Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

Centers for Disease Control and Prevention (CDC)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this funding opportunity announcement (FOA) might differ from those used by the HHS National Institutes of Health (NIH). If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information.

Components of Participating Organizations

National Institute for Occupational Safety and Health (NIOSH)

Funding Opportunity Title

Centers for Agricultural Safety and Health (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

Reissue of PAR-15-353

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-OH-22-002

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.262

Funding Opportunity Purpose

The National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention (CDC) invites applications for the Centers for Agricultural Safety and Health (Ag Centers). These centers are expected to conduct high quality research and subsequently disseminate their findings and recommendations in audience appropriate products to contribute to improving the safety and health of agriculture, forestry, and fishing workers. Center structure should take advantage of diverse scientific resources and focus on local, regional, and/or national worker safety and health issues. Emphasis should be placed on the creation and implementation of evidence-based solutions that address important agricultural, forestry, and fishing safety and health problems. Centers should also use innovative approaches to identifying, understanding, and developing strategies for overcoming barriers to the adoption, adaptation, integration, scale-up and sustainability of evidence-based solutions. Collaborations with other academic institutions, nonprofit organizations, and other occupational safety and health focused groups are expected. Applicants must concisely describe the occupational safety and health burden within their service area and directly link research and outreach activities to help alleviate the burden. Applicants should also clearly articulate the anticipated impacts of the proposed work, both during the project period and beyond.

Key Dates
Posted Date

November 23, 2021

Open Date (Earliest Submission Date)

December 1, 2021

Letter of Intent Due Date(s)

December 17, 2021. Thereafter, 30 days prior to the application due date

Application Due Date(s)

January 24, 2022; October 24, 2022; October 24, 2023; October 22, 2024  

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. Late applications will not be accepted for this announcement. On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 5:00 PM U.S. Eastern Time.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May 2022; March 2023; March 2024; March 2025

Advisory Council Review

June 2022; April 2023; April 2024; April 2025

Earliest Start Date

September 1, 2022

Expiration Date

December 1, 2024

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.



  3. Table of Contents

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

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    Agriculture, forestry, and fishing (AgFF) occupations have long been recognized as some of the most dangerous in the country. The AgFF sector has a workforce over 2 million strong, and many of these laborers are at significant risk due to a combination of factors. AgFF 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. Furthermore, many laborers in these industries are foreign born and therefore encounter language and cultural barriers that might exacerbate these threats. Additionally, factors such as limited access to health care and worker training resources may also intensify these hazards. Finally, the seasonal nature of some crops might also 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 funding opportunity is to provide support for Centers for Agricultural Safety and Health (Ag Centers) to address the significant and varied morbidity and mortality burden in U.S. AgFF occupations. Ag Centers conduct research and outreach activities as a means of building and expanding upon existing scientific evidence and transferring evidence-based research findings to appropriate stakeholders for adoption, adaptation, integration, scale-up and sustainability.  The overarching goal of the Ag Centers is to reduce adverse outcomes in AgFF worker health and safety.

    Healthy People 2030

    The United States Public Health Service (PHS) is committed to achieving a society in which all people live long, healthy lives. The vision, mission, and goals are found in Healthy People 2030, a PHS-led national activity to achieve better health in the United States by the year 2030. This funding announcement is linked to the goals of Healthy People 2030, that are intended to prevent work-related diseases, injuries, and deaths while improving worker health, safety, and well-being.

    According to the Healthy People 2030, more than 160 million people participate in the U.S. labor force, and their work has an intrinsic connection to their safety and health. Decades of public health surveillance and research have demonstrated that work-related injuries adversely affect employers, workers, and communities. Workplace settings vary widely in size, sector, design, location, processes, culture, and resources. In addition, workers themselves have different ages, genders, education levels, cultural backgrounds, health practices, vulnerabilities, and levels of access to preventive health care. This translates into great diversity and disparity in the safety and health risks for each industry sector and the need for tailored interventions.

    Public Health Impact

    Ag Centers are expected to have a significant and sustained impact on reducing morbidity and mortality in the AgFF workforce. Despite safety advances in many areas of this sector, and recently documented decreases in adverse health outcomes for this workforce, AgFF workers are still disproportionately affected in comparison to workers in 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 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-11-022PAR-06-057RFA-OH-03-002, and RFA-OH-01-004.

    Ag Centers conduct high quality research and subsequently disseminate their findings and recommendations to appropriate audiences and stakeholders through outreach and education activities. The centers identify practical solutions to complex problems while cultivating collaboration and partnerships. 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 AgFF workers. Although 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. In some cases, this may involve translation research where one center is using the evidence base developed by another center to test intervention effectiveness in a different population. Centers 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 AgFF workforce which are too large and diverse for any single center to adequately address. Applicants should clearly describe how the intended outcomes of the proposed work will contribute to the specified goals in NIOSH's Strategic Plan and, in particular, those identified in the NIOSH Priority Goals for Extramural Research.

    Ag Center Structure

    NIOSH Ag Centers provide interdisciplinary research and outreach efforts to address AgFF-related occupational health and safety problems. Applicants should keep in mind the required and optional components essential to Ag Center function, 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 AgFF worker health and safety.

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

    • Evaluation and Planning Core
    • Outreach Core
    • Research Projects (collectively, the "Research Core", along with the optional Pilot/Feasibility Program)

    Evaluation and Planning Core. The purpose of the Evaluation and Planning Core is to 1) provide oversight, leadership, and management for the Center, including establishment and maintenance of advisory committees; 2) engage in long-range planning, coordination, and implementation of work that crosses multiple cores, programs or projects; and 3) develop and assist in implementing evaluation efforts at the Center, core, program and project levels. Any collaborative projects with other Ag Centers should include the Evaluation and Planning Core for the purposes of oversight and coordination.

    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 to benefit workers and their associated work environments. 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.

    Research Core. The purpose of the Research Core is to develop programs and projects in response to the goals identified in the Center's strategic plan and subsequently manage, monitor, and coordinate this work within the Center. Research activities include basic/etiologic, intervention, translation, and surveillance. Activities can vary widely, from pilot or feasibility studies that are minimally resourced and may be exploratory in nature to large, R01-like projects that require preliminary data and significant investment in personnel, equipment, time, and space. The Research Core is comprised of the required research projects and the optional Pilot/Feasibility Program Please note, the "Research Core" is not an actual component within the application - instead it is a construct to address budget limits across multiple and varied activities (i.e., required research projects and the optional pilot/feasibility program). There is no limitation to the number of research projects that applicants can propose as long as they stay within the annual direct costs requirements.

     

    Objectives/Outcomes

    The primary goal of an Ag Center is to conduct high quality scientific research and outreach efforts to address local, regional, and national AgFF problems. This will ultimately be accomplished through the goals in the Center’s Strategic Plan. However, the operational process for accomplishing these goals should not be overlooked and therefore, each core, program and project should develop operational objectives to support the goals in the Plan.

    Target Population

    There are many affected subpopulations in AgFF 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 outputs and 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 AgFF 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.

     

    Industry Sectors, Health and Safety Cross-sectors, and Goals

    In the Project Description/Abstract of the application, state which industry sector(s) and health and safety cross-sector(s) the proposed work will address. Provide a clear rationale for how the intended outcomes of the proposed project will contribute to the specified goals in NIOSH's Strategic Plan and, in particular, those identified in the NIOSH Priority Goals for Extramural Research.

    Diversity, Equity and Inclusion

    In June 2019, NIOSH began an initiative to take substantive action in creating greater diversity, equity, and inclusion in its workforce, the workplace and in its service to the public.  This initiative led to the establishment of the NIOSH Diversity and Inclusion Office. The associated strategic plan is intended to guide actions that specifically address diversity, equity and inclusion (DEI) in all aspects of NIOSH's work, including NIOSH-supported extramural programs. Ag Centers should demonstrate a commitment to DEI in all aspects of their center.  This commitment should be reflected in the center's core values, mission and outputs.

    Asymmetrical power relationships along social axes such as age, class, gender, nativity, and race/ethnicity not only result in social, economic, and environmental disadvantages that impact the distribution of work-related benefits and risks but also result in exclusionary research practices.  Developing inclusive research practices, and the institutional capacity to effectively produce data driven solutions that reduce these avoidable inequities, is essential to ensuring the well-being of the increasingly diverse AgFF workforce. 

    Applicants should describe how they propose to ensure inclusive governance and practice in the required center components (Evaluation and Planning, Outreach, and Research). Discussion should include, but not be limited to, how historically underrepresented groups will be included in agenda setting for the work of the center. For example, this may include participation on advisory boards, as researchers/staff and through partnerships.  Applicants should also identify how the center will ensure that research questions, data collection methods and analysis, and dissemination of results will be inclusive of the diversity in the AgFF workforce, especially those from historically underrepresented groups. Applicants should demonstrate how the design, content, format, and dissemination of outreach efforts will be tailored to the needs of workers from diverse backgrounds. 

    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

    All Center activities should be managed and coordinated as part of the Evaluation and Planning Core. This core is responsible for all new and ongoing center-wide evaluation activities as well as supporting program and project level evaluation efforts. These activities should all be described in a Center evaluation plan. Ag Centers are also strongly encouraged to interact with each other on evaluation methods and best practices, to increase awareness of activities and evaluation techniques. Similarly, centers will work with each other and NIOSH during the performance period to develop shared logic models on common AgFF health and safety outcomes. In addition to center-specific evaluation and performance measurement, Ag Centers may be asked to participate in NIOSH evaluation efforts related to the NIOSH AgFF Program and the NIOSH Evaluation Capacity Building Plan.

    Translation Plan

    The transfer of evidence-based approaches to intermediaries such as unions, manufacturers, worker groups and end users (employers and workers) through training, conferences, community gatherings, social media, blogs, websites and infographics, peer-reviewed and lay publications, etc. is an essential function of the Outreach Core. While 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.

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

    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    New
    Renewal
    Resubmission
    Revision

    Note to Applicants

    After the January 2022 application due date, only Revision and Resubmission applications from the funded centers will be accepted for research projects that competed and were not funded in FY2022. New and Renewal applications will not be accepted for future application due dates.

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Clinical Trial?

    Optional: Accepting applications that either propose or do not propose clinical trial(s)

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    Estimated Total Funding: $15-18 million total costs (direct and indirect costs) in FY 2022.

    NIOSH intends to commit approximately $80-100 million in total costs (direct and indirect) over the entire project period (up to 5 years).  

    Anticipated number of awards: NIOSH anticipates funding approximately 10-12 awards through this announcement.

    Awards issued under this announcement are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

    Award Budget

    $1,400,000 Direct Costs per budget period

    Award Ceiling: $1,400,000 direct costs per budget period

    Award Floor: $800,000 direct costs per budget period

    It is anticipated that the maximum amount for each application/award will be $1,400,000 in direct costs for each 12-month budget period.

    Award Project Period

    5 years

     

    The total project period for an application submitted in response to this funding opportunity may not exceed 5 years.

    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 interests of the federal government

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    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
    Foreign Institutions

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

    Applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The HHS Grants Policy Statement states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
      • PLEASE NOTE: For applications due on or after January 25, 2022, applicants must have a unique entity identifier (UEI) at the time of application submission. Grant application forms and instructions will be updated to reflect and require UEI instead of DUNS.
    • System for Award Management (SAM) – 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

    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.

    Eligible Individuals (Program Director/Principal Investigator)

    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 CDC/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 SF424 (R&R) Application Guide.

    Responsiveness

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

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

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

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

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

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

    CDC/NIOSH will not accept any application in response to this announcement that is essentially the same as one currently pending initial peer review, unless the applicant withdraws the pending application.

    Section IV. Application and Submission Information
    1. Requesting an Application Package

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

    2. Content and Form of Application Submission

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

    Applicants must use FORMS-G application packages for due dates on or after January 25, 2022 and must use FORMS-F application packages for due dates on or before January 24, 2022.

    Application guides for FORMS-G application packages will be posted to the How to Apply - Application Guide page no later than October 25, 2021.

    Letter of Intent

    Due Date: December 17, 2021. Thereafter, 30 days prior to the future submission due dates.

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

    By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

    • Descriptive title of proposed center
    • Titles for each proposed research project (and pilot/feasibility program, if applicable)
    • Name(s), address(es), email(s), and telephone number(s) of the PD(s)/PI(s) for the center as well as for all proposed components
    • Names of other key personnel
    • Participating institution(s)
    • Number and title of this funding opportunity

    The letter of intent should be sent to:

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

    Page Limitations

    In most cases, research strategy page limits are either 6 pages or 12 pages. Unless otherwise specified in this announcement, the page limit for each component is determined by the proposed total direct cost over the entire project period, regardless of the number of years in that component's project period. When a component's total direct costs across the project period are $500K or less, the limit is 6 pages. When a component's total direct costs across the project period are greater than $500K, the limit is 12 pages. The Overall component is allowed 15 pages.

    Only include proposed (prospective) work in the research strategy attachment to the PHS 398 Research Plan (i.e., "3. *Research Strategy"). Past performance and/or prior accomplishments, whether for new or renewal applicants, is limited to 6 pages per component and should be attached to the Appendix of the PHS 398 Research Plan (i.e., "12. Appendix"). Related publications for the particular proposed component, whether for new or renewal applicants, should be attached to the progress report publication list of the PHS 398 Research Plan (i.e., "4. Progress Report Publication List"). There is no page limit for related publications attachments.

    Follow the page limits specified in this table:

    Available Component Types

    Research Strategy Page Limits

    Overall

    15

    Evaluation and Planning Core

    12

    Outreach Core

    12

    Pilot/Feasibility Program

    6

    Research Projects with direct costs of $500K or less during the project period

    6

    Research Projects with direct costs of more than $500K during the project period

    12

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

    Note: References are not included in the page limits

    Instructions for the Submission of Multi-Component Applications

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

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

    The application should consist of the following components:

    • Overall: required
    • Evaluation and Planning Core: required
    • Outreach Core: required
    • Pilot/Feasibility Program: optional
    • Research Projects: required

    Note: Research Projects will be listed in the final application in the order in which they were entered in ASSIST as Research-Project 1, Research-Project 2, etc. There is no limit to the number of research projects, but they must conform with annual direct costs requirements for the entire research core. The "Research Core" is not a component within the application - instead it is a construct to address budget limits across multiple and varied activities (i.e., required research projects and the optional pilot/feasibility program).

    Please enter in ASSIST in the following order:

    Overall Component

    When preparing your application, use Component Type ‘Overall’

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

    SF424 (R&R) Cover (Overall)

    Complete entire form.

     
    PHS 398 Cover Page Supplement (Overall)

     

    Research & Related Other Project Information (Overall)

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

    Project Narrative: In 1-3 sentences, describe the relevance of the research and outreach efforts proposed by the Center.

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

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

    Project/Performance Site Location(s) (Overall)

    Enter primary site only.

     

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

     

    Research & Related Senior/Key Person Profile (Overall)

    Include only the Project Director/Principal Investigator (PD/PI). Component leads and other Senior/Key individuals should only be listed in the components in which they are active.

    The Center will be an identifiable organizational unit formed by a single institution or a consortium of cooperating institutions. Therefore, lines of authority must be clearly specified. Each applicant institution will name a Director (Project Director/Principal Investigator, PD/PI) who will be the key figure in the administration, management and coordination of the cooperative agreement. This individual will be responsible for the organization and operation of the Center. The PD/PI should be a scientific leader experienced in their field of research and must be able to coordinate, integrate, and provide guidance in the establishment of the cores, programs, and projects.

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

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

     

    Research & Related Budget (Overall)

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

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

     

    PHS 398 Research Plan (Overall)

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

     

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

     

    Research Strategy: Provide an overview that describes the key scientific aspects of the center and how the proposed center structure (cores, programs, and projects) addresses the purpose and objectives described in this funding announcement. The application should be comprised of interrelated projects, programs, and cores, each capable of standing on its own merit but complementary and necessary for accomplishing the Center's proposed objectives. This section provides the applicant an opportunity to give a conceptual framework for the center and a broad strategy for accomplishing the strategic goals. It also allows the applicant to collectively address the proposed research projects as well as identifying connections with Outreach Core activities.

    Focusing on the center as a whole, address (1) the importance of the overall goals of the center and the critical barrier(s) to progress in the field that will be the focus, (2) how the resources of the proposed center will improve scientific knowledge, technical capability, and/or improved practice and outreach, and (3) how the concepts, methods, technologies, services, or interventions that drive the AgFF occupational safety and health field will be changed if the proposed aims are achieved.

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

    Include the major proposed efforts and studies and show how the cores, programs, and projects complement each other or are interdependent. Describe the mechanisms that will ensure the coherence and cohesiveness of the center while maintaining a multidisciplinary focus.

    Include the Institutional Commitment to the Ag Center.

    Identify the States that will be covered by the Ag Center.

    Discuss the research projects individually and collectively as a research core and provide a clear and considered agenda supporting the Centers' overall efforts. Applicants should address the following:

    • Provide a brief description of the overall research objectives
    • Describe how all research projects within the center will be managed, monitored, and coordinated
    • Identify the category of the proposed individual research projects (i.e., basic/etiologic, translation, intervention or surveillance as discussed below)
    • Provide a brief description of the Pilot/Feasibility Program (this is an optional component)

    Basic/Etiologic Research Projects - These projects build a foundation of scientific knowledge upon which future interventions are based. Research in this category tries to identify and document the nature and extent of occupational safety and health problems, often through laboratory studies. Basic/etiologic research includes methods development, toxicology studies, and risk assessment. One-time data collection/analysis on risk factors, work practices, injuries, illnesses or hazardous exposures (even if the assessments may potentially be repeated in the future) also fit in this category.

    Intervention Research Projects - Interventions are technology, equipment, training and communication resources, workplace policies, practices, or programs, and social marketing campaigns that may be implemented to improve workplace safety and health. Projects in this category can involve designing a new intervention, testing the efficacy or effectiveness of an intervention, or improving upon an existing intervention. Efficacy research evaluates the initial impact intervention among the individuals in the target population when it is delivered under optimal or laboratory conditions (or in an ideal setting). Efficacy trials typically use random allocation of participants and/or units and ensure highly controlled conditions, with a focus on internal validity or on establishing a causal relationship between the exposure to an intervention and the outcomes of interest. Effectiveness research assesses the impact of an intervention with demonstrated efficacy when it is delivered under “real-world” conditions. Effectiveness trials often use designs for less controlled research settings with a focus on external validity or achieving (generalizable) results.

    Translational Research Projects - Translation research (also referred to as translational research) is the study of the process of engaging with stakeholders to develop, test and move evidence-based interventions (technologies, knowledge and training products, and workplace policies, procedures, and practices) into real-world settings to equitably reach diverse worker populations.  Translation (or translational) research focuses on moving research along the research continuum so that useful and timely research results are made available for dissemination and implementation (D&I). D&I research specifically focuses on the later stages of the translation(al) research spectrum and examines the processes by which interventions—developed and tested earlier in the translational research pipeline—are disseminated, adopted, implemented, and maintained/sustained. While efficacy and effectiveness research are concerned with investigating specific interventions and health or safety outcomes in either ideal or real-world settings, translation research is particularly concerned with the adoption, successful implementation, and sustainability of the intervention. Research under this area will identify, develop, test, evaluate, and/or refine strategies to disseminate and implement evidence-based interventions into community/workplace settings in the agricultural sector. Studies to advance D&I research methods and measures for agricultural safety and health are also relevant.

    Surveillance research projects - Surveillance research projects may include developing new surveillance methods, tools, and analytical techniques or ongoing, systematic surveillance. 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 AgFF surveillance. The analyses of available surveillance data are not considered research in this context.

    Progress Report Publication List: Related publications within the last 5 years for the overall proposed center, whether for new or renewal applicants, should be attached

     

    Letters of Support or Collaboration: Include signed letters of support or collaboration from participating institutions. These can be included in the overall component, or with specific components if closely related to the aims in those cores, programs, or projects.

     

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

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

    Appendix: Past performance and/or prior accomplishments within the last 5 years, whether for new or renewal applicants, are limited to 6 pages. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Only the items listed in NOT-OD-17-098, plus additional items specifically listed in this funding opportunity announcement, are allowed.

    Note: The applicant should include a Human Subjects summary table that lists all proposed relevant cores, programs, and projects along with human subjects information (project title, performance sites, FWAs, IRB approval date/status). Applicants may elect to place logic models in the research strategy or in the appendix.

     

    PHS Human Subjects and Clinical Trials Information (Overall)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

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

     

    When preparing your application, use Component Type ‘Eval Plan Core’

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

    SF424 (R&R) Cover (Evaluation and Planning Core)

    Complete only the following fields:

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

     

    PHS 398 Cover Page Supplement (Evaluation and Planning Core)

     

    Research & Related Other Project Information (Evaluation and Planning Core)

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

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

    Equipment: Describe any equipment that is shared across components

    Project /Performance Site Location(s) (Evaluation and Planning Core)

    List all performance sites that apply to the specific component.

     

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

     

    Research & Related Senior/Key Person Profile (Evaluation and Planning Core)

     

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

     

    In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. An Associate (or Deputy) Director may be named who will be involved in the administrative and scientific efforts of the Center. If named, specify Project Role of ‘Other’ with Category of ‘Associate Director.’

     

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

     

    Research & Related Budget (Evaluation and Planning Core)

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

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

    Applicants may request up to $300K in direct costs per year for the Evaluation and Planning Core. This includes required (administration, evaluation) and optional (emerging issues) elements.

    Center Administration is a required element of the Evaluation and Planning Core. Applicants may propose budgets up to $150K annually (direct costs) to support overall administration, coordination, and oversight activities.

    The Evaluation Program is a required element of the Evaluation and Planning Core. Applicants may propose up to $100K annually (direct costs) to cover all evaluation activities within the Center.

    The Emerging Issues Program within the Evaluation and Planning Core is an optional element 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.

    Applicants should budget for an annual Center Directors Meeting. This required meeting will provide an opportunity for Ag Center leadership and NIOSH staff to discuss developing and emerging issues in AgFF worker safety and health and to further encourage a spirit of collaboration in addressing challenges and advances in AgFF worker safety and health. Applicants should also budget for an evaluation meeting at least every two years to ensure that NIOSH and centers have the opportunity to engage on cross-center, collaborative evaluation efforts.

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

    If applicable, use SF424 R&R Subaward Budget Attachment Forms for each consortium/subaward recipient. Similarly, use the PHS Additional Indirect Costs Form to account for indirect costs on the first $25,000 of each subaward.

     

    PHS 398 Research Plan (Evaluation and Planning Core)

    Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

     

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

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

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

    Required center administrative 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 principal 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 AgFF issues they are working to remediate. The core should develop and maintain a strategic plan with a vision, mission statement, and goals that the Center will work toward achieving during the course of the performance period and beyond. 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 Evaluation Program may include a logic model that describes inputs, activities, outputs, transfer, intermediate and end outcomes. The model combined with the strategic plan can serve as the Center’s strategic roadmap as it plans, coordinates, implements, and assesses its impact over the funding period (and some intermediate and end outcomes that may occur beyond the period of funding). Consideration should be given to factors including, but not limited to, the NIOSH Strategic Plan, regional and national burden and need information, stakeholder input, potential for input, evaluation feedback, Center expertise, and previously work. Since NIOSH has moved to primarily demonstrating their program impact by assessing contribution, specifically through contribution analysis, rather than attribution, the Evaluation Program should create an evaluation plan that includes tracking outputs and identifying, collecting, and documenting intermediate outcomes that contribute to the Center’s strategic goals (end outcomes in the logic model). The evaluation plan should also describe how the Program will assist in planning and implementing evaluation efforts at the individual project and program level, particularly as it applies to the efficacy and effectiveness of proposed interventions. Any other evaluation activities that the Center plans to conduct for the purposes of assessing impact or Center/program improvement should also be incorporated into the evaluation plan.

    The Emerging Issues Program is intended to assist centers in addressing new or emerging problems within their region that were not present or recognizable at the time of application. 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.

    Progress Report Publication List: Related publications in the past 5 years for the evaluation and planning core, whether for new or renewal applicants, should be attached.

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

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

    Appendix: Past performance and/or prior accomplishments in the past 5 years, whether for new or renewal applicants, is limited to 6 pages. Do not use the appendix to circumvent page limits. Follow all other instructions for the Appendix as described in the SF424 (R&R) Application Guide. Only the items listed in NOT-OD-17-098, plus additional items specifically listed in this funding opportunity announcement, are allowed. Applicants may elect to place logic models in the research strategy or in the appendix.

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

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

    Outreach Core (Required)

    When preparing your application, use Component Type ‘Outreach Core’

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

    SF424 (R&R) Cover (Outreach Core)

    Complete only the following fields:

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

    PHS 398 Cover Page Supplement (Outreach Core)

    Research & Related Other Project Information (Outreach Core)

    Project Summary/Abstract: Provide a succinct summary of the proposed outreach efforts.

    Project Narrative: In 1-3 sentences describe the public health relevance of the proposed activities.

     

    Project /Performance Site Location(s) (Outreach Core)

    List all performance sites that apply to the specific component.

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

     

    Research & Related Senior/Key Person Profile (Outreach Core)

    In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field. In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

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

    The Outreach Core lead should have the expertise appropriate to manage all aspects of the Core successfully.

     

    Research & Related Budget (Outreach Core)

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

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

    Applicants may propose budgets up to $200K annually (direct costs) to support all work within the Outreach core.

    If applicable, use SF424 R&R Subaward Budget Attachment Forms for each consortium/subaward recipient. Similarly, use the PHS Additional Indirect Costs Form to account for indirect costs on the first $25,000 of each subaward.

     

    PHS 398 Research Plan (Outreach Core)

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

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

    Research Strategy:  This core should be broad in scope and prioritize activities that will have an impact on AgFF worker health and safety. The Outreach Core must develop an outreach plan that aligns with the Center's goals and considers the diverse needs of stakeholders outlined in their logic model to support successful transfer and adoption by intermediaries and/or end users. When developing the plan, the Center should consider its Strategic Plan and logic model, anticipated project outputs and primary target audiences. The applicant should describe the anticipated strategies for translation and/or dissemination of research findings, including the audiences to be reached and the methods to reach those audiences.

    The plan should also reflect how personnel in this core will work with those in other components to better integrate, at project conception, consideration of primary target audiences, modalities (the most appropriate outputs) to reach them, and a plan for achieving impact.

    Progress Report Publication List: Related publications in the past 5 years for the Outreach Core, whether for new or renewal applicants, should be attached.

    Letters of Support: Provide any letters of support that are specific to this core, particularly focusing on non-profits, community organizations, stakeholders, and other key partners in outreach and educational efforts.

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

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

    Appendix: Past performance and/or prior accomplishments in the last 5 years and related to proposed outreach activities, whether for new or renewal applicants, is limited to 6 pages. Do not use the appendix to circumvent page limits. Follow all other instructions for the Appendix as described in the SF424 (R&R) Application Guide. Only the items listed in NOT-OD-17-098, plus additional items specifically listed in this funding opportunity announcement, are allowed. Applicants may elect to place logic models in the research strategy or in the appendix.

     

    PHS Human Subjects and Clinical Trials Information (Outreach Core)

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

    Pilot/Feasibility Program (Optional)

    When preparing your application, use Component Type ‘Pilot Program’

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

    SF424 (R&R) Cover (Pilot/Feasibility Program)

    Complete only the following fields:

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

    PHS 398 Cover Page Supplement (Pilot/Feasibility Program)

     

    Research & Related Other Project Information (Pilot/Feasibility Program)

     

    Project /Performance Site Location(s) (Pilot/Feasibility Program)

    List all performance sites that apply to the specific component.

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

     

    Research & Related Senior/Key Person Profile (Pilot/Feasibility Program)

     

    Research & Related Budget (Pilot/Feasibility Program)

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

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

    The Pilot/Feasibility Program is an optional component and must fit within the overall funding limits of the Research Core. The Research Core is comprised of all research projects and the pilot/feasibility program, if proposed. The overall funding level for the Research Core is $900K direct costs, annually. 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

    If applicable, use SF424 R&R Subaward Budget Attachment Forms for each consortium/subaward recipient. Similarly, use the PHS Additional Indirect Costs Form to account for indirect costs on the first $25,000 of each subaward.

     

    PHS 398 Research Plan (Pilot/Feasibility Program)

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

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

    Research Strategy:  Describe the anticipated strategies for developing and managing this program as well as the translation and/or dissemination of research findings.

    Progress Report Publication List: Renewal applicants should attach a publications list for the past 5 years for their pilot/feasibility program. New applicants can provide publications of small research projects that they or other center key personnel have been affiliated with or managed.

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

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

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

    Appendix: Past performance and/or prior accomplishments in the past 5 years, whether for new or renewal applicants, is limited to 6 pages. Do not use the appendix to circumvent page limits. Follow all other instructions for the Appendix as described in the SF424 (R&R) Application Guide. Only the items listed in NOT-OD-17-098, plus additional items specifically listed in this funding opportunity announcement, are allowed. Applicants may elect to place logic models in the research strategy or in the appendix.

     

    PHS Human Subjects and Clinical Trials Information (Pilot/Feasibility Program)

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

    Research Projects (Required)

    When preparing your application, use Component Type ‘Research Project’

    Applicants will complete this form set for each individual research project.

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

    SF424 (R&R) Cover (Research Projects)

    Complete only the following fields:

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

    PHS 398 Cover Page Supplement (Research Projects)

     

    Research & Related Other Project Information (Research Projects)

    Project Summary/Abstract: Provide a succinct summary of the proposed research.

    Project Narrative: In 1-3 sentences describe the public health relevance of the proposed research.

     

    Project /Performance Site Location(s) (Research Projects)

    List all performance sites that apply to the project.

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

    Research & Related Senior/Key Person Profile (Research Projects)

     

    Research & Related Budget (Research Projects)

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

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

    There are no established funding limits for individual research projects. Applicants must work within the overall funding level for the Research Core ($900K direct costs annually). The Research Core is comprised of all research projects and the pilot/feasibility program, if proposed, as this is an optional component. Research projects can span any number of years within the Center's five-year project period. That is, research projects can be from 1 to 5 years in length.

    If applicable, use SF424 R&R Subaward Budget Attachment Forms for each consortium/subaward recipient. Similarly, use the PHS Additional Indirect Costs Form to account for indirect costs on the first $25,000 of each subaward.

    PHS 398 Research Plan (Research Projects)

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

    Research Strategy: It is anticipated that proposed research projects will vary widely in terms of topic/focus, degree of difficulty, and required resources. Proposed research projects should clearly fit within the overall goals of the Ag Center Strategic Plan. Page limits for the research strategy are either 6 or 12 pages, based on total proposed costs across the project period.

    Progress Report Publication List: Related publications in the past 5 years for the research project, whether for new or renewal applicants, should be attached.

    Letters of Support: Provide any letters of support that are specific to the research project, particularly for letters of collaboration or from consultants.

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

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

    Appendix: Past performance and/or prior accomplishments in the last 5 years related to the proposed research, whether for new or renewal applicants, is limited to 6 pages. Do not use the appendix to circumvent page limits. Follow all other instructions for the Appendix as described in the SF424 (R&R) Application Guide. Only the items listed in NOT-OD-17-098, plus additional items specifically listed in this funding opportunity announcement, are allowed. Applicants may elect to place logic models in the research strategy or in the appendix.

    PHS Human Subjects and Clinical Trials Information (Research Projects)

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

    3. Unique Entity Identifier and System for Award Management (SAM)

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

    PLEASE NOTE: For applications due on or after January 25, 2022, applicants must have a unique entity identifier (UEI) at the time of application submission. Grant application forms and instructions will be updated to reflect and require UEI instead of DUNS.

    4. Submission Dates and Times

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

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

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    All HHS/CDC awards are subject to the federal regulations, 45 CFR 75, terms and conditions, and other requirements described in the HHS Grants Policy Statement. Pre-award costs may be allowable as an expanded authority, but only if authorized by CDC.

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

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

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

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

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

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

    7. Other Submission Requirements and Information

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

                                                              

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

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

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

    Important reminders:

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

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

    See more tips for avoiding common errors.

    Risk Assessment Questionnaire Requirement

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

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

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

    Duplication of Efforts

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

    Report Submission: The applicant must upload the report under “Other Attachment Forms.” The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap.

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

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

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

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process. Applications submitted to the CDC/NIOSH in support of occupational safety and health research are evaluated for scientific and technical merit through the CDC/NIOSH peer review system.

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

    • A summary evaluation of the Overall Center (considering all component Cores, Programs, and Projects)
    • A separate evaluation of the Evaluation and Planning Core
    • A separate evaluation of the Outreach Core
    • A separate evaluation of the Pilot/Feasibility Program, if proposed
    • A separate evaluation of each Research Project
    Overall Impact

    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 Center proposed).

    Scored Review Criteria - Overall Ag Center

    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 component that by its nature is not innovative may be essential to advance a field.

    Significance

    Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/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 overall center scientifically compelling?  How will impacts be measured? Does the creation or continuation of the Center meet identified needs in AgFF? Are there evidence or indications of collaborative relationships that are likely to contribute to the knowledge base or practice? Is the Center likely to have an impact in meeting the regional and national need in AgFF occupational safety and health?

    For Renewal applications: In addition to the criteria above, have existing Centers made significant contributions to improving health and safety for AgFF workers as demonstrated by their accomplishments? Is there evidence of progress and impact specific to this program since the previous competitive review? Is there a plan for interactions with other NIOSH-supported Ag Centers, organizations, and communities? Does the applicant document evidence of outcomes and impacts? Does the applicant provide evidence of past success in meeting the national need for healthy worksites and healthy workers through research, education, and partnership activities?  

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? Will the PD(s)/PI(s) devote adequate time and effort? 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 goals in the Center's Strategic Plan? Has a multidisciplinary team with the appropriate and complementary expertise required to accomplish the proposed research program been assembled? Do the Center investigators have a successful track record in AgFF research?  Is there evidence of high-quality outputs from Center investigators, and have they contributed to improvements in AgFF occupational safety and health? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the center? 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 of the Center? 

    Innovation

    Does the application challenge and seek to shift current research or practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the center? Is it evident and logical how oversight, coordination, and collaboration within the Center and between the Center and its stakeholders (e.g., other Ag Centers, NIOSH, labor, industry, professional groups, and community organizations) will be conducted? Is the Center Strategic Plan cohesive and feasible? Is it clear how staff across the three cores will work together to implement the Center strategic Plan? Is the logic model clear, feasible, and aligned with the Center Strategic Plan? Do proposed projects and programs support the goals within the Center’s Strategic Plan? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed work? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? Is there evidence of adequate integration and meaningful interdisciplinary or multidisciplinary collaboration among the various cores, programs, and projects? Are the sizes of the programs and cores sufficient to afford effective interaction focused on specific goals in the Center’s Strategic Plan, but sufficiently diverse in scientific disciplines to achieve meaningful contributions in agricultural health and safety at the regional or national level? Are external factors that could potential affect progress presented? If so, are potential mitigating strategies addressed? Are monitoring and evaluation practices in place to observe external factors and track affect(s) of mitigating factors?

    If the center involves human subjects and/or NIH-defined clinical research, are the plans to address:

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

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

    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 project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of adequate integration and meaningful interdisciplinary or multidisciplinary collaboration among the various cores, programs, and projects? 

    Overall Impact – Individual Components

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

    Scored Review Criteria – Individual Components

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

    Evaluation and Planning Core

    Significance

    Does the proposed Planning and Evaluation Core have an appropriate and adequate 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? Does the Ag Center’s Strategic Plan reflect national and regional high priority areas as evidenced by planning (NIOSH Strategic Plan, surveillance and survey data, stakeholder feedback, etc.) and production (facilities, funds, personnel, etc.) inputs? Is the logic model well-reasoned? Do Ag Center projects and programs align with the Ag Center Strategic Plan and logic model?

    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?

    Investigator(s)

    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 staff appropriate to contribute to the needs and conduct of the program’s planning and evaluation activities?

    Innovation

    Does the applicant seek to assess the 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)?

    Approach

    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 organizational structure provide clear lines of authority? Is there sufficient evidence that the lines of authority and the administrative structure are designed for effective management of the Center? Does the organizational structure facilitate communication and collaborations within, among and between programmatic elements of the Center in an efficient and effective manner to promote planning and evaluation activities? Does the Center have a strategic plan? Does the center have a logic model? Are the Strategic Plan and logic model well-reasoned? Does the Center’s evaluation plan include a reasonable and feasible way to identify, collect, and document intermediate outcomes? Does the evaluation plan articulate how the core will assist the research core in assessing the efficacy and effectiveness of interventions (e.g., training, communication and educational material, web applications) where appropriate?  

    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?

    Outreach Core

    Significance

    Do the proposed activities reasonably facilitate the transfer of occupational safety and health findings to appropriate intermediaries and end users who can contribute to changes in occupational safety and health outcomes? Do the proposed outreach activities support the goals in the Center's Strategic Plan and logic model?

    For renewal applications, does the center have a successful history of activities that positively impact the AgFF 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 AgFF 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 Center have an outreach plan? Have target audiences for projects and programs been clearly defined? Do proposed outputs and channels of dissemination seem reasonable given the desired target audiences? Are appropriate occupational safety and health constituents engaged in the program or projects?

    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?

    Pilot/Feasibility Program and Research Projects

     

    Significance

    Does the project contribute to the Center’s Strategic Plan? 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? What is the estimated public health benefit of the research? Do the existing data, public health needs and type of research justify dissemination and implementation? 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? Will potential adopters and organizations be able to determine the applicability of these knowledge or resources to their setting? How broad a reach (to the population that will benefit from the knowledge/intervention) will be achieved and how equitable will reach and outcomes likely be through the knowledge/service delivery contexts selected? 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?

     

    Investigator(s)

    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)? Are the investigators part of stakeholder teams or have strong links and engagement of stakeholders necessary to accomplish the project aims?

     

    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? Does the proposed research use proven models, research designs, methods, and measures to contribute new concepts, outcomes, and/or approaches to OSH research? Does the study proposed hold promise for speeding the translation of research into practice and/or produce novel and robust findings?

     

    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 (e.g., basic or intervention research), timing of the proposed work, or a particular knowledge gap that will be filled if successful? Does the applicant demonstrate an understanding of dissemination and implementation research principles? Has the applicant justified the study design on the basis of the relevant contextual factors (e.g., that consider business size, the regulatory environment, etc.)? Is the D&I approach appropriate to the problem and population using research methods that are relevant, rigorous and practical? Are the procedures to assess and analyze the strategies appropriate? Are the measurements and analysis plan linked to the study aims, and does the analysis incorporate the best available data to track D&I process and impact, including cost-effectiveness? Where applicable, does the proposed plan for analysis take into account hierarchical relationships among multiple levels of outcomes (e.g., worker, employers, etc.)? How appropriate are the plans to sustain effective D&I approaches once the research-funding period has ended? 

    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? Are the applicants to influence large or influential networks capable of taking the results of the proposed study to scale to achieve impact? Do the proposed approaches take advantage of unique features of the intervention delivery environment or employ useful, collaborative arrangements? Is there evidence of institutional support to sustain dissemination or implementation strategies once the research funding ends? 

    Additional Review Criteria - Overall, Cores, Programs, and Research Projects

    As applicable for the components 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

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

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

    Inclusion of Women, Minorities, and Individuals Across the Lifespan  

    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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed.  For additional information on review of the Inclusion section, please refer to the policy on the Inclusion of Women and Racial and Ethnic Minorities in Research and the policy on the Inclusion of Persons Under 21 in Research.

    Vertebrate Animals

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

    Dual Use Research of Concern

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

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

    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.

    Additional Review Considerations - Overall, Cores, Programs, and Research Projects

    As applicable for the components 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.

    Research to Practice (r2p)

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

    Outputs and Outcomes

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

    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) Genomic Data Sharing Plan .


    Authentication of Key Biological and/or Chemical Resources

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

    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.

    2. Review and Selection Process

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

    As part of the scientific peer review, all applications:

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

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

    Applications will be assigned to NIOSH. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review. The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed center or component as determined by scientific peer review.
    • Geographic balance of Centers among regions of the country.
    • Relevance of the proposed Center to NIOSH AgFF program priorities and the NIOSH strategic plan.
    • The extent to which the components of the proposed center would be coordinated into one multidisciplinary effort within the Center.
    • The extent to which the proposed center would coordinate and collaborate with NIOSH intramural staff.
    • Commitment of the applicant institution.
    • Administrative and managerial capability of the applicant.
    • Results (outputs and outcomes) and management of prior AgFF awards funded by CDC/NIOSH or others.
    • Commitment of the applicant institution to diversity, equity, and inclusion.
    • Commitment of the applicant institution to supporting the OSH research and outreach goals and activities of the center.
    • Availability of funds.
    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

    Section VI. Award Administration Information
    1. Award Notices

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

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

    Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

    Expanded authorities: Expanded authorities: CDC has automatically waived the prior approvals listed in 45 CFR 75.308(d) (1) through (3) for any award resulting from an application under this announcement.

    In accordance with HHS regulation and CDC guidance, the awardee will have the following three Expanded Authorities:

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

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

    Diversity Supplements: NIOSH supports efforts to enhance diversity of the research workforce through recruitment and support for students, post-doctorates, and eligible investigators from diverse backgrounds and groups under-represented in OSH research. To help accomplish this, supplemental funding will be considered after an application is awarded. Please refer to PA-21-071 for information or contact the NIOSH Scientific Program Official (SPO) assigned to this FOA. Diversity supplements are contingent upon administrative review and availability of funds.

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

    PHS Human Subjects and Clinical Trials Information

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

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

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

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

    2. Administrative and National Policy Requirements

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

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

    Additional Requirements (ARs)

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

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

    AR-1: Human Subjects Requirements

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

    AR-3: Animal Subjects Requirements

    AR-9: Paperwork Reduction Act Requirements

    AR-10: Smoke-Free Workplace Requirements

    AR-11: Healthy People 2020

    AR-12: Lobbying Restrictions

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

    AR-14: Accounting System Requirements

    AR-16: Security Clearance Requirement

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

    AR-22: Research Integrity

    AR-24: Health Insurance Portability and Accountability Act Requirements

    AR-25: Data Management and Access

    AR-26: National Historic Preservation Act of 1966

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

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

    AR-30: Compliance with Section 508 of the Rehabilitation Act of 1973

    AR-31: Research Definition

    AR-32: Appropriations Act, General Provisions

    AR-34: Accessibility Provisions and Non-Discrimination Requirements

    AR-36: Certificates of Confidentiality

    AR-37: Prohibition on certain telecommunications and surveillance services or equipment for all awards issued on or after August 13, 2020

    Organization Specific ARs:

    AR-8: Public Health System Reporting Requirements

    AR-15: Proof of Non-profit Status

    AR-23: Compliance with 45 CFR Part 87

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

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

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

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

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

    Review of Risk Posed by Applicants

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

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

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

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

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

    Additional Policy Requirements

    The following are additional policy requirements relevant to this FOA:

    HHS Policy on Promoting Efficient Spending: Use of Appropriated Funds for Conferences and Meetings, Food, Promotional Items and Printing Publications This policy supports the Executive Order on Promoting Efficient Spending (EO 13589), the Executive Order on Delivering and Efficient, Effective, and Accountable Government (EO 13576) and the Office of Management and Budget Memorandum on Eliminating Excess Conference Spending and Promoting Efficiency in Government (M-35-11). This policy applies to all new obligations and all funds appropriated by Congress. For more information, visit the HHS website.

    Federal Funding Accountability and Transparency Act of 2006. Federal Funding Accountability and Transparency Act of 2006 (FFATA), P.L. 109–282, as amended by section 6202 of P.L. 110–252, requires full disclosure of all entities and organizations receiving Federal funds including grants, contracts, loans and other assistance and payments through a single, publicly accessible website, USAspending.gov. For the full text of the requirements, please review the following website: Federal Funding Accountability and Transparency Act Subaward Reporting System.

    Plain Writing Act. The Plain Writing Act of 2010, Public Law 111-274 was signed into law on October 13, 2010. The law requires that federal agencies use "clear Government communication that the public can understand and use" and requires the federal government to write all new publications, forms, and publicly distributed documents in a "clear, concise, well-organized" manner. For more information on this law, go to: Law and Requirements.

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

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

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

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

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

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

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

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

    Data Management Plan(s)

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

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

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

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

    Cooperative Agreement Terms and Conditions of Award

    The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and CDC grant administration policies.

    The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial CDC programmatic involvement with the recipients is anticipated during the performance of the activities

    Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; CDC Project Officers are not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and HHS/CDC as defined below.

    The PD/PI 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.

    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)
    • Participating in NIOSH evaluation efforts related to the NIOSH Agriculture, Forestry, and Fishing Program and the NIOSH Evaluation Capacity Building Plan.
    • 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.
    3. Reporting

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

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

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

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

    Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law require information to be collected and reported by recipients:

    1) Information on executive compensation when not already reported through the SAM Registration; and

    2) Similar information on all sub-awards/ subcontracts/ consortiums over $25,000. It is a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.

    All recipients of applicable CDC grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the HHS Grants Policy Statement.

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

    Submission of Reports

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

    1. Yearly Non-Competing Grant Progress Report is due 90 to 120 days before the end of the current budget period. The RPPR (https://grants.nih.gov/grants/rppr/index.htm; https://grants.nih.gov/grants/rppr/rppr_instruction_guide.pdf) is to be completed on the eRA Commons website. The progress report will serve as the non-competing continuation application. Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence ofsatisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.

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

    Failure to submit the required information in a timely manner may adversely affect the future funding of this project. If the information cannot be provided by the due date, you are required to submit a letter explaining the reason and date by which the Grants Officer will receive the information.

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

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

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

    4. Final Report should provide sufficient detail for CDC/NIOSH to determine if the stated outcomes for the funded research have been achieved and if the research findings resulted in public health impact based on the investment.

    The final RPPR, the Final Invention Statement and Certification form, equipment/inventory report, and the Final financial and performance reports (FFR) are required no more than 90 days after the end of the project period.

    Section VII. Agency Contacts

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

    Application Submission Contacts

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

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

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

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

    Scientific/Research Contact(s)

    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 30329
    404-498-6382
    SDearwent@cdc.gov

    Peer Review Contact(s)

    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

    Financial/Grants Management Contact(s)

    LaQuanda Lewis
    Grants Management Specialist
    Office of Grant Services
    Office of Financial Resources 
    Centers for Disease Control and Prevention

    2960 Brandywine Road, Mail Stop E-01
    Atlanta, Georgia 30341
    770-488-2969
    hrf6@cdc.gov

    Section VIII. Other Information

    Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.    

     

    Authority and Regulations

    Awards are made under the authorization of the Occupational Safety and Health Act of 1970, Section 20(a) and 21(a) (29 USC 669(a) and 29 USC 670); Federal Mine Safety and Health Act, Section 501(a), 30 USC 1 (Note), and 30 USC 951(a); and Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52. All awards are subject to 45 CFR Part 75, the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.    

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