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.

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

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 fatalities. The industry is comprised of diverse vessels and gear used to catch seafood and while there are hazards which are pervasive such as dangerous weather conditions, specific hazards and the risk of those hazards vary 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 commercial 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). 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 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 commercial fishermen (NIOSH Unpublished Dataset, 2018). The leading causes of fatal vessel disasters vary from region to region. During 2010-2014, the West Coast has the highest percentage of fatalities due to vessel disasters (60%), and many of these incidents are 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 safety training and intervention activities remains essential. Training in emergency drills, survival, damage control, fire prevention and firefighting, stability, seamanship, fatigue awareness and prevention, watchkeeping and weather forecasting is needed to reduce occupational safety risk in the US fishing industry. Having trained crew and operators that know how to prevent and appropriately respond to at-sea emergencies can mean the difference between life and death, particularly in remote, offshore locations where assistance may be delayed. Purpose The Commercial Fishing Occupational Safety Training Grant 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 municipalities, port authorities, other appropriate public entities, not-for-profit organizations, and other qualified persons to conduct commercial fishing vessel safety training for vessel operators and crewmembers. Safety training courses could include the following topics: emergency drills, survival, damage control, fire prevention and firefighting, stability, seamanship, fatigue awareness and prevention, watchkeeping, and weather forecasting. The program is also authorized to provide funding for the purchase of safety equipment and training aids for use in those safety training programs. The goal of the training grant program is to enhance the quality and availability of safety training for United States commercial fishermen. Availability includes the frequency, geographic considerations, channels or partners of dissemination, culturally and/or educational appropriate training material, and other characteristics of a successful training program. As a result, the Coast Guard and NIOSH invite applications to support the development and implementation of training and education programs that meet some (or all) of the following: develop and deliver training which addresses the needs of commercial fishermen in the United States; increase the number of qualified marine safety instructors to conduct these types of training; evaluate the effectiveness and impact of the training program on reducing injuries among commercial fishermen; coordinate with existing training programs and partnerships with industry, fishermen, and agencies; and conform to 46 U.S.C. 4502 (i) Safety Standards for commercial fishing safety training. 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.

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

The Commercial Fishing Occupational Safety Training Grant Program is intended to improve availability and quality of commercial fishing training across the United States and especially in underserved geographic regions and/or high-risk fisheries. Moreover, it provides an opportunity to address gaps in current training materials, particularly those related to the unique needs of specific regions/fleets. An immediate goal of safety and health training for commercial fishermen is to provide them with relevant knowledge regarding hazards encountered in the maritime environment, personal protective equipment for protection of health and safety, along with practical tools for reducing risks for injuries and illness. Primary prevention of injuries among commercial fishermen depends to a great extent on proper use and maintenance of vessels and engineering controls. Training programs should include these topics as part of an integrated approach. The training program should assist commercial fishermen in becoming active participants in determining and improving the safety conditions under which they work and in establishing collaborative employer-employee relationships for creating safe workplaces. Applicants should justify the choice of location in terms of need, potential impact (for example, the number of commercial fishermen trained, changes in competencies/behavior relevant to health and safety improvements, and reductions in incidents), as well as accessibility, feasibility, and cost. Ideally, training should be hands-on and occur in fishing communities on or near the water. Applicants should also provide information on the frequency of the training, along with characteristics of the commercial fishermen cohort, if known (target and/or vulnerable workforce). The application must clearly identify the professional and experiential credentials of those performing the training. NIOSH organizes its research and training 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 workplace interventions. Participation in NORA is broad, including stakeholders from universities, large and small businesses, professional societies, government agencies, and worker organizations. Commercial fishing falls under the scope of the NORA Agriculture, Forestry and Fishing Sector Council https://www.cdc.gov/nora/councils/agff/default.html. 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 for commercial fishing industry. This training grant program specifically supports the following Agriculture, Forestry, and Fishing NORA objectives https://www.cdc.gov/nora/councils/agff/default.html. 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 Consider the purpose and intent of the Commercial Fishing Occupational Safety Training Program as described in the Coast Guard Authorization Act of 2010 and the NORA Agriculture, Forestry, and Fishing objectives as you develop proposals. Clearly identify the objectives that the proposed training grant will support. Funding priority will be given to those applications that clearly address the purpose and intent of the training program and the NORA objectives. Applicants are encouraged to propose innovative or novel training approaches that address critical commercial fishing safety issues and improve the delivery and effectiveness of the training provided. 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 training, and the potential for impact or likelihood of success. Applicants should provide data to support their selection of proposed training, such as fatalities or fatality rates, indicators of the size of the population at risk including estimates of the target population's potential risk of exposure to the hazard, frequency of exposure, or sociodemographic factors such as age, gender, and race/ethnicity. Similarly, applicants may provide qualitative data that describe exposures, the magnitude of the problem, and potential benefits and impacts of addressing the issue. Qualitative data, such as case studies, may be necessary when the nature of the exposure or population at risk make finding large-scale, representative quantitative data difficult. The proposed commercial fishing occupational safety training program should accomplish some (or all) of the following: address the training needs of commercial fishermen, with regional differences and specific fleets in mind; increase the number of qualified marine safety instructors and drill conductors in the United States to conduct these types of training; develop/offer and implement "train the trainer" and refresher courses; develop and deliver hands on safety training to commercial fishermen; and provide qualified instructors and faculty to achieve the goals of this program. At the close of the grant period (end of FY2022 and FY2023) the results of a quantitative and qualitative evaluation of the effectiveness and impact of the training program, with regard to changes in the following: safety-relevant behavior; operational practices that reduce commercial fishermen risks and reduce incidents; frequency and severity of injuries; productivity and effectiveness of training and other indicators of performance; and coordinate with other existing marine safety training programs. 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 training in the Description (Abstract) and in the Research Strategy (Significance).

Target Population

The beneficiaries of these proposed training project grants are workers in the U.S. commercial fishing industry.

Collaborations/Partnerships

Partnerships are integral to the Fishing Safety Training Grant 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 and health of commercial fishermen, helps in setting research and training priorities. Partners often add expertise or specialized experience to the research/training team, which contributes to the success of the overall project. Applicants will institute collaborative partnerships with local and state organizations, universities, manufacturers, government agencies, professional organizations, engineering and safety training partner organizations, community organizations, health care institutions, business groups, and labor organizations to carry out training activities, conduct outreach programs, promote awareness, and disseminate information. Partnerships are also critical to translate project 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 health and promoting overall worker health in commercial fishing environments. Note to Applicants Include collaborations or partnerships that strengthen the proposed training in terms of OSH, or related, expertise and resources.

Evaluation/Performance Measurement

An evaluation plan that addresses the impact of training on the safety of commercial fishermen must be included in the application. The plan should clearly describe how training quality, effectiveness, and impact (short-term and long-term) will be evaluated. Governmental agencies/organizations have been faced with increasing demand to measure the effectiveness of their funded projects in improving public health. Effectiveness can be measured by the products (outputs) of project activities and subsequent outcomes, i.e., benefits or changes at an individual or population level. Evaluations provide information for management to improve program effectiveness. The CDC program evaluation framework (http://www.cdc.gov/eval/framework/index.htm) and NIOSH training evaluation tips (https://www.cdc.gov/niosh/mining/content/trainingresearch/trainingevaltips.html) may be helpful. The evaluations must also contain data for the calculation of return on USCG investment.

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 training 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.

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

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.

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.

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.

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.

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 training will contribute to the specified priority area(s).

Explain how the proposed training 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.

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

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).

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.

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.

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: [email protected]

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.

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.

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

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

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

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

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.

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

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

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

The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Training Program Plan that consists of 13 components. Not all 13 components of the Research Training Program Plan apply to this announcement; therefore, only include the components listed below. See PHS 398 Research Training Program Plan Form for additional information.

Follow the page limits stated in the SF 424 (R&R) unless otherwise specified in this announcement. As applicable to and specified in this announcement, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

• Program Plan. Document the need for the program; provide the rationale for the training program and the potential for a positive impact on OSH training. Describe the Program Director’s qualifications for providing leadership for the program; describe participating key personnel s qualifications and expertise relevant to the training and level of collaboration in teaching and mentoring trainees; describe the program s evaluation plan; concisely describe the program’s curriculum; provide details on past performance, including trainees career advancement in OSH practice or research.
• Multiple PD/PI Leadership Plan
• Participating Faculty Biosketches. (Limited to 5 pages each)
• Letters of Support. Provide the sponsoring institution’s letter of commitment and support, as well as letters from other stakeholders.
• Consortium/Contractual Arrangements. Describe arrangements between the applicant and other organizations.
• Appendix

Note: clinical research will not be funded under this NOFO.

*** Resource Sharing Plans are not applicable for this NOFO ***

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.

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.

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.

For this NOFO, applications from foreign institutions are not allowed

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

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

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

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.

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.

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.

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

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

Does the project 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?

Significance is evaluated by considering the impact the proposed training program has in meeting an identified regional or national need for occupational safety and health training. Does the training program have the potential to successfully meet stated goals and objectives and impact the health and safety of the workforce through its training program? Does the creation or continuation of the training program advance the field of occupational safety and health in the commercial fishing industry? Does the training program’s past performance reflect a successful track record of OSH training for commercial fishing vessel safety? Is there evidence that this program integrates with and complements other NIOSH supported training programs?

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?

Does the Program Director for the proposed training program have experience in managing a high-quality commercial fishing vessel safety and health training program? Do the key personnel identified have strong histories of providing this type of training to their target audience? Are the key personnel accomplished practitioners or trainers, as evidenced by their biosketches and experiences?

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?

Does the proposed training program involve innovative approaches to achieving and maintaining highly effective commercial fishing vessel safety training? Are there innovative approaches in recruiting underserved or underrepresented individuals?

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?

Is there an evaluation plan to determine the effectiveness of the training program? Is there evidence of active participation by an Advisory Committee either internally or externally? Is the training curriculum consistent with a high-quality US Coast Guard accepted training program in commercial fishing vessel safety? If applicable, what is the accreditation status of the training program? Does the training program have a successful history of reaching its intended target audience? Are there plans to obtain and incorporate feedback from stakeholders, including current and former trainees to changes to improve performance?

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?

Will the training environment contribute to the probability of improving commercial fishing vessel safety? Is there evidence of organizational or institutional commitment to support the goals of the training program? Are the facilities and equipment adequate and appropriate to support the proposed training?

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

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

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

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).

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.

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

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

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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

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.

Not applicable. Applications from foreign institutions are not allowed.

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

Reviewers will 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.

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;
• Administrative/managerial capability of the applicant organization;
• Adequacy of training program evaluation plan;
• Commitment of the applicant institution to collaborative efforts; and

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

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

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

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

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

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.

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.

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

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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 [email protected]. 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

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (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: [email protected]

Bridgette Garrett, PhD
National Institute for Occupational Safety and Health (NIOSH)
Centers for Disease Control and Prevention (CDC)
Telephone: 770-488-5715
Email: [email protected]

Michael Goldcamp, PhD
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
Telephone: 304-285-5951
Email: [email protected]

Mary Pat Shanahan
Office of Grants Services (OGS)
Centers for Disease Control and Prevention (CDC)
Telephone: 412-386-4453
Email: [email protected]

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.