Required Application Instructions

Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted in paper format. Application materials may be obtained from Grants.gov. PHS 398 application forms and instructions (revised 8/2012) must be used. Download the application forms and instructions from https://grants.nih.gov/grants/forms.htm. A registration process is necessary before submission, and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. 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 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

Statutory Authority

Awards are made under the authorization of the Occupational Safety and Health Act of 1970, Section 20(a) and 21(a) (29 USC 669(a) and 29 USC 670); Federal Mine Safety and Health Act, Section 501(a), 30 USC 951(a); and Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.

1. Background and Purpose

Agriculture, forestry, and fishing (AFF) occupations have long been recognized as some of the most dangerous in the country. The AFF sector has a workforce over 2 million strong, and many of these laborers are at significant risk due to a combination of factors. AFF workers encounter numerous physical, chemical, and biological hazards during their daily routines. Physical hazards may include the dangers associated with the use of tractors and other heavy equipment, working in extreme temperatures, or coping with large livestock. Chemical hazards may include inadvertent exposure to pesticides and herbicides during their application or to potentially hazardous commodities during the production or harvesting processes (such as in green tobacco sickness). Biological hazards may include the threat of exposure to zoonosis for those who are in nearly continuous contact with swine, poultry, or other animal vectors. Beyond these hazards typically found in the AFF environment, many laborers are foreign born and therefore encounter language and cultural barriers that might exacerbate these threats. Factors exacerbating these hazards may include limited access to health care and worker training resources. The seasonal nature of some crops might create an economically driven, forced migration that may generate unintended second-order effects in the workforce in areas such as housing, diet, and social support systems.

The purpose of this program is to support existing (and establish new) Centers for Agricultural Safety and Health (Ag Centers) to address the significant and varied morbidity and mortality burden in U.S. AFF occupations. Ag Centers address these burdens through a variety of approaches. Centers are expected to include scientific research in developing (or strengthening) the evidence base for mitigating particular threats or hazards. Centers may need to test these new approaches through the use of intervention studies. Research translation activities are anticipated to move scientific findings into pragmatic efforts aimed at controlling specific hazards, minimizing associated threats, and improving health in the workforce. Finally, outreach programs can facilitate understanding and uptake of the information by the working population, by their supervisors and managers, and at the organizational or company level.

Healthy People 2020 and other National Strategic Priorities

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, a PHS-led national activity for setting priority areas to achieve better health in the United States by the year 2020. This Funding Opportunity Announcement (FOA) is closely linked to several overarching goals of Healthy People 2020, with the intent to prevent diseases, injuries, and deaths due to working conditions.

Public Health Impact

Ag Centers are expected to have a significant and sustained impact on reducing morbidity and mortality in the AFF workforce. Despite safety advances in many areas of this sector, and recently documented decreases in adverse health outcomes for this workforce, AFF workers are still disproportionately affected in comparison with other industrial sectors. Because of the diversity of activities in agriculture, forestry, and fishing jobs, Ag Centers must be sensitive to regional work practices and how these practices can be modified and improved to increase protections for the worker population. Ag Centers should also attempt to facilitate the use and adaption of new approaches or best practices in similar segments of the workforce or regions of the country through collaboration and coordination with fellow Ag Centers, academic institutions, nonprofit entities, industry, and labor organizations.

Relevant Work

In 1990, Public Law 101-517 directed NIOSH to establish a program of improving the health and safety of agricultural workers and their families. Details in the Senate appropriations language of PL 101-517 included the innovative call to establish centers for agricultural occupational safety and health. Beginning in 1990, NIOSH established and maintained these centers through a series of competitive FOAs, including PAR-11-022, PAR-06-057, RFA-OH-03-002, and RFA-OH-01-004.

Ag Centers conduct high quality research and help translate scientific discoveries into practical applications to improve agricultural worker health and safety. The centers help find practical solutions to complex problems, cultivate collaboration and partnerships, and conduct outreach/education efforts for specific issues or worker populations. Ag Centers are distributed throughout the nation to be responsive to agricultural safety and health issues unique to different regions. Links to the Ag Centers currently funded by NIOSH are provided at NIOSH Ag Centers.

2. Approach

Ag Centers should address agriculture, forestry, and fishing issues in a cohesive and coordinated fashion, focusing on problems that are particularly burdensome in their region or potential solutions that are reasonably anticipated to have a high likelihood of improving the health and well-being of AFF workers. Although Ag Center applicants are asked to define the region of the country where they will focus their efforts, NIOSH recognizes that many of the occupational safety and health concerns in this workforce are not constrained by geographic boundaries. Therefore, it is anticipated that Ag Centers will, on occasion, work on problems that go beyond their predefined region or catchment area. In these cases, centers in the respective regions should work together to identify synergies and avoid duplicative efforts.

Centers will inherently have different abilities, strengths, and experiences, so clear communication and coordination (with each other and with NIOSH) are strongly encouraged in trans-regional efforts. Centers are encouraged to develop a networked approach to address complex problems within the AFF workforce which are too large and diverse for any single center to adequately address.

Essential Ag Center Components

NIOSH Ag Centers provide interdisciplinary research and outreach to address AFF-related occupational health and safety problems. Applicants should keep in mind the components essential to Ag Center design, detailed below, in providing an overall description of the proposed Ag Center, addressing 1) the burden of occupational injuries and illnesses within their region for this work sector, 2) the regional and national need for the Ag Center’s proposed programs and projects, and 3) the Center’s impact or potential for impact on AFF worker health and safety. Applicants should consider the current goals for the AFF workforce, as discussed in the National Occupational Research Agenda (NORA) document for this work sector (http://www.cdc.gov/niosh/nora/comment/agendas/AgForFish/pdfs/AgForFishDec2008.pdf). Although the NORA agenda will be in transition from the second decade (2006-2015) to the third decade (2016-2025) during the Ag Center application and review period, it is anticipated that the current AFF goals will still be very relevant in the future.

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

• Planning and Evaluation Core
• Research Core
• Outreach Core

Planning and Evaluation Core. The purpose of the Planning and Evaluation Core is to provide oversight, leadership, and management for the center; to engage 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 to establish and maintain advisory committees. Any collaborative projects with other Ag Centers should include the Planning and Evaluation Core for the purposes of 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.

Research Core. The purpose of the Research Core 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, R01-like projects that require significant investment in personnel, equipment, time, and space.

Outreach Core. 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.

Objectives/Outcomes

The primary goal of an Ag Center is to conduct high-caliber scientific research while providing leadership and outreach to address local, regional, and national AFF problems. Objectives will include the implementation of evidence-based solutions that address important agricultural safety and health problems by means of a collaborative approach. Projects will range from basic/etiologic research on specific problems to research translation and outreach activities that will ensure affected populations benefit from the center’s expertise and knowledge.

Target Population

There are many affected subpopulations in AFF professions. The attributes of these affected subpopulations (such as demographics, size, risks/hazards encountered, and resources available to educate or assist in addressing the problem) will drive the proposed projects and their anticipated impacts. Ag Centers are distributed throughout the nation to be responsive to safety and health issues unique to different regions of the country. The risks inherent to an AFF job are often dependent on the work environment, local/industry work practices, and specific job tasks. Therefore, Ag Centers should clearly describe the specific target populations they are focusing their efforts on and provide information to support the need for these proposed efforts.

Collaboration/Partnerships

Ag Centers must demonstrate collaborative efforts by working with a diverse and broad range of organizations to enhance worker safety and health in their region. Possible collaborators include universities, labor and professional associations, nonprofit organizations, businesses, and federal, state, or local public health and regulatory agencies. Centers should seek to address a wide range of occupational safety and health concerns in their region, as determined by the burdens posed by these problems or hazards, and their funding applications must describe how their efforts will alleviate or eliminate these burdens.

Evaluation/Performance Measurement

Ongoing evaluation of center-wide activities as well as specific research and outreach projects or programs is expected and should be managed and coordinated by the Planning and Evaluation Core. Ag Centers 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, Ag 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 Ag Center program.

Translation Plan

The translation of evidence-based approaches into workplace practice through educational, outreach, and other adoption-focused efforts is of utmost importance in this work sector. Too often, easily preventable errors lead to adverse consequences in the AFF workforce. 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.

Throughout the project period, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ asfr/ogapa/aboutog/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• 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 NIH 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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

• 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) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIOSH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS 398 Application Guide.

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

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

Applicants must download the Grant Application PHS 398 for this funding opportunity announcement from Grants.gov.

For further assistance, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at 770.488.2700 or pgotim@cdc.gov.

Telecommunication for the hearing impaired or disabled is available at TTY 1-888-232-6348.

Applicants must follow the instructions in the PHS 398 Application Guide, except where instructed in this FOA to do otherwise, and conform to Application Guide requirements. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The PHS 398 should include assurances and certifications required by the agency for a complete application. These forms can be downloaded from the following link: https://grants.nih.gov/grants/forms.htm.

Information in the remainder of this section describes special content to be included, budget restrictions, items to be addressed for a complete application, and application organization.

Purpose of Ag Centers

Ag Centers are composed of cores, programs, and individual projects that work together to address the center’s proposed goals and objectives. A particular challenge facing centers is the development of a cohesive portfolio of individual research projects that are technically and scientifically meritorious in their own right and integrated with center-wide goals and objectives. Ag Centers are not just a collection of projects addressing various AFF concerns. Instead, they provide collaborative, coordinated approaches to addressing these concerns through various research and outreach projects or programs

Center-wide goals and objectives should be clearly stated in the application and directly linked to the occupational health and safety burdens being addressed by the proposed programs and projects. Applicants are expected to justify their programs and projects, by describing the burden of the problem, the need for the proposed research or program activity, and the potential for impact or likelihood of success. Applicants should provide data to support their selection of proposed programs and projects, 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 that describe exposures, the magnitude of the problem, and potential benefits and impacts of addressing the issue. Qualitative data may be necessary when the nature of the exposure or population at risk make collecting large-scale, representative quantitative data difficult.

These data will help provide the context and estimate the burden of the problems being addressed, the need for the proposed work, impact on the workforce, and the potential long-term benefits of the proposed projects and activities. Additionally, the AFF issues that a center proposes to address can be contextualized through economic metrics such as the societal cost, medical cost, productivity losses and disability costs.

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. However, centers are encouraged to address their research goals and objectives by using appropriate approaches based on need that include a range of activity from basic research to intervention, translation, and outreach.

Structure of Ag Centers Cores, Programs, and Projects

Ag Centers comprise three required components: (1) a Planning and Evaluation Core, (2) a Research Core, and (3) an Outreach Core. The purpose and budget allowances for each core and its associated programs and projects are described in detail below. Center applications must include descriptions of all three cores in order to proceed to peer review.

Planning and Evaluation Core (Required)

Applicants may request up to $300K annually (direct costs) for the Planning and Evaluation Core, which includes required and optional components.

Center Administration (Required)

Center Administration is a require component of the Planning and Evaluation Core. Applicants may propose budgets up to $150K annually (direct costs) to support overall administration, coordination, and oversight activities. Required activities 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 principle investigators, project directors, and other key personnel in the center are expected to maintain close communication and collaboration to ensure that the center cohesively addresses multiple aspects of the AFF issues they are working to remediate. The Planning and Evaluation Core should have a strategic plan with a vision, mission, and goals/objectives, 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.

Ag Centers should establish (or maintain) an advisory board of stakeholders knowledgeable about agriculture health and safety in the region served by the center. The board should reflect the diversity of production agriculture, commercial forestry, or commercial fishing activities in (1) the area or region served by the Ag Center, (2) the projects being undertaken by the Center, and (3) the goals of the Center. Committee members may include regional or national agriculture experts, producers, farmers, ranchers, workers, extension specialists, insurers, equipment dealers or manufacturers, healthcare providers, and community organizations. The advisory board should meet at least annually and provide input to Ag Center leadership on a wide range of topics, including setting and reaching goals/objectives, integrating cross-disciplinary expertise, and addressing new or emerging issues. Centers can have multiple advisory boards, and this decision is left to their discretion.

Applicants should budget for an annual Center Directors Meeting. This required meeting will provide an opportunity for Ag Center leaders across the country and NIOSH Program Officials to discuss developing and emerging issues in AFF worker safety and health and to further encourage a spirit of collaboration in addressing challenges and advances in AFF worker safety and health.

Evaluation Program (Required)

The Evaluation Program is a required component of the Planning and Evaluation Core. Applicants may propose up to $100K annually (direct costs) to cover all evaluation activities within the center. The evaluation program must include a program logic model and evaluation plan that contemplates the input of key stakeholders and needs assessment data into the center’s overall strategic plan, defines metrics that will be used to measure and track outputs and outcomes, and describes the intended long-term goals and impact of each proposed research or outreach project and of the Ag Center as a whole. Additionally, applicants should budget for one annual meeting that will be convened with all Ag Center evaluators/directors and NIOSH staff to assist the Institute in developing a cohesive evaluation plan and associated metrics for assessing the collective Ag Centers contributions and impacts.

Emerging Issues Program (Optional)

The Emerging Issues Program within the Planning and Evaluation Core is an optional component and 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 annually (direct costs) for this program. 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 threats. 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. At a minimum, this reporting should occur as part of the noncompeting continuation process. Preferably, center directors will maintain a continuous line of communication with NIOSH on the proposed use of these funds, as opposed to relying on the required annual reporting mechanisms.

Research Core (Required)

The Research Core manages, monitors, and coordinates all research projects within the center. Applicants may propose budgets up to $850K annually (direct costs) to support all research projects within this core. 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 Ag Center. The Research Core 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.

Applicants should clearly identify their proposed individual research projects in one of four categories: 1) basic/etiologic, 2) intervention, 3) research translation, and 4) surveillance research. Applicants will not be required to propose a specific number of projects within each research category; however, centers should consider covering the full research continuum, where feasible, when addressing their AFF issues or concerns.

Centers will likely have projects in many of the 4 research categories. There are no funding limits established for individual projects or research categories. Applicants must work within the overall funding level for the Research Core ($850K direct costs annually).

Pilot/Feasibility Program (Optional)

The Pilot/Feasibility Program is an optional component and must fit within the overall funding limits of the Research Core. Pilot/Feasibility Programs may request a maximum of $100K annually (direct costs). Centers may support short-term projects (12 18 months and up to $30K direct costs per project) that provide investigators with seed money to explore new activities or directions or to enable the collection of sufficient preliminary data to pursue support through other funding mechanisms (for example, pilot data in support of an R01 application). 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.

Research Project Categories

Basic/Etiologic Research Projects

Basic/etiologic research builds the evidence base upon which future programs, policies, and progress are based. Examples of research falling within this category may include toxicological and epidemiological studies; laboratory work bolstering analytic sensitivity, specificity, and efficiency; improvements or innovations in sampling equipment and methods development; or other projects that work to reveal disease and injury causation or exacerbation. Results from this type of research are most frequently disseminated via publications and conference presentations.

Intervention Research Projects

Intervention research engages in the development, testing, or evaluation of a solution to an occupational safety and health problem or the improvement of an existing intervention. Intervention research may include the development of a new training program, testing of a new technology or approach, 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, whereas translational research develops mechanisms to disseminate these strategies.

Translational Research Projects

Translational research develops strategies to transform 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 personal protective equipment, engineering controls, and sampling equipment) into the marketplace or work setting. 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.

Surveillance Research Projects

Public health surveillance research guides efforts to detect and monitor disease and injuries as well as assess the impact of interventions. Surveillance information can inform policy changes, new program interventions, public communications, and priorities for research investment. NIOSH encourages Ag Centers to propose projects that address the current challenges in AFF surveillance. This surveillance research may involve the identification and melding of disparate, available data sources to generate reliable morbidity and mortality estimates or the development of unique surveillance methods for specific industries, commodities, hazards, or adverse health outcomes. The analyses of available surveillance data is not considered research in this context.

Outreach Core (Required)

Outreach is an essential and required core for all Ag Centers. Applicants may propose budgets up to $200K annually (direct costs) to support all work within this core. This core should be broad in scope and prioritize activities that will have an impact on AFF worker health and safety. Outreach programs or projects should provide a strategy that will result in meaningful impacts to worker health and safety, including reaching underrepresented and vulnerable subpopulations, and contribute to the goals and objectives of the Center. This strategy should clearly articulate the regional needs that will be addressed, the unique attributes that the outreach strategy or efforts will include, and how these efforts are anticipated to impact the AFF workforce.

Examples of successful Ag Center outreach activities include promoting worker awareness of heat-related illnesses and prevention activities through extension agents; conducting workshops on vulnerable and temporary workers; initiating research to practice activities with other institutions, businesses, or agencies located within the center s region; integrating occupational safety and health principles and concepts within agriculture-related educational curricula; creating cooperative and collaborative arrangements with professional societies, municipal and local governments, and scientific associations; and increasing awareness of the region’s AFF challenges and methods to mitigate them by working with educational institutions, labor and management organizations, not-for-profit and community associations, and industry partners.

Table of Contents

The following section supplements the instructions found in the PHS 398 Application Guide and should be used for preparing a multicomponent application.

Applicants must use the PHS 398 version and instructions that are current at the time of their application. The application forms submitted in response to this announcement are complex. The scientific and programmatic information needed to properly assess them is not fully accommodated within the basic PHS 398. Consequently, applicants will need to modify and expand the PHS 398 to properly organize the necessary information for reviewers. To help facilitate an effective and efficient peer review process, the following components should constitute a complete, discrete unit within the application, with minimal duplication elsewhere:

• Planning and Evaluation Core (required)
• Individual projects within the Research Core (required)
• Pilot/Feasibility Program within the Research Core (optional)
• Outreach Core (required)

All applicants should use the following outline:

• PHS 398 Face Page (Form Page 1)
• Form Page 1 continued (only if multiple PD/PIs are proposed)
• Summary, Relevance, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (use Form Page 2 and include additional continuation pages as needed)
• Table of Contents (Form Page 3)
• Detailed Budget for the Initial Budget period for the entire Ag Center (first 12 month budget period for all components, in the order that they appear in the application, using Form Page 4)
• Budget for the entire proposed project period (all years, all components using Form Page 5)
• Biographical Sketches for Center Director (or co-Directors)
• Other Support for Center Director (or co-Directors)
• Biographical Sketches for Key Personnel
• Other Support for Key Personnel
• Institutional Resources (6-page maximum; use Resources Format Page)
• Overall Description of the Ag Center (10-page maximum)
• Past Performance/Accomplishments in last project period (for existing Ag Centers) or relevant to Ag Center goals and objectives (for new applicants) (5-page maximum)
• Institutional Commitment to the Ag Center (2-page maximum)
• Identification of States that will be covered by the Ag Center
• Human Subjects summary table that lists all the projects and human subjects information (project title, performance sites, FWAs, IRB approval date/status)
• Planning and Evaluation Core Cover Sheet (with section title, PI name, and table of contents for the section)
• Planning and Evaluation Core Description (see outline and page limits below)
• Research Core Cover Sheet (should serve as table of contents for the section by including each project title, PI, type of project, and first page of each project)
• Individual Research Core Project Plans (A, B, etc. see outline and page limits below)
• Outreach Program Cover Sheet (with section title, PI/Program Director, and table of contents for the section)
• Outreach Program (see outline and page limits below)
• Checklist
• Appendix

Note: Each individual core, program, or project should constitute a complete, discrete unit within the application and should use the following outline:

• PHS 398 Face Page (Form Page 1)
• Summary, Relevance, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (use Form Page 2, additional Project/Performance Site pages, and additional continuation pages as needed)
• Table of Contents
• Past Performance/Accomplishments in last project period (for existing Ag Centers) or relevant to Ag Center goals, for new applicants (5-page maximum)
• Detailed Budget for the Initial Budget Period for Individual Core, Program, or Project (Form Page 4)
• Budget for the Entire Proposed Period for Individual Core, Program, or Project (Form Page 5)
• Biographical Sketches for Program Directors/Principal Investigators
• Other Biographical Sketches
• Other Support
• Resources (facilities, scientific environment, physical resources)
• Research Plan (or Program Plan)
• Introduction (for resubmission applications, 1 page)
• Specific Aims (1 page)
• Research Strategy (or Program Strategy): follow the page limits specified below.
  

  Significance
  Innovation
  Approach
  Preliminary Studies for New Applications/Progress Report for Renewal

• Applications (see note below)
• Inclusion Enrollment Report (renewal or revision applications only)
• Bibliography and References Cited/Progress Report Publication List
• Protection of Human Subjects
• Inclusion of Women and Minorities
• Targeted/Planned Enrollment Table
• Inclusion of Children
• Vertebrate Animals
• Select Agent Research
• Multiple PD/PI Leadership Plan
• Consortium/Contractual Arrangements
• Letters of Support (e.g., consultants, collaborators, including NIOSH)
• Resource Sharing Plan(s)
• Checklist

Research Strategy Page Limits for Individual Research Projects/Programs:

Large research projects/programs have a 12-page limit for the research strategy, whereas small research projects/programs have a 6-page limit. Large research projects are those that require the majority of the 5-year project period to conduct the work and are funded at levels greater than ~$200K to $250K direct costs annually; small research projects/programs require less time and funding.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows 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 center
• Titles for each proposed research project (excluding pilot/feasibility program)
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) for the center as well as for all proposed research projects
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Steve Dearwent, PhD
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS E-74
Atlanta, GA 30333
Telephone: (404) 498-6382
Email: sed7@cdc.gov

Overnight address:
2400 Century Parkway NE (4th floor)
Atlanta, GA 30345-3114

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Concurrently, submit two photocopies of the application and three CD ROM disks containing appendix materials to this address:

Michael Goldcamp, PhD
Scientific Review Official
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1095 Willowdale Road, MS 1808
Morgantown, WV 26505
Phone: 304-285-5951
Email: MGoldcamp@cdc.gov

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, except where superseded by directions in this announcement.

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

This initiative is not subject to intergovernmental review.

All HHS/CDC awards are subject to the terms and conditions, cost principles, and other requirements described in the HHS Grants Policy Statement. Pre-award costs may be allowable as an expanded authority, but only if authorized by CDC. For more information on expanded authority and pre-award costs, go to: http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Applications Involving a Single Institution

Applicants whose PDs/PIs are all within a single institution should simply follow the instructions contained in this FOA; there are no special instructions.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institutions must be requested via a subcontract to be administered by the prime institution. The prime institution should submit its budget details on PHS 398 forms, and the other institutions should attach their individual PHS 398 budget forms to those of the prime institution.

If the applicant has an FWA number, enter the 8-digit number. Do not enter the letters FWA before the number. If a Project/Performance Site is engaged in research involving human subjects, the applicant organization is responsible for ensuring that the Project/Performance Site operates under and appropriate Federal Wide Assurance for the protection of human subjects and complies with 45 CFR Part 46 and other CDC human subject related policies described in Part II of the SF 424 (R&R) Application Guide and in the HHS Grants Policy Statement.

Upon receipt, applications will be evaluated for completeness by the CDC Procurement and Grants Office (PGO) and responsiveness by PGO and NIOSH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Electronically submitted applications must be submitted no later than 5:00 p.m., ET, on the listed application due date.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

As part of the CDC mission, all applications submitted to the CDC in support of public health activities are evaluated for scientific and technical merit through the NIOSH peer review system. Only the review criteria described below will be considered in the review process.

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, Programs, and Projects)
• A separate evaluation of the Planning and Evaluation Core
• A separate evaluation of each Project/Program within the Research Core (including the Pilot/Feasibility Program, if proposed)
• A separate evaluation of the Outreach Core

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the projects proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Review Criteria for the Overall Center

Significance
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 local, regional or national agricultural safety and health needs through effective research, intervention, translation, outreach, education, and partnership activities? How will scientific knowledge be advanced by the Center? How will impacts be measured? Is there evidence or indications of collaborative relationships that are likely to contribute to the knowledge, benefits, and sustainability of prevention or intervention efforts to improve agricultural health and safety?

For Renewal Applicants, have existing Centers made significant contributions to improving agricultural safety and health as demonstrated by their accomplishments? Is there evidence of progress and achievements specific to this program since the previous competitive review?

Investigators
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? 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 project? Are the Center Director’s leadership skills, scientific stature, and ability to meet the program’s demands of time and effort adequately described? 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?

Innovation
Does the application challenge and seek to shift current paradigms or industry practices by utilizing novel theoretical concepts, approaches, methodologies, instrumentation, or interventions? Are these novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new approach proposed? Does the Center propose new and novel projects? 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 address the distinct characteristics, specific populations, and safety and health needs in the agricultural workforce?

Approach
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 there evidence of meaningful interdisciplinary or multidisciplinary collaboration and synergistic potential among the various cores, programs, and projects? 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 in agricultural health and safety at the regional or national level?

Are the overall strategy, methods, 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 how will particularly risky aspects be managed? If the project research involves human subjects or a clinical investigation, are the plans for (1) protection of human subjects from research risks and (2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Is the Center cohesive in integrating projects, facilitating interdisciplinary and transdisciplinary interaction and likely to produce results that are translatable to occupational safety and health?

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?

For Renewal Applicants, 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?

Environment
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 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 sufficient 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?

Review Criteria for the Planning and Evaluation Core

Significance
Does the proposed Planning and Evaluation Core have an appropriate and adequate administrative structure with an internal organization capable of planning, conducting, and evaluating Center activities? Does the core clearly delineate procedures and plans for center administration, planning and evaluation? 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? 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 Applicants, 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?

Investigators
Do Center 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?

Innovation
Does the applicant seek to have an impact on agricultural worker health and safety by using novel approaches for Ag Center activities (interdisciplinary and multidisciplinary coordination and research, diversity recruitment and retention, and outreach)?

Approach
Does the application describe an evaluation plan to determine the impact, quality, and effectiveness of Ag Center activities? Are there plans to obtain feedback from stakeholders, including Center advisors? Are there plans to incorporate feedback and make changes to improve performance?

Are there adequate administrative and management plans to support all operational facets of the Center? Is the Center Director adequately supported, and is there sufficient management depth to provide long-term continuity of Center leadership? Does the administrative structure facilitate communication among Center leaders and project scientists? Are plans for routine management, allocation of funds, and partnerships designed to effectively achieve Center objectives? Is there sufficient evidence that the lines of authority and the administrative structure are designed for effective management of the Center? Does the program’s internal plan promote coordination of interdisciplinary research and stimulate collaborations among constituent research projects and cores, particularly with regard to biomedical and non-biomedical project interactions?

Does the application describe evaluation of scientific projects, the overall Center, and Center objectives to assess the effectiveness of the Center? Are there plans to obtain feedback from advisors, partners, stakeholders, workers, or employers to assess the quality and effectiveness of agricultural health and safety prevention, intervention, translation, promotion, or protection programs? Is it clear how evaluation will be used to provide feedback to projects/programs for improvement?

Environment
Are institutional facilities and resources available to the Ag Center investigators and key personnel? Is there evidence of institutional commitment to the goals of the Center? Does the institutional environment support high quality, multidisciplinary interaction among the Ag Center components? Will the environment contribute to the probability of success for the Center?

Review Criteria for Individual Research Core Projects/Programs

Significance
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? Does the applicant fully justify and provide data to describe the burden of the problem(s) being addressed? If the aims of the project are achieved, how will scientific knowledge, technical capability, or practices be improved? 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 be utilized in agricultural health and safety? If successful, would the project provide information and knowledge to prevent or reduce fatalities or nonfatal injuries? Will the project provide rigorous scientific data that might be used for effective decision-making?

Investigators
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their fields? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Innovation
Does the application challenge and seek to shift current research paradigms (or industry practices) by utilizing novel theoretical concepts, approaches, methodologies, instrumentation, or interventions? Are these novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application proposed? Does the project address an innovative hypothesis or critical barrier to progress in the field or to progress in understanding a pertinent issue, concern, or problem in agricultural health and safety?

Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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 will particularly risky aspects be managed? If the project has research involving human subjects, are the plans for (1) protection of human subjects from research risks and (2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Does the project apply an integrated approach to address a national agricultural health and safety goal, with appropriate focus on a regional issue? Does the applicant justify the need for the type of work proposed (basic or intervention research, outreach activities, etc.), timing of the proposed work, or a particular knowledge gap that will be filled if successful?

Environment
Will the scientific environment 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 there evidence of institutional support?

Review Criteria for the Outreach Core

Significance
Does the proposed work facilitate the translation of occupational safety and health findings into the work environment? Are appropriate occupational safety and health constituents engaged in the program or projects? Will the proposed activities have an impact on the AFF workforce or ability to affect occupational safety and health?

Is there evidence that the proposed work is responsive to regional needs for worker safety and health? For renewal applications, does the center have a successful history of activities that positively impact the AFF workforce? Does the applicant adequately describe activities that will impact other institutions or agencies located within the Ag Center’s region?

Key Personnel
Do the Outreach Core leaders and staff have expertise in AFF occupational safety and health, and in developing, managing, and evaluating an outreach program in an institutional setting? Is there adequate administrative support for effective outreach that complements the Ag Center’s goals and objectives?

Innovation
Does the applicant propose new and innovative outreach approaches relevant to OSH? Does the plan include reaching underserved and underrepresented worker populations?

Approach
Does the applicant adequately describe projects or programs that will include other institutions or agencies located within the Ag Center region? Are appropriate occupational safety and health constituents engaged in the efforts? Do the projects or programs include strategic partnerships and collaborations to diffuse into the workplace new evidenced-based practices for preventing AFF-related illness, injury, and death? Is there a process for ensuring that the communication materials developed are culturally, linguistically, and educationally appropriate?

Environment
Are there sufficient resources for the successful delivery of high quality outreach efforts? Will outreach efforts benefit from the environment in which the Ag Center is located? Is there evidence of an institutional commitment to outreach in Ag Center goals and objectives?

As applicable for the projects proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the HHS/CDC Requirements under AR-1 Human Subjects Requirements.

If your proposed research involves the use of human data and/or biological specimens, you must provide a justification for your claim that no human subjects are involved in the Protection of Human Subjects section of the Research Plan.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the policy on the Inclusion of Women and Racial and Ethnic Minorities in Research (http://www.cdc.gov/maso/Policy/Policy_women.pdf and http://www.gpo.gov/fdsys/pkg/FR-1995-09-15/pdf/95-22950.pdf#page=1) and the policy on the Inclusion of Persons Under 21 in Research (http://www.cdc.gov/maso/Policy/policy496.pdf).

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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.

Resubmissions

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.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

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.

r2p

Does the applicant provide information about how the proposal addresses r2p?

Outcomes and Outputs

Does the applicant provide information about the expected outcomes and outputs and how this research will impact the field of agricultural health and safety?

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by an appropriate peer review group, in accordance with CDC peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

• Will undergo a selection process in which all responsive applications will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Applications will be assigned to the National Institute for Occupational Safety and Health. Applications will compete for available funds with all other applications submitted in response to this FOA. Following initial peer review, applications will receive a second level of review for programmatic relevance and priority.

The following factors 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 program priorities.
• Geographic balance of Centers among regions of the country.
• Statutory and program purposes to be accomplished.
• The extent to which the components of the proposed center would be coordinated into one multidisciplinary effort within the Center.
• The extent to which Center activities would be coordinated with similar efforts of other organizations.
• Commitment of the applicant institution.
• Administrative and managerial capability of the applicant.
• 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.

Any applications awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements. If the application is under consideration for funding, HHS/CDC will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the Grants Management Officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions as described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be allowable as an expanded authority, but only if authorized by CDC.

All HHS/CDC grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement Part II: Terms and Conditions of Award (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf).

Awardees must comply with the administrative requirements (AR) outlined in 45 Code of Federal Regulations (CFR) Part 74 or Part 92, as appropriate, as well as any additional requirements included in the FOA.

Specific requirements that apply to this FOA are the following:

Any activities involving information collection (i.e., surveys, questionnaires, etc.) from 10 or more non-Federal individuals/entities are subject to OMB/PRA requirements and may require the CDC to coordinate an OMB Information Collection Clearance.

The following are additional policy requirements relevant to this FOA:

HHS Policy on Promoting Efficient Spending: Use of Appropriated Funds for Conferences and Meetings, Food, Promotional Items and Printing Publications

This policy supports the Executive Order on Promoting Efficient Spending (EO 13589), the Executive Order on Delivering and Efficient, Effective, and Accountable Government (EO 13576) and the Office of Management and Budget Memorandum on Eliminating Excess Conference Spending and Promoting Efficiency in Government (M-35-11). This policy apply to all new obligations and all funds appropriated by Congress. For more information, visit the HHS website at: http://www.hhs.gov/asfr/ogapa/acquisition/effspendpol_memo.html)

Federal Funding Accountability and Transparency Act of 2006

Public Law 109-282, the Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), requires full disclosure of all entities and organizations receiving Federal funds including grants, contracts, loans and other assistance and payments through a single publicly accessible Web site, www.USASpending.gov (http://www.usaspending.gov/). For the full text of the requirements, please review the following website: https://www.fsrs.gov/.

Plain Writing Act

The Plain Writing Act of 2010 was signed into law on October 13, 2010. The law requires that federal agencies use "clear Government communication that the public can understand and use" and requires the federal government to write all new publications, forms, and publicly distributed documents in a "clear, concise, well-organized" manner. For more information on this law, go to: http://www.plainlanguage.gov/plLaw/index.cfm.

Tobacco and Nutrition Policies

The CDC supports implementing evidence-based programs and policies to reduce tobacco use and secondhand smoke exposure, and to promote healthy nutrition. CDC encourages all awardees to implement the following optional evidence-based tobacco and nutrition policies within their organizations. These policies build on the current federal commitment to reduce exposure to secondhand smoke, which includes The Pro-Children Act, 20 U.S.C. 7181-7184 that prohibits smoking in certain facilities that receive federal funds.

Tobacco:

• Tobacco-free indoors no use of any tobacco products (including smokeless tobacco) or electronic cigarettes in any indoor facilities under the control of the applicant.
• Tobacco-free indoors and in adjacent outdoor areas no use of any tobacco products or electronic cigarettes in any indoor facilities, within 50 feet of doorways and air intake ducts, and in courtyards under the control of the applicant.
• Tobacco-free campus no use of any tobacco products or electronic cigarettes in any indoor facilities and anywhere on grounds or in outdoor space under the control of the applicant.

Nutrition:

• Healthy food service guidelines that at a minimum align with Health and Human Services and General Services Administration Health and Sustainability Guidelines for Federal Concessions and Vending Operations for cafeterias, snack bars, and vending machines in any facility under the control of the recipient organization and in accordance with contractual obligations for these services. The following are resources for healthy eating and tobacco free workplaces:

http://www.gsa.gov/graphics/pbs/Guidelines_for_Federal_Concessions_and_Vending_Operations.pdf

http://www.cdc.gov/nccdphp/dnpao/hwi/toolkits/tobacco/index.htm

http://www.cdc.gov/chronicdisease/resources/guidelines/food-service-guidelines.htm

Applicants should state whether they choose to participate in implementing these two optional policies. However, no applicants will be evaluated or scored on whether they choose to participate in implementing these optional policies.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; CDC Project Officers are not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and HHS/CDC as defined below.

The PDs/PIs will have the primary responsibility for

• Management, administrative, and scientific aspects of the Center, including associated data, resources, and operations
• Coordination of 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
• Retaining custody of and primary rights to the information, data, and software developed under this award, subject to U.S. Government rights of access consistent with current HHS/CDC policies
• Obtaining and maintaining all appropriate human and animal subject approvals (IRB/IUCAC)
• Establishing advisory committee(s) that includes expertise from agricultural experts in the region and the nation to help guide the Ag Center.

Awardees will 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.

CDC staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• Participating in grantee meetings (in person or via regularly scheduled conference calls) to provide insight on NIOSH programs and priorities
• Independent evaluation of progress toward specific aims or overall center goals and objectives
• Providing guidance as needed or requested on project/program design, implementation, and/or interpretation
• Linking extramural researchers with intramural scientists

Areas of Joint Responsibility include

• Meeting annually with NIOSH to facilitate the sharing of information about activities and accomplishments among the Centers (meetings may be coordinated with major scientific meetings that center staff attend or utilize current technology suitable for distance meetings)
• Maintaining clear and consistent lines of communication between PIs/PDs, key personnel, and NIOSH staff (extramural program official, personnel in the Office of Agriculture Safety and Health, and interested scientists throughout the institute) to ensure awareness of work and to seek input and consensus on complex issues.

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement.

A final progress report, invention statement, equipment inventory list and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.

Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity depend upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.

Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law require information to be collected and reported by recipients: 1) information on executive compensation when not already reported through the SAM Registration; and 2) similar information on all sub-awards/ subcontracts/ consortiums over $25,000. It is a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable CDC grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the HHS Grants Policy Statement (http:// www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf) for additional information on this reporting requirement.

Recipient Organization must provide HHS/CDC with an original plus one hard copy of the following reports:

1. Non-Competing Grant Progress Report (use form PHS 2590, posted on the HHS/CDC website http://www.cdc.gov/od/pgo/funding/forms.htm and at https://grants.nih.gov/grants/funding/2590/2590.htm), no less than 120 days prior to the end of the current budget period. The progress report will serve as the noncompeting continuation application and should include a matrix detailing information on subprojects including participating institutions, principle investigators or project directors, assurance numbers and IRB/IACUC approval dates. A matrix template will be provided.

2. 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 clearly identify major accomplishments and impacts during the reporting period.

3. Financial status report, no more than 90 days after the end of the budget period.

4. Final financial and performance reports, no more than 90 days after the end of the project period.

5. Final Invention Statement and Certification form

The Recipient Organization must forward these reports by the U.S. Postal Service or express delivery to the Grants Management Specialist listed in the Agency Contacts section of this FOA.

Although the financial plans of the NIOSH provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interests of the Federal government.

A. Submission of Reports

The Recipient Organization must provide HHS/CDC with an original, plus one hard copy of the following reports:

1. Yearly Non-Competing Grant Progress Report, (use form PHS 2590, posted on the HHS/CDC website, www.grants.gov and at https://grants.nih.gov/grants/funding/2590/2590.htm), is due 90 to 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application. Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.

2. Annual Federal Financial Report (FFR) SF 425 is required and must be submitted through eRA Commons within 90 days after the end of the calendar quarter in which the budget period ends.

3. A final progress report, invention statement, equipment/inventory report, and the final FFR are required 90 days after the end of the project period.

B. Content of Reports

1. Yearly Non-Competing Grant Progress Report - The grantee s continuation application/progress report should include:

• Description of Progress during Annual Budget Period: Current Budget Period Progress reported on the PHS 2590 (http://grants1.nih.gov/grants/funding/2590/2590.htm) with a detailed narrative report for the current budget period that directly addresses progress towards the Measures of Effectiveness included in the current budget period proposal.
• Research Aims: list each research aim/project
• Research Aim/Project: purpose, status (met, ongoing, and unmet), challenges, successes, and lessons learned
• Leadership/Partnership: list project collaborations and describe the role of external partners.
• Translation of Research (1 page maximum). When relevant to the goals of the research project, the PI should describe how the significant findings may be used to promote, enhance, or advance translation of the research into practice or may be used to inform public health policy. This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers, and other potential users. The PI should identify the research findings that were translated into public health policy or practice and how the findings have been or may be adopted in public health settings. Or, if they cannot be applied yet, this section should address which research findings may be translated, how these findings can guide future research or related activities, and recommendations for translation. If relevant, describe how the results of this project could be generalized to populations and communities outside of the study. Questions to consider in preparing this section include:
• How will the scientific findings be translated into public health practice or inform public health policy?
• How will the project improve or effect the translation of research findings into public health practice or inform policy?
• How will the research findings help promote or accelerate the dissemination, implementation, or diffusion of improvements in public health programs or practices?
• How will the findings advance or guide future research efforts or related activities?
• Public Health Relevance and Impact (1 page maximum). This section should address improvements in public health as measured by documented or anticipated outcomes from the project. The PI should consider how the findings of the project relate beyond the immediate study to improved practices, prevention or intervention techniques, inform policy, or use of technology in public health. Questions to consider in preparing this section include:
• How will this project lead to improvements in public health?
• How will the findings, results, or recommendations been used to influence practices, procedures, methodologies, etc.?
• How will the findings, results, or recommendations contributed to documented or projected reductions in morbidity, mortality, injury, disability, or disease?
• Current Budget Period Financial Progress: Status of obligation of current budget period funds and an estimate of unobligated funds projected provided on an estimated FFR.
• New Budget Period Proposal:
• Detailed operational plan for continuing activities in the upcoming budget period, including updated Measures of Effectiveness for evaluating progress during the upcoming budget period. Report listed by Research Aim/Project.
• Project Timeline: Include planned milestones for the upcoming year (be specific and provide deadlines).
• New Budget Period Budget: Detailed line-item budget and budget justification for the new budget period. Use the CDC budget guideline format.
• Publications/Presentations: Include publications/presentations resulting from this CDC grant only during this budget period. If no publication or presentations have been made at this stage in the project, simply indicate Not applicable: No publications or presentations have been made."
• IRB Approval Certification: Include all current IRB approvals to avoid a funding restriction on your award. If the research does not involve human subjects, then please state so. Please provide a copy of the most recent local IRB and CDC IRB, if applicable. If any approval is still pending at time of APR due date, indicate the status in your narrative.

2. Annual Federal Financial Reporting

The Annual Federal Financial Report (FFR) SF 425 is required and must be submitted through eRA Commons within 90 days after the end of the calendar quarter in which the budget period ends. The FFR should only include those funds authorized and disbursed during the timeframe covered by the report. The final FFR must indicate the exact balance of unobligated funds and may not reflect any unliquidated obligations. There must be no discrepancies between the final FFR expenditure data and the Payment Management System's (PMS) cash transaction data.

Failure to submit the required information in a timely manner may adversely affect the future funding of this project. If the information cannot be provided by the due date, you are required to submit a letter explaining the reason and date by which the Grants Officer will receive the information. All CDC Financial Expenditure data due on/after October 1, 2012 must be submitted using the FFR via the eFSR/FFR system in the eRA Commons. All Federal Reporting in the Payment Management System is unchanged. All new submissions should be prepared and submitted as FFRs.

CDC's implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs will be 90 days after the end of the calendar quarter in which the budget period ends. Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter. For example, if the budget period ends 1/30/2012, the annual FFR is due 6/30/2012 (90 days after the end of the calendar quarter of 3/31/2012). Due dates of final reports will remain unchanged. The due date for final FFRs will continue to be 90 days after the project period end date.

Grantees must submit closeout reports in a timely manner. Unless the Grants Management Officer (GMO) of the awarding Institute or Center approves an extension, grantees must submit a final FFR, final progress report, and Final Invention Statement and Certification within 90 days of the end of grant period. Failure to submit timely and accurate final reports may affect future funding to the organization or awards under the direction of the same Project Director/Principal Investigator (PD/PI).

FFR (SF 425) instructions for CDC grantees are now available at https://grants.nih.gov/grants/forms.htm. For further information, contact GrantsInfo@nih.gov. Additional resources concerning the eFSR/FFR system, including a User Guide and an on-line demonstration, can be found on the eRA Commons Support Page: http://www.cdc.gov/grants/interestedinapplying/applicationresources.html

FFR Submission: The submission of FFRs to CDC will require organizations to register with eRA Commons (Commons) (https://commons.era.nih.gov/commons/). CDC recommends that this one time registration process be completed at least 2 weeks prior to the submittal date of a FFR submission.

Organizations may verify their current registration status by running the List of Commons Registered Organizations query found at: http://era.nih.gov/commons/. Organizations not yet registered can go to https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp for instructions. It generally takes several days to complete this registration process. This registration is independent of Grants.gov and may be done at any time.

The individual designated as the PI on the application must also be registered in the Commons. The PI must hold a PI account and be affiliated with the applicant organization. This registration must be done by an organizational official or their delegate who is already registered in the Commons. To register PIs in the Commons, refer to the eRA Commons User Guide found at: http://era.nih.gov/commons/index.cfm.

3. Final Reports

Final reports should provide sufficient detail for CDC to determine if the stated outcomes for the funded research have been achieved and if the research findings resulted in public health impact based on the investment. The grantee’s final report should include:

• Research Aim/Project Overview: The PI should describe the purpose and approach to the project, including the outcomes, methodology and related analyses. Include a discussion of the challenges, successes and lessons learned. Describe the collaborations/partnerships and the role of each external partner.
• Translation of Research Findings: The PI should describe how the findings will be translated and how they will be used to inform policy or promote, enhance or advance the impact on public health practice. This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers and other potential end users. The PI should also provide a discussion of any research findings that informed policy or practice during the course of the project period. If applicable, describe how the findings could be generalized and scaled to populations and communities outside of the funded project.
• Public Health Relevance and Impact: This section should address improvements in public health as measured by documented or anticipated outcomes from the project. The PI should consider how the findings of the project related beyond the immediate study to improved practices, prevention or intervention techniques, or informed policy, technology or systems improvements in public health.
• Publications; Presentations; Media Coverage: Include information regarding all publications, presentations or media coverage resulting from this CDC funded activity. Please include any additional dissemination efforts that did or will result from the project.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Steve Dearwent, PhD
Scientific Program Official
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road NE, Mailstop E74
Atlanta, GA 30333
Phone: 404-498-6382
Fax: 404-498-2571
Email: SDearwent@cdc.gov

Michael Goldcamp, PhD
Scientific Review Officer
Office Of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1095 Willowdale Road, MS 1808
Morgantown, WV 26505
304-285-5951
MGoldcamp@cdc.gov

Brandis Belser
Grants Management Specialist
Procurement and Grants Office
Centers for Disease Control & Prevention
2960 Brandywine Road, Mail Stop E-01
Atlanta, Georgia 30341
Phone: 770-488-2676
Fax: 770-488-2640
Email: BBelser@cdc.gov

Other CDC funding opportunity announcements can be found at www.grants.gov.

All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Awards are made under the authorization of sections of the Public Health Service Act as amended and under the Code of Federal Regulations.