Centers for Disease Control and Prevention - ERA logo

Commercial Fishing Occupational Safety Research Cooperative Agreement (U01)

Centers for Disease Control and Prevention - ERA

Funding Amount

$150,000 - $975,000

Deadline

January 31, 2028

663 days left

Grant Type

federal

Overview

Commercial Fishing Occupational Safety Research Cooperative Agreement (U01)

The Fishing Safety Research Grant Program 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), is intended to provide funding to individuals in academia, members of non-profit organizations and businesses involved in fishing and maritime matters, and other persons with expertise in commercial fishing safety. The funding will be used to support research on improving the occupational safety of workers in the commercial fishing industry. This includes: improving vessel design; developing and improving emergency and survival equipment; enhancing vessel monitoring systems; improving communication devices, de-icing technology, and severe weather detection. In order to support and administer the grant program, the Coast Guard and NIOSH signed a Memorandum of Understanding on May 17, 2018. While the Coast Guard, along with the Occupational Safety and Health Administration (OSHA), provides regulatory oversight for safety and health matters within the commercial fishing industry, NIOSH is an agency operating under the Centers for Disease Control and Prevention (CDC) with the mission of generating new knowledge in occupational safety and health and transferring that knowledge into practice to prevent worker injury, illness and death. NIOSH conducts and funds scientific research, develops methods to prevent occupational hazards, develops guidance and authoritative recommendations, translates scientific knowledge into products and services, disseminates information, identifies factors underlying work-related disease and injury and responds to requests for workplace health hazard evaluations. NIOSH has an extensive history of conducting research to understand and to reduce hazards in the commercial fishing industry. This research has largely been conducted in close collaboration with crews, industry and the US Coast Guard. To learn more about NIOSH’s work in commercial fishing safety and health, visit https://www.cdc.gov/niosh/topics/fishing/default.html. Research objectives supported by NIOSH include, but are not limited to, the following: identification and investigation of the relationships between hazardous working conditions and associated occupational injuries and fatalities; development of more sensitive means of evaluating hazards at work sites; development of methods for measuring early markers of injuries and fatalities; development of new protective equipment and engineering control technology to reduce work-related injuries and fatalities; development of work practices that reduce the risks of occupational hazards; and evaluation of the technical feasibility or application of a new or improved occupational safety procedure, method, technique, or system, including assessment of economic and other factors that influence their diffusion and successful adoption in workplaces.

Eligibility

Eligible Applicant Types

county_governmentsstate_governmentsspecial_district_governmentspublic_and_indian_housing_authoritiesprivate_institutions_of_higher_educationnonprofits_non_higher_education_without_501c3federally_recognized_native_american_tribal_governmentsother_native_american_tribal_organizationsnonprofits_non_higher_education_with_501c3independent_school_districtspublic_and_state_institutions_of_higher_educationcity_or_township_governmentsfor_profit_organizations_other_than_small_businessesothersmall_businesses

How to Apply

Foa_Content_of_RFA-OH-22-005.pdf

Centers for Disease Control and Prevention
NIOSH - NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH
Commercial Fishing Occupational Safety Research Cooperative Agreement (U01)
RFA-OH-22-005
08/30/2022

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Table of Contents
Section I. Funding Opportunity Description ...................................................................................7
Section II. Award Information .......................................................................................................14
Section III. Eligibility Information ................................................................................................16
Section IV. Application and Submission Information ...................................................................20
Section V. Application Review Information .................................................................................29
Section VI. Award Administration Information ............................................................................36
Section VII. Agency Contacts .......................................................................................................50
Section VIII. Other Information ....................................................................................................50
Overview
Participating Organization(s)
Centers for Disease Control and Prevention
Components of Participating Organizations
Components of Participating Organizations:
National Institute for Occupational Safety and Health
Notice of Funding Opportunity (NOFO) Title
Commercial Fishing Occupational Safety Research Cooperative Agreement (U01)
Activity Code
Notice of Funding Opportunity Type
Reissue of RFA-OH-20-002
Agency Notice of Funding Opportunity Number
RFA-OH-22-005
Assistance Listings Number(s)
93.262
Category of Funding Activity
HL - Health
NOFO Purpose
The Commercial Fishing Occupational Safety Research Cooperative Agreement was established
by The Coast Guard Authorization Act of 2010 (P.L. 111-281), as amended by the Howard
Coble Coast Guard and Maritime Transportation Act of 2014 (P.L. 113-281), and is intended to
provide funding to individuals in academia, members of non-profit organizations and businesses
involved in fishing and maritime matters, and other entities with expertise in commercial fishing
safety. The funding will be used to support research on improving the occupational safety of
workers in the commercial fishing industry. This includes:
 Improving vessel and deck equipment design
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 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.
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 the NIOSH Commercial Fishing Safety webpage.
Tailored research objectives for particular geographic regions or fleets are encouraged. Research
objectives supported by these grants include, but are not limited to, the following:
 Identification and investigation of the relationships between hazardous working
conditions and associated occupational injuries and fatalities
 Development of more sensitive means of evaluating hazards at work sites, including
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 recipients in
an area representing their specific competencies and based on the mission of NIOSH and the US
Coast Guard. The research plan proposed by the applicant must be related to the stated program
interests of NIOSH and the US Coast Guard to improve safety in the commercial fishing
industry.
Commercial Fishing Occupational Safety Research Cooperative Agreement applications are
expected to have a detailed discussion of the occupational safety and health issue. Preliminary
data are preferred. Appropriate justification for the proposed work can be provided through
literature citations, data from other sources, and from investigator-generated data.
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Key Dates
Publication Date:
To receive notification of any changes to RFA-OH-22-005, return to the synopsis page of this
announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link.
An email address is needed for this service.
Letter of Intent Due Date:
The LOI date will generate once the Synopsis is published if Days or a Date are entered.
July 29, 2022; December 30, 2022; July 28, 2023; December 29, 2023; July 26, 2024; December
27, 2024; August 1, 2025; January 2, 2026; July 31, 2026; December 31, 2026
Application Due Date:
08/30/2022
August 30, 2022; January 27, 2023; August 25, 2023; January 26, 2024; August 23, 2024;
January 24, 2025; August 29, 2025; January 30, 2026; August 28, 2026; January 29, 2027
On-time submission requires that electronic applications be error-free and made available to
CDC for processing from the NIH eRA system on or before the deadline date. Applications must
be submitted to and validated successfully by Grants.gov no later than 11:59 PM U.S. Eastern
Time.
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 it provides a validation of
all requirements prior to submission and prevents errors.
For more information on 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.
 E-mail: 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
Note: HHS/CDC grant submission procedures do not provide a grace period beyond the
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).
Scientific Merit Review:
11/02/2022
November 2, 2022; May 17, 2023; November 1, 2023; May 15, 2024; November 6, 2024; May
14, 2025; November 5, 2025; May 13, 2026; November 4, 2026; May 5, 2027
Secondary Review:
12/08/2022
December 8, 2022; June 8, 2023; December 7, 2023; June 6, 2024; December 5, 2024; June 5,
2025; December 4, 2025; June 4, 2026; December 3, 2026; June 3, 2027
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Estimated Start Date:
09/01/2023
September 1, 2023; September 1, 2024; September 1, 2025; September 1, 2026; September 1,
2027
Expiration Date:
01/31/2028
Required Application Instructions
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.
Note:The Research Strategy component of the Research Plan is limited to 12 pages.
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.
Applications that do not comply with these instructions may be delayed or may not be accepted
for review.
Telecommunications for the Hearing Impaired: TTY 1-888-232-6348
Executive Summary
Purpose
The Commercial Fishing Occupational Safety Research Cooperative Agreement was established
by The Coast Guard Authorization Act of 2010 (P.L. 111-281), as amended by the Howard
Coble Coast Guard and Maritime Transportation Act of 2014 (P.L. 113-281), and is intended to
provide funding to individuals in academia, members of non-profit organizations and businesses
involved in fishing and maritime matters, and other persons with expertise in commercial fishing
safety. The funding will be used to support research on improving the occupational safety of
workers in the commercial fishing industry. This includes:
 Improving vessel 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
Page 4 of 51

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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.
Mechanism of Support
Cooperative Agreement: A support mechanism used when there will be substantial Federal
scientific or programmatic involvement. Substantial involvement means that, after award,
CDC/NIOSH scientific or program staff will assist, guide, coordinate, or participate in project
activities. See Section VI.4 for additional information about the substantial involvement for this
NOFO.
Funds Available and Anticipated Number of Awards
The anticipated funds available for this NOFO is $19.5 million total cost (direct and indirect
costs). NIOSH anticipates funding 20 awards through this announcement. Awards issued under
this NOFO are contingent upon availability of funds and a sufficient number of meritorious
applications. Because the nature and scope of the proposed research will vary from application to
application, it is also anticipated that the size and duration of each award may also vary. The
total amount awarded and the number of awards will depend upon the number, quality, duration,
and cost of the applications received.
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Budget and Period of Performance
The estimated total funding (direct and indirect) for a 36-month budget period, 9/1/2023 -
8/31/2026, is $975,000, including a 25% cost match requirement. The estimated total funding
(direct and indirect) for the entire Period of Performance, 9/1/2023 - 8/31/2026, is
$975,000. Cost matching (25% of total proposed cost) is required. The source and amount of
costs and/or the value of third-party in-kind contributions proposed by the applicant to meet the
cost match requirement must be identified in the application budget. The Notice of Award will
state the amount of Federal funding and the amount of 25% cost match requirement. As an
example, a total award of $975,000 will consist of $731,250 in Federal funds and $243,750
as non-Federal cost matching. Applicants may refer to page I-24 of the HHS Grants Policy
Statement and 45 CFR 75.306 for specific information on cost matching. Inclusion of cost
matching information is required for an application to proceed to peer review. NOTE: Unlike
standard awards with 12-month budget periods, the budget period for these awards is 36 months
and is the same as the project period of performance.
Application Research Strategy Length
Page limits for the Research Strategy are clearly specified in Section IV. Application and
Submission Information of this announcement.
Eligible Institutions/Organizations
Institutions/organizations listed in Section III.1 are eligible to apply.
Eligible Project Directors/Principal Investigators (PDs/PIs)
Individuals with the skills, knowledge, and resources necessary to carry out the proposed
research are invited to work with their institution/organization to develop an application for
support.
Note to Applicants:
CDC does not make awards to individuals directly. Individuals from underrepresented racial and
ethnic groups as well as individuals with disabilities are always encouraged to apply.
Number of PDs/PIs
Multiple PDs/PIs are allowed.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is
scientifically distinct. PLEASE NOTE: For applications due on or after April 4, 2022,
applicants must have a unique entity identifier (UEI) at the time of application
submission. In preparation for the federal government’s April 4, 2022, transition from the Data
Universal Numbering System (DUNS) to the Unique Entity Identifier (UEI), applicants must
obtain a UEI. 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
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UEI.
Application Type
New - An application that is submitted for funding for the first time.
Renewal - Competing for additional years of funding to continue original project.
Revision - Request for additional funds for a current award to expand the scope of work.
Applicants should contact the awarding agency for advice on submitting any
revision/supplement application.
Resubmission - For NOFOs with multiple receipt dates. Application previously reviewed. A
revised or amended application addresses reviewer feedback.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application
types. Only those application types listed here are allowed for this NOFO.
Special Date(s)
Not applicable
Application Materials
See Section IV.1 for application materials.
Hearing Impaired
Telecommunications for the hearing impaired are available at: TTY: 1-888-232-6348.
Section I. Funding Opportunity Description
Statutory Authority
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.
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. All awards are subject to 45 CFR Part 75,
the terms and conditions of the notice of grant award, and other considerations described in
the HHS Grants Policy Statement.
1. Background and Purpose
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
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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:
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 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
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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.
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2. Approach
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
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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
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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.
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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.
3. Funding Strategy
N/A
Section II. Award Information
Funding Instrument Type:
CA (Cooperative Agreement)
A support mechanism used when there will be substantial Federal scientific or programmatic
involvement. Substantial involvement means that, after award, scientific or program staff will
assist, guide, coordinate, or participate in project activities.
Application Types Allowed:
New - An application that is submitted for funding for the first time. Includes multiple
submission attempts within the same round.
Renewal (formerly Competing Continuation) - Previous years of funding for the project have
elapsed. Competing for additional years of funding to continue original project.
Revision (formerly Competing Supplement) - Request for additional funds for a current award to
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expand the scope of work. Applicants should contact the awarding agency for advice on
submitting any revision/supplement application.
Resubmission (formerly Revision or Amended Application) - For NOFOs that with multiple
receipt dates. Application previously reviewed. A revised or amended application addresses
reviewer feedback.
Estimated Total Funding:
$975,000
Estimated total funding (direct and indirect costs) for the 36-month budget period is $975,000,
including a 25% cost match requirement.
Estimated total funding (direct and indirect costs) for the entire period of performance is
$975,000, including a 25% cost match requirement.
Anticipated Number of Awards:
20
Estimated total funding (direct and indirect costs) for the 36-month budget period is $975,000,
including a 25% cost match requirement.
Estimated total funding (direct and indirect costs) for the entire period of performance is
$975,000, including a 25% cost match requirement.
Anticipated number of awards that will be made under this NOFO: 20
Awards issued under this NOFO are contingent on the availability of funds and submission of a
sufficient number of meritorious applications.
Award Ceiling:
$975,000
Per Project Period
Award Floor:
$150,000
Per Project Period
Total Period of Performance Length:
3 year(s)
Throughout the Period of Performance, CDC's commitment to continuation of awards will
depend on the availability of funds, evidence of satisfactory progress by the recipient (as
documented in required reports), and CDC’s determination that continued funding is in the best
interest of the Federal government.
HHS/CDC grants policies as described in the HHS Grants Policy Statement
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(https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will
apply to the applications submitted and awards made in response to this NOFO.
If you are successful and receive a Notice of Award, in accepting the award, you agree that the
award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in
effect or implemented during the period of the award, other Department regulations and policies
in effect at the time of the award, and applicable statutory provisions.
Section III. Eligibility Information
1. Eligible Applicants
Eligibility Category:
00 (State governments)
01 (County governments)
02 (City or township governments)
04 (Special district governments)
05 (Independent school districts)
06 (Public and State controlled institutions of higher education)
07 (Native American tribal governments (Federally recognized))
08 (Public housing authorities/Indian housing authorities)
11 (Native American tribal organizations (other than Federally recognized tribal governments))
12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher
education)
13 (Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education)
20 (Private institutions of higher education)
22 (For profit organizations other than small businesses)
23 (Small businesses)
25 (Others (see text field entitled "Additional Information on Eligibility" for clarification))
Additional Eligibility Category:
The following types of Higher Education Institutions are always encouraged to apply for CDC
support as Public or Private Institutions of Higher Education:
Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Nonprofits (Other than Institutions of Higher Education):
Nonprofits (Other than Institutions of Higher Education)
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Governments:
Eligible Agencies of the Federal Government
U.S. Territory or Possession
Other:
Faith-based or Community-based Organizations
Regional Organizations
Bona Fide Agents: A Bona Fide Agent is an agency/organization identified by the state as
eligible to submit an application under the state eligibility in lieu of a state application. If
applying as a bona fide agent of a state or local government, a legal, binding agreement from the
state or local government as documentation of the status is required. Attach with "Other
Attachment Forms."
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.
2. Foreign Organizations
Foreign Organizations are not eligible to apply.
Foreign components of U.S. Organizations are not eligible to apply.
For this announcement, applicants may not include collaborators or consultants from foreign
institutions. All applicable federal laws and policies apply.
3. Additional Information on Eligibility
Entities involved in fishing and maritime matters, and those with expertise in commercial fishing
safety.
4. Justification for Less than Maximum Competition
N/A
5. Responsiveness
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
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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 training will contribute to the specified priority area(s). Explain how the
proposed training will contribute to the NIOSH Research to Practice (r2p) initiative and state the
expected Outcomes and Outputs (see Section I - Approach). Place this information in both the
Project Abstract and in the Research Strategy (Significance) sections of the application. 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.
6. Required Registrations
Applicant organizations must complete the following registrations as described in the SF 424
(R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a
valid Unique Entity Identifier (UEI) number in order to begin each of the following registrations.
PLEASE NOTE: Effective April 4, 2022, applicants must have a Unique Entity Identifier
(UEI) at the time of application submission. The UEI replaced the Data Universal Numbering
System (DUNS) and 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.
 (Foreign entities only): Special Instructions for acquiring a Commercial and
Governmental Entity (NCAGE) Code:
https://eportal.nspa.nato.int/AC135Public/Docs/US Instructions for NSPA NCAGE.pdf
 System for Award Management (SAM) – must maintain current registration in SAM (the
replacement system for the Central Contractor Registration) to be renewed annually,
SAM.gov.
 Grants.gov
 eRA Commons
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.
All Senior/Key Personnel (including Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons or ensure their
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existing Principal Investigator (PD/PI) eRA Commons account is affiliated with the eRA
commons account of the applicant organization. All registrations must be successfully completed
and active before the application due date. Applicant organizations are strongly encouraged to
start the eRA Commons registration process at least four (4) weeks prior to the application due
date. ASSIST requires that applicant users have an active eRA Commons account in order to
prepare an application. It also requires that the applicant organization's Signing Official have an
active eRA Commons Signing Official account in order to initiate the submission process.
During the submission process, ASSIST will prompt the Signing Official to enter their
Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the
submission, therefore the applicant organization must ensure that their Grants.gov AOR
credentials are active.
7. Universal Identifier Requirements and System for Award Management (SAM)
All applicant organizations must obtain a Unique Entity Identifier (UEI) number as the
Universal Identifier when applying for Federal grants or cooperative agreements. The UEI
number is a twelve-digit number assigned by SAM.gov. An AOR should be consulted to
determine the appropriate number. If the organization does not have a UEI number, an AOR
should register through SAM.gov. Note this is an organizational number. Individual Program
Directors/Principal Investigators do not need to register for a UEI number.
Additionally, organizations must maintain the registration with current information at all times
during which it has an application under consideration for funding by CDC and, if an award is
made, until a final financial report is submitted or the final payment is received, whichever is
later.
SAM.gov is the primary registrant database for the Federal government and is the repository into
which an entity must provide information required for the conduct of business as a recipient.
Additional information about registration procedures may be found at SAM.gov and the
SAM.gov Knowledge Base.
If an award is granted, the recipient organization must notify potential sub-recipients that no
organization may receive a subaward under the grant unless the organization has provided its
UEI number to the recipient organization.
8. Eligible Individuals (Project Director/Principal Investigator) in
Organizations/Institutions
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed
research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her
organization to develop an application for support. Individuals from underrepresented racial and
ethnic groups as well as individuals with disabilities are always encouraged to apply for
HHS/CDC support.
9. Cost Sharing
This NOFO does require cost sharing as defined in the HHS Grants Policy Statement
(http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).
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10. Number of Applications
As defined in the HHS Grants Policy Statement,
(https://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.
Applicant organizations may submit more than one application, provided that each application is
scientifically distinct.
Section IV. Application and Submission Information
1. Address to Request Application Package
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.
2. Content and Form of Application Submission
Applicants must use FORMS-G application packages.
Application guides for FORMS-G application packages 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 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.
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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.
Please use the form and instructions for SF424 (R&R) Form G. Applicants must use FORMS-G
application packages for due dates on or after April 4, 2022.
3. Letter of Intent
Number Of Days from Publication 30
The LOI date will generate once the Synopsis is published if Days or a Date are entered.
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 above and 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
4. Required and Optional Components
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.
5. PHS 398 Research Plan Component
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 How to Apply

  • Application Guide for additional information. Please attach applicable sections of the following

  • Research Plan components as directed in Part 2, Section 1 (Notice of Funding Opportunity
    Description).
    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:
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    1. 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.
    2. Specific Aims – state the problem the proposed research addresses and how it will result
    in public health impact and improvements in population health.
    3. Research Strategy – the research strategy should be organized under 3 headings:
    Significance, Innovation and Approach. Describe the proposed research plan, including
    staffing and time line.
    4. Progress Report Publication List (for Continuation ONLY)
    Other Research Plan Sections
    5. Vertebrate Animals
    6. Select Agent Research
    7. Multiple PD/PI Leadership Plan.
    8. Consortium/Contractual Arrangements
    9. Letters of Support
    10. Resource Sharing Plan(s)
    11. Authentication of Key Biological and/or Chemical Resources
    12. 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; and
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     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
    Applicants must use FORMS-G application packages.
    Application guides for FORMS-G application packages are posted to the How to Apply -
    Application Guide page.
    Please use the form and instructions for SF424 (R&R) Form G. Applicants must use FORMS-G
    application packages for due dates on or after April 4, 2022.
    6. Appendix
    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.
    7. Page Limitations
    All page limitations described in this individual NOFO must be followed. For this specific
    NOFO, the Research Strategy component of the Research Plan narrative is limited to 12 pages.
    Supporting materials for the Research Plan narrative included as appendices may not exceed 10
    PDF files with a maximum of 100 pages for all appendices. Pages that exceed page limits
    described in this NOFO will be removed and not forwarded for peer review, potentially affecting
    an application's score.
    8. 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.
    Applicants must use FORMS-G application packages.
    Application guides for FORMS-G application packages are posted to the How to Apply -
    Application Guide page.
    Please use the form and instructions for SF424 (R&R) Form G. Applicants must use FORMS-G
    application packages for due dates on or after April 4, 2022.
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    9. Submission Dates & Times
    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.
    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
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    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
    08/30/2022
    Electronically submitted applications must be submitted no later than 11:59 p.m., ET, on the
    listed application due date.
    10. Funding Restrictions
    Expanded Authority:
    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.
    Public Health Data:
    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).
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    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
    Human Subjects:
    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.
    11. Other Submission Requirements and Information
    Risk Assessment Questionnaire Requirement
    CDC is required to conduct pre-award risk assessments to determine the risk an applicant poses
    to meeting federal programmatic and administrative requirements by taking into account issues
    such as financial instability, insufficient management systems, non-compliance with award
    conditions, the charging of unallowable costs, and inexperience. The risk assessment will include
    an evaluation of the applicant’s CDC Risk Questionnaire, 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
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    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.
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    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.6 "Required Registrations" contains information about registration.
    For assistance with your electronic application or for more information on the electronic
    submission process, visit Applying Electronically (http://grants.nih.gov/grants/guide /url_
    redirect.htm? id=11144).
    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 it provides on the application
    is the same number used in the organization’s profile in the eRA Commons and for the
    System for Award Management (SAM). Additional information may be found in the
    SF424 (R&R) Application Guide.
    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/
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    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.
    Section V. Application Review Information
    1. Criteria
    Only the review criteria described below will be considered in the review process. As part of the
    CDC 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.
    Overall Impact
    Reviewers will provide an overall impact/priority score to reflect their assessment of the
    likelihood for the project to exert a sustained, powerful influence on the research field(s)
    involved, in consideration of the following review criteria and additional review criteria (as
    applicable for the project proposed).
    Scored Review Criteria
    Reviewers will consider each of the review criteria below in the determination of scientific
    merit and give a separate score for each. An application does not need to be strong in all
    categories to be judged likely to have major scientific impact. For example, a project that by its
    nature is not innovative may be essential to advance a field.
    Significance
    Does the project address an important problem or a critical barrier to progress in the field? If the
    aims of the project are achieved, how will scientific knowledge, technical capability, and/or
    clinical practice be improved? How will successful completion of the aims change the concepts,
    methods, technologies, treatments, services, or preventative interventions that drive this field?
    Does the project address the burden (including preliminary data when available), need, and
    impact of the occupational exposures and hazards that are the focus of the proposed research?
    Does the applicant fully justify and provide data to describe the burden of the problem(s) being
    addressed? Is the project likely to have an impact in meeting local, regional or national
    occupational safety and health needs through effective research, intervention, translation,
    outreach, education, or partnership activities? Are appropriate impacts identified?
    In addition, for applications proposing clinical trials:
    Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or
    intervention well-supported by preliminary data, clinical and/or preclinical studies, or
    information in the literature or knowledge of biological mechanisms? For trials focusing on
    clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy
    or effectiveness of an intervention that could lead to a change in clinical practice, community
    behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological,
    biochemical, or other biomedical endpoints, is this trial needed to advance scientific
    understanding?
    Investigator(s)
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    Are the PD/PIs, collaborators, and other researchers well suited to the project? Have they
    demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the
    project is collaborative or multi-PD/PI, do the investigators have complementary and integrated
    expertise; are their leadership approach, governance and organizational structure appropriate for
    the project?
    In addition, for applications proposing clinical trials:
    With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have
    the expertise, experience, and ability to organize, manage and implement the proposed clinical
    trial and meet milestones and timelines? Do they have appropriate expertise in study
    coordination, data management and statistics? For a multicenter trial, is the organizational
    structure appropriate and does the application identify a core of potential center investigators
    and staffing for a coordinating center?
    Innovation
    Does the application challenge and seek to shift current research or clinical practice paradigms
    by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or
    interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions
    novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new
    application of theoretical concepts, approaches or methodologies, instrumentation, or
    interventions proposed?
    In addition, for applications proposing clinical trials:
    Does the design/research plan include innovative elements, as appropriate, that enhance its
    sensitivity, potential for information or potential to advance scientific knowledge or clinical
    practice?
    Approach
    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to
    accomplish the specific aims of the project? Are potential problems, alternative strategies, and
    benchmarks for success presented? If the project is in the early stages of development, will the
    strategy establish feasibility, and will particularly risky aspects be managed?
    If the project involves 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
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    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?
    Environment
    Will the scientific environment in which the work will be done contribute to the probability of
    success? Are the institutional support, equipment and other physical resources available to the
    investigators adequate for the project proposed? Will the project benefit from unique features of
    the scientific environment, subject populations, or collaborative arrangements?
    In addition, for applications proposing clinical trials:
    If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers,
    appropriate for the trial proposed? Does the application adequately address the capability and
    ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop
    enrollment centers, as needed, appropriate?
    If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll
    the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in using secure,
    accurate, and timely methods; and (4) operate within the proposed organizational structure?
    2. Additional Review Criteria
    As applicable for the project proposed, reviewers will evaluate the following additional items
    while determining scientific and technical merit, and in providing an overall impact/priority
    score, but will not give separate scores for these items.
    Protections for Human Subjects
    If the research involves human subjects but does not involve one of the six categories of research
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    that are exempt under 45 CFR Part 46, the committee will evaluate the justification for
    involvement of human subjects and the proposed protections from research risk relating to their
    participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of
    protection against risks, 3) potential benefits to the subjects and others, 4) importance of the
    knowledge to be gained, and 5) data and safety monitoring for clinical trials.
    For research that involves human subjects and meets the criteria for one or more of the six
    categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the
    justification for the exemption, 2) human subjects involvement and characteristics, and 3)
    sources of materials. For additional information on review of the Human Subjects section, please
    refer to the HHS/CDC Requirements under AR-1 Human Subjects Requirements
    (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.
    Inclusion of Women, Minorities, and Children
    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).
    Vertebrate Animals
    The committee will evaluate the involvement of live vertebrate animals as part of the scientific
    assessment according to the following four points: 1) proposed use of the animals, and species,
    strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the
    appropriateness of the species and numbers proposed; 3) procedures for limiting discomfort,
    distress, pain and injury to that which is unavoidable in the conduct of scientifically sound
    research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable
    restraining devices; and 4) methods of euthanasia and reason for selection if not consistent with
    the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate
    Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section
    (https://grants.nih.gov/grants/olaw/VASchecklist.pdf).
    Biohazards
    Reviewers will assess whether materials or procedures proposed are potentially hazardous to
    research personnel and/or the environment, and if needed, determine whether adequate
    protection is proposed.
    Dual Use Research of Concern
    Reviewers will identify whether the project involves one of the agents or toxins described in the
    US Government Policy for the Institutional Oversight of Life Sciences Dual Use Research of
    Concern, and, if so, whether the applicant has identified an IRE to assess the project
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    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.
    3. Additional Review Considerations
    As applicable for the project proposed, reviewers will consider each of the following items, but
    will not give scores for these items, and should not consider them in providing an overall
    impact/priority score.
    Resubmissions
    For Resubmissions, the committee will evaluate the application as now presented, taking into
    consideration the responses to comments from the previous scientific review group and changes
    made to the project.
    Renewals
    For Renewals, the committee will consider the progress made in the last funding period. Is there
    sufficient information provided describing how the research has achieved the goals of the
    previous funding period? Is there sufficient information on how the goals for future years build
    on the previous successes? Does the applicant describe and provide evidence of outcomes and
    impacts achieved?
    Revisions
    For Revisions, the committee will consider the appropriateness of the proposed expansion of the
    scope of the project. If the Revision application relates to a specific line of investigation
    presented in the original application that was not recommended for approval by the committee,
    then the committee will consider whether the responses to comments from the previous scientific
    review group are adequate and whether substantial changes are clearly evident.
    Research to Practice
    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.
    Applications from Foreign Organizations
    N/A
    Resource Sharing Plan(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
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    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; and
     Plans for archiving and long-term preservation of the data, or explaining why long-term
    preservation and access are not justified (this section should address archiving and
    preservation of identifiable and de-identified data).
    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, http://www.usgs.gov//products/data-and-
    tools/data-management/data-management-plans
    Budget and Period of Support
    Reviewers will consider whether the budget and the requested period of support are fully
    justified and reasonable in relation to the proposed research. The applicant can obtain guidance
    for completing a detailed justified budget on the CDC website, at the following Internet
    address: http://www.cdc.gov/grants/interestedinapplying/application-resources.html
    The budget can include both direct costs and indirect costs as allowed.
    Indirect costs could include the cost of collecting, managing, sharing and preserving data.
    Indirect costs on grants awarded to foreign organizations and foreign public entities and
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    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.
    4. Review and Selection Process
    Applications will be evaluated for scientific and technical merit by an appropriate peer review
    group, in accordance with CDC peer review policy and procedures, using the stated review
    criteria.
    As part of the scientific peer review, all applications:
     Will receive a written critique.
    Applications will be assigned to the appropriate HHS/CDC Center, Institute, or Office.
    Applications will compete for available funds with all other recommended applications
    submitted in response to this NOFO. Following initial peer review, recommended applications
    will receive a second level of review. The following will be considered in making funding
    recommendations:
     Scientific and technical merit of the proposed project as determined by scientific peer
    review.
     Availability of funds.
     Relevance of the proposed project to program priorities.
     Relevance of the proposed research to program priorities as outlined by 46 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.
     Adequacy of resource-sharing plan.
    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
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    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:
    (1) Financial stability;
    (2) Quality of management systems and ability to meet the management standards prescribed in
    this part;
    (3) 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;
    (4) Reports and findings from audits performed under 45 CFR Part 75, subpart F, or the reports
    and findings of any other available audits; and
    (5) 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.
    5. Anticipated Announcement and Award Dates
    After the peer review of the application is completed, the PD/PI will be able to access his or her
    Summary Statement (written critique) and other pertinent information via the eRA Commons.
    Section VI. Award Administration Information
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    1. Award Notices
    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).
    PLEASE NOTE: Effective April 4, 2022, 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.11. 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.
    2. CDC Administrative Requirements
    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-11: Healthy People 2030
    AR-12: Lobbying Restrictions
    AR-13: Prohibition on Use of CDC Funds for Certain Gun Control Activities
    AR-14: Accounting System Requirements
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    AR-16: Security Clearance Requirement
    AR-21: Small, Minority, And Women-owned Business
    AR-22: Research Integrity
    AR-24: Health Insurance Portability and Accountability Act Requirements
    AR-25: Data Management and Access
    AR-26: National Historic Preservation Act of 1966
    AR-28: Inclusion of Persons Under the Age of 21 in Research
    AR-29: Compliance with EO13513, “Federal Leadership on Reducing Text Messaging while
    Driving”, October 1, 2009
    AR-30: Information Letter 10-006, - Compliance with Section 508 of the Rehabilitation Act of
    1973
    AR-31: Research Definition
    AR-32: Appropriations Act, General Provisions
    AR-33: United States Government Policy for Institutional Oversight of Life Sciences Dual Use
    Research of Concern
    AR-36: Certificates of Confidentiality
    AR-37: Prohibition on certain telecommunications and surveillance services or equipment for all
    awards issued on or after August 13, 2020
    Organization Specific ARs:
    AR-8: Public Health System Reporting Requirements
    AR-15: Proof of Non-profit Status
    AR 23: Compliance with 45 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.
    To view brief descriptions of relevant CDC requirements,
    visit: https://www.cdc.gov/grants/additionalrequirements/index.html.
    3. Additional Policy Requirements
    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
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    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.
    HHS Policy on Promoting Efficient Spending: Use of Appropriated Funds for Conferences
    and Meetings, Food, Promotional Items and Printing Publications This policy supports the
    Executive Order on Promoting Efficient Spending (EO 13589), the Executive Order on
    Delivering and Efficient, Effective, and Accountable Government (EO 13576) and the Office of
    Management and Budget Memorandum on Eliminating Excess Conference Spending and
    Promoting Efficiency in Government (M-35-11). This policy applies to all new obligations and
    all funds appropriated by Congress. For more information, visit the HHS website
    at: https://www.hhs.gov/grants/contracts/contract-policies-regulations/efficient-
    spending/index.html.
    Federal Funding Accountability and Transparency Act of 2006 Federal Funding
    Accountability and Transparency Act of 2006 (FFATA), P.L. 109–282, as amended by section
    6202 of P.L. 110–252, requires full disclosure of all entities and organizations receiving Federal
    funds including grants, contracts, loans and other assistance and payments through a single,
    publicly accessible website, 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"
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    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,
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    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
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    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.
    4. Cooperative Agreement Terms and Conditions
    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
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     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.
    5. Reporting
    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.
    A final progress report, invention statement, equipment inventory list and the expenditure data
    portion of the Federal Financial Report are required for closeout of an award, as described in the
    HHS Grants Policy Statement.
    Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards
    pursuant to this funding opportunity depend upon the availability of funds, evidence of
    satisfactory progress by the recipient (as documented in required reports) and the determination
    that continued funding is in the best interest of the Federal government.
    The Federal Funding Accountability and Transparency Act of 2006
    (Transparency Act), includes a requirement for 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
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    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).
    A. Submission of Reports
    The Recipient Organization must submit:
    1. 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_instr
    uction_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.
    2. Annual Federal Financial Report (FFR) SF 425 (Reporting | Grants | CDC ) is
    required and must be submitted to the Payment Management System accessed through
    the FFR navigation link in eRA Commons or directly through PMS within 90 days after
    the budget period ends.
    3. A final progress report, invention statement, equipment/inventory report, and the final
    FFR are required 90 days after the end of the period of performance.
    B. Content of Reports
    1. 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
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    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).
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     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:
    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.
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    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.
    2. 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 budget period. 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.
    Additional resources on the Payment Management System (PMS) can be found at
    https://pms.psc.gov.
    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 period of performance. 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).
    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.
    3. Final Reports: Final reports should provide sufficient detail for CDC to determine if the
    stated outcomes for the funded research have been achieved and if the research findings resulted
    in public health impact based on the investment. The grantee's final report should include:
     Research Aim/Project Overview: The PI should describe the purpose and approach to the
    project, including the outcomes, methodology and related analyses. Include a discussion
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    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.
    6. 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; or
    (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.
    Page 48 of 51

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    7. Reporting of Foreign Taxes (International/Foreign projects only)
    A. Valued Added Tax (VAT) and Customs Duties – Customs and import duties, consular fees,
    customs surtax, valued added taxes, and other related charges are hereby authorized as an
    allowable cost for costs incurred for non-host governmental entities operating where no
    applicable tax exemption exists. This waiver does not apply to countries where a bilateral
    agreement (or similar legal document) is already in place providing applicable tax exemptions
    and it is not applicable to Ministries of Health. Successful applicants will receive information on
    VAT requirements via their Notice of Award.
    B. The U.S. Department of State requires that agencies collect and report information on the
    amount of taxes assessed, reimbursed and not reimbursed by a foreign government against
    commodities financed with funds appropriated by the U.S. Department of State, Foreign
    Operations and Related Programs Appropriations Act (SFOAA) (“United States foreign
    assistance funds”). Outlined below are the specifics of this requirement:
    1) Annual Report: The recipient must submit a report on or before November 16 for each foreign
    country on the amount of foreign taxes charged, as of September 30 of the same year, by a
    foreign government on commodity purchase transactions valued at 500 USD or more financed
    with United States foreign assistance funds under this grant during the prior United States fiscal
    year (October 1 – September 30), and the amount reimbursed and unreimbursed by the foreign
    government. [Reports are required even if the recipient did not pay any taxes during the reporting
    period.]
    2) Quarterly Report: The recipient must quarterly submit a report on the amount of foreign taxes
    charged by a foreign government on commodity purchase transactions valued at 500 USD or
    more financed with United States foreign assistance funds under this grant. This report shall be
    submitted no later than two weeks following the end of each quarter: April 15, July 15, October
    15 and January 15.
    3) Terms: For purposes of this clause:
    “Commodity” means any material, article, supplies, goods, or equipment;
    “Foreign government” includes any foreign government entity;
    “Foreign taxes” means value-added taxes and custom duties assessed by a foreign government
    on a commodity. It does not include foreign sales taxes.
    4) Where: Submit the reports to the Director and Deputy Director of the CDC office in the
    country(ies) in which you are carrying out the activities associated with this cooperative
    agreement. In countries where there is no CDC office, send reports to VATreporting@cdc.gov.
    5) Contents of Reports: The reports must contain:
    a. recipient name;
    b. contact name with phone, fax, and e-mail;
    c. agreement number(s) if reporting by agreement(s);
    d. reporting period;
    e. amount of foreign taxes assessed by each foreign government;
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