proposed projects are not expected to span the full research continuum (that is, for a scientific finding to be discovered, tested as an intervention, and then implemented) all within a single 5-year project period. Centers are expected to address their research goals and objectives by using appropriate approaches that include a range of activity from basic research to intervention, translation, and outreach.

Centers of Excellence for TWH are expected to conduct research, planning and evaluation, and outreach and education that integrate traditional occupational safety and health (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 has published a national 10-year agenda that is intended to define and prioritize relevant areas of emphasis. See the National TWH Agenda (2016-2026) webpage for more information.

The priority areas in the Agenda include:

• Research: Advance and conduct basic/etiologic, intervention, translational, and surveillance research that builds the evidence base for effectively integrating protection from work-related safety and health hazards with promotion of injury and illness prevention efforts to advance worker well-being.
• Practice: Increase the awareness and adoption of effective 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.
• Policy: Create guidance for policies that integrate protection from work-related safety and health hazards with promotion of injury and illness prevention efforts to advance worker well-being.
• Capacity-Building: Build professional capacity to strengthen the TWH workforce and TWH field to support the development, growth, and maintenance of 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.

These priority areas provide a general outline for the direction the field will take in the coming years. A detailed framework for the TWH approach is still evolving. As a start, NIOSH has developed an abbreviated catalogue of a wide-ranging list of issues that are relevant to the advancement of worker well-being (Issues Graphic). Currently a set of 76 issues are grouped into ten broad topic categories.

NIOSH has developed additional tools that can guide researchers and practitioners seeking to advance worker safety, health, and well-being. One is the NIOSH TWH Research Program Logic Model. Another is a conceptual tool that establishes a hierarchy for the different means of approaching safety and health in the workplace that builds in the traditional prevention principles of the NIOSH Hierarchy of Controls. The TWH Hierarchy can be used as a model for determining how to implement the most feasible and effective TWH strategies in the workplace, and emphasizes an approach in which organizational-level interventions are considered before individualized, worker-specific interventions.

Centers will have different strengths experiences, capacities and focus areas. Clear communication and coordination between centers and with NIOSH is expected for research, outreach, evaluation, and emerging issues that are multi-regional or national in scope.

Structure of TWH Centers: Components, Essential Cores, Programs, and Projects

NIOSH TWH Centers of Excellence provide interdisciplinary research and outreach to build the scientific evidence base for TWH policies and programs. This facilitates development of evidence-based policies and practices that can be mobilized, transferred, or incorporated into workplaces. It also helps foster partnerships among academic institutions, businesses, labor, non-profit organizations, government, and the community. Through these partnerships, TWH Centers can identify opportunities for implementation, education and training, and building overall capacity across all sizes and types of industries improve workplace and worker safety and health nationwide.

Applicants must keep in mind the components essential to Center structure and function detailed below in providing an overall description of the proposed Center, addressing the research objectives of the most critical issues from the TWH-related goals that are found in the NIOSH Strategic Plan: FY’s 2019-2023 (specifically in the NIOSH Priority Goals for Extramural Research), to include TWH-related intermediate goals 7.11 (Construction), 7.12 (Healthcare and Social Assistance), 7.14 (Public Safety), and 7.15 (Services); the TWH Priority Areas and Emerging Issues; and the specific strategic, intermediate, and activity/output goals of National TWH Agenda (2016-2026).

Table 1 summarizes funding information for the required and optional cores and components for TWH Centers.

Table 1. Summary of TWH Center Components

TWH Center Components	Funding Information	Required	Optional
EVALUATION AND PLANNING CORE Up to 25% of total costs per year X Center Administration X Evaluation Program X Emerging Issues Program Up to $50K direct costs/year X
OUTREACH CORE Up to 25% of total costs per year X Communication and Dissemination Activities X Education Activities X Implementation Activities X
RESEARCH PILOT PROJECT PROGRAM Up to $50K direct costs/year X Short-term projects (12 18 months); up to $25K direct costs per project
RESEARCH PROJECTS X
Small Research Projects Type 1 Up to 2-year project period $50K direct costs/year X Small Research Projects Type 2 Up to 2-year project period $275K direct cost/project X Applicants may submit either type of small research project. Research Strategy page limit is 6-pages.
Large Research Projects 3 to 5-year project period Greater than $250K direct costs/year X Research Strategy page limit is 12-pages
Note: A minimum of 2 and a maximum of 5 projects. At least 1 large project must be submitted

The following required components enable Centers of Excellence to cohesively address their goals and objectives for providing impact:

Evaluation and Planning Core: Required

• Center Administration (Required)
• Evaluation Program (Required)
• Emerging Issues Program (Optional)

Outreach Core: Required (each of the following is required)

• Communication and Dissemination Activities
• Education Activities
• Implementation Activities

Research Pilot Project Program (optional)

Research Projects: Required

• Small Research Projects
• Large Research Projects

Evaluation and Planning Core (Required)

The Evaluation and Planning Core is necessary to carry out the objectives of the Center and plan for new directions. Applicants may request up to 25% of total costs per year for the Evaluation and Planning Core, which includes required and optional components.

The Evaluation and Planning Core provides oversight, leadership, and management for the center; engages in long-range planning, coordination, and implementation of work that crosses multiple cores (such as the translation of scientific findings into educational materials or outreach efforts); and establishes and maintains Center advisory committees. Collaborative projects with other TWH Centers should include the Evaluation and Planning Core for oversight and coordination. All evaluation efforts, from specific project or program evaluation activities to center-wide evaluation, should be initiated and managed within this core.

Center Administration (Required)

The Center Administration is a required component of the Evaluation and Planning Core. Responsibilities of this component include establishing and maintaining advisory committees, ensuring human subject and animal use protocols are obtained and maintained, and meeting all reporting requirements as detailed in the notice of award.

The ability of the center's principal investigator and center 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 is 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 can provide scientific leadership for the administration and integration of the program. Elements of an effective evaluation and planning core include (1) the coordination and integration of Center components and activities; (2) the organization and input of the Advisory Committee(s); and (3) a plan for interactions with other NIOSH funded centers and other organizations, and communities.

The Evaluation and Planning 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 (4) organize and make available facilities to center partners to conduct activities such as seminars, workshops, reference collection, and computer support.

This core manages, monitors, and coordinates all research projects within the center.

The Center Director must commit at least 1.2 person-months effort (direct and/or in-kind) to the Core. Each member of the internal advisory committee should provide a minimum of 0.6 person-months effort commitment for the COE Evaluation and Planning Core.

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 cores, programs and projects.

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.

Note: An expert may be considered for service on multiple advisory committees as long as conflicts of interest are fully disclosed and properly managed. Committee members must be cautious about serving on advisory committees for multiple TWH Centers if they are competing for the same funding. Caution is also advised to ensure that over commitment of time does not occur.

Center Administration: Centers Directors Meetings. These meetings provide an opportunity for TWH COE leaders across the country and NIOSH Program Officials to discuss developing and emerging issues currently relevant to advancing worker well-being and to further encourage a spirit of collaboration in addressing challenges and advances in workers' safety and health. The Center Director and another key personnel should attend. A minimum of two one-day Centers Directors Meetings will be held throughout the project period.

Center Administration: International Symposium to Advance TWH. The Symposium’s focus is to advance TWH research, practice, policies, and programs. Bringing together experts from academia, labor, business, and government, the Symposium examines opportunities to make workplaces safer and improve the health and well-being of the workforce across the nation and world. These meetings can be attended by key personnel and will be held at a location agreed-upon site following consultation with NIOSH staff.

Evaluation Program (Required)

Applicants should provide a detailed evaluation plan identifying expected outputs and outcomes/impact for the TWH Center and for each Center program.

Logic Model. The evaluation program must include 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. This includes defined metrics for measuring and tracking outputs and outcomes. It also describes the long-term goals and impact of the Center and each Center core. Applicants should describe Inputs, activities, outputs, intermediate outcomes, and expected long-term outcomes in their logic models. The CDC document "Applying the Knowledge to Action Framework" (https://www.cdc.gov/chronicdisease/pdf/K2A-Framework-6-2015.pdf) is a useful resource.

Evaluations. 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.

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.

Emerging Issues Program (Optional, strongly encouraged)

This program is intended to assist centers in addressing new or emerging problems within their region that were not present or recognizable at the time of application. Applicants may propose budgets up to $50K of direct costs per year for this program (These costs should be considered in the 25% total costs per year limitation for this Core). As the specific work within this program is inherently difficult to describe in detail at the time of application, applicants should describe the process by which they plan to identify, prioritize, and address newly arising concerns. Applicants should describe how the program will be managed and utilized to respond to emerging issues. Once these funds are awarded, centers will have some latitude in using them to address new or emerging problems within their region. Centers must report the use of these funds, including rationale and any related outcomes, to the NIOSH Scientific Program Official. While NIOSH encourages frequent communication and updates including emerging issues and budget, at a minimum reporting should occur as part of the noncompeting continuation process.

Outreach Core (Required)

The purpose of the Outreach Core is to ensure that evidence-based approaches, technologies, guidelines, policies, best practices, or similar activities are promoted and implemented in affected populations such that workers and their associated work environments benefit. Much of the work in the Outreach Core will be implemented through partnerships and collaborations with nonprofit organizations, community groups, industry groups, employers, or similar entities.

Applicants may propose budgets up to 25% of total costs per year to support work within this core which is comprised of three activity groups:

Communication and Dissemination, Education, and Implementation. These are vital to center efforts to deliver science-based information to workers across the country. Outreach can increase access to, and adoption of, evidence-based best practices for worker safety and health. Through partnerships with public and private regional, state, community, and nonprofit organizations, diverse and high-need groups may be reached. These partnerships can provide opportunities to engage in dialogue to better understand the needs, questions, and concerns of those intended to benefit from the research NIOSH supports.

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 TWH 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 TWH 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.

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 and well-being, 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

• Raise awareness and increase public access to timely evidence-based knowledge and practice through partnerships with key recipients effectively (focused dissemination). Key recipients may include but are not limited to academia, labor, industry sectors, industry stakeholders, small businesses, low-wage workers, immigrant populations, supervisors, human resources, and insurance brokers.
• Advance and promote the implementation and adoption of promising or best practices, programs, and policies that advance the safety, health, and well-being of workers.
• Foster strategic partnerships and collaborations to actively participate in research and disseminate evidence-based practices.
• Explore feasibility, develop necessary tools, and/or develop partnerships to strengthen existing or emerging TWH research and practice.
• Partner with NIOSH, other NIOSH-funded Centers, and other organizations.

Education 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:

• Provide educational opportunities to researchers and practitioners on issues relevant to the integration of health protection with interventions that comprehensively promote workers well-being.
• Foster the development of communities of practice that advance the development of population- and outcome-specific information to improve the safety, health, and well-being of workers.
• Involve special emphasis on the education of and outreach to underserved populations in educational activities by designing programs to reach these groups in their own communities and through their own organizations.
• Expand practitioner-based national and regional networks and resources that aim to build capacity and support for TWH principles and practices.
• Take necessary steps toward transferring existing knowledge and products to partners who can refine them to the benefit of overall worker safety, health, and well-being.
• 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 .

Implementation Activities

Implementation science is the scientific study of methods to promote the systematic uptake of research findings and other evidence-based practices into routine practice to improve relevance and impact of occupational safety and health research, education and outreach. It consists of creating awareness; engagement and Interactions; decisions to adopt, implementation, confirm/sustain and evaluate. The goal of the outreach implementation activities is to increase capacity of organizations, groups of professionals, workers or community members to engage with, implement, adopt, and sustain TWH principles that promote safety and health, prevent disease, and advance the well-being of American workers in the workplace. For more guidance on implementation activities, outputs or products and outcomes refer to the Total Worker Health Centers of Excellence: Logic Model for Outreach Core. See below for details of the outreach logic model.

Examples include, but are not limited to, the following:

• Conduct assessment activities with organizations, workers, or community members (e.g. TWH needs assessments, or readiness assessments). Outputs could include: the number and type of existing activities, initiatives, strategies, and policies; identification of communication and organizing structures such as coalitions or collaboratives; documentation of learning or intervention needs for target audiences; documentation of barriers and facilitators of worker health.
• Provide technical assistance/consultation to organizations and community members (e.g. One-on-one or small group expert consultations. Outputs could include: the number of hours spent providing technical assistance; number of meetings, time, attendance; number of scientists and practitioners, and professional networks, and organizations, number of industries or community groups represented, number of multi-group collaboratives; number of technical assistance partnerships formed; number of evaluation measures for knowledge, skills, and practice.
• Initiate community level change to increase the impact of TWH principles (e.g. Develop a collaborative learning community to share information and resources, Coalition building to foster collaboration to achieve common goals and activities). Outputs could include number of meetings, time, attendance; number of materials exchanged, number of collaborative projects or events, pre-post satisfaction in service delivery, reported quality and usefulness of information, number of multi-sector partners/ people participating.

The Outreach Core Logic Model is a guidance graphic that shows the shared relationships among the COEs program resources, activities, outputs, outcomes, and impact. It provides examples of measurable activities, outputs, outcomes (short and long-term), and future impact in three Outreach Core areas of Communication/Dissemination, Education/Training, and Implementation.

The guidance graphic is not meant to be all-inclusive nor would a proposed Center measure all elements provided within the graphic. A Center would select those elements that are important to the mission of the Center as well as meeting the identified needs of the community, region, etc.

Total Worker Health Communication and Outreach Logic Model

	Activities		Outputs	Short-term Outcomes		Long-term Outcomes	Future Impact
Outreach Communication Dissemination	Present or publish TWH research findings Share educational materials on websites/social media Maintain and expand partnership (i.e. government, business, community) to increase TWH awareness Develop resources to increase adoption of TWH practices	# of presentations and papers # of dissemination channels (websites, Twitter, Facebook, etc.) # of partners, coalitions and materials for events and campaigns # of resources (toolkits, handouts, webinars, online modules, etc.)		Increased TWH awareness and strengthened existing or emerging TWH knowledge base Increased traffic and engagement with TWH websites and social media Increased relationship building among partners Adoption of curriculum/toolkits across industries and worker groups		Increased research to practitioner and community connections Increased multisector networks Increased TWH capability through example and support Increased implementation and adoption of TWH activities Increased collaboration between TWH Centers, practitioners, and community organizations	Improved safety, health, and well-being among organizations and communities Evidence-based workplace and public policy changes Collaboration between TWH Centers, practitioners, and community organizations Increased knowledge, use and dissemination of TWH approaches across industries and communities Increased capacity for TWH in practice Diffusion of culture of TWH across industry sectors, professionals, practitioners, and communities
Education Training	Customize TWH education content based on needs and feedback of different audiences Deliver TWH trainings/workshops through multiple formats (e.g., in person, online)		Workshop materials and educational content Evaluation measures (Knowledge/skills pre-post, focused discussions with stakeholders, etc.) # of workshops, trainings, resources, participants	Increased TWH knowledge/skills TWH research findings integrated into trainings/workshops/materials Increased learning opportunities and TWH-trained practitioners, professionals, researchers, and students		Tailored content to address new and diverse needs and audiences TWH concepts integrated into workplace practice through trained TWH professionals Develop multi-disciplinary approach to TWH research, practice, and policy
Implementation	Conduct needs assessments with organizations, workers, or community members Provide technical assistance/consultation to organizations and community members Initiate community level change to increase the impact of TWH principles		# and type of existing activities, initiatives, strategies, and policies Documentation of learning or intervention needs for target audience # of meetings, hours spent providing TA to partners Surveys assessing satisfaction, information quality and usefulness # of multi-sector partners	Increased knowledge, skills, confidence to implement TWH Inclusion of TWH principles and resources in organizational and community programs or initiatives	Increased integration of TWH into policy and systems Adoption of TWH principles and resources in organizational and community programs or initiatives Increased participation of workers leading initiatives Leadership support and resource commitment for TWH implementation

Research Pilot Project Program (Optional)

The Research Pilot Project Program is an optional component and must fit within the overall funding limits of the Research Projects component. The Center Director may request a maximum of $50K direct costs per year for the Research Pilot Project program.

For this program Centers should have a process for funding short-term projects (12 18 months and up to $25K direct costs per project) to explore the feasibility of new projects in any of the Center's program areas. This program will enable investigators to collect enough data to pursue support through other funding mechanisms.

The pilot program must include a process for soliciting pilot projects with peer review and award mechanisms.

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.

These projects are intended to address the exploration and development of new, creative intervention-effectiveness research, education, and translation projects.

These projects should not be used to supplement ongoing research or to support previously funded research that no longer has funding support. The intent of this program is to foster new and creative research while also increasing the breadth and depth of the program through interaction and support of other interested researchers and stakeholders from the Center s region.

Pilot projects can include, but are not limited to, the following:

• Providing initial support for new investigators to develop innovative TWH concepts and approaches of investigation that address the Center’s mission and objectives.
• Encouraging investigators from other fields of study to apply their expertise to approaches, methods, and barriers in implementing health protection and workplace well-being.
• Allowing research students to work with experienced researchers in the field to develop the knowledge to conduct future research programs that integrate health protection with activities that advance the overall well-being of workers.
• Developing new partnerships to address emerging safety, health and well-being concerns.
• Providing initial support for a translational/research-to-practice project.
• Obtaining preliminary data, mining existing datasets, or pursuing critical data gaps.

Although the administrative framework for management of the Center’s Research 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:

• Appropriate announcement of funding available for pilot projects and solicitation of proposals.
• Merit review of proposals. Copies of all proposals, with documentation of their reviews, relative ranking, and final action must be retained by the Center and must be available to the NIOSH Office of Extramural Programs (OEP) Program Official and to reviewers participating in any site visits conducted by NIOSH.
• Recording and reporting results of each funded project (abstract, publications, subsequent grant applications, etc.) should be available to the NIOSH OEP Scientific Program official and to reviewers participating in site visits conducted by NIOSH. Input from the Internal and External Advisory Committees into the management of the program is strongly recommended.
• Appropriate IRB review and approval are required for all pilot projects involving human subjects, to ensure protection of their rights and welfare (see 45 Code of Federal Regulations part 46). This must be obtained upon project funding and applies also to projects conducted by other institutions. The IRB must be registered with the DHHS Office of Human Research Protections and must have a current Federal-wide Assurance Number. Documentation of IRB approval of protocols and copies of currently approved consent forms must be maintained in the Center’s administrative files. In addition, all Center project protocols must comply with all applicable Federal and State regulations.

Research Projects (Required)

It is anticipated that proposed research activities will vary widely in terms of topic/focus, degree of difficulty, and required resources. Proposed research projects should clearly fit within the overall goals and objectives of the TWH COE. The center component should not simply be a collection of projects whose focus is driven by available expertise at the applicant institution. Instead, the focus should be on projects that are individually meritorious while also filling a data gap or role in the center s overall efforts to address goals and objectives.

The purpose of the Research Projects component is to identify research needs that contribute to the Center’s goals and objectives, develop research strategies and projects in response to the identified needs, and subsequently manage, monitor, and coordinate all research projects within the center. Research activities can vary widely, from pilot or feasibility studies that are minimally resourced to large projects that require significant investment in personnel, equipment, time, and space.

The applicant should describe how all research projects within the center will be managed, monitored, and coordinated.

This component is essential to advance research relevant to the strategic goals described in the NIOSH Strategic Plan: FY’s 2019-2023 (specifically those provided in the NIOSH Priority Goals for Extramural Research), to include TWH-related intermediate goals 7.11 (Construction), 7.12 (Healthcare and Social Assistance), 7.14 (Public Safety), and 7.15 (Services); the TWH Priority Areas and Emerging Issues; and the specific strategic, intermediate, and activity/output goals of the National TWH Agenda (2016-2026).

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.

Centers will likely have projects in many of the 4 research categories. There are no funding limits established for individual projects or research categories.

NIOSH welcomes research projects with a range in scope and duration that meet the specific review criteria for the research projects in the FOA. The range of projects may include projects with preliminary supporting data, and exploratory or developmental research projects that identify and address novel scientific ideas or new model systems, tools, or technologies. NIOSH recognizes that TWH research incorporates a wide array of multidisciplinary research topics and uses diverse methods that may benefit from a range of disciplinary perspectives. NIOSH expects that these diverse methods and research perspectives will be apparent in these applications.

Applicants will not be required to propose a specific number of projects within each research category; however, the center must include a minimum of 2 and a maximum of 5 projects. At least 1 large project must be submitted.

Small Projects: Maximum two-year project period with a 6-page limit for the research strategy.

Limited funding is provided for a short period of time to support a variety of types of projects, including:

• Small projects with a maximum budget of $50K per year in direct costs and limited scope that use widely accepted approaches and methods within well-established fields. Research activities can vary widely, from pilot or feasibility studies, collection of preliminary data, secondary analysis of existing data, development of research methodology, etc. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies,

and/or

• Small projects with a maximum of a two-year budget total of $275K in direct costs, for assess the feasibility of exploratory and novel research that has the potential to lead to advances in health research. These projects could assess the feasibility of exploratory and novel research that has the potential to lead to advances in health research. These projects do not require extensive background material or preliminary information. Although no preliminary data are required, the COE may include little preliminary data in support of the proposed research if it is available.

Large Projects: Three to five-year project period with a budget of greater than $250K in direct costs per year and have a 12-page limit for the research strategy.

Long-term projects that require significant investment in personnel, equipment, time, and space. These projects are designed to increase knowledge in a well-established area. They are used to support a discrete, specified, circumscribed research project. Preliminary data in support of the proposed research are required.

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 TWH 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.

Basic/Etiologic Research

Etiologic research builds a foundation of scientific knowledge upon which future interventions are based. Except for projects categorized as surveillance, which merit their own category, this research identifies and documents the nature and extent of an OSH problem. Examples include, but are not limited to:

• Advance and conduct etiologic research that builds the evidence base for effectively integrating health protection with policies, programs, and practices that promote safety and health, prevent disease, and advance well-being in the workplace.
• Identify key work-related factors associated with hazardous occupational exposures and risk-related behaviors.
• Identify underlying causes and effects of disparities in the health of people who work, such as underserved populations, low-wage workers, contingent workers, and aging workers.
• Develop appropriate measurement tools to enable research on integrated programs.
• Develop new methods for establishing integrated programs of worker protection and activities that advance the overall well-being of workers.
• Conduct economic methods and modeling research to develop improved approaches to predicting, assessing, and documenting the economic value of the health-related benefits of successful programs.

Intervention Research

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:

• Investigate the merits of interventions that integrate OSH protection with policies, programs, and practices that promote safety and health, prevent disease, and advance well-being in the workplace, as compared to interventions that are independently implemented and not integrated.
• Address a broad range of outcomes, to include the following:
• subclinical (such as biomarkers), health status (morbidity and mortality), and health-related quality of life indicators of illness, injury, and well-being, to better understand the efficacy and effectiveness of integrated intervention strategies; and
• measures of organizational effectiveness (turnover, presenteeism, and other performance indicators) and economic indicators, to better understand the cost effectiveness/benefit of TWH programs and help establish the business case for integrated prevention strategies.
• Give further attention to the theoretical underpinnings of TWH intervention studies to better understand why and under what circumstances TWH interventions can be effective.
• Investigate organizational policies and practices that support or detract from the adoption, development, effectiveness, efficacy, and sustainability of integrated OSH protection with policies, programs, and practices that promote safety and health, prevent disease, and advance well-being in the workplace.
• Investigate the broader integration of workplace prevention activities (such as benefit programs and policies, Employee Assistance Programs), together with OSH and well-being activities, and community and public health prevention activities, together with workplace prevention activities.
• Design TWH interventions to target workers at high risk for exposure to both work-related and other hazards.
• Design TWH interventions for especially prevalent and costly conditions (such as mental health outcomes) that result from joint exposure to work-related and other hazards.

Translational Research

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. Translation research characterizes the process in which a proven scientific discovery or evidence-based public health intervention is successfully integrated into established practice and policy.

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:

• Translate interventions that lead to the development of best practices guides, toolkits, or other materials that address health protection with policies, programs, and practices that promote safety and health, prevent disease, and advance well-being in the workplace.
• Translate and deliver the findings from the Center’s research and other relevant research to those in a position to develop and implement improved prevention programs and help overcome barriers to dissemination and adoption of valid approaches to protect and improve the health of people who work.
• Investigate the translation of successful pilot-tested interventions to other populations and worksites.
• Examine the effects of integrated interventions on both OSH outcomes and interventions that promote comprehensive changes in workers well-being in controlled/pilot settings.
• Evaluate the generalizability (to other populations and other kinds of worksites) of successful pilot-tested interventions.
• Determine and document effective practices and policies leading to successful integration of health protection with activities that advance the overall well-being of workers in diverse settings.
• Evaluate research to determine the aspects of policies, programs, and interventions that are effective and those that are not in addressing health and safety and well-being with accommodations for age, family, and life stage.
• Evaluate the effectiveness of partnership and outreach activities and processes on integrating effective TWH concepts and programs.
• Examine organizational-level or individual-level determinants of implementation of TWH.

Surveillance Research

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:

• Advance and conduct surveillance research that builds the evidence base for effectively integrating health protection with policies, programs, and practices that promote safety and health, prevent disease, and advance well-being in the workplace.
• Improve surveillance systems to expand study of risks to worker safety, health, and well-being by incorporating more information on:
• work-related exposures in public health surveys and other surveillance systems
• other conditions and exposures in OSH hazard surveys and other surveillance systems.
• Expand current surveillance systems or develop new ones to track the adoption and reach of TWH interventions over time.
• Develop measures to guide integrated interventions in organizations, such as Health Risk Appraisals, that reliably capture both work-related and other exposures that pose safety and health risks.

Needs Assessment

Center applicants are expected to document that their proposed research and outreach programs meet specific regional or national workforce needs and demands.

Data Resources

Specific information about risk factors related to work that contribute to health problems previously considered unrelated to work, the important influence that work has on well-being and the TWH approach to improve well-being in the American workforce may be obtained at the NIOSH Total Worker Health Topic Page.

In addition, NIOSH has a number of data resources available to researchers on the NIOSH Data and Statistics Gateway. This includes Worker Health Charts that use worker health data gathered by NIOSH from the Bureau of Labor Statistics to create specialized charts to assess the rates, distribution, and trends in workplace injuries, illnesses and deaths. Additionally, issues can be contextualized through economic metrics such as the societal cost, medical cost, productivity losses and disability costs

Objectives/Outcomes

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.

Proposed goals and objectives should be clearly stated in the application and directly linked to the occupational health and safety issues that will be addressed. Applicants are expected to justify their proposal by describing the research gap or emerging issue that is addressed, and the potential impact the proposed work may have.

Applicants should provide data to support their selection of proposed work, such as morbidity or mortality rates, indicators of the size of the population at risk including estimates of the target population's potential risk of exposure to the hazard, frequency of exposure, or sociodemographic factors such as age, gender, and race/ethnicity. Similarly, applicants may provide qualitative data and/or information that describe exposures, the magnitude of the problem, and potential benefits and impacts of addressing the issue. Qualitative data and/or information may be necessary when the nature of the exposure or population at risk make collecting large-scale, representative quantitative data difficult.

Outputs and Outcomes

Governmental agencies and organizations have been faced with increasing demand to measure the effectiveness of their funded research in improving public health. Effectiveness can be measured by the products (outputs) of research activities and subsequent outcomes, that is, benefits or changes at an individual or population level. Outputs are the immediate products or direct result of research activities. Examples include publications, reports, conference proceedings, presentations/posters, investigator career development, databases, tools, methods, guidelines, recommendations, and education and training materials.

The causes of work-related injuries and illnesses are complex and determining the effect that specific research activities have on them can take years. Thus, outcomes can be measured over time as either intermediate or end outcomes.

Intermediate outcomes are specific changes that occur as a result of research activities. Examples of intermediate outcomes include public or private policy changes, conduct of training or workshops based on project outputs, citations in the literature, inventions and patents, and adoption of technologies or methods developed by the researcher.

End outcomes are the goal of the research and the result of what individuals or institutions do with the knowledge or products generated by the research. Examples of end outcomes include reduction in workplace illnesses, injuries, fatalities, and/or hazardous exposures.

Note to Applicants

Provide a rationale for how the proposed center will contribute to NIOSH’s strategic goals and priority research areas to include the recently published NIOSH Strategic Plan. For example, the overall center and individual research projects in the application should indicate if and how they address any of the priority TWH-related goals that are found in the NIOSH Strategic Plan: FY’s 2019-2023 (specifically those provided in the NIOSH Priority Goals for Extramural Research), to include TWH-related intermediate goals 7.11 (Construction), 7.12 (Healthcare and Social Assistance), 7.14 (Public Safety), and 7.15 (Services). Additionally, the application should describe responsiveness to any identified TWH Priority Areas and Emerging Issues and any of the specific strategic, intermediate, and activity/output goals of the National TWH Agenda (2016-2026).

In the Project Description/Abstract and in the Research Strategy state which industry sector(s) and health and safety cross-sector(s) the proposed work will address and the expected outputs and outcomes of your proposed research. Provide a clear rationale for how the intended outcomes of the proposed project will contribute to the specified strategic and intermediate goals.

Target Population

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.

Regional Presence

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.

Collaboration/Partnerships

Centers will institute collaborative partnerships with local and state agencies, community organizations, universities, health care institutions, business groups (for-profit and non-profit organizations), 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 effective work practices and training 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.

Evaluation/Performance Measurement

Evaluations provide information for management to improve program effectiveness. The CDC document A Framework for Program Evaluation can be helpful.

Effective program evaluation is a systematic way to improve and account for public health actions by involving procedures that are useful, feasible, ethical, and accurate. Understanding and applying the elements of this framework for research projects may enhance planning effective public health strategies, improving existing programs including evidence-based activities, and demonstrating beneficial results and impact of federal funding.

Ongoing evaluation of center-wide activities as well as specific research, programs, policies, and outreach projects or programs related to the overall functioning and objectives of the Center, is expected and should be managed and coordinated by the Evaluation and Planning Core. TWH COE are also strongly encouraged to interact with each other on evaluation methods and best practices, to increase awareness of projects and evaluation techniques across the regional centers. Similarly, centers will work with NIOSH in a post-award process to develop common evaluation metrics across shared subject-matter areas. In addition to center-specific evaluation and performance measurement, the Centers may be asked to contribute to program reviews that may be undertaken on occasion in collaboration with NIOSH to demonstrate the impact of the TWH COE program.

Translation Plan

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. The translation of evidence-based approaches into workplace practice through educational, outreach, and other adoption-focused efforts is of utmost importance for the TWH program. Although research strengthens our understanding of the determinants of injury, illness, and death, the potential for impact of research findings is found when paired with pragmatic approaches to move findings into practice.

In addition to NORA, NIOSH has established a Research to Practice (r2p) approach to reduce or eliminate occupational illness and injury by increasing the transfer and translation of knowledge, interventions, and technologies into highly effective prevention practices and products into the workplace (https://www.cdc.gov/niosh/r2p).

R2p is an approach to collaborations with partners and stakeholders on the use, adoption, and adaptation of NIOSH knowledge, interventions, and technologies that will move research into practice in order to reduce and eliminate injuries, illness, and fatalities.

The r2p approach is an interactive process in which the occupational safety and health community - including researchers, communicators, decision-makers, and employer/employee groups - work collaboratively to:

• Identify research needs;
• Design, plan, and conduct studies;
• Translate and disseminate existing knowledge, interventions, and technologies to relevant users for implementation in the workplace; and to
• Evaluate results to determine the impact on occupational safety and health.

Note to Applicants

Applicants must provide a brief statement about how their proposed research addresses r2p in both the Description (Abstract) and in the Research Strategy (Significance). Describe the anticipated strategies for translation and/or dissemination of research findings, including the audiences to be reached and the methods to reach those audiences.

See Section VIII. Other Information for award authorities and regulations.

HHS/CDC grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by the state as eligible to apply under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via Grants.gov .

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 HHS Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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 HHS Grants Policy Statement states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.
  Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration. All applicant organizations must register with Grants.gov. Please visit www.grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The one-time registration process will take 3-5 days to complete. However, it is best to start the registration process at least two weeks prior to application 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 Center 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 CDC/NIOSH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Center Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

A letter of intent is required, the information that it contains allows NIOSH staff to estimate the potential review workload and plan the review.

If an applicant exceeds the five-year period of performance limit or the total cost limit of $1,400,000 budget period (including consortium F&A costs), CDC/NIOSH will consider the application non-responsive, and it will not enter the peer review process. CDC/NIOSH will notify the applicant that the application did not meet the submission requirements.

Upon receipt, applications will be evaluated for completeness by NIH/CSR and CDC/NIOSH. CDC/NIOSH will review all applications for responsiveness. Incomplete and/or non-responsive applications will not be reviewed.

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

Only one application per institution (normally identified by having a unique DUNS number) is allowed.

The FOA governs new, renewal, revision and resubmission applications.

The CDC/NIOSH will not accept duplicate or highly overlapping applications under review at the same time. This means that the CDC/NIOSH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

As defined in the HHS Grants Policy Statement, applications received in response to the same notice of funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review, unless the applicant withdraws the pending application.

Applications that are incomplete or non-responsive to the eligibility criteria listed in this section will not be reviewed.

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide (Multi - Project Instructions for NIH and Other PHS Agencies), except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Due Date: November 2, 2020. Thereafter, 30 days prior to the future submission due dates.

A letter of intent is required, the information that it contains allows NIOSH 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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Michael Goldcamp, PhD
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
Telephone: 304-285-5951
Email: MGoldcamp@cdc.gov

Overall TWH Center of Excellence page limits

New applicants and subsequent resubmission: Within the 12-page limit, provide information on preliminary organizational work, experience, potential for developing new and exciting research, and specific plans for implementation of the proposed Center.

Renewal applicants: Provide Past Performance and Accomplishments during the prior project period that address the major scientific achievements. Page limits for renewal applicants are up to 22 pages.

Evaluation and Planning Core and Outreach Core page limits

New applicants and subsequent resubmission: Within the 12-page limit, provide information on preliminary organizational work, experience, potential for developing new and exciting research, and specific plans for implementation of the proposed Center.

Renewal applicants: Provide Past Performance and Accomplishments during the prior project period that address the major scientific achievements. Page limits for renewal applicants are up to 18 pages.

Research Pilot Project Program

New applicants and subsequent resubmission: Within the 6-page limit, provide preliminary organizational work, experience, potential for developing new and exciting research, and specific plans for implementation of the proposed Research Pilot Project Program.

Renewal applicants: Provide Past Performance and Accomplishments during the prior project period that address the major scientific achievements of the Research Pilot Project Program. Page limits for renewal applicants are up to 12 pages.

Individual Research Projects

New applicants and subsequent resubmission: Within the respective page limit for small (6 pages) and large projects (12 pages), provide preliminary organizational work, experience, potential for developing new and exciting research, and specific plans for implementing the proposed project.

Renewal applicants/new projects: follow the instructions for new applicants.

Renewal applicants/renewal projects: Provide Past Performance and Accomplishments during the prior project period that address the major scientific achievements of each project proposed for renewal. Page limits for renewal applicants/renewal projects are up to 12 pages for each small project and up to 18 pages for each large project.

Available Component Types	Research Strategy/Program Plan Page Limits for NEW applications	Research Strategy/Program Plan Page Limits for RENEWAL applications
OVERALL (Use for Description of the Overall TWH Center of Excellence)	12	22
EVAL PLAN CORE (Use for Evaluation and Planning Core)	12	18
OUTREACH CORE	12	18
PILOT PROGRAM (Use for optional Research Pilot Project Program)	6	12
RESEARCH PROJECT	Small projects: 6 Large projects: 12	New Small projects: 6 New Large projects: 12 Renewal Small projects: 12 Renewal Large projects: 18

Follow the additional page limits specified in this table:

Section of Application	Page Limits
Project Summary/Abstract	30 lines of text
Project Narrative	three sentences
Introduction to Resubmission and Revision Applications	1
Specific Aims	1
Biographical Sketch	5

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

Note: The references are not included in the page limits.

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Evaluation and Planning Core: required
• Outreach Core: required
• Pilot Program: optional
• Research Projects: 2-5 required

Note: Projects will be listed in the final application in the order in which they were entered in ASSIST as Research-Project 1, Research-Project 2, etc.

Note: Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed above may not apply to the revision application.

When preparing your application, use Component Type Overalll.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete entire form SF424 (R & R).

PHS 398 Cover Page Supplement (Overall)

Research & Related Other Project Information (Overall)

Project Summary/Abstract: Provide a succinct summary of the proposed work for the entire Center.

Project Narrative: In 1-3 sentences describe the relevance of the research to be conducted by the Center on public health.

Facilities and Other Resources: Shared resources across cores should be described in the Facilities and Other Resources attachment. Information from this attachment will be used to evaluate the quality of the scientific environment for the research proposed.

Equipment: Do not include. Equipment should be identified in the appropriate components. Equipment that is shared across components should be described in the Evaluation and Planning Core.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

The Center will be an identifiable organizational unit formed by a single institution or a consortium of cooperating institutions. Therefore, lines of authority must be clearly specified. Each applicant institution will name a Director (PD/PI) who will be the key figure in the administration, management and coordination of the grant. The Director will be responsible for the organization and operation of the Center.

The PD/PI should be a scientific leader experienced in their field of research and must be able to coordinate, integrate, and provide guidance in the establishment of programs in this research and allied areas.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application. Component leads and other Senior/Key individuals should only be listed in the components in which they are active.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Each Senior/Key Person, including the PD/PI, is allowed one biosketch for the entire application. If an individual will participate on multiple components, attach the biosketch to any single component. The biosketches must be comprehensive, covering multiple roles if a single individual has multiple roles within the application.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

An Overall TWH COE budget summary will be generated in the Overall section within ASSIST, by compiling the budgets from the individual cores and components.

Introduction to Application: For Resubmission and Revision, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the aims of the overall center and outline how each component will contribute to these aims.

Research Strategy: Overall Description of the TWH Center. Provide an overview that succinctly describes the key scientific aspects of the center and how the proposed center structure (e.g., research projects and cores) addresses the purpose and objectives of the FOA. The application should be comprised of interrelated research projects and cores, each capable of standing on its own merit but complementary and necessary for accomplishing the proposed objectives. This section provides the team of investigators an opportunity to give a conceptual wholeness to the entire program and then lays out a broad strategy for accomplishing the stated goals. The center must address all the stated research objectives.

Describe the anticipated strategies for translation and/or dissemination of research findings, including the audiences to be reached and the methods to reach those audiences. Provide a rationale for how the proposed research will address the research objectives identified in the TWH-related goals that are found in the NIOSH Strategic Plan: FY’s 2019-2023 (specifically those provided in the NIOSH Priority Goals for Extramural Research), to include TWH-related intermediate goals 7.11 (Construction), 7.12 (Healthcare and Social Assistance), 7.14 (Public Safety), and 7.15 (Services); the TWH Priority Areas and Emerging Issues; and the specific strategic, intermediate, and activity/output goals of the National TWH Agenda (2016-2026).

Significance: Focusing on the center as a whole address (i) the importance of the overall goals of the center or critical barrier to progress in the field that the proposed center is focused on, (ii) how the resources of the proposed center will improve scientific knowledge, technical capability, and/or clinical practice, (iii) how the concepts methods, technologies, treatments, services, or preventive interventions that drive this field will be changed if the proposed aims are achieved.

Renewal Applications: Describe any changes in research emphasis.

Innovation: Considering the entire center, show how the proposed research seeks to shift current research or clinical practice paradigms through use of novel concepts, approaches, methodologies, instrumentation, or interventions. Does the proposed work refine, improve, or apply in a new way present/existing/current concepts, approaches, methodologies, instrumentation, or interventions?

Approach: Include the major approaches and studies in the application showing how the approaches of cores and research projects complement each other or are inter-dependent. Describe the mechanisms that will ensure the coherence of the center and maintain a multidisciplinary focus.

Renewal Applications: Provide Past Performance/Accomplishments in last project period that addresses the major scientific achievements.

In lieu of a Past Performance/Accomplishments, new applications will be evaluated based on preliminary organizational work, experience, potential for developing new and exciting research, and specific plans for implementation of the new program.

Include the Institutional Commitment to the TWH COE.

Identify the States that will be covered by the TWH COE

The applicant should provide the following information for each of the Research Projects in the overall component:

• Describe how all research projects within the center will be managed, monitored, and coordinated.
• Brief description of the overall Research Projects component.
• Proposed research projects should clearly fit within the overall goals and objectives of the TWH COE.
• Identify the category of the proposed individual research projects.
• Brief description of the Research Pilot Project Program. This is an optional component.
• Renewal Applications: Provide Past Performance/Accomplishments in last project period that addresses the major scientific achievements.

Letters of Support: Include signed letters of support from all collaborating institutions.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Note: The applicant should include in the section "Other Requested Information" a Human Subjects summary table that lists all the projects and human subjects information (project title, performance sites, FWAs, IRB approval date/status)

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Eval Plan Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Project Summary/Abstract: Provide a succinct summary of the proposed work for the Evaluation and Planning Core.

Project Narrative: In 1-3 sentences describe the relevance of the research to be conducted by the proposed core on public health.

Facilities and Other Resources: Provide a description of all resources for all proposed cores and projects in the Facilities and Other Resources attachment. The information will be used to evaluate the quality of the overall environment for the Center.

Equipment: Describe any equipment that is shared across components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

The Program Director/Principal Investigator of the proposed Center should also be the Evaluation and Planning Core Project Lead. In the Project Director/Principal Investigator section, use Project Role of Other with Category of Center Director and provide a valid eRA Commons ID in the Credential field. The biographical sketch should present evidence of scientific expertise relevant to the themes of the Center and demonstrate the capacity for the leadership of the Center.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

An Associate Director may be named who will be involved in the administrative and scientific efforts of the Center. If named, specify Project Role of Other with Category of Associate Director .

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

Budget forms appropriate for the specific component will be included in the application package.

For this FOA, CDC/NIOSH requires a detailed budget for each budget period requested.

Applicants may request up to 25% of total costs per year for the Evaluation and Planning Core. Changes in percentage allocation exceeding 5% to the allocation selected in year 1 require prior approval by the Scientific Program Officer (SPO).

The budget of the Evaluation and Planning Core must include the following:

• Meetings: Funds to accommodate travel by the director of the center and another key personnel to attend two one-day Center Directors Meetings throughout the project period. These meetings will be held at a location agreed-upon site following consultation with NIOSH staff.
  International Symposium to Advance TWH: Funds to accommodate travel by the director of the center and other key personnel to attend two-day meeting throughout the project period. These quadrennial symposiums start during the second year of the award. These meetings are anticipated to be held at an agreed-upon site following consultation with NIOSH staff.
• The center director must commit at least 1.2 person-months effort (direct and in-kind) to the Core.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

If applicable, use SF424 R&R Subaward Budget Attachment Forms for each consortium/subaward recipient.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required.

Specific Aims: Clearly state how the Evaluation and Planning Core will contribute to the goals of the Center and how this core integrates with other projects and cores. Provide an overview of how the Evaluation and Planning will set the overall direction of the Center and ensure optimal utilization of Center resources.

Research Strategy: Describe the anticipated strategies for translation and/or dissemination of research findings, including the audiences to be reached and the methods to reach those audiences.

Renewal Applications: Provide Past Performance/Accomplishments in last project period that addresses the major scientific achievements.

In lieu of a Past Performance/Accomplishments, new applications will be evaluated based on preliminary organizational work, experience, potential for developing new and exciting research, and specific plans for implementation of the proposed core.

Organize the Research Strategy of the Evaluation and Planning Core into the required and optional components:

• Center Administration
• Evaluation Program
• Emerging Issues Program (Optional)

Letters of Support: Provide any letters of support that are specific to this specific core. Include a Letter of Support for each Advisory Committee members.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

PHS Human Subjects and Clinical Trials Information (Evaluation and Planning Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide.

When preparing your application, use Component Type Outreach Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Project Summary/Abstract: Provide a succinct summary of the proposed work for the Outreach Core.

Project Narrative: In 1-3 sentences describe the relevance of the activities to be conducted by the proposed core on public health.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• The Core Lead should have the expertise appropriate to manage all aspects of the Core successfully.

Budget forms appropriate for the specific component will be included in the application package.

For this FOA, CDC/NIOSH requires a detailed budget for the initial budget year and a budget foreach consecutive year of support.

Applicants may request budgets up to 25% of total costs per year for the Outreach Core.

Changes in percentage allocation exceeding 5% to the allocation selected in year 1 require prior approval by the Scientific Program Officer (SPO).

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

If applicable, use SF424 R&R Subaward Budget Attachment Forms for each consortium/subaward recipient.

Introduction to Application: For resubmission or revision, an Introduction to Application is required for each core.

Specific Aims: Briefly describe the overall specific aims, and the proposed activities and services of the Outreach Core. Clearly describe the relationship of the Core to the overall center s goals and how the proposed activities relate to the other research projects and cores.

Outreach Strategy: Describe the anticipated strategies for translation and/or dissemination of research findings, including the audiences to be reached and the methods to reach those audiences.

Provide a statement about significance, approach and innovation.

Renewal Applications: Provide Past Performance/Accomplishments in last project period that addresses the major scientific achievements.

In lieu of a Past Performance/Accomplishments, new applications will be evaluated based on preliminary organizational work, experience, potential for developing new and exciting research, and specific plans for implementation of the proposed core.

Organize the Research Strategy of the Outreach Core into the required components:

• Communication and Dissemination Activities
• Education Activities
• Implementation Activities

Letters of Support: Provide any letters of support that are specific to the relevant core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Outreach Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide.

When preparing your application, use Component Type Pilot Program.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Project Summary/Abstract: Provide a succinct summary of the proposed work for the Pilot Program.

Project Narrative: In 1-3 sentences describe the relevance of the research to be conducted by the Pilot Program on public health

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Program Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the program.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• The principal investigator of the program Lead should have the expertise appropriate to manage all aspects of this specific component successfully.

Budget forms appropriate for the specific component will be included in the application package.

The budget of the pilot program must include the following:

• Detailed Budget for the Initial Budget period for the program (first 12-month budget period for all components, in the order that they appear in the application)
• Budget for the entire proposed period for the program.
• Investigators may request a maximum of $50K annually (direct costs).
• Centers can consider for funding under this program short-term projects (12 18 months and up to $25K direct costs per project) to explore the feasibility of new projects in any of the Center's program areas.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

If applicable, use SF424 R&R Subaward Budget Attachment Forms for each consortium/subaward recipient.

Introduction to Application: For resubmission or revision, an Introduction to Application is required.

Specific Aims: Briefly describe the overall specific aims, and the proposed activities and services of the Pilot Program. Clearly describe the relationship of the Program to the overall center’s goals.

Research Strategy: Describe the anticipated strategies for translation and/or dissemination of research findings, including the audiences to be reached and the methods to reach those audiences.

Renewal Applications: Provide Past Performance/Accomplishments in last project period that addresses the major scientific achievements.

Follow all instructions for the Research Strategy as described in the SF424 (R&R) Application Guide.

Letters of Support: Provide any letters of support that are specific to the program.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Research Pilot Project Program)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide.

When preparing your application, use Component Type Research Project

All instructions in the SF424 (R&R) Application Guide must be followed by each individual research project, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Project Summary/Abstract: Provide a succinct summary of the proposed work for each project.

Project Narrative: In 1-3 sentences describe the relevance of the research to be conducted by each project on public health.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• The Research Project Lead should have the expertise appropriate to manage all aspects of the Research Project successfully.

Each individual research project must have its own detailed budget and set of budget forms.
The applicant must complete for each individual research project a separate detailed budget for each budget period requested. All instructions in the SF424 (R&R) Application Guide (Multi - Project Instructions for NIH and Other PHS Agencies) must be followed.

Applicants should consider the following information for the budget of small and large projects:

Small Projects: Maximum two-year project period.

Limited funding is provided for a short period of time to support a variety of types of projects, including:

• Small projects with a maximum budget of $50K per year in direct costs and limited scope that use widely accepted approaches and methods within well-established fields,

and/or

• Small projects with a maximum of a two-year budget total of $275K in direct costs for exploratory and novel research that has the potential to lead to advances in health research

Large Projects: Three to five-year project period with a budget of greater than $250K in direct costs per year.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

If applicable, use SF424 R&R Subaward Budget Attachment Forms for each consortium/subaward recipient.

Introduction to Application: For Resubmission or Revision, an introduction is required for each project.

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, the center must include a minimum of 2 and a maximum of 5 projects. At least one large project must be submitted.

The instructions apply for each individual research project:

Specific Aims: Briefly describe the overall specific aims of the research project. Clearly describe the relationship of the research project to the overall center’s goals.

Research Strategy: Describe the anticipated strategies for translation and/or dissemination of research findings, including the audiences to be reached and the methods to reach those audiences.

Large projects have a limit of 12 pages per project for the research strategy and small projects have a 6-page limit for each project.

Provide a statement about significance, approach and innovation.

Significance: Address for each project (i) the importance of the problem or critical barrier to progress in the field that the proposed project is focused on, (ii) how the resources of the proposed project will improve scientific knowledge, technical capability, and/or clinical practice, (iii) how the concepts methods, technologies, treatments, services, or preventive interventions that drive this field will be changed if the proposed aims are achieved.

Renewal Applications: Describe any changes in research emphasis.

Innovation: Provide a brief description of how the proposed project seeks to shift current research or clinical practice paradigms through use of novel concepts, approaches, methodologies, instrumentation, or interventions. Does the proposed work refine, or improve, or apply in a new way, the concepts, approaches, methodologies, instrumentation, or interventions proposed?

Approach: Provide a statement about significance and innovation. Include the major approaches and studies in the application showing how the approaches of the proposed project complements each other or are inter-dependent. Describe the mechanisms that will ensure the coherence of each project and maintain a multidisciplinary focus.

Renewal Applications: Provide Past Performance/Accomplishments in last project period that addresses the major scientific achievements.

In lieu of a Past Performance/Accomplishments, new applications will be evaluated based on preliminary organizational work, experience, potential for developing new and exciting research, and specific plans for implementation of the proposed project.

Letters of Support: Provide any letters of support that are specific to each proposed project.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Research Project)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All HHS/CDC awards are subject to the federal regulations, 45 CFR 75, terms and conditions, 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.

In accordance with the United States Protecting Life in Global Health Assistance policy, all non-governmental organization (NGO) applicants acknowledge that foreign NGOs that receive funds provided through this award, either as a prime recipient or subrecipient, are strictly prohibited, regardless of the source of funds, from performing abortions as a method of family planning or engaging in any activity that promotes abortion as a method of family planning, or to provide financial support to any other foreign non-governmental organization that conducts such activities. See Additional Requirement (AR) 35 for applicability https://www.cdc.gov/grants/additionalrequirements/ar-35.html

For more information on expanded authority and pre-award costs, go to: HHS Grants Policy Statement.

CDC requires that mechanisms for, and cost of, public health data sharing be included in grants, cooperative agreements, and contracts. The cost of sharing or archiving public health data may also be included as part of the total budget requested for first-time or continuation awards.

Fulfilling the data-sharing requirement must be documented in a Data Management Plan (DMP) that is developed during the project planning phase prior to the initiation of generating or collecting public health data and must be included in the Resource Sharing Plan(s) section of the PHS398 Research Plan Component of the application.

Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds (for example, privacy and confidentiality considerations, embargo issues).

Recipients who fail to release public health data in a timely fashion will be subject to procedures normally used to address lack of compliance (for example, reduction in funding, restriction of funds, or award termination) consistent with 45 CFR 74.62 or other authorities as appropriate. For further information, please see: https://www.cdc.gov/grants/additionalrequirements/ar-25.html for revised AR-25.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Risk Assessment Questionnaire Requirement
CDC is required to conduct pre-award risk assessments to determine the risk an applicant poses to meeting federal programmatic and administrative requirements by taking into account issues such as financial instability, insufficient management systems, non-compliance with award conditions, the charging of unallowable costs, and inexperience. The risk assessment will include an evaluation of the applicant’s CDC Risk Questionnaire, as well as a review of the applicant’s history in all available systems; including OMB-designated repositories of government-wide eligibility and financial integrity systems (see 45 CFR 75.205(a)), and other sources of historical information. These systems include, but are not limited to: FAPIIS , including past performance on federal contracts as per Duncan Hunter National Defense Authorization Act of 2009; Do Not Pay list; and System for Award Management (SAM) exclusions.

CDC requires all applicants to complete the Risk Questionnaire, OMB Control Number 0920-1132 annually. This questionnaire, which is located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf , along with supporting documentation must be submitted with your application by the closing date of the Funding Opportunity Announcement. If your organization has completed CDC’s Risk Questionnaire within the past 12 months of the closing date of this FOA, then you must submit a copy of that questionnaire, or submit a letter signed by the authorized organization representative to include the original submission date, organization’s EIN and DUNS.

When uploading supporting documentation for the Risk Questionnaire into this application package, clearly label the documents for easy identification of the type of documentation. For example, a copy of Procurement policy submitted in response to the questionnaire may be labeled using the following format: Risk Questionnaire Supporting Documents _ Procurement Policy.

Duplication of Efforts

Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e. grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year. Programmatic overlap occurs when (1) substantially the same project is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific objective and the project design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source. Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source. Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the application. Overlap, whether programmatic, budgetary, or commitment of an individual s effort greater than 100 percent, is not permitted. Any overlap will be resolved by the CDC with the applicant and the PD/PI prior to award.
Report Submission: The applicant must upload the report under Other Attachment Forms. The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap.

Important reminders: 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.

Note: If issues resulting from the coronavirus pandemic may have limited the progress of existing projects and they are not resolved prior to the award date, these will need to be specified by the applicant to be taken into consideration.

See more resources to avoid common errors and submitting, tracking, and viewing applications:

• http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm
• http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm
• https://era.nih.gov/files/ASSIST_user_guide.pdf
• http://era.nih.gov/erahelp/ASSIST/

Upon receipt, applications will be evaluated for completeness by the CDC Office of Grants Services (OGS) and responsiveness by OGS and CDC/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. Applications submitted to the CDC in support of occupational safety and health research are evaluated for scientific and technical merit through the CDC/NIOSH peer review system.

As part of the initial merit review, all applicants will receive a written summary statement consisting of the following elements:

• A summary evaluation of the Overall Center (considering all component Cores, Research Projects and Program)
• A separate evaluation of the Evaluation and Planning Core
• A separate evaluation of the Outreach Core
• A separate evaluation of the Research Pilot Project Program
• A separate evaluation of each Individual the Research Project

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 project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific and technical merit and in providing an overall impact score 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 component that by its nature is not innovative may be essential to advance a field.

Does the Center address important problems or critical barriers to progress in the field? If the aims of the Center are achieved, how will scientific knowledge, technical capability, or best practices be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this 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? How will impacts be measured? 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? Is there evidence or indications of collaborative relationships that are likely to contribute to the knowledge, benefits, and sustainability of health protection interventions that promote comprehensive well-being programs for workers? Is the overall center scientifically compelling? Do the combined research projects and cores comprehensively address any of the TWH Priority Areas and Emerging Issues? Further, do they address any of the specific strategic, intermediate, and activity/output goals of the National TWH Agenda (2016-2026); and or any of the TWH goals that are found in the NIOSH Strategic Plan 2019-2023 (specifically in the NIOSH Priority Goals for Extramural Research)? Intermediate goals in the latter include 7.11 (Construction), 7.12 (Healthcare and Social Assistance), 7.14 (Public Safety), and 7.15 (Services).

For Renewal applications: In addition to the criteria above, have existing Centers made significant contributions to improving TWH and well-being programs for workers as demonstrated by their accomplishments? Is there evidence of progress and achievements specific to this program since the previous competitive review? 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 applicant provide evidence of past success in meeting the national need for healthy worksites and healthy workers through research, education, and partnership activities?

Do/does the PD(s)/PI(s) have the leadership and scientific capabilities to develop an integrated and focused research program? Will the PD(s)/PI(s) devote adequate time and effort to the program? Does the experience and scientific leadership of the Center Director, co-Directors, and key personnel allow them to effectively direct a large, complex, multidisciplinary program? Has the Center Director demonstrated the appropriate ability and experience to coordinate the interactions of the Research Projects, with effective utilization of cross-core activities, to achieve Center goals and objectives? Has a multidisciplinary team with the appropriate and complementary expertise required to accomplish the proposed research program been assembled? 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? Are the levels of commitment and ability adequate to develop a well-defined focus for the Center? If Early Stage Investigators or New Investigators, or investigators in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their fields? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise? Is the leadership approach, governance, and organizational structure appropriate for the Center? Are the qualifications of the Center Director and Program Directors, as evidenced by education, experience, and accomplishments, adequate to accomplish the goals and objectives of the Center.
Is the level of commitment for the PD(s)/PI(s) of the Research Projects adequate to manage the overall program? Do(es) the PD(s)/PI(s) of the Research Projects have the leadership, expertise, and skills to effectively manage and direct an integrated and focused research program? Does the team have the necessary multidisciplinary expertise to achieve the proposed research goals and address the FOA purpose and objectives?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? 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 appropriately build on past or current projects, if applicable? 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 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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Are potential problems, alternative strategies, and benchmarks for success presented? If the Center is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed? Is the Center cohesive in integrating projects, facilitating transdisciplinary interaction and likely to produce results that are translatable into practice in the TWH field? Are the projects integrated around clearly defined goals/objectives, missions, focus areas, or common topics? Are there plans to effectively pursue interdisciplinary research and outreach objectives? Does the program propose a plan for the development of interdisciplinary collaboration among all or many components of the program? Is there evidence of adequate integration of the various cores, programs, and projects? Is there evidence for the translation and delivery of the research findings to appropriate audiences? Is there evidence of integration/interaction between health- and non-health-related portions of the Center? Is there a systematic focus on outcomes and impacts? Is the size of the program sufficient to afford effective interaction focused on specific goals and objectives but sufficiently diverse in scientific disciplines to achieve meaningful contributions integrate traditional OSH protection with interventions that protect, preserve, and advance the overall well-being of workers at the regional or national level? Is there an evaluation plan or program in place for the entire Center? Does the Center address national goals with a focus on regional issues? 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 demonstrated on the Center’s logic model? Does the center include discrete, specified, circumscribed research projects with preliminary supporting data? Does the center incorporate exploratory or developmental research projects that identify and address novel scientific ideas or new model systems, tools, or technologies?

If the Center involves human subjects and clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals based on sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Are the proposed human studies to be conducted and/or human samples to be used appropriate for accomplishing the project objectives, and relevant to the FOA purpose and objectives?

For Renewal Applications: Has the organization and structure of the Center contributed to producing measurable results and accomplishments? Is there evidence of integration and synergy among the projects, programs, and cores during the prior funding period? Is there documentation through publications, conferences, etc., that collaboration between or among projects has occurred? Is there evidence that the cores have met their objectives and been well utilized by the individual research projects? Is there adequate justification for adding new projects or cores or for deleting components previously supported? Is there evidence of transfer of research findings? Have the specific commitments and plans for the Center from the previous project period been met?

Are the institutional support, equipment, and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of institutional commitment in terms of enough resources, technical support, and administrative arrangements and facilities that encourage collaboration among researchers? Is there a plan for reaching out to other university environments, state agencies, and professional groups? Do the presence, stature, and effectiveness of the Center represent an established organizational component within the institution?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for each core 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 core proposed).

Reviewers will consider each of the review criteria below, as appropriate for each individual core, in the determination of scientific merit and provide an overall impact score for each core.

Does the proposed Evaluation and Planning 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? Is a strategic plan outlined which identifies the short-term and long-term goals of the Center, and a well-defined process for implementing the activities to achieve the goals set by the Center? 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? Is the administrative, evaluation and planification plan appropriate to facilitate the achievement of the objectives of the proposed core? Does the organizational structure provide clear lines of authority to promote planning and evaluation activities as well as collaborations and interactions within, among and between programmatic elements of the Center in an efficient and effective manner? Does the administrative structure facilitate communication among the Center leaders and the core, program or project directors?

For Renewal Applications: Is there sufficient information 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’s support? Does the renewal application describe the program accomplishments to date? Does the applicant provide evidence of past success in interdisciplinary coordination?

Are the experience, level of commitment, and availability of the Core Lead, Program Administrator, and any additional staff adequate to manage the overall program? Is the staffing appropriate to facilitate attainment of the objectives of the proposed program? Do core leaders have appropriate experience, and have they demonstrated effective and responsible leadership in the past? Is the percent effort requested adequate? Are the qualifications, duties, and time commitments of administrative staff appropriate to contribute to the needs and conduct of the program’s research and outreach activities? Are there appropriate plans for organizing and convening internal and external committees to advise the Center Director? Are the qualifications and time commitments of Advisory Committees members adequate to provide appropriate guidance for center activities?

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)?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the core? Are potential problems, alternative strategies, and benchmarks for success presented? Is the plan to organize communications, group meetings, and teleconferences adequate and appropriate? Are the plans for coordination, problem identification and resolution, and establishment of a strong collaborative environment for the program appropriate? Are the plans for resource allocation within the program adequate and appropriate? Are the plans for communication and collaboration with other centers adequate? 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?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Is the proposed core justified and relevant to the theme of the overall program? Does the core support and promote the implementation and adoption of best practices, programs, and policies that advance worker safety, health, and well-being? Does the core identify and include strategic partnerships and collaborations to disseminate evidenced-based practices for preventing work-related illness and injury? Does the core describe educational opportunities on relevant issues to increase TWH awareness, knowledge and strategic skills? Do the outreach activities include implementation strategies that promote TWH? Does the program facilitate the translation of TWH findings into the work environment? Are appropriate constituents engaged in the program? Will the proposed activities have potential short, medium, or long-term impact on the practitioner or ability to affect TWH in practice? Is there a well-defined evaluation plan, including process and outcome measures? Will the proposed activities have an impact on the practitioner or ability to affect occupational safety and health? Is there evidence that the that the proposed work 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/TWH practitioner community? Does the application describe how to transfer existing knowledge and products to partners who can adapt and refine them to the benefit of overall worker safety, health, and well-being? Does the program adequately describe activities that will impact other institutions or agencies located within the TWH Center region?

Are the proposed personnel appropriate to lead and staff the core? Are the experience, level of commitment, and availability of the Core Lead adequate? Is there adequate administrative support for an effective outreach program that complements the TWH Center’s goals and objectives?

Does the applicant propose new and innovative outreach approaches relevant to OSH?

Does the core facilitate the translation of OSH findings into the work environment at the local, regional and national level? Are appropriate occupational safety and health constituents engaged in the core? Are culturally, linguistically, and educationally appropriate communication interventions used to promote the adoption of evidence-based health-protection practices? Does the core include strategic partnerships and collaborations to communicate evidence-based practices for preventing work-related illness and injury? Does the project describe how to educate community partners and provide assistance and consultations 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 academic departments to offer seminars, workshops, and courses on TWH for undergraduate and graduate students in various disciplines? 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? Are TWH center researchers encouraged to participate in outreach activities? Is there a well-defined evaluation plan, including process and outcome measures, to determine the efficiency and effectiveness of the techniques or programs?

Are the relevant facilities and/or services provided appropriate for the activities proposed? Are there enough resources for the successful delivery of high-quality outreach efforts? Will the core benefit from the environment in which the TWH Center is located?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Research Pilot Project Program 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 core proposed).

Reviewers will consider each of the review criteria below, as appropriate for the Research Pilot Project Program, in the determination of scientific merit and provide an overall impact score for the program.

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?

Does the program support junior investigators or those new to the field to advance or develop innovative TWH concepts and areas of investigation that address the Center’s mission and objectives? Does the program support preliminary research in emerging issues related to center objectives?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed research pilot project program?

Is there evidence of institutional commitment to support the goals of the Pilot Project Research Program of the Center?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project 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 project 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.

Does the project contribute to the Center’s overall proposed goals and objectives? Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, or practices be improved? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, programs or interventions that drive the TWH field? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? If the study is successful, would it lead to an incremental advance, or would it provide a substantial or transformative step forward that would likely not be achieved through mechanisms other than this center-based program? If successful, will the project result in knowledge or resources that could advance the TWH priorities and promote health protection and workplace well-being programs?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the investigators have a successful track record in TWH research or other research that will translate to TWH?

In addition, for applications proposing clinical trials

Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Are the projects innovative and relative to integrating the new concept of health protection and workplace well-being programs?

In addition, for applications proposing clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility, and are alternate strategies provided for potential problem areas? Does the project apply an integrated approach to advance research relevant to the strategic goals in the National TWH Agenda (2016-2026) with appropriate focus on a regional issue? Does the applicant adequately justify the need for the type of work proposed (basic or intervention research, outreach activities, etc.), timing of the proposed work, or a knowledge gap that will be filled if successful? For intervention efficacy and effectiveness projects, is the focus on protecting and maintaining the health status of the workforce? Is the project appropriate in scope, based on proposed timeline and budget?

If the Center involves human subjects and clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals based on sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Are the proposed human studies to be conducted and/or human samples to be used appropriate for accomplishing the project objectives, and relevant to the FOA purpose and objectives?

In addition, for applications proposing clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

As applicable for the project 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.

For research that involves human subjects but does not involve one of the 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 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.

When the proposed project involves human subjects and/or 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 individuals of all ages (including children and older adults) 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 and the policy on the Inclusion of Persons Under 21 in Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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.

Reviewers will identify whether the project involves one of the agents or toxins described in the US Government Policy for the Institutional Oversight of Life Sciences Dual Use Research of Concern, and, if so, whether the applicant has identified an IRE to assess the project for DURC potential and develop mitigation strategies if needed.

For more information about this Policy and other policies regarding dual use research of concern, visit the U.S. Government Science, Safety, Security (S3) website at: http://www.phe.gov/s3/dualuse. Tools and guidance for assessing DURC potential may be found at: http://www.phe.gov/s3/dualuse/Pages/companion-guide.aspx.

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.

Note: If issues resulting from the coronavirus pandemic may have limited the progress of existing projects and they are not resolved prior to the award date, these will need to be specified by the applicant to be taken into consideration.

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.

Reviewers will assess if the applicant has demonstrated about how their proposal addresses the research to practice (r2p) approach.

Reviewers will assess whether the applicant has provided sufficient information about the expected outcomes and outputs of the proposal and how the research, education and training activities of the center and its components will promote safer and healthier work environments and impact on workers health and well-being.

Not applicable. Applications from foreign institutions are not allowed.

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).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

CDC requires recipient for projects and programs that involve data collection or generation of data with federal funds to develop and submit a Data Management Plan (DMP) for each collection of public health data.

If applicable, include a DMP in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application for each proposed collection of public health data. If the public health data to be collected or created are not appropriate for release, provided a concise rationale or justification in the DMP.

The DMP should be developed during the project planning phase prior to the initiation of collecting or generating public health data and will be submitted with the application. The submitted DMP will be evaluated for completeness and quality at the time of submission.

The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

• A description of the data to be collected or generated in the proposed project;
• Standards to be used for the collected or generated data;
• Mechanisms for, or limitations to, providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights - this section should address access to identifiable and de-identified data);
• Statement of the use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use; and
• Plans for archiving and long-term preservation of the data or explaining why long-term preservation and access are not justified (this section should address archiving and preservation of identifiable and de-identified data).

Examples of DMPs may be found at found at University of California or USGS.

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: https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

CDC Additional Requirement (AR)-25 outlines the components of a DMP and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation.

Applications submitted without the required DMP may be deemed ineligible for award unless submission of DMP is deferred to a later period depending on the type of award, in which case, funding restrictions may be imposed pending submission and evaluation.

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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.

The budget can include both direct costs and indirect costs as allowed.

Indirect costs could include the cost of collecting, managing, sharing and preserving data.

If requesting indirect costs in the budget based on a federally negotiated rate, a copy of the indirect cost rate agreement is required. Include a copy of the current negotiated federal indirect cost rate agreement or cost allocation plan approval letter.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by CDC/NIOSH in accordance with NIOSH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the National Institute for Occupational Safety and Health. Applications will compete for available funds with all other recommended 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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Relevance of the proposed Center to NIOSH TWH priorities.
• Geographic balance of Centers among regions of the country.
• The extent to which the components of the proposed center would be coordinated into one multidisciplinary effort within the Center.
• Commitment of the applicant institution.
• Administrative and managerial capability of the applicant.
• How well the application addresses the TWH Priority Areas and Emerging Issues; how they address any of the specific strategic, intermediate, and activity/output goals of National TWH Agenda (2016-2026); and how they address any of the TWH intermediate goals that are found in the NIOSH Strategic Plan 2019-2023 (specifically in the NIOSH Priority Goals for Extramural Research). Intermediate goals in the latter include 7.11 (Construction), 7.12 (Healthcare and Social Assistance), 7.14 (Public Safety), and 7.15 (Services).
• Availability of funds.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

If the application is under consideration for funding, CDC/NIOSH will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement .

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.

Recipients must comply with any funding restrictions described in Section IV.6. 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/NIOSH.

Any application awarded in response to this announcement will be subject to terms and conditions found on the CDC Office of Financial Resources website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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.

Expanded authorities: Expanded authorities: CDC has automatically waived the prior approvals listed in 45 CFR 75.308(d) (1) through (3) for any award resulting from an application under this NOFO. Changes in percentage allocation exceeding 5% to the allocation selected in year 1 require prior approval by the Scientific Program Officer (SPO).
In accordance with HHS regulation and CDC guidance, the awardee will have for the following three Expanded Authorities:

• Carryover of unobligated balances from one budget period to a subsequent budget period. Unobligated funds may be used for purposes within the scope of the project as originally approved. Recipients will report use, or intended use, of unobligated funds in Section 12 Remarks of the annual Federal Financial Report submitted in eRA Commons. If the GMO determines that some or all the unobligated funds are not necessary to complete the project, the GMO may restrict the recipient’s authority to automatically carry over unobligated balances in the future, use the balance to reduce or offset CDC funding for a subsequent budget period, or use a combination of these actions.
• Extension of final budget period of a period of performance without additional funds up to 12 months with no change in the scope of work to ensure adequate completion of the originally approved project or program. The recipient must notify the awarding office, in writing, of the extension 10 days before the expiration date of the period of performance. Upon notification, the awarding office will revise the period of performance ending date and provide an acknowledgement to the recipient.
• Pre-award costs up to (and including) 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The Expanded Authorities will be specified in the recipient award notices issued under this FOA.

Diversity Supplements: NIOSH support efforts to enhance diversity of the research workforce through recruitment and support for students, post-doctorates, and eligible investigators from diverse backgrounds and groups under-represented in OSH research. To help accomplish this, supplemental funding will be considered after an application is awarded. Please refer to FOA PA-20-222 for information or contact the NIOSH Scientific Program Official (SPO) assigned to this FOA. Diversity supplements are contingent upon administrative review and availability of funds.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in CDC/NIOSH-funded studies, the awardee must provide CDC/NIOSH copies of documents related to all major changes in the status of ongoing protocols.

PHS Human Subjects and Clinical Trials Information

Note: The revised Common Rule defined clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Including behavioral health-related outcomes recognized that clinical trials may occur outside a biomedical context (https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html).

On June 18, 2018, HHS and 16 other federal departments and agencies issued a Final Rule to further delay the general compliance date for changes recently made to the revised Federal Policy for the Protection of Human Subjects (the Common Rule) for an additional 6 months until January 21, 2019 (https://www.hhs.gov/ohrp/final-rule-delaying-general-compliance-revised-common-rule.html).

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Packages (Multi - Project Instructions for NIH and Other PHS Agencies) must be followed along with any additional instructions provided in this FOA.

All CDC/NIOSH cooperative agreement awards include the HHS Grants Policy Statement as part of the Notice of Award.

Overview of Terms and Conditions of Award and Requirements for Specific Types of Grants

Additional Requirements (ARs)

ARs outline the administrative requirements found in 45 CFR Part 75 and the HHS Grants Policy Statement and other requirements as mandated by statute or CDC policy. Recipients must comply with administrative and national policy requirements as appropriate. For more information on the Code of Federal Regulations, visit the National Archives and Records Administration.

Specific additional requirements that apply to this FOA are the following:

AR-1: Human Subjects Requirements

AR-2: Inclusion of Women and Racial and Ethnic Minorities in Research

AR-3: Animal Subjects Requirements

AR-9: Paperwork Reduction Act Requirements

AR-10: Smoke-Free Workplace Requirements

AR-11: Healthy People 2020

AR-12: Lobbying Restrictions

AR-13: Prohibition on Use of CDC Funds for Certain Gun Control Activities

AR-14: Accounting System Requirements

AR-16: Security Clearance Requirement

AR-21: Small, Minority, and Women-Owned Business

AR-22: Research Integrity

AR-24: Health Insurance Portability and Accountability Act Requirements

AR-25: Release and Sharing of Data

AR-26: National Historic Preservation Act of 1966

AR-28: Inclusion of Persons Under the Age of 21 in Research

AR-29: Compliance with EO13513, Federal Leadership on Reducing Text Messaging while Driving, October 1, 2009

AR-30: Information Letter 10-006, Compliance with Section 508 of the Rehabilitation Act of 1973

AR-31: Research Definition

AR-32: FY 2012 Enacted General Provisions

Organization Specific ARs:

AR-8: Public Health System Reporting Requirements

AR-15: Proof of Non-profit Status

AR 23: Compliance with 45 C.F.R. Part 87

To view brief descriptions of relevant CDC requirements visit: HHS/CDC Requirements.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination based on race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html./index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to CDC/NIOSH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Review of Risk Posed by Applicants

Prior to making a Federal award, CDC is required by 31 U.S.C. 3321 and 41 U.S.C. 2313 to review information available through any OMB-designated repositories of government-wide eligibility qualification or financial integrity information as appropriate. See also suspension and debarment requirements at 2 CFR parts 180 and 376.

In accordance with 41 U.S.C. 2313, CDC is required to review the non-public segment of the OMB-designated integrity and performance system accessible through SAM (currently the Federal Awardee Performance and Integrity Information System (FAPIIS)) prior to making a Federal award where the Federal share is expected to exceed the simplified acquisition threshold, defined in 41 U.S.C. 134, over the period of performance. At a minimum, the information in the system for a prior Federal award recipient must demonstrate a satisfactory record of executing programs or activities under Federal grants, cooperative agreements, or procurement awards; and integrity and business ethics. CDC may make a Federal award to a recipient who does not fully meet these standards, if it is determined that the information is not relevant to the current Federal award under consideration or there are specific conditions that can appropriately mitigate the effects of the non-Federal entity's risk in accordance with 45 CFR 75.207.

CDC’s framework for evaluating the risks posed by an applicant may incorporate results of the evaluation of the applicant's eligibility or the quality of its application. If it is determined that a Federal award will be made, special conditions that correspond to the degree of risk assessed may be applied to the Federal award. In evaluating risks posed by applicants, CDC will use a risk-based approach and may consider any items such as the following:

• Financial stability;
• Quality of management systems and ability to meet the management standards prescribed in this part;
• History of performance. The applicant's record in managing Federal awards, if it is a prior recipient of Federal awards, including timeliness of compliance with applicable reporting requirements, conformance to the terms and conditions of previous Federal awards, and if applicable, the extent to which any previously awarded amounts will be expended prior to future awards;
• Reports and findings from audits performed under subpart F 45 CFR 75 or the reports and findings of any other available audits; and
• The applicant's ability to effectively implement statutory, regulatory, or other requirements imposed on non-Federal entities.

CDC must comply with the guidelines on government-wide suspension and debarment in 2 CFR part 180 and require non-Federal entities to comply with these provisions. These provisions restrict Federal awards, subawards and contracts with certain parties that are debarred, suspended or otherwise excluded from or ineligible for participation in Federal programs or activities.

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 applies to all new obligations and all funds appropriated by Congress. For more information, visit the HHS website.

Federal Funding Accountability and Transparency Act of 2006. Federal Funding Accountability and Transparency Act of 2006 (FFATA), P.L. 109 282, as amended by section 6202 of P.L. 110 252, 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 website, USAspending.gov. For the full text of the requirements, please review the following website: Federal Funding Accountability and Transparency Act Subaward Reporting System.

Plain Writing Act. The Plain Writing Act of 2010, Public Law 111-274 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: Law and Requirements.

Pilot Program for Enhancement of Employee Whistleblower Protections. All applicants will be subject to a term and condition that applies the terms of 48 CFR section 3.908 to the award and requires that recipient inform their employees in writing (in the predominant native language of the workforce) of employee whistleblower rights and protections under 41 U.S.C. 4712.

Copyright Interests Provision. This provision is intended to ensure that the public has access to the results and accomplishments of public health activities funded by CDC. Pursuant to applicable grant regulations and CDC s Public Access Policy, Recipient agrees to submit into the National Institutes of Health (NIH) Manuscript Submission (NIHMS) system an electronic version of the final, peer-reviewed manuscript of any such work developed under this award upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. Also, at the time of submission, Recipient and/or the Recipient’s submitting author must specify the date the final manuscript will be publicly accessible through PubMed Central (PMC). Recipient and/or Recipient’s submitting author must also post the manuscript through PMC within twelve (12) months of the publisher's official date of final publication; however, the author is strongly encouraged to make the subject manuscript available as soon as possible. The recipient must obtain prior approval from the CDC for any exception to this provision.

The author's final, peer-reviewed manuscript is defined as the final version accepted for journal publication and includes all modifications from the publishing peer review process, and all graphics and supplemental material associated with the article. Recipient and its submitting authors working under this award are responsible for ensuring that any publishing or copyright agreements concerning submitted articles reserve adequate right to fully comply with this provision and the license reserved by CDC. The manuscript will be hosted in both PMC and the CDC Stacks institutional repository system. In progress reports for this award, recipient must identify publications subject to the CDC Public Access Policy by using the applicable NIHMS identification number for up to three (3) months after the publication date and the PubMed Central identification number (PMCID) thereafter.

Language Access for Persons with Limited English Proficiency. Recipients of federal financial assistance from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. Recipients of federal financial assistance must take the reasonable steps to provide meaningful access to their programs by persons with limited English proficiency.

Dual Use Research of Concern. On September 24, 2014, the US Government (USG) Policy for the Institutional Oversight of Life Sciences Dual Use Research of Concern was released. Recipients (foreign and domestic) receiving CDC funding on or after September 24, 2015 are subject to this policy. Research funded by CDC involving the agents or toxins named in the policy, must be reviewed to determine if it involves one or more of the listed experimental effects and if so, whether it meets the definition of DURC. This review must be completed by an Institutional Review Entity (IRE) identified by the funded institution.

Recipients also must establish an Institutional Contact for Dual Use Research (ICDUR). The award recipient must maintain records of institutional DURC reviews and completed risk mitigation plans for the term of the research grant, cooperative agreement or contract plus three years after its completion, but no less than eight years, unless a shorter period is required by law or regulation.

If a project is determined to be DURC, a risk/benefit analysis must be completed. CDC will work collaboratively with the award recipient to develop a risk mitigation plan that the CDC must approve. The USG policy can be found at Dual Use Research of Concern.

Non-compliance with this Policy may result in suspension, limitation, restriction or termination of USG funding, or loss of future USG funding opportunities for the non-compliant USG-funded research project and of USG funds for other life sciences research at the institution, consistent with research project and of USG funds for other life sciences research at the institution, consistent with existing regulations and policies governing USG funded research, and may subject the institution to other potential penalties under applicable laws and regulations.

Data Management Plan(s)

CDC requires that all new collections of public health data include a Data Management Plan (DMP). For purposes of this announcement, public health data means digitally recorded factual material commonly accepted in the scientific community as a basis for public health findings, conclusions, and implementation.

This new requirement ensures that CDC is in compliance with the following; Office of Management and Budget (OMB) memorandum titled Open Data Policy Managing Information as an Asset (OMB M-13-13); Executive Order 13642 titled Making Open and Machine Readable the New Default for Government Information ; and the Office of Science and Technology Policy (OSTP) memorandum titled Increasing Access to the Results of Federally Funded Scientific Research (OSTP Memo).

The AR-25 outlines the components of a DMP and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation.

Certificates of Confidentiality: Institutions and investigators are responsible for determining whether research they conduct is subject to Section 301(d) of the Public Health Service (PHS) Act. Section 301(d), as amended by Section 2012 of the 21st Century Cures Act, P.L. 114-255 (42 U.S.C. 241(d)), states that the Secretary shall issue Certificates of Confidentiality (Certificates) to persons engaged in biomedical, behavioral, clinical, or other research activities in which identifiable, sensitive information is collected. In furtherance of this provision, CDC supported research commenced or ongoing after December 13, 2016 in which identifiable, sensitive information is collected, as defined by Section 301(d), is deemed issued a Certificate and therefore required to protect the privacy of individuals who are subjects of such research. Certificates issued in this manner will not be issued as a separate document but are issued by application of this term and condition to this award. See Additional Requirement 36 to ensure compliance with this term and condition. The link to the full text is at: https://www.cdc.gov/grants/additionalrequirements/ar-36.html.

Cooperative Agreement Terms and Conditions of Award

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 Part 75, 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 recipients 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and HHS/CDC as defined below.

The PD(s)/PI(s) will have the primary responsibility for the following elements:

• Provide administrative oversight for the Center, including management and coordination of the Research Projects and Cores within the overall program
• Establish a highly integrated TWH COE of research, education, and translation projects to reduce work-related health risk, promote health, and prevent disease and injury in the workplace
• Coordinate all technical, scientific, and administrative aspects of activities at the awarded institution and at other sites that may be supported by subcontracts to this award
• Ensure that data and results are published in a timely manner and shared publicly with the research community
• Propose evaluation measures for activities conducted in support of all parts of this program, including process evaluation and outcome measures where feasible
• Interface with NIOSH programmatic staff to insure the required collaborative effort during the term of the cooperative agreement award
• Work in collaboration with others NIOSH funded COE
• Establish advisory committee(s) that includes expertise from TWH experts in the region and the nation to help guide the TWH COE
• Retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and CDC policies
• Prepare written yearly annual report. NIOSH will use these summaries to share information with the public, stakeholders, partner organizations, and others interested in NIOSH TWH research and related activities
• Participate in regularly scheduled and/or ad hoc conference calls with NIOSH to review progress to date, review planned activities, and exchange ideas for future activities
• Facilitate collaboration with investigators, partners, and institutions to share existing expertise and engage in joint interventions to advance the scientific evidence related to TWH
• Meet with NIOSH Scientific Program Official, NIOSH Project Scientist and other staff of the NIOSH TWH Program to review progress, share information, and coordinate activities. The meeting will be a coordinated effort and should be held on an annual or bi-annual basis depending on the needs. For budget preparation, assume a full 1-day meeting and two nights lodging
• Obtain and maintain all appropriate human and animal subject approvals (IRB/IACUC)

Grant Stewardship

Grant management, programmatic, scientific, and stewardship responsibilities will be provided by Maria’s Lioce, MD or other assigned NIOSH Scientific Program Official named in the notice of grant award. These responsibilities are inherently governmental and are separate from any substantial involvement with scientific and technical matters. This helps ensure that the sponsoring agency is appropriately managing the research and related activities of the recipient institution funded under a cooperative agreement as a federal assistance funding mechanism.

Business and other non-Programmatic Management

The assigned CDC Grants Management Officer and Grants Management Specialist are responsible for managing the business, financial, other non-programmatic, and fiscal aspects of a cooperative agreement funded under this announcement. This includes compliance with statutes, regulations, guidelines, and policies for federal assistance awards and certain terms and conditions in the notice of grant award.

Coordination, Communication, and Cooperation

Federal agency personnel involved with all awards made under this announcement will work together cooperatively as a team to help ensure 1) proper stewardship of the funds awarded, 2) accurate and clear communications with the awardee(s), and 3) regular evaluation of awardee progress and performance toward completing the project on time and within budget.

Substantial Involvement

NIOSH will have substantial involvement with regard to scientific and technical expertise on research activities, strategic planning, prospective coordination, national sector goals and activities, and time-critical data needs or reporting. All such activities will be fully coordinated between the NIOSH Project Scientist, the NIOSH's Office of Extramural Programs (OEP) and the award recipient. Participating in grantee meetings (in person or via regularly scheduled conference calls) to provide insight on NIOSH programs and priorities.

NIOSH Project Scientist

A NIOSH Intramural Scientist may serve as a Project Scientist to provide substantial scientific involvement and subject matter expertise around 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. Specific responsibilities may include the following:

• Assist the NIOSH's Office of Extramural Programs (OEP) and TWH intramural researchers 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.
• Provide expert consultation in the area of occupational safety and health generally, and TWH specifically, regarding policies, programs, and practices that promote safety and health, prevent disease, and advance well-being in the workplace, and provide other occupational health related functions and activities as needed.
• Collaborate on scientific projects, upon request.
• Attend and present at meetings, workshops, and other events, upon invitation by Center(s).
• Facilitate coordination and collaboration among awardees at recurring meetings (see TWH Center Directors Calls below), including meeting agendas and topics, prevention activities, and other opportunities, as needed.
• Facilitate collaborative efforts with and between NIOSH intramural scientists, Centers, and other partners and stakeholders to conduct research, compile and disseminate program results through presentations, publications, and other relevant channels.
• In accordance with HHS/CDC/NIOSH policies and guidelines, the NIOSH Project Scientist may publish with the awardee, if mutually agreeable and warranted by the nature and extent of their intellectual contribution to the program or project.

Areas of Joint Responsibility

Joint responsibilities may include:

• Participating in a conference, meeting, or calls to be held in conjunction with NIOSH, Centers and Partners to disseminate research findings and outcomes to the public health community and stakeholders.
• Collaborative work to address occupational safety and health issues at a national level.
• Working groups may be created for specific purposes.


• TWH Centers Directors Meeting
  This required meeting will provide an opportunity to discuss progress, successes, challenges and emerging issues related to the NIOSH-funded TWH COE, the NIOSH Office of Extramural Program, and the NIOSH TWH Office. A minimum of two one-day Centers Directors Meetings throughout the project period should be budgeted to review and share recipient information and products, discuss technical and coordination plans or emerging issues, build partnership among the funded institutions and between the funded institutions and NIOSH, and coordinate partnership and/or training activities.


• International Symposium to Advance TWH
  The symposium a will provide an opportunity for TWH COE leaders across the country to interact with NIOSH researchers and attendees from a broad spectrum of fields, including occupational safety, ergonomics, worksite health, occupational medicine, academia, and human resources to discuss health and safety challenges and opportunities in industry and worker populations; methodologies and innovations related to TWH interventions.


• TWH Center Directors' Call

Calls held three times a year between the Centers Directors (and their additional representatives) and NIOSH occur to facilitate sharing of information about activities and accomplishments among and between the Centers and NIOSH.
The following will serve as a guide for roles and responsibilities for these calls:

• NIOSH will schedule calls between the Centers and NIOSH and lead them
• NIOSH will designate a Chair among the Center Directors. The Centers Chair (CC) will rotate for a 12-month term (January December) among the Center Directors.
• NIOSH will communicate with CC Chair to determine agenda items roughly two-three weeks prior to each scheduled call
• The CC will seek agenda item input from all Centers and provide that input to NIOSH roughly one-two weeks prior to the scheduled call. Each Center representative will also be expected to provide a brief update of Center activities during each call.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements.

A final progress report, invention statement, 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 recipients 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 recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.

All recipients 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. See the HHS Grants Policy Statement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

Submission of Reports

The Recipient Organization must provide CDC/NIOSH the following reports:

1. Yearly Non-Competing Grant Progress Report is due 90 to 120 days before the end of the current budget period. The RPPR (https://grants.nih.gov/grants/rppr/index.htm; https://grants.nih.gov/grants/rppr/rppr_instruction_guide.pdf) is to be completed on the eRA Commons website. 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 ofsatisfactory 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. 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.

Recipients must submit closeout reports in a timely manner. Unless the Grants Management Officer (GMO) of the awarding Institute or Center approves an extension, recipients 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 recipients are now available at https://grants.nih.gov/grants/forms/report_on_grant/federal_financial_report_ffr.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: https://grants.nih.gov/support/index.html.

3. Annual report suitable for public distribution submitted to the NIOSH/OEP Scientific program official at the end of the federal fiscal year (September 30). This report should include narrative descriptions of high-impact outcomes of individual programs that are noteworthy. Specific guidance on report content will be provided by NIOSH.

4. Final Report should provide sufficient detail for CDC/NIOSH 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 final progress report, the Final Invention Statement and Certification form, equipment/inventory report, and the Final financial and performance reports (FFR) are required no more than 90 days after the end of the project period. Specific guidance on report content will be provided by NIOSH.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Maria Lioce, MD
National Institute for Occupational Safety and Health (NIOSH)
Centers for Disease Control and Prevention (CDC)
Telephone: 404-498-2575
Email: MLioce@cdc.gov

Michael Goldcamp, PhD
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
Telephone: 304-285-5951
Email: MGoldcamp@cdc.gov

Mary Pat Shanahan
Centers for Disease Control and Prevention (CDC)
Grants Management Specialist
Office of Financial Resources (OFR)
Office of Grants Services (OGS)
Telephone: 412-386-4453
Email: MShanahan@cdc.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. 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 1 (Note), and 30 USC 951(a); and Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52. All awards are subject to 45 CFR Part 75, the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement .