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

Centers for Disease Control and Prevention (CDC)

CDC and CDC/NIOSH disclaimer:

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

Commercial Fishing Occupational Safety Research Cooperative Agreement (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of RFA-OH-19-004

Related Notices
  • October 19, 2020 - Change in Award Budget Ceiling for Commercial Fishing Occupational Safety Research Cooperative Agreement (U01). See Notice NOT-OH-21-005.
  • September 29, 2020 - Changes to Budget/Project Period for Commercial Fishing Occupational Safety Research Cooperative Agreement (U01). See Notice NOT-OH-20-014
Funding Opportunity Announcement (FOA) Number

RFA-OH-20-002

Companion Funding Opportunity

None

Number of Applications

Eligible applicant institutions may submit more than one application.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.262 

Funding Opportunity Purpose

This Commercial Fishing Occupational Safety Research Cooperative Agreement was established by The Coast Guard Authorization Act of 2010 (P.L. 111-281), as amended by the Howard Coble Coast Guard and Maritime Transportation Act of 2014 (P.L. 113-281), and is intended to provide funding to individuals in academia, members of non-profit organizations and businesses involved in fishing and maritime matters, and other entities with expertise in commercial fishing safety. The funding will be used to support research on improving the occupational safety of workers in the commercial fishing industry. This includes:

  • improving vessel design;
  • developing and improving emergency and survival equipment;
  • enhancing vessel monitoring systems;
  • improving communication devices, deicing technology, and severe weather detection.

In order to support and administer the grant program, the Coast Guard and NIOSH signed a Memorandum of Understanding on May 17, 2018. While the Coast Guard, along with the Occupational Safety and Health Administration (OSHA), provides regulatory oversight for safety and health matters within the commercial fishing industry, NIOSH is an agency operating under the Centers for Disease Control and Prevention (CDC) with the mission of generating new knowledge in occupational safety and health and transferring that knowledge into practice to prevent worker injury, illness and death. NIOSH conducts and funds scientific research, develops methods to prevent occupational hazards, develops guidance and authoritative recommendations, translates scientific knowledge into products and services, disseminates information, identifies factors underlying work-related disease and injury and responds to requests for workplace health hazard evaluations.

NIOSH has an extensive history of conducting research to understand and to reduce hazards in the commercial fishing industry. This research has largely been conducted in close collaboration with crews, industry and the US Coast Guard. To learn more about NIOSH's work in commercial fishing safety and health, visit https://www.cdc.gov/niosh/topics/fishing/default.html.

Tailored research objectives for particular geographic regions or fleets are encouraged. Research objectives supported by these grants include, but are not limited to, the following:

  • identification and investigation of the relationships between hazardous working conditions and associated occupational injuries and fatalities;
  • development of more sensitive means of evaluating hazards at work sites, including the use of opioids as a contributor to occupational injuries and fatalities;
  • development of methods for measuring early markers of injuries and fatalities;
  • development of new protective equipment and engineering control technology to reduce work-related injuries and fatalities;
  • development of work practices that reduce the risks of occupational hazards; and
  • evaluation of the technical feasibility or application of a new or improved occupational safety procedure, method, technique, or system, including assessment of economic and other factors that influence their diffusion and successful adoption in workplaces.

The Commercial Fishing Occupational Safety Research Cooperative Agreement is an award made to support a distinct, specific, defined project to be performed by the named recipients in an area representing their specific competencies and based on the mission of NIOSH and the US Coast Guard. The research plan proposed by the applicant must be related to the stated program interests of NIOSH and the US Coast Guard to improve safety in the commercial fishing industry.

Commercial Fishing Occupational Safety Research Cooperative Agreement applications are expected to have a detailed discussion of the occupational safety and health issue. Preliminary data are preferred. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, and from investigator-generated data.

Key Dates
Posted Date

November 21, 2019

Open Date (Earliest Submission Date)

November 22, 2019

Letter of Intent Due Date(s)

December 22, 2019; December 22, 2020

Application Due Date(s)

January 21, 2020; January 21, 2021

Electronically submitted applications must be submitted no later than 5:00 p.m., ET.

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.

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

May 2020; May 2021

Advisory Council Review

June 2020; June 2021

Earliest Start Date

September 1, 2020; September 1, 2021

Expiration Date

January 30, 2022

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO 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. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. 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

    Commercial fishing is one of the most dangerous occupations in the United States, with workers at high risk for many different kinds of injuries and illnesses or even death. The industry is comprised of a diverse population of vessels and associated gear used to catch seafood. There are hazards which are pervasive, such as dangerous weather conditions, and specific hazards. However, the risk of those specific hazards varies by vessel and gear type. During 2000-2016, an annual average of 41 deaths occurred in the industry - a fatality rate of 115 deaths per 100,000 workers, compared with an average of 4 deaths per 100,000 workers among all U.S. workers (NIOSH, 2018). The National Institute for Occupational Safety and Health (NIOSH) found that from 2000-2016, 755 commercial fishermen died while fishing in the United States (NIOSH, 2018). Nearly half of these fatalities (364, 48%) occurred after a vessel disaster, 30% (227) when a fisherman fell overboard, and 13% (97) from injuries sustained onboard (NIOSH, 2018). The remaining 67 (9%) fatalities occurred either while diving or from onshore injuries (NIOSH, 2018). Fatal injuries sustained onboard include unintentional overdoses that occurred on vessels.

    NIOSH has looked at some of these types of events more carefully to identify risk factors. For instance, from 2000-2016, none of the victims in fatal falls overboard were wearing a personal flotation device (PFD) when they drowned. In addition, 59% of the falls were unwitnessed, and alcohol and drugs contributed to over 18% of all fatalities (Case et al, 2018). Fatigue or falling asleep at the helm was a known contributing factor in 42% of all fishing vessel disasters during 2010-2015 (fatal and non-fatal) that began with the vessel running aground (79) (NIOSH Unpublished Dataset, 2018). While on-deck injuries account for just 13% of fatal injuries, they account for the largest number of hospitalized non-fatal injuries among fishermen (NIOSH Unpublished Dataset, 2018). The leading causes of fatal vessel disasters vary from region to region. During 2010-2014, the West Coast had the highest percentage of fatalities due to vessel disasters (60%), and many of these incidents were due to crossing dangerous river bars (NIOSH, 2017). In comparison, vessel disasters accounted for 33% of fatalities in Alaska, with most victims working in small, undecked skiffs (NIOSH, 2017). Vessels operating in Alaska also have an increased risk of icing, which can lead to vessel instability and subsequent capsizing. In the Gulf of Mexico, fatal vessel collisions were more prevalent than in other regions (NIOSH, 2017). Vessel disasters and falls overboard resulted in the same number of fatalities on the East Coast, and three of the most high-risk fisheries in the country are in this region (NIOSH, 2017).

    Despite some recent successes in reducing fatal work-related injuries within the commercial fishing industry, the need for occupational safety research remains essential. This research provides the scientific evidence necessary to expose and understand critical safety issues, develop recommendations and practical solutions to mitigate risk, and support arguments for the inclusion of health and safety measures within the development of policies which directly and indirectly affect commercial fishermen.

    Purpose

    This Commercial Fishing Occupational Safety Research Cooperative Agreement was established by The Coast Guard Authorization Act of 2010 (P.L. 111-281), as amended by the Howard Coble Coast Guard and Maritime Transportation Act of 2014 (P.L. 113-281), and is intended to provide funding to individuals in academia, members of non-profit organizations and businesses involved in fishing and maritime matters, and other persons with expertise in commercial fishing safety. The funding will be used to support research on improving the occupational safety of workers in the commercial fishing industry. This includes:

    • improving vessel design;
    • developing and improving emergency and survival equipment;
    • enhancing vessel monitoring systems;
    • improving communication devices, deicing technology, and severe weather detection.

    In order to support and administer the grant program, the Coast Guard and NIOSH signed a Memorandum of Understanding on May 17, 2018. While the Coast Guard, along with the Occupational Safety and Health Administration (OSHA), provides regulatory oversight for safety and health matters within the commercial fishing industry, NIOSH is an agency operating under the Centers for Disease Control and Prevention (CDC) with the mission of generating new knowledge in occupational safety and health and transferring that knowledge into practice to prevent worker injury, illness and death. NIOSH conducts and funds scientific research, develops methods to prevent occupational hazards, develops guidance and authoritative recommendations, translates scientific knowledge into products and services, disseminates information, identifies factors underlying work-related disease and injury and responds to requests for workplace health hazard evaluations.

    Tailored research objectives for particular geographic regions or fleets are encouraged. Research objectives supported by these grants include, but are not limited to, the following:

    • identification and investigation of the relationships between hazardous working conditions and associated occupational injuries and fatalities;  
    • development of more sensitive means of evaluating hazards at work sites;
    • development of methods for measuring early markers of injuries and fatalities;
    • development of new protective equipment and engineering control technology to reduce work-related injuries and fatalities;
    • development of work practices that reduce the risks of occupational hazards; and
    • evaluation of the technical feasibility or application of a new or improved occupational safety procedure, method, technique, or system, including assessment of economic and other factors that influence their diffusion and successful adoption in workplaces.

    The Commercial Fishing Occupational Safety Research Cooperative Agreement is an award made to support a distinct, specific, defined project to be performed by the named grantees in an area representing their specific competencies and based on the mission of NIOSH and the US Coast Guard. The research plan proposed by the applicant must be related to the stated program interests of NIOSH and the US Coast Guard to improve safety in the commercial fishing industry.

    Commercial Fishing Occupational Safety Research Cooperative Agreement applications are expected to have a detailed discussion of the occupational safety and health issue. Preliminary data are preferred. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, and from investigator-generated data.

    Healthy People 2020 and other National Strategic Priorities

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

    Public Health Impact

    NIOSH Programs support 1) research that addresses worker safety, accident prevention, and health concerns across a wide spectrum of industries and occupations, and 2) approaches that include basic research though translation research. The latter approach takes research knowledge and works to put it to use by promoting engineering controls, new technologies, and communication products. Through this announcement, NIOSH encourages qualified applicants to submit applications that will reduce or prevent occupational injury and/or death among workers in the commercial fishing industry.

    Relevant Work

    NIOSH has an extensive history of conducting research to understand and to reduce hazards in the commercial fishing industry. This research has largely been conducted in close collaboration with crews, industry and the US Coast Guard. To learn more about NIOSH's work in commercial fishing safety and health, visit https://www.cdc.gov/niosh/topics/fishing/default.html.

    Commercial fishing is one of the most hazardous occupations in the United States with a fatality rate 29 times higher than the national average. Since 1991, the NIOSH Western States Division (WSD) has conducted studies of fishing safety to reduce the incidence of injuries and fatalities among the nation's fishermen. NIOSH studies show that the greatest dangers to fishermen are vessel disasters, falls overboard, and machinery on deck. NIOSH continues to identify high-risk fisheries nationwide, make recommendations, and create targeted interventions to reduce risks.

    Approach

    Commercial Fishing Occupational Safety Research Cooperative Agreements will support research on improving the occupational safety of workers in the commercial fishing industry, including, but not limited to:

    • improving vessel design;
    • developing and improving emergency and survival equipment;
    • enhancing vessel monitoring systems;
    • improving communication devices, deicing technology, and severe weather detection.

    NIOSH organizes its research program under the framework of the National Occupational Research Agenda (NORA), which can be found at https://www.cdc.gov/nora/default.html. NORA is a partnership program to stimulate innovative research and improved workplace practices. Based on a collaborative effort from Sector Council members, the most recent NORA agenda prioritizes the knowledge and actions most urgently needed to identify occupational risk factors to prevent adverse health outcomes among workers. The agenda also provides a vehicle for stakeholders to describe the most relevant safety and health issues, research gaps, and needs. Occupational safety and health objectives for the commercial fishing industry falls within the scope of the NORA Agriculture, Forestry and Fishing Sector Council. Relevant Agriculture, Forestry, and Fishing NORA research objectives (https://www.cdc.gov/nora/councils/agff/default.html)  are as follows:

    FI-01: Reduce the risk of fatal and non-fatal injuries in the commercial fishing sub-sector.

    FI-02: Reduce the risk of work-related illness to workers in the commercial fishing sub-sector.

    FI-03: Increase safety and health data meshing, information sharing, and collaboration among fishing safety researchers for workers in the fishing sub-sector.

    FI-04: Reduce injuries and illness in the vulnerable worker populations in the fishing sub-sector.

    Note to Applicants

    Applicants are strongly encouraged to review the language from the Coast Guard Authorization Act of 2010 (See Section VII) which explains the intent behind the grant program as well as the NORA Agriculture, Forestry, and Fishing objectives. Consider the intent of the grant program as well as the NORA objectives as you develop proposals. Researchers are encouraged to propose innovative or novel approaches to address the major safety issues facing commercial fishermen in the U.S., especially for the purpose statements articulated in this announcement.

    Data Resources

    Specific information about risks among commercial fishermen including data by region and fishing fleet may be obtained at the NIOSH Commercial Fishing Research Topic Safety Page (https://www.cdc.gov/niosh/topics/fishing/).

    In addition, NIOSH has a number of data resources available to researchers at the NIOSH Data and Statistics Gateway (https://www.cdc.gov/niosh/data/default.html). This includes Worker Health Charts (https://wwwn.cdc.gov/NIOSH-whc) that use worker health data gathered by NIOSH from the Bureau of Labor Statistics to create specialized charts to assess the rates, distribution, and trends in workplace injuries, illnesses and deaths.

    These data and information on the commercial fishing website may be used to help provide the context and estimate the burden of the problems being addressed, the need for the proposed work, the impact on the workforce, and the potential long-term benefits of the proposed projects and activities. Additionally, issues can be contextualized through economic metrics such as the societal cost, medical cost, productivity losses and disability costs.

    In addition, the US Coast Guard has the following two websites with hazard information related to commercial fishing safety: https://www.dco.uscg.mil/Our-Organization/Assistant-Commandant-for-Prevention-Policy-CG-5P/Inspections-Compliance-CG-5PC-/Commercial-Vessel-Compliance/Fishing-Vessel-Safety-Division/ and www.fishsafewest.info.

    Objectives

    Proposed goals and objectives should be clearly stated in the application and directly linked to the occupational health and safety burdens being addressed. Applicants are expected to justify their proposal by describing the burden of the problem, the need for the proposed research or activity, and the potential for impact or likelihood of success.

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

    Outputs and Outcomes

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

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

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

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

    Note to Applicants

    Provide a brief statement about expected outputs and outcomes of the proposed research in the Description (Abstract) and in the Research Strategy (Significance).

    Target Population

    The beneficiaries of these proposed research projects are workers in the U.S. commercial fishing industry.

    Collaborations/Partnerships

    Partnerships are integral to the Commercial Fishing Occupational Safety Research Cooperative Agreement Program. They facilitate advances in the safety and health of U.S. commercial fishing workers. Input from industry and stakeholder groups, which have inherent knowledge and concern about the safety of fishermen will enhance research projects. Partners often add expertise or specialized experience to the research team, which contributes to the success of the overall project.

    Applicants should institute collaborative partnerships. These can be with commercial fishing organizations, local and state organizations, universities, manufacturers, government agencies, other professional organizations, engineering and safety training partner organizations, community organizations, health care institutions, business groups, and labor organizations to carry out these proposed research activities.

    Partnerships are also critical to translate research findings into effective training and work practices and are encouraged by the NIOSH Research-to-Practice Program (r2p). Interdisciplinary and transdisciplinary collaborations that share expertise are essential to advancing occupational safety and promoting overall worker safety in commercial fishing environments.

    Note to Applicants

    Include collaborations or partnerships that strengthen the proposed research in terms of OSH, or related, expertise and resources.

    Evaluation/Performance Measurement

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

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

    Translation Plan

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

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

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

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

    Note to Applicants

    Applicants must provide a brief statement about how their proposed research addresses r2p in both the Description (Abstract) and in the Research Strategy (Significance). Describe the anticipated strategies for translation and/or dissemination of research findings, including by audience segmentation and by the characteristics of the channels or modes of dissemination. A logic model that describes the inputs, activities, outputs, intermediate outcomes, and expected long-term outcomes may be included. The CDC document "Applying the Knowledge to Action Framework" (https://www.cdc.gov/chronicdisease/pdf/K2A-Framework-6-2015.pdf) is a useful resource.

    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, CDC/NIOSH 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 NOFO.

    Application Types Allowed

    New - An application that is submitted for funding for the first time. Renewal (formerly Competing Continuation) - Previous years of funding for the project have elapsed. Competing for additional years of funding to continue original project.

    Revision (formerly Competing Supplement) - Request for additional funds for a current award to expand the scope of work. Applicants should contact the awarding agency for advice on submitting any revision/supplement application.

    Resubmission (formerly Revision or Amended Application - For NOFOs with multiple receipt dates. Application previously reviewed. A revised or amended application addresses reviewer feedback.

    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 NOFO.

    Clinical Trial?

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

    Funds Available and Anticipated Number of Awards

    Estimated Total Funding:

    $3 million total cost (direct and indirect costs)

    Anticipated number of awards per year: 6

    NIOSH anticipates funding 12 awards through this announcement.

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

    Award Budget

    $650,000 Total Costs (direct and indirect costs), including the 50% Cost Match Requirement

    Note: Unlike standard awards with 12-month budget periods, the budget period for these awards is 24 months and is the same as the project period/period of performance. The award ceiling and floor are based on a 24-month budget period.

    Award Ceiling: $650,000 Per Budget Period

    Award Floor: $150,000 Per Budget Period

    Total Period of Performance Length: 2 years

    The estimated total funding for a single award consisting of a 24-month budget period, 9-1-2020 to 8-31-2022 and 9-1-2021 to 8-31-2023, is $650,000. Total funding (direct and indirect costs) for the entire two-year period of performance is the same. Cost matching (50% of total proposed cost) is required. The source and amount of costs and/or the value of third-party in-kind contributions proposed by the applicant to meet a matching or cost-sharing requirement must be identified in the application budget.

    The maximum total award, including the 50% cost match, is $650,000. The Notice of Award will state the amount of Federal funding and the amount of 50% cost match. As an example, a total award of $650,000 will consist of $325,000 in Federal funds and $325,000 as non-Federal cost matching.

    Applicants may refer to page I-24 of the HHS Grants Policy Statement (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) and 45 CFR 75.306 (https://www.govregs.com/regulations/expand/title45_chapterA_part 75_subpartD_subjgrp24_section75.306) for specific information on cost matching.

    Inclusion of cost matching information is required for an application to proceed to peer review.

    Award Project Period

    2 years 

    The total project period for an application submitted in response to this funding opportunity may not exceed 2 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 NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

    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)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession

    Other

    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    • Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via Grants.gov (https://www.grants.gov/ )
    • Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to https://gov.ecfr.io/cgi-bin/searchECFR.
    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.

    For this funding opportunity, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

    http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch16.htm#_Toc271265275

    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 NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.  Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

    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.

    Note to All Interested Applicants:

    Per the authorizing legislation referenced in this announcement, and in accordance with the HHS Grants Policy Statement, and 45 CFR 75.306 (https://www.govregs.com/regulations/expand/title45_chapterA_part75_subpartD_subjgrp24_section75.306), documentation of how the required 50% non-Federal cost match will be met must be included for an application to proceed to peer review.

    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

    Applications that exceed the two-year period of performance limit or the total cost limit of $650,000 per two-year performance period (including consortium F&A costs) will be considered non-responsive and will not be reviewed.

    Applications will be considered non-responsive if they do not clearly indicate how the required 50% non-Federal cost match will be met. A letter of commitment should be included in the application to indicate the amount and the source of the cost match. If this information is not provided, CDC/NIOSH will notify the applicant and request that the application be withdrawn. A withdrawn application will not be peer-reviewed. 

    Matching is generally calculated on the basis of the federal award amount and is comprised of recipient contributions proposed to support anticipated costs of the project during a specific budget period (confirmation of the existence of funding is supplied by the recipient via their Federal Financial Report). The recipient must be able to account separately for stewardship of the federal funding and for any required matching; it is subject to monitoring, oversight, and audit. The recipient may not use matching expenditures to count toward any Maintaining State Funding requirement.

    Matching Sources: The following sources can be used for the 50% cost match: program income, subrecipient costs, in-kind support, and indirect costs.

    The use of other federal funds for matching is not allowed. The matching percentage is non-negotiable and is calculated as a percentage of the total proposed cost.

    Upon receipt, applications will be evaluated for completeness by CDC/NIOSH. CDC/NIOSH will screen all applications for responsiveness. Incomplete or non-responsive applications will not be reviewed. Applicants will be requested to withdraw non-responsive applications.

    Note to All Interested Applicants:

    Provide a statement about which 46 U.S.C. § 4502 (j) Safety Standards and the NORA Agriculture, Forestry, and Fishing objectives are being addressed. Provide a rationale for how the proposed research will contribute to the specified priority area(s).

    Explain how the proposed research will contribute to the NIOSH Research to Practice (r2p) initiative and state the expected Outcomes and Outputs (see Section I - Approach).

    Place this information in both the Project Abstract and in the Research Strategy (Significance) sections of the application.

    2. Cost Sharing

    This NOFO does require cost sharing as defined in the HHS Grants Policy Statement.

    3. Additional Information on Eligibility
    Number of Applications

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

    Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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

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

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. 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 Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    Letter of Intent

    Due Date for Letter of Intent: 12/16/2019 and 12/14/2020

    Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

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

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

    The letter of intent should be sent to:

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

    Page Limitations

    All page limitations described in this individual NOFO must be followed. For this specific NOFO, the Research Strategy component of the Research Plan narrative is limited to 12 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 100 pages for all appendices. Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

    Instructions for Application Submission

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    SF424(R&R) Senior/Key Person Profile

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

    R&R Budget

    All instructions in the SF424 (R&R) Application Guide must be followed. For this NOFO, CDC/NIOSH requires a detailed budget for the entire 24-month budget period and should reflect the total budget requested, including the federal share and the 50% cost match. Modular budgets are not allowed. Clearly indicate how the required 50% non-Federal match will be met.

    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    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.

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

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

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

    • Descriptions of the data to be produced in the proposed project;
    • How access will be provided to the data (including provisions for protection of privacy, confidentiality, security, intellectual property, or other rights);
    • Use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use; and
    • Plans for archival and long-term preservation of the data or explaining why long-term preservation and access cannot be justified.

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

    CDC Additional Requirement (AR)-25 (https://www.cdc.gov/grants/additionalrequirements/ar-25.html) outlines the components of a DMP and provides additional information for investigators about the requirements for data accessibility, storage, and preservation. The DMP should be developed during the project planning phase, prior to the initiation of collecting or generating public health data and be submitted with the application.

    CDC Additional Requirement (AR)-25 outlines the components of a DMP and provides additional information for investigators about the requirements for data accessibility, storage, and preservation. The DMP should be developed during the project planning phase, prior to the initiation of collecting or generating public health data and be submitted with the application.

    Applications that do not comply with these instructions may be delayed or not accepted for review.

    All instructions in the SF424 (R&R) Application Packages must be followed along with any additional instructions provided in this NOFO.

    Appendix:

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

    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 (and when applicable, clinical trials research experience) 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 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.

    Format for Attachments

    Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded to the system.

    CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide.

    Foreign Institutions

    For this NOFO, applications from foreign institutions are not allowed  

    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

    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). 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/additionalrequirements/ar-35.html

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

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

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

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

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

    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.

    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) 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. See Section III of this NOFO for information on registration requirements.

    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. Additional information may be found in the SF424 (R&R) Application Guide.

    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.

    See more tips for avoiding common errors.

    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.

    Clearly indicate how the non-federal cost match requirement will be met.  A letter of commitment should be included in the application to indicate the amount and the source of the cost match.

    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.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

    Section V. Application Review Information
    1. Criteria

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

    Overall Impact

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

    Scored Review Criteria

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

    Significance

    Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

    Does the project address the burden (including preliminary data when available), need, and impact of the occupational exposures and hazards that are the focus of the proposed research? Does the applicant fully justify and provide data to describe the burden of the problem(s) being addressed? Is the project likely to have an impact in meeting local, regional or national occupational safety and health needs through effective research, intervention, translation, outreach, education, or partnership activities? Are appropriate impacts identified?

    In addition, for applications proposing clinical trials:

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

    Investigator(s)

    Are the PD/PIs, collaborators, and other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

    In addition, for applications proposing clinical trials:

    With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?  

    Innovation

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

    In addition, for applications proposing clinical trials:

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

    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 involves human subjects research, are there 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?

    In addition, for applications proposing clinical trials:

    Does the application adequately address the following, if applicable?

    Study Design

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

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

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

    Data Management and Statistical Analyses

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

    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?

    In addition, for applications proposing clinical trials:

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

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

    Additional Review Criteria

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

    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 Guidelines for the Review of Human Subject the HHS/CDC Requirements under AR-1 Human Subjects Requirements.

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

    Inclusion of Women, Minorities, and 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 inclusion of minorities and members of both genders, as well as the inclusion of children. 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 (https://www.cdc.gov/maso/Policy/Policy_women.pdf and the policy on the Inclusion of Persons Under 21 in Research (https://www.cdc.gov/maso/Policy/policy496.pdf).   

    Vertebrate Animals

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

    Biohazards

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.  

         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.

    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. Is there sufficient information provided describing how the research has achieved the goals of the previous funding period. Is there sufficient information on how the goals for future years build on the previous successes? Does the applicant describe and provide evidence of outcomes and impacts achieved?

    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

    As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

    Research to Practice

    Reviewers will assess if the applicant has demonstrated about how their proposal addresses the research to practice (r2p) approach (https://www.cdc.gov/niosh/r2p/).

    Outcomes and Outputs

    Reviewers will assess if the applicant provided the information about the expected outcomes and outputs of the proposal and how this research will impact occupational health and safety in commercial fishing.

    Applications from Foreign Organizations

    Not applicable. Applications from foreign institutions are not allowed.

    Select Agent Research

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

    Resource Sharing Plans

    HHS/CDC policy requires that recipients of grant awards make research resources and data readily available for research purposes to qualified individuals within the scientific community after publication. Please see: https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

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

    Investigators responding to this NOFO should include a detailed DMP in the Resource Sharing Plan(s) section of the PHS 398 Research Plan Component of the application. The AR-25 outlines the components of a DMP and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation.

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

    The DMP should include, at a minimum, a description of the following:

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

    Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. The applicant can obtain guidance for completing a detailed justified budget on the CDC website, at the following Internet address:
    http://www.cdc.gov/grants/interestedinapplying/applicationresources.html.

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

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

    The budget should be for the entire 24-month budget period. The total amount of the budget should include the 50% cost match requirement.

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

    2. Review and Selection Process

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

    As part of the scientific peer review, all applications:

    • 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.

    Applications will be assigned to the appropriate HHS/CDC Center, Institute, or Office. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review. The following will be considered in making funding recommendations:

    • Scientific and technical merit of the proposed project as determined by scientific peer review;
    • Availability of funds;
    • Relevance of the proposed project to program priorities;
    • Relevance of the proposed research to program priorities as outlined by 46 US Code 4502 which is supported by NIOSH/USCG;
    • Contribution toward development of guidelines or best practices for improved commercial fishing vessel safety;
    • Contribution to advance occupational safety and health aspects of commercial fishing vessel operations;
    • Commitment of the applicant institution to collaborative efforts; and
    • Adequacy of resource-sharing plan.

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

    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 HHS Grants Policy Statement.

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

    Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. Expanded authorities are authorized under this NOFO and will be specified in the recipient award notices issued under this NOFO.

    2. Administrative and National Policy Requirements

    All HHS CDC grant and 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

    Administrative and National Policy Requirements, Additional Requirements (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 requirements that apply to this NOFO are the following:

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

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

    The following Expanded Authorities are allowed:

    • 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 extension10 days before the expiration date of the period of performance. Upon notification, the awarding office 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.

    Recipients of federal financial assistance (FFA) 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.  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 grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    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 Requirements (ARs)

    ARs outline the administrative requirements found in 45 CFR Part 75, 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: http://www.access.gpo.gov/nara/cfr/cfr-table- search.html.

    Information on additional requirements that apply to this NOFO can be found at the following CDC website https://www.cdc.gov/grants/additionalrequirements/.

    Generally applicable ARs are:

    AR-1: Human Subjects Requirements
    AR-2: Inclusion of Women and Racial and Ethnic Minorities in Research
    AR-3: Animal Subjects Requirements
    AR-9: Paperwork Reduction Act Requirements
    AR-10: Smoke-Free Workplace Requirements
    AR-11: Healthy People 2020
    AR-12: Lobbying Restrictions
    AR-13: Prohibition on Use of CDC Funds for Certain Gun Control Activities
    AR-14: Accounting System Requirements
    AR-16: Security Clearance Requirement
    AR-21: Small, Minority, and Women-Owned Business
    AR-22: Research Integrity
    AR-24: Health Insurance Portability and Accountability Act Requirements
    AR-25: Release and Sharing of Data
    AR-26: National Historic Preservation Act of 1966
    AR-28: Inclusion of Persons Under the Age of 21 in Research
    AR-29: Compliance with EO13513, “Federal Leadership on Reducing Text Messaging while Driving,” October 1, 2009
    AR-30: Information Letter 10-006, Compliance with Section 508 of the Rehabilitation Act of 1973
    AR-31: Research Definition
    AR-32: FY 2012 Enacted General Provisions

    Organization Specific ARs:

    AR-8: Public Health System Reporting Requirements
    AR-15: Proof of Non-profit Status
    AR 23: Compliance with 45 C.F.R. Part 87

    Additional Policy Requirements

    The following are additional policy requirements relevant to this NOFO:

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

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

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

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

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

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

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

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

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

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

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

    Data Management Plan(s)

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

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

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

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

    Cooperative Agreement Terms and Conditions of Award

    Substantial Involvement

    NIOSH will have substantial involvement with regard to scientific and technical expertise on research activities, strategic planning, prospective coordination, national sector goals and activities, and time-critical data needs or reporting. All such activities will be fully coordinated between NIOSH's Office of Extramural Programs (OEP) and the award recipient. In-person meetings, ad hoc meetings, and requests for information are anticipated, but with minimal cost implications unless specified otherwise in the Notice of Award. Site visits with the award recipient will be a coordinated effort involving OEP personnel. Substantial programmatic involvement and agency-level coordination will be provided by CAPT Jennifer Lincoln, PhD. Bridgette Garrett, PhD or other assigned NIOSH Scientific Program Officials named in the Notice of Award, will serve as the primary OEP point of contact.

    Grant Stewardship

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

    Business and other non-Programmatic Management

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

    Coordination, Communication, and Cooperation

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

    Annual Summary of Major Grantee Accomplishment and Impact

    NIOSH will use these summaries to share information with the public, stakeholders, partner organizations, and others interested in NIOSH commercial fishing safety and health research and related activities. They must be written in plain language and be Section 508 compliant, and they will be due at the end of each budget period. Prior reports can be found at the NIOSH OEP website. NIOSH will negotiate the page limit with the awardee. Annual summaries will be posted on the OEP website and must comply with NIOSH website and public document policies.

    3. Reporting

    Award recipients will be required to submit annual progress reports and financial statements as required in the HHS Grants Policy Statement.

    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:

    Yearly Grant Progress Report is due 90 to 120 days before the end of the current year of funding. Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.

    Annual Federal Financial Report (FFR) SF 425 is required and must be submitted through eRA Commons at the end of the first quarter of the calendar year. 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.

    Final Report

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

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

    Specific guidance for the final report and annual outcome update is available on the NIOSH OEP website (https://www.cdc.gov/niosh/oep/grants.html ) under Grant Closeout.

    Additional Reporting Requirements

    Successes: A description of progress on completing activities outlined in the work plan and any additional successes achieved in the past year (identified through evaluation results or lessons learned, for instance).

    Challenges: A description of any challenges that might affect the ability to achieve annual and project-period outcomes, conduct performance measures, or complete the activities in the work plan, plus additional challenges encountered in the past year (identified through evaluation results or lessons learned, for instance).

    Outputs, Outcomes, and Research to Practice (r2p): Provide in the purpose section of each progress report a brief statement about expected outputs, outcomes, and/or r2p of the project.

    Outputs are the immediate products or direct result of project activities, including publications, reports, conference proceedings, presentations/posters, investigator career development activities, databases, tools, methods, guidelines, recommendations, and education and training materials. List the products, tools, guidance, or policy documents developed and whether they are available for use by others; specify when and how they are being shared; and report on methods generated, their implementation, and their success.

    Outcomes can be measured over time as either intermediate or end. Intermediate outcomes are specific changes that occur as a result of project activities, such as public or private policy changes; training or workshops based on project outputs; citations in the literature; inventions and patents; and adoption of technologies or methods developed.

    Research to Practice is the transfer and translation of knowledge, interventions, and technologies into highly effective prevention practices and products that are adopted in the workplace.

    http://grants.nih.gov/grants/policy/myf.htm

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

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

    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)

    Bridgette Garrett, PhD
    National Institute for Occupational Safety and Health (NIOSH)
    Centers for Disease Control and Prevention (CDC)
    Telephone: 770-488-5715
    Email: BGarrett@cdc.gov

    Peer Review Contact(s)

    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

    Financial/Grants Management Contact(s)

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

    Section VIII. Other Information
    Authority and Regulations

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

    This program is described in the Catalog of Federal Domestic Assistance and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. Awards are made under the authorization of the Occupational Safety and Health Act of 1970, Section 20(a) and 21(a) (29 USC 669(a) and 29 USC 670); Federal Mine Safety and Health Act, Section 501(a), 30 USC 1 (Note), and 30 USC 951(a); and Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52. All awards are subject to 45 CFR Part 75, the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

    Funding is authorized under The Coast Guard Authorization Act of 2010 (P.L. 111-281) as amended by the Howard Coble Coast Guard and Maritime Transportation Act of 2014 (P.L. 113-281). All awards are subject to 45 CFR Part 75, the terms and conditions, and other considerations described in the HHS Grants Policy Statement.

    Cost matching information

    The Coast Guard Authorization Act of 2010 (P.L. 111-281), as amended by the Howard Coble Coast Guard and Maritime Transportation Act of 2014 (P.L. 113-281), requires a 50% non-Federal cost match for a grant application to be funded.

    Applicants must consider the information in determining how to best meet the cost matching requirement of this announcement:

    • Program income, subrecipient costs, in-kind support, and indirect costs are allowable sources for matching funds.
    • Use of other federal funds for matching is not allowed.
    • The matching percentage is non-negotiable and is calculated as a percentage of the total proposed cost.

    For additional information on cost matching, please refer to the HHS Grants Policy Statement (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), 45 CFR 75.306 (https://www.govregs.com/regulations/expand/title45_chapterA_part75_subpartD_subjgrp24_section75.306), or contact one of the agency staff listed in this announcement.

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.