It is critical that applicants follow the instructions in the How to Apply - Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) 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.
Page Limitations: Pages that exceed the page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.
Note: The Research Strategy component of the Research Plan is limited to 12 pages.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Telecommunications for the Hearing Impaired: TTY 1-888-232-6348
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
- Use the NIH ASSIST system to prepare, submit and track your application online.
- Use an institutional system-to-system (S2S) solution to prepare and submit your application
to Grants.gov and eRA Commons to track your
application. Check with your institutional officials regarding availability.
- Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
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 and puts workers at high risk for severe injuries, illnesses, and death. The industry is comprised of a diverse population of vessels and associated gear used to catch seafood. Many commercial fishing operations are characterized by hazardous working conditions, strenuous labor, long work hours, and harsh weather conditions (NIOSH, Commercial Fishing Safety National Overview). During 2000-2015, an annual average of 42 deaths occurred in the commercial fishing industry (117 deaths per 100,000 workers), compared with an average of 5,247 deaths (4 deaths per 100,000 workers) among all U.S. workers (US Department of Labor Statistics).
Data from the National Institute for Occupational Safety and Health (NIOSH) Commercial Fishing Incident Database (CFID) show that from 2000-2015:
725 commercial fishermen died while fishing in the U.S.
Nearly half of all fatalities (354, 49%) occurred after a vessel disaster
Another 221 (30%) fatalities were due to falls overboard
Another 87 (12%) fatalities resulted from an injury onboard
The remaining 63 (9%) fatalities occurred while diving or from onshore injuries
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). This study also found that fatalities associated with unintentional falls overboard occurred most frequently on the East Coast (30%), followed by the Gulf of Mexico (29%), Alaska (25%), and the West Coast (13%). Five deaths occurred off the Hawaiian Coast.
The leading causes of fatal vessel disasters vary from region to region. During 2010-2014, the West Coast had the highest percentage of fatalities due to vessel disasters (60%), and many of these incidents were due to crossing dangerous river bars. In comparison, vessel disasters accounted for 33% of fatalities in Alaska, with most victims working in small, undecked skiffs. 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. Vessel disasters and falls overboard resulted in the same number of fatalities (37%) on the East Coast, and three of the most high-risk fisheries in the country are in this region.
Although fatality rates in the commercial fishing industry have been declining, the need for occupational safety research remains essential. This research will provide the scientific evidence necessary to expose and understand critical safety issues, develop recommendations and practical solutions to mitigate risk, and support arguments for the inclusion of health and safety measures in the development of policies that directly and indirectly affect commercial fishermen.
The Commercial Fishing Occupational Safety Research Cooperative Agreement program was established by The Coast Guard Authorization Act of 2010 (P.L. 111-281), as amended by the Howard Coble Coast Guard and Maritime Transportation Act of 2014 (P.L. 113-281), and is intended to provide funding to individuals in academia, members of non-profit organizations and businesses involved in fishing and maritime matters, and other persons with expertise in commercial fishing safety. The funding will be used to support research on improving the occupational safety of workers in the commercial fishing industry. This includes:
Improving vessel and deck equipment design
Developing and improving emergency and protective equipment
Improving vessel and fishing processes to reduce safety risks
Enhancing vessel monitoring systems
Improving communication devices, deicing technology, and severe weather detection
In order to support and administer the grant program, the Coast Guard and NIOSH signed a Memorandum of Understanding on May 17, 2018. While the Coast Guard, along with the Occupational Safety and Health Administration (OSHA), provides regulatory oversight for safety and health matters within the commercial fishing industry, NIOSH is an agency operating under the Centers for Disease Control and Prevention (CDC) with the mission of generating new knowledge in occupational safety and health and transferring that knowledge into practice to prevent worker injury, illness, and death. NIOSH conducts and funds scientific research, develops methods to prevent occupational hazards, develops guidance and authoritative recommendations, translates scientific knowledge into products and services, disseminates information, identifies factors underlying work-related disease and injury, and responds to requests for workplace health hazard evaluations.
Tailored research objectives for particular geographic regions or fleets are encouraged. Research objectives supported by this cooperative agreement include, but are not limited to the following:
Identification and investigation of the relationships between hazardous working conditions and associated occupational injuries and fatalities
Development of more sensitive means of evaluating hazards at work sites, including fatigue, stress, or the use of opioids as contributors to occupational injuries and fatalities
Development of methods for measuring leading indicators of injuries and fatalities
Development of new protective equipment and engineering control technology to reduce work-related injuries and fatalities
Development of work practices that reduce the risks of occupational hazards
Evaluation of the technical feasibility or application of a new or improved occupational safety procedure, method, technique, or system, including assessment of economic and other factors that influence their diffusion and successful adoption in workplaces
The Commercial Fishing Occupational Safety Research
Cooperative Agreement is an award made to support a distinct, specific, defined
project to be performed by the named grantees in an area representing their
specific competencies and based on the mission of NIOSH and the US Coast Guard.
The research plan proposed by the applicant must be related to the stated program
interests of NIOSH and the US Coast Guard to improve safety in the commercial
fishing industry.
Commercial Fishing Occupational Safety Research Cooperative Agreement
applications are expected to have a detailed discussion of the occupational
safety and health issue. Preliminary data are preferred. Appropriate
justification for the proposed work can be provided through literature
citations, data from other sources, and from investigator-generated data.
Healthy People 2030 and other National Strategic Priorities
The United States Public Health Service (PHS) is committed to achieving a society in which all people live long, healthy lives. The vision, mission, and goals of PHS are found in Healthy People 2030, a PHS-led national activity to achieve better health in the United States by the year 2030. This funding announcement is linked to the goals of Healthy People 2030, that are intended to prevent work-related diseases, injuries, and deaths while improving worker health, safety, and well-being.
According to the Healthy People 2030, more than 160 million people participate in the U.S. labor force, and their work has an intrinsic connection to their safety and health. Decades of public health surveillance and research have demonstrated that work-related injuries adversely affect employers, workers, and communities. Workplace settings vary widely in size, sector, design, location, processes, culture, and resources. In addition, workers themselves have different ages, genders, education levels, cultural backgrounds, health practices, and levels of access to preventive health care. This translates into great diversity and disparity in the safety and health risks for each industry sector and the need for tailored interventions.
The Healthy People 2030 occupational safety and health objectives aim to prevent illness, injury, and disease due to working conditions. All objectives, core and developmental, align with NIOSH’s strategic plan and are addressed through the National Occupational Research Agenda (NORA). NORA is a program established by NIOSH that works with partners from academia, industry, labor, and government to stimulate research and improve workplace practices.
Public Health Impact
NIOSH Office of Extramural Programs supports national occupational safety and health research and training programs to reduce work-related injuries and illnesses. Commercial fishing is one of the most dangerous occupations in the United States, and the need for targeted safety research and training is critical. Through this funding opportunity announcement, NIOSH encourages qualified applicants to submit applications that will reduce or prevent occupational illness, injury, and death among workers in the commercial fishing industry.
Relevant Work
The Commercial Fishing Occupational Safety Cooperative
Agreement program 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), to support research on improving the
occupational safety of workers in the commercial fishing industry.
Commercial fishing is one of the most hazardous occupations in the United
States with a fatality rate 29 times higher than the national average. NIOSH
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 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 NIOSH's Commercial Fishing Safety webpage.
The Commercial Fishing Occupational Safety Research Cooperative Agreement (U01) will support research on improving the occupational safety of workers in the commercial fishing industry, including, but not limited to:
Improving vessel and deck equipment design
Developing and improving emergency and protective equipment
Improving vessel and fishing processes to reduce safety risks
Enhancing vessel monitoring systems
Improving communication devices, deicing technology, and severe weather detection
NIOSH organizes its research program under the framework of the National Occupational Research Agenda (NORA). NORA is a partnership program to stimulate innovative research and improved workplace practices. Based on a collaborative effort from Sector Council members, the most recent NORA agenda prioritizes the knowledge and actions most urgently needed to identify occupational risk factors to prevent adverse health outcomes among workers. The agenda also provides a vehicle for stakeholders to describe the most relevant safety and health issues, research gaps, and needs. Occupational safety and health objectives for the commercial fishing industry fall within the scope of the NORA Agriculture, Forestry, and Fishing Sector Council. Relevant Agriculture, Forestry, and Fishing NORA research objective are as follows:
FI-01: Reduce the risk of fatal and non-fatal injuries in
the commercial fishing sub-sector
FI-02: Reduce the risk of work-related illness to workers in the commercial
fishing sub-sector
FI-03: Increase safety and health data meshing, information sharing, and
collaboration among fishing safety researchers for workers in the fishing
sub-sector
FI-04: Reduce injuries and illness in the vulnerable worker populations in the
fishing sub-sector
Note to
Applicants:
Applicants are strongly encouraged to review the language from the Coast
Guard Authorization Act of 2010, which explains the intent behind the
cooperative agreement program as well as the NORA Agriculture, Forestry, and
Fishing objectives. Consider the intent of the cooperative program as well as
the NORA objectives as you develop proposals. Applicants are encouraged to
propose innovative or novel approaches to address the major safety issues
facing commercial fishermen in the U.S., especially those described in the
purpose section of this announcement.
Objectives/Outcomes
Potential outcomes of proposed projects include:
Improving vessel and deck equipment design
Developing and improving emergency and protective equipment
Improving vessel and fishing processes to reduce safety risks
Enhancing vessel monitoring systems
Improving communication devices, deicing technology, and severe weather detection
Proposed goals and objectives should be clearly stated in
the application and directly linked to the occupational health and safety
burdens being addressed. Applicants are expected to justify their proposal by
describing the burden of the problem, the need for the proposed research or activity,
and the potential for impact or likelihood of success.
Applicants should provide data to support their selection of proposed work,
such as morbidity or mortality rates, indicators of the size of the population
at risk including estimates of the target population's potential risk of
exposure to the hazard, frequency of exposure, or sociodemographic factors such
as age, gender, and race/ethnicity. Similarly, applicants may provide
qualitative data and/or information that describe exposures, the magnitude of
the problem, and potential benefits and impacts of addressing the issue.
Qualitative data and/or information may be necessary when the nature of the
exposure or population at risk makes collecting large-scale, representative
quantitative data difficult.
Governmental agencies and organizations have been faced with increasing demand
to measure the effectiveness of their funded research in improving public
health. Effectiveness can be measured by the products (outputs) of research
activities and subsequent outcomes, i.e., benefits or changes at an individual
or population level. Outputs are the immediate products or direct result of
research activities. Examples include publications, reports, conference
proceedings, presentations/posters, investigator career development, databases,
tools, methods, guidelines, recommendations, education, and training materials.
The causes of work-related injuries and illnesses are
complex and determining the effect that specific research activities have on
them can take years. Thus, outcomes can be measured over time as either
intermediate or end outcomes.
Intermediate outcomes are specific changes that occur as a result of research
activities. Examples of intermediate outcomes include public or private policy
changes, conduct of training or workshops based on project outputs, citations
in the literature, inventions and patents, and adoption of technologies or
methods developed by the researcher.
End outcomes are the ultimate goal of the research and the result of what
individuals or institutions do with the knowledge or products generated by the
research. Examples of end outcomes include reduction in workplace illnesses,
injuries, fatalities, and/or hazardous exposures.
Note to Applicants:
Provide a brief statement about expected outputs and outcomes of the proposed research in the Description (Abstract) and in the Research Strategy (Significance) sections of your application.
Target Population
The beneficiaries of the proposed research projects are workers in the U.S. commercial fishing industry.
Diversity, Equity, and Inclusion
In June 2019, NIOSH began an initiative to take substantive action in creating greater diversity, equity, and inclusion in its workforce, the workplace and in its service to the public. This initiative led to the establishment of the NIOSH Diversity and Inclusion Office. The associated strategic plan is intended to guide actions that specifically address diversity, equity, and inclusion (DEI) in all aspects of NIOSH's work, including NIOSH-supported extramural programs. Applicants should demonstrate a commitment to DEI in all aspects of their proposed research.
Asymmetrical power relationships along social axes such as age, class, gender, nativity, and race/ethnicity not only result in social, economic, and environmental disadvantages that impact the distribution of work-related benefits and risks, but also result in exclusionary research practices. Developing inclusive research practices, and the institutional capacity to effectively produce data-driven solutions that reduce these avoidable inequities, is essential to ensuring the well-being of the increasingly diverse workforce. Applicants should identify how research questions, data collection methods and analysis, and dissemination of results will be inclusive of the diversity in the commercial fishing workforce, especially those from historically underrepresented groups. Applicants should also demonstrate how the design, content, format, and dissemination of outreach efforts will be tailored to the needs of workers from diverse backgrounds.
Collaboration/Partnerships
Partnerships are integral to the Commercial Fishing
Occupational Safety Research Cooperative Agreement Program. They
facilitate advances in the safety and health of U.S. commercial fishing
workers. Input from industry and stakeholder groups, which have inherent
knowledge and concern about the safety of fishermen, will enhance research
projects. Partners often add expertise or specialized experience to the
research team, which contributes to the success of the overall project.
Applicants should institute collaborative partnerships. These can be with
commercial fishing organizations, local and state organizations, universities,
manufacturers, government agencies, other professional organizations,
engineering and safety training partner organizations, community organizations,
healthcare institutions, business groups, and labor organizations to carry out
these proposed research activities.
Partnerships are also critical to translate research findings into effective training and work practices that are encouraged by the NIOSH Research-to-Practice Program (r2p). Interdisciplinary and transdisciplinary collaborations that share expertise are essential to advancing occupational safety and promoting overall worker safety in commercial fishing environments.
Note to Applicants:
Include collaborations or partnerships that strengthen the proposed research in terms of OSH, or related, expertise and resources.
Evaluation/Performance Measurement
Evaluations provide information for management to improve program effectiveness. The CDC document A Framework for Program Evaluation can be helpful.
Effective program evaluation is a systematic way to improve and account for public health actions by involving procedures that are useful, feasible, ethical, and accurate. Understanding and applying the elements of this framework for research projects may enhance planning effective public health strategies, improving existing programs, including evidence-based activities, and demonstrating beneficial results and impact of federal funding.
Translation Plan
In addition to NORA, NIOSH has established a Research-to-Practice (r2p) approach to reduce or eliminate occupational illness and injury by increasing the transfer and translation of knowledge, interventions, and technologies into highly effective prevention practices and products into the workplace.
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, works 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
Evaluate results to determine the impact on occupational safety and health
Note to Applicants:
Applicants must provide a brief statement about how their proposed research addresses r2p in both the Description (Abstract) and in the Research Strategy (Significance) sections of the application. Describe the anticipated strategies for translation and 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 (K2A) Framework is a useful resource.
See Section VIII. Other Information for award authorities and regulations.
Higher Education Institutions
Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for CDC/NIOSH support as Public or Private Institutions of Higher Education:
o Hispanic-serving Institutions
o Historically Black Colleges and Universities (HBCUs)
o Tribally Controlled Colleges and Universities (TCCUs)
o Alaska Native and Native Hawaiian Serving Institutions
o 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)
Local 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)
Federal Governments
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
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 by the HHS
Grants Policy Statement, are not
allowed.
For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.
Applications that exceed the 36-month period of performance
limit or the total cost limit of $975,000 per 36-month performance period
(including consortium F&A costs) will be considered
non-responsive. CDC/NIOSH will notify the applicant and request that the
application be withdrawn. A withdrawn application
will not be peer-reviewed.
Applications will be considered non-responsive if they do not clearly
indicate how the required 25% 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.
Applicants must provide a statement about which 46
U.S.C. 4502 (j) Safety Standards and the NORA Agriculture,
Forestry, and Fishing objectives are being addressed. Provide a rationale
for how the proposed research will contribute to the specified priority
area(s). Explain how the proposed research will contribute to the NIOSH
Research to Practice (r2p) initiative and state the expected Outcomes and
Outputs (see Section I - Approach). Place this information in both the Project
Abstract and in the Research Strategy (Significance) sections of the
application. 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.
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.
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.
NOTE: Applicants must have a unique entity identifier (UEI) at the time of application submission. The UEI is generated as part of SAM.gov registration. Current SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and grants.gov. Additional information is available on the GSA website, SAM.gov, and Grants.gov-Finding the UEI.
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.
o 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.
o Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 SAM registration in order to complete the Grants.gov registration.
All applicant organizations must register with Grants.gov.
Please visit www.Grants.gov at least 30
days prior to submitting your application to familiarize yourself with the registration
and submission processes. The one-time registration process will take
three to five days to complete. However, it is best to start the registration
process at least two weeks prior to application submission.
Program
Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for HHS/CDC support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This NOFO does require cost matching as defined in the HHS Grants Policy Statement, (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
As defined in the HHS Grants Policy Statement, (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), 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.
The CDC/NIOSH will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the CDC/NIOSH will not accept:
A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
Entities involved in fishing or maritime matters, and those with expertise in commercial fishing safety are eligible to apply.
Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because, unlike other platforms, it provides a validation of all requirements prior to submission and prevents errors.
To use ASSIST, applicants must visit https://public.era.nih.gov where you can login using your eRA Commons credentials and enter the Notice of Funding Opportunity Number to initiate the application, and begin the application preparation process.
If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via: http://grants.nih.gov/support/index.html.
Email: commons@od.nih.gov.
Phone: 301-402-7469 or (toll-free) 1-866-504-9552.
Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding
Federal holidays.
Applicants must use FORMS-G application packages for due dates on or after April 4, 2022. Application guides for FORMS-G application package are posted to the How-to-Apply-Application Guide page.
It is critical that applicants follow the instructions in
the SF-424 (R&R) Application Guide How-to-Apply-Application
Guide except where instructed in this Notice of Funding Opportunity
(NOFO) 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.
The package associated with this NOFO includes all applicable
mandatory and optional forms. Please note that some forms marked optional in
the application package are required for submission of applications for
this NOFO. Follow the instructions in the SF-424 (R&R) Application
Guide to ensure you complete all appropriate optional components.
When using ASSIST, all mandatory forms will appear as separate tabs at the top
of the Application Information screen; applicants may add optional forms
available for the NOFO by selecting the Add Optional Form button in
the left navigation panel.
NOTE: Please use the form and instructions for SF424 (R&R) Form G.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information it contains allows CDC staff to 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:
Name of Applicant
Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity
The letter should be sent to:
Michael Goldcamp, PhD
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
Telephone: 304-285-5951
Email: MGoldcamp@cdc.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
In addition, 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.
A complete application has many components, both required and optional. The forms package associated with this NOFO in Grants.gov includes all applicable components for this NOFO, required and optional. In ASSIST, all required and optional forms will appear as separate tabs at the top of the Application Information screen.
The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of components. Not all components of the Research Plan apply to all Notices of Funding Opportunities (NOFOs). Specifically, some of the following components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide at Guide How-to-Apply-Application Guide for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2 (Approach) of Section 1 (Funding Opportunity Description) of this NOFO.
Follow the page limits stated in the SF 424 unless otherwise specified in the NOFO. As applicable to and specified in the NOFO, 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:
Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the NOFO.
Specific Aims state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.
Research Strategy the research strategy should be organized under 3 headings: Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline.
Progress Report Publication List (for Continuation ONLY)
Other Research Plan Sections:
Vertebrate Animals
Select Agent Research
Multiple PD/PI Leadership Plan.
Consortium/Contractual Arrangements
Letters of Support
Resource Sharing Plan(s)
Authentication of Key Biological and/or Chemical Resources
Appendix
All instructions in the SF424 (R&R) Application Guide at How-to-Apply-Application Guide must be followed along with any additional instructions provided in the NOFO.
Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application. A DMP is required for each collection of public health data proposed. 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.
The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:
A description of the data to be collected or generated in the proposed project
Standards to be used for the collected or generated data
Mechanisms for, or limitations to, providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights - this section should address access to identifiable and de-identified data)
Statement of the use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use
Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified (this section should address archiving and preservation of identifiable and deidentified data)
CDC OMB approved templates may be used (e.g. NCCDPHP
template https://www.cdc.gov/chronicdisease/pdf/nofo/DMP-Template-508.docx)
Other examples of DMPs may be found here: USGS, http://www.usgs.gov//products/data-and-tools/data-management/data-management-plans
NOTE: Applicants must use FORMS-G application packages for application submission.
Application guides for FORMS-G application packages are posted to the How-to-Apply-Application Guide page.
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.
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:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix:
Only limited 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. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publicly available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Format for Attachments:
Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded to the system.
CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide at How-to-Apply-Application Guide.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
For this NOFO, applications from foreign institutions are not allowed.
See Part 2. 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. Applicants are strongly encouraged to allocate additional time and submit in advance of the deadline to ensure they have time to make any corrections that might be necessary for successful submission. This includes the time necessary to complete the application resubmission process that may be necessary if errors are identified during validation by Grants.gov and the NIH eRA systems. The application package is not complete until it has passed the Grants.gov and NIH eRA Commons submission and validation processes. Applicants will use a platform or system to submit applications. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission. If ASSIST detects errors, then the applicant must correct errors before their application can be submitted. Applicants should view their applications in ASSIST after submission to ensure accurate and successful submission through Grants.gov. If the submission is not successful and post-submission errors are found, then those errors must be corrected and the application must be resubmitted in ASSIST.
Applicants are able to access, view, and track the status of their applications in the eRA Commons.
Information on the submission process is provided in the SF-424 (R&R) Application Guidance and ASSIST User Guide at https://era.nih.gov/files/ASSIST_user_guide.pdf.
Note: HHS/CDC grant submission procedures do not provide a grace period beyond the grant application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).
Applicants who encounter problems when submitting their
applications must attempt to resolve them by contacting the NIH eRA Service
desk at:
Toll-free: 1-866-504-9552; Phone: 301-402-7469
http://grants.nih.gov/support/index.html
Hours: Mon-Fri, 7 a.m. to 8 p.m. Eastern Time (closed on Federal holidays)
Problems with Grants.gov can be resolved by contacting the
Grants.gov Contact Center at:
Toll-free: 1-800-518-4726
https://www.grants.gov/web/grants/support.html
support@grants.gov
Hours: 24 hours a day, 7 days a week; closed on Federal holidays
It is important that applicants complete the application submission process well in advance of the due date time.
After submission of your application package, applicants will receive a "submission receipt" email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. A third and final e-mail message is generated once the applicant's application package has passed validation and the grantor agency has confirmed receipt of the application.
Unsuccessful Submissions: If an application submission was unsuccessful, the applicant must:
1. Track submission and verify the submission status (tracking should be done initially regardless of rejection or success).
a. If the status states "rejected," be sure to save time stamped, documented rejection notices, and do #2a or #2b
2. Check emails from both Grants.gov and NIH eRA Commons for rejection notices.
a. If the deadline has passed, he/she should email the Grants Management contact listed in the Agency Contacts section of this announcement explaining why the submission failed.
b. If there is time before the deadline, correct the problem(s) and resubmit as soon as possible.
Due Date for Applications 08/30/2022
Electronically submitted applications must be submitted no later than 5:00 p.m., ET, on the listed application due date.
This initiative is not subject to intergovernmental review.
For more information on expanded authority and pre-award costs, go to
https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf and speak to your GMS.
All HHS/CDC awards are subject to the federal regulations, in 45 CFR Part 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.
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.
Data Management Plan:
Fulfilling the data-sharing requirement must be documented in a Data Management Plan (DMP) that is developed during the project planning phase prior to the initiation of generating or collecting public health data and must be included in the Resource Sharing Plan(s) section of the PHS398 Research Plan Component of the application.
Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds (for example, privacy and confidentiality considerations, embargo issues).
Recipients who fail to release public health data in a timely fashion will be subject to procedures normally used to address lack of compliance (for example, reduction in funding, restriction of funds, or award termination) consistent with 45 CFR 74.62 or other authorities as appropriate. For further information, please see: https://www.cdc.gov/grants/additional-requirements/ar-25.html.
Funds relating to the conduct of research involving human subjects will be restricted until the appropriate assurances and Institutional Review Board (IRB) approvals are in place. Copies of all current local IRB approval letters and local IRB approved protocols (and CDC IRB approval letters, if applicable) will be required to lift restrictions.
If the proposed research project involves more than one institution and will be conducted in the United States, awardees are expected to use a single Institutional Review Board (sIRB) to conduct the ethical review required by HHS regulations for the Protections of Human Subjects Research, and include a single IRB plan in the application, unless review by a sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy or a compelling justification based on ethical or human subjects protection issues or other well-justified reasons is provided. Exceptions will be reviewed and approved by CDC in accordance with Department of Health and Human Services (DHHS) Regulations ( 45 CFR Part 46), or a restriction may be placed on the award. For more information, please contact the scientific/research contact included on this NOFO.
Note: The sIRB requirement applies to participating sites in the United States. Foreign sites participating in CDC-funded, cooperative research studies are not expected to follow the requirement for sIRB.
CDC is required to conduct pre-award risk assessments to determine the risk an applicant poses to meeting federal programmatic and administrative requirements by taking into account issues such as financial instability, insufficient management systems, non-compliance with award conditions, the charging of unallowable costs, and inexperience. The risk assessment will include an evaluation of the applicant’s CDC Risk Questionnaire, located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, as well as a review of the applicant’s history in all available systems; including OMB-designated repositories of government-wide eligibility and financial integrity systems (see 45 CFR 75.205(a)), and other sources of historical information. These systems include, but are not limited to: FAPIIS (https://www.fapiis.gov/), including past performance on federal contracts as per Duncan Hunter National Defense Authorization Act of 2009; Do Not Pay list; and System for Award Management (SAM) exclusions.
CDC requires all applicants to complete the Risk Questionnaire, OMB Control Number 0920-1132 annually. This questionnaire, which is located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, along with supporting documentation must be submitted with your application by the closing date of the Notice of Funding Opportunity Announcement. If your organization has completed CDC’s Risk Questionnaire within the past 12 months of the closing date of this NOFO, then you must submit a copy of that questionnaire, or submit a letter signed by the authorized organization representative to include the original submission date, organization’s EIN and UEI.
When uploading supporting documentation for the Risk Questionnaire into this application package, clearly label the documents for easy identification of the type of documentation. For example, a copy of Procurement policy submitted in response to the questionnaire may be labeled using the following format: Risk Questionnaire Supporting Documents _ Procurement Policy.
Duplication
of Efforts
Applicants are responsible for reporting if this application will result in
programmatic, budgetary, or commitment overlap with another application or
award (i.e., grant, cooperative agreement, or contract) submitted to another
funding source in the same fiscal year. Programmatic overlap occurs when
(1) substantially the same project is proposed in more than one application or
is submitted to two or more funding sources for review and funding
consideration or (2) a specific objective and the project
design for accomplishing the objective are the same or closely related in two
or more applications or awards, regardless of the funding
source. Budgetary overlap occurs when duplicate or equivalent
budgetary items (e.g., equipment, salaries) are requested in an application but
already are provided by another source. Commitment overlap occurs
when an individual’s time commitment exceeds 100 percent, whether or not salary
support is requested in the application. Overlap, whether programmatic,
budgetary, or commitment of an individual’s effort greater than 100 percent, is
not permitted. Any overlap will be resolved by the CDC with the applicant
and the PD/PI prior to award.
Report Submission: The applicant must upload the report under "Other Attachment Forms." The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap."
Cost Match Requirement
A 25% cost match is required for this NOFO. Clearly indicate
how the non-federal 25% 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.
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 25%
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.
Application Submission
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
Applicants must complete all required registrations before the application due date. Section III.1 "Required Registrations" contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically (How to Apply - Application Guide | grants.nih.gov).
Important
reminders:
All Senior/Key Personnel (including any Program Directors/Principal
Investigators (PD/PIs) must include their eRA Commons ID in the Credential
field of the Senior/Key Person Profile Component of the SF 424(R&R)
Application Package. Failure to register in the Commons and to include a valid
PD/PI Commons ID in the credential field will prevent the successful submission
of an electronic application to CDC.
It is also important to note that for multi-project applications, this requirement also applies to the individual components of the application and not to just the Overall component.
The applicant organization must ensure that the UEI number provided on the application is the same number used in the organization s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.
NOTE: Applicants must have a unique entity identifier (UEI) at the time of application submission. The UEI is generated as part of SAM.gov registration. Current SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and grants.gov. Additional information is available on the GSA website, SAM.gov, and Grants.gov-Finding the UEI.
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 resources to avoid common errors and submitting, tracking, and viewing applications:
http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm
http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm
https://era.nih.gov/files/ASSIST_user_guide.pdf
http://era.nih.gov/erahelp/ASSIST/
Upon receipt, applications will be evaluated for completeness by the CDC Office of Grants Services (OGS) and responsiveness by OGS and the Center, Institute or Office of the CDC. 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 mission (http:// www.cdc.gov/ about/ organization/ mission.htm), all applications submitted to the CDC in support of public health research are evaluated for scientific and technical merit through the CDC 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? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Does the project address the burden (including preliminary data when available), need, and impact of the occupational exposures and hazards that are the focus of the proposed research? Does the applicant fully justify and provide data to describe the burden of the problem(s) being addressed? Is the project likely to have an impact in meeting local, regional or national occupational safety and health needs through effective research, intervention, translation, outreach, education, or partnership activities? Are appropriate impacts identified?
In addition, for applications proposing clinical trials:
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well-supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD/PIs, collaborators, and other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
In addition, for applications proposing clinical trials:
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
In addition, for applications proposing clinical trials:
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
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 clinical research, are there plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
In addition, for applications proposing clinical trials:
Does the application adequately address the following, if applicable?
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well-justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, ensure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analyses
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition, for applications proposing clinical trials:
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in using secure, accurate, and timely methods; and (4) operate within the proposed organizational structure?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the HHS/CDC Requirements under AR-1 Human Subjects Requirements (https://www.cdc.gov/grants/additional-requirements/ar-1.html).
If your proposed research involves the use of human data and/or biological specimens, you must provide a justification for your claim that no human subjects are involved in the Protection of Human Subjects section of the Research Plan.
When the proposed project involves 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.
Dual Research of Concern
Reviewers will identify whether the project involves one of the agents or toxins described in the US Government Policy for the Institutional Oversight of Life Sciences Dual Use Research of Concern, and, if so, whether the applicant has identified an IRE to assess the project for DURC potential and develop mitigation strategies if needed.
For more information about this Policy and other policies regarding dual use research of concern, visit the U.S. Government Science, Safety, Security (S3) website at: http://www.phe.gov/s3/dualuse. Tools and guidance for assessing DURC potential may be found at: http://www.phe.gov/s3/dualuse/Pages/companion-guide.aspx.
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.
Reviewers will assess if the applicant has demonstrated 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.
N/A
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).
HHS/CDC policy requires that recipients of grant awards make research resources and data readily available for research purposes to qualified individuals within the scientific community after publication. Please see: https://www.cdc.gov/grants/additional-requirements/ar-25.html.
New additional requirement: CDC requires recipients for projects and programs that involve data collection or generation of data with federal funds to develop and submit a Data Management Plan (DMP) for each collection of public health data.
Investigators responding to this Notice of Funding Opportunity should include a detailed DMP in the Resource Sharing Plan(s) section of the PHS 398 Research Plan Component of the application. The AR-25 outlines the components of a DMP and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation.
The DMP should be developed during the project planning phase prior to the initiation of collecting or generating public health data and will be submitted with the application. The submitted DMP will be evaluated for completeness and quality at the time of submission.
The DMP should include, at a minimum, a description of the following:
A description of the data to be collected or generated in the proposed project
Standards to be used for the collected or generated data
Mechanisms for, or limitations to, providing access to and sharing of the data (include
a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights - this section should address access to identifiable and de-identified data)
Statement of the use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use
Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified (this section should address archiving and preservation of identifiable and de-identified data)
Applications submitted without the required DMP may be deemed ineligible for award unless submission of DMP is deferred to a later period depending on the type of award, in which case, funding restrictions may be imposed pending submission and evaluation.
CDC OMB approved templates may be used (e.g., NCCDPHP template
https://www.cdc.gov/chronicdisease/pdf/nofo/DMP-Template-508.docx
Other examples of DMPs may be found here USGS, Data Management Plans | U.S. Geological Survey (usgs.gov)
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
The budget can include both direct
costs and indirect costs as allowed.
Indirect costs could include the cost of collecting, managing, sharing, and
preserving data.
Indirect costs on grants awarded to foreign organizations and foreign public
entities and performed fully outside of the territorial limits of the U.S. may
be paid to support the costs of compliance with federal requirements at a fixed
rate of eight percent of modified total direct costs exclusive of tuition and
related fees, direct expenditures for equipment, and subawards in excess of
$25,000. Negotiated indirect costs may be paid to the American
University, Beirut, and the World Health Organization.
Indirect costs on training grants are limited to a fixed rate of eight percent
of MTDC exclusive of tuition and related fees, direct expenditures for
equipment, and sub-awards in excess of $25,000.
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.
Relevance of the proposed project to program priorities.
Relevance of the proposed research to program priorities as outlined by 46 USC 4502, which is supported by NIOSH/USCG.
Contribution toward development of guidelines or best practices for improved commercial fishing vessel safety.
Contribution to advance occupational safety and health aspects of commercial fishing vessel operations.
Commitment of the applicant institution to collaborative efforts.
Administrative/managerial capability of the applicant organization.
Adequacy of resource-sharing plan.
Availability of funds.
Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.
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 Recipient
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. The evaluation criteria is
described in this Notice of Funding Opportunity.
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 45 CFR Part 75, subpart F, or the reports and findings of any other available audits
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.
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) and other pertinent information via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Any applications awarded in response to this NOFO will be subject to the UEI, SAM Registration, and Transparency Act requirements. If the application is under consideration for funding, HHS/CDC will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).
NOTE: Applicants must have a unique entity identifier (UEI) at the time of application submission. The UEI is generated as part of SAM.gov registration. Current SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and grants.gov. Additional information is available on the GSA website, SAM.gov, and Grants.gov-Finding the UEI .
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.
Recipient must comply with any funding restrictions as described in Section IV.5. Funding Restrictions.
Selection of an application for award is not an authorization to begin
performance. Any costs incurred before receipt of the NoA are at the
recipient's risk. These costs may be allowable as an expanded authority, but
only if authorized by CDC.
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: https://www.archives.gov/.
Specific requirements that apply to this NOFO are the following:
AR-1: Human Subjects Requirements
AR-2: Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research
AR-3: Animal Subjects Requirements
AR-9: Paperwork Reduction Act Requirements
AR-10: Smoke-Free Workplace Requirements
AR-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-24: Health Insurance Portability and Accountability Act Requirements
AR-25: Data Management and Access
AR-26: National Historic Preservation Act of 1966
AR-28: Inclusion of Persons Under the Age of 21 in Research
AR-30: Information Letter 10-006, - Compliance with Section 508 of the Rehabilitation Act of 1973
AR-32: Appropriations Act, General Provisions
AR-36: Certificates of Confidentiality
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 full text of the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards, 45 CFR part 75, can be found at: https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75.
The following are additional policy requirements relevant to this NOFO:
Should you successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy).This includes taking reasonable steps to provide meaningful access to persons with limited English proficiency and providing programs that are accessible to and usable by persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.
Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting your legal obligation to take reasonable steps to ensure meaningful access to your programs or activities by limited English proficient individuals, see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
For information on your specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and taking appropriate steps to provide effective communication, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html.
For guidance on administering your project in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws, see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
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 at: https://www.hhs.gov/grants/contracts/contract-policies-regulations/efficient-spending/index.html.
Federal Funding Accountability and Transparency Act of 2006
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, www.usaspending.gov. For the full text of the requirements, please review the following website: https://www.fsrs.gov/.
Plain Writing Act
The Plain Writing Act of 2010, 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: http://www.plainlanguage.gov/plLaw/index.cfm.
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 grantees 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 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 Policy for the Institutional Oversight of Life Sciences Dual Use Research of Concern was released. Grantees (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 http://www.phe.gov/s3/dualuse.
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 existing regulations
and policies governing USG-funded research, and may subject the
institution to other potential penalties under applicable laws and regulations.
Data Management Plan(s)
CDC requires that all new collections of public health data
include a Data Management Plan (DMP). For purposes of this announcement,
public health data means digitally recorded factual material commonly
accepted in the scientific community as a basis for public health findings,
conclusions, and implementation.
This new requirement ensures that CDC is in compliance with the following;
Office of Management and Budget (OMB) memorandum titled Open
Data Policy Managing Information as an Asset (OMB M-13-13);
Executive Order 13642 titled Making Open and Machine Readable the New Default
for Government Information ; and the Office of Science and Technology Policy
(OSTP) memorandum titled Increasing Access to the Results of Federally Funded
Scientific Research (OSTP Memo).
The AR-25 https://www.cdc.gov/grants/additional-requirements/ar-25.html outlines
the components of a DMP and provides additional information for
investigators regarding the requirements for data accessibility, storage, and
preservation.
Certificates of Confidentiality: Institutions and investigators are
responsible for determining whether research they conduct is subject to Section
301(d) of the Public Health Service (PHS) Act. Section 301(d), as amended
by Section 2012 of the 21st Century Cures Act, P.L. 114-255 (42 U.S.C. 241(d)),
states that the Secretary shall issue Certificates of Confidentiality
(Certificates) to persons engaged in biomedical, behavioral, clinical, or other
research activities in which identifiable, sensitive information is collected.
In furtherance of this provision, CDC-supported research commenced or ongoing
after December 13, 2016 in which identifiable, sensitive information is
collected, as defined by Section 301(d), is deemed issued a Certificate and
therefore required to protect the privacy of individuals who are subjects of
such research. Certificates issued in this manner will not be issued as a
separate document, but are issued by application of this term and condition to
this award. See Additional Requirement 36 to ensure compliance with this
term and condition. The link to the full text is at: https://www.cdc.gov/grants/additional-requirements/ar-36.html.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and CDC
grant administration policies.
The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial CDC programmatic
involvement with the recipients is anticipated during the performance of
the activities. Under the cooperative agreement, the HHS/CDC purpose is to support
and stimulate the recipients' activities by involvement in and otherwise
working jointly with the award recipients in a partnership role; CDC Project
Officers are not to assume direction, prime responsibility, or a dominant role
in the activities. Consistent with this concept, the dominant role and prime
responsibility resides with the recipients for the project as a whole, although
specific tasks and activities may be shared among the recipients and
HHS/CDC as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
Designing and conducting research to address the described research objectives in this cooperative agreement
Coordinating all technical, scientific, and administrative aspects of activities at the awarded institution, and at other sites that may be supported by this award
Defining objectives and approaches; collecting and analyzing data; and publishing results, interpretations, and conclusions of studies conducted under the terms and conditions of the program award
Ensuring that appropriate Institutional Review Board approvals for research involving human subjects for all participating sites, collaborators, or partners are obtained
Retaining custody of, and primary rights to, the data and software developed under this award, subject to Government rights of access consistent with current DHHS, PHS, and CDC policies
Consulting with CDC/NIOSH to ensure compliance with relevant grant policies and regulations
CDC staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Participating in quarterly meetings (in person or virtually) with other commercial fishing award recipients, USCG and NIOSH
Coordinating ad hoc meetings and requests for information as needed
Conducting site visits with the award recipients, which will be a coordinated effort involving NIOSH personnel
Independent evaluation of progress toward specific aims or overall goals and objectives
Additionally, a NIOSH Scientific Program Official (SPO) will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the Notice of Award. NIOSH staff with the relevant subject matter expertise will also have substantial programmatic involvement and provide agency-level coordination of research activities.
Areas of Joint Responsibility include:
All responsibilities are divided between recipients and CDC staff as described
above.
Diversity Supplements: NIOSH supports efforts to enhance diversity of the research workforce through recruitment and support for students, post-doctorates, and eligible investigators from diverse backgrounds and groups under-represented in OSH research. To help accomplish this, supplemental funding will be considered after an application is awarded. Please refer to PA-21-071 for information or contact the SPO assigned to this NOFO. Diversity supplements are contingent upon administrative review and availability of funds.
Recipients will be required to complete Research Performance Progress Report (RPPR) in eRA Commons at least annually (see https://grants.nih.gov/grants/rppr/index.htm; https://grants.nih.gov/grants/forms/report_on_grant.htm) and financial statements as required 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 (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).
The Recipient Organization must provide HHS/CDC with the following reports:
Yearly Non-Competing Grant Progress Report, is due 90 to 120 days before the end of the current budget period. The RPPR form (https://grants.nih.gov/grants/rppr/index.htm; https://grants.nih.gov/grants/rppr/rppr_instruction_guide.pdf) is to be completed on the eRA Commons website. The progress report will serve as the non-competing continuation application. Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence 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 (https://grants.nih.gov/grants/forms/report_on_grant/federal_financial_report_ffr.htm) is required and must be submitted through eRA Commons within 90 days after the end of the calendar quarter in which the budget period ends.
Yearly Non-Competing Grant Progress Report: The grantee's continuation application/progress should include:
Description of Progress during Annual Budget Period: Current Budget Period Progress reported on the RPPR form in eRA Commons (https://grants.nih.gov/grants/rppr/index.htm). Detailed narrative report for the current budget period that directly addresses progress towards the Measures of Effectiveness included in the current budget period proposal
Research Aims: list each research aim/project
a) Research Aim/Project: purpose, status (met, ongoing, and unmet), challenges, successes, and lessons learned
b) Leadership/Partnership: list project collaborations and describe the role of external partners
Translation of Research (1 page maximum). When relevant to the goals of the research project, the PI should describe how the significant findings may be used to promote, enhance, or advance translation of the research into practice or may be used to inform public health policy. This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers, and other potential users. The PI should identify the research findings that were translated into public health policy or practice and how the findings have been or may be adopted in public health settings. Or, if they cannot be applied yet, this section should address which research findings may be translated, how these findings can guide future research or related activities, and recommendations for translation. If relevant, describe how the results of this project could be generalized to populations and communities outside of the study. Questions to consider in preparing this section include:
How will the scientific findings be translated into public health practice or inform public health policy?
How will the project improve or effect the translation of research findings into public health practice or inform policy?
How will the research findings help promote or accelerate the dissemination, implementation, or diffusion of improvements in public health programs or practices?
How will the findings advance or guide future research efforts or
related activities?
Public Health Relevance and Impact (1 page maximum). This section should address improvements in public health as measured by documented or anticipated outcomes from the project. The PI should consider how the findings of the project relate beyond the immediate study to improved practices, prevention, or intervention techniques, inform policy, or use of technology in public health. Questions to consider in preparing this section include:
How will this project lead to improvements in public health?
How will the findings, results, or recommendations been used to influence practices, procedures, methodologies, etc.?
How will the findings, results, or recommendations contribute to documented or projected reductions in morbidity, mortality, injury, disability, or disease?
Current Budget Period Financial Progress: Status of obligation of current budget period funds and an estimate of unobligated funds projected provided on an estimated FFR.
New Budget Period Proposal:
Detailed operational plan for continuing activities in the upcoming budget period, including updated Measures of Effectiveness for evaluating progress during the upcoming budget period. Report listed by Research Aim/Project.
Project Timeline: Include planned milestones for the
upcoming year (be specific and provide deadlines).
New Budget Period Budget: Detailed line-item budget and
budget justification for the new budget period. Use the CDC budget guideline
format.
Publications/Presentations: Include publications/presentations resulting from this CDC grant only during this budget period. If no publication or presentations have been made at this stage in the project, simply indicate "Not applicable: No publications or presentations have been made."
IRB Approval Certification: Include all
current IRB approvals to avoid a funding restriction on your award.
If the research does not involve human subjects, then please state so. Please
provide a copy of the most recent local IRB and CDC IRB, if
applicable. If any approval is still pending at time of APR due date, indicate
the status in your narrative.
Update of Data Management Plan: The DMP is considered a living document that will require updates throughout the lifecycle of the project. Investigators should include any updates to the project’s data collection such as changes to initial data collection plan, challenges with data collection, and recent data collected. Applicants should update their DMP to reflect progress or issues with planned data collection and submit as required for each reporting period.
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.
NIOSH Research-to-Practice Program (r2p) is an approach for the transfer and translation of knowledge, interventions, and technologies into highly effective prevention practices and products that are adopted in the workplace.
Annual Federal Financial Reporting
The Annual Federal Financial Report (FFR) SF 425 is required
and must be submitted through the Payment Management System (PMS) within 90
days after the end of the calendar quarter in which the budget period ends. The
FFR should only include those funds authorized and disbursed during the
timeframe covered by the report. The final FFR must indicate the exact balance
of unobligated funds and may not reflect any unliquidated obligations. There must
be no discrepancies between the final FFR expenditure data and the Payment
Management System's (PMS) cash transaction data.
Failure to submit the required information in a timely
manner may adversely affect the future funding of this project. If the information
cannot be provided by the due date, you are required to submit a letter
explaining the reason and date by which the Grants Officer will receive the
information.
The due date for final FFRs is 90 days after the
Period of Performance end date.
Recipients must submit closeout reports in a timely manner.
Unless the Grants Management Officer (GMO) of the awarding Institute or Center
approves an extension, recipients must submit a final FFR, final progress
report, and Final Invention Statement and Certification within 90 days of the
end of grant period. Failure to submit timely and accurate final reports may
affect future funding to the organization or awards under the direction of the
same Project Director/Principal Investigator (PD/PI).
FFR (SF 425) instructions for CDC recipients are now available at https://grants.nih.gov/grants/forms/report_on_grant/federal_financial_report_ffr.htm. For further information, contact GrantsInfo@nih.gov. Additional resources on the Payment Management System (PMS) can be found at https://pms.psc.gov.
Organizations may verify their current registration status
by running the List of Commons Registered Organizations query found at: https://era.nih.gov/registration_accounts.cfm.
Organizations not yet registered can go to https://commons.era.nih.gov/commons/ for
instructions. It generally takes several days to complete this registration
process. This registration is independent of Grants.gov and may be done at any
time.
The individual designated as the PI on the application must also be registered in the Commons. The PI must hold a PI account and be affiliated with the applicant organization. This registration must be done by an organizational official or their delegate who is already registered in the Commons. To register PIs in the Commons, refer to the eRA Commons User Guide found at: https://era.nih.gov/docs/Commons_UserGuide.pdf.
Final Reports
Final reports should provide sufficient detail for CDC to determine if the stated outcomes for the funded research have been achieved and if the research findings resulted in public health impact based on the investment. The grantee's final report should include:
Research Aim/Project Overview: The PI should describe the purpose and approach to the project, including the outcomes, methodology and related analyses. Include a discussion of the challenges, successes and lessons learned. Describe the collaborations/partnerships and the role of each external partner.
Translation of Research Findings: The PI should describe how the findings will be translated and how they will be used to inform policy or promote, enhance or advance the impact on public health practice. This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers and other potential end users. The PI should also provide a discussion of any research findings that informed policy or practice during the course of the Period of Performance. If applicable, describe how the findings could be generalized and scaled to populations and communities outside of the funded project.
Public Health Relevance and Impact: This section should address improvements in public health as measured by documented or anticipated outcomes from the project. The PI should consider how the findings of the project related beyond the immediate study to improved practices, prevention or intervention techniques, or informed policy, technology or systems improvements in public health.
Publications; Presentations; Media Coverage: Include information regarding all publications, presentations or media coverage resulting from this CDC-funded activity. Please include any additional dissemination efforts that did or will result from the project.
Final Data Management Plan: Applicants must include an updated final Data Management Plan that describes the data collected, the location of where the data is stored (example: a repository), accessibility restrictions (if applicable), and the plans for long term preservation of the data.
Termination
CDC may impose other enforcement actions in accordance with 45 CFR 75.371- Remedies for Noncompliance, as appropriate.
The Federal award may be terminated in whole or in part as follows:
(1) By the HHS awarding agency or pass-through entity, if the non-Federal entity fails to comply with the terms and conditions of the award
(2) By the HHS awarding agency or pass-through entity for cause
(3) By the HHS awarding agency or pass-through entity with the consent of the non-Federal entity, in which case the two parties must agree upon the termination conditions, including the effective date and, in the case of partial termination, the portion to be terminated
(4) By the non-Federal entity upon sending to the HHS awarding agency or pass-through entity written notification setting forth the reasons for such termination, the effective date, and, in the case of partial termination, the portion to be terminated. However, if the HHS awarding agency or pass-through entity determines in the case of partial termination that the reduced or modified portion of the Federal award or subaward will not accomplish the purposes for which the Federal award was made, the HHS awarding agency or pass-through entity may terminate the Federal award in its entirety
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Grants.gov Customer
Support (Questions regarding Grants.gov registration and submission,
downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov
Hours: 24 hours a day, 7 days a week; closed on Federal holidays
Finding Help Online: https://grants.nih.gov/support/index.html
(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information
(Questions regarding application instructions, application processes, and NIH
grant resources)
Email: GrantsInfo@nih.gov (preferred
method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding
Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Bridgette Garrett, PhD
National Institute for Occupational Safety and Health
(NIOSH)
Telephone: 770-488-5715
Email: BGarrett@cdc.gov
Michael Goldcamp, PhD
National Institute for Occupational Safety and Health
(NIOSH)
Telephone: 304-285-5951
Email: MGoldcamp@cdc.gov
Mary Pat Shanahan
Office of Grants Services (OGS)
Telephone: 412-386-4453
Email: MShanahan@cdc.gov
Other CDC Notices of Funding Opportunities can be found at www.grants.gov.
All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Awards are made under the authorization of the Public Health Service Act as amended and under the Code of 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). These Acts stipulate that grants are to be awarded on a competitive basis and can cover up to 75 percent of allowable costs for training or research activities. This requires that recipients have an approved 25% cost match to receive a notice of grant award. Specific information on cost sharing/matching can be found in 45 CFR 75.306.
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), and requires a 25% non-Federal cost match for a grant application to be funded.
Applicants must consider the following 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, 45 CFR 75.306, or contact one of the agency staff listed in this announcement.
and Human Services (HHS)
